chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a contactable consumer (patient).    A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose1, single for COVID-19 immunisation; palbociclib (IBRANCE), route of administration, start and stop date, lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced rash on an unspecified date. A Consumer called for information about her symptoms during the use of Ibrance tablets could be related with the treatment and if they could get worse. The Consumer reported that she started Ibrance not so long ago and she is currently on her second cycle of the treatment. It was reported that between the first and the second cycle she developed a rash in the legs. The Consumer reported that she was administrated with the first dose of the Pfizer's COVID 19 vaccine before the symptoms appeared, but she is not sure if these symptoms are related to the vaccine or the treatment. The Consumer reported that her Physician recommended her to use Benadryl for the management of the symptoms. Therapeutic measures taken as a result of rash included treatment with Benadryl. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Little Sore Arm; A little tired; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 33-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on 12Feb2021 (age at vaccination was 33 years,  non pregnant) (Batch/Lot number was not reported) as dose number unknown single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. it was unknown that patient had been tested for COVID-19 since the vaccination. On 13Feb2021, after receiving the vaccine the patient experienced little sore arm, a little tired.  The patient did not received treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. Information on lot/batch number could not be requested. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Foot deformity, Investigation, Limb discomfort, Muscle spasms
Clinical narrative: tremors; my  fingers on my right hand started to curl under involuntarily; right eye started to twitch like, Blinky like/Twitching in eyes; I feel like my nerves are jumping in my legs, front and back of legs, and the curling starts again all over.; I feel like my nerves are jumping in my legs, front and back of legs, and the curling starts again all over.; Twitching in eyes and my hands/ I feel little lower but it is worst in my right hand and my right eye; My left toes, toes on left foot, curling under; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 (Batch/Lot Number: EM9809) as single dose for COVID-19 immunisation. Medical history included Fuchs Corneal dystrophy, Hashimoto disease, problems with heart, her regular primary does not really know her history. Has supraventricular tachycardia, atrial fibrillation, and on Blood thinners, autoimmune diseases, but when they pull up, the tests never come up with anything. The patient received the covid pfizer vaccine 06Feb2021, three days later, she started to have a reaction. Her fingers on right hand started to curl under involuntarily, then started separating on their own, her right eye started to twitch like, Blinky like, the eye is still the same today and was happening more and is also on the other eye. Her left toes, toes on left foot, curling under, no cramping, when she have her shoe off, she observe them and they separate and curl under. Her left arm was the injection site. She felt like her nerves are jumping in legs, front and back of legs, and the curling starts again all over. The patient was having a side effect, she was getting like tremors and everything since she had her first dose. She was supposed to get the second dose next Saturday, don't know what to do. When she started getting it with her eye, she heard some people reported Bell's Palsy. The reporter asked if any reports of neurological effects like this, if it is safe to have the second dose and what if she had one dose. Twitching in eyes and my hands, she could feel it in her legs and her upper leg and lower leg, her calf, she felt little lower but it was worst in right hand and right eye. The patient underwent lab tests and procedures which included investigation: never come up with anything on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Nervous system disorder, Tremor
Clinical narrative: tremors; my  fingers on my right hand started to curl under involuntarily; right eye started to twitch like, Blinky like/Twitching in eyes; I feel like my nerves are jumping in my legs, front and back of legs, and the curling starts again all over.; I feel like my nerves are jumping in my legs, front and back of legs, and the curling starts again all over.; Twitching in eyes and my hands/ I feel little lower but it is worst in my right hand and my right eye; My left toes, toes on left foot, curling under; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 (Batch/Lot Number: EM9809) as single dose for COVID-19 immunisation. Medical history included Fuchs Corneal dystrophy, Hashimoto disease, problems with heart, her regular primary does not really know her history. Has supraventricular tachycardia, atrial fibrillation, and on Blood thinners, autoimmune diseases, but when they pull up, the tests never come up with anything. The patient received the covid pfizer vaccine 06Feb2021, three days later, she started to have a reaction. Her fingers on right hand started to curl under involuntarily, then started separating on their own, her right eye started to twitch like, Blinky like, the eye is still the same today and was happening more and is also on the other eye. Her left toes, toes on left foot, curling under, no cramping, when she have her shoe off, she observe them and they separate and curl under. Her left arm was the injection site. She felt like her nerves are jumping in legs, front and back of legs, and the curling starts again all over. The patient was having a side effect, she was getting like tremors and everything since she had her first dose. She was supposed to get the second dose next Saturday, don't know what to do. When she started getting it with her eye, she heard some people reported Bell's Palsy. The reporter asked if any reports of neurological effects like this, if it is safe to have the second dose and what if she had one dose. Twitching in eyes and my hands, she could feel it in her legs and her upper leg and lower leg, her calf, she felt little lower but it was worst in right hand and right eye. The patient underwent lab tests and procedures which included investigation: never come up with anything on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: chest pain; Chest pressure; This is a spontaneous report from a contactable pharmacist. A 64-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced chest pain and chest pressure on unspecified date. Reporter is a pharmacist who is seeking further guidance on a patient (64 y/o female) who experienced an AE after the first Pfizer Covid vaccine dose. States the patient experienced chest pain and pressure within 30 mins after receiving the dose and then a similar response later in the day. He states that the patient has experienced similar symptoms in the past. Reporter added that he had a patient who on the initial dose experienced chest pain initially and afterwards had chest pressure in the evening. This information was reported to the doctor and the vaccine website as well.  Reporter stated he does not feel this is a big adverse effect. However, he is looking for clinical guidance on how to proceed in regards to this patient should get the second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast disorder, Dizziness, Erythema, Fatigue
Clinical narrative: pain in the arm; pain in the arm and shoulder; injection site has been very painful; redness; swollen lymph nodes; knots in her breasts; not feeling good; fatigued; lot of pain; dizziness; couldn't move and can't stand; nauseous; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9269) via an unspecified route of administration on 07Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pain in the arm and shoulder, injection site has been very painful, redness, swollen lymph nodes, knots in her breasts, not feeling good, fatigued, lot of pain, dizziness, couldn't move and can't stand, nauseous on an unspecified date. Reporter reporting for his wife who is experiencing several side effects after receiving the 1st dose of the vaccine with lot number EL9269 on 7Feb2021 at 3:20-3:30pm at the (hospital name). Both of them received it on that day and experienced pain in the arm and shoulder for the first few days. His arm got better, but his wife got worst. The effects are ongoing for 4-5 days already. Her injection site has been very painful, there has been redness that has been increasing and radiating to under her armpit, swollen lymph nodes which are also red, knots in her breasts, not feeling good, very fatigued, a lot of pain, some dizziness, she can't do anything, she couldn't move and can't stand, and nauseous. He mentioned that they put ice packs and ointment on her shoulder and back which did not alleviate the symptoms. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Movement disorder, Nausea, Pain
Clinical narrative: pain in the arm; pain in the arm and shoulder; injection site has been very painful; redness; swollen lymph nodes; knots in her breasts; not feeling good; fatigued; lot of pain; dizziness; couldn't move and can't stand; nauseous; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9269) via an unspecified route of administration on 07Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pain in the arm and shoulder, injection site has been very painful, redness, swollen lymph nodes, knots in her breasts, not feeling good, fatigued, lot of pain, dizziness, couldn't move and can't stand, nauseous on an unspecified date. Reporter reporting for his wife who is experiencing several side effects after receiving the 1st dose of the vaccine with lot number EL9269 on 7Feb2021 at 3:20-3:30pm at the (hospital name). Both of them received it on that day and experienced pain in the arm and shoulder for the first few days. His arm got better, but his wife got worst. The effects are ongoing for 4-5 days already. Her injection site has been very painful, there has been redness that has been increasing and radiating to under her armpit, swollen lymph nodes which are also red, knots in her breasts, not feeling good, very fatigued, a lot of pain, some dizziness, she can't do anything, she couldn't move and can't stand, and nauseous. He mentioned that they put ice packs and ointment on her shoulder and back which did not alleviate the symptoms. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: pain in the arm; pain in the arm and shoulder; injection site has been very painful; redness; swollen lymph nodes; knots in her breasts; not feeling good; fatigued; lot of pain; dizziness; couldn't move and can't stand; nauseous; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9269) via an unspecified route of administration on 07Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pain in the arm and shoulder, injection site has been very painful, redness, swollen lymph nodes, knots in her breasts, not feeling good, fatigued, lot of pain, dizziness, couldn't move and can't stand, nauseous on an unspecified date. Reporter reporting for his wife who is experiencing several side effects after receiving the 1st dose of the vaccine with lot number EL9269 on 7Feb2021 at 3:20-3:30pm at the (hospital name). Both of them received it on that day and experienced pain in the arm and shoulder for the first few days. His arm got better, but his wife got worst. The effects are ongoing for 4-5 days already. Her injection site has been very painful, there has been redness that has been increasing and radiating to under her armpit, swollen lymph nodes which are also red, knots in her breasts, not feeling good, very fatigued, a lot of pain, some dizziness, she can't do anything, she couldn't move and can't stand, and nauseous. He mentioned that they put ice packs and ointment on her shoulder and back which did not alleviate the symptoms. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Illness, Nausea
Clinical narrative: high fever; chills; headache; slight joint aching; Woke up at 3am post-vaccination feeling nauseous, then went back to sleep; Slept all day; Still feel very sick; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 26-year-old non pregnant female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 17Feb2021 13:15 (vaccination at the age of 26 years) as dose 2, single for COVID-19 immunization at Workplace clinic. The patient medical history was none. Patient was had no known allergies. Concomitant medications in two weeks included ethinylestradiol, norgestimate (ESTARYLLA), valaciclovir (VALACICLOVIR), cyanocobalamin (B12 [CYANOCOBALAMIN]), colecalciferol (D3), iron (IRON) all taken for an unspecified indication, start and stop date were not reported. Patient historically received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 26Jan2021 13:15 (vaccination at the age of 26 years) as dose 1, single for COVID-19 immunization at Workplace clinic. On 18Feb2021 03:00 AM, patient experienced feeling nauseous and at 07:00 AM patient experienced high fever, chills, nausea, headache, slight joint aching. Reportedly, slept all day and felt very sick. Reportedly, the patient woke up at 3am post-vaccination feeling nauseous, then went back to sleep. The patient woke up at 7 am with fever, chills, nausea, headache, slight joint aching. 4:30pm filling this out. Slept all day. Still feel very sick. Three other colleagues and her department out sick after second vaccine with same symptoms (received 17Feb2021) on 18Feb2021. Upon return to site on 22Feb2021, she learned that it was a total of at least six employees in my department out sick with similar symptoms out 18Feb2021 or/and 19Feb2021. Patient stated, four of us all woke up between 2-3am with noticeable symptoms, including high fever and chills. Please note that 5/6 mentioned employees are in our mid 20s to early 30s in age (in case there's a trend). We have all since recovered. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not tested for COVID post vaccination. No therapeutic measures were taken as a result of the events. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: high fever; chills; headache; slight joint aching; Woke up at 3am post-vaccination feeling nauseous, then went back to sleep; Slept all day; Still feel very sick; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 26-year-old non pregnant female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 17Feb2021 13:15 (vaccination at the age of 26 years) as dose 2, single for COVID-19 immunization at Workplace clinic. The patient medical history was none. Patient was had no known allergies. Concomitant medications in two weeks included ethinylestradiol, norgestimate (ESTARYLLA), valaciclovir (VALACICLOVIR), cyanocobalamin (B12 [CYANOCOBALAMIN]), colecalciferol (D3), iron (IRON) all taken for an unspecified indication, start and stop date were not reported. Patient historically received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 26Jan2021 13:15 (vaccination at the age of 26 years) as dose 1, single for COVID-19 immunization at Workplace clinic. On 18Feb2021 03:00 AM, patient experienced feeling nauseous and at 07:00 AM patient experienced high fever, chills, nausea, headache, slight joint aching. Reportedly, slept all day and felt very sick. Reportedly, the patient woke up at 3am post-vaccination feeling nauseous, then went back to sleep. The patient woke up at 7 am with fever, chills, nausea, headache, slight joint aching. 4:30pm filling this out. Slept all day. Still feel very sick. Three other colleagues and her department out sick after second vaccine with same symptoms (received 17Feb2021) on 18Feb2021. Upon return to site on 22Feb2021, she learned that it was a total of at least six employees in my department out sick with similar symptoms out 18Feb2021 or/and 19Feb2021. Patient stated, four of us all woke up between 2-3am with noticeable symptoms, including high fever and chills. Please note that 5/6 mentioned employees are in our mid 20s to early 30s in age (in case there's a trend). We have all since recovered. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not tested for COVID post vaccination. No therapeutic measures were taken as a result of the events. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder soreness/pain; This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 26Jan2021 (at the age of 27-years-old) at dose 1, single (lot number: EL3247) and via an unspecified route of administration in left arm on 17Feb2021 (at the age of 28-years-old- as reported) at dose 2, single (lot number: EL3247) for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. She has no known allergies and has no COVID prior to vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not tested for COVID post vaccination. On 26Jan2021, after the first dose of the vaccine, the patient experienced shoulder soreness/pain which recovered without treatment. She again experienced shoulder soreness/pain on 17Feb2021 after the second dose of the vaccine. She did not receive any treatment in response to the event. The outcome of the event was recovered on Feb2021. The event was reported as non-serious.   No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site haematoma, Vaccination site swelling
Clinical narrative: few days it became kinda hard and firm/hematoma; severe headaches; her arm was beginning to swell/injection site swelling up; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. This 82-year-old female consumer patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266), dose 1 via an unspecified route of administration on 11Feb2021 as single dose for covid-19 immunization.  Medical history included allergy had a lot of trouble with allergies). The patient concomitant medications was unknown.  The Caller states that after receiving her first dose, she waited for 15 minutes to an hour and had no reaction, but later that evening about bedtime noticed her arm was beginning to swell. Caller describes it as "very, very sore" and states it bothered her for about 2-3 days. Caller reported that after that the swelling went down a little to "about the size of a walnut" and states it felt "hard to the touch, did not go around the area" and stated it looks like a hematoma to her. Caller also reported getting severe headaches despite not doing anything at the time they occur. Caller stated these headaches were "mostly during the day, sometimes in the evening" and were on either side of her head and "right on top of my head" and states they come and go. On 11Feb2021 evening the injection site was swelling up, and then after a few days it became kinda hard and firm- it was not in a red way. The clinical outcome of the event vaccination site swelling was resolving, unknown for vaccination site hematoma and not resolved for severe headaches.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymph node pain, Muscle strain, Swelling
Clinical narrative: A lot of pain and swelling in her armpit; A lot of pain and swelling in her armpit; Pain in her lymph left nodes - under her left armpit; felt like she was pulling her left chest muscle, felt like her muscle was going to pop; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 12Feb2021 14:15 (Batch/Lot Number: EM9809; Expiration Date: 30Jun2021) (at the age of 33 years old) as single dose for Covid-19 immunisation. Medical history included Covid-19 from an unknown date (99 days ago; prior to the vaccination), and acne (prior to the vaccination), ongoing hair loss (prior to the vaccination and continues to see hair loss over the past few weeks). There was no increased in weight. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient took the first dose on Friday (12Feb2021) which was 6 days ago. On 13Feb2021 at 09:00, the patient experienced a lot of pain and swelling in her armpit, she had pain in her lymph left nodes - under her left armpit and she did not know if that was something that should be of concern. It hurts when she sleeps on her side. Either side. If she sleeps on the left side, it was too much pressure/body weight on it. If she sleeps on right side, it felt like she was pulling her left chest muscle, felt like her muscle was going to pop if she over did anything on 13Feb2021. She just did not know if that was something she should escalate and go see the doctor. She took Tylenol for a day nothing got any better and then she switched to Advil on Sunday and she got may be 20-25% better and now it was still there. 5 days later, 6 days later. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: chills; Fever; weakness; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 16Feb2021 (at the age of 36 years old) at dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 26Jan2021 at dose 1, single for covid-19 immunisation. Patient had no known allergies. Prior to vaccination the patient was not diagnosed with COVID-19. Post The patient had not been tested for COVID-19. No other vaccine in four weeks and it was unknown any other medications in two weeks. On 17Feb2021, the patient experienced chills, fever and weakness. No treatment received for the events. The clinical outcome of the all events were recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itching where she got her vaccine/bad itchy rash; rash where she got the vaccine; headache; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb2021 08:00 (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid, caffeine, ergotamine tartrate (SYDOLIL) taken for migraine, start and stop date were not reported. On 10Feb2021, the patient experienced headache. The next day she had to take Tylenol for her headache and by midday on 11Feb2021 the headache was gone. Tylenol: Lot Number: SFA011 and Expiry: Apr2022. On 18Feb2021, the patient experienced bad itchy rash. This morning she experienced some itching where she got her vaccine. Last week she got the vaccine on Wednesday. The only thing she had was a headache that night until the next day. It is really itching bad and there is a rash where she got the vaccine. She wants to see if it is still safe to get the second? Caller clarified that she would like information about her side effects and the second dose. The itch won't go away. It has gotten less red but it is more itchy. The rash and itchiness is on left arm where she got the vaccine. Therapeutic measures were taken as a result of headache. The outcome of the event headache was recovered on 11Feb2021, while not recovered for the event itching where she got her vaccine/bad itchy rash, recovering for the event rash where she got the vaccine.   No follow up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pruritus, Rash
Clinical narrative: rash; scratching and itching so bad; bruising; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 11Feb2021 at 13:45 (at the age of 78-years-old) at dose 1, single in the left arm for COVID-19 immunisation. Medical history included heart problems and triple bypass, both about 9 years ago. The patient's concomitant medications were not reported. On 12Feb2021, the patient experienced a rash after receiving the first dose of the Pfizer COVID-19 vaccine. The patient was asking if she should still get the second dose. The patient saw her doctor today for the rash. The patient's doctor saw that the rashes breakout on all of the patient's body. The patient took Benadryl tablet as treatment for the rash. On Sunday, on an unspecified date in 2021, the patient was scratching and itching so bad and was bruising herself. Since the dosage on the label was two tablets for an adult, the patient has taken two tablets each day since then. The patient stated that her rash seems to have new ones and today. In the morning, there seemed to be new ones, mostly on her back and on her front. There were not too many on her arms and legs, but mostly, the rash was on the patient's body. The patient cannot see her back, but her doctor looked at her back and said that there was a lot. The patient said that she was usually not allergic to anything, and has taken a lot of different medications, even trial drugs, and those didn't bother her. The patient received treatment of Benadryl for all the events. Outcome of all the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Rash macular
Clinical narrative: Rash (red spotty) on neck, chest, stomach; Nausea; Body Aches; Headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN 5318, Expiration Date: 31May2021), via an unspecified route of administration, administered in left arm on 16Feb2021 13:00 (at the age of 31-year-old) as dose 2, single for COVID-19 immunisation at workplace clinic. Medical history included migraines, dairy allergy and egg whites allergy. intolerance from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing. Concomitant medications received within 2 weeks of vaccination included ethinylestradiol, norgestimate (SPRINTEC); propranolol; escitalopram oxalate (LEXAPRO); famotidine (FAMOTIDIN). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318, Expiration Date: 31May2021), via an unspecified route of administration, administered in left arm on 26Jan2021 08:00 (at the age of 31-year-old) as single dose for COVID-19 immunisation. Patient previously took amoxicillin and experienced allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 17Feb2021, patient experienced nausea, headache and body aches. On 18Feb2021, she had rash (red spotty) on neck, chest and stomach. Patient did not receive treatment in response to the events. Outcome of the event rash (red spotty) on neck, chest and stomach was not resolved and rest all the events were resolve don an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Illness, Pain in extremity
Clinical narrative: She felt "off' as if she was getting sick/Feelings of being ill; Very fatigued and weak; Very fatigued and weak; Very sore arm; This is a spontaneous report from a contactable nurse reported for a female patient (daughter). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced she felt off as if she was getting sick/feelings of being ill, very fatigued and weak, very sore arm. Nurse reported that, the afternoon after receiving the second dose of BNT162b2 in her left arm stated that she felt off as if she was getting sick. She felt very fatigued and weak. Her arm was very sore, much more sore than after the first vaccination. She reported that her daughter also had the same reaction as she did, with severe fatigue and feelings of being ill but with no fever and a very sore arm. Event took place after use of product. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Her arm was very sore, much more sore than after the first vaccination; This is a spontaneous report from contactable nurse (patient herself) via Pfizer Sales Representa-tive. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, in left arm on an unspecified date as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. The afternoon after receiving the second dose of BNT162b2 in her left arm she felt "off" as if she was get-ting sick. She felt very fatigued and weak. Her arm was very sore, much more sore than after the first vaccination. She reported that her daughter also had the same reaction as she did, with severe fatigue and feelings of being ill but with no fever and a very sore arm. The next day she had pain in her neck and upper back and a sharp pain in her left axilla. She described the pain as if "someone injected the axilla with a long needle." When she examined the axilla, pressing into her arm pit she reported a sharp pain that radiated down her left arm and wrapped around her thumb. She also reported tingling in her fingers when she explores the axilla. The discomfort has lasted 72 hours after her vaccination. She cannot feel a lump on her axilla, just localized tenderness. The outcome of event for "much more sore than after the first vaccination" was unknown.   Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Limb mass, Malaise, Pain
Clinical narrative: felt lousy; aches from head to toe; slight fever of 102; lump under her left arm; the worst chills she has had in a long time; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on 18Feb2021 (age at the time of vaccination was 72-year-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date (age at the time of vaccination was 72-year-old) as a single dose for COVID-19 immunization. On an unspecified date, the patient experienced felt lousy, aches from head to toe, slight fever of 102, lump under her left arm and the worst chills she has had in a long time. The caller stated she received the second dose of the vaccine yesterday and has felt lousy since yesterday evening. She aches from head to toe, has a slight fever of 102, a lump under her left arm, and the worst chills she has had in a long time, and she still feels kind of bad. Consumer stated, I got my second Covid shot (Clarified as Covid 19 vaccine) yesterday Pfizer and I was feeling warmed. I got to see was I had a little temperature of 102 and I ache from head to toe and I have got a lump under my left arm which was where I got the injection. I was looking at all the literature that was given and it does not say anywhere in there that I can take. Can I take Ibuprofen or acetaminophen or aspirin to get rid some of these thing. I do not want to take something that is going to be wrong, but I like to. When paraphrased the concern, Consumer stated, Absolutely, yes. I can't move and this lump under my left arm I think is like (incomplete sentence). Everything hurts. On an unspecified date, the patient underwent lab and medical procedure which included Body temperature which showed result of little temperature of 102. Outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: felt lousy; aches from head to toe; slight fever of 102; lump under her left arm; the worst chills she has had in a long time; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on 18Feb2021 (age at the time of vaccination was 72-year-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date (age at the time of vaccination was 72-year-old) as a single dose for COVID-19 immunization. On an unspecified date, the patient experienced felt lousy, aches from head to toe, slight fever of 102, lump under her left arm and the worst chills she has had in a long time. The caller stated she received the second dose of the vaccine yesterday and has felt lousy since yesterday evening. She aches from head to toe, has a slight fever of 102, a lump under her left arm, and the worst chills she has had in a long time, and she still feels kind of bad. Consumer stated, I got my second Covid shot (Clarified as Covid 19 vaccine) yesterday Pfizer and I was feeling warmed. I got to see was I had a little temperature of 102 and I ache from head to toe and I have got a lump under my left arm which was where I got the injection. I was looking at all the literature that was given and it does not say anywhere in there that I can take. Can I take Ibuprofen or acetaminophen or aspirin to get rid some of these thing. I do not want to take something that is going to be wrong, but I like to. When paraphrased the concern, Consumer stated, Absolutely, yes. I can't move and this lump under my left arm I think is like (incomplete sentence). Everything hurts. On an unspecified date, the patient underwent lab and medical procedure which included Body temperature which showed result of little temperature of 102. Outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: She felt a little sore at the injection site; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support from a contactable female consumer (patient). A female patient of unspecified age received unknown dose of bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection), via an unspecified route on an unspecified date as a single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient felt a little sore at the injection site and just wanted to know if she can take Tylenol to feel better. The clinical outcome of the event was unknown.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site swelling
Clinical narrative: Caller discovered a red lump and swelling next to the injection site.; Caller discovered a red lump and swelling next to the injection site.; Caller discovered a red lump and swelling next to the injection site.; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 12Feb2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient received 2nd dose yesterday. Patient discovered a red lump and swelling next to the injection site. Patient asked is that a reason for a concern. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Myalgia
Clinical narrative: muscle and joint aches primarily in the, shoulders, neck arms, wrists in particular and ankles, and along the spine; muscle and joint aches; generally not feeling well; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EL3247), via an unspecified route of administration, administered in left arm on 17Feb2021 15:00 (age at the time of vaccination was 35 years old) as dose 2, single for covid-19 immunisation. The facility type was other. The medical history included cough variant asthma from an unknown date and unknown if ongoing. Also known allergies were reported as no. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EL3247), via an unspecified route of administration, administered in left arm on 27Jan2021 15:00 as dose 1, single for covid-19 immunisation. It was reported that no other vaccine was administered in four weeks. The patient had no covid prior vaccination. On 18Feb2021 21:30, the patient experienced muscle and joint aches, muscle and joint aches primarily in the, shoulders, neck arms, wrists in particular and ankles, and along the spine. It was reported that, the onset 28-32 hrs post second dose, muscle and joint aches primarily in the shoulders, neck, arms, wrists in particular and ankles, and along the spine and generally not feeling well. It was reported that the patient first noticed the symptoms of an AE on 18Feb around 9:30pm. She did not realize they were part of an AE until the morning of 19Feb, when they had not improved. The patient was not tested for covid post vaccination. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Paraesthesia, Salivary gland enlargement, Swelling face, Tenderness
Clinical narrative: Whole part of my left face became swelled and very tender to the touch; Whole part of my left face became swelled and very tender to the touch; I was feeling like tingling like if you have eaten something sour; I have a salivary gland clog; swollen lymph node/left side of the salivary gland started to swell; I have a salivary gland clog; swollen lymph node/left side of the salivary gland started to swell; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Lot Number: EL9266; Expiration Date: May2021) (at the age of 68-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. Concomitant medication(s) included Clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported. On 17Feb2021, the patient experienced her left side of the salivary gland started to swell and feeling like tingling like if you have eaten something sour, on 18Feb2021, the whole part of her left face became swelled and very tender to the touch and on unspecified date in Feb2021, patient experienced swollen lymph node. The clinical details of the events as follows: She stated that on Saturday 13Feb she received her first dose of the Pfizer covid vaccine and on Wednesday night, her left side of the salivary gland started to swell. Next day it was tender and swollen. She went to the urgent care and they prescribed her antibiotic for it and night at around 10:30, she was eating something, and she was feeling like tingling like if you have eaten something sour and then whole part of her left face became swelled and very tender to the touch. She really did not think it was anything related to the vaccine because, she had the shot five days ago and had no reaction, nothing. She went to the urgent care today, who said she had the Covid shot who was a Nurse Practitioner, who thought that she had a salivary gland clog and she put her on antibiotic (Treatment) and she was talking to her daughter and her daughter said, she just read Pfizer again and swollen lymph node which was her gland is a side effect. Treatment: Consumer stated the only thing, she went to Urgent care and she gave her antibiotic and she actually taken one dose of that antibiotic, which she thought was Amoxicillin. She wanted to know if its ok to take antibiotic before her next dose of the covid vaccine. She wanted to know if it is possible side effects of the vaccine happened 5 days later. She has an ENT appointment on Monday. No Investigation Assessment was provided. This case reported as non-serious. The patient outcome of the events was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.