chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse food reaction, Fatigue, Headache, Muscular weakness, Pain
Clinical narrative: persistent headaches for more than 2 weeks; muscle weakness; easy tiredness; ligament and body aches; After the second dose of vaccine patient felt like as she ingested a barrel of soy, she had all the symptoms of her sensitivities; This is a spontaneous report from a contactable female consumer (Patient) reported for herself. A 53-year-old non-pregnant female patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Batch/Lot number: EW 0170), via an unspecified route of administration on 09May2021 (age at vaccination: 53-year-old), as a single dose for COVID-19 immunization. Medical history included pretty bad food sensitivities for dairy and soy which make her body hurt as if she had a bad arthritis. The patient previously took penicilina [benzylpenicillin]. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient not been tested for COVID-19. On 09May2021 at 17:00pm, the patient experienced persistent headaches for more than 2 weeks, her muscles become weak, and she was not able to function, muscle weakness, easy tiredness, ligament and body aches, she has a pretty bad food sensitivities for dairy and soy which make her body hurt as if she had had a bad arthritis. She completely avoids these foods and without them she did not have any symptoms of pain, nor did she have arthritis. After the second dose of vaccine patient felt like as she ingested a barrel of soy, she had all the symptoms of her sensitivities. The pain and aches went away in about 1/12 weeks, but muscle weakness persists. Since the second dose of vaccine, she was having headache every day. The clinical outcome of pain and aches went away in about 1/12 weeks, patient seldom have any headaches at all/not recovered, muscle weakness persists, easy tiredness and after the second dose of vaccine, she had all the symptoms of her sensitivities was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Fatigue, Heart rate, Heart rate abnormal
Clinical narrative: sore arm; sore lymph nodes in armpits,; temp. 99.5; fatigue and racing heart; heart rate fluctuates but up to 165; chest pain/fluttering,; racing heart; This is a spontaneous report from a contactable consumer (patient's mother).  A 18-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on 23May2021 15:00 (at the age of 18-year-old) as a dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. It was unknown if patient had other vaccine in four weeks. It was unknown if patient was tested post COVID vaccination. Reporter was not sure if patient had other medications in two weeks. It was unknown if prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, has the patient been tested for COVID-19. On 23May2021 the patient experienced sore arm, sore lymph nodes in armpits, temp. 99.5, fatigue and racing heart, chest pain/fluttering, heart rate fluctuates but up to 165. The patient had the physician office visit for the reported events. The patient underwent lab tests and procedures which included body temperature (temp) 99.5 and heart rate up to 165 both on 23May2021. Outcome for the all reported events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: sore arm; sore lymph nodes in armpits,; temp. 99.5; fatigue and racing heart; heart rate fluctuates but up to 165; chest pain/fluttering,; racing heart; This is a spontaneous report from a contactable consumer (patient's mother).  A 18-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on 23May2021 15:00 (at the age of 18-year-old) as a dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. It was unknown if patient had other vaccine in four weeks. It was unknown if patient was tested post COVID vaccination. Reporter was not sure if patient had other medications in two weeks. It was unknown if prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, has the patient been tested for COVID-19. On 23May2021 the patient experienced sore arm, sore lymph nodes in armpits, temp. 99.5, fatigue and racing heart, chest pain/fluttering, heart rate fluctuates but up to 165. The patient had the physician office visit for the reported events. The patient underwent lab tests and procedures which included body temperature (temp) 99.5 and heart rate up to 165 both on 23May2021. Outcome for the all reported events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Decreased appetite, Grip strength decreased, Muscle tightness
Clinical narrative: Feels really weak, cannot grip anything; Feels really weak, cannot grip anything; Tightness in the arm; Fever; Loss of appetite; Loss of taste; taste just feels messed up or nothing tastes right; Skin feels like burning; This is a spontaneous report from a contactable consumer reported for a female patient (wife).  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EW0178, Expiry date was not reported), via an unspecified route of administration on 23May2021 as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: ER8735, Expiry date was not reported), via an unspecified route of administration on 02May2021 as dose 1, single for COVID-19 immunization. The patient received a first dose of our COVID-19 vaccine last 02May, and received the second dose last 23May, which was exactly 21 days apart, on an unspecified date in 2021, after the second dose his wife felt really weak, could not grip anything, had fever had loss of appetite and loss of taste and her skin felt like burning. They don't know what to do with the patient. Reporter stated, like tightness in the arm and then still today, she said her taste just felt messed up or nothing tastes right. Reporter stated, no, it says the date that you received it. There was no expiration date. Reporter stated, she was not taking any medication. Reporter stated, there was no medical condition or lab test. The patient did not received treatment for the events. The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin burning sensation
Clinical narrative: Feels really weak, cannot grip anything; Feels really weak, cannot grip anything; Tightness in the arm; Fever; Loss of appetite; Loss of taste; taste just feels messed up or nothing tastes right; Skin feels like burning; This is a spontaneous report from a contactable consumer reported for a female patient (wife).  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EW0178, Expiry date was not reported), via an unspecified route of administration on 23May2021 as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: ER8735, Expiry date was not reported), via an unspecified route of administration on 02May2021 as dose 1, single for COVID-19 immunization. The patient received a first dose of our COVID-19 vaccine last 02May, and received the second dose last 23May, which was exactly 21 days apart, on an unspecified date in 2021, after the second dose his wife felt really weak, could not grip anything, had fever had loss of appetite and loss of taste and her skin felt like burning. They don't know what to do with the patient. Reporter stated, like tightness in the arm and then still today, she said her taste just felt messed up or nothing tastes right. Reporter stated, no, it says the date that you received it. There was no expiration date. Reporter stated, she was not taking any medication. Reporter stated, there was no medical condition or lab test. The patient did not received treatment for the events. The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hypersensitivity, Lip swelling, Palpitations
Clinical narrative: I had all the symptoms of severe allergic reaction; My face has been swollen, my lips, my tongue; My face has been swollen, my lips, my tongue; My face has been swollen, my lips, my tongue; I have been having rashes; Heart has been racing; Increased heart rate; Throat swelling; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection lot Number ER8732) via an unspecified route of administration on 24Apr2021 as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection lot Number ER2613) via an unspecified route of administration on 15May2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient had all the symptoms of severe allergic reaction, had swollen face, lips and tongue, had rashes, heart had been racing, increased heart rate and had throat swelling. It was reported that patient had multiple instances where patient had swelling, breakout in rashes and heart had been racing. My heart usually at night like I will get a fever, my heart will start racing. Patient was wondering what to do because patient knew that all the side effect from reading the paperwork and patient had been having this for over probably a month now, maybe it had been longer than a month. The patient underwent lab tests and procedures which included heart rate resulted as increased on an unspecified date. The clinical outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Rash, Swelling face, Swollen tongue
Clinical narrative: I had all the symptoms of severe allergic reaction; My face has been swollen, my lips, my tongue; My face has been swollen, my lips, my tongue; My face has been swollen, my lips, my tongue; I have been having rashes; Heart has been racing; Increased heart rate; Throat swelling; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection lot Number ER8732) via an unspecified route of administration on 24Apr2021 as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection lot Number ER2613) via an unspecified route of administration on 15May2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient had all the symptoms of severe allergic reaction, had swollen face, lips and tongue, had rashes, heart had been racing, increased heart rate and had throat swelling. It was reported that patient had multiple instances where patient had swelling, breakout in rashes and heart had been racing. My heart usually at night like I will get a fever, my heart will start racing. Patient was wondering what to do because patient knew that all the side effect from reading the paperwork and patient had been having this for over probably a month now, maybe it had been longer than a month. The patient underwent lab tests and procedures which included heart rate resulted as increased on an unspecified date. The clinical outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy internal hives on lower half of torso and thighs/had internal hives inside her torso; Itchy internal hives on lower half of torso and thighs; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient).  A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch no: not reported/lot number: EP7534) via an unspecified route of administration on 09Mar2021 (Age at vaccination 65 years old) as dose 1 single for covid-19 immunization at Pharmacy. Medical history included ongoing Hashimoto she has had thyroid issues for 40 years. The patient's concomitant medications were not reported. Family Medical History Relevant to AE(s) was none. No additional vaccines administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the vaccine. Patient reported a side effect related to the Covid Vaccine. On 26Mar2021 17 days after getting the dose 1, the patient experienced itchy internal hives on lower half of torso and thighs/had internal hives inside her torso, they were itchy in her torso. Patient emphasizes that the hives were not on the outside of her skin, but on the inside on her entire lower torso and upper thighs and scratching does not help. The reaction was worse the first time around. AE(s) require a visit to Physician office through telehealth appointment for the reported events Itchy internal hives on lower half of torso and thighs and did not require to visit Emergency Room. Her doctor told her to wait until event subsided to take dose 2 and her doctor thinks the patient had a Cytokine reaction. She did not know if it was a side effect of the vaccine at that time and Itching was worse at night. Events lasted for about 5-6 days. She was asking for any analysis why she was getting this. Relevant Tests were reported as none. Her sister- in law recommended Benadryl cream and stated that helped her as therapeutic measure as the result of the events. Investigation Assessment was reported as no. Patient stated that it was related to the vaccine. The outcome of the events was recovered on an unknown date in 2021.  Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pruritus, Urticaria
Clinical narrative: internal hives/had internal hives inside her torso; Itchy; First dose of Covid Vaccine was on 09Mar2021; Second dose on 06May2021; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0176), via an unspecified route of administration on 06May2021 (at the age of 66-year-old) as single dose for covid-19 immunization. Medical history included Ongoing Hashimoto's (when asked how long she has had this condition the patient stated she has had thyroid issues for 40 years). The patient had no family medical history relevant to AE(s). There were no concomitant medications. The patient had no additional vaccines administered on same date of the Pfizer Suspect considered as suspect. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) and no AE(s) following prior vaccinations. The patient previously received first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534), via an unspecified route of administration on 09Mar2021 (at the age of 65-year-old) as single dose for covid-19 immunization and experienced hives. About 2 and a half weeks after each dose of the Covid Vaccine she started getting internal hives. States they were itchy in her torso. Patient emphasizes that the hives were not on the outside of her skin, but on the inside. They were on her entire lower torso and upper thighs. Nothing seemed to help them. Her sister in law recommended Benadryl cream, the patient states that helped. States the itching was worse at night. Patient states the reaction was worse the first time around. She did not know if it was a side effect of the vaccine at that time. When it happened again with the exact same timing after the second vaccine, she thought it must be related to the vaccine. The patient was reporting a side effect related to the Covid Vaccine. Says it did not occur to her that it was related to the vaccine until after she had both doses. Patient states she waited longer between shots because she had the hives right before the second dose was due and the doctor told her to wait until they subsided. Once they had subsided the doctor told her to go ahead and try and get the second dose. Patient states her doctor thinks the patient had a Cytokine reaction. The patient states that she has Hashimoto's. Patient said she experienced unusual reactions to both the first and second dose of the Pfizer COVID Vaccine. She he had internal hives inside her torso and not on the skin on 17 days after getting both the first and second dose. She said that these were not normal hives. And scratching does not help. She was asking for any analysis why she was getting this. The patient had no relevant tests. Outcome of the events Itchy internal hives was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Computerised tomogram, Enteritis
Clinical narrative: "severe stomach cramping after 1st dose /stomach cramping started on 5/25; ilietis; This is a spontaneous report from a contactable consumer (patient) reported for herself that.  A 50-years-old female patient received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 24May2021 09:15 (Batch/Lot Number: Ew0187.) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 29Apr2021 (Batch/Lot Number: EW0167) as DOSE 1, SINGLE for covid-19 immunization (Age at vaccination 50 years). Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. The patient past medical history included High cholesterol from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing and hypothyroidism from an unknown date and unknown if ongoing. The patient has received other medications in two weeks. 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 vaccine within 4 weeks prior to covid-19 vaccination. Since the vaccination, has the patient has not been tested for COVID-19. On 03May2021, 10 days after the administration of vaccine the patient experienced severe stomach cramping after 1st dose /stomach cramping started on 5/25 and ER and a CT scan showed ileitis on unspecified date in May2021. The Ae resulted in - Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included computerized tomogram: CT scan showed ileitis on unspecified date. The patient received a treatment with antibiotics and the pain was gone. The event outcome was not recovered for Stomach cramps and unknown for ileitis.  Device Date: 26May2021  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: awful menstrual cramps that lasted about 9 days; awful menstrual cramps that lasted about 9 days; This is a spontaneous report from a contactable consumer. This 43-year-old female consumer (patient) reported. A 43-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on 21Mar2021 11:45 (at the age of 43-years-old) as a single dose for covid-19 immunization. Medical history included endometriosis, vaso vele, gallbladder disease, chronic fatigue syndrome, migraines. There were no concomitant medications. The patient previously took compazine spansule and experienced drug hypersensitivity. The patient had allergies with Compazine. The patient had no other vaccine within four weeks and no other medications received 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. On 29Mar2021, the patient developed awful menstrual cramps that lasted about 9 days (she had finished menstruation right before vaccine). Then towards the end of the 9 days, menstruation returned for about 3 days. It ended. The came back again about a week and a half later. She have had her period about 6 separate times since her first shot. The patient did not receive any treatment. Outcome of the event was recovered with sequelae.  Follow-up attempts are completed. No further information is expected. 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 completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling, Fatigue, Nausea
Clinical narrative: the corner of my left eye got itchy and swollen; the corner of my left eye got itchy and swollen; very tired; nauseous; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient reported that I received the COVID 19 vaccine today and 2 hours later the corner of my left eye got itchy and swollen. I also got very tried and nauseous. The outcome of the events unknown.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding, Menstrual disorder
Clinical narrative: changes in my menstrual cycle/my period was due to start on May12. However, I did not start my period until today, May26; abnormal spotting for 5 days straight; heavier flow; stronger cramps than usual; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications were not reported. 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 05May2021, the patient experienced changes in her menstrual cycle, not related to any other changes made in her personal life. Patient experienced abnormal spotting for 5 days straight, which was a brownish/red color. Very abnormal for the patient to have that for more than the occasional 1 day before or after an actual period. This started on May 5, a week before her period was due to start on May 12. However, Patient did not start period until today, May 26, making it 2 weeks late. Patient was also experiencing a heavier flow and stronger cramps than usual. It is not a huge cause for concern, as patient believe it will resolve itself, and patient don't want this to dissuade anyone from being vaccinated, but think women should know what to expect, especially because patient heard similar stories from many other women who have been vaccinated. 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. The clinical outcome of event abnormal spotting was resolved on 10May2021. The clinical outcome of events "changes in my menstrual cycle/my period was due to start on May12. However, I did not start my period until today, May26"; heavier flow; stronger cramps than usual was unknown at the time of report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 10May2021 as a single dose for COVID-19 immunisation.  Follow-up (19Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pruritus, Rash
Clinical narrative: Itchy red; Rash like on arm; Lump in armpit; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 55-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248; Expiration Date: Apr2021), intramuscular, administered in Arm Right (Upper Right Arm) on 25Jan2021 (age at the time of vaccination was 55 years) at 16:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Family medical history relevant to ae(s) and prior vaccinations was within 4 weeks were reported as none. On 27Jan2021, the patient experienced lump in armpit. On 06Feb2021, the patient experienced itchy red and rash like on arm. Therapeutic measures were taken as a result of itchy red and rash like on arm which included topical hydrocortisone cream. The outcome of all the events was recovered on an unspecified date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash on my chest and it itches really bad; Rash on my chest and it itches really bad; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration, administered in arm left on 21May2021 as dose 1, single (at the age of 53-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced rash on my chest and it itches really bad and rash. The patient received Covid-19 Vaccine and she developed a rash on her chest and it itches really bad. She knew that it could be one of the side effect but she was wondering what would be the best treatment because she did not want to buy any ointment if it just going to continue to be more like this was the cause of it. The outcome of the rash pruritic was unknown while outcome of the event rash was not recovered.   Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Inappropriate schedule of product administration, Rash, SARS-CoV-2 test
Clinical narrative: Bronchitis; all over body rash; Dose 1: 29Mar2021; Dose 2: 19May2021; This is a spontaneous report from a contactable consumer (patient).   A 53-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route, administered in arm left on 19May2021 (age at vaccination was 53 years) as dose 2, single for covid-19 immunization at other facility. The patient was not pregnant at the time of vaccination. Other medications received within 2 weeks of vaccination was reported as none. Medical history was reported as none. No known allergies were reported. There were no concomitant medications reported. The patient previously received bnt162b2 (Batch/Lot number: er2613), via an unspecified route, administered in arm left on 29Mar2021 at 10:30 AM (age at vaccination was 53 years) as dose 1, single for covid-19 immunization. Patient had Inappropriate schedule of vaccine administered. On 21May2021, the patient experienced bronchitis and all over body rash. The adverse events resulted in visit to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The report was non-serious. The patient underwent lab tests and procedures which included sars-cov-2 test unknown (Nasal Swab) on an unspecified date. Therapeutic measures taken as a result of the bronchitis and all over body rash included unspecified antibiotics steroids and inhaler. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. Outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected. Information about lot/batch number cannot be obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Heavy period off schedule from pill pack since first vaccine (19Apr).; This is a spontaneous report from a contactable consumer (patient herself).  A 19-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0162, Expiry date was not reported), via an unspecified route, administered in left arm on 19Apr2021 at 14:00 (Age at vaccination 19-yearsold) as dose 1, single for COVID-19 immunization. The patient was not pregnant at time of vaccination. The facility type vaccine was hospital. Medical history was none. The patient had no known allergies. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), cefalexin monohydrate (LEXIPRON), ethinylestradiol, levonorgestrel (VIENVA) taken for an unspecified indication, start and stop date were not reported. The patient experienced heavy period off schedule from pill pack since first vaccine on 19Apr2021. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received vyvanse, lexipro and vineva other medications 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 received pain medication, saline hydration drip treatment for the events. Therapeutic measures were taken for the results. The clinical outcome for the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have what appears to look like bites throughout my body.  It reminds me of Chicken Pox; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in right arm on 06Apr2021 at 12:00 (at the age of 51-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing mixed connective tissue disease (MCTD). The patient had known allergies to Citrus. Patient's concomitant medication were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in right arm on 11Mar2021 (at the age of 51-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient did not receive any vaccination within 4 weeks prior to the covid vaccine. Patient had no covid prior vaccination and not tested positive post vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Patient reported that on 06Apr2021, I had what appears to look like bites throughout my body. It reminded me of chicken pox. The patient received steroid and BRM4 500Mg for the event. The outcome was not recovered for the event.   Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Cold sweat, Cough, Dizziness
Clinical narrative: I slept until almost 5pm with exhaustion and trouble breathing.; I slept until almost 5pm with exhaustion and trouble breathing.; severe migraine, muscle pain, weakness, high fever over 100; severe migraine, muscle pain, weakness, high fever over 100; weakness; high fever over 100/on and off light fever; cold sweats; nausea; difficulty moving; coughing/Mild cough; dizziness/ some dizziness; and coming home before 12pm, I slept until almost 5pm; inability to stand; This is a spontaneous report from a contactable consumer (patient herself). A 24-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0178; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 24May2021 10:45 (at the age of 24-years-old) as DOSE 2, SINGLE and patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0178; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 03May2021 10:45 (at the age of 24-years-old) as DOSE 1, SINGLE both for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included rheumatoid arthritis, anaemia and drug hypersensitivity; sulfa medications from an unknown date and unknown if ongoing. Concomitant medication(s) included ferrous sulfate (FERROUS SULFATE) taken for an unspecified indication. The patient previously took Enbrel and Indomethacin [indometacin] and experienced drug hypersensitivity. 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, after receiving the vaccine and coming home before 12PM on an unspecified date in May2021 patient slept until almost 5pm with exhaustion and trouble breathing. Symptoms subsided and after a hot shower around 10Pm patient experience a severe migraine, muscle pain, weakness, high fever over 100, cold sweats, nausea, difficulty moving, coughing, and inability to stand until 8Am. Patient did not receive any treatment for adverse event. This report was not serious. Since the vaccination, patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: over 100 on an unspecified date. The outcome of all events was resolved with sequel.  Follow-Up (25Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Dysstasia, Fatigue, Migraine, Movement disorder
Clinical narrative: I slept until almost 5pm with exhaustion and trouble breathing.; I slept until almost 5pm with exhaustion and trouble breathing.; severe migraine, muscle pain, weakness, high fever over 100; severe migraine, muscle pain, weakness, high fever over 100; weakness; high fever over 100/on and off light fever; cold sweats; nausea; difficulty moving; coughing/Mild cough; dizziness/ some dizziness; and coming home before 12pm, I slept until almost 5pm; inability to stand; This is a spontaneous report from a contactable consumer (patient herself). A 24-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0178; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 24May2021 10:45 (at the age of 24-years-old) as DOSE 2, SINGLE and patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0178; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 03May2021 10:45 (at the age of 24-years-old) as DOSE 1, SINGLE both for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included rheumatoid arthritis, anaemia and drug hypersensitivity; sulfa medications from an unknown date and unknown if ongoing. Concomitant medication(s) included ferrous sulfate (FERROUS SULFATE) taken for an unspecified indication. The patient previously took Enbrel and Indomethacin [indometacin] and experienced drug hypersensitivity. 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, after receiving the vaccine and coming home before 12PM on an unspecified date in May2021 patient slept until almost 5pm with exhaustion and trouble breathing. Symptoms subsided and after a hot shower around 10Pm patient experience a severe migraine, muscle pain, weakness, high fever over 100, cold sweats, nausea, difficulty moving, coughing, and inability to stand until 8Am. Patient did not receive any treatment for adverse event. This report was not serious. Since the vaccination, patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: over 100 on an unspecified date. The outcome of all events was resolved with sequel.  Follow-Up (25Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Somnolence
Clinical narrative: I slept until almost 5pm with exhaustion and trouble breathing.; I slept until almost 5pm with exhaustion and trouble breathing.; severe migraine, muscle pain, weakness, high fever over 100; severe migraine, muscle pain, weakness, high fever over 100; weakness; high fever over 100/on and off light fever; cold sweats; nausea; difficulty moving; coughing/Mild cough; dizziness/ some dizziness; and coming home before 12pm, I slept until almost 5pm; inability to stand; This is a spontaneous report from a contactable consumer (patient herself). A 24-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0178; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 24May2021 10:45 (at the age of 24-years-old) as DOSE 2, SINGLE and patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0178; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 03May2021 10:45 (at the age of 24-years-old) as DOSE 1, SINGLE both for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included rheumatoid arthritis, anaemia and drug hypersensitivity; sulfa medications from an unknown date and unknown if ongoing. Concomitant medication(s) included ferrous sulfate (FERROUS SULFATE) taken for an unspecified indication. The patient previously took Enbrel and Indomethacin [indometacin] and experienced drug hypersensitivity. 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, after receiving the vaccine and coming home before 12PM on an unspecified date in May2021 patient slept until almost 5pm with exhaustion and trouble breathing. Symptoms subsided and after a hot shower around 10Pm patient experience a severe migraine, muscle pain, weakness, high fever over 100, cold sweats, nausea, difficulty moving, coughing, and inability to stand until 8Am. Patient did not receive any treatment for adverse event. This report was not serious. Since the vaccination, patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: over 100 on an unspecified date. The outcome of all events was resolved with sequel.  Follow-Up (25Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nodule, Pain in extremity, Rash, Skin discolouration
Clinical narrative: Swelling and intense pain in Palm and ankles; Swelling and intense pain in Palm and ankles; Swelling and intense pain in Palm and ankles; Some discoloration; Rashes; Some nodules in the palm that are painful to touch; This is a spontaneous report from a contactable consumer (patient) reported that. A 54-years-old female patient received BNT162B2 (BioNTech/Pfizer vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 (Batch/Lot Number: EW0161) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 54 years). Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient past medical history included diabetes mellitus from an unknown date and unknown if ongoing. There were no allergies reported. Concomitant medication(s) included insulin human, insulin human injection, isophane (INSULIN NOVOLIN) taken for an unspecified indication, start and stop date were not reported; insulin porcine zinc suspension (amorphous), insulin porcine zinc suspension (crystalline) (INSULIN LENTE S) taken for an unspecified indication, start and stop date were not reported and metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (BioNTech/Pfizer vaccine, solution for injection, Batch Number/ Expiration date: EP6955), via intramuscular route of administration on 24Mar2021 as single dose in the ; Right arm for COVID-19 immunization. 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 vaccine within 4 weeks prior to covid-19 vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 03May2021, the patient experienced Swelling and intense pain in Palm and ankles and see some discoloration and rashes in both palm and ankles. The swelling has reduced overtime, but the pain has not subsided yet. After the swelling reduced, we notice some nodules in the palm that are painful to touch. The Ae resulted in: [Doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care]. No treatment was received. The event outcome was Not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling and intense pain in Palm and ankles; Swelling and intense pain in Palm and ankles; Swelling and intense pain in Palm and ankles; Some discoloration; Rashes; Some nodules in the palm that are painful to touch; This is a spontaneous report from a contactable consumer (patient) reported that. A 54-years-old female patient received BNT162B2 (BioNTech/Pfizer vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 (Batch/Lot Number: EW0161) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 54 years). Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient past medical history included diabetes mellitus from an unknown date and unknown if ongoing. There were no allergies reported. Concomitant medication(s) included insulin human, insulin human injection, isophane (INSULIN NOVOLIN) taken for an unspecified indication, start and stop date were not reported; insulin porcine zinc suspension (amorphous), insulin porcine zinc suspension (crystalline) (INSULIN LENTE S) taken for an unspecified indication, start and stop date were not reported and metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (BioNTech/Pfizer vaccine, solution for injection, Batch Number/ Expiration date: EP6955), via intramuscular route of administration on 24Mar2021 as single dose in the ; Right arm for COVID-19 immunization. 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 vaccine within 4 weeks prior to covid-19 vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 03May2021, the patient experienced Swelling and intense pain in Palm and ankles and see some discoloration and rashes in both palm and ankles. The swelling has reduced overtime, but the pain has not subsided yet. After the swelling reduced, we notice some nodules in the palm that are painful to touch. The Ae resulted in: [Doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care]. No treatment was received. The event outcome was Not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: Neck and shoulder pain two days after 2nd vaccine, on same side of body (left); Neck and shoulder pain two days after 2nd vaccine, on same side of body (left); This is a spontaneous report from a contactable consumer (Patient). A 50-year-old non pregnant female received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0187, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 25May2021 at 10:00 (age at vaccination: 50year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included escitalopram and bupropion taken for an unspecified indication, start and stop date were not reported. Patient had known allergies. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior and received other medications 2 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The patient previously took levaquin and experienced drug hypersensitivity and historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0170, Expiry date was not reported) via an unspecified route of administration, administered in Right arm on 03May2021 at 16:00 for COVID-19 immunisation. On an unspecified date in May2021, it was reported that patient had Neck and shoulder pain two days after 2nd vaccine, on same side of body (left). Its persistent, doesn't come and go. Maybe lymph node in neck is swollen? Shoulder pain not only at injection site but back of shoulder and beneath shoulder blade. Patient was not prolonged hospitalization. No treatment was received for any event. The outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.