chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 102.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Sore; This is a spontaneous report from a Pfizer sponsored program. A 102-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9265), via an unspecified route of administration in the upper left arm, on 01Feb2021, as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (Lot Number: EK9231), via unspecified route of administration in the upper left arm, on 11Jan2021 in the morning, as a 1st dose, 0.3 ml, single dose for COVID-19 immunisation. She did not receive any other vaccines outside of the Pfizer Covid 19 vaccine within 4 weeks. The patient reported, she received both doses of the Pfizer BioNTech vaccine. She tested her immunity and found out she doesn't have immunity. She had questions about the lack of efficacy. She was a little bit sore on the same date as the injection. It went away in a few hours. The patient was treated with some ice. The outcome of the sore was recovered.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: arm really sore/ arm hurt all night; "uncomfort" in his arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number was not reported as patient did not card with him), via an unspecified route of administration, on an unspecified date (at age of 58-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration, on an unspecified date as single dose for covid-19 immunization. On an unspecified date, the patient stated that he woke up in the morning with a sore arm after receiving the second dose of the Pfizer COVID vaccine yesterday. He said that he did not have any issues with the first dose. The patient said that he talked to three people as wanted to know if this side effect was normal or if he should seek emergency care from a doctor. The patient had "uncomfort" in his arm and arm was sore. His arm was hurting all night and was uncomfortable. The patient was concerned because he had never experienced this before, and he did not know if he needed to see a doctor for the arm pain. The patient was informed about the role of Pfizer. When probed, patient stated that he was not at his home and did not have vaccination card with him. Product details (ndc# upc# and treatment) and pharmacy details could not be probed as he was unwilling to share further information. Hence, further probing could not be done and limited information available over the call. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased
Clinical narrative: ALT was really high/A couple days ago had blood work and ALT was like super high; This is spontaneous report from contactable female consumer (patient). A 21-year-old female patient 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, administered in arm left on 16May2021 15:00 (at the age of 21-year-old) at a 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was taking unspecified thyroid medications. No family history was reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took flu shot and thought she had adverse reaction because the patient like passed out or something. The patient experienced alt was really high/a couple days ago had blood work and alt was like super high on 28May2021. Patient asking for advise following her first Pfizer vaccine she is scheduled this Sunday for the 2nd one. Patient stated, On Friday, she got blood work, went to see my primary care physician, ALT was really high. Patient was not taking anything other than thyroid medication, thinking maybe it is the vaccine. They were going to repeat the blood work in 6 weeks. Had tests done 4 or 5 months ago and were fine. The patient was a consumer reporting she had not received the second dose Pfizer Covid Vaccine and was scheduled to receive the second dose Pfizer Covid Vaccine on Sunday, 06JUN2021. The patient stated she received the first dose Pfizer Covid Vaccine. A couple days ago had blood work done and ALT was like super high: A couple days ago the patient had blood work done and the patient's ALT was like super high. The patient stated this was her liver she guessed. The patient went to her primary care and the primary care stated maybe the vaccine caused the ALT to go up so high. The patient stated she was not taking any medications or anything or doing anything differently. The patient was wondering if she should still receive the second dose Pfizer Covid Vaccine. The patient underwent lab tests and procedures which included ALT was like really high on 28May2021. Therapeutic measures (unspecified) were taken as a result of alt was really high/a couple days ago had blood work and alt was like super high. Outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Headache, Nasopharyngitis, Rhinorrhoea
Clinical narrative: Headache; Runny nose; Cough; Back pain; Cold; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer (patient) reported for herself that she received first dose of BNT162B2 (bnt162b2, formulation: Solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration on 21May2021 at 10:30 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 22May2021 the patient experienced headache, runny nose, cough, back pain and cold. Patient had undergone unspecified lab tests a month ago before the shot on an unspecified date and not recently. Patient had mentioned the second dose will be taken on 09Jun2021. Patient didn't receive any other vaccinations with in 4weeks of vaccination. The outcome of the events headache, back pain was recovering whereas outcome of other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Helplessness, Malaise
Clinical narrative: Very little reaction the next day; feeling sickening; feels helpless; feels like her heart is heavy and  in the middle of all over the face and on her forehead and then she just can not do anything; Very little reaction the next day; feeling sickening; feels helpless; feels like her heart is heavy and  in the middle of all over the face and on her forehead and then she just can not do anything; Very little reaction the next day; feeling sickening; feels helpless; feels like her heart is heavy and  in the middle of all over the face and on her forehead and then she just can not do anything; This is a spontaneous report from a contactable consumer. A female patient (reporter's daughter) received second dose of BNT162B2 (COVID Vaccine, Solution for injection, Batch/lot number: Unknown (reported as did not know whether EW0178), Expiry date: Unknown, NDC/UPC number: Unknown) via an unspecified route of administration in May2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of Covid-19 vaccine as single dose for Covid-19 immunization. On an unspecified date, the patient experienced very little reaction the next day; feeling sickening; felt helpless; felt like her heart was heavy and in the middle of all over the face and on her forehead and then she just could not do anything: Reporter stated, "the patient got her second shot, last Friday. She was 17 years old. She had very little reaction the next day but then she was saying she was feeling sickening feeling you know she feels helpless. She was here so did not know if that was expected or what she was to do. She felt like her heart was very heavy and in the middle of all over the face and on her forehead and then she just could not do anything". Reporter was informed about the Medical Information Department for the concern and was provided with the contact number for Pfizer Medical Information, Option 3, and was informed that the department opens from Monday to Friday, from 8 am to 8 pm and 9 am to 3 pm on Saturday and Sunday as per EST. Reporter hung up abruptly. Hence, limited information available. Reporter seriousness for the event was unspecified. Outcome of the events was unknown.  Follow-up attempts are needed; information about lot/batch number requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: severe dizziness; vertigo; This is a spontaneous report received from a contactable female consumer (patient). A 31-year-old (non-pregnant) 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 ad-ministration, administered in arm right on 27May2021 15:00 (at the age of 31-year-old) as a 2nd dose, single dose for COVID-19 immunization. The patient 's medical history was not reported. The patient had no known allergies. The patient's concomitant medication included doxycycline monohydrate 100 mg. The patient 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, administered in arm right on 06May2021 (at the age of 31-year-old) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe dizziness and vertigo on 01Jun2021 10:00 PM. Patient was not diagnosed for COVID-19 prior to vaccination. The patient had not tested COVID-19 post vaccination. The patient did not receive any treatment medication for the events. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal chest pain, Pain
Clinical narrative: felt tired in the evening; pain in her side; had pain in her side where her ribs are; This is a spontaneous report from Medical information team. A contactable consumer (patient) reported that a 70-year-old female (same age during vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had Tetanus shot on an unspecified date. As per reported, the caller stated she already called this morning. She had the first covid shot yesterday at 11:00 am. She felt tired in the evening, but it says you can get tiredness. She woke up around 5:30 am and had a pain in her side. It started suddenly, abruptly, and severely. She expected pain in her arm, and she has had tetanus shots and she was expecting muscle pain in her arm. But she had pain in her side where her ribs are, and it says you can get muscle pain. She had to take acetaminophen, an over-the-counter pain medication to take the edge off and it is not as bad now, but she still feels it and she will probably have to take another. She stated it may not be from the vaccine, she probably slept on her side wrong or something, but she doesn't normally have this. Outcome of events was unknown.  Information about batch/lot number has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain in extremity
Clinical narrative: arm sore; got a little warm; got a little headache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration in arm left, on 22Apr2021 (Lot Number: EW0171) and on 14May2021 (Lot Number: EW0182), (at the age of 28-years-old) respectively, both as single doses for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that his second shot was scheduled at the location where he got his first dose, but he could not go to that location, so he rescheduled the second dose at different location. Further he added that, the guy at the second location did not know he was going to get the second shot hence, the patient was afraid if he might get the first shot twice and wanted to know if he should be concerned about this. On an unspecified date in May2021, the patient had arm sore, got a little warm and headache. The patient experienced the same side effects as he did with the first dose and stated that the symptoms started the next day after each dose and lasted about two days (exact dates were unknown). The outcome of the events was unknown.   Additional information is requested.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Illness, Insomnia, Lethargy, Malaise
Clinical narrative: he was still feeling sick; he was still feeling sick; lethargic; cant sleep night; has a sense of feeling of a warm oil running through his veins; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at unknown, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, he got the Pfizer vaccine 3 weeks ago tomorrow and he was still feeling sick, lethargic, could not sleep night, and has a sense of feeling of a warm oil running through his veins. Reporter explained the vaccine was for COVID. Also reported that his cousin had a severe side effect, Cousin was sick with it for 2 days. Declined to complete a report for his cousin. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: Lethargic; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0177, Expiration date and NDC number: unknown), via an unspecified route of administration on 14May2021 (3 weeks ago) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date of May2021, patient was just lethargic for 2 days and after 48 hours she was fine. Patient's husband stated that vaccine shot did not bother her. Patient's husband declined to complete a report for the patient. The event recovered on May2021. Investigation Assessment: Not Provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea; Loose stools; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE, lot/batch number unknown) intramuscularly in left deltoid on 16Mar2021 09:15AM at the age of 65-years-old at 2nd dose single dose for COVID-19 immunization. Medical history included fractures at wrist from 23Jan2021, and hematuria/nephrolith from 01Jan2021 and ongoing. The historic vaccine was bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE, lot/batch number unknown) intramuscularly in left deltoid on 23Feb2021 03:15 PM at the age of 65-years-old at 1st dose single dose for COVID-19 immunization and experienced sore arm, queasiness in stomach 18 hours later, and loose stool. Concomitant medications were none. The patient did not take any relevant test. Prior vaccinations within 4 weeks were reported as none. The patient experienced nausea on 17Mar2021 15:00, and loose stools on 17Mar2021. The Seriousness criteria was reported as not serious. No treatment received. The outcome of events was recovered.   Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Cough, Dyspnoea, Nasal congestion
Clinical narrative: chills; cough; shortness of breath; body aching; loss of taste; lots of nasal congestion and mucus; lots of nasal congestion and mucus; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route of administration on 14May2021, as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 18May2021, 4 days after receiving the vaccine, patient experienced chills, cough, shortness of breath, body aching, loss of taste, lots of nasal congestion and mucus, did not have a fever. Therapeutic measure taken for the events included unspecified antibiotics. The patient underwent lab test and procedure on 24May2021 which included for COVID-19 virus test and tested negative. Patient wanted to know if she could receive the second dose of the vaccine on Friday if they are still taking antibiotics. It was reported that no contraindications for patients with infections taking antibiotics. The patient stated that she prefers to make a written report and accepted to get contacted back. The patient was referred to her physician for treatment recommendations. The outcome of the events was unknown.   Information about Lot Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021651028 Same reporter/drug/event, different patient.;US-PFIZER INC-2021651029 Same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: chills; cough; shortness of breath; body aching; loss of taste; lots of nasal congestion and mucus; lots of nasal congestion and mucus; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route of administration on 14May2021, as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 18May2021, 4 days after receiving the vaccine, patient experienced chills, cough, shortness of breath, body aching, loss of taste, lots of nasal congestion and mucus, did not have a fever. Therapeutic measure taken for the events included unspecified antibiotics. The patient underwent lab test and procedure on 24May2021 which included for COVID-19 virus test and tested negative. Patient wanted to know if she could receive the second dose of the vaccine on Friday if they are still taking antibiotics. It was reported that no contraindications for patients with infections taking antibiotics. The patient stated that she prefers to make a written report and accepted to get contacted back. The patient was referred to her physician for treatment recommendations. The outcome of the events was unknown.   Information about Lot Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021651028 Same reporter/drug/event, different patient.;US-PFIZER INC-2021651029 Same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Eye disorder, Fatigue, Feeling cold
Clinical narrative: dizziness; did not allow me to have my eyes open; blood pressure was high; felt my body very cold; arm was very swollen; pain, a sharp pain, especially on the right side of the brain and the part of my head; tiredness; heaviness in the head; anxious; felt a lot of heat in my body; One hour later in her right arm she had a lot of pain; This is a spontaneous report received 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 01Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had first dose of the Pfizer COVID 19 vaccine on 01Jun2021 and ten minutes after that she started feeling dizzy and could not keep her eyes open and since she was still at the vaccination facility, they took her blood pressure, and it was high. One hour later in her right arm she had a lot of pain and it was swollen she felt the pain was a sharp pain that was on her right arm which was the arm she had the injection. Caller also felt pain in her brain and part of the head. Caller also reported being tired and had dizziness. Caller stated the headache and dizziness was constant, but she felt it mostly on the right side of her body which was the side she received the injection. Caller had to close her eyes so the dizziness would stop. Caller stated this happened on 01Jun2021 and 02Jun2021 and it was making her feel very anxious and she felt really really hot and when she had her blood pressure high, she felt her body cold. The clinical outcome of the events were unknown.    Follow-up 2 (PRD 03Jun2021): This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: dizziness, did not allow me to have my eyes open, blood pressure was high, felt my body very cold, arm was very swollen, pain, a sharp pain, especially on the right side of the brain and the part of my head, tiredness, heaviness in the head, anxious, felt a lot of heat in my body, one hour later in her right arm she had a lot of pain.  Information on the lot/batch number has been requested. further information has been request-ed.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Head discomfort, Headache, Hypertension, Pain in extremity
Clinical narrative: dizziness; did not allow me to have my eyes open; blood pressure was high; felt my body very cold; arm was very swollen; pain, a sharp pain, especially on the right side of the brain and the part of my head; tiredness; heaviness in the head; anxious; felt a lot of heat in my body; One hour later in her right arm she had a lot of pain; This is a spontaneous report received 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 01Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had first dose of the Pfizer COVID 19 vaccine on 01Jun2021 and ten minutes after that she started feeling dizzy and could not keep her eyes open and since she was still at the vaccination facility, they took her blood pressure, and it was high. One hour later in her right arm she had a lot of pain and it was swollen she felt the pain was a sharp pain that was on her right arm which was the arm she had the injection. Caller also felt pain in her brain and part of the head. Caller also reported being tired and had dizziness. Caller stated the headache and dizziness was constant, but she felt it mostly on the right side of her body which was the side she received the injection. Caller had to close her eyes so the dizziness would stop. Caller stated this happened on 01Jun2021 and 02Jun2021 and it was making her feel very anxious and she felt really really hot and when she had her blood pressure high, she felt her body cold. The clinical outcome of the events were unknown.    Follow-up 2 (PRD 03Jun2021): This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: dizziness, did not allow me to have my eyes open, blood pressure was high, felt my body very cold, arm was very swollen, pain, a sharp pain, especially on the right side of the brain and the part of my head, tiredness, heaviness in the head, anxious, felt a lot of heat in my body, one hour later in her right arm she had a lot of pain.  Information on the lot/batch number has been requested. further information has been request-ed.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: dizziness; did not allow me to have my eyes open; blood pressure was high; felt my body very cold; arm was very swollen; pain, a sharp pain, especially on the right side of the brain and the part of my head; tiredness; heaviness in the head; anxious; felt a lot of heat in my body; One hour later in her right arm she had a lot of pain; This is a spontaneous report received 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 01Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had first dose of the Pfizer COVID 19 vaccine on 01Jun2021 and ten minutes after that she started feeling dizzy and could not keep her eyes open and since she was still at the vaccination facility, they took her blood pressure, and it was high. One hour later in her right arm she had a lot of pain and it was swollen she felt the pain was a sharp pain that was on her right arm which was the arm she had the injection. Caller also felt pain in her brain and part of the head. Caller also reported being tired and had dizziness. Caller stated the headache and dizziness was constant, but she felt it mostly on the right side of her body which was the side she received the injection. Caller had to close her eyes so the dizziness would stop. Caller stated this happened on 01Jun2021 and 02Jun2021 and it was making her feel very anxious and she felt really really hot and when she had her blood pressure high, she felt her body cold. The clinical outcome of the events were unknown.    Follow-up 2 (PRD 03Jun2021): This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: dizziness, did not allow me to have my eyes open, blood pressure was high, felt my body very cold, arm was very swollen, pain, a sharp pain, especially on the right side of the brain and the part of my head, tiredness, heaviness in the head, anxious, felt a lot of heat in my body, one hour later in her right arm she had a lot of pain.  Information on the lot/batch number has been requested. further information has been request-ed.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: high blood pressure; This is a spontaneous report from a non-contactable pharmacist. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on Feb2021 as 1ST DOSE, SINGLE DOSE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced high blood pressure. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema
Clinical narrative: she was given the second dose of the Pfizer Covid vaccine subcutaneously rather than IM; redness to her arm around the injection site; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer sponsored program via medical information team. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), subcutaneously on 27May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), dose 1 on unspecified date for covid-19 immunisation. The patient stated that she was given the second dose of the Pfizer Covid vaccine subcutaneously rather than IM (intramuscular). She stated that she had the second dose of the Pfizer Covid vaccine on the 27May2021. She noticed redness to her arm around the injection site but not on it which was resolving. The patient queried that "Can I go get a Antibody test to determine if I am protected" and the response was as follows: CDC states that antibody testing is not recommended to assess for immunity to SARS-CoV-2 [the virus that causes COVID-19] following COVID-19. In addition, antibody tests currently authorized under an Emergency Use Authorization (EUA) are not authorized for the review of an immune response in vaccinated people. The patient also queried that "If I was given the vaccine subcutaneously rather than in the muscle, I'm I protected fully? I spoke to the pharmacist where I had the vaccine and they said it would be alright. Outcome of the event redness to her arm around the injection site was reported as resolving.  Information about lot/batch number is requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: shooting pain down both arms; shooting pain down both arms; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 25May2021 (Batch/Lot Number: EW0185) as single dose for COVID-19 immunisation. Medical history included 8 years ago he threw his back out at work and his left leg died almost overnight, lost all the muscle, it was just bone, caller was tearful, 4 years ago he had a viral infection and abscess on L4, L5, vertebrae. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/lot number: EW0171), administered in right arm on an unspecified date for COVID-19 immunisation. It was reported that the patient got second shot on 25May2021 and his arms were killing him. Got shot in right arm and it was his left arm that was having a constant shooting pain that goes all the way down his arm. The patient stated that he will just be relaxing and then all of a sudden the arm would feel like he was having a shot in his arm, he could feel the veins popping out of his wrist, and felt like they were stretching. Patient called his doctor but they will not call him back. The patient was encouraged to reach out to a HCP or urgent care for any medical advice. There was no investigation assessment. Outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; tired; This is a spontaneous report from a contactable consumer reported for her father (a male consumer age not provided) that: A male patient of an unspecified age received unknown dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient relevant family medical history include: she says her parents and sister all were vaccinated and were fine but her dad and sister have heart conditions but have been fine, no one had any effects other than like sore arm and tired. The patients concomitant medications were not reported. On an unknown date the patient experienced sore arm and tired. No other products provided and Investigations not provided. The outcome of events was  Communication: Report 2 of 3. AE identified after the caller unable to clarify with the caller the specific product received by her father. No further information provided.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Arm was hurting after first dose; Was getting itching in his hands; Finger tips had swelling; This is a spontaneous report from a Pfizer-sponsored program . This is a spontaneous report from a non-contactable male consumer reported for himself that: A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. Medical history included Herniated disc and Back pain from an unknown date and unknown if ongoing. Concomitant medication(s) included hydrocodone (HYDROCODONE) taken for Herniated disc and Back pain, start and stop date were not reported. On an unspecified date, the patient experienced his arm was hurting, added that about a week ago, he was getting to itch in his hands; his fingertips would swell up, not on the nail side. It started on one hand and the other day was on the other hand. Yesterday swelling was on right hand and today it was on the left hand. The itching had gone away. The patient was taking 5mg for about 2 years for a herniated disc and back pain. He wanted to know if it was safe to take the second shot with the medication. Caller clarified pain medication as Hydrocodone 5mg, one every 8 hours. The outcome of the events Arm was hurting after first dose and Fingertips had swelling was unknown and for was getting to itch in his hands it was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Chills, Cough, Dyspnoea, Nasal congestion
Clinical narrative: Chills; Cough; Shortness of breath; Body aching; Loss of taste; Lots of nasal congestion and mucus; Lots of nasal congestion and mucus; This is a spontaneous report from a contactable consumer (parent). A 15-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/batch no. was not reported) via unspecified route, as 1st dose, single dose on 14May2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that on an unspecified date in May2021, a day later one of her children experienced chills, cough, shortness of breath, body aching, loss of taste, lots of nasal congestion and mucus, did not have a fever, then she presented the symptoms 4 days after receiving the vaccine and her other son presented it a week later. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24May2021. Therapeutic measures were taken as a result of events with antibiotics. The report was non-serious. Outcome of the events was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021650327 Same reporter/drug/event, different patient.;US-PFIZER INC-2021651029 Same reporter/drug/event, different patient.
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Chills; Cough; Shortness of breath; Body aching; Loss of taste; Lots of nasal congestion and mucus; Lots of nasal congestion and mucus; This is a spontaneous report from a contactable consumer (parent). A 15-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/batch no. was not reported) via unspecified route, as 1st dose, single dose on 14May2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that on an unspecified date in May2021, a day later one of her children experienced chills, cough, shortness of breath, body aching, loss of taste, lots of nasal congestion and mucus, did not have a fever, then she presented the symptoms 4 days after receiving the vaccine and her other son presented it a week later. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24May2021. Therapeutic measures were taken as a result of events with antibiotics. The report was non-serious. Outcome of the events was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021650327 Same reporter/drug/event, different patient.;US-PFIZER INC-2021651029 Same reporter/drug/event, different patient.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vomiting
Clinical narrative: Puked all over the work; Feel sick alittle; This is a spontaneous report from a contactable consumer (patient).   A 39-years-old male consumer reported for himself that he 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 05May2021 at 21:15 in left arm as a single dose for covid-19 immunization. Medical history and concurrent conditions were reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine or any other medications within two weeks of vaccination. Concomitant medications and relevant past drug history were not reported. The patient received first dose of vaccine on 05May2021 at 21:15 and felt fine that night. On an unknown date in May2021, he went to work and felt sick a little, puked all over the work van and he felt fine after two days. The events were assessed as non-serious. Patient was not hospitalized for the events. The outcome of the events was resolved in May2021.  Information about batch/Lot number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Dysgeusia, Pain in extremity, Pruritus
Clinical narrative: fever; arm got itchy and sore; arm got itchy and sore; felt dizzy and woozy; tasted a metal-ish taste; This is a spontaneous report from a contactable consumer (patient herself). A 66-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0172, Expiry date: Unknown) via an unspecified route of administration on 07Apr2021 on left arm as 1st dose, single dose for COVID-19 immunization. The patient's medical history included systemic lupus erythematosus, diagnosed in 2010 and is under control and COVID-19 as caller did not want to get COVID again bad. There were no concomitant medications. On 07Apr2021, the same day of vaccination, the patient experienced felt dizzy and woozy, tasted a metalish taste, on 08Apr2021, experienced fever, arm got itchy and sore. After the caller left the vaccination site, she drove about a block and then she tasted a metalish taste and felt dizzy but it went away. A couple of days after receiving the first dose, the caller's arm got itchy and sore. The caller got a fever of 99.2 which lasted about 2 days. After about 2 weeks, the fever and arm soreness flared back up, right before it was time for her second shot. The caller's arm was sore in that area and around the shoulder a little bit. Then the caller was feeling okay. The patient underwent lab tests and procedures include fever of 99.2 and shoulder x-ray which was negative on 27May2021. The outcome of the events felt dizzy and woozy and tasted a metalish taste recovered on 07Apr2021, fever recovered on 10Apr2021 and arm got itchy and sore was recovered on an unspecified date in 2021.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, X-ray limb
Clinical narrative: fever; arm got itchy and sore; arm got itchy and sore; felt dizzy and woozy; tasted a metal-ish taste; This is a spontaneous report from a contactable consumer (patient herself). A 66-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0172, Expiry date: Unknown) via an unspecified route of administration on 07Apr2021 on left arm as 1st dose, single dose for COVID-19 immunization. The patient's medical history included systemic lupus erythematosus, diagnosed in 2010 and is under control and COVID-19 as caller did not want to get COVID again bad. There were no concomitant medications. On 07Apr2021, the same day of vaccination, the patient experienced felt dizzy and woozy, tasted a metalish taste, on 08Apr2021, experienced fever, arm got itchy and sore. After the caller left the vaccination site, she drove about a block and then she tasted a metalish taste and felt dizzy but it went away. A couple of days after receiving the first dose, the caller's arm got itchy and sore. The caller got a fever of 99.2 which lasted about 2 days. After about 2 weeks, the fever and arm soreness flared back up, right before it was time for her second shot. The caller's arm was sore in that area and around the shoulder a little bit. Then the caller was feeling okay. The patient underwent lab tests and procedures include fever of 99.2 and shoulder x-ray which was negative on 27May2021. The outcome of the events felt dizzy and woozy and tasted a metalish taste recovered on 07Apr2021, fever recovered on 10Apr2021 and arm got itchy and sore was recovered on an unspecified date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: increased blood pressure and never had it before; This is a spontaneous report from a contactable physician. A 101-year-old female patient received bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The caller's cousin got the vaccine and after that she developed increased blood pressure and never had it before. Outcome of the event was unknown.  Follow-up attempts are needed . Further information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Vaccination site swelling
Clinical narrative: First dose: Swelling at the injection site; The first dose was annoying and she slept for a day; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection) via an unspecified route of administration, in arm right on 06May2021 (at the age of 57-year-old) (Lot Number: EW976) as 1st dose, single dose for covid-19 immunization. The patient medical history included ulcer (Diagnosed in 2020 and patient could not take Ibuprofen because of this). The patient concomitant medications were not reported. On 06May2021 (reported as after 6 hours of first dose of vaccine), the patient experienced swelling at the injection site. The patient reported that the first time she had a swelling the size of her hand at the injection site. The first dose was annoying, and she slept for a day on an unknown date in 2021. The patient was prone to swelling, she never progressed after the second round of allergies shots because of the swelling. The swelling happened after every allergy shot, she ever had this was 20 years ago. The swelling would start about a day later. The patient would get one allergy shot on a Monday (date unspecified) and then one shot on a Friday (date unspecified). The outcome of the event was swelling at the injection site was recovered on 10May2021and for hypersomnia was recovered on 2021.  No follow-up attempts possible. No further information expected.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was given the Dtap/IPV portion of PENTACEL and did not get the ActHIB part, no AE; Upon Internal review a signification amendment was performed on 04-Jun-2021, to change the product code of Pentacel from 242 to 520.  Initial information received on 14-Dec-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 2 months old female patient who was given the first dose of DTAP/IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Lot number UJ336AAA and expiration date 05-Jul-2021) and did not get the ACT-HIB part, via intramuscular route in the right thigh for prophylactic vaccination on 10-Dec-2020 (Product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique (same day latency).  Physician stated that an employee gave the DTAP/IPV portion of PENTACEL. She wanted to know how to proceed, to give them just an ActHIB or another Pentacel. The physician stated that an employee at the office gave the DTaP/IPV portion of Pentacel on 10-Dec-2020.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: U
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient was administered with second dose of fluzone quadrivalent 18 days after initial dose with no reported adverse event; This case is submitted following an incorrect Worldwide ID in case ID 2021SA019150 which will be deleted. This report contains no new information.   Initial information was received on 14-Jan-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 4-year-old patient (gender unknown) who was administered with second dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] 18 days after initial dose with no reported adverse event (lot number and expiry date not reported) via an unknown route at an unknown administration site on an unknown date for prophylactic vaccination, (inappropriate schedule of product administration).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was an actual medication error due to inappropriate schedule of vaccine administered. (latency: unknown).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the lot number for this case.