chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Diagnosed with/tested positive for COVID19; Diagnosed with/tested positive for COVID19; This is a spontaneous report from a contactable consumer or other non health care professional. A 36-years-old male patient received first dose bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL3248, expiry date: 30Apr2021) via intramuscular route of administration in Arm Left on 28Jan2021 10:00 (age at vaccination 35 years) as DOSE 1, SINGLE for covid-19 immunization and second dose bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL3248; expiry date: 30Apr2021) via intramuscular route of administration in Arm Left on 19Feb2021 10:00 (age at vaccination 35 years) as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination. Patient received other medications Novolog, Tresiba, Levothyroxin, Lisinopril within 2 weeks to vaccination. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. Concomitant medications included insulin aspart (NOVOLOG) taken for an unspecified indication, start and stop date were not reported; insulin degludec (TRESIBA) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19 prior to vaccination and patient was tested to COVID-19 since the vaccination. On 26Jul2021 at 11:30, the patient experienced diagnosed with/tested positive for covid19. No treatment was received for the covid-19 event. Patient had physician office visit for covid-19 event. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Jul2021 Nasal Swab. The outcome of the events vaccination failure was unknown, and covid-19 was recovered. A product quality complaint group providing investigation results concluded that the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3248 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3248, fill lot EL3231, and the formulated drug product lot EL3224. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: association with myopericarditis after getting the vaccine; This is a spontaneous report from a contactable physician. This physician reported for a patient that: A patient of an unspecified age and gender received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as Dose number Unknown, Single for COVID-19 immunization. The patient's medical history was not reported. The patient concomitant medications were not reported. The patient had association with myopericarditis after getting the vaccine. On an unspecified date patient experienced myopericarditis (myocarditis). Pfizer employee states that she gave the physician the name of the person at the state and that is why she was cc'd on the email. Physician was emailing the (State withheld), asking about the vaccine and its association with myopericarditis. There is no patient specific information to provide or product information to provide. In the email, the physician asked if he were to provide the names of individuals who developed temporary associated myopericarditis after getting the vaccine, could he be provided with the lot numbers used. They are putting together a case series from  that patients did well, and many pediatricians are now hesitant to vaccinate. It was reported that she has no other information and does not know this physician. It was reported again clarified that she has no patient information, just that she knows the patients are adolescents. Again, clarified the details previously stated from the email. They are putting together a case series at (name withheld). They all did well thankfully. He needs information to help move the needle on this. The data will show he assumes that the incidence is very low, outcome is very good, and no specific lot number was a problem. The physician had asked if there was a website or specific literature. Pfizer employee states she has no other information to provide. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported event of myocarditis.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Contusion, Dysphonia, Dyspnoea, Pyrexia
Clinical narrative: bruising; bad breathing; hoarse voice; fever/between 99.4 and 100.1; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered on arm left on 28Jul2021 (at the age of 52-years-old) as dose 1, single for covid-19 immunisation. The patient medical history included mild lupus and Raynaud's syndrome both from an unknown date. The patient's concomitant medications were not reported. The fever started the next day (29Jul2021), and it hasn't broken, it was still between 99.4 and 100.1 constantly. Last night (03Aug2021), the patient realized, she have a severe bruising on her leg, on her upper leg and it was severe, she did not bumped to anything, and her voice was very harsh/hoarse and it's bad breathing. The patient also asked if it was normal to be bruising like that or even having a fever for a week. The patient received ibuprofen as treatment for the events. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain, Condition aggravated, Herpes zoster
Clinical narrative: Shingles; abdominal pain symptoms; worsening of rheumatoid arthritis symptoms; This is a spontaneous report from a contactable other-HCP.  A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration in Apr2021 (age at the vaccination 63-year-old), dose 2, single dose for covid-19 immunization and tofacitinib citrate (XELJANZ, Formulation: Tablet, Lot number was not reported) at 5 mg twice daily via oral from Sep2019 to an unspecified date for rheumatoid arthritis. The patient's medical history included rheumatoid arthritis. Historical vaccine included bnt162b2 for covid-19 immunization in Mar2021 (age at 64 years, dose 1 and No events reported.). Concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine (Mar/Apr2021). The initial start of therapy on Sep2019 with several stops and restarts for different reasons. The patient experienced shingles, followed by shingles vaccines, abdominal pain symptoms on 01Aug2021. Patient reported worsening of rheumatoid arthritis symptoms due to missed doses in 2021, with some improvement noted since restart and MD awareness not stated and no other details provided. The patient received treatment for the adverse event worsening of rheumatoid arthritis. The outcome of the events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Illness, SARS-CoV-2 test
Clinical narrative: sick at home; COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; headache; Fatigue; This is a spontaneous report from a contactable consumer reported for a patient. A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in Apr2021 (age at vaccination was unknown) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in May2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 31Jul2021, the patient experienced headache, fatigue, fever, sore throat, cough. It was reported that on 31Jul2021-01Aug2021, the patient stated experiencing headache, fatigue, fever, sore throat, cough. On 02Aug2021, the patient tested positive for COVID. The patient underwent lab test which included Sars-cov-2 test: positive on 02Aug2021. As of 03Aug2021, he was sick at home, no hospitalization. The event took place after use of product. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: sick at home; COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; headache; Fatigue; This is a spontaneous report from a contactable consumer reported for a patient. A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in Apr2021 (age at vaccination was unknown) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in May2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 31Jul2021, the patient experienced headache, fatigue, fever, sore throat, cough. It was reported that on 31Jul2021-01Aug2021, the patient stated experiencing headache, fatigue, fever, sore throat, cough. On 02Aug2021, the patient tested positive for COVID. The patient underwent lab test which included Sars-cov-2 test: positive on 02Aug2021. As of 03Aug2021, he was sick at home, no hospitalization. The event took place after use of product. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: chest pain; shortness of breath; tiredness/extreme fatigue; acid reflux; This is a spontaneous report from a contactable consumer. This consumer (patient's Mother) reported for a 28-year-old male patient (reporter's son) that: A patient received bnt162b2 (PFIZER-BIONTECH COVID VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. Medical history included ongoing Asthma he had asthma as a child, he really does not have many problems with asthma as an adult, maybe an occasional seasonal flare up, he hasn't had to use an inhaler in a long time. The patient's concomitant medications were not reported. The patient experienced Chest pain, Shortness of breath and Tiredness/Extreme fatigue on May2021, Acid reflux in 2021. The patient underwent lab tests and procedures which included blood test: normal on May2021, Echocardiogram: negative on an unspecified date an echo of his heart was done, which also came back negative, echocardiogram: normal on Jun2021, Electrocardiogram: normal on May2021, Electrocardiogram: normal on Jun2021. Therapeutic measures were taken acid reflux as heartburn medicine. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. Caller asking if Pfizer has heard of anyone developing acid reflux after the Covid vaccine. He didnot have that before. Is there any information about the safety of him getting a second shot if they had a strong reaction to the first one. The outcome of all the events was recovering except for the event acid reflux it was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gastrooesophageal reflux disease
Clinical narrative: chest pain; shortness of breath; tiredness/extreme fatigue; acid reflux; This is a spontaneous report from a contactable consumer. This consumer (patient's Mother) reported for a 28-year-old male patient (reporter's son) that: A patient received bnt162b2 (PFIZER-BIONTECH COVID VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. Medical history included ongoing Asthma he had asthma as a child, he really does not have many problems with asthma as an adult, maybe an occasional seasonal flare up, he hasn't had to use an inhaler in a long time. The patient's concomitant medications were not reported. The patient experienced Chest pain, Shortness of breath and Tiredness/Extreme fatigue on May2021, Acid reflux in 2021. The patient underwent lab tests and procedures which included blood test: normal on May2021, Echocardiogram: negative on an unspecified date an echo of his heart was done, which also came back negative, echocardiogram: normal on Jun2021, Electrocardiogram: normal on May2021, Electrocardiogram: normal on Jun2021. Therapeutic measures were taken acid reflux as heartburn medicine. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. Caller asking if Pfizer has heard of anyone developing acid reflux after the Covid vaccine. He didnot have that before. Is there any information about the safety of him getting a second shot if they had a strong reaction to the first one. The outcome of all the events was recovering except for the event acid reflux it was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer or other non-HCP. A 34-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single and received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 34-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient medical history and concomitant was not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient received no other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 02Aug2021, the patient had signs of illness came on quickly. Started with a tickle in her throat in the afternoon, then woke up very ill in the middle of the night and tested positive the following morning. The patient informed tested positive for COVID on 03Aug2021 via rapid test (nasal swab). The adverse events resulted in doctor or other healthcare professional office/clinic visit. The treatment medication included cough syrup thus far, only 1.5 days into illness. The outcome of the event COVID-19 was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: developed a condition where his heart lost its rhythm; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer- sponsored program (patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient developed a condition where his heart lost its rhythm after both doses. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Blood immunoglobulin G, Blood immunoglobulin G increased, Inflammation, Pulmonary fibrosis
Clinical narrative: blood immunoglobulin g: over 2500 on did an IG test and had over 2500 on unspecified date; Medical Information Potential AE; Tinnitus and hears a song in her head/a lot of ringing in the ears; inflammation; scar tissue in the lungs; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from Jan2021 to an unknown date, asthma from an unknown date and unknown if ongoing asthma worsened treated with Prednisone starting on Day 6 and changed to Dexamethasone on Day 10 , rash from an unknown date and unknown if ongoing She experienced a rash , vein rupture from an unknown date and unknown if ongoing She experienced bulging veins , dyspnoea from an unknown date and unknown if ongoing.On day 5 during the time caller had Covid Virus caller couldn't breathe , tinnitus from an unknown date and unknown if ongoing she is getting a lot of ringing in the ears and had the ringing in ears before. The patient's concomitant medications were not reported. The patient previously took prednisone, dexamethasone. The patient experienced medical information potential ae on an unspecified date, scar tissue in the lungs on 2021, tinnitus and hears a song in her head/a lot of ringing in the ears on 2021, inflammation on 2021. The patient underwent lab tests and procedures which included blood immunoglobulin g: over 2500 on did an IG test and had over 2500 on unspecified date. The outcome of the events adverse event NOS, pulmonary fibrosis, tinnitus, inflammation was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: blood immunoglobulin g: over 2500 on did an IG test and had over 2500 on unspecified date; Medical Information Potential AE; Tinnitus and hears a song in her head/a lot of ringing in the ears; inflammation; scar tissue in the lungs; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from Jan2021 to an unknown date, asthma from an unknown date and unknown if ongoing asthma worsened treated with Prednisone starting on Day 6 and changed to Dexamethasone on Day 10 , rash from an unknown date and unknown if ongoing She experienced a rash , vein rupture from an unknown date and unknown if ongoing She experienced bulging veins , dyspnoea from an unknown date and unknown if ongoing.On day 5 during the time caller had Covid Virus caller couldn't breathe , tinnitus from an unknown date and unknown if ongoing she is getting a lot of ringing in the ears and had the ringing in ears before. The patient's concomitant medications were not reported. The patient previously took prednisone, dexamethasone. The patient experienced medical information potential ae on an unspecified date, scar tissue in the lungs on 2021, tinnitus and hears a song in her head/a lot of ringing in the ears on 2021, inflammation on 2021. The patient underwent lab tests and procedures which included blood immunoglobulin g: over 2500 on did an IG test and had over 2500 on unspecified date. The outcome of the events adverse event NOS, pulmonary fibrosis, tinnitus, inflammation was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive and had COVID; tested positive and had COVID; This is a spontaneous report from a non-contactable representative. This reported is for a female patient.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient underwent lab test for COVID. Tested positive on an unspecified date. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient mentioned she had tested positive and had COVID, she also said she had been vaccinated, she assumed it was the Pfizer vaccine, but was not certain. The events were serious. It was unknown if treatment was taken. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Bumpy rash breakout on the head of penis; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 29Jul2021 at 18:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications included iron (MANUFACTURER UNKNOWN), vitamin B12 (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jul2021 at 21:00, the patient experienced bumpy rash breakout on the head of penis. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event bumpy rash breakout on the head of penis was unknown at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sponsored program. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Aug2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache after getting the 1st dose on 02Aug2021. The patient would like to know if Tylenol would lessen the effectiveness of the Pfizer-BioNTech COVID-19 vaccine. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 RNA
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 51-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3247; Expiration date: unknown) intramuscular, administered in Arm Left on Jan2021 (at age of 51-years-old) as DOSE 1, SINGLE and patient had received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration date was not reported) intramuscular, administered in Arm Left on 09Feb2021 (at age of 51-years-old) as DOSE 2, SINGLE both for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included ARMOUR THYROID taken for an unspecified indication start date and stop dates were not mentioned. There was not any past drug event. 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. On 31Jul2021 patient experienced fatigue, headache, cough, and congestion. On 02Aug2021 the patient experienced SARS COV 2 RNA/positive (drug ineffective and COVID-19). Patient did not receive any treatment for events. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included COVID test post vaccination on 02Aug2021 (Nasal Swab) which was positive. The outcome of event SARS COV 2 RNA/positive was unknown while outcome of events fatigue, headache, cough and congestion was resolving.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heavy menstrual bleeding, Lethargy, Migraine
Clinical narrative: Chills; Migraine; Lethargy; Menstrual cycle that lasts 3-4 weeks,; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731), via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 16Apr2021 at 22:00, the patient experienced chills, migraine and lethargy lasting 2 days following the 2nd dose and also menstrual cycle that lasted for 3-4 weeks, following the 2nd dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, migraine, lethargy and menstrual cycle that lasted for 3-4 weeks were resolved on an unknown date in 2021.    No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: UNK
Symptoms: Drug ineffective, Drug interaction, SARS-CoV-2 antibody test negative
Clinical narrative: likely from his Xeljanz supressing his immune system; had the Pfizer COVID vaccines but they did not work; Xeljanz suppressing his immune system; This is a spontaneous report received from a contactable Other HCP and consumer (patient) and a consumer. A 70-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at age of 70 years on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation; tofacitinib citrate (XELJANZ) strength: 5mg, via an unspecified route of administration from 10May2017 (Batch/Lot number was not reported) to 25Jul2021, at 5 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient said he had the Pfizer COVID vaccines but they did not work (likely from his Xeljanz suppressing his immune system). He said he's done multiple antibody tests and they are showing none developed. He wanted to get the COVID vaccines again, and not just the booster. He stopped taking his Xeljanz 8 days before in anticipation for this. He said his MD could not provide him any recommendations. The action taken in response to the events for tofacitinib citrate was unknown.  The lot number for the vaccine, [Pfizer/BioNTech COVID-19 Vaccine], was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently provided, the company deems there are no evidence or arguments of any relatedness between BNT162b2 and Xeljanz administration and the reported drug interaction and drug ineffective that, therefore, are assessed as unrelated to both study drugs. Similarly, the reported drug immunosuppression is evaluated as unrelated to BNT162b2, whereas it cannot be excluded as related to Xeljanz.  The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, Autoimmune disorder, Gait disturbance, Musculoskeletal stiffness
Clinical narrative: developed an autoimmune condition; probably has sjogren's syndrome; she couldn't walk; morning stiffness; joint pain; This is a spontaneous report from a contactable nurse (patient).  This 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at age of 69-year-old) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date (at age of 69-year-old) for covid-19 immunisation. The nurse stated she was a registered nurse and recipient of the Pfizer COVID vaccine. The nurse stated she had called and reported that a few weeks after receiving the second dose of the Pfizer COVID vaccine she had a reaction or potential reaction from the vaccine and she reported it to be cautious. The nurse stated she developed an autoimmune condition which was something that she never had before. The nurse stated a colleague of hers also developed the same symptoms. The nurse stated she tested positive for all of the ANA panels which were indicative of autoimmune disease. The nurse stated her rheumatologist stated that she probably had Sjgren's syndrome. The nurse stated she had a few symptoms of rheumatoid arthritis but the rheumatoid arthritis test was negative. The nurse stated she would still receive a third dose of the vaccine but just reported her side effects for Pfizer's tracking. The nurse stated she was already being treated and on a low dose prednisone while they figure out what's going on. Her husband was a physician and his office was next door to a rheumatologist. The nurse stated her husband started her on prednisone because she couldn't walk with the morning stiffness and joint pain she was experiencing after the vaccine. Therapeutic measures were taken as a result of all events. Events outcome was unknown.  Follow-up (11Aug2021): This follow-up is being submitted to notify that the Batch/lot number not available for [Vaccine/BNT162B2] despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.; Sender's Comments: based on the available information the events auto immune disorders , sjogrens syndrome , arthralgia , stiffness  musculoskeletal , and the suspect vaccine BNT162B2 cannot be ruled out completely ,Linked Report(s) : US-PFIZER INC-202101002751 same product/event, different patient
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Sjogren's syndrome
Clinical narrative: developed an autoimmune condition; probably has sjogren's syndrome; she couldn't walk; morning stiffness; joint pain; This is a spontaneous report from a contactable nurse (patient).  This 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at age of 69-year-old) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date (at age of 69-year-old) for covid-19 immunisation. The nurse stated she was a registered nurse and recipient of the Pfizer COVID vaccine. The nurse stated she had called and reported that a few weeks after receiving the second dose of the Pfizer COVID vaccine she had a reaction or potential reaction from the vaccine and she reported it to be cautious. The nurse stated she developed an autoimmune condition which was something that she never had before. The nurse stated a colleague of hers also developed the same symptoms. The nurse stated she tested positive for all of the ANA panels which were indicative of autoimmune disease. The nurse stated her rheumatologist stated that she probably had Sjgren's syndrome. The nurse stated she had a few symptoms of rheumatoid arthritis but the rheumatoid arthritis test was negative. The nurse stated she would still receive a third dose of the vaccine but just reported her side effects for Pfizer's tracking. The nurse stated she was already being treated and on a low dose prednisone while they figure out what's going on. Her husband was a physician and his office was next door to a rheumatologist. The nurse stated her husband started her on prednisone because she couldn't walk with the morning stiffness and joint pain she was experiencing after the vaccine. Therapeutic measures were taken as a result of all events. Events outcome was unknown.  Follow-up (11Aug2021): This follow-up is being submitted to notify that the Batch/lot number not available for [Vaccine/BNT162B2] despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.; Sender's Comments: based on the available information the events auto immune disorders , sjogrens syndrome , arthralgia , stiffness  musculoskeletal , and the suspect vaccine BNT162B2 cannot be ruled out completely ,Linked Report(s) : US-PFIZER INC-202101002751 same product/event, different patient
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Nephrolithiasis, Pain, Scan
Clinical narrative: Peeing blood; they were able to see the stone; Pain; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on 27Apr2021 16:00 (age at vaccination 53 Years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (Pfizer BioNTech Covid 19 vaccine, Solution for injection) dose 1 on 30Mar2021 for covid-19 immunisation. The patient experienced peeing blood in Apr2021, they were able to see the stone in May2021 in a Scan report. The patient developed pain in Apr2021. The patient was hospitalized for peeing blood on 30Apr2021. She didn't have pain for three weeks except for an occasional sharp stab here and there. After three weeks it got really bad again. She went to her primary care provider and got another scan. The pain has not stopped this time. She is in constant pain from this. She states she was very healthy before this, she takes no medications, and was biking, kayaking and scuba diving. She knows the Pfizer vaccine caused these kidney stones, there was no way it wasn't from the vaccine- it was too coincidental. She wanted to know if this is a side effect of the vaccine. The patient underwent lab tests and procedures which included scan was did not see any stones on Apr2021 (but the doctor believed it was a kidney stone because there was no UTI), scan was they were able to see the stone on May2021. She was given antibiotics and pain medication. She stated she took the antibiotics but not the pain medication because she doesn't like to take them, and only took Tylenol. On this scan they were able to see the stone. She was started on another antibiotic which she finished last Saturday. The outcome of events peeing blood, pain was not recovered, while for kidney stone, the outcome was unknown.  Information on the lot/batch number has been requested.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT; This is a spontaneous report from a contactable physician via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1 SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The HCP received a phone call from another doctor, who had a patient who developed a DVT on an unspecified date 5 days after the 1st Pfizer vaccine dose. The HCP was asking this HCP, if the patient should receive the 2nd Pfizer vaccine dose. The outcome of the event was unknown.   Information about lot and batch number was requested.; Sender's Comments: As there is limited information in the case provided, a plausible temporal relationship, a possible causal association between the events "Deep Vein Thrombosis" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Product use issue, Pyrexia
Clinical narrative: Pain; Fever; I was breastfeeding at the time of my vaccinations; I was breastfeeding at the time of my vaccinations; This is a spontaneous report from a contactable consumer. A 32-year-old female consumer (patient) reported for herself.  A 32-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0217, Expiration date: unknown), via unspecified route, administered in left arm on 25Jun2021 (at the age of 32-year-old) as dose 2, single for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0187, Expiration date: unknown), via unspecified route, administered in right arm on 04Jun2021 (at the age of 32-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported, and concomitant medications include Ascorbic Acid, Biotin, Minerals Nos, Nicotinic Acid, Retinol, Tocopherol, Vitamin B Nos, Vitamin D Nos (PRENATAL VITAMINS). Patients receive no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. Patient reported that she was breastfeeding at the time of her vaccinations, and her baby still got COVID-19, so the antibodies transferred through her breastmilk wasn't enough to protect her baby. On 29Jul2021, after the vaccination, the patient experienced pain and fever. Adverse event result in healthcare professional office/clinic visit. Treatment was given with Tylenol. The outcome of the events product use issue and off label use was unknown and pain and pyrexia is recovering or resolving.  No follow-up attempts possible. No further information expected.  Follow-up (16Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101000457 Baby case
Sex: F
Vaccine: COVID19
Symptoms: Haematological malignancy
Clinical narrative: blood cancer; This is a spontaneous report from a Pfizer-sponsored Program. A contactable female consumer (patient) of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Mar2021, as the second single dose, for COVID-19 immunisation. Medical history included ongoing autoimmune disease and ongoing asthma. The first dose of BNT162B2 vaccine was administered on an unknown date. Concomitant medications were not provided. The patient had been recently diagnosed with cancer after she was vaccinated. She thought she has had this for a long time. She had blood cancer. Her doctor wanted her to get a booster. She knew there was none right now but she wanted to be in a clinical study and she said she also had an immunologist. She was on a steroid and will be starting chemo soon. Event outcome was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Protein S abnormal, Suspected COVID-19
Clinical narrative: spike protein was negative; Doesn't think the vaccine is working if his spike protein is negative.; Doesn't think the vaccine is working if his spike protein is negative; This is a spontaneous report from a contactable nurse (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered on the right deltoid on 18Dec2020 12:00 (at the age of 45-year-old) as dose 1, single (lot: EH9899, expiry: 18Dec2020) and intramuscular, administered on the right deltoid on 08Jan2021 12:00 (at the age of 45-year-old) as dose 2, single (lot number: EL1284, Expiration Date: 08Jan2021) for COVID-19 immunisation. Medical history included donate his blood in May2021. There were no concomitant medications. Patient has been monitoring his spike protein to donate blood. His spike protein level has been positive around late Feb and in early Mar, he was able to donate his blood. He donated again in May and his spike protein was negative. At the end of Jun or early Jul, he donated again his blood and has not received the results for his spike protein. He imagined it would be positive since it was negative on May or end of Apr. His last spike protein was negative, and he was tested around May2021. Five months after the vaccine. Spike protein was previously positive. Reporter seriousness for Negative Spike Protein: Medically significant, Life threatening. Doesn't think the vaccine is working if his spike protein was negative. Stated he was moderately to severely physically active. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown. Relatedness of drug to the event Negative Spike Protein was considered Related by the primary Source Reporter (Method of assessment: Global Introspection).; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.