chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: fever; chills; nausea; joint pain; tiredness; This is a spontaneous report received from a contactable (Patient, self-reporting). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unknown date as second dose, single for COVID-19 immunisation and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unknown date as second dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient received her second COVID-19 vaccine and experienced fever, chills, nausea, joint pain and tiredness for approximately 24 hours afterwards. All symptoms have now resolved except for tiredness and joint pain. The outcome of the event tiredness and joint pain was unknown and outcome of the other events were resolved.  Follow-up attempts are needed. Further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: have experienced muscle soreness that radiate through the neck.; This is a spontaneous report from a contactable pharmacist. A 39-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm on May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included shoulder injury from an unknown date and unknown if ongoing, shoulder operation from an unknown date and unknown if ongoing (Operation of the injured arm). The patient's concomitant medications were not reported. The pharmacist reported that after their 1st dose, the patient experienced muscle soreness that radiate through the neck on May2021. The reporter mentioned that they are not certain if the adverse event was due to the vaccine administered or a shoulder injury. The reporter would like to know if they can administer the vaccine on the same arm where the 1st dose was given. It was also reported that patient was about to receive second dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Depression, SARS-CoV-2 test
Clinical narrative: completely sick again with COVID; depressing; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date in 2021 (reported as last Thursday, about 5'o clock) as unknown, single dose for covid-19 immunisation. Medical history included covid from an unknown date to an unknown date. The patient's concomitant medications were not reported. The patient underwent lab tests and procedures which included covid: positive on an unspecified date. It was reported that the patient took it last Thursday about 5'o clock and for 48 hours (2021), patient was completely sick again with COVID, it was just like when patient had it before and patient didn't really understand why this was the case. Patient reported that it was just depressing as patient didn't wanted the shot in the first place and it was just as if patient had it all over again. The outcome of the events "sick again with COVID" and "depressing" was unknown.  Information on the batch/lot has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Energy increased, Feeling hot
Clinical narrative: felt kind of low; got hot; got a burst of energy as if she had an energy drink; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on 22May2021 11:00 as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, caller stated, after she received the Pfizer COVID vaccine on 22May2021, she got a burst of energy. At first she felt kind of low and got hot and then got a burst of energy as if she had an energy drink on an unspecified date in May2021. Reporter would like to know if this has been reported before or not. Reporter stated people did not think she received the Pfizer COVID vaccine because she had a burst of energy. Reporter stated she had only heard of this being reported once before. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: Significant flare after her covid shot; This is a spontaneous report from a contactable nurse from a Pfizer sponsored program. A 63-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; tofacitinib citrate (XELJANZ XR, 11Mg tablet), oral from Oct2020 (Batch/Lot number was not reported) to an unspecified date, at 11 mg, daily for Arthropathic psoriasis. The patient medical history and concomitant medications were not reported. Patient reported that significant flare after having her covid shot. Did not hold Xeljanz. No additional information provided. Outcome of the event was not recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick with both of her vaccines; This spontaneous report from a contactable consumer reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1ST dose single dose and 2ND dose single dose for covid-19 immunization. The patient past medical history and concomitant medication was not reported. The patient got sick with both of her vaccines and she received her last dose on Monday and she was still out of work. The outcome for the event was unknown.  Information on the lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Back disorder
Clinical narrative: he is also scheduled on June 10 for the injection on his lower back and neck.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient himself) reported that, a male patient of an unspecified age received 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 10May21 (shown on his vaccination card) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that, he will be having his 2nd dose of the Pfizer COVID-19 Vaccine on June 1st and he was also scheduled on 10Jun2021 for the injection on his lower back and neck. He wanted to know if he needed to reschedule his injection scheduled on the 10th of June. Outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: nausea; stomach pain; This is a spontaneous report from a contactable consumer and nurse, based on information received by Pfizer (manufacturer control number: EC-2021-092476) for BNT162B2.  A male patient of unspecified age received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration on an unknown date as a single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient's co-suspects included on 09Apr2021, the patient started receiving Lenvatinib mesylate (LENVIMA) with a lot number:1391915 and expiration date: 04/30/2022 at a dose of 18 milligram by oral route of administration, once daily for mal neoplasm of UNSP kidney except renal pelvis. Other medications which were used at or around the time of adverse events were: Bisacodyl (DULCOLAX), Cabozantinib S-Malate (CABOMETYX), Folic acid and Cyanocobalamin (VITAMIN B-12). It was reported that on an unknown date after receiving the COVID shot, the patient experienced stomach upset with nausea and stomach pain. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeding disorder, Headache
Clinical narrative: Not able to eat; My head is hurting really bad.; Chills; This is a spontaneous report from a contactable consumer (patient itself). A 23-years-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0187), via an unspecified route of administration, in the left arm on her shoulder, on 25May2021 (reported as yesterday) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was not able to eat, head was hurting really bad and chills. The patient took Tylenol as treatment for the adverse events. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This is a spontaneous report from a contactable consumer (patient) reporting on himself. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8733 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient received the second dose of Pfizer COVID 19 vaccine on 16Apr2021. The patient medical history and concomitant medications were not reported.  It was reported that, the patient experienced pain in arm on an unknown date in 2021. The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This is a spontaneous report from a non-contactable consumer.   An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient died on an unspecified date.  It was not reported if an autopsy was performed.  Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Death
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in jaw
Clinical narrative: Extreme headache; Jaw pain; This is a spontaneous report from a contactable consumer reported that a 54-year-old male patient that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that his brother received the first dose of Pfizer vaccine and developed extreme headache and jaw pain for 1 week. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient contracted Covid19 after being fully vaccinated; Patient contracted Covid19 after being fully vaccinated; This is a spontaneous report from a contactable nurse. A 56-year-old male consumer (patient) received bnt162b2 (lot/batch number unknown) via an unspecified route of administration on 28Jan2021 at 1st dose single, and then via an unspecified route of administration on 24Feb2021 at 2nd dose single, all for COVID-19 immunization. The patient had no known allergies. Medical history included hypertension from an unknown date. There was none other medications the patient received within 2 weeks of vaccination. The patient contracted Covid19 after being fully vaccinated on 25May2021. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures, which included Covid test name post vaccination: Rapid PCR test, covid test type post vaccination: Nasal Swab, results: positive on 25May2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measures were taken as a result of event which included symptom management. The outcome of event was recovering.  Information about lot/batch number has been requested.; Sender's Comments: Based on the known safety profile and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Covid-19 as a result of possible Vaccination Failure.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse vaccine reaction; : A STUDY TO EVALUATE THE SAFETY OF THE PFIZER-BIONTECH COVID-19 VACCINE IN HEALTHCARE WORKERS, THEIR FAMILIES, AND THEIR COMMUNITIES  This is a report from a safety study.  A 33-year-old female subject started to receive study vaccine, BNT162B2, first dose on 23Dec2020, second dose on 15Jan2021, both for COVID-19 immunization. Relevant medical history and concomitant medications were both unknown. On 23Dec2020, the subject experienced adverse vaccine reaction, assessed as serious as an important medical event. The clinical course was as follows: On 23Dec2020, the subject presented to emergency department and stated 10 minutes after receiving the COVID-19 vaccination, she developed funny sensation of the lips and neck and felt as though she had trouble breathing. She was treated with epinephrine, antihistamines and corticosteroids and her symptoms resolved to baseline. No prior history of anaphylaxis. The subject was discharged home the same day. Emergency department discharge diagnosis: Reaction Allergic Initial. On 31Dec2020, subject followed-up at out-patient clinic. The clinic physician notes: The 33-year-old female who experienced an adverse reaction to the Pfizer COVID vaccine on 23Dec2020. The clinical notes suggested that there were no objective findings, and the adverse reaction consisted more of symptoms or subjective findings. It was unclear whether the adverse vaccine reaction represented anaphylaxis or not. The action taken with product BNT162B2 was not applicable. The outcome of the event was recovered on 23Dec2020.  The investigator considered there was a reasonable possibility that the event adverse vaccine reaction was related to BNT162B2, but unrelated to concomitant drugs.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Vaccination adverse reaction. 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: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Electrocardiogram, Full blood count, Heart rate
Clinical narrative: palpitation; lightheadedness; Nausea; HERO-TOGETHER: A POST-EMERGENCY USE AUTHORIZATION OBSERVATIONAL COHORT STUDY TO EVALUATE THE SAFETY OF THE PFIZER-BIONTECH COVID-19 VACCINE IN US HEALTHCARE WORKERS  This is a report from a non-interventional study source and post authorization safety study for Protocol C4591008. This is a Non-Interventional Study report with non-serious event only. A 49-year-old female subject participated in above mentioned study. The subject received first dose of BNT162B2 (reported as Pfizer COVID-19 vaccine, lot/batch number has been requested) on 17Dec2020 via an unspecified route of administration as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The subject experienced adverse vaccine reaction on 17Dec2020 and reported as non-serious event. On 17Dec2020, the subject presented to emergency department with concern of palpitations and lightheadedness after receiving the COVID vaccine. Denied chest pain. She received the COVID vaccine and then a short while later began to have some palpitations and lightheadedness with some nausea. This was coming and going and currently denied symptoms while in emergency department. She had no other complaints. Vital signs at 12:42: pulse 95, respiratory rate 15, blood pressure 139/97. Vital signs at 13:49: pulse 62, respiratory rate 14, blood pressure 123/82.  The subject was brought to exam room, interviewed and examined. An IV was established and labs obtained. EKG was sinus rhythm, rate 88, nonspecific ST-T wave changes without signs of acute ischemia. She was treated with normal saline bolus as well as ondansetron (ZOFRAN) and diphenhydramine hydrochloride (BENADRYL). complete blood count (CBC) and chemistries were stable. She was feeling better on recheck and would be discharged home to follow-up with primary physician to recheck symptoms and return for worsening. Discharge code: T50.Z95A Adverse effect of other vaccines and biological substances, initial encounter. The subject received unknown manufacturer COVID-19 vaccine as second dose on 18Mar2021. The action taken in response to the event for BNT162B2 was not applicable.  The outcome of the event was recovered on 17Dec2020.  The reporter considered the event was related to COVID-19 vaccine.; Sender's Comments: ALL events Palpitations, lightheadedness and Nausea are reported to occur after administration of bnt162B2 (reported as Pfizer COVID-19 vaccine). Due to strong temporal relationship between the events and administration of vaccine., all the events are considered as related to the vaccine.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Nausea, Palpitations, Respiratory rate
Clinical narrative: palpitation; lightheadedness; Nausea; HERO-TOGETHER: A POST-EMERGENCY USE AUTHORIZATION OBSERVATIONAL COHORT STUDY TO EVALUATE THE SAFETY OF THE PFIZER-BIONTECH COVID-19 VACCINE IN US HEALTHCARE WORKERS  This is a report from a non-interventional study source and post authorization safety study for Protocol C4591008. This is a Non-Interventional Study report with non-serious event only. A 49-year-old female subject participated in above mentioned study. The subject received first dose of BNT162B2 (reported as Pfizer COVID-19 vaccine, lot/batch number has been requested) on 17Dec2020 via an unspecified route of administration as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The subject experienced adverse vaccine reaction on 17Dec2020 and reported as non-serious event. On 17Dec2020, the subject presented to emergency department with concern of palpitations and lightheadedness after receiving the COVID vaccine. Denied chest pain. She received the COVID vaccine and then a short while later began to have some palpitations and lightheadedness with some nausea. This was coming and going and currently denied symptoms while in emergency department. She had no other complaints. Vital signs at 12:42: pulse 95, respiratory rate 15, blood pressure 139/97. Vital signs at 13:49: pulse 62, respiratory rate 14, blood pressure 123/82.  The subject was brought to exam room, interviewed and examined. An IV was established and labs obtained. EKG was sinus rhythm, rate 88, nonspecific ST-T wave changes without signs of acute ischemia. She was treated with normal saline bolus as well as ondansetron (ZOFRAN) and diphenhydramine hydrochloride (BENADRYL). complete blood count (CBC) and chemistries were stable. She was feeling better on recheck and would be discharged home to follow-up with primary physician to recheck symptoms and return for worsening. Discharge code: T50.Z95A Adverse effect of other vaccines and biological substances, initial encounter. The subject received unknown manufacturer COVID-19 vaccine as second dose on 18Mar2021. The action taken in response to the event for BNT162B2 was not applicable.  The outcome of the event was recovered on 17Dec2020.  The reporter considered the event was related to COVID-19 vaccine.; Sender's Comments: ALL events Palpitations, lightheadedness and Nausea are reported to occur after administration of bnt162B2 (reported as Pfizer COVID-19 vaccine). Due to strong temporal relationship between the events and administration of vaccine., all the events are considered as related to the vaccine.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Tenderness, Vaccination site inflammation, Vaccination site pain
Clinical narrative: Left armpit is swollen and tender; Left armpit is swollen and tender; Is the same side as the injection; Typical soreness where the shot was; This is a spontaneous report received from a contactable consumer or other non hcp. A 51-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch number: ER8731 and Expiry date: Unknown), via an unspecified route of administration, on 24May2021 13:00 as 1st dose, single dose on left arm for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the shot on typical soreness where the shot and Is the same side as the injection has not really had any side effects until this morning. On the same date he got the shot he had some tenderness at the site. The patient experienced left armpit is swollen and tender and is the same side as the injection on 27May2021. The events assessed as non-serious. The patient initially stated this was subsided, but clarified it was still ongoing even though he initially said he had no side effects until today as well. If he touches it, it was still tender. Outcome of the events Is the same side as the injection and Typical soreness where the shot was resolving while outcome of the remaining events was unknown.  Information on Lot/Batch number is available; Further information has been requested
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Stomatitis, Stress, Ulcer haemorrhage
Clinical narrative: a bunch of sores in the mouth/don't sting or burn, but they bleed a lot; a bunch of sores in the mouth/don't sting or burn, but they bleed a lot; stress; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and expiry dates were not reported), via unspecified route of administration on 22May2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unknown date, for COVID-19 Immunization. On an unknown date in May2021, the patient experienced a bunch of sores in the mouth and the sores were attached to the gum which meets the tooth. The patient also stated that the sore did not sting or burn, but they bleed a lot and that they could be from stress. The patient have read on the internet that other people were also experiencing this, after vaccination and felt he should report it. He did not report any other symptoms. The patient stated that he had friends who vaccinated with the second dose and they laid them out but that he felt completely fine. The Health professional told him that he would be completely fine, however he wanted to report to Pfizer and wanted to know if there were other reports with the same symptoms. The outcome of the events was unknown.  Information about Lot/batch number is requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Lethargy
Clinical narrative: have extreme fatigue; lethargy; cramping; diarrhea; nausea; muscle and joint pain at the sites of previous injuries that had healed; headache and blurred vision; headache and blurred vision; muscle and joint pain; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172), via an unspecified route of administration, administered in right arm on 04May2021 at 15:00 as a single dose for COVID-19 immunization. The patients past medical history included the 1st dose of bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EW0153) in right arm on 13Apr2021 for COVID-19 immunization. The concomitant medications were not reported. Patient was not taking other products. Patient did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. On 05May2021 at 03:00, (about 12 hours after the vaccine), the patient experienced extreme fatigue (worsened), lethargy, cramping, diarrhea, nausea, muscle and joint pain at the sites of previous injuries that had healed, headache and blurred vision. The patient still had side effects from the second dose 23 days later. All events persisted except for his extreme fatigue, muscle pain, joint pain, and blurred vision, which had worsened. Patient did not require emergency room visit. The patient had physician office visit. The patient was not given treatment. The clinical outcome for the events were not resolved.  Follow up (27May2021): This is a spontaneous report from a contactable consumer. This 40-year-old female consumer (patient) reported. New information included: dose information (first dose, on 13Apr2021; Lot Number: EW0153 in right arm and second dose on 04May2021; Lot Number: EW0172 in right arm).  Caller provided with report reference: 6FUIG32Y. INT-00267000.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Nausea, Vision blurred
Clinical narrative: have extreme fatigue; lethargy; cramping; diarrhea; nausea; muscle and joint pain at the sites of previous injuries that had healed; headache and blurred vision; headache and blurred vision; muscle and joint pain; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172), via an unspecified route of administration, administered in right arm on 04May2021 at 15:00 as a single dose for COVID-19 immunization. The patients past medical history included the 1st dose of bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EW0153) in right arm on 13Apr2021 for COVID-19 immunization. The concomitant medications were not reported. Patient was not taking other products. Patient did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. On 05May2021 at 03:00, (about 12 hours after the vaccine), the patient experienced extreme fatigue (worsened), lethargy, cramping, diarrhea, nausea, muscle and joint pain at the sites of previous injuries that had healed, headache and blurred vision. The patient still had side effects from the second dose 23 days later. All events persisted except for his extreme fatigue, muscle pain, joint pain, and blurred vision, which had worsened. Patient did not require emergency room visit. The patient had physician office visit. The patient was not given treatment. The clinical outcome for the events were not resolved.  Follow up (27May2021): This is a spontaneous report from a contactable consumer. This 40-year-old female consumer (patient) reported. New information included: dose information (first dose, on 13Apr2021; Lot Number: EW0153 in right arm and second dose on 04May2021; Lot Number: EW0172 in right arm).  Caller provided with report reference: 6FUIG32Y. INT-00267000.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19, COVID19, UNK
Symptoms: Dyspnoea, Musculoskeletal chest pain, Pain
Clinical narrative: I was woken up at 01:30am in extreme pain; Sharp pain in the left side chest wall muscle; Difficult to breathe normally without significant pain; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 10May2021 as 2ND DOSE, SINGLE for Covid-19 immunisation. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on unspecified date as first dose, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 14May2021 the patient went to lay down then suddenly, the patient got sharp pain in the left side of the chest wall muscle, the patient found it difficult to breathe normally without significant pain. The patient had applied heat, balms, icy hot as corrective therapy. Last night the patient was woken up at 01:30 in extreme pain, the muscle pain was so sharp and debilitating, the patient seriously thought of calling 911. The outcome of the events was unknown.  Information about the Lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19, UNK
Symptoms: Chest pain, Dyspnoea, Myalgia, Sleep disorder
Clinical narrative: I was woken up at 01:30am in extreme pain; Sharp pain in the left side chest wall muscle; Difficult to breathe normally without significant pain; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 10May2021 as 2ND DOSE, SINGLE for Covid-19 immunisation. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on unspecified date as first dose, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 14May2021 the patient went to lay down then suddenly, the patient got sharp pain in the left side of the chest wall muscle, the patient found it difficult to breathe normally without significant pain. The patient had applied heat, balms, icy hot as corrective therapy. Last night the patient was woken up at 01:30 in extreme pain, the muscle pain was so sharp and debilitating, the patient seriously thought of calling 911. The outcome of the events was unknown.  Information about the Lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood cholesterol, Limb discomfort
Clinical narrative: She has been experiencing intermittent back, shoulder, and arm pain; She has been experiencing intermittent back, shoulder, and arm pain; She has been experiencing intermittent back, shoulder, and arm pain; This is a spontaneous report from a Pfizer sponsored program support. A contactable 69-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number; NDC number: unknown, Expiration Date: unknown), via an unspecified route of ad-ministration, administered in arm left on 24May2021 as single dose for covid-19 immunisation. Medical history included diabetic, hypertension (diagnosed when she was 55), stage 1 breast cancer from Jun2017 (she had a mastectomy on 22Aug2017), patient was allergic to sulfa and penicillin, patient was immunocompromised. The patient previously took anastrozole for the past 4 years (1mg every night) for breast cancer and still ongoing. The patient was taking smarty pants vitamin for women for a year and a half which contains vitamin a, c, d, e, k, thiamine, B3, B6, B12, and biotin. Concomitant medication included pravastatin taken for blood cholesterol as 20 mg, hydralazine 50 mg, 2x/day, metformin 850 mg, 2x/day, lisinopril 10 mg, daily and glipizide ER as 10mg daily with breakfast. There was investigation assessment. The patient experienced a side effect 24 hours after the first dose of the Pfizer covid vaccine which she received on 24May2021. Since the vaccine, the patient had experienced back pain, shoulder pain, and arm pain on and off. She was supposed to go back to work but because of this pain she was able too. The patient was immunocompromised and takes anastrozole. She had a history of stage 1 breast cancer and had a mastectomy. This morning (27May2021), the patient woke up at about 1:00 am and her back and arms were aching. The back pain, shoulder pain, and arm pain all started on 25May2021. She later clarifies and confirmed that the back pain, shoulder pain, and arm pain all began on 26May2021. She wants to make sure that nothing will happen to her. She had to take the second dose of the Pfizer covid vaccine on 15Jun2021. Sometimes the patient has back pain when she was really tired at work, prior to the vaccine. The back pain that the patient was experiencing after the vaccine goes away for about 2 hours and then it comes back, she knows it will come back. Right now, her pain was gone. The patient lab tests included cholesterol was kind of high on her most recent blood work. The patient took one Tylenol yesterday, 26May2021. The outcome of the events was not resolved.  Information about batch/Lot number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Oxygen saturation decreased, Pain, Pulmonary oedema
Clinical narrative: feels like lungs are filled up with water; could not breathe; reduction in oxygen; achy; fever; diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), dose 2 via an unspecified route of administration on 15Mar2021(at the age of 65-years-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Medical history included immunosuppression with lung cancer. rheumatoid arthritis, and COPD all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 22May2021, the patient experienced signs of SARs-COV-2 including could not breathe", achy, fever, feels like lungs are filled up with water, diarrhea and reduction in oxygen. On an unknown date, the patient was tested for SARs-COV-2 today (reported as) and was awaiting results. Therapeutic measures were taken as a result of the events which included antibiotics, a Medrol dose pack and vitamin C. Caller was asked when she can return to work and a recommendation on a potential booster dose of product. Seriousness reported as NO, by consumer. The outcome of the events was reported as unknown.  Information about lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: feels like lungs are filled up with water; could not breathe; reduction in oxygen; achy; fever; diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), dose 2 via an unspecified route of administration on 15Mar2021(at the age of 65-years-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Medical history included immunosuppression with lung cancer. rheumatoid arthritis, and COPD all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 22May2021, the patient experienced signs of SARs-COV-2 including could not breathe", achy, fever, feels like lungs are filled up with water, diarrhea and reduction in oxygen. On an unknown date, the patient was tested for SARs-COV-2 today (reported as) and was awaiting results. Therapeutic measures were taken as a result of the events which included antibiotics, a Medrol dose pack and vitamin C. Caller was asked when she can return to work and a recommendation on a potential booster dose of product. Seriousness reported as NO, by consumer. The outcome of the events was reported as unknown.  Information about lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Haematoma
Clinical narrative: Second hematoma in eye; hematoma; This is a spontaneous report received from a contactable consumer (reporting on herself). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unspecified route of administration in Arm Right 05May202115:30 as 1st dose, single dose for COVID-19 immunization. Medical history included ongoing arthralgia. The patient's concomitant medications were not reported. Previously patient received Tetanus Vaccine and experienced sore arm in 2016 or 2017. Patinet received the first dose of the Pfizer Covid 19 vaccine on 5May2021 and developed a hematoma in the right eye 3 days later on 08May2021.  A few days later she developed a second hematoma in the right eye on 12May2021. Her vision has not been effected. she was concerned that this may happen somewhere else in her body if she gets the next dose. patinet at risk of it just causing more kinds of things like that if she get the second dose. Patient saying it called a subconjunctival hemorrhage- its kind of like a bleeding disorder right. Asking If she miss her dose do we have a certain window that we can get the second dose. She wants to know if someone can give her some guidance.  She was hesitant to get the second shot. States it was like a vessel on the white part of her eye burst.  States it did not effect her eye sight. States she didn't think much of it, but then her sister got the Covid shot and also developed a hematoma in her eye. Patinet states she was wondering why they had the same reaction. She was supposed to be going to get her second shot but was concerned if this was something that could happen somewhere else in her body. Outcome of the events were recovering.    Information on batch/Lot number was obtained. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: patient was hospitalized after experiencing chest discomfort after receiving the 2nd dose of the Pfizer COVID Vaccine; This is a spontaneous report received from a contactable consumer (reporter's grandson) via Medical Information Team. A 20-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 Immunization. It was reported that, the patient was hospitalized after experiencing chest discomfort on an unspecified date after receiving the 2nd dose of the Pfizer COVID Vaccine. The seriousness of the event was reported as hospitalization. The outcome of the event was reported as unknown.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Haemoptysis, Hyperhidrosis, Hypoaesthesia
Clinical narrative: had a decreased oxygen saturated levels where she had to increase her oxygen; fever; sweats; body aches; loss of appetite; numbness; tingling sensation in her left arm; productive cough; coughing up blood; doesn't have a lot of energy; This is a spontaneous report from a contactable nurse (patient herself). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had a decreased oxygen saturated levels where she had to increase her oxygen, fever, sweats, body aches, loss of appetite, numbness, tingling sensation in her left arm, productive cough, coughing up blood and doesn't have a lot of energy. The reporter said normally she was on 2L but had to increase to 3L. The event of oxygen saturation decreased was considered to be medically significant. She heard that more people had a reaction with the 2nd dose than the 1st dose of the vaccine. With this, she wants to know the percentage of people who had a reaction with the 1st dose, and those who had it with the 2nd dose. The reporter wanted to know if she should still get the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine based on the symptoms that she had with the 1st dose. She told the health care professional (HCP) that there was no information about loss of appetite, coughing up blood, numbness tingling sensations, productive cough, and decreased oxygen saturated levels associated with the vaccine. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events fever, sweating, appetite lost, energy decreased and the suspect drug BNT162B2. As there is limited information in the case provided, the causal association between the event low oxygen saturation, general body pain, numbness, tingling sensation, productive cough, coughing blood and the suspect drug BNT162B2 cannot be excluded.  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: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pain, Paraesthesia, Productive cough, Pyrexia
Clinical narrative: had a decreased oxygen saturated levels where she had to increase her oxygen; fever; sweats; body aches; loss of appetite; numbness; tingling sensation in her left arm; productive cough; coughing up blood; doesn't have a lot of energy; This is a spontaneous report from a contactable nurse (patient herself). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had a decreased oxygen saturated levels where she had to increase her oxygen, fever, sweats, body aches, loss of appetite, numbness, tingling sensation in her left arm, productive cough, coughing up blood and doesn't have a lot of energy. The reporter said normally she was on 2L but had to increase to 3L. The event of oxygen saturation decreased was considered to be medically significant. She heard that more people had a reaction with the 2nd dose than the 1st dose of the vaccine. With this, she wants to know the percentage of people who had a reaction with the 1st dose, and those who had it with the 2nd dose. The reporter wanted to know if she should still get the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine based on the symptoms that she had with the 1st dose. She told the health care professional (HCP) that there was no information about loss of appetite, coughing up blood, numbness tingling sensations, productive cough, and decreased oxygen saturated levels associated with the vaccine. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events fever, sweating, appetite lost, energy decreased and the suspect drug BNT162B2. As there is limited information in the case provided, the causal association between the event low oxygen saturation, general body pain, numbness, tingling sensation, productive cough, coughing blood and the suspect drug BNT162B2 cannot be excluded.  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.