chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Intermenstrual bleeding, Menstrual disorder
Clinical narrative: This is a spontaneous report from a contactable other hcp (Patient). A 44-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Batch/Lot Number: ER2613) via an unspecified route of administration, administered in Arm Left on 17Mar2021 at 12:30 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included, adenoma benign from an unknown date and unknown if ongoing Other medical history: papillary adenofibroma; infertility; quamous cell carcinoma (RLL) , infertility from an unknown date and unknown if ongoing Other medical history: papillary adenofibroma; infertility; squamous cell carcinoma (RLL), squamous cell carcinoma from an unknown date and unknown if ongoing Other medical history: papillary adenofibroma; infertility;squamous cell carcinoma (RLL), from an unknown date and unknown if ongoing Known allergies: NKDA. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported.The patient had no covid prior vaccination and no covid tested post vaccination. Historical Vaccine included as bnt162b2 (BNT162B2, Batch/Lot Number: ER2613) via an unspecified route of administration, administered in Arm Left on 24Feb2021 at 02:30 PM as DOSE 1, SINGLE for covid-19 immunisation. On 15Mar2021, The patient experienced extreme fatigue, daily menstrual spotting for 90days and lack of menstrual period for 90 days. Doctor or other healthcare professional office/clinic visit required for events. Treatment reported as No. The outcome of the events was recovered on an unspecified date in 2021.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Muscle spasms
Clinical narrative: I had chills and muscle cramps after first shot.; I had chills and muscle cramps after first shot.; This is a spontaneous report from a contactable consumer (patient).  A 51-year-old male patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6201 and expiry date was not reported), via an unspecified route of administration, on 11Mar2021 at 11:00 AM (age at vaccination: 51 years), on left arm as a dose 1, single for COVID-19 immunization. The patients medical history includes pancreatitis. The patient concomitant medication includes Norvas, Pepcid,protonax, and multi vitamins. It was reported that the patient had no known allergies. It was reported that the patient had not received any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. It was reported that patient was tested to COVID post vaccination. On 11Mar2021 03:00 PM patient had chills and muscle cramps after first shot. Patient had not received any treatment for the events reported. outcome of events recovered on unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding, Menstruation irregular, Off label use, Product use issue, SARS-CoV-2 test
Clinical narrative: This last period (the first since being fully vaccinated) came three days early; I recently stopped breastfeeding; I recently stopped breastfeeding; I recently stopped breastfeeding; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 33-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 01Jun2021 at 12:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization (at the age of 33-years-old). The patient medical history and concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. It was reported by the patient that her period has always been very regular. It has come on the Tuesday of the week expecting every month for the last 15 years with the exception of the months she was pregnant and breastfeeding. She stated that she recently stopped breastfeeding and her period came back, also on a Tuesday. The period following that was also very regular. This last period (the first since being fully vaccinated) came three days early on 18Jul2021. The patient underwent lab tests and procedures which included nasal swab (SARS-CoV-2 test): unknown on an unspecified date. The outcome of the events was unknown.   Information about lot and batch number was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100921081 mother/baby
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: right armpit swelling; This is a spontaneous report from a contactable consumer or other non hcp. A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for in-jection, lot number and expiration date was not reported), via an unspecified route of administra-tion, administered in Right Arm on 12Jul2021 (Age at vaccination was 23 years) as dose 2, single for covid-19 immunization. The patient medical history, family history none and concomitant medications were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on Jun2021 (Age at vaccination was 23 years) as dose 1, single for COVID-19 immunization. On 13Jul2021 the patient had a reaction and he and his family were looking into it. The patient's right armpit which, was the arm that was vaccinated, was getting swollen. Patient wants to know if this is a normal reaction to the vaccine, He also said he read on the internet that it may last until 6 weeks. With that, he wants to know how long he should wait before contacting his HCP. Patient did not go to Emergency Room or Physician Office. The outcome of event was recovering.  Information on the Batch/Lot number has been requested.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Two weeks ago his son had a cold. It was not Covid. He was tested and was negative for Covid.; This is a spontaneous case received from a contactable consumer (patient's father) via. A 14-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot/batch number was not reported) via an unspecified route of administration on 23May2021 09:00 (age at vaccination 14-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history was none. Concomitant medication was not reported. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. AE does not require a visit to emergency room/physician office. Prior Vaccinations (within 4 weeks) list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. AE following prior vaccinations was none. It was stated that two weeks ago his son had a cold. It was not COVID. The patient underwent lab test which included COVID test and was negative. The outcome of the event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Chills, Headache, Investigation, Myalgia
Clinical narrative: headache; muscle ache; Fever; chills; This is a spontaneous report from a contactable consumer (patient) via sponsored program.   A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 23May2021 as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 14Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history was included cancer B cell lymphoma. She just came back from a 2week treatment of Biaxin. The patient had her last chemo treatment on 28Dec2020. She mentioned she was a part of group that could only receive the Pfizer COVID-19 vaccine in March2021. She mentioned she was tested positive for COVID before getting the vaccine. She was also hospitalized. The patient had a significant reaction to the first dose of the vaccine. The reaction with the first dose was more significant. The reaction with the second dose was milder. On an unknown date, the patient had significant fever with the first dose and second dose. she had chills and muscle ache and headache for a day. She got her antibody test 2 weeks ago later. It came back negative. Patient did another test. This was to test the level of her vaccine. she don't know what test it was. she scared now because of the delta variant. Patient was asking has Pfizer provided a statement on the need for a booster dose (3rd dose). Caller wants to know should she get three doses instead of two to ensure protection against COVID infection. Patient wants to know If MRI Godium contrast can have an impact on the effectiveness of the vaccine? Caller also wanted to know about Lymphoma Clinical Trials. At the time of this report outcome of the event fever was unknown and other event outcome was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: headache; muscle ache; Fever; chills; This is a spontaneous report from a contactable consumer (patient) via sponsored program.   A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 23May2021 as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 14Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history was included cancer B cell lymphoma. She just came back from a 2week treatment of Biaxin. The patient had her last chemo treatment on 28Dec2020. She mentioned she was a part of group that could only receive the Pfizer COVID-19 vaccine in March2021. She mentioned she was tested positive for COVID before getting the vaccine. She was also hospitalized. The patient had a significant reaction to the first dose of the vaccine. The reaction with the first dose was more significant. The reaction with the second dose was milder. On an unknown date, the patient had significant fever with the first dose and second dose. she had chills and muscle ache and headache for a day. She got her antibody test 2 weeks ago later. It came back negative. Patient did another test. This was to test the level of her vaccine. she don't know what test it was. she scared now because of the delta variant. Patient was asking has Pfizer provided a statement on the need for a booster dose (3rd dose). Caller wants to know should she get three doses instead of two to ensure protection against COVID infection. Patient wants to know If MRI Godium contrast can have an impact on the effectiveness of the vaccine? Caller also wanted to know about Lymphoma Clinical Trials. At the time of this report outcome of the event fever was unknown and other event outcome was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Insomnia, Sitting disability
Clinical narrative: Feeling jittery; difficulty sleeping; she was not able to sit down; This is a spontaneous report from a Pfizer sponsored Program COVAX US Support. A contactable consumer reported for a female patient (reporter's daughter). A female patient with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, batch/lot number: unknown) via unknown route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. After the vaccine within half an hour the patient felt jittery, could not sit still and could not sleep. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Illness, Pain in extremity
Clinical narrative: feel tired with a sore arm; feel tired with a sore arm; he lost smell and taste; he lost smell and taste; woke up sick; faint taste but is unable to smell.; This is a spontaneous report from a contactable consumer or other non hcp(patient).A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,solution for injection,Lot number-not reported),via an unspecified route of administration on 19Jul2021 as DOSE 1, SINGLE for covid-19 immunization.The patient's medical history and concomitant medications were not reported. It was reported that patient received the 1st dose of the Pfizer COVID-19 Vaccine yesterday on 19Jul2021. His symptoms kind of began yesterday and the vaccine provider was aware of them and advised that the patient would feel tired with a sore arm on 20Jul2021.On 19Jul2021 he stated that he has faint taste but was unable to smell. He was calling today to see if loosing taste or anything was normal.He stated that he was not super freaked out or anything.He stated he received his 1st dose of the Pfizer vaccine yesterday and he woke up this morning with common side effects.On 20Jul2021 he stated he lost smell and taste and he doesn't know if that was normal .On 20Jul2021 he stated that he woke up sick on and hasn't been in contact with anyone with Covid.He was asking was this normal.He stated he still has faint taste but he cannot smell anymore.He stated that yesterday he had taken a nap and woke up and noticed that he had lost a little bit of taste and he thought it might be a side effect.He was asking how long it takes to make a report and declines to make a report stating he was looking for information.He clarified it was the Pfizer Covid 19 vaccine.The outcome of all events was unknown.  No follow-up attempts are possible. Information about batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: feel tired with a sore arm; feel tired with a sore arm; he lost smell and taste; he lost smell and taste; woke up sick; faint taste but is unable to smell.; This is a spontaneous report from a contactable consumer or other non hcp(patient).A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,solution for injection,Lot number-not reported),via an unspecified route of administration on 19Jul2021 as DOSE 1, SINGLE for covid-19 immunization.The patient's medical history and concomitant medications were not reported. It was reported that patient received the 1st dose of the Pfizer COVID-19 Vaccine yesterday on 19Jul2021. His symptoms kind of began yesterday and the vaccine provider was aware of them and advised that the patient would feel tired with a sore arm on 20Jul2021.On 19Jul2021 he stated that he has faint taste but was unable to smell. He was calling today to see if loosing taste or anything was normal.He stated that he was not super freaked out or anything.He stated he received his 1st dose of the Pfizer vaccine yesterday and he woke up this morning with common side effects.On 20Jul2021 he stated he lost smell and taste and he doesn't know if that was normal .On 20Jul2021 he stated that he woke up sick on and hasn't been in contact with anyone with Covid.He was asking was this normal.He stated he still has faint taste but he cannot smell anymore.He stated that yesterday he had taken a nap and woke up and noticed that he had lost a little bit of taste and he thought it might be a side effect.He was asking how long it takes to make a report and declines to make a report stating he was looking for information.He clarified it was the Pfizer Covid 19 vaccine.The outcome of all events was unknown.  No follow-up attempts are possible. Information about batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Swelling
Clinical narrative: he had his 2nd dose of the vaccine 2 months ago and 7 days after that his lymph nodes were swollen and sore; he had his 2nd dose of the vaccine 2 months ago and 7 days after that his lymph nodes were swollen and sore; the base of his neck is also swollen, not that swollen but it is visible; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot/NDC/UPC number and Expiry date were unknown), via an unspecified route of administration, administered in right arm on an unspecified date as dose 2, single for covid-19 immunization. Medical history included first dose of COVID-19 Vaccine as immunisation. Concomitant medications were not reported.The patient he had his 2nd dose of the vaccine 2 months ago and 7 days after that his lymph nodes were swollen and sore (lymphadenopathy), (lymph node pain), the base of his neck is also swollen, not that swollen but it is visible (swelling). Patient stated he had the second dose of the Pfizer vaccine and 7 days after he got it his lymph nodes were sore and swollen. He added that, he never had a swollen lymph nodes before not until he got the 2nd dose of the Pfizer BioNTech COVID-19 Vaccine. Patient stated, "Yes, mostly it was on the side that I had gotten the shot and it was painful to the touch and lot more than it is now and now I have lymph node (Incomplete sentence)." His right side is now going down to normal but his left lymph nodes are still swollen. Patient said, he already contacted CDC and reported his side effects but according to CDC they don't have information about swollen lymph nodes. He wants to know what to do. He's not capable of seeing an HCP and don't want to spend money for it. He has no insurance and is upset. Caller also stated that we really don't care about them. Caller is upset because of his swollen lymph nodes from 2 months ago for his 2nd dose of the vaccine. About 7 days afterwards his lymph nodes swell and currently now after just being the left side it is in both sides that is swollen after 2 months and he says that it is painful as well." The outcome of the events was unknown.  Information on the lot/batch number has been requested. Complainant hung up abruptly/transfer incomplete.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dyspnoea, Eye irritation, Lacrimation increased, Respiratory disorder
Clinical narrative: have been having lots of breathing problems ever since; eyes are burning, watering, it's affecting my eye sight and my breathing that's and I must be allergic to these shots or something; eyes are burning, watering, it's affecting my eye sight and my breathing that's and I must be allergic to these shots or something; eyes are burning, watering, it's affecting my eye sight and my breathing that's and I must be allergic to these shots or something; eyes are burning, watering, it's affecting my eye sight and my breathing that's and I must be allergic to these shots or something; have not been able to breath good ever since I got them; 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) via an unspecified route of administration on an unspecified date (Batch/lot number, Expiry Date, NDC number, UPC number: unknown) as dose 1, single and dose 2 via an unspecified route of administration on 08Mar2021 (Batch/lot number, Expiry Date, NDC number, UPC number: unknown) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she had those the shots, the COVID shots and I had been having lots of breathing problems ever since, she had it, eyes were burning, watering, it was affecting her eye sight and her breathing that's (on an unspecified date) and she must be allergic to these shots or something and had not been able to breath good (on an unspecified date), she stated Probably which would they got one in within 3 weeks and then got the other one and the COVID yes, she confirmed the date of vaccination of second shot as 08Mar2021, Well, it was three months, I mean three weeks before this last one. She did not have my vaccination card, so asked that should she find out the information and then call back. The patient further stated that she better call back, she did not understand how they spell, she was having hard time, was not breathing too well right now anyway. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: have been having lots of breathing problems ever since; eyes are burning, watering, it's affecting my eye sight and my breathing that's and I must be allergic to these shots or something; eyes are burning, watering, it's affecting my eye sight and my breathing that's and I must be allergic to these shots or something; eyes are burning, watering, it's affecting my eye sight and my breathing that's and I must be allergic to these shots or something; eyes are burning, watering, it's affecting my eye sight and my breathing that's and I must be allergic to these shots or something; have not been able to breath good ever since I got them; 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) via an unspecified route of administration on an unspecified date (Batch/lot number, Expiry Date, NDC number, UPC number: unknown) as dose 1, single and dose 2 via an unspecified route of administration on 08Mar2021 (Batch/lot number, Expiry Date, NDC number, UPC number: unknown) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she had those the shots, the COVID shots and I had been having lots of breathing problems ever since, she had it, eyes were burning, watering, it was affecting her eye sight and her breathing that's (on an unspecified date) and she must be allergic to these shots or something and had not been able to breath good (on an unspecified date), she stated Probably which would they got one in within 3 weeks and then got the other one and the COVID yes, she confirmed the date of vaccination of second shot as 08Mar2021, Well, it was three months, I mean three weeks before this last one. She did not have my vaccination card, so asked that should she find out the information and then call back. The patient further stated that she better call back, she did not understand how they spell, she was having hard time, was not breathing too well right now anyway. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report from a contactable consumer (patient's mother). A 42-years-old male 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 left arm on Apr2021 (at the age of 42-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The  medical history included problem with the heart valve diagnosed when the patient was in his 30s, blood pressure and heart operation. The concomitant medications included blood pressure medicine low dose. On Apr2021, patient was tired after the first dose, this started a few hours after he got the vaccine and the next day. The patient rested for the day and then was fine. The outcome of the tired was recovered on Apr2021.   Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: Had another friend that reported the same experience /two weeks later she started a period and has not stopped since then; Had another friend that reported the same experience /Her bleeding is also very different, it is blood like she cut her wrist; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number/expiry Date: Unknown), via an unspecified route of administration, on an unspecified date, as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter explains that she had another friend (patient) that reported that 2 weeks later she started her period and it has yet to stop. She explained it has gotten less but it was still going and going since then after having Pfizer vaccine. The caller says she thinks it was a little less; it will get less and she will think it's almost over but then 12 hours later she was back to bleeding again. Her bleeding was also very different, it was blood like she cut her wrist. The outcome of the events was unknown.  The lot/batch number was not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: her friend who is a nurse said she is still feeling sore; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER COVID19 VACCINE,solution for injection, Batch/Lot number was unknown,exipery date was not reported),via an unspecified route of administration,adminstered in left arm on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and The patient's concomitant medications were not reported. The patient experienced her friend who is a nurse said she is still feeling sore (pain) on an unspecified date. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Oropharyngeal pain, Pain in extremity
Clinical narrative: left eye is swollen; right arm is very sore; throat is a little sore; This is a spontaneous report from a contactable consumer or other non hcp (parent) via Pfizer-sponsored program. A 17-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number was not reported, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 19Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient got his first dose of the Pfizer BioNTech covid 19 vaccine 2 days ago, and that his left eye is swollen (on the bottom and down, almost as if he'd been punched), was real puffy and his right arm is very sore (injection was on the right). She wants to know if it's a normal reaction. She confirms what study relayed, that he does have some kind of abnormality with his eye as underlying condition, which is that he gets allergies associated with conjunctivitis, but this does not look like that. She also stats that his throat is a little sore, but does not have a fever. The outcome for the events was unknown.  Information about the Lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Pharyngeal swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (BNT162b2, Formulation: Solution for injection, Batch/Lot number: not provided, expiration date not provided), via an unspecified route of administration, administered on 30Jun2021 as (at the age of 39-year-old) DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced difficulty swallowing and feeling of a swollen throat on 30Jun2021. The patient wanted to know whether that was a common side effect of the vaccine. The patient reported that she scheduled to get the second dose and she was not sure what she should done. The outcome of events was unknown. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Inflammation
Clinical narrative: Inflammation (particularly after 2nd dose); Inflammation (particularly after 2nd dose) which exacerbated pre existing conditions.; This is a spontaneous report from a contactable consumer or other non hcp.   A 43-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 30Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation  .  Medical history included autonomic nervous system imbalance from an unknown date and unknown if ongoing , ehlers-danlos syndrome from an unknown date and unknown if ongoing. Concomitant medication(s) included hydroxyzine (HYDROXYZINE) taken for an unspecified indication, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported; thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported; clonazepam (KLONOPIN) taken for an unspecified indication, start and stop date were not reported; ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported; turmeric [curcuma longa rhizome] (TURMERIC) taken for an unspecified indication, start and stop date were not reported; ginger [zingiber officinale rhizome] (GINGER) taken for an unspecified indication, start and stop date were not reported.  The patient experienced inflammation (particularly after 2nd dose) (inflammation) (non-serious) on 2021 with outcome of recovered , inflammation (particularly after 2nd dose) which exacerbated pre existing conditions. (condition aggravated) (non-serious) on 2021 with outcome of recovered.  The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of inflammation (particularly after 2nd dose) (inflammation), inflammation (particularly after 2nd dose) which exacerbated pre existing conditions. (condition aggravated).
Sex: U
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: My face is swollen; This is a spontaneous report from a contactable Consumer or other non health professional (Patient).  A patient of unspecified age and gender received bnt162b2 (COVID VACCINE, Formulation: Solution for injection, Batch/Lot number FA74 believed 85) via an unspecified route of administration on 21Jul2021 as dose unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that the face was swollen on 22Jul2021. Consumer stated that the COVID Vaccine was received yesterday, the Pfizer. On the day of report had facial swelling and face was swollen. NDC number, UPC number and Expiry Date of COVID Vaccine were unknown. Consumer wanted to ask is there anything need to worry about. The outcome of event was reported as unknown.  LOT#: Consumer stated, "FA74 I believe 85."  Information on lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haematoma
Clinical narrative: hematoma at their injection site; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a female patient that: A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Deltoid Left on 08Jul2021 single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included 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, as single dose for covid-19 immunisation. Pharmacist reported that she has a patient (female, no age provided) who received their second Pfizer Covid vaccine dose on 08Jul2021. The patient has had a hematoma at their injection site (left deltoid) since that date (08Jul2021). The patient feels that since there was a hematoma, that the vaccine went into their blood vessel and not into their muscle tissue. The patient wants to know if they need to be revaccinated since there is a possibility that the vaccine could be less effective if it went into the bloodstream and not the muscle tissue. The outcome of the event was reported as unknown.   Information on Lot/Batch information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal distension, Ear discomfort, Panic attack, Tinnitus
Clinical narrative: I had some ear ringing and fullness after the first. Is this common; I had some ear ringing and fullness after the first. Is this common; fullness; had a panic attack the first time; This is a spontaneous report from a sponsored program reported by contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that I am due for my second shot, had a panic attack the first time and asked if it is ok to take hydroxyzine before the second. Also, I had some ear ringing and fullness after the first and asked if this is common. Response received that Pfizer is unable to make treatment recommendations and as per attached VR, no information on drug interactions between hydroxizine and Pfizer Covid vaccine. The clinical outcome of the events was unknown.  Information about batch/Lot number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Neck pain
Clinical narrative: general feeling of being unwell; my head and neck to hurt; my head and neck to hurt; This is a spontaneous report from a contactable consumer, reported for herself. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm Left on 01Jul2021 12:00 as a single dose for covid-19 immunization. Medical history included hypersensitivity- Sulfamethoxazole drugs, food allergy -Allergies: hazelnuts/Almonds. There were no concomitant medications. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Jul2021 21:30, the patient experienced general feeling of being unwell, my head and neck to hurt. The patient did not receive any treatment. Outcome of the event was not recovered. Device Date was 23Jul2021.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: The caller's doctor has a man who had the same exact symptoms as the caller and it lasted 2 weeks after the vaccine/nausea; This is a spontaneous report from a contactable consumer or other non hcp. This Consumer reported for a male patient that. A male patient of an unspecified age 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 at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced the caller's doctor has a man who had the same exact symptoms as the caller and it lasted 2 weeks after the vaccine/nausea. Outcome of the event was unknown.   Information on lot/batch number has been requested.  Follow-up (03Sep2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Endoscopy, Therapeutic response unexpected
Clinical narrative: I still have throat discomfort and a very recent endoscopy confirmed my entire esophagus, stomach, and small intestine are still inflamed, but I am feeling much better than before the vaccine; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history included covid-19 from Jan2021 to Jan2021, pneumonia from 2021, throat swelling from 2021, neck swelling from 2021, pain from 2021. Concomitant medications were not reported. It was reported that, patient wanted to thank Pfizer directly for offering the Covid-19 vaccine, and share patients unique experience how it helped me within ONLY 24 hours which patient actually captured on video! These were the only email addresses patient could find so patient hope this routes to the appropriate party. Patient was diagnosed with Covid-19 in Jan2021 which developed into several symptoms, including pneumonia and constant throat and neck swelling which resulted in pain 24/7. Considered a long-hauler, many of my symptoms lasted 4 months UNTIL patient received the first dose of the Pfizer COVID vaccine. Patient had been to several doctors, ENT, pulmonologist, cardiologist, speech Therapist, gastro, and even paid for a 30 minute consult, Silent Reflux was the diagnosis for patient constant throat/neck pain and swelling. Patient would periodically make videos for patient family to provide them updates on patient health, and wanted to share patient condition right before patient left patients home to get first dose of the Pfizer Covid vaccine, and then 24 hours after that first dose. Since these were made for patient family please excuse the loving gestures. Patient truly blessed and thankful it has helped!!! patient still have throat discomfort and a very recent endoscopy confirmed patient entire esophagus, stomach, and small intestine are still inflamed, but patient feeling much better than before the vaccine. The patient underwent lab tests and procedures which included endoscopy: inflamed (entire esophagus, stomach, and small intestine are still inflamed) on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: Felt tired, after second vaccine; First and Second vaccines were administered 9 weeks apart.; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported for herself. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization and patient experienced felt sick, vertigo, dizziness. On an unspecified date, the patient felt tired, after second vaccine, first and second vaccines were administered 9 weeks apart. Outcome of the event was unknown. Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (patient herself). A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via intramuscular route, administered in arm (upper arm as reported) on 21Jul2021 03:00 as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. On an unspecified date in Jul2021, patient experienced headache. Treatment in response to adverse event given was with Tylenol, Aspirin. The outcome of event was recovered on an unspecified date in 2021.   Information about batch/lot number has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discharge
Clinical narrative: There was a very small amount of leakage from the injection site.; This is a spontaneous report from a contactable Pharmacist. A 18-year old female patient received BNT162b2 (COMIRNATY, Formulation: solution for injection, Batch/lot number: not reported, Expiry date: Not reported), via an unspecified route of administration as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. Reporter stated that patient took her first dose of vaccine and was waited for 15 minutes and came back to pharmacist and showed that there was a very small amount of leakage from the injection site. The outcome of the event was unknown.  Follow up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Headache, Nausea, Pyrexia
Clinical narrative: Cough; Vomiting/throwing up; Nausea; Fever of 101; Headache; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for a 66-year-old female patient (reporters wife) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date of vaccine was not provided), via an unspecified route of administration, on Friday morning 23Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. On an unspecified date in Jul2021, the patient had experienced vomiting, nausea, fever of 101 and headache. On 24Jul2021, (Saturday) she also experienced a cough. Reporter wanted to know if this was typical after first dose. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date in Jul2021. The clinical outcome of the events were unknown.  Follow-up activities closed. Batch/lot number not available for [Vaccine BNT162B2].
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Cough; Vomiting/throwing up; Nausea; Fever of 101; Headache; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for a 66-year-old female patient (reporters wife) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date of vaccine was not provided), via an unspecified route of administration, on Friday morning 23Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. On an unspecified date in Jul2021, the patient had experienced vomiting, nausea, fever of 101 and headache. On 24Jul2021, (Saturday) she also experienced a cough. Reporter wanted to know if this was typical after first dose. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date in Jul2021. The clinical outcome of the events were unknown.  Follow-up activities closed. Batch/lot number not available for [Vaccine BNT162B2].
Sex: F
Vaccine: COVID19
Symptoms: Angiopathy, Nodule
Clinical narrative: This is a spontaneous report from a contactable physician. A 44-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, Mar 2021, single dose; for COVID-19 immunization; and received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, Apr 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On an unspecified date (7 months post Sculptra aesthetic injection to temples, jawlines, cheeks and chin), patient experienced hard, spiderweb-like areas and nodule where Sculptra was injected. Outcome of the event: unknown. The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaginal haemorrhage
Clinical narrative: Ongoing moderate vaginal bleeding started the morning after my vaccine; vaccine administration in Leg Left; This is a spontaneous report from a contactable other hcp. A 40-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EW0217), dose 1 via an unspecified route of administration in Leg Left (Vaccine administered at inappropriate site) on 22Jul2021 at 11:30 as single dose for COVID-19 immunisation. Medical history included asthma and Mild thyroid disorder treated with levothyroxine from an unknown start and stop date. No known allergies were reported. Concomitant medication(s) included spironolactone taken for an unspecified indication, start and stop date were not reported. No COVID prior vaccination and not tested for COVID post vaccination. The patient experienced ongoing moderate vaginal bleeding started the morning after vaccine on 23Jul2021. Patient had a clockwork cycle of 27-29 days, and this was her ovulation week (so day 15 of cycle). Patient did not receive treatment for the adverse event. The outcome of the event was reported as not recovered and outcome of Vaccine administered at inappropriate site was unknown.  Follow-up attempts are completed. No further information is expected.