chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing
Clinical narrative: tired; my face became flushed; This is a spontaneous report from a contactable consumer (patient). An 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered in arm left (upper) on 05Mar2021 12:30 (Batch/Lot Number: EN6208) (at the age of 68-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included back pain and blood cholesterol from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL 12HOUR) taken for back pain from an unspecified start date and ongoing; atorvastatin taken for blood cholesterol, start and stop date were not reported; glucosamine chondroitin pm (GLUCOSAMINE CHONDROITIN PM); monascus purpureus (RED YEAST RICE); colecalciferol (VIT D3); fish oil; and ubidecarenone (COQ-10). Historical vaccine included BNT162B2 dose 1 intramuscular in the left upper arm, on 12Feb2021 12:30 (at 68 years of age) (lot/batch number-EM9809) for COVID-19 immunisation and experienced swelling of face and swollen eyes. The patient experienced her face became flushed on 05Mar2021 11:00 with outcome of recovered in Mar2021 and tired on 06Mar2021 with outcome of unknown. It was reported that after the second vaccine, the patient's face became flushed at 11 am and in the evening the same day as the vaccine. She immediately took a BENADRYL and was just tired the next day. Therapeutic measures were taken as a result of her face became flushed (flushing).  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: 2 hours after the injection he developed pain in his left upper extremity which was not injected. The following morning he awoke with numbness and tingling in the right ring and small fingers as well; The following morning he awoke with numbness and tingling in the right ring and small fingers/numbness and tingling radiating up to the hypothenar area and to the forearm; The following morning he awoke with numbness and tingling in the right ring and small fingers/numbness and tingling radiating up to the hypothenar area and to the forearm; extreme pain in right hand; Medial and antecubital elbow pain too.; This is a spontaneous report from a contactable physician.  A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8735), via intramuscular route, administered in Right arm on 28Apr2021 at 19:00 as dose 1, single (at the age of 77-years-old), for covid-19 immunization. Medical history was not reported. It was unknown if the patient had known allergies or not. The patient was taking unspecified prescribed concomitant medications (Other medications in two weeks: prescription medications). It was unknown if patient was administered with other vaccine in four weeks. It was stated that, on an unspecified date in 2021, 02 hours after the injection, the patient developed pain in his left upper extremity which was not injected. The following morning, unknown date in 2021, he woke with numbness and tingling in the right ring and small fingers as well as extreme pain in right hand and medial and antecubital elbow pain too. It was described that ring and small numbness and tingling radiating up to the hypothenar area and to the forearm. The events were reported as serious with seriousness criteria as hospitalization (from unknown date in 2021 to unknown date in 2021). No. of days for hospitalization were 5. Adverse events also resulted in: doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not have covid prior vaccination and had not tested for covid post vaccination. No treatment was received for the events. The outcome for all the events was reported as not recovered, at the time of report.  No FU attempts possible. No further information expected.; Sender's Comments: Based on the available information in the case, the causal association between the events pain in extremity, hypoesthesia, paresthesia, arthralgia  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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Four of my friends actually did get covid and they were all vaccinated; Four of my friends actually did get covid and they were all vaccinated; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer sponsored program. A patient of unspecified age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 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 2, single and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 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 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was stated that they had been fully vaccinated, her husband and her friends. It had a ninety plus efficacy rate and we were told with the Withheld study it's only at a 42 percent efficacy. She don't understand. On an unspecified date, Four of her friends actually did get covid and they were all vaccinated (medically significant). Our last vaccination was February the ninth. Advisable booster to be given eight months after the second shot, was that correct. Not at all immunocompromised. Not eight months after the second dose. We were told that the efficacy rate was 90/95 percent. We are in our 70s. Does the rate diametrically go down as time goes on. Clinic study says right it's at 42 percent at like 6 months after the second shot. Until when? Unknown efficacy rate after a certain amount of time. On 18Aug2021, withheld have announced a plan to begin offering COVID-19 booster shots in the fall.3 This is for a wider population (i.e., not limited to immunocompromised individuals). The Withheld does not currently recommend booster shots for this wider population. The clinical outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-1 test positive
Clinical narrative: have a friend who's daughter is positive, she is on day 8 and doing great; This is a spontaneous report from a contactable consumer or other non hcp.    A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant was not reported. It was Reported that, The patient experienced have a friend whose daughter is positive; she is on day 8 and doing great on 2021 with outcome of recovering.    The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer.  A 22-years-old male patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection) first dose (Lot number: EN5318) on 23Jan2021 and second dose (Lot number: EL9266) on 12Feb2021, both via unspecified route of administration as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On 05May2021 (after 3 months of vaccination), patient was tested positive for COVID virus, after being fully vaccinated. Caller states that Covid positive is defined as having both vaccines, and testing positive for Covid longer than two weeks after both doses. Caller states they are monitoring and tracking the vaccine breakthrough cases in their area and she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. Lab test included positive COVID-19 test on 05May2021. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202101075254 same reporter, drug, AE different patient.
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 37 patients. This report is for 22nd of 37 patients. This consumer reported for a 38-year-old female patient. A 38-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN5318) via an unspecified route of administration on 26Jan2021 as dose 1, single and she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: N6203) via an unspecified route of administration on 24Feb2021 as dose 2, single for COVID-19 immunization at Public Health Clinic. The patient medical history and concomitant medications were not reported. On 01Aug2021 the patient experienced she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. the lot number provided (medically significant). It was reported that tested positive for COVID virus, after being fully vaccinated. Caller states that COVID positive was defined as having both vaccines and testing positive for COVID longer than two weeks after both doses. On 01Aug2021 the patient underwent lab tests and procedures which included body mass index (48.5) and sars-cov-2 test (positive). Reporter stated that an individual (non-HC) they are monitoring and tracking the vaccine breakthrough cases in their area and she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The caller at the time, did not have the NDC or expiration date, however, was going to work on pulling patient information so that she would be able to have this information available to provide to DSU upon transfer. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated.; Tested positive for Covid virus, after being fully vaccinated.; This is a spontaneous report from a contactable consumer or other non hcp.   A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3249), via an unspecified route of administration on 19Jan2021 dose 1, single and received dose 2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection Lot Number: EN5318) via an unspecified route of administration on 05Feb2021 as dose 2, single for COVID-19 immunisation. Medical history included ongoing thyroid disorder. Concomitant medications were not reported. The patient tested positive for COVID virus, after being fully vaccinated on 06Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 06Aug2021. The outcome of the events was unknown.  Product Quality Complaint: Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp, Report 29 of 37. A 52-years-old male patient received second dose of bnt162b2 (BNT162B2) PFIZER-BIONTECH COVID-19 VACCINE, (Lot Number: EN5318 Expiration Date: 31May2021) via an unspecified route of administration on 05Feb2021 as Dose 2, single for covid-19 immunisation. Medical history included covid-19 from 28Nov2020 to an unknown date, History of Covid. The patient's concomitant medications were not reported. Historical vaccine included dose 1 (Lot: EL3249 expiration: unknown) via unspecified route of administration on 15Jan2021 as a single dose for COVID-19 immunisation. Reporter stated they are monitoring and tracking the vaccine breakthrough cases in their area and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The reporter at the time, did not have the NDC or expiration date, however, was going to work on pulling patient information so that she would be able to have this information available to provide upon transfer. Reporter stated that Covid positive is defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. Testing positive for Covid virus, after both vaccines. On 06Aug2021, tested positive for Covid. Description of complaint: Caller reporting on the Pfizer Covid 19 vaccine. Outcome of the events was unknown.  The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root causes were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Sender's Comments: Linked Report(s): US-PFIZER INC-202101075254 Same reporter, drug, AE, different patients.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Had the COVID Vaccine, but tested positive for COVID; Had the COVID Vaccine but tested positive for COVID; This is a spontaneous report received from a contactable consumer. This consumer reported for patient.  A female patient of an unspecified age received BNT162B2 (COVID-19 VACCINE MANUFACTURER UNKNOWN; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the COVID vaccine, but tested positive for COVID on 17Aug2021. The reported was calling about the patient who had the COVID vaccine and was not sure which one she received. The patient underwent lab tests and procedures which included SARS-CoV-2 test positive on 17Aug2021. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Vaccine was incorrectly diluted. It was diluted with 0.8 vice 1.8 ml dilutent. One dose of 0.3ml was drawn up and given.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Injection site inflammation, Injection site mass, Injection site pain, Polymenorrhoea
Clinical narrative: 7 days after vaccination large, inflamed lump at injection site hit to touch   7 days after vaccination - started menestral cycle 7 days early while on birth control - menestral bleeding for10 days [normal cycle is 5 days]
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Dysmenorrhoea, Inappropriate schedule of product administration, Lymphadenopathy, Menstrual disorder
Clinical narrative: Menstrual cycle changed; Bell's Palsy; Lot of cramps before my cycle; Lymphnodes of the axillas enlarged; Renal impairment; Have lupus and it activated; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0164), via an unspecified route of administration, administered in Arm Left on 17Apr2021 09:30 (at the age of 46-years-old) as dose 2, single for covid-19 immunization. Medical history included lupus erythematosus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EE0164), via an unspecified route of administration, administered in Arm Left on 17Apr2021 09:30 (at the age of 46-years-old) as dose 1, single for covid-19 immunization. No known allergies. No other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 21Apr2021 09:00, 4 days after the second dose of the vaccine, she woke up with Bells Palsy and with the lymph nodes of the axillas enlarged. Her menstrual cycle changed completely, and she started to feel a lot of cramps before her cycle. She had lupus and it activated after the vaccine with renal impairment. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care and hospitalization for 2 days. The patient was treated with Corticosteroids and blood thinners (Clexane). The outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Renal impairment, Systemic lupus erythematosus
Clinical narrative: Menstrual cycle changed; Bell's Palsy; Lot of cramps before my cycle; Lymphnodes of the axillas enlarged; Renal impairment; Have lupus and it activated; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0164), via an unspecified route of administration, administered in Arm Left on 17Apr2021 09:30 (at the age of 46-years-old) as dose 2, single for covid-19 immunization. Medical history included lupus erythematosus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EE0164), via an unspecified route of administration, administered in Arm Left on 17Apr2021 09:30 (at the age of 46-years-old) as dose 1, single for covid-19 immunization. No known allergies. No other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 21Apr2021 09:00, 4 days after the second dose of the vaccine, she woke up with Bells Palsy and with the lymph nodes of the axillas enlarged. Her menstrual cycle changed completely, and she started to feel a lot of cramps before her cycle. She had lupus and it activated after the vaccine with renal impairment. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care and hospitalization for 2 days. The patient was treated with Corticosteroids and blood thinners (Clexane). The outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) received from program. A 65-years-old male (reporter) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8732), via an unspecified route of administration on 28Mar2021 as dose 2, single, and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on 07Mar2021 as dose 1, single, both (at the age of 65-years-old) for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD), he had been diagnosed for 3 years and he is on 3 different inhalers for it. Concomitant medications included BREO ELLIPTA, VENTOLIN, and SPIRIVA RESPIMAT all taken for chronic obstructive pulmonary disease from an unspecified start date and ongoing. On 02Aug2021, the patient tested positive for the delta variant. It was reported that the reporter, patient, had Pfizer COVID vaccines and then tested positive for the delta variant on 02Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive for delta variant on 02Aug2021. The clinical outcome for the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202101075459 Same reporter, drug, event for different patients.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a follow-up spontaneous report from a contactable consumer received from Pfizer sponsored program COVAX US support. A 40-year-old patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date Apr2021 (age at vaccination 40-year-old) as single dose, and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. Medical history included ongoing adult ADHD (attention deficit hyperactivity disorder) he has had this for probably his entire life, but he was just diagnosed about a year ago. There were no concomitant medications. On 05Aug2021, the patient tested positive for the delta variant. It was reported that the reporter patient had their Pfizer COVID vaccines and then tested positive for the delta variant on 05Aug2021. The reporter stated that the patient got his second dose about 2 weeks after the reporter had hers. She confirms that patient got his last dose after she had her last dose which was on 28Mar2021.The patient underwent lab test and procedures which included sars-cov-2 test positive for delta variant on 05Aug2021. The clinical outcome for the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202101075459 Same reporter, drug, event for different patients.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizures; This is a spontaneous report from a contactable consumer (patient's mother)   A 26-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Aug2021 16:00 (Lot Number: EW0181) as single dose (at the age of 26) for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced seizures on 05Aug2021 (about an hour and a half or an hour and 20 minutes after the vaccine). She states her son has never had a seizure before. Caller states her son had 2 seizures minutes apart the day before yesterday. Then he had a seizure yesterday as well. Caller states that her son went to the emergency room and yesterday he went to his family doctor. Monday he is going to a neurologist so they can do testing to determine what type of seizures he is having.The outcome was not recovered.    Follow-up (24Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chills, Loss of consciousness, Panic attack, SARS-CoV-2 test negative
Clinical narrative: panic had atrial fibrillation of which I have never had any heart issues at all; I actually blacked out for several minutes; I woke up at 2:00 am with chills; panic had atrial fibrillation of which I have never had any heart issues at all; This is a spontaneous report from a contactable consumer (patient)   A 58-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 05May2021 14:45 (Lot Number: Ew0172) as single dose (at the age of 58) for covid-19 immunisation. The first dose (lot#Ew0158) was administered arm right on 12Apr2021 04:00 pm. Medical history included blood pressure (the patient received within 2 weeks of vaccination: Blood pressure meds). The patient experienced panic had atrial fibrillation of which i have never had any heart issues at all on 06May2021 02:00 am, i actually blacked out for several minutes on 06May2021 02:00 am, i woke up at 2:00 am with chills on 06May2021 02:00. No treatment received. The events outcome was recovered with sequelae.  Follow-up (23Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain in extremity, Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: Hives; Itchiness; Big bumps; Sore arm; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3180), via an unspecified route of administration, administered in left arm on 11Aug2021 09:30 (at the age of 30-year-old), as dose 1, single for COVID-19 immunisation.  Medical history included mild asthma from an unknown date. Patient had known allergies to shellfish and pineapples. Concomitant medications were reported as none. Prior vaccination, patient was diagnosed with COVID and reported as patient had no other vaccine in four week. The patient was not pregnant at the time of vaccination. On 12Aug2021, the patient experienced hives, itchiness, big bumps and sore arm.  The patient underwent lab tests and procedures which included on 13Aug2021, SARS-COV-2 test, nasal swab: found negative. No treatment was given in response to the events. The outcome of the events was not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: This is a spontaneous report from a Contactable other HCP. A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date in Mar2021 (age at vaccination: 57-years) as dose number unknown, single for Covid-19 immunization. Medical history included ongoing rheumatoid arthritis since 11Jan2021. Co-suspect drug included ongoing Xeljanz XR 11 mg, daily, oral, taken since 11Jan2021, for rheumatoid arthritis. Concomitant medications were not reported. Patient reported she had been off of xeljanz xr during the time of receiving the pfizer covid 19 vaccine at the end of Mar2021, and when diagnosed with covid 19 end of Jun2021. Patient reported during the time she was without xeljanz xr she had pain but, when she had covid she didn't notice any pain. No exact dates, further details provided, and md is aware. The patient underwent lab test which included SARS-CoV-2 antibody test, with positive results on an unspecified date in Jun2021 (diagnosed with covid 19 end of June). The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, COVID-19 and suspect drug BNT162B2 cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 51-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6207, Expiry date was not reported) via an unspecified route of administration, administered in arm left on 15Apr2021 07:00 as dose 2, single and first dose via an unspecified route of administration, administered in arm left on 22Feb2021 07:00 (Lot Number: Ew0169, Expiry date was not reported) (age at the vaccination 51-year-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient medical history was not reported. The patient had no known allergies. Concomitant medications included PROBIOTICS taken for an unspecified indication, start and stop date were not reported. The patient had experienced covid test result as positive on 19Aug2021, 1st dose 22feb2021/2nd dose 15apr2021, cold like symptoms, cough, runny nose on 18Aug2021 05:00. The patient did not receive treatment for the adverse event. The patient underwent lab tests and procedures which included sars-cov-2 test as positive on 19Aug2021 Nasal Swab. The patient received probiotics medications in two weeks. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested positive since the vaccination. The outcome of the event Covid test result: Positive was unknown and rest of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration
Clinical narrative: Contracted Covid on 16Aug2021; Contracted Covid on 16Aug2021; administration date=28Dec2020/other vaccine same date vaccine date=28Dec2020; This is a spontaneous report from a contactable Nurse(reporter). A 51-years-old non-pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL1284), via an unspecified route of administration on 28Dec2021in right arm as DOSE 1, SINGLE and also received second dose (COMIRNATY, Solution for injection, Batch/Lot Number: EK9231), via an unspecified route of administration on 28Dec2021 in right arm as DOSE 2, SINGLE for covid-19 immunization (at the age of 51 years)at Workplace clinic. The patient medical history and concomitant medications were not reported. The patient had not any known history of allergies. The patient had not diagnosed with COVID-19 prior to vaccination. It was reported that patient did not take any vaccine within 4 weeks prior to Covid vaccine. On 16Aug2021 the patient had experienced Contracted Covid-19. The patient underwent lab tests and procedures, which included Nasal Swab and was diagnosed as having covid test Positive after vaccination on 16Aug2021. Therapeutic measures were taken as a result of adverse events. The outcome of the events were recovering; Sender's Comments: As there is limited information in the case provided, the causal association between the event drug ineffective and Covid 19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: Renal disorder, Renal pain
Clinical narrative: a very severe painful kidney reaction, pain is fluctuating; a very severe painful kidney reaction, pain is fluctuating; This is a spontaneous report from a contactable pharmacist.  A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 20Aug2021 (Lot Number: EW0918, Expiry date not reported) as dose 2, single for covid-19 immunization.  The patient medical history included "hematochromia" (discrepantly reported).  The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on an unspecified date (Lot Number: EW0191) as dose 1, single for covid-19 immunization.  On an unspecified date, the patient experienced a very severe painful kidney reaction and the pain is fluctuating. It was reported the patient refused to go to emergency room. Treatment for the events was not reported. The outcome for the events was not reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received her first dose of the Covid vaccine and then twelve days later was diagnosed with Covid; This is a spontaneous report from a non-contactable consumer or other non hcp.    A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant was not reported. The patient experienced received her first dose of the covid vaccine and then twelve days later was diagnosed with covid on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: arm is swollen/ Severe swelling, redness, pain and itching of injection site approximately 8 centimeters in diameter; arm is itchy/ Severe swelling, redness, pain and itching of injection site approximately 8 centimeters in diameter; My arm is so sore/ Severe swelling, redness, pain and itching of injection site approximately 8 centimeters in diameter; arm is red / Severe swelling, redness, pain and itching of injection site approximately 8 centimeters in diameter; This is a spontaneous report from a contactable nurse (patient). A 73-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm right on 20Aug2021 10:00 (Lot Number: EW0170) (at the age of 73-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included 9/11 lung disease, penicillin allergy and contrast dye allergy. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient stated that she just wanted to report a side effect from the COVID-19 vaccination as she had the reaction. The patient experienced severe swelling, redness, pain and itching of injection site approximately 8 centimeters in diameter on 21Aug2021 02:00 AM. The patient woke up on the morning of day of reporting and her arm was swollen, red and itchy. The adverse event led to doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the adverse event. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, both doses Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and on an unspecified date as dose 2, single both for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown whether COVID was diagnosed prior vaccination. It was reported that, on an unspecified date, patient had contracted COVID, after 4-5 months of receiving 2nd dose. Post vaccination, the patient had been tested for COVID-19. The outcome of the event was recovering.  No follow up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration, Vasculitis
Clinical narrative: Vasculitis in fingers and toes; fleshy part of fingertips got red/purple,seemed almost like a burn.  As well as his big toes.; This is a spontaneous report from a non-contactable consumer (Patient). A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 05Aug2021 (age at vaccination 12 years) as dose 1, single for covid-19 immunisation. The patient medical history was none. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Aug2021 the patient experienced vasculitis in fingers and toes, fleshy part of fingertips got red/purple, seemed almost like a burn. as well as his big toes. Patient visited healthcare professional office/clinic visit. The patient received aspirin for treatment. The outcome of event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: I have had Diarrhea Ever since; everything I eat I go straight to go loo.; This is a spontaneous report from a contactable consumer (patient).   A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 17Aug2021 (at the age 62-years-old) as dose 1, single for covid-19 immunization.  Medical history included type 2 diabetes mellitus, blood cholesterol, slow blood flow and high blood. The patient's concomitant medications were not reported. Prior to vaccination, the patient did not receive any other vaccines. On Tuesday (17Aug2021) after the first dose of vaccine patient was having diarrhea. Patient reported everything she eats go straight to loo. 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: U
Vaccine: COVID19
Symptoms: Diarrhoea, Exposure via breast milk
Clinical narrative: The day after receiving my second dose of COVID-19 vaccine, my breastfed baby (4 mo) developed diarrhea.; The day after receiving my second dose of COVID-19 vaccine, my breastfed baby (4 mo) developed diarrhea.; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). This consumer or other non hcp reported information for both mother and baby. This is a baby report. A 04-month-old patient of unspecified gender was exposed to bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via transmammary route, administered in Left arm on 17Aug2021 as dose 2, single for covid-19 immunisation from the mother. The patient's medical history was not reported. Concomitant medication included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Device Date : 20Aug2021. It was reported that the day after receiving her second dose of COVID-19 vaccine, her breastfed baby (4 mo) developed diarrhea on 18Aug2021. No treatment was received for adverse events. The reporter assessed events as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. Adverse events resulted in none of the above. The outcome of events was recovered on an unspecified date in 2021.  The lot number for the vaccine,[BNT162B2], was not provided and will be requested during follow up.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: High fever started 10 hours after shot lasted for 24 hours. 102-104.7  fever above 104 for 4 hours; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0173), via an unspecified route of administration, administered in left arm on 19Aug2021 12:00 (at the age of 12-year-old) as dose 2, single for COVID-19 immunisation. Medical history included allergies and asthma from an unknown date. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), via an unspecified route of administration in left arm, on 29Jul2021 17: 30 (at the age of 12-year-old), as single dose for COVID-19 immunization. Patient had no known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEK) and fluticasone propionate (FLONASE ALLERGY RELIEF) both taken for an unspecified indication. Prior vaccination, patient was not diagnosed with COVID and did not receive other vaccine in four weeks. On 19Aug2021 22:00, the patient experienced high fever which started 10 hours after the shot, temperature was 102-104.7, where temperature was above 104 for 4 hours. The fever lasted for 24 hours. The event resulted in doctor's office visit/urgent care.. The patient was not tested COVID since vaccination. Therapeutic measures in response to the event included, alternate use of Ibuprofen 800 mg and Aspirin 600 mg. The outcome of the event was recovered on 20Aug2021 22: 00.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Lip disorder, Muscle rigidity
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0153), via an unspecified route of administration, in the arm right on 11Apr2021 10:00 as dose 2, single (at the age of 35-years-old) for covid-19 immunization. Medical history included blood cholesterol increased and seasonal allergy. Concomitant medications included LIPITOR, CoQ 10, and FISH OIL. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EP7534), via an unspecified route of administration, in the arm right on 19Mar2021 as dose 1, single (at the age of 35-years-old) for covid-19 immunization. On 01Jul2021, the patient's upper lip was not moving correctly when he speak. Patient's upper lip felt rigid and not malleable when he speaks. Patient worried this was a case of bell's palsy. The patient seeing a doctor for the first time on 24Aug to evaluate this. Therapeutic measures were not taken for the events. The patient did not have covid prior to vaccination and did not tested for covid post vaccination. The patient visited the doctor or other healthcare professional office. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Neck mass, Pruritus, Rash papular
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). An unspecified aged female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history includes she had an autoimmune disease and had a severe allergic reaction after a previous dose of this vaccine. Patient concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date patient stated that she developed a lump on her neck (she did not say swollen lymph node) and three days after both doses she broke out with raised red bumps on her arm, looked like chicken pox and itched. She went to a urgent care and received benadryl and steroid cream with little relief. She also shares that she has an autoimmune disease. The seriousness of the event she broke out with raised red bumps on her arm, looked like chicken pox, and itched was considered medically significant. The outcome of the events was recovering. Cannot assess causality between experienced side effect (lump on neck) and Pfizer COVID-19 vaccine. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer female
Clinical narrative: Breast cancer; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported for a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced breast cancer but was not in active treatment. It was not clarified that the patient had breast cancer before taking either dose of the Covid vaccine. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Breast Cancer and the suspect BNT162B2 cannot be excluded. The case will be reassessed once new information is available.