chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Product administered at inappropriate site, Shoulder injury related to vaccine administration, Vaccination site joint movement impairment, Vaccination site joint pain
Clinical narrative: SIRVA (Shoulder injury related to vaccine administration); The vaccine was not injected into the muscle itself but into the muscle attachment or possibly the bursa; There is no noticeable improvement yet; Shoulder hurts at night; range of motion were limited; This is a spontaneous report from a contactable other healthcare professional (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (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. The patient reported that since the vaccination he has been suffering from quite severe shoulder problems, which have been diagnosed with a high degree of certainty as SIRVA (Shoulder injury related to vaccine administration). The vaccine was not injected into the muscle itself but into the muscle attachment or possibly the bursa. The patient wanted to know whether the vaccination was as effective as it would be if it were administered correctly, despite the fact that it was administered incorrectly. He said after more than four months with two cortisone treatments and physical exercises, there was no noticeable improvement so far. The shoulder hurts at night and range of motion were limited. He wanted to know about suggestions for a better therapy. Patient was treated by HCP. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 06Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 16Jul2021 as dose 1, single for covid-19 immunisation. On unspecified date, the patient experienced enlarged lymph glands and that are really painful. The outcome of the events was unknown. Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I had horrible tinnitus; 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, Formulation: Solution for injection, Batch/lot number, NDC number, UPC number and Expiry date are Unknown), via an unspecified route of administration on 26Jul2021 as dose 1, single for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. It was reported that the patient got vaccinated on 26Jul with first dose and since then the patient has had horrible tinnitus on an unspecified date in Jul2021. The reporter asked, why would the vaccine cause this? The reporter stated, I am sorry. I am getting tinnitus. I need to know why this is happening with your vaccine. When probed for further probing: the reporter stated, No, I really gonna get my answer first like my question answer because this is driving me insane. So, I got to go. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a slight soreness in the arm later; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer (father). A 91-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a slight soreness in the arm later. Reportedly, caller states she has a 10-year-old son and she is eager to get him vaccinated. Caller states she understands it is only approved for 12 and older but that her son is a tall 10-year-old and he is going back to school in 3 weeks. Caller states that she has had the Pfizer vaccine with no side effects and her dad had it and had no side effects only a slight soreness in the arm later that day and that it was fantastic. Caller asks if the dose for 12 and up is a different dose. Response: Read from attached FAQ-COVID-19 Vaccine use in children. When will the vaccine be authorized for use in children < 12 years of age. Caller wants to get her 10-year-old son vaccinated with Covid. When do you anticipate it being approved for under 12 years old. Is there a Covid trial she can get her son into. She added her parents, her husband and herself all got the Pfizer Covid vaccine and none of them had any problems other than a sore arm for just a couple of hours. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101031454 same reporter/drug/event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in leg; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced pain in leg. The outcome of event was unknown.  Information about lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear swelling, Hypoacusis, Joint stiffness, Lymphadenopathy
Clinical narrative: Swelling and pressure behind right ear spreading to neck and jaw; Swelling and pressure behind right ear spreading to neck and jaw; Swelling and pressure behind right ear spreading to neck and jaw; Swelling and pressure behind right ear spreading to neck and jaw; Swelling and pressure behind right ear spreading to neck and jaw; partial hearing loss; Stiff jaw; swollen lymph nodes on side of injection; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 03Aug2021 at 09:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN); both on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Aug2021 at 14:00, the patient experienced swelling and pressure behind right ear spreading to neck and jaw, partial hearing loss, stiff jaw and swollen lymph nodes on side of injection. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling and pressure behind right ear spreading to neck and jaw, partial hearing loss, stiff jaw and swollen lymph nodes on side of injection was not recovered at the time of this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Swelling, Swelling face
Clinical narrative: Swelling and pressure behind right ear spreading to neck and jaw; Swelling and pressure behind right ear spreading to neck and jaw; Swelling and pressure behind right ear spreading to neck and jaw; Swelling and pressure behind right ear spreading to neck and jaw; Swelling and pressure behind right ear spreading to neck and jaw; partial hearing loss; Stiff jaw; swollen lymph nodes on side of injection; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 03Aug2021 at 09:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN); both on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Aug2021 at 14:00, the patient experienced swelling and pressure behind right ear spreading to neck and jaw, partial hearing loss, stiff jaw and swollen lymph nodes on side of injection. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling and pressure behind right ear spreading to neck and jaw, partial hearing loss, stiff jaw and swollen lymph nodes on side of injection was not recovered at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: left calf is twice the size of my right/ Left leg is so swelled up; foot on his left side gets really hot; arm was sore; This is a spontaneous report from a contactable consumer (reported for himself). A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FAR484/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 07Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0189/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 17Jul2021as dose 1, single for covid-19 immunisation and tylenol experienced drug hypersensitivity. On an unspecified date in 2021, the patient experienced left calf is twice the size of my right/ left leg is so swelled up, foot on his left side gets really hot and arm was sore. The outcome of the events was unknown.  This follow-up is being submitted to notify theta the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: headache; not feeling good; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: FA6780) via an unspecified route of administration on 31Jul2021 as dose 2, single for COVID-19 immunization. Medical history included diabetes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 administered on an unspecified date for COVID-19 immunization. On an unspecified date in 2021 the patient experienced headache and not feeling good. Therapeutic measures were taken as a result of the adverse events, the patient was treated with Ibuprofen. The clinical outcome of headache was not recovered, while the outcome of another event was unknown.  Description of Product Complaint: Consumer stated, I am calling about some questions regarding, if you can tell me about the side effects of the Pfizer vaccine how long it last for. My kids all have their second dose on the same day, 3 of my kid. My children 3 children have vaccination, second dose at the same time at same day. One kid has stomachache and was really yucky for couple of days. My other child has continue to have headache since during the second shot migraine headaches since the second vaccine. I myself personally had my second shot. There is, last Saturday and I am having headache so, like bad headache, may get headache all days. So, I take two Ibuprofen (Hence, captured as suspect) it is (headache) not going away so, I just want to know. I want to know, my son is Type-1 diabetic, and it is not little managed, and he had his first vaccination try to figure out to have my second and he did not tried Ketone and BKA since he got his first vaccination, his first shot. He is not feeling good at all, he is been sick, he had no energy and he just feel yucky. So, how long last for how long before we are ok, just wanted to know about headache and stuff. When probed for the confirmation vaccine name as Pfizer COVID 19 vaccine, Consumer stated, I got my second shot since he got his first shot, yes. Name of Vaccine: Consumer stated, it is the Pfizer one. Yes, Pfizer BioNTech COVID 19 Vaccine. LOT#: Consumer stated, FA6780 and I got my second shot on 31Jul (Further Confirmed as 31Jul). LOT# of Sons Vaccine: Consumer stated, I do not feel fare that I have to give you with that when I have to call back and talk to somebody else about my questions. I can call them tomorrow on that number. It is the same LOT# as mine, the same number (Further confirmed as FA6780).  Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling abnormal
Clinical narrative: stomach ache; yucky; This is a spontaneous report from a contactable consumer (parent) reported for a patient (her kid) that: A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Consumer stated, he was calling about some questions regarding, if you can tell me about the side effects of the Pfizer vaccine how long it last for his kids all have their second dose on the same day, 3 of his kid. His 3 children have vaccination, second dose at the same time at same day. One kid has stomachache and was yucky for couple of days on an unspecified date in 2021. Another child has continued to have headache since during the second shot migraine headaches since the second vaccine. He personally had his second shot. There is, last Saturday and he has having headache so, like bad headache, may get headache all days. So, He take two Ibuprofen (Hence, captured as suspect) it is (headache) not going away so, he just wants to know. He wants to know, his son is Type-1 diabetic, and it is not little managed, and he had his first vaccination try to figure out to his second and he did not tried Ketone and BKA since he got his first vaccination, his first shot. He is not feeling good at all, he is been sick, he had no energy and he just feel yucky. So, how long last for how long before we are ok, just wanted to know about headache and stuff. When probed for the confirmation vaccine name as Pfizer COVID 19 vaccine, Consumer stated, he got his second shot since he got his first shot, yes. The event outcome was Recovered on unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Headache; Migraine headaches; This is a spontaneous report from a contactable consumer (parent). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: FA6780, expiration date was not reported), via an unspecified route of administration on 31Jul2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. There is a Product Complaint. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. It was reported that, the reporters other child has continue to have headache since during the second shot migraine headaches since the second vaccine. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Nasal congestion, Pyrexia
Clinical narrative: covid test result=Positive; covid test result=Positive; Covid-19 Symptoms: slight congestion; mild to moderate fever; chills primarily in the nighttime and overnight.; This is a spontaneous report from a contactable consumer.  A 25 year old male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 20Jan2021 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration, administered in Arm Left in 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported a covid test result, Nasal Swab positive on 10Aug2021 with outcome of recovering. Covid-19 symptoms: slight congestion on 10Aug2021 with outcome of recovering, mild to moderate fever on 10Aug2021 with outcome of recovering, chills primarily in the nighttime and overnight on 10Aug2021 with outcome of recovering. No treatment was done. The patient underwent lab tests done on 10Aug2021of sars-cov-2 test: positive Covid test post vaccination Nasal Swab test result positive
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: covid test result=Positive; covid test result=Positive; Covid-19 Symptoms: slight congestion; mild to moderate fever; chills primarily in the nighttime and overnight.; This is a spontaneous report from a contactable consumer.  A 25 year old male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 20Jan2021 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration, administered in Arm Left in 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported a covid test result, Nasal Swab positive on 10Aug2021 with outcome of recovering. Covid-19 symptoms: slight congestion on 10Aug2021 with outcome of recovering, mild to moderate fever on 10Aug2021 with outcome of recovering, chills primarily in the nighttime and overnight on 10Aug2021 with outcome of recovering. No treatment was done. The patient underwent lab tests done on 10Aug2021of sars-cov-2 test: positive Covid test post vaccination Nasal Swab test result positive
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: I had strange pain in my shot site, it's not pain its mostly like a something running through my arm pulling on my arms; I had strange pain in my shot site, it's not pain its mostly like a something running through my arm pulling on my arms; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 77-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- E252267) via an unspecified route of administration in left arm on 10Aug2021 11:00 as dose 2, single (at the age of 77-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration in left arm on 20Jul2021 as dose 1, single for COVID-19 immunization. On 10Aug2021 11:00, it was reported that patient experienced some strange side effects from his most recent second Covid shot vaccine shot, he just had it yesterday on the 10Aug2021 at 11 in the morning and everything fine but he had strange pain in his shot site, it was not pain it was mostly like something running through his arm pulling on my arms. Patient was wondering, if this was going away or it was going to be better or if he should go to the doctor or emergency room. Patient took some 2 Tylenol within a period of day 5 hours apart as a treatment for the adverse events. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Myocarditis, Pericarditis
Clinical narrative: Myocarditis; pericarditis; fever; chills; injection site pain; tiredness; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 11:00 (Batch/Lot Number: ER8730) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included Kidney failure, heart bypass, and diabetes. Patient has no known allergies. The patient's concomitant medications were not reported. On 01Apr2021 08:00, the patient experienced Myocarditis,  pericarditis, fever, chills, injection site pain, tiredness and diarrhea. The patient was hospitalized due to the events for 10 days. Reported treatment for the event (not specified) included "heart stint" (as reported). Outcome of events was reported as recovered with sequelae (Recovered with lasting effects). Event was considered as serious (events caused hospitalization).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Myocarditis; pericarditis; fever; chills; injection site pain; tiredness; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 11:00 (Batch/Lot Number: ER8730) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included Kidney failure, heart bypass, and diabetes. Patient has no known allergies. The patient's concomitant medications were not reported. On 01Apr2021 08:00, the patient experienced Myocarditis,  pericarditis, fever, chills, injection site pain, tiredness and diarrhea. The patient was hospitalized due to the events for 10 days. Reported treatment for the event (not specified) included "heart stint" (as reported). Outcome of events was reported as recovered with sequelae (Recovered with lasting effects). Event was considered as serious (events caused hospitalization).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Paraesthesia oral, Pruritus, Rash, Skin burning sensation
Clinical narrative: Rash/breaking out with a rash on the inside of her left arm; itching/itching all over; stinging/ skin started stinging on the outside like she was being stung by an ant; If she tried to rub or touch it, it would sting and burn/felt like she was sunburned; feeling like her lips were tingling; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FC3180), via an unspecified route of administration in the left arm on 06Aug2021 at 10:0 (at the age of 72-year-old), dose 1, single for COVID-19 immunisation. Medical history included open heart surgery (2013), she was fairly health. The patient had no family history. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was asked to take the shingles vaccine and she declined it. It was reported that the patient was fine the first day and did not really feel any strange side effect. On 07Aug2021, the patient's skin started stinging on the outside like she was being stung by an ant but there was nothing there. The patient started itching all over on the same day, then she started breaking out with a rash on the inside of her left arm and it itched a lot. If she tried to rub or touch it, it would sting and burn. This went on all day long. The patient's daughter was a registered nurse and her daughter told her to take Benadryl. The patient took a child's dose of Benadryl since Benadryl makes her go to bed. On 08Aug2021, the patient woke up feeling like her lips were tingling and the itching continued, and she felt like she was sunburned. It was further reported that the ash still itches in the area once in a while but it was not visible. The patient was still getting the stinging itching feeling that goes all over, it is intermittent, it stings on her leg then on her back, then on her arm, and it was all over, it was just the weirdest thing. The patient's lips were not tingling after she took the Benadryl. The patient reported that she locked herself in the house and was not going anywhere. Something tells her it had to do with the sun. The patient also mentioned that she got the first dose against her will. The patient did not undergo lab tests and procedures. The event did not result in physician office visit or emergency room visit. The patient had not been tested for COVID-19 since vaccination. The outcome of the event 'rash/breaking out with a rash on the inside of her left arm' was recovering. The outcome of the event 'feeling like her lips were tingling' was recovered and outcome of 'itching/itching all over' and 'stinging/ skin started stinging on the outside like she was being stung by an ant' was not recovered. Outcome of the event 'If she tried to rub or touch it, it would sting and burn/felt like she was sunburned' was unknown.  No follow-up attempts are possible; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain, Peripheral swelling, Vaccination site mass
Clinical narrative: pain; swelling of right arm; a round lump the size of a "50 cent piece"/where she got the shot she has a lump; dizziness; This is a spontaneous report from a contactable consumer reporting for herself. A 58-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 12Aug2021 as single dose for covid-19 immunization. Medical history included, diabetes mellitus, and Crohn's disease from an unknown date and unknown if ongoing. The patient previously received first dose of bnt162b2 (Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unknown date as single dose for covid-19 immunization and experienced dizzy. The patient concomitant medications were not reported. On unknown date in Aug2021, the patient experienced pain, swelling of right arm, and a round lump the size of a "50 cent piece" and dizziness. It was reported that, she got the second Pfizer shot yesterday morning and she woke up this morning, and where she got the shot, she has a lump. She was calling about the covid vaccine. She was asking if it was normal. She has a side effect sheet and does not see it. The first shot she got was fine, she had no pain, nothing. Yesterday when she got the second shot, she did experience dizziness. She did get dizzy with the first shot and it passed in one or two hours and was not concerned about that part. She got her second shot in her right arm and her right arm was swollen and she has a lump, it was not a big lump. She was diabetic and has Crohn's disease and she was not sure if that has anything to do with it. She got the shots through her doctor and that has been her doctor for seven years. The outcome of the event pain resolved on unknown date in Aug2021, while the outcome of other events was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Throat irritation, Throat tightness, Wheezing
Clinical narrative: 30 minutes after the vaccine my throat became scratchy and started closing; 30 minutes after the vaccine my throat became scratchy and started closing; My chest was tight; wheezing; This is a spontaneous report from a contactable consumer. This 53-year-old female consumer (patient) reported for herself that a 53-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EP7534 and Expiry date was not reported), dose 1 via an unspecified route of administration in arm left on 03Mar2021 12:00 PM (age at vaccination was 53-year-old) as dose 1, single dose for covid-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included asthma, IBS-M, 16p Duplication, Occipital Neuropathy, anxiety, allergies from an unknown date and unknown if ongoing. Prior to vaccination, was the patient diagnosed with COVID-19 was unknown. Since the vaccination, patient had not tested for COVID-19. Patient had not covid tested post vaccination. The patient had known allergies with erythromycin and floxmax. Concomitant medications received within 2 weeks of vaccination was venlafaxine (VENLAFAXINE), ibuprofen (ADVIL 12 HOUR), gabapentin (GABAPENTIN), d-mannose (D-MANNOSE), colecalciferol (VITAMIN D 3) all these taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 21Mar2021 12:45 AM, 30 minutes after the vaccine her throat became scratchy and started closing, her chest was tight, and she was wheezing. She took albuterol inhaler and Benadryl, and everything subsided within 20 additional minutes. No seriousness criteria reported. Treatment received for the events was albuterol inhaler and Benadryl. Outcome of the events was recovered on an unspecified date in 2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Vaginal haemorrhage
Clinical narrative: extreme vaginal bleeding; stomach pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: was not reported), via an unspecified route of administration, administrated in left arm on 09Jul2021 14:00 (age at the time of vaccination 43-years-old) as a single dose for COVID-19 immunization. Patient previously received first dose of BNT162b2 vaccine, on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had known allergy to Penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Jul2021, the patient experienced extreme vaginal bleeding, and stomach pain. Patient visited to the emergency room for pain, was prescribed antibiotics for a possible infection. The outcome for all the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain, Vaccination site swelling
Clinical narrative: I am looking in the mirror and its little bit kind of swollen in that area; Pain; almost like a deep bruise in my shoulder where the shot was; Pain; almost like a deep bruise in my shoulder where the shot was; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm on 14Aug2021 as dose 1, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Aug2021 early, the patient got the Pfizer first shot (Covid-19 Vaccine) and patient got some pain, felt almost like a deep bruise in shoulder where the shot was. So, moved arm around and when woke up (15Aug2021) and arm was still sores feels like it got a little worse but looking in the mirror and its little bit kind of swollen in that area and the patient was calling to see if had any tips, advice or anything like that. The patient's outcome of the event vaccination site pain was not recovered and other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Oropharyngeal pain
Clinical narrative: Sore throat; Diarrhea; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter's mother). A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number: EY0584, Expiry date: was not reported) via an unspecified route of administration on 07Aug2021 as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Reporter stated, So, his/ her mom had a shot a week ago that day (07Aug2021) and she mean she had sore throat for the last almost three days and she had the diarrhea (Aug2021). Do he/she need to take for the check or was that the regular side effect for the shot. The clinical outcome of events was unknown. No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Hepatic enzyme increased
Clinical narrative: liver enzymes elevated; This is a spontaneous report from a contactable Pharmacist(patient)  A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533), via an unspecified route of administration on 06Apr2021 (at 49 years) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant included tumeric supplement  (ingredients were reported as tumeric 150,tumeric extract 130,carrot 50mg,ginger root 20mg and black pepper fruit extract 5 mg) at 150mg one a day  . Patient received the first dose of the vaccine (lot EP7534) on 14Mar2021 (at 49 years) in left arm for covid-19 immunisation. The patient experienced liver enzymes elevated on 11Aug2021.  The patient underwent lab tests on 11Aug2021  which showed alanine aminotransferase (ALT) increased at 63 IU/L and aspartate aminotransferase (AST) increased at 42 IU/L.  Outcome of the events was not recovered.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Loss of personal independence in daily activities, Speech disorder
Clinical narrative: it has gotten worse; He had a severe headache, so much that he can't talk; severe headache/Or it is just extremely painful that makes the headache ramp up even more; He has been unable to work since that time; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 16Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. This female consumer reported for brother that a 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as dose 1, single, on 07Apr2021 (Batch/Lot number was not reported) as dose 2, single (both at the age of  62-year-old) for COVID-19 immunisation.  Medical history included blood pressure high.  There were no concomitant medications.   There were not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  The patient started experiencing a severe headache after the first dose of the Pfizer COVID vaccine on 18Mar2021.  He had a severe headache, so much that he could not talk on 18Mar2021. Or it was just extremely painful that made the headache ramp up even more. He had been unable to work on 18Mar2021 since that time. The consumer thought it would go away in 2 months, but it has gotten worse.  The consumer clarified the patient works, but he only went in a few hours a week and he could not handle it anymore and then went home. He was still trying to work, it's just not happening.  He had not gone to the ER. The patient had been in severe pain and has been to his regular doctor. He was now seeing a headache specialist. He only had video appointments with the specialist because he didn't want to drive to the office.  Relevant Tests: None; He had the MRI coming up on 03Sep2021.  Outcome of the events was not resolved.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Lethargy
Clinical narrative: vision blurriness; a severe headache; a fever of 102; chills; body aches; nausea; lethargy; dizziness; not feeling all that great/was pretty sick; This is a spontaneous report from a contactable other health professional (patient). A 77-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Aug2021 (Batch/Lot number was not reported) as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. In Aug2021, the patient experienced a severe headache, a fever of 102, chills, body aches, nausea, lethargy, vision blurriness and dizziness. She was still experiencing a dull headache and vision blurriness. Patient reported she had several unpleasant side effects and still not feeling all that great. Patient was wondering if the second dose was more severe because she was pretty sick this time, and if she should get the second dose. Patient's second dose was due on 01Sep2021. The patient underwent lab tests and procedures which included body temperature was 102 in Aug2021. The outcome of events "vision blurriness, headache" was not recovered; of other events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Pyrexia, Vision blurred
Clinical narrative: vision blurriness; a severe headache; a fever of 102; chills; body aches; nausea; lethargy; dizziness; not feeling all that great/was pretty sick; This is a spontaneous report from a contactable other health professional (patient). A 77-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Aug2021 (Batch/Lot number was not reported) as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. In Aug2021, the patient experienced a severe headache, a fever of 102, chills, body aches, nausea, lethargy, vision blurriness and dizziness. She was still experiencing a dull headache and vision blurriness. Patient reported she had several unpleasant side effects and still not feeling all that great. Patient was wondering if the second dose was more severe because she was pretty sick this time, and if she should get the second dose. Patient's second dose was due on 01Sep2021. The patient underwent lab tests and procedures which included body temperature was 102 in Aug2021. The outcome of events "vision blurriness, headache" was not recovered; of other events was unknown.   Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received first dose of Covid-19 Vaccine 24Jul2021 and tested positive on 09Aug2021; Received first dose of Covid-19 Vaccine 24Jul2021 and tested positive on 09Aug2021; This is a spontaneous report from a non-contactable consumer(patient's son) via the Pfizer sponsored program. A 65-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 24Jul2021 (Batch/Lot number was not reported) at the age oof 65 years, as DOSE 1, SINGLE for COVID-19 immunization.  Medical history included was none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that the patient received first dose of the Pfizer Covid 19 Vaccine on 24Jul2021 and tested positive for Covid on 09Ag2021. The son informed that his mother was scheduled "today" for her second dose, missed her second dose today and wanted to ask when could she have the second dose. The patient had lab tests which included sars-cov-2 test: positive on 09Aug2021. The patient did not receive any treatment for the tested positive on 09Ag2021. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for Covid; positive for Covid; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is first of six reports. A 65-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at the age of 65-year-old on 28Mar2021 (Lot Number: ER8734; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced positive for COVID on an unspecified date. Caller states she is reporting a situation. Caller states that there is an outbreak of Covid in the long term care setting, and there are 7 or 8 people positive for Covid. Caller states all of the individuals have already received the Covid vaccine, and 6 of them received the Pfizer Covid-19 vaccine. Caller states that the Lot# is ER8734 and they were received at (Address Withheld) on 28Mar2021.  Transferring agent stated, "Caller on the line report an AE for the Pfizer BioNTech Covid19 vaccine. She is calling to report an outbreak of covid in the long term care setting where she works at. She said that they have 7 or 8 people positive for covid at this time and 6 of these people have received the vaccine. She said all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine. She said that they received the vaccine at (store) at (city, state) and I didn't confirm the date of first dose or second dose yet but she gave me the date of 28Mar2021." The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unknown date.  The outcome of events was unknown. As of 19Aug2021, Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8734 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8734, fill lot EP8686, and the formulated drug product lot EP8573. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Complaint confirmed unique was not confirmed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101063533 same product and event, different patient;US-PFIZER INC-202101063334 same product and event, different patient;US-PFIZER INC-202101063595 Same product and event, different patient;US-PFIZER INC-202101063605 same product and event, different patient;US-PFIZER INC-202101065553 same product and event, different patient
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burn oral cavity, Hypoaesthesia oral, Lymphadenopathy, Oropharyngeal pain, Paraesthesia oral
Clinical narrative: Tongue warm, tingling, and numb-ish.; Injection site 5 inch swollen; fevered; injection site red; Under same arm, lymph gland swollen about same size and tender; Under same arm, lymph gland swollen about same size and tender; Tongue warm, tingling, and numb-ish.; Tongue warm, tingling, and numb-ish.; Glands in throat itchy and random sharp pain.; Glands in throat itchy and random sharp pain.; This is a spontaneous report from a non-contactable consumer (patient). A 56-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 13Aug2021 at 12:00 (Lot Number: FC3180) at the age of 56-year-old as single dose for COVID-19 immunization. Medical history included multiple environmental allergies. Prior to vaccination, the patient was not diagnosed with COVID-19.  Known allergies included demerol. Since the vaccination, the patient had not been test for COVID-19. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included Spring Valley 10. The patient previously received Demerol and experienced allergy. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 23Jul2021 at 10:00 AM (Lot Number: FA6780) at the age of 56-year-old as single dose for COVID-19 immunization. On 13Aug2021 at 14:00, the patient experienced injection site 5 inch swollen, fevered, and red. Under same arm, lymph gland swollen about same size and tender. Glands in throat itchy and random sharp pain. Tongue warm, tingling, and numb-ish. No treatment was received. The outcome of events was not recovered.  No follow-up attempts are possible;  No further information is expected.