chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Drug intolerance
Clinical narrative: My boys and I get the same dose and it's toxic; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (Patient's mother) reported for a 14-year-old male patient (reporter's son) that patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. They will get their second shot on 21Jul2021. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced my boys and i get the same dose and it's toxic. Reporter stated my boys are small. The caller wants to get the smaller dose for the second one instead of full 30 mcg. I think it's too much. It's too toxic. I've read that their are people having heart issues. I know that there is a small risk but everyday I am just reading stuff. It's toxic and we need a smaller dose. I've read that it doesn't take much to get an immune response. The vaccines are not only based on people's weight, they are based on people's age. I am a small person and I am receiving the same dose my husband is 4x at. He has no side effects. My boys and I get the same dose and it's toxic. It's a poison. I am a super healthy person I exercise couple miles a day and I don't feel how I used to feel. I regret the first shot I don't wanna do further damage. Caller wants to know if she can get the second dose and not the full shot of the dose, if not if she can just get one dose of the vaccines since she cannot tolerate the side effects. Caller mentioned that women are sometimes responding stronger to the shot because of their inflammatory response because of estrogens compared to testosterone in men and stuff. Would it be beneficial to take Ibuprofen if she starts feeling symptoms to help reduce the inflammation after getting the shot which can cause the spinal neurological symptoms. She is worried about neurological symptoms. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Drug intolerance
Clinical narrative: My boys and I get the same dose and it's toxic; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for 16-year-old male patient (reporter's son). A 16-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (age at vaccination 16-year-old) as dose 1, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that she didn't want to get the full dose of 30 mcg shot because she felt weird after getting the first shot, she felt shaky and quavering inside. Her boys were small. The caller wanted to get the smaller dose for the second one instead of full 30 mcg. She thought it was too much and It was too toxic. She read that there were people having heart issues. She knew that there was a small risk but every day she was just reading stuff. It's toxic and they need a smaller dose. She read that it didn't take much to get an immune response. Caller stated that the vaccines were not only based on people's weight, but they were also based on people's age. She was a small person, and she was receiving the same dose her husband was 4x at. He had no side effects. Her boys and her got the same dose and it was toxic. It was a poison. The outcome of the event was unknown.  Information about Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on 01Jul2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, I have gain a rash on all over my body as per, in my arms and my legs on an unspecified date in Jul2021. Patient took a vaccine on the 01Jul2021 and I was wondering, that's normal or do I have to go to ask. The outcome of event was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Fever; Having reactions to the second dose of the Pfizer vaccine; This is a spontaneous report from a contactable consumer or other non hcp.  A female patient of an unspecified age received bnt162b2 (COVID Vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (an unspecified age) as DOSE 2, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient previously took ( COVID Vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (an unspecified age) as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, the patient experienced fever, having reactions to the second dose of the pfizer vaccine. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Product preparation error, Pyrexia
Clinical narrative: 13 year old male administered a full undiluted vial of the Pfizer COVID 19 vaccine; administered a full undiluted vial of the Pfizer COVID 19 vaccine; fever; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported that a 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose (NDC number: not provided/Expiry Date: unknown /lot: EW0181) on 16Jun2021 as single dose for COVID-19 immunization. Patient medical history and Family medical history was unknown. Prior Vaccination (within 4 weeks) was None. Concomitant medications were unknown. Reporter is a pharmacist  who stated that the patient was administered an undiluted vial of the Pfizer COVID 19 vaccine. She was asking for recommendations for procedures and follow up if the next dose is needed and would like to know if there is any information or guidance from Pfizer on this case and if the second dose should be given as scheduled. Reporter clarifies that another pharmacist gave the vaccine to the patient. Patient was doing OK for first 24hrs after the 1st dose full vial overdose. After the first 24 hrs the patient had little bit of a fever. The patient received second dose on 08Jul2021, Batch/Lot number: EW0198 (exp unknown). Relevant test was unknown. Investigation Assessment was Not Provided. The outcome of the event was unknown.  Follow-up (23Jul2021): New information reported from a contactable Pharmacist in response to HCP letter sent via telephonic follow-up activity which included: New event (fever), Deleted event (Inappropriate age at vaccine administration and Off label use), Product details, Event detail, Patient history.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis, Lymphadenopathy, Muscle spasms, Periorbital oedema, SARS-CoV-1 test
Clinical narrative: lymphadenitis; gland swelling; periorbital edema; severe muscle cramping; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 21May2021 08:00 am (batch/lot number EW0161 and expiry date unknown) at 60 years of age as dose 1, single for covid-19 immunization. The patient informed that the facility where the most recent COVID-19 vaccine was administered was in the hospital. Medical history included graves disease. The patient had no covid prior vaccination/was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included levothyroxine for unspecified indication from unspecified. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In May2021, the patient experienced lymphadenitis, gland swelling, periorbital edema, severe muscle cramping. The events resulted to emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. The patient was hospitalized for 1 day due to the events. The patient underwent lab tests and procedures which included COVID-19 (BP) (nasal swab) on 24May2021, 01Jun2021, 10Jun2021, 15Jun2021, 21Jun2021, 29Jun2021, and COVID-19 (RAPID) (nasal swab) on 24Jun2021; all negative. The patient received treatment of prednisone w/taper, magnesium. The outcome of the events was not recovered.; Sender's Comments: The contributory role of the suspect product  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), (batch/lot number EW0161 and expiry date unknown) to reported events is possible based on temporal association and known profile of the product.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram head, Electrocardiogram, Illness, Urine analysis
Clinical narrative: benign proximal positional vertigo; sick; This is a spontaneous report from a contactable consumer. This 69-year-old female consumer reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0182) via an unspecified route of administration on 10May2021 09:30 on arm left (at 69-year-old), as dose 2, single for COVID-19 immunization. Medical history of the patient included stroke. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0170) via an unspecified route of administration on 19Apr2021 at 09: 30 AM on left arm at 69-year-old), as dose 1, single for COVID-19 immunization. Caller reported that she received both doses of the Pfizer Covid-19 vaccine and later, on an unknown date she was sick. She went to an Urgent Care, and Ear, Nose, and Throat doctor, who diagnosed her with benign paroxysmal positional vertigo on 06Jun2021. On an unknown date in 2021 the patient underwent lab tests and procedures which included blood test: her bloodwork, computerized tomogram head, electrocardiogram and urine analysis were normal. Her question was could the vaccine have caused this condition. Therapeutic measures were taken with a full course of Prednisone prescribed by the Urgent Care for benign proximal positional vertigo (vertigo positional). The outcome of event benign proximal positional vertigo was not recovered and for sick was unknown. The patient reported that she had no health insurance and does not like or take drugs. She was normally a very healthy person, who did not have a vaccine pressure, but peer pressure got her to take this vaccine.  No further details were provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo positional
Clinical narrative: benign proximal positional vertigo; sick; This is a spontaneous report from a contactable consumer. This 69-year-old female consumer reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0182) via an unspecified route of administration on 10May2021 09:30 on arm left (at 69-year-old), as dose 2, single for COVID-19 immunization. Medical history of the patient included stroke. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0170) via an unspecified route of administration on 19Apr2021 at 09: 30 AM on left arm at 69-year-old), as dose 1, single for COVID-19 immunization. Caller reported that she received both doses of the Pfizer Covid-19 vaccine and later, on an unknown date she was sick. She went to an Urgent Care, and Ear, Nose, and Throat doctor, who diagnosed her with benign paroxysmal positional vertigo on 06Jun2021. On an unknown date in 2021 the patient underwent lab tests and procedures which included blood test: her bloodwork, computerized tomogram head, electrocardiogram and urine analysis were normal. Her question was could the vaccine have caused this condition. Therapeutic measures were taken with a full course of Prednisone prescribed by the Urgent Care for benign proximal positional vertigo (vertigo positional). The outcome of event benign proximal positional vertigo was not recovered and for sick was unknown. The patient reported that she had no health insurance and does not like or take drugs. She was normally a very healthy person, who did not have a vaccine pressure, but peer pressure got her to take this vaccine.  No further details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: insomnia; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 22Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced insomnia on 23Jun2021. The clinical course was reported as she received her first dose of the Pfizer BioNTech Covid-19 Vaccine on 22Jun2021. After this day she has been unable to sleep for three weeks. She has insomnia. She has seen multiple doctors including a neurologist and a therapist who prescribed her zolpidem to help her sleep. She still cannot sleep. She was not being able to fall asleep until 5:00AM. She is scheduled for her second dose of the Pfizer BioNTech Covid-19 Vaccine today. if she should get the second dose of the vaccine. The clinical outcome of the event was unknown. Therapeutic measures were taken as a result of insomnia.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: joint pain; muscle pain; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on unspecified date as single dose for covid-19 immunisation. The patient experienced joint pain, muscle pain on an unspecified date. The clinical course was reported as she received second dose of the Pfizer covid vaccine one month ago. States one week after the second shot, she developed joint pain and muscle pain which is still ongoing. The clinical outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain, Burning sensation, Erythema, Feeling hot, Pain in extremity
Clinical narrative: Friday received 2nd vaccine arm hurting; my upper left arm got more red warm; my upper left arm got more red warm; my upper left arm got more red warm to touch tender; my upper left arm got more red warm to touch tender burning; burning and itchy at the same time; slight pain under my left breast that went away after a few hours; This is a spontaneous report from a contactable consumer. A 68-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EW0183; Expiry date 07Sep2021) dose 2 via an unspecified route of administration, administered in Arm Left on 09Jul2021 13:45 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included arthritis had problem from an unknown date and unknown if ongoing, Blood clots from 2017 to an unknown date on coumadin 5 daily. Concomitant medications included vitamin d (vitamin d Nos) (VITAMIN D [VITAMIN D NOS]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID; zinc (ZINC), warfarin sodium (COUMADIN) taken for an unspecified indication, start and stop date were not reported. Not known allergies. The patient previously received first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On 10Jul2021 Friday received 2nd vaccine arm hurting this I expected and thought only would last 3 days my upper left arm got more red warm to touch tender burning and itchy at the same time and seems to be spreading over a wider area on my upper arm and. Had a slight pain under my left breast that went away after a few hours. Left a message with my family Dr no response as yet. was wondering how long this will last and am I being an alarmist and go to the (Name withheld) as It does not seem better and it's the 4th day since the 2nd vaccine. The patient did not received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Tenderness
Clinical narrative: Friday received 2nd vaccine arm hurting; my upper left arm got more red warm; my upper left arm got more red warm; my upper left arm got more red warm to touch tender; my upper left arm got more red warm to touch tender burning; burning and itchy at the same time; slight pain under my left breast that went away after a few hours; This is a spontaneous report from a contactable consumer. A 68-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EW0183; Expiry date 07Sep2021) dose 2 via an unspecified route of administration, administered in Arm Left on 09Jul2021 13:45 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included arthritis had problem from an unknown date and unknown if ongoing, Blood clots from 2017 to an unknown date on coumadin 5 daily. Concomitant medications included vitamin d (vitamin d Nos) (VITAMIN D [VITAMIN D NOS]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID; zinc (ZINC), warfarin sodium (COUMADIN) taken for an unspecified indication, start and stop date were not reported. Not known allergies. The patient previously received first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On 10Jul2021 Friday received 2nd vaccine arm hurting this I expected and thought only would last 3 days my upper left arm got more red warm to touch tender burning and itchy at the same time and seems to be spreading over a wider area on my upper arm and. Had a slight pain under my left breast that went away after a few hours. Left a message with my family Dr no response as yet. was wondering how long this will last and am I being an alarmist and go to the (Name withheld) as It does not seem better and it's the 4th day since the 2nd vaccine. The patient did not received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash
Clinical narrative: Friday received 2nd vaccine arm hurting; my upper left arm got more red warm; my upper left arm got more red warm; my upper left arm got more red warm to touch tender; my upper left arm got more red warm to touch tender burning; burning and itchy at the same time; slight pain under my left breast that went away after a few hours; This is a spontaneous report from a contactable consumer. A 68-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EW0183; Expiry date 07Sep2021) dose 2 via an unspecified route of administration, administered in Arm Left on 09Jul2021 13:45 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included arthritis had problem from an unknown date and unknown if ongoing, Blood clots from 2017 to an unknown date on coumadin 5 daily. Concomitant medications included vitamin d (vitamin d Nos) (VITAMIN D [VITAMIN D NOS]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID; zinc (ZINC), warfarin sodium (COUMADIN) taken for an unspecified indication, start and stop date were not reported. Not known allergies. The patient previously received first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On 10Jul2021 Friday received 2nd vaccine arm hurting this I expected and thought only would last 3 days my upper left arm got more red warm to touch tender burning and itchy at the same time and seems to be spreading over a wider area on my upper arm and. Had a slight pain under my left breast that went away after a few hours. Left a message with my family Dr no response as yet. was wondering how long this will last and am I being an alarmist and go to the (Name withheld) as It does not seem better and it's the 4th day since the 2nd vaccine. The patient did not received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain, Burning sensation, Erythema, Feeling hot, Pain in extremity
Clinical narrative: painful red hot rash spreading on her injection site; This is a spontaneous report from a contactable other hcp (nurse) (patient) from a Pfizer-sponsored program. A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Jul2021 (at the age of 68-year-old) at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 16Jun2021 (at the age of 68-year-old) at dose 1, single for covid-19 immunisation. On an unspecified date the patient experienced painful red hot rash spreading on her injection site. Reporter calling to advise of an adverse reaction she is feeling now after the second dose given on 09Jul2021, on Friday, there is a painful red hot rash spreading on her injection site, the arm, and she is wondering if it will last for more than 3 days, and she went with her husband who is also having redness and soreness on the arm of the injection site. Asking if it will last for more than 3 days. Confirmed they received Pfizer COVID 19 vaccine. Transfer agent states the first dose was on 16Jun2021. Reporter stated she hasn't worked since 2017. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Tenderness
Clinical narrative: painful red hot rash spreading on her injection site; This is a spontaneous report from a contactable other hcp (nurse) (patient) from a Pfizer-sponsored program. A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Jul2021 (at the age of 68-year-old) at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 16Jun2021 (at the age of 68-year-old) at dose 1, single for covid-19 immunisation. On an unspecified date the patient experienced painful red hot rash spreading on her injection site. Reporter calling to advise of an adverse reaction she is feeling now after the second dose given on 09Jul2021, on Friday, there is a painful red hot rash spreading on her injection site, the arm, and she is wondering if it will last for more than 3 days, and she went with her husband who is also having redness and soreness on the arm of the injection site. Asking if it will last for more than 3 days. Confirmed they received Pfizer COVID 19 vaccine. Transfer agent states the first dose was on 16Jun2021. Reporter stated she hasn't worked since 2017. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash
Clinical narrative: painful red hot rash spreading on her injection site; This is a spontaneous report from a contactable other hcp (nurse) (patient) from a Pfizer-sponsored program. A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Jul2021 (at the age of 68-year-old) at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 16Jun2021 (at the age of 68-year-old) at dose 1, single for covid-19 immunisation. On an unspecified date the patient experienced painful red hot rash spreading on her injection site. Reporter calling to advise of an adverse reaction she is feeling now after the second dose given on 09Jul2021, on Friday, there is a painful red hot rash spreading on her injection site, the arm, and she is wondering if it will last for more than 3 days, and she went with her husband who is also having redness and soreness on the arm of the injection site. Asking if it will last for more than 3 days. Confirmed they received Pfizer COVID 19 vaccine. Transfer agent states the first dose was on 16Jun2021. Reporter stated she hasn't worked since 2017. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, SARS-CoV-2 test
Clinical narrative: Can't sleep; Muscle pain arm for over 2 weeks was not at the time of shoot. Just started recently 2 weeks ago.; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 04Jun2021 at 14:00 (at the age of 41-years-old) in right arm as a single dose for covid-19 immunization. Medical history included thyroid removal from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with covid-19. No known allergies were reported. Concomitant medication received in two weeks included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine received within four weeks included first dose of BNT162B2 (COVID Pfizer vaccine; lot number: unknown) on an unspecified date for covid-19 immunization. On 01Jul2021 the patient experienced muscle pain in arm for over 2 weeks and it was not at the time of shoot. She also reported that she can't sleep. The patient did not receive any treatment for the events. Post vaccination, the patient had been tested for covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab) as negative on 19Jun2021. The outcome of the events was not recovered.  Information on the Batch/Lot number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: the site of the first vaccination is still painful today; This is a Spontaneous report from a contactable consumer (patient herself). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 11:30 (at the age of 41-year-old) as single dose for covid-19 immunisation. Patient's medical history reported as none and she was very healthy. Patient's family history was not provided, and no relevant test was performed. Concomitant medication(s) included ascorbic acid (VITAMIN C CITRUS) taken for an unspecified indication, start and stop date were not reported and sporadically takes a multivitamin when she thinks she has not eaten well. It was not provided that patient received any other vaccine four weeks prior vaccination. Patient reported she had the shot in different arms because her left arm was still sore on 11Mar2021, and she requested to get the second dose in the other arm. She reported the site of the first vaccination is still painful today. When she moves her arm around, like if her left arm was next to a clock and she tried to move it a full hour, the pain begins at eight o'clock, and then at ten to eleven it is very painful then at twelve she can bring it back down again without pain. Eleven is the position that really hurts, and she swims butterfly stroke, and she can't do it anymore because of the pain. When she brings her arm up, she has to drop it immediately. Mentioned she still does push ups and yoga and there is some pain but not as much, but she has gotten no relief from stretching or physical therapy. Reports she can't remember exactly when she started to feel the pain in her left arm, but she thinks it was within the first three hours or the same evening as the first dose of the Pfizer COVID 19 vaccination. It was bad for seven days then the pain subsided, but she started to feel like her arm was stuck at that one point, and there is an ache in the centre of the muscle, in the centre in her arm stated she tried to isolate the source of the pain, but she can't put the fingers on the place she only has the pain when she rotates her arm or when she starts moving it. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in right arm on 31Mar2021 at 15:15 as single dose for covid-19 immunisation. Patient was not visited to emergency room or physician's office for the event. Therapeutic measures were taken as a result of the event. The outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: it was still sore from the first dose; This is a spontaneous report received from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry Date were not reported), via an unspecified route of administration on 11Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she received her first vaccine dose on 11Mar2021 and her second dose on 31Mar2021. She had to request her second dose be in her opposite arm of the first dose because it was still sore from the first dose, and now (as reported) the muscle in her arm still hurt when she rotated it 360 degrees. She stated that it also hurt when she extended her arm backwards. She asked if other people have had this or should she go see a doctor. She also asked which healthcare professional (HCP) should go to. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pruritus, Erythema, Feeling hot, Skin fissures
Clinical narrative: right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack/her other ear was burning, red, felt hot and started cracking again; right ear itching and burning and then the skin started to crack/her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; This is a spontaneous report from a contactable consumer via Pfizer Sponsored Program. The report is first of four different patients.  A patient of unspecified age and gender received 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 on an unspecified date as dose 1, single and received 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 on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient had right ear itching and burning and then the skin started to crack. On an unspecified date, patient's other ear was burning, red, felt hot and started cracking again. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Aggression
Clinical narrative: Aggressive behaviors; This is a spontaneous report from a contactable consumer (patient's parent). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in left arm, on 26Mar2021 at 12:00 PM (at the age of 17 years) (pending clarification), as dose 1, single, for COVID-19 immunization. The patient's medical history included severe autism. The patient's concomitant medications were not reported. 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-19 vaccine. The patient was fine up until he received his first dose Pfizer vaccine. In Mar2021 (also reported as 25Mar2021 at 01:00 PM, pending clarification), the patient developed aggressive behaviors. The event resulted in disability or permanent damage (also considered medically significant). It was unknown if treatment was received for the event. On 13Apr2021 at 12:00 PM, the patient was administered with the second dose of BNT162B2 in left arm. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site swelling
Clinical narrative: Arm hurt; swelling on the left arm at injection site; This is a spontaneous report from a contactable consumer (Patient, self-reporting). A 57-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration dates were not reported), via an unspecified route of administration in arm left on an unspecified date in Mar2021 at 01:30 (at the age of 57-years-old) as dose 1, single for COVID-19 immunisation. Medical history included manage bursitis in right hip and mild inflammation soreness. Patient had no past drug history. Concomitant medication included naproxen (NAPROXEN) 1 or 2 (500MG) tablets taken for an unspecified indication, within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 13Mar2021 at 14:30, the patient experienced arm hurt, swelling on the left arm at injection site. Arm hurt after first shot in march and there was swelling on the left arm at injection site. Pain and swelling was still present when she received the second shot. It was now over 3.5 months past the second shot and I still have pain at injection site and swelling. Patient often have stabs of pain shooting from the site down the length of arm. Tender at site to pressure and had some mild inflammation soreness in shoulder 1 month prior to shot from working at home poor ergonomics. Since the shots the shoulder also went into a chronic pain. About 8 weeks after receiving vaccinations she got a Cortizone shot in left should to help eliminate pain and had 12 sessions of PT. Very painful when pressure was put on injection site. Physical therapist reported an increase of cases with people who had old shoulder injuries were coming in with flare ups and do not know if the two are related but she was hoping the symptoms would have subsided after 90 days. Some times it is just a chronic ache at injection site. Facility where the most recent COVID-19 vaccine was administered was other only. The outcome of events were not recovered.  Follow up information is excepted. Further information is requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vaginal lesion, Vulvovaginal pain
Clinical narrative: vaginal lesions developed, they were extremely painful; vaginal lesions developed, they were extremely painful; a high fever (102); body aches; chills; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER 8735) at the age of 33-years, via an unspecified route of administration, administered in left arm on 22Apr2021 at 10:00 at single dose for COVID-19 immunisation, at pharmacy or drug store. Medical history included IBS. The patient was not pregnant at 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. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING). The patient previously took the first single dose of BNT162B2 (lot number: EW0150) at the age of 33-years, via an unspecified route of administration, administrated in left arm, on 01Apr2021 at 10:00 for COVID-19 immunisation. Vaginal lesions developed about 36 hours after vaccine. They were extremely painful and healed after a week. The event occurred on 23Apr2021 at 22:00. Also experienced body aches and chills about 8 hours after the vaccine (on 22Apr2021 at 18:00), and a high fever (102) beginning about 16 hours after vaccine (on 23Apr2021 02:00, lasting about 10 hours on and off). The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received lidocaine for pain as treatment. Outcome of fever was recovered/resolved on 23Apr2021 at 12:00; of vaginal lesions developed, they were extremely painful was recovered/resolved; while of remain was unknown. Since the vaccination, the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Feeling abnormal, Illness
Clinical narrative: contracted the Delta variant; contracted the Delta variant; sick/a general feeling of illness; fever; aches; head congestion; fatigue; brain fog; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the consumer had been double vaccinated early in Jan2021 with Pfizer and contracted the Delta variant from the patient who also had the Pfizer. The patient got it in another country. He gave it to the consumer and another 32-year-old woman who was J&J vaccinated. All of them got very sick with fever, aches, head congestion, fatigue, brain fog and a general feeling of illness. The consumer had now lost taste and smell. This had been ongoing for 6 days. Outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Upper respiratory tract congestion
Clinical narrative: contracted the Delta variant; contracted the Delta variant; sick/a general feeling of illness; fever; aches; head congestion; fatigue; brain fog; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the consumer had been double vaccinated early in Jan2021 with Pfizer and contracted the Delta variant from the patient who also had the Pfizer. The patient got it in another country. He gave it to the consumer and another 32-year-old woman who was J&J vaccinated. All of them got very sick with fever, aches, head congestion, fatigue, brain fog and a general feeling of illness. The consumer had now lost taste and smell. This had been ongoing for 6 days. Outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Feeling abnormal
Clinical narrative: Very heavy nose bleed; Got another very heavy nose bleed; Very tired; Not feeling well; This is a spontaneous report from a contactable consumer or other non-health care professional (parent- mother). A 14-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0182), via an unspecified route of administration (at the age of 14-years), on 09Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0182), via an unspecified route of administration on 18Jun2021 as dose 1, single for COVID-19 immunization. On 12Jul2021, the patient experienced very heavy nose bleed, got another very heavy nose bleed. On Jul2021, experienced very tired and not feeling well. Reporter stated that I am calling about my son, he was 14 years old and he had his second vaccine this past Friday and two nights in a row, he has had very heavy nose bleed but he does not get these bloody noses ever but it started last night and then he just got another very heavy nose bleed. I just do not know if we need to watch for this or worry about this just because as I said he just had his second and he has never ever had nose bleeds. She stated that her 14 year old son received his second dose of the Pfizer COIVD-19 vaccine on 09July2021 and the past two nights has been having nose bleeds and is looking for any information on this, has this been reported, what to look for? She stated that her sons first and second doses were the same LOT number, EW0182, and they did not provide NDC/EXP for either dose on the vaccine card. She clarified that it was after he had the second dose, now he is having bloody noses and she would like to know if she should worry or is this normal and others have reported experiencing this. Is there a product complaint to report?-Yes, Description of complaint: This is a follow up report. Report Reference: Unknown, caller says this was not provided during the call she made yesterday. Pfizer COVID-19 vaccine: Caller says that her son's first and second doses were the same LOT number, EW0182, and they did not provide NDC/EXP for either dose on the vaccine card. Product strength and count size dispensed: not provided, second dose. Additional lot numbers: N/A. Is a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact? not provided. Is there a medical information request?-Yes. Please describe the medical information request she would like to know if she should worry or is this normal and others have reported experiencing bloody noses after second dose of Pfizer COVID-19 vaccine?  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, X-ray
Clinical narrative: The evening after the first shot, I had intense leg cramps all night, that kept me awake.; This is a spontaneous report from a contactable 56-year-old female consumer.  A 56-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL6198, Expiration date: unknown), via unspecified route, administered in left arm on 09Mar2021 04:00 PM as DOSE 1, SINGLE for COVID-19 immunization. Patient took the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6208, Expiration date: unknown) via unspecified route, administered in left arm on 26Mar2021 04:00 PM as DOSE 2, SINGLE. The patient medical history includes Osteoarthritis, Atrial fibrillation, Enlarged Thyroid, Goiters, and Sulphonamide allergy. Past drug events include CEFZIL induced Drug hypersensitivity and MACROBID induced Drug hypersensitivity. Concomitant medications include bisoprolol fumarate, hydrochlorothiazide (BISPROLOL), Vitamin D, cyanocobalamin (B-12), acetylsalicylic acid (ASPIRIN). Patient was not tested positive prior and post vaccination. No other vaccines were taken in four weeks. On 09Mar2021, 10:00 PM in the evening after the first dose of vaccination, the patient experienced intense leg cramps all night, that kept the patient awake. Adverse event resulted in Doctor or other healthcare professional office/clinic visit and doctor suggested an x-ray, ice and exercise. Lab data includes X-Ray on an unspecified date with normal results. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected