chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: diarrhea on the third day; When given the shot, a sensation ran up the left side of my neck; my arm hurt; felt ill within an hour; achy; headache; fatigue; increased blood pressure; felt unwell and had a headache for three days; This is a spontaneous report from a contactable consumer reporting for herself. A 59-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6200; Expiration date was not reported), via an unspecified route of administration in arm left on 26Feb2021 at 09:15 (at the age of 59-years-old) as dose 1, single for COVID-19 immunisation at hospital. Medical history included type 2 diabetes mellitus (MODY diabetic, 40 years), blood cholesterol (medicated for cholesterol), hypothyroidism (underactive thyroid) from an unknown date and unknown if ongoing. Concomitant medications in two weeks included glimepiride (GLIMEPIRIDE), metformin (METFORMIN) taken for type 2 diabetes mellitus; levothyroxine (LEVOTHYROXINE) taken for hypothyroidism; atorvastatin (ATORVASTATIN) taken for blood cholesterol, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity (known allergies: codeine). Patient had no other vaccine in four weeks. Patient had COVID prior vaccination and not tested for covid post vaccination. The patient experienced when given the shot, a sensation ran up the left side of her neck, arm hurt, felt ill within an hour, achy, headache, fatigue, increased blood pressure, felt unwell and had a headache for three days on 26Feb2021 at 10:00, diarrhea on the third day on 28Feb2021. The patient underwent lab tests and procedures which included mild COVID-19- tested positive on 10Dec2020; blood pressure measurement: 155/86, which is high for patient on 26Feb2021. When given the shot, a sensation ran up the left side of her neck. The sensation lasted all day; patient arm hurt and felt ill within an hour; achy, headache, fatigue; increased blood pressure (155/86, which is high for patient); felt unwell and had a headache for three days; diarrhea on the third day. No treatment was received. Clinical outcome of the event fatigue was recovered on 28Feb2021 and all other events were recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Fever for 3 days reaching 103.4; chills; sweats; shaking; headache; Hard lump on left arm size of baseball that has not gone away.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 52-years-old non-pregnant female patient received second dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine, solution for injection, batch/lot number: unspecified), via an unspecified route of administration in left arm on 28Feb2021 at 16:30 (age at the time of vaccination 52-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She had no known allergies. No other medications in two weeks. The patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: unspecified), via an unspecified route of administration in left arm on 07Feb2021 as historical vaccination as single dose for COVID-19 immunisation. On 01Mar2021 at 08:00, the patient experienced fever for 3 days reaching 103.4, chills, sweats, shaking, headache and hard lump on left arm size of baseball that has not gone away. The patient had neither COVID prior vaccination nor COVID tested post vaccination. No treatment received for adverse events. The outcome of the adverse events was not recovered.  No follow-up attempts are needed. information about lot/batch number could not be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vaccination site mass
Clinical narrative: Fever for 3 days reaching 103.4; chills; sweats; shaking; headache; Hard lump on left arm size of baseball that has not gone away.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 52-years-old non-pregnant female patient received second dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine, solution for injection, batch/lot number: unspecified), via an unspecified route of administration in left arm on 28Feb2021 at 16:30 (age at the time of vaccination 52-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She had no known allergies. No other medications in two weeks. The patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: unspecified), via an unspecified route of administration in left arm on 07Feb2021 as historical vaccination as single dose for COVID-19 immunisation. On 01Mar2021 at 08:00, the patient experienced fever for 3 days reaching 103.4, chills, sweats, shaking, headache and hard lump on left arm size of baseball that has not gone away. The patient had neither COVID prior vaccination nor COVID tested post vaccination. No treatment received for adverse events. The outcome of the adverse events was not recovered.  No follow-up attempts are needed. information about lot/batch number could not be obtained. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Discomfort, Dry skin, Headache
Clinical narrative: headaches; muscle aches; pains; chills; other flu-like symptoms; Hard of hearing; Kind of stiff; Little bit of discomfort; Trouble in seeing; I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it.; Skin dry; This is a spontaneous report from a contactable consumer or other non-HCP (patient). An 85-years-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 04Feb2021 (age at the time of vaccination 85-years-old), as single dose for COVID-19 immunization. The patient's medical history included Hypertension, Stroke, Heart attack, and on an unspecified date Aug2020, Covid-19, I actually had a mild case of COVID. The patient's concomitant medication included Isosorbide, Losartan, and Cartia Xt (Diltiazem Hydrochloride). On an unspecified date, the patient experienced headaches, muscle aches, pains, chills, other flu-like symptoms, Hard of hearing, Kind of stiff, Little bit of discomfort, Trouble in seeing, I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it, and Skin dry. On an unspecified date Aug2020, the patient underwent lab tests and procedures which included Covid-19: positive, I actually had a mild case of COVID. The outcome for all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Influenza like illness, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: headaches; muscle aches; pains; chills; other flu-like symptoms; Hard of hearing; Kind of stiff; Little bit of discomfort; Trouble in seeing; I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it.; Skin dry; This is a spontaneous report from a contactable consumer or other non-HCP (patient). An 85-years-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 04Feb2021 (age at the time of vaccination 85-years-old), as single dose for COVID-19 immunization. The patient's medical history included Hypertension, Stroke, Heart attack, and on an unspecified date Aug2020, Covid-19, I actually had a mild case of COVID. The patient's concomitant medication included Isosorbide, Losartan, and Cartia Xt (Diltiazem Hydrochloride). On an unspecified date, the patient experienced headaches, muscle aches, pains, chills, other flu-like symptoms, Hard of hearing, Kind of stiff, Little bit of discomfort, Trouble in seeing, I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it, and Skin dry. On an unspecified date Aug2020, the patient underwent lab tests and procedures which included Covid-19: positive, I actually had a mild case of COVID. The outcome for all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage, Visual impairment
Clinical narrative: headaches; muscle aches; pains; chills; other flu-like symptoms; Hard of hearing; Kind of stiff; Little bit of discomfort; Trouble in seeing; I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it.; Skin dry; This is a spontaneous report from a contactable consumer or other non-HCP (patient). An 85-years-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 04Feb2021 (age at the time of vaccination 85-years-old), as single dose for COVID-19 immunization. The patient's medical history included Hypertension, Stroke, Heart attack, and on an unspecified date Aug2020, Covid-19, I actually had a mild case of COVID. The patient's concomitant medication included Isosorbide, Losartan, and Cartia Xt (Diltiazem Hydrochloride). On an unspecified date, the patient experienced headaches, muscle aches, pains, chills, other flu-like symptoms, Hard of hearing, Kind of stiff, Little bit of discomfort, Trouble in seeing, I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it, and Skin dry. On an unspecified date Aug2020, the patient underwent lab tests and procedures which included Covid-19: positive, I actually had a mild case of COVID. The outcome for all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: baseball sized lump in left armpit near the crease; This is a spontaneous report from a contactable consumer (patient).  A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 as (at the age of 49-years-old) DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No Prior Vaccinations within 4 weeks. No Relevant Tests were reported. The patient experienced baseball sized lump in left armpit near the crease on 27Feb2021. It was reported that Caller is calling about the Pfizer vaccine, clarified the COVID 19 vaccine. She got the injection 25Feb2021 and on Saturday, 27Feb2021 she noticed a lump under her arm pit. The lump is on the left side, the same side as she received her shot. The lump is the size of a baseball, the lump is not hard, the lump feels uncomfortable. Caller would say it's right below where the crease is. Located more south in her armpit. It was reported that she was taking vitamin c, elderberry, and natural supplements. No AE following prior vaccinations. Patient did not require a visit emergency room or physician Office. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Vaccination site bruising, Vaccination site mass, Vaccination site swelling
Clinical narrative: had a large lump on my arm at the injection site and the area was already bruised (approximately 2 inches wide and 1 X inches in height); had a large lump on my arm at the injection site and the area was already bruised (approximately 2 inches wide and 1 X inches in height); swollen site; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported; Expiration Date: not reported), via an unspecified route of administration on 19Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 29Jan2021 as dose 1, single for covid-19 immunisation. On 19Feb2021, probably 30 minutes after receiving the injection, the patient experienced a large lump on her arm at the injection site and the area was already bruised (approximately 2 inches wide and 1 x inches in height), swollen site. Perhaps, five hours later the hard lump area began to soften some. The area became slightly sore, but no pain was felt. Patient slept on left side that night and was comfortable with no pain. The patient underwent lab tests and procedures which included antibody test: negative on an unspecified date. The outcome of the events were unknown.  No follow up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Cold-stimulus headache, Fatigue, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: facial numbness changed locations, moving to below tongue and some of throat; facial numbness changed locations, moving to below tongue and some of throat; sporadic pain; headache; feeling of brain freeze; injection site pain; general fatigue; facial numbness; Had to stop lecturing due to facial muscles sore; This is a spontaneous report from a contactable consumer. A 36-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6200; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 26Feb2021 08:15 hr (at the age of 36-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included obesity, plantar fasciitis, sleep apnea from an unknown date and unknown if ongoing. Concomitant or other medications in two weeks, other vaccine in four weeks, COVID prior vaccination, if COVID tested post vaccination was reported as none. The patient previously took Sulfa drops and experienced hypersensitivity (known allergies). The patient experienced feeling of brain freeze, injection site pain, general fatigue, facial numbness on 26Feb2021, sporadic pain, headache on 27Feb2021, facial numbness changed locations, moving to below tongue and some of throat on 28Feb2021, had to stop lecturing due to facial muscles sore on unspecified date in Feb2021. Adverse events start time was reported as 08:30 hr on 26Feb2021. It was reported that adverse events on day 1 could be described as the feeling of brain freeze after drinking a smoothie too quickly about 20-25 minutes after injection, leading to injection site pain and general fatigue which has mostly continued and what could best be described as facial numbness. Day 2 most of face was numb, sporadic pain, injection site pain, fatigue, headache. Day3 facial numbness changed locations, moving to below tongue and some of throat, injection site pain and fatigue. Day 4-6 changing facial numbness and pain around face and top of head. Had to stop lecturing due to facial muscles sore (as if you hurt from laughing, but constant). Day 7 some fatigue and facial numbness and pain. There were no signs of stroke, no facial droop, nor uneven paralysis. No treatment was given for the events. Clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pharyngeal hypoaesthesia, Vaccination site pain
Clinical narrative: facial numbness changed locations, moving to below tongue and some of throat; facial numbness changed locations, moving to below tongue and some of throat; sporadic pain; headache; feeling of brain freeze; injection site pain; general fatigue; facial numbness; Had to stop lecturing due to facial muscles sore; This is a spontaneous report from a contactable consumer. A 36-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6200; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 26Feb2021 08:15 hr (at the age of 36-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included obesity, plantar fasciitis, sleep apnea from an unknown date and unknown if ongoing. Concomitant or other medications in two weeks, other vaccine in four weeks, COVID prior vaccination, if COVID tested post vaccination was reported as none. The patient previously took Sulfa drops and experienced hypersensitivity (known allergies). The patient experienced feeling of brain freeze, injection site pain, general fatigue, facial numbness on 26Feb2021, sporadic pain, headache on 27Feb2021, facial numbness changed locations, moving to below tongue and some of throat on 28Feb2021, had to stop lecturing due to facial muscles sore on unspecified date in Feb2021. Adverse events start time was reported as 08:30 hr on 26Feb2021. It was reported that adverse events on day 1 could be described as the feeling of brain freeze after drinking a smoothie too quickly about 20-25 minutes after injection, leading to injection site pain and general fatigue which has mostly continued and what could best be described as facial numbness. Day 2 most of face was numb, sporadic pain, injection site pain, fatigue, headache. Day3 facial numbness changed locations, moving to below tongue and some of throat, injection site pain and fatigue. Day 4-6 changing facial numbness and pain around face and top of head. Had to stop lecturing due to facial muscles sore (as if you hurt from laughing, but constant). Day 7 some fatigue and facial numbness and pain. There were no signs of stroke, no facial droop, nor uneven paralysis. No treatment was given for the events. Clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Intermenstrual bleeding
Clinical narrative: Sore arm; Fatigue; Headache; Fever; Chills; hot/cold sweat; nausea; Menstrual cycle spotting; This is a spontaneous report from a non-contactable other health care professional.  A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: Not reported), via intramuscular route, administered in left arm on 26Feb2021 at 08:30 (at the age of 26-year-old) as dose 2, single for COVID-19 immunization. Medical history included goitre from an unknown date. The patient was not pregnant at the time of vaccination. The patient had no allergy. The patient concomitant medications were not reported. Patient received Oral contraceptives within 2 weeks of vaccination. No other vaccinations within four weeks prior. Patient was not tested Covid post vaccination. Patient not had Covid prior vaccination. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: Not reported), via intramuscular route, administered in right arm on 26Feb2021 at 11:15 (at the age of 26-year-old) as dose 1, single for COVID-19 immunization. The patient experienced sore arm, fatigue, headache, fever, chills, hot/cold sweats, nausea and menstrual cycle spotting on 26Feb2021 at 21:00. Patient did not receive any treatment as a result of events. The outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fatigue; Headache; Fever; Chills; hot/cold sweat; nausea; Menstrual cycle spotting; This is a spontaneous report from a non-contactable other health care professional.  A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: Not reported), via intramuscular route, administered in left arm on 26Feb2021 at 08:30 (at the age of 26-year-old) as dose 2, single for COVID-19 immunization. Medical history included goitre from an unknown date. The patient was not pregnant at the time of vaccination. The patient had no allergy. The patient concomitant medications were not reported. Patient received Oral contraceptives within 2 weeks of vaccination. No other vaccinations within four weeks prior. Patient was not tested Covid post vaccination. Patient not had Covid prior vaccination. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: Not reported), via intramuscular route, administered in right arm on 26Feb2021 at 11:15 (at the age of 26-year-old) as dose 1, single for COVID-19 immunization. The patient experienced sore arm, fatigue, headache, fever, chills, hot/cold sweats, nausea and menstrual cycle spotting on 26Feb2021 at 21:00. Patient did not receive any treatment as a result of events. The outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Mass, Pruritus, Rash, Rhinorrhoea
Clinical narrative: she developed a lump on her elbow; runny nose; cold like symptoms; rash on forearm; forearm, burning itching sensation like fire ants/burning itching sensation on head/Behind ears and neck also felt this way; This is a spontaneous report from a non-contactable consumer, the patient. A 58 age (unit not reported) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on 05Mar2021 as a single dose for covid-19 immunization. Medical history included psoriasis (She has a past medical history of psoriasis and was on Otezla for 4 years but discontinued using it in September. Before receiving the vaccine she had a small patch of psoriasis on her breast), pruritus (Burning itching sensation on head. Has a history of this on other parts of her body but not on her head). The patient's concomitant medications were not reported. The patient previously took otezla for psoriasis. On 07Mar2021, after receiving the vaccine she developed a lump on her elbow, a runny nose and cold like symptoms into Sunday. Sunday around 11 she developed a rash on forearm, burning itching sensation like fire ants, put ice on it and feeling went away. Last night around 9 pm, she started having burning itching sensation on head. Has a history of this on other parts of her body but not on her head. Behind ears and neck also felt this way but she did not put ice on them. Can the vaccine trigger psoriasis and will it ever go away. Outcome of the event pruritus was recovered and for rest other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Gait disturbance, Hypertension
Clinical narrative: got the shot, got up to walk to the waiting area but I didn't make it; pulling my mask off, like I wasn't getting enough air; dizzy; B/P was high at 158/86; my legs were really shaky; This is a spontaneous report from a Pfizer-sponsored program . A female patient of an unspecified age (Age: 58; Units: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06Mar2021 as dose 1, single for covid-19 immunisation. Medical history included allergies to seafood and fish and carries an EpiPen. The patient's concomitant medications were not reported. On 06Mar2021, the patient experienced she got the shot, got up to walk to the waiting area but didn't make it, pulling her mask off, like she wasn't getting enough air, got dizzy, b/p was high at 158/86, her legs were really shaky.  The patient underwent lab tests and procedures which included blood pressure measurement: 158/86 on 06Mar2021. Patient wanted to know if she can get the 2nd or not. The outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: got the shot, got up to walk to the waiting area but I didn't make it; pulling my mask off, like I wasn't getting enough air; dizzy; B/P was high at 158/86; my legs were really shaky; This is a spontaneous report from a Pfizer-sponsored program . A female patient of an unspecified age (Age: 58; Units: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06Mar2021 as dose 1, single for covid-19 immunisation. Medical history included allergies to seafood and fish and carries an EpiPen. The patient's concomitant medications were not reported. On 06Mar2021, the patient experienced she got the shot, got up to walk to the waiting area but didn't make it, pulling her mask off, like she wasn't getting enough air, got dizzy, b/p was high at 158/86, her legs were really shaky.  The patient underwent lab tests and procedures which included blood pressure measurement: 158/86 on 06Mar2021. Patient wanted to know if she can get the 2nd or not. The outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Vaccination site swelling
Clinical narrative: Large lump hard "3 inches. Does not bother unless he puts pressure.; His arm is swollen where he got the shot; This is a spontaneous report from a contactable consumer or other non-HCP (patient's wife). An 86-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration on 05Mar2021 (age at the time of vaccination 86-years-old), as a single dose for COVID-9 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date, the patient experienced Large lump hard "3 inches. Does not bother unless he puts pressure; and His arm is swollen where he got the shot. Patient did not received treatment for adverse events. Caller stated, should he take the second dose. The outcome for all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysphagia, Mouth haemorrhage, Pain, Pain in extremity
Clinical narrative: wasn't able to swallow well; I had swelling of my tongue that started on Saturday; blood vessels formed and burst under the tongue; blood vessels formed and burst on the side of the tongue; swelling was so close to roof of mouth; left arm and shoulder were really painful and she couldn't lift her arm; left arm and shoulder were really painful and she couldn't lift her arm; left arm and shoulder were really painful and she couldn't lift her arm; This is a spontaneous report from a contactable consumer or other non-HCP. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203; Expiration Date: 30Jun2021), via an unspecified route of administration on 28Feb2021 03:30 as DOSE 1, 0.3 ML SINGLE (at the age of: 68-year-old) for covid-19 immunization  The patient medical history and concomitant medication was not reported. Vaccine is not Administered at Facility. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Physician Office was visited on 09MAR2021. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination. No Family Medical History Relevant to AE was reported. On 28Feb2021 the patient experienced  left arm and shoulder were really painful and she couldn't lift her arm. On 06Mar2021 17:00 the patient experienced she had swelling of her tongue that started on Saturday. On 06Mar2021 the patient experienced swelling was so close to roof of mouth, blood vessels formed and burst on the side of the tongue, On 07Mar2021 the patient experienced wasn't able to swallow well. Therapeutic measures were taken as a result of the patient had swelling of her tongue that started on saturday, wasn't able to swallow well, swelling was so close to roof of mouth, blood vessels formed and burst on the side of the tongue, blood vessels formed and burst under the tongue as Benadryl, states she is on that everyday, twice a day. She is hoping the swelling will go down. The outcome of event left arm and shoulder were really painful and she couldn't lift her arm was recovered on 01Mar2021 while outcome of event blood vessels formed and burst under the tongue was not recovered. The outcome of rest all event was recovering. Description of complaint: Caller was reporting an AE with the Covid vaccine. She began to get a swollen tongue and she wasn't able to swallow well because the swelling was so close to roof of mouth. States her tongue started to swell up too. States she took Benadryl but it is still swollen, but not as bad as it was Saturday. She states that she took one Benadryl immediately and waited and gave her husband instructions to call 911 if she couldn't swallow. Then 30 minutes later took another half. She took 1.5 Benadryl total and it started to get better and not as swollen.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Palatal swelling, Swollen tongue
Clinical narrative: wasn't able to swallow well; I had swelling of my tongue that started on Saturday; blood vessels formed and burst under the tongue; blood vessels formed and burst on the side of the tongue; swelling was so close to roof of mouth; left arm and shoulder were really painful and she couldn't lift her arm; left arm and shoulder were really painful and she couldn't lift her arm; left arm and shoulder were really painful and she couldn't lift her arm; This is a spontaneous report from a contactable consumer or other non-HCP. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203; Expiration Date: 30Jun2021), via an unspecified route of administration on 28Feb2021 03:30 as DOSE 1, 0.3 ML SINGLE (at the age of: 68-year-old) for covid-19 immunization  The patient medical history and concomitant medication was not reported. Vaccine is not Administered at Facility. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Physician Office was visited on 09MAR2021. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination. No Family Medical History Relevant to AE was reported. On 28Feb2021 the patient experienced  left arm and shoulder were really painful and she couldn't lift her arm. On 06Mar2021 17:00 the patient experienced she had swelling of her tongue that started on Saturday. On 06Mar2021 the patient experienced swelling was so close to roof of mouth, blood vessels formed and burst on the side of the tongue, On 07Mar2021 the patient experienced wasn't able to swallow well. Therapeutic measures were taken as a result of the patient had swelling of her tongue that started on saturday, wasn't able to swallow well, swelling was so close to roof of mouth, blood vessels formed and burst on the side of the tongue, blood vessels formed and burst under the tongue as Benadryl, states she is on that everyday, twice a day. She is hoping the swelling will go down. The outcome of event left arm and shoulder were really painful and she couldn't lift her arm was recovered on 01Mar2021 while outcome of event blood vessels formed and burst under the tongue was not recovered. The outcome of rest all event was recovering. Description of complaint: Caller was reporting an AE with the Covid vaccine. She began to get a swollen tongue and she wasn't able to swallow well because the swelling was so close to roof of mouth. States her tongue started to swell up too. States she took Benadryl but it is still swollen, but not as bad as it was Saturday. She states that she took one Benadryl immediately and waited and gave her husband instructions to call 911 if she couldn't swallow. Then 30 minutes later took another half. She took 1.5 Benadryl total and it started to get better and not as swollen.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Neck pain, Swelling, Vaccination site pain
Clinical narrative: Pain at injection site; base of neck hurt; felt a lump near my collarbone, lump was floating and moving, hurt/tender to the touch; collar bone area swollen; This is a spontaneous report from a contactable consumer reported for herself. A 61-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for Injection, Lot number: EN6205) via an unspecified route in the right arm on 06Mar2021 at 10:00, as a single dose for covid-19 immunization. Medical history included covid-19, allergic to Lipitor, statins, high blood pressure and slightly overweight. Concomitant medications included naproxen sodium (ALEVE), minocycline, VITAMIN C (ascorbic acid), VITAMIN D (colecalciferol) and quinapril hydrochloride (ACCUPRIL). Prior to vaccination, patient was diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. On 07Mar2021 (Sunday) at 15:45, patient experienced pain at injection site, base of neck hurt, felt a lump near collarbone, lump was floating and moving, hurt/tender to the touch and collar bone area swollen. Adverse events resulted in doctor or other health care professional clinic visit. Patient went to dermatologist today felt that it may be nothing and was prescribed to minocycline a day for a week. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Migraine, Vomiting
Clinical narrative: Breakthrough menstrual bleeding (came on 3 hours after the 2nd dose.Onset migraine with vomiting (4 days after 2nd dose); Breakthrough menstrual bleeding (came on 3 hours after the 2nd dose.Onset migraine with vomiting (4 days after 2nd dose); Breakthrough menstrual bleeding (came on 3 hours after the 2nd dose.Onset migraine with vomiting (4 days after 2nd dose); This is a spontaneous report from a contactable consumer (patient). A 38-years-old non pregnant adult female patient received second dose of bnt162b2 (BNT162B2, solution for injection, (Batch/Lot Number: EM9810) administered in left arm via an unknown route  (at the age of 38 years old) on 05Mar2021 at 12:00pm as dose 2, single for covid-19 immunisation.  Medical history included known allergies to Penicillin, Sulfa, Strawberries, Malt. The patient previously received first dose of bnt162b2 (BNT162B2, solution for injection, (Batch/Lot Number: EL9269) administered in left arm via an unknown route in Feb2021 at 11:00 am as dose 1, single for covid-19 immunization and experienced no adverse event. There was no other medical history. No other vaccine was administered in four weeks. Concomitant medications in two weeks included Desogestrel, Ethinylestradiol (ISIBLOOM) Cetirizine hydrochloride (ZYRTEC), Colecalciferol (VITAMIN D [COLECALCIFEROL, Vitamin b complex (B COMPLEX), Vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). prior vaccination, patient has not diagnosed with covid. Patient was not tested for covid post vaccination. On 05Mar2021 at 03:00pm, the patient had breakthrough menstrual bleeding (came on 3 hours after the 2nd dose). On 09Mar2021, the patient experienced migraine with vomiting (4 days after 2nd dose) with breakthrough menstrual bleeding (came on 3 hours after the 2nd dose. No treatment was received for the events. The outcome of all the events was reported as recovering.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dry mouth, Dyspnoea, Erythema, Fatigue
Clinical narrative: Headache; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; hot to the touch; pain and soreness on the injection site and arm; dry mouth; very thirsty; nauseouseness; some Pins and needless on my left arm/hand,face, neck and torso; Fatigue were I need to lay down and sleep; Mild shortness of breath like if I've been running and need to stop and catch my breath; Some mild diarrhea; This is a spontaneous report from a contactable consumer(patient). A 52-year-old non pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EN6200), via an unspecified route of administration on 05Mar2021 at 13:30 (at the age of 52-year-old) into left arm as a single dose for COVID-19 immunization at Public Health Clinic. The patient medical history Rheumatoid Arthritis, Fibromyalgia, Spinal Disk Compression. Concomitant medication(s) included calcium; levothyroxine; multivitamin. The patient had allergies to Penicillin, Sulfate Drugs, NSAIDS, Latex. The patient previously took Percocet, codeine and experienced allergy. On 05Mar2021 at 09:30 PM, the patient experienced Headache, a red lump with swelling, then itchy traveling redness around the arm, hot to the touch, pain and soreness on the injection site and arm, also dry mouth, very thirsty, some nauseouseness and some Pins and needles on my left arm/hand, face, neck and torso. Fatigue where she needs to lay down and sleep. Mild shortness of breath like if she has been running and need to stop and catch my breath, and Some mild diarrhea. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment medications were received for the adverse events. The outcome of the evens was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Mass, Nausea, Paraesthesia
Clinical narrative: Headache; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; hot to the touch; pain and soreness on the injection site and arm; dry mouth; very thirsty; nauseouseness; some Pins and needless on my left arm/hand,face, neck and torso; Fatigue were I need to lay down and sleep; Mild shortness of breath like if I've been running and need to stop and catch my breath; Some mild diarrhea; This is a spontaneous report from a contactable consumer(patient). A 52-year-old non pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EN6200), via an unspecified route of administration on 05Mar2021 at 13:30 (at the age of 52-year-old) into left arm as a single dose for COVID-19 immunization at Public Health Clinic. The patient medical history Rheumatoid Arthritis, Fibromyalgia, Spinal Disk Compression. Concomitant medication(s) included calcium; levothyroxine; multivitamin. The patient had allergies to Penicillin, Sulfate Drugs, NSAIDS, Latex. The patient previously took Percocet, codeine and experienced allergy. On 05Mar2021 at 09:30 PM, the patient experienced Headache, a red lump with swelling, then itchy traveling redness around the arm, hot to the touch, pain and soreness on the injection site and arm, also dry mouth, very thirsty, some nauseouseness and some Pins and needles on my left arm/hand, face, neck and torso. Fatigue where she needs to lay down and sleep. Mild shortness of breath like if she has been running and need to stop and catch my breath, and Some mild diarrhea. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment medications were received for the adverse events. The outcome of the evens was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Thirst, Vaccination site pain
Clinical narrative: Headache; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; hot to the touch; pain and soreness on the injection site and arm; dry mouth; very thirsty; nauseouseness; some Pins and needless on my left arm/hand,face, neck and torso; Fatigue were I need to lay down and sleep; Mild shortness of breath like if I've been running and need to stop and catch my breath; Some mild diarrhea; This is a spontaneous report from a contactable consumer(patient). A 52-year-old non pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EN6200), via an unspecified route of administration on 05Mar2021 at 13:30 (at the age of 52-year-old) into left arm as a single dose for COVID-19 immunization at Public Health Clinic. The patient medical history Rheumatoid Arthritis, Fibromyalgia, Spinal Disk Compression. Concomitant medication(s) included calcium; levothyroxine; multivitamin. The patient had allergies to Penicillin, Sulfate Drugs, NSAIDS, Latex. The patient previously took Percocet, codeine and experienced allergy. On 05Mar2021 at 09:30 PM, the patient experienced Headache, a red lump with swelling, then itchy traveling redness around the arm, hot to the touch, pain and soreness on the injection site and arm, also dry mouth, very thirsty, some nauseouseness and some Pins and needles on my left arm/hand, face, neck and torso. Fatigue where she needs to lay down and sleep. Mild shortness of breath like if she has been running and need to stop and catch my breath, and Some mild diarrhea. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment medications were received for the adverse events. The outcome of the evens was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: fever; chills; pain at injection site; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).   A 28-year-old non-pregnant female patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581), via an unspecified route of administration, administered in the left arm on 09Feb2021,at  11:45 as a single dose for covid-19 immunization.  Medical history included bipolar 2, depression, anxiety and obesity from unknown dates. Concomitant medications included alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported; venlafaxine hydrochloride (VENLAFAXINE XR) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported, zolpidem tartrate (AMBIEN) taken for an unspecified indication, start and stop date were not reported; lamotrigine (LAMICTAL XR) taken for an unspecified indication, start and stop date were not reported. The patient had allergy to codeine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 09Feb2021, at 21:00 the patient experienced fever, chills, pain at injection site with outcome of recovered on 12Feb2021. Details were as follows: noted fever and chills each night for three nights after first dose and pain at injection site for three days. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of fever, chills, pain at injection site; the treatment taken for the adverse events included ibuprofen (MANUFACTURER UNKNOWN). The patient underwent lab tests and procedures which includes Saliva RT PCR: COVID  test result was negative on 05Mar2021. The outcome of fever, chills, pain at injection site was recovered on 12Feb2021.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Tachypnoea
Clinical narrative: My breathing is picked up is labored little bit this morning; I am still shortness of breath vision; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-year-old male patient received bnt162b2 (BNT162B2  PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6205), via an unspecified route of administration on 04Mar2021 at 10:30 (at the age of 58-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included blood pressure, cholesterol and Emphysema COPD pretty chronic. The concomitant medications included losartan (LOSARTAN) and metoprolol (METOPROLOL) and Perforomist. No Investigation Assessment was reported. The patient stated she got the first vaccine shot (Pfizer Covid-19 Vaccine) previous day and she noticed that her breathing is picked up is labored little bit that morning and she was on the medicine on a Perforomist and she noticed that morning. Previous night when she took that treatment, she still had shortness of breath vision, even she had took the treatment something. She stated that had any kind of side effects reported like that from people those are chronic pulmonary. She stated she got the shot on previous day (04Mar2021) at 10:30 in the morning and then that overnight started noticing, she was having more after 12 that morning was when she noticed that shortness of breath at 03:05 AM. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.