chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Crying, Feeling hot, Headache
Clinical narrative: woke up writhing in pain; had chills so bad my teeth were chattering; had fevers through night; headache 6/10 /My head hurt so bad 10/10; thought I would throw up; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; muscle and bone aches; muscle and bone aches; I was just crying; This is a spontaneous report from a contactable nurse, the patient.  A 49-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3302, intramuscular in the left arm on 18Jan2021 at 12:45 (at the age of 49-years-old) as a single dose for COVID-19 vaccination.  Medical history included hyperthyroidism from an unknown date. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included Levothyroxine, Liothyronine, CoQ10, McIntyre Vit D, and Probiotics all from unspecified dates for unspecified indication. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL1284, intramuscular in the left arm on 28Dec2020 at 09:00 as a single dose for COVID-19 vaccination. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. On 19Jan2021 at 12:30, the patient experienced writhing in pain and had chills so bad her teeth were chattering. She had fevers through night. From 12:30-4 am. Her head hurt so bad 10/10 she was just crying and thought she would throw up. Her arm was dead weight, she couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch. This morning just muscle and bone aches and headache 6/10. The patient  did not receive treatment for the events. The clinical outcome of the events writhing in pain and had chills so bad her teeth were chattering. She had fevers through night. From 12:30-4 am. Her head hurt so bad 10/10 she was just crying and thought she would throw up. Her arm was dead weight, she couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Limb discomfort, Myalgia, Nausea, Pain
Clinical narrative: woke up writhing in pain; had chills so bad my teeth were chattering; had fevers through night; headache 6/10 /My head hurt so bad 10/10; thought I would throw up; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; muscle and bone aches; muscle and bone aches; I was just crying; This is a spontaneous report from a contactable nurse, the patient.  A 49-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3302, intramuscular in the left arm on 18Jan2021 at 12:45 (at the age of 49-years-old) as a single dose for COVID-19 vaccination.  Medical history included hyperthyroidism from an unknown date. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included Levothyroxine, Liothyronine, CoQ10, McIntyre Vit D, and Probiotics all from unspecified dates for unspecified indication. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL1284, intramuscular in the left arm on 28Dec2020 at 09:00 as a single dose for COVID-19 vaccination. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. On 19Jan2021 at 12:30, the patient experienced writhing in pain and had chills so bad her teeth were chattering. She had fevers through night. From 12:30-4 am. Her head hurt so bad 10/10 she was just crying and thought she would throw up. Her arm was dead weight, she couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch. This morning just muscle and bone aches and headache 6/10. The patient  did not receive treatment for the events. The clinical outcome of the events writhing in pain and had chills so bad her teeth were chattering. She had fevers through night. From 12:30-4 am. Her head hurt so bad 10/10 she was just crying and thought she would throw up. Her arm was dead weight, she couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Sensitive skin
Clinical narrative: woke up writhing in pain; had chills so bad my teeth were chattering; had fevers through night; headache 6/10 /My head hurt so bad 10/10; thought I would throw up; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; muscle and bone aches; muscle and bone aches; I was just crying; This is a spontaneous report from a contactable nurse, the patient.  A 49-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3302, intramuscular in the left arm on 18Jan2021 at 12:45 (at the age of 49-years-old) as a single dose for COVID-19 vaccination.  Medical history included hyperthyroidism from an unknown date. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included Levothyroxine, Liothyronine, CoQ10, McIntyre Vit D, and Probiotics all from unspecified dates for unspecified indication. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL1284, intramuscular in the left arm on 28Dec2020 at 09:00 as a single dose for COVID-19 vaccination. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. On 19Jan2021 at 12:30, the patient experienced writhing in pain and had chills so bad her teeth were chattering. She had fevers through night. From 12:30-4 am. Her head hurt so bad 10/10 she was just crying and thought she would throw up. Her arm was dead weight, she couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch. This morning just muscle and bone aches and headache 6/10. The patient  did not receive treatment for the events. The clinical outcome of the events writhing in pain and had chills so bad her teeth were chattering. She had fevers through night. From 12:30-4 am. Her head hurt so bad 10/10 she was just crying and thought she would throw up. Her arm was dead weight, she couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain where injections was given; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he had the injection yesterday (unspecified date in Jan2021) and saw that one of side effects is pain where injections was given, which is the only side effect he has had. The outcome of event was unknown.  Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient tested positive for Covid after receiving the first dose; patient tested positive for Covid after receiving the first dose; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 7 patients. This report is for 5th of 7 patient.   A patient of unspecified age and gender received the first dose of BNT162B2 (BNT162B2 also reported as Pfizer Covid vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer reported that 7 coworkers was tested positive for COVID after receiving first dose of the Pfizer Covid vaccine on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045622 same drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient tested positive for Covid after receiving first dose; patient tested positive for Covid after receiving first dose; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 7 patients. This report is for the 7th of 7 patients.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number and expiry date were not reported, via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that patient tested positive for Covid after receiving first dose of the Pfizer Covid vaccine on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045622 same reporter, drug and event, different patient
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This is a spontaneous report from a contactable consumer (patient). A 97-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, 07Jan2021 at a single dose for COVID-19 immunization  Medical history included cardiac failure congestive. The patient's concomitant medications were not reported. Patient was not pregnant at time of vaccination. The patient previously took quinine and experienced allergy. The patient experienced nausea starting approximately 1 week after shot on 15Jan2021 and continuing for 5 days. Outcome of the event was recovering. No treatment was received. The event was considered non-serious. Patient was not diagnosed with COVID-19 prior to vaccination.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 19Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable healthcare professional (patient herself) received from a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if it is okay to take the 2nd dose after taking ibuprofen. She mentioned that she did not feel anything after the 1st dose aside from sore arm. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain of skin, Rash
Clinical narrative: breaking out on the skin/ the pain on the skin; breaking out on the skin/ the pain on the skin; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported a male patient of an unspecified received bnt162b2 (), via an unspecified route of administration from Jan2021 at a single dose for Covid-19 immunization.  The patient medical history and concomitant medications were not reported. The patient got the vaccine yesterday and he is experiencing breaking out on the skin. Her husband already took diphenydramine yesterday, which is an antihistamine to reduce the pain on the skin. His doctor advised not to take the second dose of the vaccine. She is asking if he can take the second dose. She knows two doses are needed of the vaccine, she is asking what his other option would be. Outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: she had a high fever of 102 degrees. She said she had a high fever all night, and her fever was a little less this morning. She said her last temperature was 100.6; Ache/ Pain/ lingering body aches; Chills; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248 and expiry date: Apr2021), via an unspecified route of administration on right upper arm on 14Jan2021 12:10 at a single dose for COVID-19 immunization. Medical history included ongoing Blood pressure high diagnosed 8-10 years ago and Arthritis for between 10-15 years started in her finger, and then progressed to other areas of her body. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications included Gabapentin. The patient did take her regular prescription medication, Gabapentin last night (14Jan2021; She takes 1 Gabapentin 100mg capsule before she goes to bed each night). On 14Jan2021 19:30, the patient experienced fever of 102 F, chills, body aches and fatigue, lasting all night. Then Fever of 100.6 F during the day (15Jan2021), with some lingering body aches. The patient reported that she had a high fever of 102 degrees. She said she had a high fever all night, and that her fever was a little lower this morning (15Jan2021). She said she checked her temperature a short time ago, and her temperature was 100.6. She said last night (14Jan2021), she had bad aches, pains, chills, and fatigue. She clarified she had a lot of little aches and pains. She said she was not sure if the aches were muscle or joint. She said her aches, pains, chills and fatigue did improve today (15Jan2021). The patient declined any treatment for the events. Reported she was told to not to take anything to treat any symptoms she may experience after receiving the COVID-19 Vaccine. She clarified she was told if her arm hurts at the location she received the COVID-19 Vaccine injection, to not take anything for the arm pain. She said the aches and pains she experienced last night after receiving the COVID-19 Vaccine went to her arthritis spots. The vaccination facility type was hospital. The events did not require a visit to Emergency Room or Physician Office. No prior vaccinations (within 4 weeks). No COVID prior vaccination. Patient was not COVID tested post vaccination. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of an unspecified age reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 15Jan2021, the patient tested positive for a COVID-19 test. The patient was put in isolation. She should receive her second dose on 19Jan2021, but she had to cancel her second shot since she was tested positive and she couldn't go. She called in because she wanted to reschedule her second shot of the vaccine. Local authorities can't give her second dose of vaccine until mid of February. She's trying to find out if it's okay. At the time of the report, the outcome of the events was unknown.  The information on the lot/batch number has been requested.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: right leg was pretty large and swollen in one spot; This is a spontaneous report from a contactable consumer (patient himself). A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EK4176, expiry date unknown), via an unspecified route of administration (left arm), on 13Jan2021, at single dose, for covid-19 immunization (also reported as take it for the epidemic). Medical history included diabetes. Ongoing concomitant medications included insulin aspart (NOVOLOG) and insulin detemir (LEVEMIR) both taken for diabetes for about 5 years. The patient stated that he just got the COVID Vaccine on Wednesday, 13Jan2021, and he had the shot in his arm. He informed that he was a diabetic and where he gives his insulin shots, he would have to move to different spots of his body due to getting hard swelling knots. This morning of 15Jan2021, when he got up, he noticed his right leg was pretty large and swollen in one spot. It was on a side where he does give his insulin shots. It was pretty large. He was wondering if this had anything to do with the COVID Vaccine; he clarified that he got the shot in his left arm. The spot was on his right leg and was pretty large and swollen, it was about the size of an egg or a little larger. He added that he does give insulin shots in both his left and his right leg. After so long of giving shots in one spot, he will notice he has been getting hard spots around there. However, this spot was different, it was way larger. Again, the size of an egg. The only difference was the size. No treatment was received for the adverse event reported. The outcome of the event was not recovered.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Groin pain, Headache, Myalgia
Clinical narrative: Soreness at the injection site; Pain and soreness in armpits and groin; Pain and soreness in armpits and groin; Headache; Fatigue; Muscle aches; This is a spontaneous report from a contactable other health care professional, the patient.  A 31-year old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), intramuscular, in the left arm on 09Jan2021 at 08:00AM (at the age of 31-year-old) as a single dose for COVID-19 immunization.  Medical history included Penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 592671001), intramuscular, left arm  on 19Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Jan2021 at 18:00 PM, the patient experienced soreness at the injection site, pain and soreness in armpits and groin, headache, fatigue, muscle aches. The patient did not receive treatment for the events. The clinical outcome of the events soreness at the injection site, pain and soreness in armpits and groin, headache, fatigue, muscle aches was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; Pain and soreness in armpits and groin; Pain and soreness in armpits and groin; Headache; Fatigue; Muscle aches; This is a spontaneous report from a contactable other health care professional, the patient.  A 31-year old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), intramuscular, in the left arm on 09Jan2021 at 08:00AM (at the age of 31-year-old) as a single dose for COVID-19 immunization.  Medical history included Penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 592671001), intramuscular, left arm  on 19Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Jan2021 at 18:00 PM, the patient experienced soreness at the injection site, pain and soreness in armpits and groin, headache, fatigue, muscle aches. The patient did not receive treatment for the events. The clinical outcome of the events soreness at the injection site, pain and soreness in armpits and groin, headache, fatigue, muscle aches was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Headache, Influenza like illness, Insomnia
Clinical narrative: Feels like he flu; Had a hard time sleeping because I was uncomfortable; Had a hard time sleeping because I was uncomfortable; Muscle aches; Head ache; Terrible; This is a spontaneous report from a non-contactable consumer. This consumer reported for a male patient (brother in law) A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 17Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced feels like he flu, had a hard time sleeping because i was uncomfortable, muscle aches, head ache, terrible, all in Jan2021 (about 8 hours after the shot). The event outcome was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Feels like he flu; Had a hard time sleeping because I was uncomfortable; Had a hard time sleeping because I was uncomfortable; Muscle aches; Head ache; Terrible; This is a spontaneous report from a non-contactable consumer. This consumer reported for a male patient (brother in law) A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 17Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced feels like he flu, had a hard time sleeping because i was uncomfortable, muscle aches, head ache, terrible, all in Jan2021 (about 8 hours after the shot). The event outcome was unknown.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure measurement, Blood test, Glycosylated haemoglobin, Hypoglycaemia
Clinical narrative: Hypoglycemic event/blood sugar dropped a bit/sweaty/clammy/hands start to shake when blood sugar is low; This is a spontaneous report from a contactable pharmacist (patient). A 43-years-old female patient receive the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 13Jan2021 at 12:30 at a single dose for COVID-19 immunization. Medical history included Type 2 Diabetic-diabetic for six to seven years and have had no hypoglycemic events. There were no concomitant medications. No additional vaccines administered on the same day of the second dose of BNT162B2. Prior vaccination within 4 weeks included the first dose of bnt162b2 on 23Dec2020 at 12:30 (lot number: EH9899). The patient also experienced arm soreness with prior vaccinations (did not provide product names). The patient is a healthcare worker, diabetic and on insulin only. The patient received the second dose of BNT162B2 on 13Jan2021, and in the last two mornings, she had hypoglycemic events. Nothing in her diet or routine has changed. In the morning of 14Jan2021, she was at work in the clinic and her blood sugar dropped but she doesn't know how low she dropped. She ate a chocolate chip cookie to correct her blood sugar. It was corrected to 91; she didn't have her machine with her. On 15Jan2021 at 1030, the patient was sweaty, clammy, and her hands start to shake when her blood sugar gets low. She had three 15gram fruit bars and two sips of Coke before she passed out. The nurses around her were doing blood pressure checks and a STAT blood sugar check. About five to ten minutes after that, her blood sugar was 93. Her blood sugar was checked again, and it was 198. She stated this is not surprising because she overcorrected her blood sugar. The events required a visit to the physician office that day. The patient clarified that she was diagnosed with type 2 diabetes, takes Lantus - dose changes; normal dose is between 40-45 units once a day with the Solostar pen. That morning, the patient was given a dose of 45 units. Humalog with pen for administration (dose: administered 2 units that morning). The patient uses Humalog only as needed. The patient had undergone blood tests and procedures which included blood sugar tests where blood work was drawn at the endocrinologist's office. The tests included A1C, C-peptide, blood sugar, and to verify which kind of diabetes she has; no results to report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation
Clinical narrative: Hypoglycemic event/blood sugar dropped a bit/sweaty/clammy/hands start to shake when blood sugar is low; This is a spontaneous report from a contactable pharmacist (patient). A 43-years-old female patient receive the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 13Jan2021 at 12:30 at a single dose for COVID-19 immunization. Medical history included Type 2 Diabetic-diabetic for six to seven years and have had no hypoglycemic events. There were no concomitant medications. No additional vaccines administered on the same day of the second dose of BNT162B2. Prior vaccination within 4 weeks included the first dose of bnt162b2 on 23Dec2020 at 12:30 (lot number: EH9899). The patient also experienced arm soreness with prior vaccinations (did not provide product names). The patient is a healthcare worker, diabetic and on insulin only. The patient received the second dose of BNT162B2 on 13Jan2021, and in the last two mornings, she had hypoglycemic events. Nothing in her diet or routine has changed. In the morning of 14Jan2021, she was at work in the clinic and her blood sugar dropped but she doesn't know how low she dropped. She ate a chocolate chip cookie to correct her blood sugar. It was corrected to 91; she didn't have her machine with her. On 15Jan2021 at 1030, the patient was sweaty, clammy, and her hands start to shake when her blood sugar gets low. She had three 15gram fruit bars and two sips of Coke before she passed out. The nurses around her were doing blood pressure checks and a STAT blood sugar check. About five to ten minutes after that, her blood sugar was 93. Her blood sugar was checked again, and it was 198. She stated this is not surprising because she overcorrected her blood sugar. The events required a visit to the physician office that day. The patient clarified that she was diagnosed with type 2 diabetes, takes Lantus - dose changes; normal dose is between 40-45 units once a day with the Solostar pen. That morning, the patient was given a dose of 45 units. Humalog with pen for administration (dose: administered 2 units that morning). The patient uses Humalog only as needed. The patient had undergone blood tests and procedures which included blood sugar tests where blood work was drawn at the endocrinologist's office. The tests included A1C, C-peptide, blood sugar, and to verify which kind of diabetes she has; no results to report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Fatigue, Inappropriate schedule of product administration
Clinical narrative: red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; Severe pain from neck to hand, shoulder blade to chest (right side); Severe pain from neck to hand; severe pain from neck to hand, shoulder blade to chest (right side); unable to lift arm above shoulder; second dose received on 12Jan2021; first dose received on 18Dec2020; Chills; fatigue; hive; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular (right arm) on 12Jan2021 (14:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: unknown) intramuscular (right arm) on 18Dec2020 for Covid-19 immunization. Medical history included "known allergies". The patient's concomitant medications were unspecified (received in 2 weeks). The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 (pending clarification), the patient experienced chills, fatigue, and hive. On 13Jan2021 (07:00), the patient experienced severe pain from neck to hand, shoulder blade to chest (right side) and unable to lift arm above shoulder, and hive. On 14Jan2021 (pending clarification), the patient experienced red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination.   Information on the Batch/Lot number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain in extremity, Urticaria, Vaccination site erythema, Vaccination site warmth
Clinical narrative: red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; Severe pain from neck to hand, shoulder blade to chest (right side); Severe pain from neck to hand; severe pain from neck to hand, shoulder blade to chest (right side); unable to lift arm above shoulder; second dose received on 12Jan2021; first dose received on 18Dec2020; Chills; fatigue; hive; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular (right arm) on 12Jan2021 (14:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: unknown) intramuscular (right arm) on 18Dec2020 for Covid-19 immunization. Medical history included "known allergies". The patient's concomitant medications were unspecified (received in 2 weeks). The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 (pending clarification), the patient experienced chills, fatigue, and hive. On 13Jan2021 (07:00), the patient experienced severe pain from neck to hand, shoulder blade to chest (right side) and unable to lift arm above shoulder, and hive. On 14Jan2021 (pending clarification), the patient experienced red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination.   Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 18Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced fever and chills on an unspecified date with outcome of unknown.  The reporter was asking if the patient can take some Motrin or Ibuprofen.
Sex: M
Vaccine: COVID19
Symptoms: Noninfective gingivitis, Pharyngeal inflammation
Clinical narrative: unusual inflammation in the mouth(throat and gums); unusual inflammation in the mouth(throat and gums); This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCIN), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced unusual inflammation in the mouth (throat and gums) in Jan2021, he did not went to see a doctor. He also indicated that he is scheduled to take the second dose but wanted to know if it is safe to proceed. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; feverish and headachy; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced feverish and headachy on an unspecified date. The outcome of the events was unknown. The patient was asking if it was okay to take Tylenol.   Information about Lot / Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in arm that got vaccinated; This is a spontaneous report from a non-contactable consumer (patient) from vacinne. This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 18Jan2021 at single dose for COVID-19 immunization. Patient wanted to know if she could take Advil since she was experiencing pain in her arm that got vaccinated with the Covid-19 vaccine on 18Jan2021. Outcome of event was unknown.  No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Fever/temperature about 101 degrees; Sweating; chills; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3247) on 14Jan2021 at single dose in Left Upper Arm for COVID-19 immunisation.  Medical history was none. There were no concomitant medications. She had vaccine on Thursday 14Jan2021 and last night or probably Saturday into Sunday she experienced the chills and fever. She was fine now, but all day on 17Jan2021 she experienced a fever of a temperature about 101 degrees, she was now back to normal. She had chills and sweating. She took Tylenol. She had her first dose on 14Jan2021. Then the symptoms started either late Saturday on the 16Jan2021 or going into Sunday on 17Jan2021. All she knows was Sunday was when she woke up with the chills and the fever. She was sweating, which started after taking the Tylenol. She took the Tylenol Sunday morning. She stated that no symptoms are ongoing at the moment. She felt good right now, there are No symptoms at the moment. She has had No positive Test for Covid before the vaccine. She had a negative Antibody Test, but it was About a good 6 months ago in 2020. She has had No issues with vaccines in the past. The outcome was recovering.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swollen lump that is quite sore on her left arm; Swollen lump that is quite sore on her left arm; This is a spontaneous report from a contactable Nurse (patient). A 84-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231, Expiry Date: Apr2021) via an unspecified route of administration in Jan2021 at single dose for vaccination. Dose injection to left deltoid around 14:00. Medical history included car wreck, hypertension, scoliosis. Concomitant medication included ongoing celecoxib (CELEBREX) for car wreck, amlodipine besilate, benazepril hydrochloride (AMLODIPINE/BENAZEPRIL) from 2017 and ongoing for anti-hypertension. The patient reported she had the Pfizer COVID-19 Vaccine a week ago and it did not really bother her until she started trying to do exercises of her arm. On 15Jan2021 she had a swollen lump that is quite sore on her left arm that did not go down and it had been 3 days now. She did not have a fever, the area was not red, it's just swollen. She just wanted to know if this event was customary with the product; and if her second dose should be given in a different anatomical location. It was just painful and swollen; had not been hospitalized for this event. She could see the difference, she was quite wrinkled now with age; but at the site of her swollen lump on left arm she had no wrinkles right now. Her second dose is scheduled for 02Feb2021 at 14:20. The outcome of events was not recovered.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cyanosis, Limb discomfort, Peripheral swelling, Skin discolouration
Clinical narrative: Swollen lump that is quite sore on her left arm; Swollen lump that is quite sore on her left arm; This is a spontaneous report from a contactable Nurse (patient). A 84-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231, Expiry Date: Apr2021) via an unspecified route of administration in Jan2021 at single dose for vaccination. Dose injection to left deltoid around 14:00. Medical history included car wreck, hypertension, scoliosis. Concomitant medication included ongoing celecoxib (CELEBREX) for car wreck, amlodipine besilate, benazepril hydrochloride (AMLODIPINE/BENAZEPRIL) from 2017 and ongoing for anti-hypertension. The patient reported she had the Pfizer COVID-19 Vaccine a week ago and it did not really bother her until she started trying to do exercises of her arm. On 15Jan2021 she had a swollen lump that is quite sore on her left arm that did not go down and it had been 3 days now. She did not have a fever, the area was not red, it's just swollen. She just wanted to know if this event was customary with the product; and if her second dose should be given in a different anatomical location. It was just painful and swollen; had not been hospitalized for this event. She could see the difference, she was quite wrinkled now with age; but at the site of her swollen lump on left arm she had no wrinkles right now. Her second dose is scheduled for 02Feb2021 at 14:20. The outcome of events was not recovered.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: Fever/patient had a 100.5 temperature; didn't feel good; This is a spontaneous report from a contactable consumer. An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249 and expiration date not provided), via an unspecified route of administration in the left arm on 14Jan2021 09:00 at a single dose for vaccination. Medical history included Defibrillator and she is on oxygen. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. There were no concomitant medications. When the reporter (patient's caregiver) got to the patient's house on 15Jan2021, the patient had a temperature of 100.5 and did not feel good. She gave the patient 2 paracetamol (TYLENOL), water and put her in bed. She was going to wake her up in a few minutes and will retake her temperature. She would like to know what to do and what do they recommend. It was reported that the patient got her first dose on 14Jan2021 and that night, she was not feeling good but the reporter did not know if the patient took her temperature, and the patient just went to bed. In the morning of 15Jan2021, the reporter got there about 11:00 and when she checked her temperature and found it was 100.5. The patient has a defibrillator and she is on oxygen. The patient had fever of 100.5 on 15Jan2021. The patient is in bed and the reporter wanted to ask for opinion on what to do because she was not familiar with any of this stuff and she just saw the paperwork that they had from the vaccination so she was calling to know what does she need. She gave her 2 TYLENOLs at 11:45 and told the patient that they will see within an hour. The outcome of the event pyrexia was not recovered while the outcome of the event malaise was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Extremity contracture, Myalgia
Clinical narrative: Had weird contractures in hands; shaking chills; fever (up to 101.8); severe joint pain; muscle soreness; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), intramuscular in the left arm on 14Jan2021 11:00 at a single dose for COVID-19 immunization. The patient has no medical history. The patient is not pregnant. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization on an unspecified date. On 14Jan2021 21:00 (reported as after the second dose), the patient developed shaking chills. Shortly after, she started developing fever (up to 101.8) and had weird contractures in hands. She also had severe joint pain. The symptoms lasted for 30 hours. She felt better the next day, just muscle soreness. Treatment was not provided in response to the events. The outcome of the events was recovering. The patient has not tested for COVID post vaccination.   Information on Lot/Batch has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Had weird contractures in hands; shaking chills; fever (up to 101.8); severe joint pain; muscle soreness; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), intramuscular in the left arm on 14Jan2021 11:00 at a single dose for COVID-19 immunization. The patient has no medical history. The patient is not pregnant. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization on an unspecified date. On 14Jan2021 21:00 (reported as after the second dose), the patient developed shaking chills. Shortly after, she started developing fever (up to 101.8) and had weird contractures in hands. She also had severe joint pain. The symptoms lasted for 30 hours. She felt better the next day, just muscle soreness. Treatment was not provided in response to the events. The outcome of the events was recovering. The patient has not tested for COVID post vaccination.   Information on Lot/Batch has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, SARS-CoV-2 test
Clinical narrative: Recurring localized migraine in left temple lasting for over a week; This is a spontaneous report from a contactable healthcare professional (patient). A 24-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on the left arm on 08Jan2021 15:15 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications taken with two weeks included melatonin, birth control, an unspecified inhaler, and vitamins. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the left arm on 20Dec2020 07:30 PM. The patient had no other vaccine in four weeks. The patient had no Covid prior to vaccination. The patient experienced recurring localized migraine in left temple lasting for over a week on 10Jan2021 21:00. Treatment for the event was unknown. The patient underwent Covid test post vaccination on 16Jan2021 with pending result. The outcome of the event was unknown.  Information on the lot/batch number has been requested.