chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: left leg I have like almost tingling; left leg I have like almost tingling and (numbness) things; This is a spontaneous report from a contactable consumer (Patient). An unspecified age and gender patient received bnt162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 29Jul2021 into left arm as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date Jul2021, the patient experienced left leg have like almost tingling and (numbness) things.The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: Tingly sensation on right leg; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 25-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09May2021 17:15 (Batch/Lot Number: EW0177) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. It was reported that 24May2021, patient experienced tingly sensation on right leg. Would not want to walk at times. Regarding reaction stop date it was mentioned as it was not a regular thing anymore. It was every now and then. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Jan2021. Outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Syringe issue, Underdose, Vaccination site extravasation
Clinical narrative: While I was administering the vaccine, some of it leaked from the syringe. So, I had the needle into the muscle the same time the syringe leaked from the site; While I was injecting it to the patient it leaked at the same time from the site.; While I was administering the vaccine, some of it leaked from the syringe; It was not fully administered.; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0196 (not clarified appropriately), NDC number, UPC number, expiry date was reported as unknown) via an unspecified route of administration on 31Jul2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that while injecting the vaccine with the needle into the muscle, some of it leaked from the syringe at the same time from the site. The vaccine was not fully administered to the patient. The reporter wanted to know what to be done in the situation. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Patient has been tired; Patient don't have more energy; This is a spontaneous report from a contactable consumer (reported for himself). An 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0175/Batch number was not reported), dose 1 via an unspecified route of administration, administered in deltoid left on 25Jul2021 (at the age of 80-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the consumer stated patient has been tired, and patient don't have more energy. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, SARS-CoV-2 test, Vaccination site bruising
Clinical narrative: hand has also weakened.; bruise the day after. It is currently a week exactly and the bruise has gotten worse. Its a bruise surrounding the injection point; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Jul2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Jul2021, the patient experienced bruise the day after receiving the vaccine, after a week the bruise gotten worse. It's a bruise surrounding the injection point and her hand was also weakened. The event resulted in doctor or other healthcare professional office/clinic visit. On an unknown date in Jul2021, the patient underwent nasal swab, SARS CoV-2 test and the result was not unknown (not reported). Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events hand has weakened and vaccination site bruise was not resolved at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: She got pain in left hip bone; This is a spontaneous report from a contactable pharmacist. A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FA74E4), via an unspecified route of administration in arm left on an unspecified date as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. It was reported that, when probed for concern, stated that, the reporter was a pharmacist from # pharmacy. Stated that, a young lady was there, she just got the second dose of the Pfizer and 2 minutes after getting the second dose, she felt pain in the left hip bone and she got the shot left shoulder. She was walking and the pain in not preventing her to walk normally and the mom said her daughter was having the pain. We don't know what it was. Stated that, she has never had any issue, any medical conditions. She wanted to speak to you guys to see whether it was a side effect that happen for this patient and what do you recommend we do. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: She is having some headache; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical and concomitant medications were not reported. The patient experienced she is having some headache on 2021. Reporter wanted to know her daughter can receive Tylenol or not for the event. The outcome of the event headache was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Nightmare
Clinical narrative: Got kind of sick, first one was the worst one; Nightmares; This is a spontaneous report received from a contactable consumer. This male consumer (patient) reported.  A 68-year-old male patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 23Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history includes asthma from an unspecified date and unknown ongoing and concomitant medications includes Salbutamol [ALBUTEROL].  On an unspecified date, after the vaccination, the patient experienced nightmares and Got kind of sick, first one was the worst one. The events assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (23Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dystonia
Clinical narrative: Dystonia; This is a spontaneous report from a contactable consumer (patient).   A 21-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02May2021 (Lot Number: EW0170) as single dose (at the age of 21-years-old) for COVID-19 immunization. The patient's 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 12Apr2021 (Lot Number: EW0151) as single dose (at the age of 21-years-old) for COVID-19 immunization. He also received the Pneumococcal vaccine in 2020 (Further clarification unknow, suspect captured as per Verbatim) for immunization and experienced swelling up of the arm and high fever. The patient experienced dystonia on 03May2021. The patient stated, "I was just trying to find out information about people having a weird side effect with the second vaccine. About a couple of months ago I was administered to the hospital, they say a weird side effect dystonia that's what they called it? Which in general was basically the body no longer responding to inputs from brain and just a causing like major weird muscular effect were similar to cramps it set up all around body so you can't step in the board and that was exact and I was waiting to see if I was going to have it again in case it wasn't the Pfizer vaccine but over the course of three months (Further clarification unknown) and for long its been and had the vaccine the second one I haven't had any effects from it. I haven't had no other signs of 'handback' (Further clarification unknown) issue so I feel like it might be the vaccine." The patient was hospitalized for dystonia from 03May2021 to 03May2021. The outcome of the event was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dysarthria, Hemiplegia, Speech disorder
Clinical narrative: stroke after taking your two vaccine shots for covid; right side is totally paralyzed; speech is slurred; very hard to even talk; This is a spontaneous report from contactable consumer (patient, self-reporting). A 79-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown; Expiry Date: Unknown), dose 2 via an unspecified route of administration in 2021 (at the age of 79-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown; Expiry Date: Unknown) dose 1 via an unspecified route of administration on 13May2021 as single dose for COVID-19 immunisation. The patient did not know about receive any vaccines within four weeks prior to the vaccination. Consumer sated, first vaccine date was 13May. In 2021, the patient had a stroke after taking two vaccine shots for Covid. Consumer further stated, he wanted to talk about, his right side was totally paralyzed. He had such, speech was slurred and he truly, he was only supported by disability and all his money was gone, he cannot get any bathtub or toilet in the house and his home therapists was running out of insurance and he need help. Consumer stated, he had a stroke, he was not a doctor. This was hard for him; it was very hard to even talk. Consumer stated, he did not remember start date of event, it was just a couple of weeks after he took the shot. He did not like giving his medical history. He was explaining that he got a stroke. Now, he had got all kinds of stroke medicines, he was taking (not clarified further). Consumer stated, He had a lot of lab tests, but he did not know what they were. He had been in a hospital, 8 weeks. He did not need to get on case book, this was ridiculous. He did not question for the stroke. Consumer stated, He did not remember anatomical site of administration, He thought it was in his left but he was not sure. Reporter seriousness for events was unspecified. Outcome of all events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Develop sort of a rash all over his body; Body is break out all over; This is a spontaneous report from a contactable consumer (patient's wife). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 17Jul2021 (Batch/Lot Number: EW0198) (at age 45-years-old) as dose 1, single for covid-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 27July2021, it's like 9-10 days after, patient developed sort of a rash all over his body. Reporter was calling to see if this could be associated with the vaccine because that never happened to him before and reporter was reading about the vaccine rash but don't know if it's applicable because it was like 9 or 10 days after the first shot. The patient was received Benadryl and a lot of cream because his body was break out all over. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Tooth disorder
Clinical narrative: I just notice my teeth gotten to rot after my second shot but I also haven't brush in two years; I just feel like ever since I got the vaccine my life is actually gone down hell; I just feel like ever since I got the vaccine my life is actually gone down hell; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 56-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included none. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 administered on an unspecified date for COVID-19 immunization. On an unspecified date the patient just noticed patient's teeth gotten to rot after the second shot, but patient also haven't brush in two years; the patient just feels like ever since got the vaccine patient's life was actually gone down hell. Consumer stated, "I just notice my teeth gotten to rot after my second shot, but I also have not brush in two years so, I am not really sure I was just wondering if it is like a co-relation that you aware of. Oh, my teeth just rotted kind of rot, but I also have not brush my teeth in two years; I just feel like ever since I got the vaccine my life is actually gone down hell." The clinical outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow up (23Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Peripheral swelling, Urticaria, Vaccination site mass, Vaccination site rash
Clinical narrative: It was the needle it was "intravenous" (not clarified) I don't know when they bring it in; Left arm is swelled up like a big knot; Developed hives; developed rash  in my left arm where I took the vaccine; huge inflamed lump in my left arm where I took the vaccine; This is a spontaneous report from a contactable consumer. This 69-year-old female consumer(patient) reported for herself.  A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0180, Expiration date: unknown) in left arm on 07Jul2021 at 11:30 am (at the age of 69-year-old) as dose 1, single for COVID-19 immunisation. Medical history of the patient included high Blood Pressure and acid Reflux Disease. Concomitant medication included Bisoprolol for High Blood Pressure and Omeprazole for unspecified indication. On an unspecified date in Jul2021, the patient experienced Left arm is swelled up like a big knot and developed some tube rash, hives and it itches hardly bad, small amount of rash was inside the vaccination area; when broke up with hives it was like broken out on hand and in arm and then huge inflamed lump in my left arm where took the vaccine. Patient reported that" it was the needle it was "intravenous" (not clarified) I don't know when they bring it in" and "I had first dose on 7th July but Pharmacy says they have batches that went bad and have to get new batches of vaccine; I am scheduled to take second vaccine in August on coming Monday".  Patient was concerned if there was any reason for her not to take the vaccine or still it is safe to take the vaccine. It was reported that "Last year I had an extreme itching and adding at the hive make "popular" (not clarified) but it wasn't severe rash and I also use Isopropyl and the antiseptic I put it on that". Treatment was taken as benadryl  and Tylenol then warm compress on arm and used warm compress the arm and it was best thing happened and it helped a lot. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Pneumonia, SARS-CoV-2 antibody test
Clinical narrative: Pneumonia; Tested positive for Covid; Her body is too week right now; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A contactable consumer (husband) reported for wife.  A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8736 and Expiry date: Unknown), via an unspecified route of administration on Arm Left on 11Jul2021 as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pneumonia, her body is too week right now. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 19Jul2021. Treatment included patient went to the hospital 3 times and stayed in the hospital for about week and half second time. Patient developed pneumonia. It was reported that Second dose is schedule today. The reporter (Patient husband) reported that there was little bit of confusion here in the hospital. She was supposed to get second shot today, her doctors told her she has to wait several weeks before she can get another shot because her body was too week right now. The outcome of events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Severe chest pain; This is a spontaneous report from a non-contactable consumer or other non hcp. A 33-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jul2021 at 13:00 (at the age of 33-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced severe chest pain on 31Jul2021 at 14:00. Patient received no other vaccine in four weeks. The event resulted in Emergency room/department or urgent care visit. No treatment was given for the event. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pneumonia, SARS-CoV-2 test
Clinical narrative: Pneumonia; COVID-19; This is a spontaneous report from a contactable consumer reporting for her wife.      A 35-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 11Jul2021 (Batch/Lot Number: ER8736) as single dose  for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced pneumonia on an unspecified date with outcome of unknown. The patient also had covid-19 on 19Jul2021 with outcome of unknown.  The patient was hospitalized because of the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 19Jul2021. It was reported that the patient  went to the hospital 3 times and stayed in the hospital for about week and half the second time. She developed pneumonia.  She was supposed to get second shot today, her doctors told her she has to wait several weeks before she can get another shot because her body is too weak right now.   Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Noticeable fatigue ongoing since the vaccinations; This is a spontaneous report from a contactable nurse, the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249) via an unspecified route of administration in the left arm on 19Jan2021 at 18:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN) and allergy to penicillin. Concomitant medication was not reported. The patient previously received naproxen (NAPROSYN) on an unknown date taken for unknown indication and experienced drug allergy. 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 20Jan2021 the patient experienced noticeable fatigue ongoing since the vaccinations. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event noticeable fatigue ongoing since the vaccinations was not recovered at the time of this report.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Chest pain, Electrocardiogram, Gynaecological examination
Clinical narrative: Tense sore chest; Tense sore chest/elbows/knees/shoulders; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 49 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 24May2021 13:15 (Batch/Lot Number: EW0187) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication from an unspecified start date and ongoing; caffeine, paracetamol (EXCEDRIN [CAFFEINE;PARACETAMOL]) taken for an unspecified indication from an unspecified start date and ongoing; diphenhydramine hydrochloride, paracetamol (TYLENOL PM) taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced tense sore chest on 05Jun2021 with outcome of unknown , tense sore chest/elbows/knees/shoulders on 05Jun2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood test, electrocardiogram, gynaecological examination and ultrasound pelvis with unknown results.  Follow-Up (10Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound pelvis
Clinical narrative: Tense sore chest; Tense sore chest/elbows/knees/shoulders; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 49 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 24May2021 13:15 (Batch/Lot Number: EW0187) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication from an unspecified start date and ongoing; caffeine, paracetamol (EXCEDRIN [CAFFEINE;PARACETAMOL]) taken for an unspecified indication from an unspecified start date and ongoing; diphenhydramine hydrochloride, paracetamol (TYLENOL PM) taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced tense sore chest on 05Jun2021 with outcome of unknown , tense sore chest/elbows/knees/shoulders on 05Jun2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood test, electrocardiogram, gynaecological examination and ultrasound pelvis with unknown results.  Follow-Up (10Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature decreased, Dysgeusia, Hypoaesthesia oral, Pain in extremity
Clinical narrative: within 30 seconds of vaccine i had a strong metal taste in my mouth; Lips numb; Very bad pain in left arm; Low grade temp in the evening; Bad pain in shoulder; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: FA7485) in the left arm on 01Aug2021 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergies. Prior to 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 were reported but not specified. On 01Aug2021 within 30 seconds of vaccination, the patient experienced strong metal taste in her mouth, lips were numb and a few hours later, the patient experienced very bad pain in her left arm and shoulder, also a low-grade temperature in the evening. On 01Aug2021, in the evening, the patient underwent lab tests and procedures which included body temperature which was of low grade. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events metal taste in mouth, lips were numb, very bad pain in left arm, bad pain in shoulder and low-grade temperature were recovering at the time of this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: within 30 seconds of vaccine i had a strong metal taste in my mouth; Lips numb; Very bad pain in left arm; Low grade temp in the evening; Bad pain in shoulder; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: FA7485) in the left arm on 01Aug2021 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergies. Prior to 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 were reported but not specified. On 01Aug2021 within 30 seconds of vaccination, the patient experienced strong metal taste in her mouth, lips were numb and a few hours later, the patient experienced very bad pain in her left arm and shoulder, also a low-grade temperature in the evening. On 01Aug2021, in the evening, the patient underwent lab tests and procedures which included body temperature which was of low grade. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events metal taste in mouth, lips were numb, very bad pain in left arm, bad pain in shoulder and low-grade temperature were recovering at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Euphoric mood, Eye disorder, Fear of death, Loss of consciousness
Clinical narrative: Felt very euphoric after getting the vaccine.; Her eyes would barely open and were bothering her; 2 days later she started throwing up and she threw up for 4 days straight.; She passed out for 4 days; I had a horrible reaction. I thought I was dying/She said that she thought she was going to die; 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), dose 1 via an unspecified route of administration on 04May2021 (Batch/Lot Number: EW0175) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took COVID19 Vaccine Pfizer and started suffering issues, she had bad reactions to the vaccine. The patient said that she had the vaccine and felt very euphoric after getting it; she said that they gave her a bottle of water and she stayed at the vaccine location for 20 minutes and felt so good that she actually bought some make up. The patient said that after that she went home and she passed out for 4 days and after she woke up, she said that her eyes would barely open and were bothering her. 2 days later she started throwing up and she threw up for 4 days straight. The patient called her doctor and her doctor told her to drink Gatorade and she did, and felt better. The patient said that she thought she was going to die. It was very frightening and she was very concerned about taking the second dose. It was also reported that "she had a antibody test and she has 50 antibodies and the pharmacist told her it was very high". The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Felt very euphoric after getting the vaccine.; Her eyes would barely open and were bothering her; 2 days later she started throwing up and she threw up for 4 days straight.; She passed out for 4 days; I had a horrible reaction. I thought I was dying/She said that she thought she was going to die; 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), dose 1 via an unspecified route of administration on 04May2021 (Batch/Lot Number: EW0175) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took COVID19 Vaccine Pfizer and started suffering issues, she had bad reactions to the vaccine. The patient said that she had the vaccine and felt very euphoric after getting it; she said that they gave her a bottle of water and she stayed at the vaccine location for 20 minutes and felt so good that she actually bought some make up. The patient said that after that she went home and she passed out for 4 days and after she woke up, she said that her eyes would barely open and were bothering her. 2 days later she started throwing up and she threw up for 4 days straight. The patient called her doctor and her doctor told her to drink Gatorade and she did, and felt better. The patient said that she thought she was going to die. It was very frightening and she was very concerned about taking the second dose. It was also reported that "she had a antibody test and she has 50 antibodies and the pharmacist told her it was very high". The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory syncytial virus infection, Sinusitis
Clinical narrative: diagnosed with 'RSV'; Sinus infection; This is a spontaneous report from a contactable consumer  reporting for himself.    A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jul2021 (Batch/Lot Number: EW0170) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient was  diagnosed with 'RSV' (respiratory syncytial virus infection) on 2021 with outcome of unknown , had a sinus infection on 2021 with outcome of unknown.  The patient was hospitalized because RSV infection.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Left leg soreness; Pins and needles almost feels like restless leg syndrome - like I need to be moving leg around.; 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: EWO217) via an unspecified route of administration in the left arm on 01Aug2021 at 10:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took cefaclor (CECLOR) and experienced a drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Aug2021, the patient experienced left leg soreness, pins and needles which almost felt like restless leg syndrome - like she needed to move her leg around. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left leg soreness, pins and needles which almost felt like restless leg syndrome- like she needed to move her leg around was not resolved at the time of this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash on my abdomen; Scalp and palm were very itchy; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the arm right on 27Jul2021 at 19:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 as prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Jul2021 at 01:30, the patient woke up with a rash on abdomen and her scalp and palms were very itchy. The events resulted in 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 reported events and included treatment with diphenhydramine hydrochloride (BENADRYL) and famotidine (PEPCID) from an unknown date. The clinical outcome of the events rash on abdomen and scalp and palm were very itchy was not resolved at the time of this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, SARS-CoV-2 test negative
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6206, expiry date: unknown) via unspecified route of administration, in right arm on 05Mar2021 12:00 (age at vaccination: 66-years-old) as dose number unknown, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history of patient included heart attacks, gall stones/gall bladder removal, low thyroid on an unspecified date (2 heart attacks, gall stones/gall bladder removal, low thyroid good health altogether). Patient had no known allergies. Concomitant medications included Synthroid and Prasugrel al, (in two weeks) taken for unspecified indication start and stop date not known. No other vaccine in four weeks was administered. On an unspecifed date in Mar2021, patient experienced intermittent diarrhea. It's gotten better, but still patient got it at least every other week. No treatment was given for the adverse event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient underwent lab test for antigen test (nasal swab) with negative results on an unspecified date in Jul2021. The outcome of event was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Feeling hot, Hypoaesthesia, Loss of consciousness
Clinical narrative: passed out in the car; tingling in my hand; pain above my ear followed by a warm sensation from the spot over my ear and into my jaw which became numb just in front of my ear; pain above my ear followed by a warm sensation from the spot over my ear and into my jaw which became numb just in front of my ear; Numbness in jaw persisted for two days; Dizziness; nauseous; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was 8R8731 and expiration date was not reported), via an unspecified route of administration, administered in Right Arm on 12Jul2021 08:30 (at the age of 47-years-old) at dose 1, single for covid-19 immunization. Medical history included known allergies to Penicillin, sulfa, lots of food and chemicals. Concomitant medications included ethinylestradiol, norethisterone acetate (MICROGESTIN); calcium; magnesium; acetylcysteine (NAC); vitamin d nos; vitamin c [ascorbic acid]. Patient was not pregnant. The patient previously took e-mycin [erythromycin], c-flox [ciprofloxacin hydrochloride] and experienced drug allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination and patient was not tested post vaccination. The patient had most recent COVID-19 vaccine at Public Health Clinic/Veterans Administration facility. It was reported that fewminutes after injection patient felt a tingling in hand then a sharp pain above ear followed by a warm sensation from  the spot over her ear and into her jawwhich became numb just in front of her ear. After 35 minutes of waiting, patient left and was dizzy walking out. She became nauseous and passed out in the car. Numbness in jawpersisted for two days. Dizziness came and went for two weeks. The events occurred on 12Jul2021 at 08:30am. The events were resulted in Doctor or other healthcare professional office/clinic visit. No treatment was given for the events. The outcome of the events was recovered.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia
Clinical narrative: passed out in the car; tingling in my hand; pain above my ear followed by a warm sensation from the spot over my ear and into my jaw which became numb just in front of my ear; pain above my ear followed by a warm sensation from the spot over my ear and into my jaw which became numb just in front of my ear; Numbness in jaw persisted for two days; Dizziness; nauseous; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was 8R8731 and expiration date was not reported), via an unspecified route of administration, administered in Right Arm on 12Jul2021 08:30 (at the age of 47-years-old) at dose 1, single for covid-19 immunization. Medical history included known allergies to Penicillin, sulfa, lots of food and chemicals. Concomitant medications included ethinylestradiol, norethisterone acetate (MICROGESTIN); calcium; magnesium; acetylcysteine (NAC); vitamin d nos; vitamin c [ascorbic acid]. Patient was not pregnant. The patient previously took e-mycin [erythromycin], c-flox [ciprofloxacin hydrochloride] and experienced drug allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination and patient was not tested post vaccination. The patient had most recent COVID-19 vaccine at Public Health Clinic/Veterans Administration facility. It was reported that fewminutes after injection patient felt a tingling in hand then a sharp pain above ear followed by a warm sensation from  the spot over her ear and into her jawwhich became numb just in front of her ear. After 35 minutes of waiting, patient left and was dizzy walking out. She became nauseous and passed out in the car. Numbness in jawpersisted for two days. Dizziness came and went for two weeks. The events occurred on 12Jul2021 at 08:30am. The events were resulted in Doctor or other healthcare professional office/clinic visit. No treatment was given for the events. The outcome of the events was recovered.  Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Deep vein thrombosis
Clinical narrative: I had a DVT in leg, then has a stroke 2 months after the DVT.; I had a DVT in leg, then has a stroke 2 months after the DVT.; This is a spontaneous report from a contactable other health care professional (nurse/patient). A 22-years-old non pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EK9231, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 30Dec2020 10:00 as dose 1, single for covid-19 immunization at the hospital. Patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL3249, expiration date unspecified), via an unspecified route of administration, administered in Arm right on an unknown date as dose 2, single for covid-19 immunization at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. Medical history included systemic Diagnosed with lupus from an unknown date, (APLS) antiphospholipid syndrome from an unknown date. The patient's concomitant medications were not reported. On 16Apr2021 01:0, the patient had a DVT in leg (deep vein thrombosis) and on an unknown date 2 months after DVT in leg the patient had a stroke. The patient was hospitalized due to the event for 6 days. The patient was treated with blood thinners during her stay in hospital. The outcome of the events was reported as recovered. No follow-up attempts are possible. No further information is expected. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event Deep vein thrombosis and cerebral vascular accident and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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 and Investigators, as appropriate
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram, Hypoaesthesia, Hypoaesthesia oral, Magnetic resonance imaging
Clinical narrative: having Bell's Palsy symptoms; Her tongue on left side becomes numb; numbness across left side of face, nose and tops of cheek and sometimes like this morning, will go up towards the eye and when it gets severe, get to left side of the upper and lower lips; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration on 26Feb2021 (at the age of 76-year-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Family medical history relevant to AE included none. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in left arm on 05Feb2021 (at the age of 76-year-old) as dose 1, single for covid-19 immunization. On an unspecified date in May2021, the patient experienced having bell's palsy symptoms, her tongue on left side becomes numb which is a funny sensation according to patient, numbness across left side of face, nose and tops of cheek and sometimes like this morning, will go up towards the eye and when it gets severe, get to left side of the upper and lower lips. Patient wanted to know if there had been any case studies like her experience. Patient reported that It's the nose and cheek and travels sporadically to the nose and tongue and then its more forceful and goes up the left eye. The patient underwent lab tests and procedures which included computerized tomogram: found nothing on 04Jul2021, magnetic resonance imaging: found nothing on 04Jul2021. The events resulted in emergency room visit and physician office visit. Therapeutic measures were taken as a result of events. The outcome of the event were not recovered.