chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation irregular, Muscle spasms
Clinical narrative: Moderate menstrual cramps; Back cramps; Early menstrual cycle; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 25-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included latex 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. Concomitant medications included ethinylestradiol; levonorgestrel (SETLAKIN) for unspecified indication from an unknown date. On an unknown date, the patient experienced moderate menstrual cramps, back cramps and early menstrual cycle. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event moderate menstrual cramps, back cramps and early menstrual cycle was unknown 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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported for a Physician. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown, expiry date: unknown) via intramuscular route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. It was unknown whether prior to vaccination, the patient diagnosed with COVID-19, and whether since the vaccination, the patient been tested for COVID-19. On an unspecified date, patient was tested positive for COVID. Doctor or other healthcare professional office/clinic visit took place due to the adverse events. The patient underwent lab test for SARS-CoV-2, with results as positive on an unspecified date. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain, Palpitations
Clinical narrative: Heart palpitations for 3 days; Muscle weakness; Shooting pain along whole right side; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Aug2021 at 17:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Aug2021 at 08:00, the patient experienced heart palpations for 3 days, muscle weakness and shooting pain along the whole right side which was ongoing at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event heart palpations was resolved on 06Aug2021 and muscle weakness and shooting pain along whole right side were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: A person who was fully vaccinated and caught covid.; A person who was fully vaccinated and caught covid.; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received and first dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single and second dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single both for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reported Event that video (link content) shows a person who was fully vaccinated and caught covid. I am unsure of the type of vaccine received. The video explains progression of symptoms. On an unspecified date, the patient experienced a person who was fully vaccinated and caught covid. No seriousness criteria were reported. The patient underwent lab tests and procedures which included sars-cov-2 test: which resulted as covid post vaccination. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Off label use, Product use issue, Therapeutic response unexpected
Clinical narrative: I am breastfeeding; I am breastfeeding; I received the vaccine Friday evening and continued to pump regularly since then and within 36 hours got my period; I received the vaccine Friday evening and continued to pump regularly since then and within 36 hours got my period; This is a spontaneous report from a contactable consumer (patient herself). A 37-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 06Aug2021 18:00 (at age of as 37-years-old) DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient's medical history and concomitant medications were not reported. Patient had not known allergies. Other medical history was reported as None. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that, on 08Aug2021 14:45 the patient was breastfeeding and she had been for 8 months and have not had menstrual cycle this whole time. Patient received the vaccine Friday evening and continued to pump regularly since then and within 36 hours got period. Patient did not receive any treatment for AEs. Since the vaccination, the patient had not been tested for COVID-19. Outcome of event I received the vaccine Friday evening and continued to pump regularly since then and within 36 hours got my period was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101015626 maternal case/Child case
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Ear pain, Migraine, Nausea
Clinical narrative: Inner ear pain; ringing in ears; migraine; Jaw pain; ear pressure; dizziness; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 (at the age of 35-years-old) as a single dose and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 12May2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included magnesium oxide (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), vitamin d (MANUFACTURER UNKNOWN) and riboflavin (VITAMIN B2). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021 the patient experienced inner ear pain, ringing in ears, migraine, jaw pain, ear pressure, dizziness and nausea. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with balance therapy (unspecified). The clinical outcome of the event inner ear pain, ringing in ears, migraine, jaw pain, ear pressure, dizziness and nausea was not resolved at the time of report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Tinnitus
Clinical narrative: Inner ear pain; ringing in ears; migraine; Jaw pain; ear pressure; dizziness; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 (at the age of 35-years-old) as a single dose and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 12May2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included magnesium oxide (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), vitamin d (MANUFACTURER UNKNOWN) and riboflavin (VITAMIN B2). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021 the patient experienced inner ear pain, ringing in ears, migraine, jaw pain, ear pressure, dizziness and nausea. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with balance therapy (unspecified). The clinical outcome of the event inner ear pain, ringing in ears, migraine, jaw pain, ear pressure, dizziness and nausea was not resolved at the time of report.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pulmonary thrombosis, Ultrasound scan
Clinical narrative: Three blood clots in lungs; one close to heart; Pain in lower leg that intensified and travelled up leg with swelling; Pain in lower leg that intensified and travelled up leg with swelling; This is a spontaneous report from a non-contactable consumer reported for a patient. A 57-years-old female patient received second 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 at an unspecified anatomical location on 02May2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient did not have any medical history, no other medical conditions or medications. The patient's concomitant medications were not reported. The patient previously 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 at an unspecified anatomical location on 03Apr2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization and had no reaction on previous exposure to vaccine. On an unspecified date in 2021, the patient experienced pain in lower leg that intensified and travelled up leg with swelling and three blood clots in lungs, one close to heart. The patient was hospitalized for the events on an unspecified date. The patient underwent lab test which included Sonogram: unknown results on an unspecified date. The caller stated that she was a Pfizer Employee calling about the COVID vaccine. Stated that she spoke with a friend about her friend's sister in law's serious reaction after the vaccine. Stated that the patient ended up with three blood clots in both of her lungs. The caller stated that she learned of these events that morning. The caller stated that a week after the second dose of the COVID vaccine the patient developed pain in her lower leg. The caller was not sure which leg. Stated that the pain intensified and started travelling up the leg with swelling in the leg. The patient went to the doctor who did a sonogram and then sent the patient to the hospital. The patient was hospitalized, dates unknown by the caller, for 3 clots in both of her lungs and one of them being close to the patient's heart. The caller stated that the patient was now under the care of a hematologist, the caller did not know the name of the hematologist. The outcome of the events was not resolved.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast tenderness, Nipple pain
Clinical narrative: Left breast hurts; Underneath the nipple its been sore; Breast tender to touch or if  move arm; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 03Aug2021 at 14:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included thyroid (ARMOUR THYROID) from an unknown date for thyroid disorder and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 04Aug2021 at 05:00, the patient experienced left breast hurts. Underneath the nipple it been sore and tender to touch or if she moved her arm. It was started the very next day and had not gotten better. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of event left breast hurt, underneath the nipple it been sore and breast tender to touch or if move arm was not resolved at the time of this report.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nasal congestion, Pyrexia, Vaccination site pain
Clinical narrative: Chills; Fever; Nasal congestion; Headache; Soreness at site of injection; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 05Aug2021 at 12:45 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. 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. On 06Aug2021 at 07:00, the patient experienced chills, fever, nasal congestion, headache and soreness at site of injection. 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 not been tested for COVID-19. The clinical outcome of the events chills, fever, nasal congestion, headache and soreness at site of injection were not resolved at the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypersensitivity, Nausea, Pharyngeal swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) reported that a 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in arm right on 02Aug2021 16:30 (at the age of 50-years-old) as dose 1, single for covid-19 immunisation. The vaccine was administered at the Pharmacy/drugstore. The patient medical history included breast cancer (TNBC), asthma, seizures, sinus, allergies, and chronic bronchitis. Concomitant medications included colecalciferol (VIT D [COLECALCIFEROL]); propranolol taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; and pantoprazole; all were taken for an unspecified indication, start and stop date were not reported. The patient previously took Neosporin, and experienced allergy. On 03Aug2021, throat feels very swollen like allergic reaction, and chills, nausea. No treatment was received for the events. The outcome of the events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Body temperature, Chills, Headache, Nasopharyngitis
Clinical narrative: Fever; temperature of 100.4/temperature was 104; Headache; Cold; Chills; acting very weird; Nightmares; This is a spontaneous report from a contactable consumer. This consumer reported for a 12-year-old male patient (reporter's son). A 12-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0173) via an unspecified route of administration on 07Aug2021 13:00 as dose 2, single (age at Vaccination: 12 years) for COVID-19 immunisation. Medical history included asthma, hypertension, ADHD, all from an unknown date and unknown if ongoing. Concomitant medications included guanfacine hydrochloride (INTUNIV) taken for hypertension, start and stop date were not reported; lisdexamfetamine mesilate (VYVANSE) taken for attention deficit hyperactivity disorder, start and stop date were not reported; albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for asthma, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The reporter stated, I am calling on behalf of my son (consumer), he received his second shot at 1 o'clock in the afternoon. On 07Aug2021, the patient experienced acting very weird he had a temperature of 100.4 and he was complaining of headache, cold, chills and like nightmares. When queried for consumers height and weight reporter stated, he is about 3 something, dont know. He had got high fever, I just want to know what is going on with him. All I want to know that if he was sick, I mean the temperature was 100, I want to speak to a Doctor what is going on and what do I need to do, do I need to bring him in. Treatment received was Tylenol as his temperature was 104. The patient underwent lab tests and procedures which included body temperature resulted as 100.4/100/104 on 07Aug2021. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Nightmare, Pyrexia
Clinical narrative: Fever; temperature of 100.4/temperature was 104; Headache; Cold; Chills; acting very weird; Nightmares; This is a spontaneous report from a contactable consumer. This consumer reported for a 12-year-old male patient (reporter's son). A 12-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0173) via an unspecified route of administration on 07Aug2021 13:00 as dose 2, single (age at Vaccination: 12 years) for COVID-19 immunisation. Medical history included asthma, hypertension, ADHD, all from an unknown date and unknown if ongoing. Concomitant medications included guanfacine hydrochloride (INTUNIV) taken for hypertension, start and stop date were not reported; lisdexamfetamine mesilate (VYVANSE) taken for attention deficit hyperactivity disorder, start and stop date were not reported; albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for asthma, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The reporter stated, I am calling on behalf of my son (consumer), he received his second shot at 1 o'clock in the afternoon. On 07Aug2021, the patient experienced acting very weird he had a temperature of 100.4 and he was complaining of headache, cold, chills and like nightmares. When queried for consumers height and weight reporter stated, he is about 3 something, dont know. He had got high fever, I just want to know what is going on with him. All I want to know that if he was sick, I mean the temperature was 100, I want to speak to a Doctor what is going on and what do I need to do, do I need to bring him in. Treatment received was Tylenol as his temperature was 104. The patient underwent lab tests and procedures which included body temperature resulted as 100.4/100/104 on 07Aug2021. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Limb discomfort
Clinical narrative: pain on the left side of the hip; preventing her from walking; She said felt heavy; This is a spontaneous report from a contactable pharmacist. A 12-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified 2021 the patient experienced pain on the left side of the hip, preventing her from walking, she said felt heavy. The outcome of event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Diarrhoea, Haematochezia, Pyrexia
Clinical narrative: Bloody stools; upset stomach; diarrhea; fever 102; This is a spontaneous report from a contactable consumer (patient). A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, in the left arm on 03Aug2021 at 11:30 (at the age of 13-years-old) as dose number unknown, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug Store. The patient medical history and concomitant medications were not reported. No known allergies. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 03Aug2021 at 17:00, the patient experienced bloody stools, upset stomach, diarrhea and fever 102. Seriousness criteria reported as no. The patient received any treatment for the event was unknown. The patient underwent lab tests and procedures which included body temperature: fever 102 on 03Aug2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Outcome of the events was recovered with sequelae on Aug2021.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest; This is a spontaneous report from a contactable consumer (patient). This 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date at age of 61-years-old as dose 2, single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  Patient reported he received the Covid vaccine and defibrillator fired 7x's and he was life lined. After second dose Covid vaccine patient was cardioverted and following second dose Covid vaccine, patient had cardiac arrest. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Illness, Vision blurred
Clinical narrative: I cannot see; Blurred vision; I am sick; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FA7485 and expiry date was not reported), via an unspecified route of administration, on 05Aug2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she did not feel well after this vaccine. She should never done it. She did not want it; now she was sick, and she cannot see, everything was blurry on an unspecified date in Aug2021. She was not doing too well and concerned about her vision. She wanted to go to hospital. Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac flutter, Fatigue, Heart rate increased, Pain, Pyrexia
Clinical narrative: Heart is fluttering, I am having a fast Heartbeat; I got my first dose vaccine, it was painful; I had a slight fever from 99.7 then it went down to 99.4 and now it is still 99.2; I have been very tired and  I started feeling more exhausted; I am having a fast Heartbeat; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: EY0584), dose 1 via an unspecified route of administration on 01Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported that my heart was fluttering, I was having a fast heartbeat, I got my first dose vaccine, it was painful, I had a slight fever from 99.7 then it went down to 99.4 and now it was still 99.2, I had been very tired and  I started feeling more exhausted, I am having a fast heartbeat. Consumer stated that, I got my first dose of Pfizer vaccine on 01Aug2021 (this past sunday) and it was painful but very normal but it went away but I have been very tired since then. This afternoon I am running a fever, I had a slight fever from 99.7 then it went down to 99.4 and now it is still 99.2 and I have been really tired. This was just my first shot of the Pfizer vaccine I mean 4 days ago. Is this was something that I need to be concerned. I had been experiencing my heart is fluttering, my hear flutters. I was having a fast heartbeat and I had been very tired since then. The events outcome was unknown.  Follow-ups attempts completed.  No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: her fogginess dissipated, things became clearer; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for COVID-19 immunization. Medical history included depression and anxiety from an unknown date and unknown if ongoing. She just got the Pfizer COVID vaccine, and she wanted to report something to Pfizer. She states she suffers from depression and anxiety, and one of the things that happens to her is that she gets befuddled- things get very foggy and don't seem straight, she gets in a big rut. She does take other drugs for it that she has been on for a couple of years. She went to get the first dose of her COVID-19 vaccine and did the 15-20 minutes of being monitored. She could taste the vaccine as soon as she got it. When she was waiting her 15-20 minutes to be monitored for any immediate side effects, the caller states things started to become clearer. When she went home and the next few days afterwards, her fogginess dissipated. She became clearer, she remembered things. She made lists and remembered them. This lasted for almost 3 weeks, maybe 2.5 weeks. She went and got her second shot and she could taste it almost immediately. She did her 15-20 minutes of waiting. She got home and she got clear again. It has been such a long time since she felt this way and she was so excited. She didn't want it to go away. She thought to herself should she get another shot. She clarifies further after the first shot, she became clear and this dissipated within 2.5-3 weeks. After the second shot, she became clear again. She became so much clearer. She clarifies what she means by clearer is that she was not sitting around lost in herself. She was not depressed. She wanted to get up and do things. She still remembers a lot. She was not sitting around lost in herself, she was not depressed; wanted to get up and do things. Outcome of the event was unknown.  Information on lot/batch has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chronic obstructive pulmonary disease, Pneumonia, Therapeutic response unexpected
Clinical narrative: recently diagnosed with COPD and Pneumonia; recently diagnosed with COPD and Pneumonia; She mentions she doesn't have a ton of energy; She got home and she got clear again/she means by clearer is that she was not sitting around lost in herself. She was not depressed; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left in 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included depression and anxiety, states that one of the things that happen to her is that she gets befuddled- things get very foggy and don't seem straight, she gets in a big rut. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 (at the age of 63- years) for Covid-19 immunization and her fogginess dissipated, things became clearer. In 2021, the patient went and got her second shot. She could taste it almost immediately. She did her 15-20 minutes of waiting. She got home and she got clear again. It has been such a long time since she felt this way and she was so excited. She didn't want it to go away. She thought to herself should she get another shot. She clarifies after the second shot, she became clear again (2021). She became so much clearer. She clarifies what she means by clearer is that she was not sitting around lost in herself. She was not depressed. She wanted to get up and do things. She still remembers a lot. She mentions she doesn't have a ton of energy right now (Jul2021) because she was recently diagnosed with COPD and Pneumonia, so her energy is a low because she is not getting a lot of oxygen. She confirms that COPD and pneumonia were diagnosed on 20Jul2021, but she doesn't believe it has anything to do with the COVID shot. The events resulted in emergency room visit. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nervousness
Clinical narrative: patient was on a stretcher and they reassured her not to worry and that some people get nervous when they see needles; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The reporter mentioned that she thinks there could be something wrong with the lot of Pfizer COVID vaccine because a lady was pulled out on a stretcher and the nurse said this really doesn't happen often and people were taken out in chairs. The patient was on a stretcher and they reassured her not to worry and that some people get nervous when they see needles. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Fatigue, Headache
Clinical narrative: Chest pains; short of breath; pounding heart beat (even if sitting or laying still); headache; body aches; tightness in chest; extreme fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 30Jul2021 at 14:00 (batch/lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took codeine and experienced allergies. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient has no other medications received within 2 weeks of vaccination. The patient experienced chest pains, short of breath, pounding heart beat (even if sitting or laying still), headache, body aches, tightness in chest, extreme fatigue on 31Jul2021 at 07:00 with outcome of not recovered. The case was assessed as serious. No treatment was received for the adverse events. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations
Clinical narrative: Chest pains; short of breath; pounding heart beat (even if sitting or laying still); headache; body aches; tightness in chest; extreme fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 30Jul2021 at 14:00 (batch/lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took codeine and experienced allergies. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient has no other medications received within 2 weeks of vaccination. The patient experienced chest pains, short of breath, pounding heart beat (even if sitting or laying still), headache, body aches, tightness in chest, extreme fatigue on 31Jul2021 at 07:00 with outcome of not recovered. The case was assessed as serious. No treatment was received for the adverse events. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Jul2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On 06Jul2021, the patient experienced headache every day since 2nd shot. The patient had headache over 30 days. Therapeutic measures were not 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 headache every day since 2nd shot was not resolved at the time of report. The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: Body hurts; Lot of itching on body; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Aug2021 at 09:00 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history included gallbladder and appendix removed and had a biopsy when patient was a year old to check out liver in 1996 (liver biopsy in 1996). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took paracetamol (TYLENOL) for unspecified indication from unknown date and experienced drug allergy. On 07Aug2021 at 12:00, the patient's body hurt and had a lot of itching on body. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not 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 body hurt and lot of itching on body was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Depressed mood, Diarrhoea, Dysphagia, Fatigue
Clinical narrative: laryngitis; cough; sore throat lower throat; swollen lymph nodes in neck both sides; swollen tonsil left side; severe tonsil pain; difficulty swallowing; Sore arm muscle; tiredness; feeling unwell; low mood; diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 52-years-old female patient (Non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in arm Left on 19Jul2021 at 14:30 pm (at the age of 52-years-old, Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. Medical history included menopausal, cervical stenosis spinal cord, pineal gland cyst, degenerative disc disease, past uterine fibroids, hypothyroidism, ovarian cysts all were from an unknown date and unknown if ongoing. Concomitant medication(s) included paracetamol (TYLENOL), melatonin and multivitamin all were taken for an unspecified indication, start and stop date were not reported. The patient previously took Levaquin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 19Jul2021 at 14:30 pm the patient received the first dose of vaccine and on day 2-3 on 20Jul2021 at 04:00 she experienced sore arm muscle, tiredness, feeling unwell, low mood, diarrhea. On day 4-8 on 22Jul2021 she had swollen lymph nodes in neck both sides, swollen tonsil left side, severe tonsil pain, difficulty swallowing. On day 9-14 on 27Jul2021 experienced sore throat lower throat, laryngitis and cough. Patient did not received any treatment to treat the events and was not hospitalized. The patient was recovered from the events of muscle pain, tiredness, feeling unwell, low mood, diarrhea on 21Jul2021, recovered from the events of swollen lymph nodes, swollen tonsils, tonsillitis and swallowing difficult on 26Jul2021 and from the events laryngitis, oropharyngeal pain and cough on 01Aug2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Laryngitis, Lymphadenopathy, Malaise, Myalgia, Oropharyngeal pain
Clinical narrative: laryngitis; cough; sore throat lower throat; swollen lymph nodes in neck both sides; swollen tonsil left side; severe tonsil pain; difficulty swallowing; Sore arm muscle; tiredness; feeling unwell; low mood; diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 52-years-old female patient (Non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in arm Left on 19Jul2021 at 14:30 pm (at the age of 52-years-old, Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. Medical history included menopausal, cervical stenosis spinal cord, pineal gland cyst, degenerative disc disease, past uterine fibroids, hypothyroidism, ovarian cysts all were from an unknown date and unknown if ongoing. Concomitant medication(s) included paracetamol (TYLENOL), melatonin and multivitamin all were taken for an unspecified indication, start and stop date were not reported. The patient previously took Levaquin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 19Jul2021 at 14:30 pm the patient received the first dose of vaccine and on day 2-3 on 20Jul2021 at 04:00 she experienced sore arm muscle, tiredness, feeling unwell, low mood, diarrhea. On day 4-8 on 22Jul2021 she had swollen lymph nodes in neck both sides, swollen tonsil left side, severe tonsil pain, difficulty swallowing. On day 9-14 on 27Jul2021 experienced sore throat lower throat, laryngitis and cough. Patient did not received any treatment to treat the events and was not hospitalized. The patient was recovered from the events of muscle pain, tiredness, feeling unwell, low mood, diarrhea on 21Jul2021, recovered from the events of swollen lymph nodes, swollen tonsils, tonsillitis and swallowing difficult on 26Jul2021 and from the events laryngitis, oropharyngeal pain and cough on 01Aug2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tonsillar hypertrophy
Clinical narrative: laryngitis; cough; sore throat lower throat; swollen lymph nodes in neck both sides; swollen tonsil left side; severe tonsil pain; difficulty swallowing; Sore arm muscle; tiredness; feeling unwell; low mood; diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 52-years-old female patient (Non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in arm Left on 19Jul2021 at 14:30 pm (at the age of 52-years-old, Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. Medical history included menopausal, cervical stenosis spinal cord, pineal gland cyst, degenerative disc disease, past uterine fibroids, hypothyroidism, ovarian cysts all were from an unknown date and unknown if ongoing. Concomitant medication(s) included paracetamol (TYLENOL), melatonin and multivitamin all were taken for an unspecified indication, start and stop date were not reported. The patient previously took Levaquin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 19Jul2021 at 14:30 pm the patient received the first dose of vaccine and on day 2-3 on 20Jul2021 at 04:00 she experienced sore arm muscle, tiredness, feeling unwell, low mood, diarrhea. On day 4-8 on 22Jul2021 she had swollen lymph nodes in neck both sides, swollen tonsil left side, severe tonsil pain, difficulty swallowing. On day 9-14 on 27Jul2021 experienced sore throat lower throat, laryngitis and cough. Patient did not received any treatment to treat the events and was not hospitalized. The patient was recovered from the events of muscle pain, tiredness, feeling unwell, low mood, diarrhea on 21Jul2021, recovered from the events of swollen lymph nodes, swollen tonsils, tonsillitis and swallowing difficult on 26Jul2021 and from the events laryngitis, oropharyngeal pain and cough on 01Aug2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.