chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pancreatitis
Clinical narrative: I have had pancreatitis before and it felt like the same thing; About 5 hours after I had the Covid shot I experienced severe abdominal pain, really the whole front of my chest below my breasts to my waist.; This is a spontaneous report from a contactable consumer reported for herself. The 73-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Brand: Pfizer, lot number: EN6201) via an unspecified route of administration on 22Feb2021 14:30 on left arm at single dose for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing, pancreatitis from an unknown date and unknown if ongoing, Allergies to medications, food, or other products: codeine, hydrocodone, amoxicillin, provostatin, narcotics, CT scan contrast IV dye.  Concomitant medication included gabapentin, amlodipine, meloxicam, calcium, centru. The patient previously took first dose of bnt162b2 (COVID 19, Brand: Pfizer, lot number: EN5318) on 01Feb2021 01.45 PM on left arm  at single dose for covid-19 immunisation, codeine and experienced drug hypersensitivity, hydrocodone and experienced drug hypersensitivity, amoxicillin and experienced drug hypersensitivity.  The patient experienced "i have had pancreatitis before and it felt like the same thing" on 22Feb2021 08:30AM with outcome of recovered, "about 5 hours after i had the covid shot i experienced severe abdominal pain, really the whole front of my chest below my breasts to my waist" on 22Feb2021 08:30AM with outcome of recovered. Therapeutic measures were taken as a result of the events included IV and blood and urine tests. She is not pregnant or not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The consumer reported that "About 5 hours after I had the Covid shot I experienced severe abdominal pain, really the whole front of my chest below my breasts to my waist. I have had pancreatitis before and it felt like the same thing. I went to the emergency room and indeed had lipase at 3640. The painful part of attack was over within another hour. This was my 5th attack of pancreatitis and I don't know if the vaccination triggered it or not. It is unknown at this time why I have had the pancreatitis attacks. I don't drink or have gall stones." Ae resulted in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, COVID-19, Drug ineffective, Fatigue
Clinical narrative: diagnosed with COVID-19 disease/testing positive/sick/all the nightmares of COVID /felt very ill/COVID took the 3 pounds off/fevers my eyes/body temperature kept dropping; diagnosed with COVID-19 disease/testing positive/sick/all the nightmares of COVID /felt very ill/COVID took the 3 pounds off/fevers my eyes/body temperature kept dropping; some fatigue/tired; stomach upset/stomach was really feeling weak; not feeling real well; nauseous; This is a spontaneous report from a contactable consumer reporting for self. This 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunisation.  Medical history included menopause hormone replacement therapy.  Concomitant medication included progesterone (PROGESTERONE), estradiol (MINIVELLE) for menopause hormone replacement therapy.  The patient received her first injection of the Pfizer-BioNTech vaccine on 23Jan2021. She reported experiencing symptoms of COVID-19 on 09Feb2021 and was diagnosed with COVID-19 disease on 11Feb2021 after testing positive. After the first injection, and prior to getting COVID-19 disease, she did experience some fatigue, stomach upset, and not feeling real well.  It was reported that when she had the first dose the only symptoms was stomach was really feeling weak, just felt extremely tired and nauseous so that was the first and then fine, by the third day she was feeling okay but then unfortunately, on 09Feb2021 and she began getting sick and went for a COVID test and tested positive on 11Feb2021.  She had experienced multiple symptoms due to her COVID-19 disease and had to go to the ER for treatment after they appeared (she went to the emergency room so they didn't keep her there, she was there for maybe 6 hours).  She felt very ill with this COVID, she had been in the hospital twice, she did not, she was not left in ICU that was good for her, but reported that "between the fevers my eyes, I don't know what happened to my eyes but ophthalmologist will be checking it seems to be same and it's been everything that you can ever think as 'hard' and I just want to know if tomorrow I can have the second boost." It was reported that when she was in the hospital because of the, body temperature kept dropping so the doctor send her to the hospital and they did blood test. Patient weight was 135 at that time, now she was 131. She thought COVID took the 3 pounds off. Her second dose of the Pfizer-BioNTech vaccine was cancelled due to her illness and now her second dose is scheduled for tomorrow (25Feb2021). The patient reported she is only now starting to feel a lot better, that she was really sick for 15 days. Today (24Feb2021) was the first day that she was feeling a little bit better from all the symptoms and all the nightmares of the COVID illness.  The outcome of events was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Malaise, Nausea, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID-19 disease/testing positive/sick/all the nightmares of COVID /felt very ill/COVID took the 3 pounds off/fevers my eyes/body temperature kept dropping; diagnosed with COVID-19 disease/testing positive/sick/all the nightmares of COVID /felt very ill/COVID took the 3 pounds off/fevers my eyes/body temperature kept dropping; some fatigue/tired; stomach upset/stomach was really feeling weak; not feeling real well; nauseous; This is a spontaneous report from a contactable consumer reporting for self. This 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunisation.  Medical history included menopause hormone replacement therapy.  Concomitant medication included progesterone (PROGESTERONE), estradiol (MINIVELLE) for menopause hormone replacement therapy.  The patient received her first injection of the Pfizer-BioNTech vaccine on 23Jan2021. She reported experiencing symptoms of COVID-19 on 09Feb2021 and was diagnosed with COVID-19 disease on 11Feb2021 after testing positive. After the first injection, and prior to getting COVID-19 disease, she did experience some fatigue, stomach upset, and not feeling real well.  It was reported that when she had the first dose the only symptoms was stomach was really feeling weak, just felt extremely tired and nauseous so that was the first and then fine, by the third day she was feeling okay but then unfortunately, on 09Feb2021 and she began getting sick and went for a COVID test and tested positive on 11Feb2021.  She had experienced multiple symptoms due to her COVID-19 disease and had to go to the ER for treatment after they appeared (she went to the emergency room so they didn't keep her there, she was there for maybe 6 hours).  She felt very ill with this COVID, she had been in the hospital twice, she did not, she was not left in ICU that was good for her, but reported that "between the fevers my eyes, I don't know what happened to my eyes but ophthalmologist will be checking it seems to be same and it's been everything that you can ever think as 'hard' and I just want to know if tomorrow I can have the second boost." It was reported that when she was in the hospital because of the, body temperature kept dropping so the doctor send her to the hospital and they did blood test. Patient weight was 135 at that time, now she was 131. She thought COVID took the 3 pounds off. Her second dose of the Pfizer-BioNTech vaccine was cancelled due to her illness and now her second dose is scheduled for tomorrow (25Feb2021). The patient reported she is only now starting to feel a lot better, that she was really sick for 15 days. Today (24Feb2021) was the first day that she was feeling a little bit better from all the symptoms and all the nightmares of the COVID illness.  The outcome of events was recovering.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Haemorrhage, Lacrimation increased, Lymphadenitis, Pain in extremity
Clinical narrative: she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed; the lymph node under her arm got inflamed; armpit swelling; her eyes was runny, sort of hurting like salt in her eye; her eyes was runny, sort of hurting like salt in her eye; arm was hurting where she got the vaccine in the right arm; she had a mucus plug and was bleeding; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 62-years, via an unspecified route of administration in right arm on 19Feb2021 at single dose for COVID-19 immunization. Medical history included hadn't had her period for 8 years. Concomitant medications were not reported. The patient historically received first single dose of BNT162B2 at the age of 62-years for COVID-19 immunization. Patient received the 2nd dose of the vaccine last Friday 19Feb2021, when she was driving home her eyes was runny, sort of hurting like salt in her eye, it was like that all evening she had to put a patch on her eye to help it. That same evening may arm was hurting where she got the vaccine in the right arm, and the lymph node under her arm got inflamed. The next morning on 20Feb2021 when she woke up she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed, but that went away. The armpit swelling has continued since the day of the vaccine. Now this morning in Feb2021 she had a mucus plug and was bleeding she haven't had her period for 8 years, every two days she had something new. Patient wanted to know what had been woken up in her body. Consumer added that she read on line that patients should wait for 5months before going to their doctor about the swollen lymph nodes because they might send the person for a test, mammogram and it may say they have cancer, in the clinical trials apparently some patients has issues with their lymph nodes and when they did testing it was found they had cancer, but it was not cancer it was the vaccine. Outcome of the event she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed was recovered/resolved in Feb2021; of the armpit swelling was not recovered/not resolved; while of remain was unknown.  Information on lot/batch has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Sensation of foreign body, Swelling
Clinical narrative: she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed; the lymph node under her arm got inflamed; armpit swelling; her eyes was runny, sort of hurting like salt in her eye; her eyes was runny, sort of hurting like salt in her eye; arm was hurting where she got the vaccine in the right arm; she had a mucus plug and was bleeding; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 62-years, via an unspecified route of administration in right arm on 19Feb2021 at single dose for COVID-19 immunization. Medical history included hadn't had her period for 8 years. Concomitant medications were not reported. The patient historically received first single dose of BNT162B2 at the age of 62-years for COVID-19 immunization. Patient received the 2nd dose of the vaccine last Friday 19Feb2021, when she was driving home her eyes was runny, sort of hurting like salt in her eye, it was like that all evening she had to put a patch on her eye to help it. That same evening may arm was hurting where she got the vaccine in the right arm, and the lymph node under her arm got inflamed. The next morning on 20Feb2021 when she woke up she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed, but that went away. The armpit swelling has continued since the day of the vaccine. Now this morning in Feb2021 she had a mucus plug and was bleeding she haven't had her period for 8 years, every two days she had something new. Patient wanted to know what had been woken up in her body. Consumer added that she read on line that patients should wait for 5months before going to their doctor about the swollen lymph nodes because they might send the person for a test, mammogram and it may say they have cancer, in the clinical trials apparently some patients has issues with their lymph nodes and when they did testing it was found they had cancer, but it was not cancer it was the vaccine. Outcome of the event she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed was recovered/resolved in Feb2021; of the armpit swelling was not recovered/not resolved; while of remain was unknown.  Information on lot/batch has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: I had a stroke; This is a spontaneous report from a non-contactable Nurse. A 61-years-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3302), via an unspecified route of administration in left arm on 02Feb2021 at single dose for Covid-19 immunisation in hospital. Medical history included hypothyroid. Patient is not pregnant. Concomitant medication included levothyroxine, trazodone, famotidine (PEPCID), cyanocobalamin (VITAMIN B 12). The patient previously took codeine and experienced drug hypersensitivity. Historical vaccination included BNT162B2(lot number:EL3248) on 12Jan2021, in left arm, first dose. No other vaccine in four weeks. No Covid prior vaccination. The patient stated I don't know if it was a result of the Covid shot. But I don't have any comorbidities and I had a stroke on to four which was two days after the shot on 04Feb2021 09:30 with outcome of recovering (as reported). AE result in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization (2 days), disability or permanent damage. The patient underwent lab tests and procedures which included Nasal Swab, Covid test result: negative.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Despite insufficient clinical information provided, by close temporal relationship and absence of factors which may provide an alternative cause, the company deems there is a reasonable possibility that the reported stroke is related to the suspect drug Comirnaty. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: hearing loss; Ringing in ears; This is a spontaneous report from a contactable other hcp.  A 57-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Jan2021 13:00 in left arm at single dose for covid-19 immunisation. Facility type vaccine was hospital. No other vaccine in four weeks. Medical history were none. No COVID prior vaccination. No COVID tested post vaccination. Known allergies: No known drug allergies (NKDA). Concomitant medication included omeprazole (PRILOSEC [OMEPRAZOLE]), zolpidem tartrate (AMBIEN CR), diazepam (DIAZEPAM) as needed. Historical vaccination included first dose of BNT162B2(lot number: ELO142) on 06Jan2021 01:00 PM in right arm for covid-19 immunisation. The patient experienced ringing in ears and hearing loss that is continually worsening on 29Jan2021 12:00 with outcome of not recovered. AE resulted in doctor or other healthcare professional office/clinic visit. it is unknown whether treatment was received.; Sender's Comments: Considering the plausible temporal association, and lacking any reported alternative explanations, a causative role of BNT162B2 vaccine for the reported worsening of ringing in ears and hearing loss cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Nausea, Palpitations
Clinical narrative: dizziness; nausea; heart palpitations; fatigue 13 days; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (herself) reported that a 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: EL9269) via an unspecified route of administration in left arm on 11Feb2021 14:00 at single dose for Covid-19 immunization. Medical history included Cholesterol, high blood pressure and history of ovarian and breast cancer. Concomitant medications included Pregabalin, rosuvastatin calcium (CRESTOR), fluoxetine hydrochloride (PROZAC) and amolodipine. Patient is good health had a bad reaction to the 1st COVID dose vaccine. Ended up in hospital emergency room on Friday 18Feb2021 with extreme dizziness and nausea and heart palpitations. Fatigue which had been going on since Friday 12Feb2021 14:30. Having had these reactions patient need to know from Pfizer is it safe for me to have second dose which is scheduled 04Mar2021. Seriousness was reported as non-serious. Patient did not receive treatment for events.  No follow-up attempts are possible. No further information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis
Clinical narrative: Lymphadenitis in the left underarm area; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247; expiry date: unknown) via an unspecified route of administration in the left arm, on 10Feb2021 at 12:30, at a single dose, for COVID -19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. On 24Feb2021, at 09:00 AM, the patient experienced lymphadenitis in the left underarm area. The event was considered non-serious. The patient did not receive treatment for the event. Outcome of the event was not recovered. The patient has not been tested for COVID-19 since vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Diarrhoea, Dizziness, Fatigue
Clinical narrative: dehydration; slight fever (99); chills; passed out in floor; sweating; Broke a tooth; Dizzy; Diarrhea; Super tired and went to bed by 8pm after COVID-19 vaccine; Arm was sore; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021 at 15:00, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. Patient did not have known allergies. Patient did not receive any other vaccine the same day and in four weeks. Patient did not have COVID-19 prior to vaccination. The patient experienced passed out in floor (medically significant) on 24Feb2021 at 10:30 PM, diarrhea (disability) on 24Feb2021, broke a tooth (medically significant) on 24Feb2021 at 10:30 PM, dehydration (disability) on 25Feb2021 12:00 AM, slight fever (99) (disability) on 25Feb2021 at 12:00 AM, chills (disability) on 24Feb2021 at 10:30 PM, super tired and went to bed by 08:00 PM after COVID-19 vaccine (non-serious) on 24Feb2021, arm was sore (non-serious) on 24Feb2021, sweating (non-serious) on 24Feb2021 at 10:30 PM, dizzy (non-serious) on 24Feb2021. No therapeutic measures were taken as a result of the events. Patient stated that all side effects resolved completely by 25Feb2021 evening, except for broke a tooth. Patient did not tested positive for COVID-19 post vaccination.  The information on the Lot/Batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Pain in extremity, Pyrexia, Tooth loss
Clinical narrative: dehydration; slight fever (99); chills; passed out in floor; sweating; Broke a tooth; Dizzy; Diarrhea; Super tired and went to bed by 8pm after COVID-19 vaccine; Arm was sore; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021 at 15:00, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. Patient did not have known allergies. Patient did not receive any other vaccine the same day and in four weeks. Patient did not have COVID-19 prior to vaccination. The patient experienced passed out in floor (medically significant) on 24Feb2021 at 10:30 PM, diarrhea (disability) on 24Feb2021, broke a tooth (medically significant) on 24Feb2021 at 10:30 PM, dehydration (disability) on 25Feb2021 12:00 AM, slight fever (99) (disability) on 25Feb2021 at 12:00 AM, chills (disability) on 24Feb2021 at 10:30 PM, super tired and went to bed by 08:00 PM after COVID-19 vaccine (non-serious) on 24Feb2021, arm was sore (non-serious) on 24Feb2021, sweating (non-serious) on 24Feb2021 at 10:30 PM, dizzy (non-serious) on 24Feb2021. No therapeutic measures were taken as a result of the events. Patient stated that all side effects resolved completely by 25Feb2021 evening, except for broke a tooth. Patient did not tested positive for COVID-19 post vaccination.  The information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Heart rate, Heart rate decreased
Clinical narrative: heart rate went "really low" / heart rate had gone down to 40-45; felt really weak; This is a spontaneous report from a contactable consumer. A 51-years-old female patient received bnt162b2 (BNT162B2) first dose, via an unspecified route of administration on 2021 at SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient experienced heart rate went "really low" / heart rate had gone down to 40-45 (medically significant) and felt really weak, both on an unspecified date with outcome of unknown.  The patient underwent lab tests which included heart rate had gone down to 40-45, normal heart rate: around 70-80 on unknown date. Patient that she received her first dose of the Pfizer BioNTech COVID-19 vaccine about 3 weeks ago and was due to receive her second dose tomorrow. She experienced a "weird side effect" after her first dose: she stated her heart rate went "really low" and felt really weak. She stated that about 36 hours after receiving her dose, she checked her pulse and found her heart rate had gone down to 40-45. She stated her normal heart rate was around 70-80.  The information on the lot/batch number has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Macular degeneration, Pruritus, Rash
Clinical narrative: developed a rash; very itchy; She said she had the feeling of needles all over her entire body and face, along with a hot feeling; her neck, chest, and upper back are a purple-red color; difficulty seeing; macular degeneration; This is a spontaneous report from a contactable consumer (patient herself). An 85-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot# EN9581), via an unspecified route of administration on 20Feb2021 09:15 (at the age of 85-years-old) in right arm at single dose for covid-19 immunisation. Patient had allergies and asthma for years. There were no concomitant medications. Patient reported she got her first COVID-19 Vaccine on Saturday, 20Feb2021. She said she developed a rash on Monday (22Feb2021), and was very itchy. She said she didn't have the rash on her legs. She said she had the feeling of needles all over her entire body and face, along with a hot feeling on 22Feb2021. She said she was contributing her rash to the COVID-19 Vaccine. She asked if she got the second COVID-19 Vaccine, would the rash occur again, and would the rash be worse. The caller said she was scheduled to receive her second COVID-19 Vaccine dose on Thursday, 11Mar2021. The caller was advised she would be transferred to Pfizer Medical Information for further assistance. She had macular degeneration and had difficulty seeing in Feb2021. She clarified she felt like her face had needles going through it. She said her neck, chest, and upper back are a purple-red color on 22Feb2021. She said she was so uncomfortable that it was hard for her to wear clothes, and she had to sleep in the nude. Treatment: she was taking diphenhydramine hydrochloride (BENADRYL) and her daughter gave her an over-the-counter cortisone cream in a tube to use for her rash. She said she just started using the cortisone cream today (25Feb2021). She said she did not have the Benadryl and cortisone cream tube with her to provide the UPC/NDC Numbers, Lot Numbers, and Expiration Dates. She planned to call her doctor to see if he will give her something for the rash once she was finished speaking with Pfizer. The events did not require emergency room or physician office. Outcome of macular degeneration and difficulty seeing was unknown, and outcome of other events were not recovered.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Visual acuity reduced
Clinical narrative: developed a rash; very itchy; She said she had the feeling of needles all over her entire body and face, along with a hot feeling; her neck, chest, and upper back are a purple-red color; difficulty seeing; macular degeneration; This is a spontaneous report from a contactable consumer (patient herself). An 85-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot# EN9581), via an unspecified route of administration on 20Feb2021 09:15 (at the age of 85-years-old) in right arm at single dose for covid-19 immunisation. Patient had allergies and asthma for years. There were no concomitant medications. Patient reported she got her first COVID-19 Vaccine on Saturday, 20Feb2021. She said she developed a rash on Monday (22Feb2021), and was very itchy. She said she didn't have the rash on her legs. She said she had the feeling of needles all over her entire body and face, along with a hot feeling on 22Feb2021. She said she was contributing her rash to the COVID-19 Vaccine. She asked if she got the second COVID-19 Vaccine, would the rash occur again, and would the rash be worse. The caller said she was scheduled to receive her second COVID-19 Vaccine dose on Thursday, 11Mar2021. The caller was advised she would be transferred to Pfizer Medical Information for further assistance. She had macular degeneration and had difficulty seeing in Feb2021. She clarified she felt like her face had needles going through it. She said her neck, chest, and upper back are a purple-red color on 22Feb2021. She said she was so uncomfortable that it was hard for her to wear clothes, and she had to sleep in the nude. Treatment: she was taking diphenhydramine hydrochloride (BENADRYL) and her daughter gave her an over-the-counter cortisone cream in a tube to use for her rash. She said she just started using the cortisone cream today (25Feb2021). She said she did not have the Benadryl and cortisone cream tube with her to provide the UPC/NDC Numbers, Lot Numbers, and Expiration Dates. She planned to call her doctor to see if he will give her something for the rash once she was finished speaking with Pfizer. The events did not require emergency room or physician office. Outcome of macular degeneration and difficulty seeing was unknown, and outcome of other events were not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Chest discomfort, Electrocardiogram, Hot flush
Clinical narrative: annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonresponsive for a few moments/was asked a question and did not respond; sweats; high blood pressure; annoying pain; itching; hives on the arms and chest; Hot flashes; This is a spontaneous report from a contactable consumer (patient)  A 56-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EN5318  at left arm on 16Feb2021 at SINGLE DOSE for covid-19 immunisation . Age at vacciantion 56 years.Vaccination Facility Type: Workplace Clinic.  Medical history included ongoing allergies (5-10 years). She had a flu shot in Oct2020.  There were no concomitant medications.Immediately after the vaccine she became nonresponsive for a few moments, broke out in sweats, had high blood pressure, annoying pain, and has been having itching and hives on the arms and chest.Clincal course was reported as follows:  On 16Feb she had hot flashes,pruritus and blood pressure has not been right .On17Feb she developed annoying feeling in her chest.Then , it was added as follows: she received the first dose of the Covid-19 vaccine on 16Feb2021. She had an allergic reaction. The second dose was due 09Mar2020.  She was under the impression that she has to take the vaccine she was told she needed a cocktail to get the shot.She had hot flashes and was itching. Her blood pressure has not been right. Her pressure was low then normal then high. She has an annoying feeling in her chest. The itching has stopped after she was medicated. She can't take Benadryl and she was given something else. She applied hydrocortisone cream and it helped.  She had a flu shot in Oct2020. She went to the ER on 20Feb2021 because her blood pressure was spiking too high. She had an EKG which was normal. When she went to the ER her blood pressure was 167/100. Yesterday her blood pressure was 167/102. She was nervous about taking the second dose. Her blood pressure usually ranges from 119-120. It was off the charts at 130/80 and 150/99. Pateint was treated for pruritus.She was wondered if she can get the second dose .Events reported as non serious.Lab data  included:EKG on20Feb2021:normal.Blood pressure measurement (16Feb2021): has not been right. Her pressure was low then normal then high , blood pressure measurement: 167/100   on 20Feb2021 , blood pressure measurement: 167/102   on 24Feb2021.Patient's recovered from pruritus while the outcome of the other events was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypersensitivity, Hypertension, Pain, Pruritus
Clinical narrative: annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonresponsive for a few moments/was asked a question and did not respond; sweats; high blood pressure; annoying pain; itching; hives on the arms and chest; Hot flashes; This is a spontaneous report from a contactable consumer (patient)  A 56-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EN5318  at left arm on 16Feb2021 at SINGLE DOSE for covid-19 immunisation . Age at vacciantion 56 years.Vaccination Facility Type: Workplace Clinic.  Medical history included ongoing allergies (5-10 years). She had a flu shot in Oct2020.  There were no concomitant medications.Immediately after the vaccine she became nonresponsive for a few moments, broke out in sweats, had high blood pressure, annoying pain, and has been having itching and hives on the arms and chest.Clincal course was reported as follows:  On 16Feb she had hot flashes,pruritus and blood pressure has not been right .On17Feb she developed annoying feeling in her chest.Then , it was added as follows: she received the first dose of the Covid-19 vaccine on 16Feb2021. She had an allergic reaction. The second dose was due 09Mar2020.  She was under the impression that she has to take the vaccine she was told she needed a cocktail to get the shot.She had hot flashes and was itching. Her blood pressure has not been right. Her pressure was low then normal then high. She has an annoying feeling in her chest. The itching has stopped after she was medicated. She can't take Benadryl and she was given something else. She applied hydrocortisone cream and it helped.  She had a flu shot in Oct2020. She went to the ER on 20Feb2021 because her blood pressure was spiking too high. She had an EKG which was normal. When she went to the ER her blood pressure was 167/100. Yesterday her blood pressure was 167/102. She was nervous about taking the second dose. Her blood pressure usually ranges from 119-120. It was off the charts at 130/80 and 150/99. Pateint was treated for pruritus.She was wondered if she can get the second dose .Events reported as non serious.Lab data  included:EKG on20Feb2021:normal.Blood pressure measurement (16Feb2021): has not been right. Her pressure was low then normal then high , blood pressure measurement: 167/100   on 20Feb2021 , blood pressure measurement: 167/102   on 24Feb2021.Patient's recovered from pruritus while the outcome of the other events was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Urticaria
Clinical narrative: annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonresponsive for a few moments/was asked a question and did not respond; sweats; high blood pressure; annoying pain; itching; hives on the arms and chest; Hot flashes; This is a spontaneous report from a contactable consumer (patient)  A 56-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EN5318  at left arm on 16Feb2021 at SINGLE DOSE for covid-19 immunisation . Age at vacciantion 56 years.Vaccination Facility Type: Workplace Clinic.  Medical history included ongoing allergies (5-10 years). She had a flu shot in Oct2020.  There were no concomitant medications.Immediately after the vaccine she became nonresponsive for a few moments, broke out in sweats, had high blood pressure, annoying pain, and has been having itching and hives on the arms and chest.Clincal course was reported as follows:  On 16Feb she had hot flashes,pruritus and blood pressure has not been right .On17Feb she developed annoying feeling in her chest.Then , it was added as follows: she received the first dose of the Covid-19 vaccine on 16Feb2021. She had an allergic reaction. The second dose was due 09Mar2020.  She was under the impression that she has to take the vaccine she was told she needed a cocktail to get the shot.She had hot flashes and was itching. Her blood pressure has not been right. Her pressure was low then normal then high. She has an annoying feeling in her chest. The itching has stopped after she was medicated. She can't take Benadryl and she was given something else. She applied hydrocortisone cream and it helped.  She had a flu shot in Oct2020. She went to the ER on 20Feb2021 because her blood pressure was spiking too high. She had an EKG which was normal. When she went to the ER her blood pressure was 167/100. Yesterday her blood pressure was 167/102. She was nervous about taking the second dose. Her blood pressure usually ranges from 119-120. It was off the charts at 130/80 and 150/99. Pateint was treated for pruritus.She was wondered if she can get the second dose .Events reported as non serious.Lab data  included:EKG on20Feb2021:normal.Blood pressure measurement (16Feb2021): has not been right. Her pressure was low then normal then high , blood pressure measurement: 167/100   on 20Feb2021 , blood pressure measurement: 167/102   on 24Feb2021.Patient's recovered from pruritus while the outcome of the other events was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Lymphocyte count, Lymphocyte count abnormal, Lymphocyte percentage, Neutrophil count
Clinical narrative: Lymphocyte abnormal; Neutrophil count abnormal; This is a spontaneous report from a contactable nurse (patient). This 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EN9581, Expiration Date: 31May2021) via intramuscular at single dose in deltoid left 30Jan2021 08:30 for COVID-19 immunization. The first dose was on 08Jan2021 at about 4:30 pm (Lot#: EL3246, Expiration Date: 30Apr2021) via intramuscular at single dose in deltoid left. Medical history was none. There was no additional vaccines administered on same date of the pfizer suspect. Prior vaccinations (within 4 weeks) was none. Concomitant medication was not reported. Patient stated she received both doses of the vaccine. She had blood work done afterwards and her neutrophil count and lymphocytes were abnormal on 20Feb2021. Patient asked if that was a normal response to getting the vaccine, if this was related to the COVID-19 vaccine. At this time, since she didn't know if it was related to the vaccine or not and if it was something to be concerned with, she would consider the events to be medically significant. She believed it was something to look into. Results of tests and procedures on 20Feb2021 included: lymphocyte percentage (normal range 20-50) was 54.8%; lymphocyte count 2.8, which was in the normal range; neutrophil percentage (normal range 50-70) 37.8%; neutrophil count (normal range 2-7.5) 1.9 mm; WBC 5.0. Patient also mentioned a test "hydrochroma", but she didn't print the results out. She has never heard of it before. Her level was like 1. The outcome of events was unknown.; Sender's Comments: The possibility that suspect drug may have contributed to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Neutrophil count abnormal, Neutrophil percentage, White blood cell count
Clinical narrative: Lymphocyte abnormal; Neutrophil count abnormal; This is a spontaneous report from a contactable nurse (patient). This 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EN9581, Expiration Date: 31May2021) via intramuscular at single dose in deltoid left 30Jan2021 08:30 for COVID-19 immunization. The first dose was on 08Jan2021 at about 4:30 pm (Lot#: EL3246, Expiration Date: 30Apr2021) via intramuscular at single dose in deltoid left. Medical history was none. There was no additional vaccines administered on same date of the pfizer suspect. Prior vaccinations (within 4 weeks) was none. Concomitant medication was not reported. Patient stated she received both doses of the vaccine. She had blood work done afterwards and her neutrophil count and lymphocytes were abnormal on 20Feb2021. Patient asked if that was a normal response to getting the vaccine, if this was related to the COVID-19 vaccine. At this time, since she didn't know if it was related to the vaccine or not and if it was something to be concerned with, she would consider the events to be medically significant. She believed it was something to look into. Results of tests and procedures on 20Feb2021 included: lymphocyte percentage (normal range 20-50) was 54.8%; lymphocyte count 2.8, which was in the normal range; neutrophil percentage (normal range 50-70) 37.8%; neutrophil count (normal range 2-7.5) 1.9 mm; WBC 5.0. Patient also mentioned a test "hydrochroma", but she didn't print the results out. She has never heard of it before. Her level was like 1. The outcome of events was unknown.; Sender's Comments: The possibility that suspect drug may have contributed to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Chest pain, Hypoaesthesia, Respiratory distress
Clinical narrative: L arm/hand numbness; blood pressure abnormality; chest pain; respiratory distress; This is a spontaneous report from a non-contactable other-HCP. This other HCP reported for a 73-Years-Old (same age at vaccination) female patient that she received the first dose of bnt162b2 (BNT162B2, Lot number EN6205), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medication was none. She had not been back to her pcp for "several years". No known history of HTN. She did have a blood pressure cuff at home. During her 15-minute waiting period after the injection on an unspecified date, the patient began to experience L arm/hand numbness. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, chest pain, rapid progression of symptoms and respiratory distress. Treatment included: no therapy. Follow up response was excellent. Patient discharge: stable to go home and follow up with PCP. Outcome of events was unknown.  No follow-up attempts are possible. No further information expected.; Sender's Comments: Based on the information provided, and on a close drug-event temporal association,  the Company  assessed there was a reasonable possibility that the reported serious events  were related to the suspect vaccine  BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Blood test, Haemorrhage, Rash pruritic, Scratch
Clinical narrative: until the vein opened up and was squirting out blood; until the vein opened up and was squirting out blood; a severe itching rash; This is a spontaneous report from a contactable consumer. An 80-year-old male patient (reporter husband) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on 29Jan2021 12:00 at SINGLE DOSE in left arm for COVID-19 immunisation. Medical history included ongoing asthma Onset Date: Probably about 20 years ago, ongoing chronic obstructive pulmonary disease Onset Date: Probably about 20 years ago, ongoing overweight Illness/AE: Little overweight. There was none family medical history relevant to AEs. There were no concomitant medications. The patient received first dose of bnt162b2 (Lot number: EC3246) on 08Jan2021 in Left arm for COVID-19 immunization. The patient experienced a severe itching rash on 01Feb2021 with the outcome not recovered. Area where a vein is very close under the skin itching that he scratched until the vein opened up and was squirting out blood on 24Feb2021 with unknown outcome. The rash hasn't gotten worse, and it is staying the same. The AEs require a visit to: Emergency Room and Physician Office. The patient underwent lab tests and procedures which included biopsy: unknown results on 25Feb2021, Bloodwork: Nothing showed up on this test. This is a non-serious report. The outcome of event a severe itching rash was not recovered, outcome of the other events was unknown.  This consumer reported she and her husband were administered second dose of Pfizer COVID-19 Vaccine on 29Jan2021. Her husband apparently has had a reaction of very itchy rash to the Pfizer COVID-19 Vaccine. She reported that the patient saw the Dermatologist and the Dermatologist thinks the Reaction of very itchy rash is a reaction to the Pfizer COVID-19 Vaccine. Regarding testing/investigations related to this report caller provided that the primary care physician ordered bloodwork and nothing showed up in that. Biopsy was taken 25Feb2021 to see if reaction of very itchy rash is related to the Pfizer COVID-19 Vaccine When queried if any adverse event required Emergency room visit, physician's office visit or hospitalization caller reported that the patient was seen in the emergency room, but not admitted to the hospital on 24Feb2021 related to patient's event of area where a vein is very close under the skin itching that he scratched until the vein opened up and was squirting out blood event-they got that situated in the emergency room. Emergency room staff were the ones that recommended that the patient start Claritin. Dermatologist office visit was regarding the reaction of very itchy rash. The patient is taking Claritin and using Calamine lotion or Calamine spray for these events. Reaction assessed: Reaction of very itchy rash, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.