chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity
Clinical narrative: pain she is having in her left shoulder/Joint pain; states the pain radiates from her back of neck and shoulder from part of her back.; since she had the vaccine she has had a pain in her left arm and it subsided today and it has gotten worse; states the pain radiates from her back of neck and shoulder from part of her back/and she can barely move her arm up; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation : solution for injection, Batch/Lot number : unknown, expiry date: not reported), via an unspecified route of administration, administered in the right arm on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  On an unspecified date, the patient experienced pain in her left shoulder, states since she had the vaccine she had a pain in her left arm and it subsided today and it has gotten worse and she can barely move her arm up; states the pain radiates from her back of neck and shoulder from part of her back, joint pain. Caller states that she was having joint pain and wanted to know if that is one of the listed side effects. Caller asked how long the report would take because she was in pain. Caller declined to complete the full report at this time and states she would like to ask how she should handle this or if she should go to the emergency room but was unable to provide treatment recommendations or medical advice and she was referred to her HCP. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Swelling face, Urticaria
Clinical narrative: Face swelling; lips were all swelled up; eyes were all swelled up and my cheeks; Face swelling; lips were all swelled up; eyes were all swelled up and my cheeks; Face swelling; lips were all swelled up; eyes were all swelled up and my cheeks; Hives all over my body; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0176, Expiry Date: Unknown) via an unspecified route of administration on 26Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP7534, Expiry Date: Unknown) via an unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunization. The patient experienced face swelling, lips were all swelled up, eyes were all swelled up and patient cheeks and hives all over patient body on an unspecified date in Apr2021. No treatment received for the events. The clinical outcome of all events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Confusional state, Hot flush
Clinical narrative: Hot flashes; Leg pain; back again aching; I was confused; Chills/ mild shivers; Fever; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient).  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0164) via an unspecified route of administration on 26Apr as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included bnt162b2 as dose 1 for covid-19 immunisation. On an unspecified date, the patient experienced hot flashes, leg pain, back again aching, i was confused, chills/ mild shivers and fever. The patient stated that she had chills and hot flashes in the night and from morning she showed fever and it kind of went up to 103 and she took a Tylenol (treatment), fever and leg pain that was in the morning. So, after taking Tylenol she felt good. Again from an hour, one hour, one and half hour she experienced mild shivers and her back again aching and she had again showing 102. The patient reported that she was confused. The patient underwent lab tests which included body temperature: 103 fahrenheit and 102 fahrenheit on an unknown date. Therapeutic measures were taken as a result of fever.  The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Hot flashes; Leg pain; back again aching; I was confused; Chills/ mild shivers; Fever; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient).  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0164) via an unspecified route of administration on 26Apr as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included bnt162b2 as dose 1 for covid-19 immunisation. On an unspecified date, the patient experienced hot flashes, leg pain, back again aching, i was confused, chills/ mild shivers and fever. The patient stated that she had chills and hot flashes in the night and from morning she showed fever and it kind of went up to 103 and she took a Tylenol (treatment), fever and leg pain that was in the morning. So, after taking Tylenol she felt good. Again from an hour, one hour, one and half hour she experienced mild shivers and her back again aching and she had again showing 102. The patient reported that she was confused. The patient underwent lab tests which included body temperature: 103 fahrenheit and 102 fahrenheit on an unknown date. Therapeutic measures were taken as a result of fever.  The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Nasal congestion
Clinical narrative: I have had some nasal congestion but its allergy; I have had some nasal congestion but its allergy; This is a spontaneous report from a Pfizer Sponsored program. This is a spontaneous report from a contactable Consumer (patient). A 40-year-old female received bnt162b2 (Pfizer-biontech COVID-19 vaccine, Solution for injection, Batch/lot number: LNER8737) via an unspecified route of administration on 07Apr2021 as DOSE 1, SINGLE for COVID-19 immunization (at an age of 40 years). The patient medical history was nasal congestion but its allergy and concomitant were not reported . On an unknown date in Apr2021 the patient had experienced some nasal congestion but its allergy. Patient has an query ,wanted to ask her second dose is scheduled tomorrow for the last week she have had some nasal congestion but its allergy. She gets this every year. She was not experiencing any other symptoms or anything like that. she wants to make sure its ok for her to still get her second vaccine. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.          No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Heart rate, Palpitations, Pyrexia
Clinical narrative: Injection site pain; Chills; Fever; Heart racing; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. Medical history included covid-19 from 17Jan2021 to an unknown date she reports that she had the Covid virus on 17Jan2021, before the Covid vaccine, and her heart rate was up to 132 beats per minute. The patient's concomitant medications were not reported.  The patient experienced injection site pain, chills, fever on an unspecified date with outcome of unknown, 15 minutes to an hour after the vaccine she had her heart racing she didn't notice it until last night which is usually high, around 80 to 90 beats per minute anyway on an unspecified date. The patient underwent lab tests and procedures which included body temperature: unknown on an unspecified date, heart rate: 132/min 132 beats on 17Jan2021, 80 to 90 beats per minute on an unspecified date.. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; Chills; Fever; Heart racing; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. Medical history included covid-19 from 17Jan2021 to an unknown date she reports that she had the Covid virus on 17Jan2021, before the Covid vaccine, and her heart rate was up to 132 beats per minute. The patient's concomitant medications were not reported.  The patient experienced injection site pain, chills, fever on an unspecified date with outcome of unknown, 15 minutes to an hour after the vaccine she had her heart racing she didn't notice it until last night which is usually high, around 80 to 90 beats per minute anyway on an unspecified date. The patient underwent lab tests and procedures which included body temperature: unknown on an unspecified date, heart rate: 132/min 132 beats on 17Jan2021, 80 to 90 beats per minute on an unspecified date.. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Glycosylated haemoglobin, Headache, Pyrexia
Clinical narrative: Slight Headache; Extreme Chills; Fever was 101; Weakness in my body was to the point where I  could not get up; This is a spontaneous report from a contactable consumer (patient himself). A 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0171; Expiration Date: unknown) via an unspecified route of administration on 22Apr2021 (at the age of 61-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included diabetes mellitus and hypertension from an unknown date and unknown if ongoing. Concomitant medications included lisinopril (LISINOPRIL) taken for hypertension and insulin (INSULIN) taken for diabetes mellitus. It was reported that patient had taken the first shot of Pfizer vaccine and he just wanted to report that 24 hours after the shot he had the adverse reactions. On 23Apr2021 he had extreme chills, fever was 101, the weakness in his body was to the point where he could not get up, slight headache. The patient underwent lab tests and procedures which included glycosylated haemoglobin (A1C): 11 on 22Apr2021 and pyrexia: normal on 23Apr2021. The outcome of all events was unknown. No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: a small swelling underneath left armpit; a pain underneath left armpit; This is a spontaneous report from a contactable consumer. This 52-year-old female consumer(patient) reported for herself. A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE; formulation: solution for injection, Lot Number: ER8730 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 as DOSE 1, SINGLE followed by patient also took bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE; formulation: solution for injection, Lot Number: ER8736 and expiration date was not reported) dose 2 via an unspecified route of administration, administered in left arm on 26Apr2021 as DOSE 2, SINGLE (at the age of 52-years-old) both for COVID-19 immunization. The patient medical history included diabetes, and hypertension. Concomitant medications included lisinopril (tablet 12.5 mg, 1x/day) taken for hypertension from an unspecified start date and ongoing, patient did not remember the start date and specified it has been long time, many years ago; and metformin (tablet, 500 mg, 2x/day) taken for diabetes from an unspecified start date and ongoing. On an unspecified date of 2021, the patient experienced a pain, a small swelling underneath left armpit. The patient had side effects from both the doses. From the first, one the patient had the same thing and after second vaccine, the same thing had occurred. The patient did not report the 1st one but did have same dose, the same side effect from the first and the second shot. Therapeutic measures were taken as a result of the events and treatment for events included Tylenol 250 mg, 2 of them once a day orally. The patient queries whether to visit the doctor and stated would go to private practitioner. The patient considered that the events were related to the COVID-19 vaccine. The clinical outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity
Clinical narrative: After the first vaccine she had pain on her arm after the first couple of hours; She has recovered completely from the bruises from the first vaccine; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:55 (at the age of 50-years-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included blood cholesterol from an unknown date. No family history. Vaccination Facility Type: caller stated it was like an area where they have groups for the vaccine. Vaccine Administered at Facility? No, it's like one of those places they have concerts. On 02Apr2021, after the first vaccine she had pain on her arm after the first couple of hours. It started on 02Apr2021 then went away on 04Apr2021. She had recovered completely from the bruises. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in Left arm on 23Apr2021 (at the age of 50 years-old) as dose 2, single for COVID-19 immunization. No prior vaccinations within 4 weeks. The outcome of pain in extremity was recovered on 04Apr2021 and out come of bruises was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in extremity, Pyrexia
Clinical narrative: headache; Fever; It's the extremities, from her wrist to the tips of her fingers and around her ankles to her toes; joint pain in fingers, hands, wrists, feet and toes/It's not like her entire body hurts, it's her shoulders, hips and elbows; It's the extremities, from her wrist to the tips of her fingers and around her ankles to her toesIt's the extremities, from her wrist to the tips of her fingers and around her ankles to her toes; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0162) via an unspecified route of administration, administered in Arm Left on 16Apr2021 14:00 (at the age of 42-year-old) as single dose for COVID-19 immunization. Medical history included ongoing hypothyroidism diagnosed in 2016. Concomitant medication(s) included levothyroxine taken for hypothyroidism from 2016 and ongoing. The patient did not have any history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient took the 1st dose on 16Apr2021, and it will be 2 weeks. The first evening (16Apr2021) was the worst headache she had ever felt in her life. She had a bad headache the next day, it lingered then it was fine. Then on the 17,18,19 headache got better. She prepared herself. She was running a fever and was not used to that. She had pain in her joints of her fingers, hands, wrist, feet and toes. It was not so painful that she could not function. The joint pain began a week after the shot, because her headache was so intense, she thinks it began the week of the 19th at midweek. If she takes Tylenol, it helps. It was definitely there. Patient worked as a medical writer and spend a lot of time on a computer, so it was definitely bothersome to her. She described it as trying to grip something, like holding a jar to open it. It was hurtful. Squeezing a lemon, these were mundane things, and nothing new to her. She wanted to build her immunity, and it was better to get the vaccine than get the infection and not be able to fight it. Patient enquired if other people experienced this kind of symptom. She knew headache, fever, body ache and fatigue. It's not like her entire body hurts, it's her shoulders, hips and elbows. It's the extremities, from her wrist to the tips of her fingers and around her ankles to her toes. AE(s) did not require a visit to Emergency Room or Physician Office. Her 2nd shot was scheduled for 07May2021. The patient had no relevant tests. Outcome of the event headache was recovered on 20Apr2021; fever was unknown; other events was not recovered.  No follow-up attempts are needed. No further information is expected
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Rash, Swelling, Vaccination site erythema, Vaccination site pain
Clinical narrative: Warm at injection site; Soreness under left armpit; Swelling under armpit; Rash on her neck and chest on left side; Injection site swelling; Redness around injection site; Little tender at injection site; This is a spontaneous report from a contactable consumer (herself). A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown) dose 1 via an unspecified route of administration, administered in Arm Left on 18Apr2021 15:45 as DOSE 1, SINGLE for covid-19 immunisation (at the age 45 years). Medical history included hypertension (Verbatim: High blood pressure), anxiety (Verbatim: Anxiety). The patient's concomitant medications were not reported. The patient previously took penicillin nos and experienced hypersensitivity, wellbutrin and experienced hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No history of all previous immunization with the Pfizer vaccine considered as suspect. The patient previously took flu shot at the age of 44. Caller stated the lot number is either EW0171 or EW0121, but it is probably more EW0171. Caller stated she also sees PS1285 which is on the same line as product name slash manufacturer. Caller stated she has high blood pressure, general allergies, and anxiety but she does not think they are relevant to her symptoms. The patient experienced injection site swelling, redness around injection, little tender at injection site, rash on her neck and chest on left side on 24Apr2021, soreness under left armpit, swelling under armpit on 27Apr2021 and warm at injection site on 28Apr2021. Caller stated just the normal symptoms of tenderness and pain in the arm. Caller stated she is calling about the COVID 19 vaccine. Caller stated she had the first dose on 18Apr2021 and she did not actually start getting any reactions until 24Apr2021 and she definitely has injection site swelling and redness around the injection site also at the site it is a little tender and hot. Caller stated she also has a rash on her neck and chest on the left side but it is a mild rash and then soreness under her left armpit which she thinks is just her lymph nodes and swelling too under her armpit. The patient did not received any treatment for all the events. The patient did not visit any emergency room or physician office. The clinical outcome of all the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm at injection site; Soreness under left armpit; Swelling under armpit; Rash on her neck and chest on left side; Injection site swelling; Redness around injection site; Little tender at injection site; This is a spontaneous report from a contactable consumer (herself). A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown) dose 1 via an unspecified route of administration, administered in Arm Left on 18Apr2021 15:45 as DOSE 1, SINGLE for covid-19 immunisation (at the age 45 years). Medical history included hypertension (Verbatim: High blood pressure), anxiety (Verbatim: Anxiety). The patient's concomitant medications were not reported. The patient previously took penicillin nos and experienced hypersensitivity, wellbutrin and experienced hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No history of all previous immunization with the Pfizer vaccine considered as suspect. The patient previously took flu shot at the age of 44. Caller stated the lot number is either EW0171 or EW0121, but it is probably more EW0171. Caller stated she also sees PS1285 which is on the same line as product name slash manufacturer. Caller stated she has high blood pressure, general allergies, and anxiety but she does not think they are relevant to her symptoms. The patient experienced injection site swelling, redness around injection, little tender at injection site, rash on her neck and chest on left side on 24Apr2021, soreness under left armpit, swelling under armpit on 27Apr2021 and warm at injection site on 28Apr2021. Caller stated just the normal symptoms of tenderness and pain in the arm. Caller stated she is calling about the COVID 19 vaccine. Caller stated she had the first dose on 18Apr2021 and she did not actually start getting any reactions until 24Apr2021 and she definitely has injection site swelling and redness around the injection site also at the site it is a little tender and hot. Caller stated she also has a rash on her neck and chest on the left side but it is a mild rash and then soreness under her left armpit which she thinks is just her lymph nodes and swelling too under her armpit. The patient did not received any treatment for all the events. The patient did not visit any emergency room or physician office. The clinical outcome of all the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Feeling hot, Neck pain, Pain in extremity
Clinical narrative: my arm is swollen and have like a  welt on the side  and it's hot; my arm is swollen and have like a  welt on the side  and it's hot; my arm is swollen and have like a  welt on the side  and it's hot; my arm is sore the whole top of my arm is swollen; still like experiencing headache sinus pain like in a neck ya neck pain; like severe tiredness and cough; like severe tiredness and cough; still like experiencing headache sinus pain like in a neck ya neck pain; still like experiencing headache sinus pain like in a neck ya neck pain; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0164, Expiry date: Unknown, NDC and UPC number: Unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. No investigation assessment was given. Medical history included depression. Concomitant medication(s) included ongoing Wellbutrin dose 20 mg taken for depression; Celexa one time a day, still taking, it's been couple of years. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number was not reported) dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, after second shot of the Pfizer vaccine had side effects after six days the patient experienced my arm was swollen and have like a welt on the side and it's hot, my arm was sore the whole top of my arm was swollen, still like experiencing headache sinus pain like in a neck ya neck pain, like severe tiredness and cough. The clinical outcome of the events was reported as unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Sinus headache, Sinus pain, Urticaria
Clinical narrative: my arm is swollen and have like a  welt on the side  and it's hot; my arm is swollen and have like a  welt on the side  and it's hot; my arm is swollen and have like a  welt on the side  and it's hot; my arm is sore the whole top of my arm is swollen; still like experiencing headache sinus pain like in a neck ya neck pain; like severe tiredness and cough; like severe tiredness and cough; still like experiencing headache sinus pain like in a neck ya neck pain; still like experiencing headache sinus pain like in a neck ya neck pain; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0164, Expiry date: Unknown, NDC and UPC number: Unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. No investigation assessment was given. Medical history included depression. Concomitant medication(s) included ongoing Wellbutrin dose 20 mg taken for depression; Celexa one time a day, still taking, it's been couple of years. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number was not reported) dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, after second shot of the Pfizer vaccine had side effects after six days the patient experienced my arm was swollen and have like a welt on the side and it's hot, my arm was sore the whole top of my arm was swollen, still like experiencing headache sinus pain like in a neck ya neck pain, like severe tiredness and cough. The clinical outcome of the events was reported as unknown.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: Right arm hurts really bad; Right shoulder hurts; Right neck hurts; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 15Apr2021 09:30 (at the age of 54-years-old) as a single dose for covid-19 immunization. Medical history included ongoing diabetes mellitus - diagnosed 15 years ago, lower limb fracture -in a wheelchair because she broke her leg that had nothing to do with the Pfizer Covid 19 vaccine. Stated that she got the Pfizer Covid 19 vaccine after she broke her leg. Concomitant medication(s) included insulin aspart (NOVOLOG) taken for diabetes mellitus. On 15Apr2021 12:30, the patient had first shot 13 days ago, her right arm hurts really bad. Stated also her right shoulder and right side of her neck hurts. Stated that she is supposed to get it on 06 May. Stated that she is getting the second one and wanted to know if she should get it in the same arm. Patient is very grateful for the vaccine. Stated that her right arm, shoulder and neck started hurting in the first 3 hours. The adverse event did not resulted in any visit emergency room or physician office. Outcome of the event right shoulder hurts was unknown and rest was not recovered, at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Body aches and temperature after first dose; Body aches and temperature after first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6206, Expiry date was not reported) via an unspecified route of administration, administered in the left arm on 12Mar2021 (age at the time of vaccination was 49-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included coronavirus infection from May2020 to an unknown date, hives from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 13Mar2021, the patient experienced normal body aches and temperature, states it only lasted 10 hours and went away. The patient underwent lab tests and procedures which included body temperature was she experienced normal body aches and temperature on 13Mar2021. The outcome for the events was resolved.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose decreased, Illness, Pyrexia
Clinical narrative: Low Blood sugar; had the fever after given half an hour suddenly; I got really sick; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 20Apr2021 (at the age of 25-years-old) as dose 1, single for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. It was reported that patient had the vaccine (Further clarification was unknown hence captured as unspecified vaccine) shot on tuesday and wednesday night on 21Apr2021 around 6pm he started having really he guess bad effects like he got low blood sugar. He got really sick. He actually had the fever after given half an hour suddenly. He was wandering is this the allergic reaction to shot. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Bronchitis, Cough, Investigation, Oxygen saturation
Clinical narrative: terrible cough; She has inflammation of the bronchiol tubes; chronic asthma; This is a spontaneous report from a contactable consumer (patient) received via Pfizer Sponsored Program Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on 09Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported that she developed a terrible cough 2 weeks after (Mar2021) getting first dose. She has chronic asthma, inflammation of the bronchial tubes (2021). She got some tests done, her lungs were clear and the oxygen in her blood was okay. She wanted to know if that was happening because of the vaccine. The patient underwent lab tests and procedures which included investigation: her lungs were clear and the oxygen in her blood was okay and oxygen saturation: oxygen in her blood was okay on an unspecified date in 2021. The clinical outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bronchitis, Cough, Dyspnoea
Clinical narrative: terrible cough; She has inflammation of the bronchiol tubes; chronic asthma; This is a spontaneous report from a contactable consumer (patient) received via Pfizer Sponsored Program Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on 09Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported that she developed a terrible cough 2 weeks after (Mar2021) getting first dose. She has chronic asthma, inflammation of the bronchial tubes (2021). She got some tests done, her lungs were clear and the oxygen in her blood was okay. She wanted to know if that was happening because of the vaccine. The patient underwent lab tests and procedures which included investigation: her lungs were clear and the oxygen in her blood was okay and oxygen saturation: oxygen in her blood was okay on an unspecified date in 2021. The clinical outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: fever; Vomiting; This is a spontaneous report from a non-contactable consumer. A 16-Years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: not reported) on an unspecified date via an unspecified route of administration as DOSE 2, single for covid-19 immunisation. Patient medical history and concomitant medication was not reported. On an unspecified date, after the second dose, the patient experienced Vomiting and fever. Treatment information not reported. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Culture, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: runny nose; fever; arm pain; sore throat; the second dose the symptoms got worse; This is a spontaneous report received from a contactable consumer (patient).  A 35-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 20Apr2021 as single dose for COVID-19 immunization. Reportedly, patient received the second dose of the Pfizer Covid 19 vaccine 14 days ago. The next day patient had a fever and arm pain that lasted 2 days, five days later patient had a sore throat that hasn't gone and 3 days ago patient started with a runny nose. Patient asked if it was normal and how long will it last? Patient went to the doctor and took antihistaminics, ibuprofen, Tylenol and does not feel any improvement. Patient had same symptoms after the first dose and went to the doctor, he suggested a throat culture and everything went well, but after the second dose the symptoms got worse. Outcome of the events were unknown.  No follow-up attempts are needed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: runny nose; fever; arm pain; sore throat; the second dose the symptoms got worse; This is a spontaneous report received from a contactable consumer (patient).  A 35-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 20Apr2021 as single dose for COVID-19 immunization. Reportedly, patient received the second dose of the Pfizer Covid 19 vaccine 14 days ago. The next day patient had a fever and arm pain that lasted 2 days, five days later patient had a sore throat that hasn't gone and 3 days ago patient started with a runny nose. Patient asked if it was normal and how long will it last? Patient went to the doctor and took antihistaminics, ibuprofen, Tylenol and does not feel any improvement. Patient had same symptoms after the first dose and went to the doctor, he suggested a throat culture and everything went well, but after the second dose the symptoms got worse. Outcome of the events were unknown.  No follow-up attempts are needed. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fever; Fatigue; Headache; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP.  A 60-years-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EN6203) via an intramuscular route of administration, administered in Arm Left on 10Mar2021 at 18:00 (age at the time of vaccination was 60 years old), as DOSE 2, SINGLE dose for COVID-19 immunization at Public Health Clinic/ Veterans Administration Facility. The relevant medical history included High blood pressure, Depression, High cholesterol, and Heart condition; all were ongoing from an unspecified date. Concomitant medications were not reported. The patient had no other vaccinations within four weeks prior to the first administration vaccine. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EL9266) via an intramuscular route of administration, administered in Arm Left on 17Feb2021 at 12:00, as a DOSE 1, SINGLE dose for COVID-19 immunization. Vaccine was not administered at Military Facility. Other Product were reported as no. On 11Mar2021, the patient experienced Fever, Fatigue and Headache. No treatment was received for adverse events. Emergency Room visit was not required. The clinical outcome of Fever was Resolved on 14Mar2021, clinical outcome of Headache was Resolved on 16Mar2021, while the clinical outcome of Fatigue was Resolving.  No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Rash
Clinical narrative: Cold and cough; Cold and cough; She developed a rash, and it has progressed to different places on her body. He states it is now on her legs, knees, arms, and hand.; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (husband).  A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: ER2613) via an unspecified route of administration, in arm left on 19Apr2021 at 11:30 as dose 1, single (age at vaccination 78 years) for covid-19 immunisation. Medical history included ongoing high blood pressure, was diagnosed 35 years ago; ongoing hypothyroidism was diagnosed 35 years ago, ongoing bloating around midsection, she was allergic to eggs, so flu shots made her sicker than dogs, the patient was in a wheel chair and the reporter had to get her around in that. The patient previously took sulfa drugs and had allergic reaction. The patient took Armor for a real long time for hypothyroidism. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for hypothyroidism within the past year since an unknown date, orally; atenolol taken for high blood pressure since an unknown date and ongoing; furosemide taken orally for bloating around her midsection since an unknown date and ongoing. On an 26Apr2021 the patient experienced Cold and cough, She developed a rash, and it has progressed to different places on her body. He states it is now on her legs, knees, arms, and hand. The patient experienced rashes after getting first dose. It was reported that a week later from getting the vaccine she developed a rash, and it had progressed to different places on her body. The reporter stated it was now on her legs, knees, arms, and hand. He stated that it originally just showed up on the side of her elbow but then progressively started spreading all over. He stated that it had not gone to her face yet. He stated that wife had a cold and she was coughing and he was having a hard time hearing over her. He stated that it was an allergy cold and she got them every other month. It started 26Apr2021 and was still ongoing and persisting. There was no history of previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. Patient scheduled for the second dose 13May2021. The events did not require a visit to emergency room or physician office. The prior vaccinations (within 4 weeks) were not reported. The patient's family medical history relevant to events was not reported. There were no relevant tests. The outcome of the events was not recovered.  Description of complaint:  Furosemide: The reporter stated the patient was bloated around the midsection and the doctor can't get the excesses water out of her. He stated that it was very uncomfortable for her. He also stated that she was allergic to eggs, so flu shots made her sicker than dogs.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: she has pain in her arm; it's swollen; pain in her neck; red and hard; This is a spontaneous report from a contactable consumer (patient) from a Pfizer- sponsored program. This contactable consumer reported for herself that a female patient of an unspecified age 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's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced, she has pain in her arm, it was swollen, red and hard and had pain in her neck. No treatment was received for events. She wants to know if this was normal. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Pain
Clinical narrative: Achiness when walking up and down stairs; Chills; Lingering cough; This is a spontaneous report from a contactable consumer (patient's mother). A male patient of an unspecified age received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Reported, Expiry Date: Not Reported), via an unspecified route of administration on an unspecified date as dose 1, single, for covid-19 immunisation. The patient medical history included covid-19. The patient's concomitant medications were not reported. On an unspecified date the patient experienced achiness when walking up and down stairs, chills, and lingering cough. The patient's mother was calling on behalf of her son regarding the Covid 19 vaccine. She was checking for her son. She had some generic questions. Her son had the Covid 19 virus and before he returned to work, he had to get a negative Covid 19 virus test. Sixteen days after he was diagnosed with the Covid 19 virus he was able to get his first Covid 19 vaccine. She was asking if that was ok. He had his first dose and like everyone else getting the vaccine he had some side effects, normal side effects. That was about two weeks ago. He was not due for his second Covid 19 vaccine until next week. All of a sudden, he was getting his side effects again. He was having achiness when walking up and down steps. He had chills but no fever. And he had a lingering cough. These are the same side effects he had when he first got the vaccine. Is that possible. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Hypersensitivity, Nausea, Pain in extremity
Clinical narrative: my ears are like red, my chest is like not a rash but you can tell that it is red; ears are itchy; palm of my hand is real itchy; my cheeks are like swollen; rubbing my hands and my face, I mean it's itchy; nauseated; bad headache; my hand was hurting a little bit; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced ears are like red, ears are itchy and palm of her hand was real itchy and her face, when she rub her nose (incomplete sentence), her cheeks were like swollen and chest was like not a rash but you can tell that it was red, rubbing my hands and my face, she meant it's itchy nauseated, bad headache and allergic reaction. The patient stated that got the shot between 5 or 6 (Clarification unknown) and then she started noticing like oh my god, she just waited for like 2-3 minutes and then noticed her hand was hurting a little bit but not as bad and then it wasn't event 2-3 hours that she started itching. It was reported that the patient got her shot received at about 10 something in the Pharmacy and the problem was her ears are like red, ears are itchy and palm of her hand was real itchy, her face, it was like when I rub her nose (incomplete sentence), her cheeks were like swollen and chest was like not a rash but you can tell that it was red. When they were on the car for home, she told her brother that she needs air. She felt like she was car sick and it anyway 'she doubted' (Clarification unknown) about the allergic reaction and she was laying down and watching TV but still kept rubbing her hands and face, she meant it's itchy. She was nauseated earlier, she not now just had a bad headache. She asked would the itching go away and if she should take a hot shower and it will just stop, should she just wait to see if this goes away. When asked about lot number, she replied that the number they gave on the card. , that Pharmacy would be. Was not on the vaccination card. That was the only number on the card, and then call hung abruptly. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.