chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: This is a spontaneous report from 2 contactable consumers or other non-healthcare professionals (one of the consumer is patient). A 12-year-old male patient received the 1st dose of BNT162B2 (Comirnaty; solution for injection; batch/lot# ER8733, expiry date: unknown), at the age of 12, intramuscularly, via unspecified route of administration, left arm, on May 18, 2021, at 08:00, single dose, for COVID-19 immunization. Medical history included food allergies: walnuts, pecans, sesame; and environmental allergies from an unknown date and unknown if ongoing. The patient's other medical history: none. The patient has not received any other vaccine within 4 weeks. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included D3 and folic acid for an unspecified indication, start and stop date not reported (other medications in two weeks). On May 23, 2021, patient experienced increased heartrate (a few days later) and frequently resting (laying down) at 115-100. No treatment received for the events. The outcome of the events unknown. Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Fatigue, Inappropriate schedule of product administration, Vaccination site erythema
Clinical narrative: She says her daughter got her second dose yesterday, August 9th; feels tired like she has been walking too much; redness at the  injection site; soreness at the injection site; some aching behind the bends of her knee; her own voice is shaky from anxiety; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for a 26-year-old female patient.  A 26-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 09Aug2021 (at the age of 26-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in right arm on Jul2021 (at the age of 26-year-old) as dose 1, single for COVID-19 immunization and patient experienced pain in extremity. The patient medical history was not reported, and concomitant medications were Ascorbic Acid, Herbal, Levoglutamide, Lysine, Magnesium, Manganese, Retinol, Riboflavin, Selenium, Tocopherol, Zinc, ELDERBERRY, VITAMIN D. On an unspecified date in Aug2021, after the vaccination, the patient experienced some aching behind the bends of her knee and feels tired like she has been walking too much. Caller wants to know if this is normal. Caller also asking what should she do for the pain and soreness at the injection site. The ache or tired like feeling just started around 3:30PM afternoon. She says she kept checking on her and last night to make sure she was not feverish or feeling bad, and in the morning, she had soreness to her arm like the first, which she had gotten in her right arm, then got the second in her left arm since they told her she couldn't take both shots in same arm. Patient was fine when she left here outside of the soreness of the arm, then she told her an hour ago she had aching to the bend of her knee like a tired feeling like she has been walking too much. The patient hasn't treated the ache or tired feeling because it just started about an hour ago. She says she thinks patient's first dose was in July, she knows it was like a two-week period between them, so she thinks it was on 30th of July or 26th of July. She says her daughter got her second dose on August 9th. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (20Sep2021), This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: She says her daughter got her second dose yesterday, August 9th; feels tired like she has been walking too much; redness at the  injection site; soreness at the injection site; some aching behind the bends of her knee; her own voice is shaky from anxiety; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for a 26-year-old female patient.  A 26-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 09Aug2021 (at the age of 26-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in right arm on Jul2021 (at the age of 26-year-old) as dose 1, single for COVID-19 immunization and patient experienced pain in extremity. The patient medical history was not reported, and concomitant medications were Ascorbic Acid, Herbal, Levoglutamide, Lysine, Magnesium, Manganese, Retinol, Riboflavin, Selenium, Tocopherol, Zinc, ELDERBERRY, VITAMIN D. On an unspecified date in Aug2021, after the vaccination, the patient experienced some aching behind the bends of her knee and feels tired like she has been walking too much. Caller wants to know if this is normal. Caller also asking what should she do for the pain and soreness at the injection site. The ache or tired like feeling just started around 3:30PM afternoon. She says she kept checking on her and last night to make sure she was not feverish or feeling bad, and in the morning, she had soreness to her arm like the first, which she had gotten in her right arm, then got the second in her left arm since they told her she couldn't take both shots in same arm. Patient was fine when she left here outside of the soreness of the arm, then she told her an hour ago she had aching to the bend of her knee like a tired feeling like she has been walking too much. The patient hasn't treated the ache or tired feeling because it just started about an hour ago. She says she thinks patient's first dose was in July, she knows it was like a two-week period between them, so she thinks it was on 30th of July or 26th of July. She says her daughter got her second dose on August 9th. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (20Sep2021), This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Diplopia, Eye pain, Lacrimation increased, Pain
Clinical narrative: tearing in the left eye; Burning; Pain in the left eye; double vision; Pain; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 56-years-old female patient received bnt162b2 , PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA7485 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 03Aug2021 10:00 at the age of 56-years-old as DOSE 1, SINGLE for covid-19 immunization. Medical history included familial Mediterranean fever, drug hypersensitivity, iodine allergy. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination.The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. Concomitant medication included colchicine taken for an unspecified indication, start and stop date were not reported.On 04Aug2021 03:00 the patient experienced tearing in the left eye, burning, pain in the left eye, double vision, pain. Patient was not revived any treatment. The outcome of events was recovering. No further in formation is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Photophobia
Clinical narrative: Usually does not have the headaches that bad and can't get rid of them; has never had one like this before; can't have light on or anything; Tiredness; This is a spontaneous report from a contactable consumer (patient herself). A 26-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date, NDC number was not reported), via an unspecified route of administration, administered in Arm Right-top on 27Jul2021 at 12-1pm (Age at vaccination 26-years-old) as dose 1, single for covid-19 immunisation (clinic). The patient medical history and concomitant medications were not reported. Prior Vaccinations, the patient had not received any other vaccine within 4 weeks. Caller thought she had side effects to the Pfizer Covid vaccine and had headaches and tiredness. Usually does not have the headaches that bad and she can't get rid of them. Got the first vaccine on Tuesday, 27Jul2021. The headaches started a few days ago, probably on 06Aug2021 and she never had one like this before. They are the same that come, but she can't have light on or anything reported on 06Aug2021. The tiredness started about the 6th or 7th of August (Aug2021) and had gotten worse over the last 2 days. No further details provided. Unable to provide the , Lot, or expiry for the first dose. Vaccine card is in the car. No problems with vaccines in past. Knows there is nothing she can do about the side effects and just wanted to report this. Wants to know if it's okay to get the second vaccine with the side effects she is having. Recommended caller to seek medical provider for further medical advice. No further details provided. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstrual cycle has changed from 4 weeks to 3 weeks; This is a spontaneous report received from a contactable consumer or other non hcp. A 45-years-old non pregnancy female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) dose number unknown via an unspecified route of administration on 15Mar2021 (age at vaccination 45years old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. Concomitant medication(s) included levothyroxine sodium (LEVOXYL) taken for an unspecified indication, start and stop date were not reported. Since the vaccination, the patient had not been tested positive for COVID-19. The patient previously took tapazole and experienced drug hypersensitivity, gluten, and experienced drug hypersensitivity. On 28Mar2021 the patient experienced menstrual cycle has changed from 4 weeks to 3 weeks. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: The first dose caused a huge reaction. Inflammation x's 1000; This is a spontaneous report from a contactable consumer (patient). A 38-years-old (Non pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered anatomical location not reported, on unspecified date as dose 1, single for COVID-19 immunization. The patient medical history included (as per the reporter): after a year and half of suffering severe joint pain and undergoing four hand surgeries patient was contracted COVID-19 unknowingly. COVID-19 attacked patient joints. COVID-19 attacked patient weaknesses. COVID-19 created widespread inflammation, causing trigger fingers, De Quervain's and ganglion cysts in patient wrists that patient was never had before. The patient reported she have one child. The patient had Carpal Tunnel during the pregnancy. The patient reported she also had Pre-eclampsia during the pregnancy. The patient reported Carpal Tunnel went away after she gave birth to her daughter prematurely (2 months early). The patient reported it never actually went away. The patient reported, she underwent tests for all autoimmune diseases and the results were negative. The patient reported, her Vitamin D was low. On unspecified date, as per the patient, the first dose of bnt162b2 vaccine caused huge reaction - Inflammation x's 1000. The patient thought she was going to end up in hospital. The patient reported, she called the CDC. The patient reported, CDC and patient connected dotes that she must have caught the COVID-19 a long time ago. The patient reported, she was there when everything shutdown in 2020, many coworkers caught the COVID-19, COVID-19 was spread to her workplace. The patient reported, that is where she believes she caught it. The patient reported, the CDC told her to wait one more day before she calls the doctor. The patient reported, CDC said it may just solve all her issues. The patient reported, CDC were right, she cannot believe it, this shot is a true miracle. The patient reported, she is so grateful, she has photos of her reaction to the shot, and she was happy to share them. The patient reported, she is so much thankful for giving her life back. The patient reported, her story is a true success and people need to hear positive things about this shot. On unspecified date, the outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Heart rate irregular, Insomnia
Clinical narrative: irregular heartbeat; My heart has been beating very fast; All night I couldn't sleep at all; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received first dose of BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 13Aug2021 at 13:00 hours as dose 1, single (at the age of 28-years-old) for Covid-19 immunisation. Patient had no medical history and had no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any concomitant medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 13Aug2021, at 16:00 hours, patient stated that his heart had been beating very fast all night, he couldn't sleep at all. On 14Aug2021, now patient do have an irregular heartbeat. The patient did not receive any treatment for the events. The outcome of all the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder, Pruritus, Psoriasis, Rash pruritic, Skin mass
Clinical narrative: had an extreme flair of psoriasis; rash very itchy to the whole body including scalp; She says that her scalp was also severely itching; cause havoc to my immune system; bumps all over her hands/welt looking on her legs; bumps all over her hands/welt looking on her legs; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FA7484) via an unspecified route of administration, administered in arm left on 31Jul2021 (at the age of 50-year-old) at dose 1, single for covid-19 immunisation. Medical history included lyme disease and suspected case of psoriasis. Reporter says it was not two weeks before the rash but a month or 30 days before that her doctor suspected she had Lyme disease, she was pretty ill, so they put her on antibiotics that she finished the antibiotics by 06Jul. No further details provided about the unspecified antibiotics. Concomitant medications were not reported. On an unspecified date in 2021 the patient experienced as per the reporter she did have a suspected case of psoriasis however after getting her first dose, had an extreme flair of psoriasis, rash very itchy to the whole body including scalp. Reporter added I think the vaccine cause havoc to my immune system, I never had psoriasis to that level before, I'm scaling, itching, scrapping everything off. Should I get the second dose. Reporter received her 1st dose on 31Jul2021 and is due for her second dose this Saturday. Reporter calling about the Pfizer COVID-19 vaccine who says she had side effects she felt were pretty severe she thinks, and she is scheduled for her second shot Saturday and is very concerned about getting the second dose, so she is seeking recommendations from the manufacturer. Reporter says her side effects began as an extreme flare of psoriasis, which she says extreme overnight in places she never had it before. She says it is like a rash to her hands that is the same as had to antibiotics at some point with bumps all over her hands and welt looking on her legs which began 7 days after she got the vaccine. No further details provided about antibiotics, and caller didn't clarify this statement. She says that her scalp was also severely itching. She says that the bumps were not treated, and they were not painful, just itchy. She says her whole body was itching, and the psoriasis flare up she had began with her elbows then overnight extreme itchy rash to her arms, legs, elbows, and scalp. She says that the scalp itching seemed like it was that severe to take her scalp off. She says that the itching is receding every day, it is not 100% better, but it seems to be getting about better. Outcome of the event she says that her scalp was also severely itching was resolving and remaining other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: had an extreme flair of psoriasis; rash very itchy to the whole body including scalp; She says that her scalp was also severely itching; cause havoc to my immune system; bumps all over her hands/welt looking on her legs; bumps all over her hands/welt looking on her legs; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FA7484) via an unspecified route of administration, administered in arm left on 31Jul2021 (at the age of 50-year-old) at dose 1, single for covid-19 immunisation. Medical history included lyme disease and suspected case of psoriasis. Reporter says it was not two weeks before the rash but a month or 30 days before that her doctor suspected she had Lyme disease, she was pretty ill, so they put her on antibiotics that she finished the antibiotics by 06Jul. No further details provided about the unspecified antibiotics. Concomitant medications were not reported. On an unspecified date in 2021 the patient experienced as per the reporter she did have a suspected case of psoriasis however after getting her first dose, had an extreme flair of psoriasis, rash very itchy to the whole body including scalp. Reporter added I think the vaccine cause havoc to my immune system, I never had psoriasis to that level before, I'm scaling, itching, scrapping everything off. Should I get the second dose. Reporter received her 1st dose on 31Jul2021 and is due for her second dose this Saturday. Reporter calling about the Pfizer COVID-19 vaccine who says she had side effects she felt were pretty severe she thinks, and she is scheduled for her second shot Saturday and is very concerned about getting the second dose, so she is seeking recommendations from the manufacturer. Reporter says her side effects began as an extreme flare of psoriasis, which she says extreme overnight in places she never had it before. She says it is like a rash to her hands that is the same as had to antibiotics at some point with bumps all over her hands and welt looking on her legs which began 7 days after she got the vaccine. No further details provided about antibiotics, and caller didn't clarify this statement. She says that her scalp was also severely itching. She says that the bumps were not treated, and they were not painful, just itchy. She says her whole body was itching, and the psoriasis flare up she had began with her elbows then overnight extreme itchy rash to her arms, legs, elbows, and scalp. She says that the scalp itching seemed like it was that severe to take her scalp off. She says that the itching is receding every day, it is not 100% better, but it seems to be getting about better. Outcome of the event she says that her scalp was also severely itching was resolving and remaining other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Rash pruritic, Skin discolouration
Clinical narrative: break out with a rash on the upper right side of my back just below the shoulder blade. Other areas began to develop rash on my trunk included abdomen, buttocks and thighs; The rash is very itchy; sites of the rash are thick and colored reddish/purple; Itching one of the sites results in a burning sensation; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in right arm on 28Apr2021 at 15:00 (at the age of 60-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The medical history included hypertension. The patient's concomitant medication(s) included ramipril (RAMIPRIL) taken 10 mg, hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken 25 mg, and lovastatin (LOVASTATIN). Patient had no known allergies. Patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8734), via an unspecified route of administration, administered in right arm on 07Apr2021 at 15:00 (at the age of 60-years-old) as DOSE 1, SINGLE for covid-19 immunisation. On May2021, approximately two weeks after receiving the final vaccination, the patient started to break out with a rash on the upper right side of my back just below the shoulder blade. Other areas began to develop rash on trunk included abdomen, buttocks and thighs. The rash was very itchy and the sites of the rash were thick and colored reddish/purple. Itching one of the sites results in a burning sensation. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient received treatment of Valacyclovir 1gram tablet and Clobetasol %0.05 for an event. Seriousness reported as non-serious. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspnoea, Headache, Vomiting
Clinical narrative: Headache; Vomiting; Stomach pain; She is not breathing; This is a spontaneous report from a contactable consumer. This consumer reported for a 16-year-old female patient (reporter's sister) that: A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 20Aug2021 as dose number unknown, single for COVID-19 immunisation at pharmacy. The patient medical history and concomitant medications were not reported. She was having some side effects. She was having headache; she has vomited and a lot of stomach pain. We only gave her Tylenol (Intent: treatment). She took the vaccine on Friday in the afternoon. She stated having them yesterday (21Aug2021) in the afternoon, but it got worse this morning. She said she was not breathing. We are going to send her to the hospital.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Hyperhidrosis, Hypersensitivity
Clinical narrative: Difficulty in breathing; I am sweating like a pig all time; Might be an allergic reaction, I mean I am sweating a lot; I am sweating like a pig all time; Might be an allergic reaction, I mean I am sweating a lot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Apr2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced difficulty in breathing, i am sweating like a pig all time; might be an allergic reaction, i mean i am sweating a lot. Patient stated that "I have the drug was the 21st of April and this is coming out with me now. I think that's something that you should be aware of". Patient took the test and it came up negative (further clarification unknown about the test). The outcome of the events was unknown.   Information about lot/batch number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash
Clinical narrative: kind of itchy and red; I think I have an allergy; Rash in my neck; kind of itchy and red; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0191; Expiration Date: 30Sep2021), dose 1 via an unspecified route of administration on 21Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. In Aug2021, the patient experienced kind of itchy and red and i think i have an allergy, rash in my neck. The patient reported that the patient was little worried because there was the events and asked what to do. 2nd dose was scheduled on 11Sep2021. When asked permission to probe further, the consumer stated that the consumer need a help with the question regarding the current situation. Outcome of the events were unknown. Reporter seriousness for the events were unspecified.  Follow-up activities closed. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, Skin swelling
Clinical narrative: Acute onset left supraclavicular lymphadenopathy/Swollen and painful lymph nodes above clavicle bone; swollen skin area about 3 inches around the lymph nodes; Dose 1: 29Apr2021 and Dose 2: 20Aug2021; This is a spontaneous report from a contactable consumer (reported for herself). A 63-years-old female non-pregnant patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FD8448/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 20Aug2021 at 16:30 (at the age of 63-years-old) as dose 2, single for covid-19 immunisation drug Store. Medical history included autoimmune disorder (Connective Tissue Autoimmune Disease), hypertension, hypothyroidism and spinal cord disorder, all from an unknown date and unknown if ongoing. Concomitant medication(s) included np thyroid (LEVOTHYROXINE, LIOTHYRONINE), estradiol (ESTRADIOL), cymbalta (DULOXETINE HYDROCHLORIDE) and verapamil hydrochloride (VERAPAMIL HYDROCHLORIDE), all the drugs taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0171/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 29Apr2021 at 20:00 (at the age of 63-years-old) as dose 1, single for covid-19 immunisation drug Store. On 22Aug2021 at 06:00, the consumer reported that, acute onset left supraclavicular lymphadenopathy. Swollen and painful lymph nodes above clavicle bone and swollen skin area about 3 inches around the lymph nodes. No treatment was given for the events. The outcome of the events was not resolved and dose 1: 29apr2021 and dose 2: 20aug2021 was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Pruritus, Vaccination site erythema, Vaccination site urticaria
Clinical narrative: her arm on the backside at the top of her arm where she got the shot had hives, and they were hot and red; face started tingling and feeling numb; really itchy; they were hot and red; feeling numb; they were hot and red; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: FC3180; Expiration Date: 31Oct2021), via an unspecified route of administration, administered in arm left (left upper arm) on 21Aug2021 (at the age of 69-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine prior vaccinations within 4 weeks. On 21Aug2021, the patient experienced her arm on the backside at the top of her arm where she got the shot had hives, and they were hot and red, face started tingling and feeling numb, really itchy, they were hot and red. Patient got the shot the Pfizer biontech, name as provided by the caller. Patient got the shot on 21Aug2021, she ended up getting first dose. Patient felt fine, but then her arm on the backside at the top of her arm where she got the shot had hives, and they were hot and red. Patient would like to know if its a normal side effect or if she needs to go to the doctor. Patient signed up with safe. Patient got the shot on the front side of arm. It makes her afraid to get the second one. Hives, and they were hot and red. Half an hour after her shot, it was really itchy. Treatment - antiitch medication. Face started tingling and feeling numb: About 10 mins after her shot her face started tingling and feeling numb. It went away after an hour and a half. It was around her cheek. Patient recovered completely. The patient received antiitch medication as treatment for the event really itchy. Outcome of the events her arm on the backside at the top of her arm where she got the shot had hives, and they were hot and red was not recovered; really itchy, they were hot and red was unknown; face started tingling and feeling numb recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected .
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: her arm on the backside at the top of her arm where she got the shot had hives, and they were hot and red; face started tingling and feeling numb; really itchy; they were hot and red; feeling numb; they were hot and red; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: FC3180; Expiration Date: 31Oct2021), via an unspecified route of administration, administered in arm left (left upper arm) on 21Aug2021 (at the age of 69-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine prior vaccinations within 4 weeks. On 21Aug2021, the patient experienced her arm on the backside at the top of her arm where she got the shot had hives, and they were hot and red, face started tingling and feeling numb, really itchy, they were hot and red. Patient got the shot the Pfizer biontech, name as provided by the caller. Patient got the shot on 21Aug2021, she ended up getting first dose. Patient felt fine, but then her arm on the backside at the top of her arm where she got the shot had hives, and they were hot and red. Patient would like to know if its a normal side effect or if she needs to go to the doctor. Patient signed up with safe. Patient got the shot on the front side of arm. It makes her afraid to get the second one. Hives, and they were hot and red. Half an hour after her shot, it was really itchy. Treatment - antiitch medication. Face started tingling and feeling numb: About 10 mins after her shot her face started tingling and feeling numb. It went away after an hour and a half. It was around her cheek. Patient recovered completely. The patient received antiitch medication as treatment for the event really itchy. Outcome of the events her arm on the backside at the top of her arm where she got the shot had hives, and they were hot and red was not recovered; really itchy, they were hot and red was unknown; face started tingling and feeling numb recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected .
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Tinnitus
Clinical narrative: Tinnitus, this getting louder and louder; This is a spontaneous report from a Pfizer-sponsored program  from a contactable female consumer (patient). A 74-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EN6201, Expiry date: Unknown, NDC and UPC number: Unknown) dose 2 intramuscular, administered in the left arm on 15Feb2021 (at the age of 74 years old) as dose 2, single for COVID-19 immunisation. PQC was not present. Investigation assessment was done. Medical history included Hashimoto's, High cholesterol, hypertension, bone density abnormal. Historical vaccine included bnt162b2 (BNT162B2, solution for injection, Lot Number: EL3247) dose 1 administered in the right arm on 20Jan2021 as dose 1, single for COVID-19 immunisation. Prior to vaccination, no other vaccines were given within 4 weeks. Concomitant medication(s) included denosumab (PROLIA) taken for bone density abnormal (shot every six months). On 17Feb2021 the patient experienced tinnitus, this getting louder and louder. No treatment was given. The patient underwent lab tests and procedures which included blood test resulted unknown results on an unknown date. The clinical outcome of the events was reported as not recovered.  Lot number requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101242529 same reporter/drug/AE, different patients
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Fatigue, Headache
Clinical narrative: Bright red itchy rash; Bright red itchy rash; Bright red itchy rash, resembling a sunburn; Other side effects: fever started Sat. night ended Tues. highest temperature 102.9; dizziness; weakness; headache; fatigue; body aches; This is a spontaneous report from a contactable consumer (patient) reported that a 53-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: fc3182), dose 1 via an unspecified route of administration, administered in Arm Left on 21Aug2021 14:45 (at the of 53 years old) as dose 1, single for covid-19 immunisation. Medical history included Ehlers Danlos and Dysautonomia, penicillin allergy. The patient Known allergy Penicillin: rash, hives. The patient previously took anaprox and experienced hypersensitivity. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Facility type vaccine: Pharmacy or Drug Store and facility country in US. Prior to vaccination patient had COVID-19. Post vaccination, the patient had not been tested for COVID-19. No treatment was received in response to the adverse events. On 21Aug2021, the patient experienced bright red itchy rash, resembling a sunburn, other side effects: fever started sat. night ended tues. highest temperature 102.9, dizziness, weakness, headache, fatigue and body aches. The patient underwent lab tests and procedures which included body temperature: 102.9 fahrenheit on an 21Aug2021. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Bright red itchy rash; Bright red itchy rash; Bright red itchy rash, resembling a sunburn; Other side effects: fever started Sat. night ended Tues. highest temperature 102.9; dizziness; weakness; headache; fatigue; body aches; This is a spontaneous report from a contactable consumer (patient) reported that a 53-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: fc3182), dose 1 via an unspecified route of administration, administered in Arm Left on 21Aug2021 14:45 (at the of 53 years old) as dose 1, single for covid-19 immunisation. Medical history included Ehlers Danlos and Dysautonomia, penicillin allergy. The patient Known allergy Penicillin: rash, hives. The patient previously took anaprox and experienced hypersensitivity. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Facility type vaccine: Pharmacy or Drug Store and facility country in US. Prior to vaccination patient had COVID-19. Post vaccination, the patient had not been tested for COVID-19. No treatment was received in response to the adverse events. On 21Aug2021, the patient experienced bright red itchy rash, resembling a sunburn, other side effects: fever started sat. night ended tues. highest temperature 102.9, dizziness, weakness, headache, fatigue and body aches. The patient underwent lab tests and procedures which included body temperature: 102.9 fahrenheit on an 21Aug2021. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pruritus, Urticaria
Clinical narrative: hives approximately 15 hours later-at first on abdomen and back then chest then tops of legs and inside of arms; Itching badly; This is a spontaneous report from a contactable consumer (Patient). A 22-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, in left arm on 24Aug2021 11:15 AM (at the age of 22-year-old) as a dose 2, single for COVID-19 immunization. The patient medical history was not reported. The concomitant medication of the patient included paracetamol (TYNELOL). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown) via unspecified route of administration on 03Aug2021 as a dose 1, single for COVID-19 immunization. The patient had no known allergies and no other medical history. Patient had no COVID prior to vaccination. The patient was tested for COVID post vaccination (negative). On 25Aug2021 02:00 AM the patient experienced hives approximately 15 hours later-at first on abdomen and back then chest then tops of legs and inside of arms. Itching badly. Patient reported that hives were worse on arm that didn't receive the injection. Patient received the treatment of Benadryl and Benadryl topical cream for the reported events. Outcome of the reported events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Dyspnoea, Euphoric mood, Hypoaesthesia
Clinical narrative: 2nd dose - after approx hour of administration - face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing; 2nd dose - after approx hour of administration - face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing; 2nd dose - after approx hour of administration - face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing; 2nd dose - after approx hour of administration - face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing; 2nd dose - after approx hour of administration - face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing; 2nd dose - after approx hour of administration - face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient (not pregnant at the time of vaccination) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and batch no: not reported/lot number: EW0181) via an unspecified route of administration, in left arm on 25Aug2021 11:00 AM (at the age of 53-years-old) as single dose of for COVID-19 immunization at Pharmacy or Drug store. Medical history included as allergy. Concomitant medications included the patient received medications within 2 weeks of vaccination included amlodipine at 2.5 mg for an unspecified indication. Historical vaccine included as patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and batch no: not reported/lot number: EW0181) via an unspecified route of administration, in left arm on 04Aug2021 11:00 AM (at the age of 53-years-old) as single dose for COVID-19 immunization and experienced tingling cold in left arm and leg within 15min of administration. The patient had not received any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, the patient has not been tested for covid-19. On 25Aug2021 at 12:15PM after approx. hour of administration, patient experienced face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing. The outcome of the events was not recovered. Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: 2nd dose - after approx hour of administration - face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing; 2nd dose - after approx hour of administration - face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing; 2nd dose - after approx hour of administration - face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing; 2nd dose - after approx hour of administration - face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing; 2nd dose - after approx hour of administration - face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing; 2nd dose - after approx hour of administration - face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient (not pregnant at the time of vaccination) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and batch no: not reported/lot number: EW0181) via an unspecified route of administration, in left arm on 25Aug2021 11:00 AM (at the age of 53-years-old) as single dose of for COVID-19 immunization at Pharmacy or Drug store. Medical history included as allergy. Concomitant medications included the patient received medications within 2 weeks of vaccination included amlodipine at 2.5 mg for an unspecified indication. Historical vaccine included as patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and batch no: not reported/lot number: EW0181) via an unspecified route of administration, in left arm on 04Aug2021 11:00 AM (at the age of 53-years-old) as single dose for COVID-19 immunization and experienced tingling cold in left arm and leg within 15min of administration. The patient had not received any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, the patient has not been tested for covid-19. On 25Aug2021 at 12:15PM after approx. hour of administration, patient experienced face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing. The outcome of the events was not recovered. Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: terrible rash/the rash got worse; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, Solution for injection; Lot Number: FA7484), via an unspecified route of administration, administered in left arm (left shoulder) on 03Aug2021 at 14:23 (at the age of 78-years-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as none. Patient did not get any other vaccines the same day or 4 weeks prior to vaccination. No problems with vaccines in past. No illness prior to getting the vaccine. On an unspecified date in Aug2021, patient experienced terrible rash probably started at least a week later of vaccination, and the week after getting the vaccine, the rash got worse and she went back to the pharmacist and showed them her arm and was told it was a rash and to have her doctor look at it. It was reported that, this was just not her saying she had a rash. Patient Stated it was getting better because she was putting on Cortisone 10 on it to control it. Therapeutic measures were taken as a result of terrible rash or the rash got worse with Cortisone 10. Adverse event not resulted in Emergency Room or Physician Office. At the time of this report, the outcome of event was recovering.  Follow-up attempts are completed. No further information is expected