chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: Ulcerative colitis flare-ups following mRNA COVID-19 vaccination; This is a literature report for the following literature source(s): (removed). Case description/methods: A 36-year-old female with past medical history of ulcerative colitis, autoimmune pancreatitis presented with intermittent lower abdominal pain and diarrhea for 2 weeks with fever for 1 day. Her last flare-up was 3 years ago before she was put on Tofacitinib. She never required hospitalization. Her symptoms started the second day after she received the second dose of Pfizer COVID-19 vaccine. She had daily 5-10 times of non-bloody diarrhea and abdominal cramps. Her symptoms subsided after 7 days of initial onset. On day 11, she started to have daily up to 15 times bloody bowel movements, along with nausea, vomiting, unable to maintain oral intake. Day 17 after vaccination, patient went to ED after fever of 100.5F. On presentation, she is afebrile, WBC 11.9, CRP 61.8, calprotectin 1840, Clostridioides difficile negative, GI Panel negative. CT showed severe colitis involving the left colon from splenic flexure to rectum. Colonoscopy showed erythematous, granular, hemorrhagic, and ulcerated mucosa in the entire examined colon. Terminal ileum, cecum, ascending, transverse, descending, sigmoid and rectum biopsies were negative for CMV, showed chronic active colitis. Patient received intravenous Methylprednisolone, then transited to oral Prednisone taper and resumed her Tofacitinib. Her symptoms gradually improved.  Discussion(s): To our best knowledge, no report has shown the association of mRNA vaccine and UC flare-up. In general, non-live vaccines are safe for UC patients regardless of immunosuppressants usage. Live vaccines are also contraindicated Tofacitinib users like our patient. In the Pfizer COVID- 19 vaccine trial, patients on immunosuppressive therapy were excluded. Given the temporal relationship between the vaccine and her flare-up in the setting of long-term remission history, we are concerned that the stress induced by the mRNA vaccine may increase the risk of flare-up. More studies need to be done to evaluate the safety profile of mRNA vaccine for UC patients on immunosuppressants.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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: COVID-19, Drug ineffective
Clinical narrative: Lady contracted covid after receiving 2 doses; Lady contracted covid after receiving 2 doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "Lady contracted covid after receiving 2 doses". It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Other medications in two weeks: unknown. Covid prior vaccination was reported as no and covid tested post vaccination was reported as yes. Patient other medical history and known allergies was reported as unknown.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram thorax, Dyspnoea, Fibrin D dimer, SARS-CoV-2 test
Clinical narrative: Severe chest pains; Shortness of breath (SOB); This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 19Oct2021 (Lot number: FF8839) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Sulfa, reaction(s): "allergies". The following information was reported: CHEST PAIN (medically significant) with onset 20Oct2021, outcome "not recovered", described as "Severe chest pains"; DYSPNOEA (medically significant) with onset 20Oct2021, outcome "not recovered", described as "Shortness of breath (SOB)". The events "severe chest pains" and "shortness of breath (sob)" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram thorax: negative; fibrin d dimer: normal; sars-cov-2 test: negative. The patient received Steroids for events. Clinical course: There was no other vaccine in four weeks. There was no covid prior vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Feeling cold, Headache
Clinical narrative: congestion that has lasted over 2 months; Fatigue; cold chills; cold chills; headache; sever cough; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 07Sep2021 14:00 (Lot number: FE3592) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Morphea" (unspecified if ongoing); "IST" (unspecified if ongoing); "LBBB" (unspecified if ongoing). Concomitant medication(s) included: CORLANOR; NEURONTIN. Past drug history included: Gemifloxacin, reaction(s): "Known allergies: Gemifloxacin". The following information was reported: PULMONARY CONGESTION (medically significant) with onset 09Sep2021 04:00, outcome "recovered with sequelae" (2021), described as "congestion that has lasted over 2 months"; FATIGUE (non-serious) with onset 09Sep2021 04:00, outcome "recovered with sequelae" (2021), described as "Fatigue"; CHILLS (non-serious), FEELING COLD (non-serious) all with onset 09Sep2021 04:00, outcome "recovered with sequelae" (2021) and all described as "cold chills"; HEADACHE (non-serious) with onset 09Sep2021 04:00, outcome "recovered with sequelae" (2021), described as "headache"; COUGH (non-serious) with onset 09Sep2021 04:00, outcome "recovered with sequelae" (2021), described as "sever cough". The events "congestion that has lasted over 2 months", "fatigue", "cold chills", "cold chills", "headache" and "sever cough" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Sep2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of pulmonary congestion, fatigue, chills, feeling cold, headache, cough and included treatment with Antibiotics, Inhaler, Cough Syrup, Covid Testing (Negative).  Clinical course: Patient did not have covid prior vaccination.; Sender's Comments: Based on the close temporal relation, the association between the event of pulmonary congestion and the suspect product of BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary congestion, SARS-CoV-2 test
Clinical narrative: congestion that has lasted over 2 months; Fatigue; cold chills; cold chills; headache; sever cough; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 07Sep2021 14:00 (Lot number: FE3592) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Morphea" (unspecified if ongoing); "IST" (unspecified if ongoing); "LBBB" (unspecified if ongoing). Concomitant medication(s) included: CORLANOR; NEURONTIN. Past drug history included: Gemifloxacin, reaction(s): "Known allergies: Gemifloxacin". The following information was reported: PULMONARY CONGESTION (medically significant) with onset 09Sep2021 04:00, outcome "recovered with sequelae" (2021), described as "congestion that has lasted over 2 months"; FATIGUE (non-serious) with onset 09Sep2021 04:00, outcome "recovered with sequelae" (2021), described as "Fatigue"; CHILLS (non-serious), FEELING COLD (non-serious) all with onset 09Sep2021 04:00, outcome "recovered with sequelae" (2021) and all described as "cold chills"; HEADACHE (non-serious) with onset 09Sep2021 04:00, outcome "recovered with sequelae" (2021), described as "headache"; COUGH (non-serious) with onset 09Sep2021 04:00, outcome "recovered with sequelae" (2021), described as "sever cough". The events "congestion that has lasted over 2 months", "fatigue", "cold chills", "cold chills", "headache" and "sever cough" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Sep2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of pulmonary congestion, fatigue, chills, feeling cold, headache, cough and included treatment with Antibiotics, Inhaler, Cough Syrup, Covid Testing (Negative).  Clinical course: Patient did not have covid prior vaccination.; Sender's Comments: Based on the close temporal relation, the association between the event of pulmonary congestion and the suspect product of BNT162B2 cannot be completely ruled out. 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: M
Vaccine: COVID19
Symptoms: Fall, Malaise, Suspected COVID-19
Clinical narrative: had a COVID-19 action and was sent to the hospital; not feeling well; fell backwards; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (hospitalization), outcome "unknown", described as "had a COVID-19 action and was sent to the hospital"; MALAISE (hospitalization), outcome "unknown", described as "not feeling well"; FALL (hospitalization), outcome "unknown", described as "fell backwards". Clinical course: The reporter stated that his son's male coworker received the first dose of the "purple cap" Pfizer COVID-19 vaccine but did not receive the second dose.  On a date not provided by the reporter, the same above male coworker was rubbing his head and stated that he was not feeling well then fell backwards.  The reporter's son's workplace stated that the above male coworker had a "COVID-19 action" and was sent to the hospital and was still there per the reporter (at the time of the initial report).  The reporter stated, "the side effects of the purple cap Pfizer COVID-19 vaccine can kill you."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Loss of consciousness
Clinical narrative: booster; passed out twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (Pfizer employee, reported for niece of reporter).  A 43 year-old female patient received bnt162b2 (BNT162B2, Brand: Pfizer), administration date 28Nov2021 (Batch/Lot number: unknown; Lot unknown reason: Not available/provided to reporter at the time of report completion) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2; brand: Pfizer; lot unknown; lot unknown reason: Not available/provided to reporter at the time of report completion), for covid 19 immunization; Bnt162b2 (Dose Number: 1; brand: Pfizer; lot unknown; lot unknown reason: Not available/provided to reporter at the time of report completion), for covid 19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset Nov2021, outcome "unknown", described as "passed out twice". The event "passed out twice" was evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of loss of consciousness. The reporter received an email from sister-in law that a very healthy niece who received her third dose of the Pfizer Covid shot the day before reporting day, passed out twice and was now at the ER in [State name]. 30 years ago her twin brother received a shot (it may have been a rubella shot), was paralyzed for a short time and still had some side effects. The reporter did not remember the name of the condition that he had.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Heart rate, Heart rate abnormal, Rash
Clinical narrative: within 30 minutes she had started experiencing anaphylaxis; She was tachycardic and remained tachycardic for 5 days; breathing problems; having trouble with her heart rate while moving around; Within 10 minutes of receiving the vaccine rashes appeared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 10Nov2021 11:00 (Lot number: FD0809) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: RASH (life threatening) with onset 10Nov2021 11:10, outcome "unknown", described as "Within 10 minutes of receiving the vaccine rashes appeared"; ANAPHYLACTIC REACTION (life threatening) with onset 10Nov2021 11:30, outcome "unknown", described as "within 30 minutes she had started experiencing anaphylaxis"; TACHYCARDIA (life threatening) with onset 10Nov2021 11:30, outcome "unknown", described as "She was tachycardic and remained tachycardic for 5 days"; DYSPNOEA (life threatening) with onset 10Nov2021 11:30, outcome "unknown", described as "breathing problems"; HEART RATE ABNORMAL (life threatening) with onset 10Nov2021 11:30, outcome "unknown", described as "having trouble with her heart rate while moving around". The events "within 10 minutes of receiving the vaccine rashes appeared", "within 30 minutes she had started experiencing anaphylaxis", "she was tachycardic and remained tachycardic for 5 days", "breathing problems" and "having trouble with her heart rate while moving around" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (10Nov2021) trouble with her heart rate while moving around, notes: trouble with her heart rate while moving around. Therapeutic measures were taken as a result of rash, anaphylactic reaction, tachycardia, dyspnoea, heart rate abnormal as the patient received steroid. Clinical course details: Within 10 minutes of receiving the vaccine rashes appeared, within 30 minutes she had started experiencing anaphylaxis. She was tachycardic and remained tachycardic for 5 days. The long lasting steroid administered helped with the breathing problems but still 20 days post vaccine having trouble with her heart rate while moving around.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: within 30 minutes she had started experiencing anaphylaxis; She was tachycardic and remained tachycardic for 5 days; breathing problems; having trouble with her heart rate while moving around; Within 10 minutes of receiving the vaccine rashes appeared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 10Nov2021 11:00 (Lot number: FD0809) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: RASH (life threatening) with onset 10Nov2021 11:10, outcome "unknown", described as "Within 10 minutes of receiving the vaccine rashes appeared"; ANAPHYLACTIC REACTION (life threatening) with onset 10Nov2021 11:30, outcome "unknown", described as "within 30 minutes she had started experiencing anaphylaxis"; TACHYCARDIA (life threatening) with onset 10Nov2021 11:30, outcome "unknown", described as "She was tachycardic and remained tachycardic for 5 days"; DYSPNOEA (life threatening) with onset 10Nov2021 11:30, outcome "unknown", described as "breathing problems"; HEART RATE ABNORMAL (life threatening) with onset 10Nov2021 11:30, outcome "unknown", described as "having trouble with her heart rate while moving around". The events "within 10 minutes of receiving the vaccine rashes appeared", "within 30 minutes she had started experiencing anaphylaxis", "she was tachycardic and remained tachycardic for 5 days", "breathing problems" and "having trouble with her heart rate while moving around" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (10Nov2021) trouble with her heart rate while moving around, notes: trouble with her heart rate while moving around. Therapeutic measures were taken as a result of rash, anaphylactic reaction, tachycardia, dyspnoea, heart rate abnormal as the patient received steroid. Clinical course details: Within 10 minutes of receiving the vaccine rashes appeared, within 30 minutes she had started experiencing anaphylaxis. She was tachycardic and remained tachycardic for 5 days. The long lasting steroid administered helped with the breathing problems but still 20 days post vaccine having trouble with her heart rate while moving around.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Acquired gene mutation, Drug ineffective, Suspected COVID-19
Clinical narrative: omicron; It is made by your drug; omicron; It is made by your drug; truly messing with people RNA; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "omicron; It is made by your drug"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "omicron; It is made by your drug"; ACQUIRED GENE MUTATION (medically significant), outcome "unknown", described as "truly messing with people RNA". No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Coxsackie viral infection
Clinical narrative: cox- sockeye virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization. The following information was reported: COXSACKIE VIRAL INFECTION (non-serious) with onset Feb2021, outcome "unknown", described as "cox- sockeye virus".  Additional information: The patient had cox- sockeye virus 5 days after their second COVID vaccine in early February.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Electrocardiogram, Pain in extremity, Upper limb fracture
Clinical narrative: L arm from shoulder to elbow hurt/ahead like a broken bone went to walk in clinic; L arm from shoulder to elbow hurt/ahead like a broken bone went to walk in clinic; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 33-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right, administration date 13Oct2021 12:00 (Lot number: FF2589) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (medically significant), UPPER LIMB FRACTURE (medically significant) all with onset 16Oct2021 04:00, outcome "recovered" (19Oct2021) and all described as "L arm from shoulder to elbow hurt/ahead like a broken bone went to walk in clinic". The events "L arm from shoulder to elbow hurt/ahead like a broken bone went to walk in clinic" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: electrocardiogram (EKG): (Oct2021) good, notes: left side hurting. Therapeutic measures were taken as a result of pain in extremity, upper limb fracture.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: a serious hive condition has developed after shot #2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "a serious hive condition has developed after shot #2". The event "a serious hive condition has developed after shot #2" was evaluated at the physician office visit.  Additional information: My wife believed in the Covid Vax. She has had 3. However, a serious hive condition has developed after shot #2. Doctors cannot figure it out. We need help from Pfizer to turn this condition around.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; Had covid after getting vaccinated; This is a spontaneous report received from a contactable reporter(s) (Physician) for a sponsored program.  A 63 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant), outcome "unknown", described as "Had covid after getting vaccinated". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: the patient had COVID (Coronavirus disease of 2019).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Urinary tract infection
Clinical narrative: UTI; too sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 82 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "UTI"; ILLNESS (non-serious), outcome "unknown", described as "too sick". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Motor dysfunction, Muscle twitching, SARS-CoV-2 test, Speech disorder
Clinical narrative: Since receiving the vaccine, she has been having body twitches; worse than shaking; loss of motor function at time; there's times she cannot talk. She can make noises and not words; Her body felt like it's trying to curl up into a ball; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 (Lot number: PAA165969) at the age of 41 years as dose 2, single for covid-19 immunisation. Patient was not pregnant at time of vaccination. Relevant medical history included: "eosinophilic esophagitis" (unspecified if ongoing); "cliff diving accident shattered pelvis" (unspecified if ongoing); "neck herniations" (unspecified if ongoing); "obesity" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known Allergies: shellfish, cholostyramine, entasa, regalin" (unspecified if ongoing). Patient had no covid prior vaccination. Patient had no other vaccine in four weeks. Concomitant medication(s) included: GABAPENTIN; LORATADINE; ARMOUR THYROID. Past drug history included: Cholestyramine, reaction(s): "Allergies"; Pentasa, reaction(s): "Allergies". Vaccination history included: Bnt162b2 (Dose 1, lot number unknown, Unable to locate or read the details), for COVID-19 immunization. The following information was reported: MUSCLE TWITCHING (disability) with onset 15May2021, outcome "not recovered", described as "Since receiving the vaccine, she has been having body twitches"; TREMOR (disability) with onset 15May2021, outcome "not recovered", described as "worse than shaking"; MOTOR DYSFUNCTION (disability) with onset 15May2021, outcome "not recovered", described as "loss of motor function at time"; SPEECH DISORDER (disability) with onset 15May2021, outcome "not recovered", described as "there's times she cannot talk. She can make noises and not words"; MALAISE (disability) with onset 15May2021, outcome "not recovered", described as "Her body felt like it's trying to curl up into a ball". The events "since receiving the vaccine, she has been having body twitches", "worse than shaking", "loss of motor function at time", "there's times she cannot talk. she can make noises and not words" and "her body felt like it's trying to curl up into a ball" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Sep2021) negative. It was unknown if therapeutic measures were taken as a result of muscle twitching, tremor, motor dysfunction, speech disorder, malaise.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Since receiving the vaccine, she has been having body twitches; worse than shaking; loss of motor function at time; there's times she cannot talk. She can make noises and not words; Her body felt like it's trying to curl up into a ball; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 (Lot number: PAA165969) at the age of 41 years as dose 2, single for covid-19 immunisation. Patient was not pregnant at time of vaccination. Relevant medical history included: "eosinophilic esophagitis" (unspecified if ongoing); "cliff diving accident shattered pelvis" (unspecified if ongoing); "neck herniations" (unspecified if ongoing); "obesity" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known Allergies: shellfish, cholostyramine, entasa, regalin" (unspecified if ongoing). Patient had no covid prior vaccination. Patient had no other vaccine in four weeks. Concomitant medication(s) included: GABAPENTIN; LORATADINE; ARMOUR THYROID. Past drug history included: Cholestyramine, reaction(s): "Allergies"; Pentasa, reaction(s): "Allergies". Vaccination history included: Bnt162b2 (Dose 1, lot number unknown, Unable to locate or read the details), for COVID-19 immunization. The following information was reported: MUSCLE TWITCHING (disability) with onset 15May2021, outcome "not recovered", described as "Since receiving the vaccine, she has been having body twitches"; TREMOR (disability) with onset 15May2021, outcome "not recovered", described as "worse than shaking"; MOTOR DYSFUNCTION (disability) with onset 15May2021, outcome "not recovered", described as "loss of motor function at time"; SPEECH DISORDER (disability) with onset 15May2021, outcome "not recovered", described as "there's times she cannot talk. She can make noises and not words"; MALAISE (disability) with onset 15May2021, outcome "not recovered", described as "Her body felt like it's trying to curl up into a ball". The events "since receiving the vaccine, she has been having body twitches", "worse than shaking", "loss of motor function at time", "there's times she cannot talk. she can make noises and not words" and "her body felt like it's trying to curl up into a ball" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Sep2021) negative. It was unknown if therapeutic measures were taken as a result of muscle twitching, tremor, motor dysfunction, speech disorder, malaise.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Immunisation
Clinical narrative: lump the size of a baseball under his armpit and it feels squishy, not hard; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101706140.  A 37 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Nov2021 14:30 (Lot number: FJ8762) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EN6201), administration date: 10Feb2021, when the patient was 36 years old, for Covid-19 immunization; Bnt162b2 (Dose: 2, Lot: EN6200), administration date: 28Feb2021, when the patient was 36 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 14:30, outcome "unknown", described as "Booster"; AXILLARY MASS (non-serious) with onset 01Dec2021, outcome "not recovered", described as "lump the size of a baseball under his armpit and it feels squishy, not hard".  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Illness, Immunology test, Neck mass
Clinical narrative: body aches/body aches and joints persisted for a long time; body aches/body aches and joints persisted for a long time; had nodules in her neck and under her arms for a long time.; had nodules in her neck and under her arms for a long time.; Body aches, headaches, and all kinds of side effects; Was ill for about three months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), administration date: 2021, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "body aches/body aches and joints persisted for a long time"; NODULE (non-serious), NECK MASS (non-serious) all with onset 2021, outcome "unknown" and all described as "had nodules in her neck and under her arms for a long time."; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Body aches, headaches, and all kinds of side effects"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Was ill for about three months". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Caller states that she has had 2 of the shots already.  She wanted to get the test before the booster because after the second shot she had nodules in her neck and under her arms for a long time.  She could not have a mammogram for a while.  Her body aches and joints persisted for a long time.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain, Viral titre
Clinical narrative: body aches/body aches and joints persisted for a long time; body aches/body aches and joints persisted for a long time; had nodules in her neck and under her arms for a long time.; had nodules in her neck and under her arms for a long time.; Body aches, headaches, and all kinds of side effects; Was ill for about three months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), administration date: 2021, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "body aches/body aches and joints persisted for a long time"; NODULE (non-serious), NECK MASS (non-serious) all with onset 2021, outcome "unknown" and all described as "had nodules in her neck and under her arms for a long time."; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Body aches, headaches, and all kinds of side effects"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Was ill for about three months". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Caller states that she has had 2 of the shots already.  She wanted to get the test before the booster because after the second shot she had nodules in her neck and under her arms for a long time.  She could not have a mammogram for a while.  Her body aches and joints persisted for a long time.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure diastolic, Blood pressure measurement, Blood test, Chest X-ray, Fatigue
Clinical narrative: extreme upper body muscle pain; terrible fatigue; low blood pressure/The diastolic is what was low, it was like 52; booster; sleeping "14 hours a day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team.  An 84-year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 01Nov2021 13:55 (Lot number: FE3590) at the age of 84 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "heart disease" (unspecified if ongoing), notes: Verbatim: Heart disease, Additional Information for Other Conditions: This is the main concern. His heart is doing fine now; "Age" (unspecified if ongoing), notes: Verbatim: Age; "Cholesterol" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Leg cramps" (unspecified if ongoing). Concomitant medication(s) included: COREG taken for cardiac disorder (ongoing); SIMVASTATIN taken for hypercholesterolaemia (ongoing); LISINOPRIL taken for hypertension (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] (ongoing); POTASSIUM taken for muscle spasms (ongoing). Vaccination history included: Bnt162b2 (second dose, Card is so messed up can hardly read it to provide product details. , Exact dates of first and second dose of Pfizer Covid Vaccine unknown to caller. , Second Dose Lot- EN5318 , Exp Unknown, thinks given in Apr, but not sure), administration date: Apr2021, when the patient was 84 years old, for COVID-19 immunization; Bnt162b2 (first dose, Card is so messed up can hardly read it to provide product details. , Exact dates of first and second dose of Pfizer Covid Vaccine unknown to caller. , First Dose Lot-EL3248 , Exp, Unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Nov2021 13:55, outcome "unknown", described as "booster"; MYALGIA (non-serious) with onset 02Nov2021 07:00, outcome "recovering", described as "extreme upper body muscle pain"; FATIGUE (non-serious) with onset 02Nov2021 07:00, outcome "recovering", described as "terrible fatigue"; HYPOTENSION (non-serious) with onset 02Nov2021, outcome "not recovered", described as "low blood pressure/The diastolic is what was low, it was like 52"; SOMNOLENCE (non-serious) with onset Nov2021, outcome "unknown", described as "sleeping "14 hours a day". The events "extreme upper body muscle pain" and "terrible fatigue" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia. Additional information: Patient did not get a Covid test. He was just told to drink plenty of water for the muscle pain and take Extra Strength Tylenol for muscle pain- 500mg, one prn. The events resulted in visit to Emergency Room. No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Immunisation, Myalgia, Pain assessment, Somnolence
Clinical narrative: extreme upper body muscle pain; terrible fatigue; low blood pressure/The diastolic is what was low, it was like 52; booster; sleeping "14 hours a day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team.  An 84-year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 01Nov2021 13:55 (Lot number: FE3590) at the age of 84 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "heart disease" (unspecified if ongoing), notes: Verbatim: Heart disease, Additional Information for Other Conditions: This is the main concern. His heart is doing fine now; "Age" (unspecified if ongoing), notes: Verbatim: Age; "Cholesterol" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Leg cramps" (unspecified if ongoing). Concomitant medication(s) included: COREG taken for cardiac disorder (ongoing); SIMVASTATIN taken for hypercholesterolaemia (ongoing); LISINOPRIL taken for hypertension (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] (ongoing); POTASSIUM taken for muscle spasms (ongoing). Vaccination history included: Bnt162b2 (second dose, Card is so messed up can hardly read it to provide product details. , Exact dates of first and second dose of Pfizer Covid Vaccine unknown to caller. , Second Dose Lot- EN5318 , Exp Unknown, thinks given in Apr, but not sure), administration date: Apr2021, when the patient was 84 years old, for COVID-19 immunization; Bnt162b2 (first dose, Card is so messed up can hardly read it to provide product details. , Exact dates of first and second dose of Pfizer Covid Vaccine unknown to caller. , First Dose Lot-EL3248 , Exp, Unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Nov2021 13:55, outcome "unknown", described as "booster"; MYALGIA (non-serious) with onset 02Nov2021 07:00, outcome "recovering", described as "extreme upper body muscle pain"; FATIGUE (non-serious) with onset 02Nov2021 07:00, outcome "recovering", described as "terrible fatigue"; HYPOTENSION (non-serious) with onset 02Nov2021, outcome "not recovered", described as "low blood pressure/The diastolic is what was low, it was like 52"; SOMNOLENCE (non-serious) with onset Nov2021, outcome "unknown", described as "sleeping "14 hours a day". The events "extreme upper body muscle pain" and "terrible fatigue" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia. Additional information: Patient did not get a Covid test. He was just told to drink plenty of water for the muscle pain and take Extra Strength Tylenol for muscle pain- 500mg, one prn. The events resulted in visit to Emergency Room. No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Macule, Mass, Nausea
Clinical narrative: She developed bumps/had these bumps on her knees and elbows and all over; rash on her knees & elbows/there was a rash all over her thighs; They are red and turned purple; They are red and turned purple; headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 03Apr2021 (Lot number: ER8733) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, LOT: EN6199, Anatomical location: Left arm), administration date: 11Mar2021, when the patient was 74 years old, for Covid-19 immunization. The following information was reported: MASS (non-serious) with onset 2021, outcome "not recovered", described as "She developed bumps/had these bumps on her knees and elbows and all over"; RASH (non-serious) with onset 2021, outcome "recovered" (2021), described as "rash on her knees & elbows/there was a rash all over her thighs"; ERYTHEMA (non-serious), MACULE (non-serious) all with onset 2021, outcome "not recovered" and all described as "They are red and turned purple"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea". The events "she developed bumps/had these bumps on her knees and elbows and all over", "rash on her knees & elbows/there was a rash all over her thighs", "they are red and turned purple", "they are red and turned purple", "headache" and "nausea" were evaluated at the physician office visit. Therapeutic measures were taken as a result of mass, rash, erythema, macule. No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: She developed bumps/had these bumps on her knees and elbows and all over; rash on her knees & elbows/there was a rash all over her thighs; They are red and turned purple; They are red and turned purple; headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 03Apr2021 (Lot number: ER8733) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, LOT: EN6199, Anatomical location: Left arm), administration date: 11Mar2021, when the patient was 74 years old, for Covid-19 immunization. The following information was reported: MASS (non-serious) with onset 2021, outcome "not recovered", described as "She developed bumps/had these bumps on her knees and elbows and all over"; RASH (non-serious) with onset 2021, outcome "recovered" (2021), described as "rash on her knees & elbows/there was a rash all over her thighs"; ERYTHEMA (non-serious), MACULE (non-serious) all with onset 2021, outcome "not recovered" and all described as "They are red and turned purple"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea". The events "she developed bumps/had these bumps on her knees and elbows and all over", "rash on her knees & elbows/there was a rash all over her thighs", "they are red and turned purple", "they are red and turned purple", "headache" and "nausea" were evaluated at the physician office visit. Therapeutic measures were taken as a result of mass, rash, erythema, macule. No follow-up attempts are possible. No further information is expected.