chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Electrocardiogram abnormal, Fatigue, Gene sequencing
Clinical narrative: Got Pfizer 1st shot 22MAR though had the virus; Got Pfizer 1st shot 22MAR though had the virus; Had terrible cough; having heart palpitation; had fatigue cough slept for 2 days; loss of breath; saw fluid on her chest.; has swollen lymph nodes; 3 abnormal EKG; A1C at 10 which used to be at 8; Right side of her foot is tingling and swollen; Right side of her foot is tingling and swollen; has aching in right arm and from the clavicles to the chest . Left arm feels same way/having different type of pain other from her chronic pain from C7; Was also having protein in urine; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization.  Medical history included the patient had neck surgery and several falls before.  The patient's concomitant medications were not reported. The patient got Pfizer 1st shot 22Mar2021 though had the virus and Doctor did not want her to have the antibody test. End up in hospital. Had terrible cough and Doctor ended giving antibiotic. Had heart check and Electrocardiogram (EKG) done. Was having heart palpitation. She saw a diabetes Doctor and nephrologist. Was ready to have back surgery 05May. Also had fatigue cough slept for 2 days and had loss of breath. Called CDC and told her it was normal and her body was building the immune system. Additionally Doctor saw fluid on her chest. Surgeon told her she had swollen lymph nodes. Now she felt better but still have the cough. She was having different type of pain other from her chronic pain from C7. She went to the ER had 3 abnormal EKG and glycemia was at 500 and A1C at 10 which used to be at 8, never saw this before. Did not have a heart attack. Right side of her foot is tingling and swollen. When legs swell has aching in right arm and from the clavicles to the chest. Left arm feels same way. Went for pre-op and surgery was cancelled due to all those bad results. Was also having protein in urine but now everything is good. Had genetic testing  but everything was negative. Also still having coughing and lost of breath. Doctor wanted her to take the 2nd dose. The outcome of the event coughing and lost of breath was not recovered, of other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Glycosylated haemoglobin increased, Hydrothorax, Lymphadenopathy, Pain
Clinical narrative: Got Pfizer 1st shot 22MAR though had the virus; Got Pfizer 1st shot 22MAR though had the virus; Had terrible cough; having heart palpitation; had fatigue cough slept for 2 days; loss of breath; saw fluid on her chest.; has swollen lymph nodes; 3 abnormal EKG; A1C at 10 which used to be at 8; Right side of her foot is tingling and swollen; Right side of her foot is tingling and swollen; has aching in right arm and from the clavicles to the chest . Left arm feels same way/having different type of pain other from her chronic pain from C7; Was also having protein in urine; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization.  Medical history included the patient had neck surgery and several falls before.  The patient's concomitant medications were not reported. The patient got Pfizer 1st shot 22Mar2021 though had the virus and Doctor did not want her to have the antibody test. End up in hospital. Had terrible cough and Doctor ended giving antibiotic. Had heart check and Electrocardiogram (EKG) done. Was having heart palpitation. She saw a diabetes Doctor and nephrologist. Was ready to have back surgery 05May. Also had fatigue cough slept for 2 days and had loss of breath. Called CDC and told her it was normal and her body was building the immune system. Additionally Doctor saw fluid on her chest. Surgeon told her she had swollen lymph nodes. Now she felt better but still have the cough. She was having different type of pain other from her chronic pain from C7. She went to the ER had 3 abnormal EKG and glycemia was at 500 and A1C at 10 which used to be at 8, never saw this before. Did not have a heart attack. Right side of her foot is tingling and swollen. When legs swell has aching in right arm and from the clavicles to the chest. Left arm feels same way. Went for pre-op and surgery was cancelled due to all those bad results. Was also having protein in urine but now everything is good. Had genetic testing  but everything was negative. Also still having coughing and lost of breath. Doctor wanted her to take the 2nd dose. The outcome of the event coughing and lost of breath was not recovered, of other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Peripheral swelling, Protein urine, Urine analysis
Clinical narrative: Got Pfizer 1st shot 22MAR though had the virus; Got Pfizer 1st shot 22MAR though had the virus; Had terrible cough; having heart palpitation; had fatigue cough slept for 2 days; loss of breath; saw fluid on her chest.; has swollen lymph nodes; 3 abnormal EKG; A1C at 10 which used to be at 8; Right side of her foot is tingling and swollen; Right side of her foot is tingling and swollen; has aching in right arm and from the clavicles to the chest . Left arm feels same way/having different type of pain other from her chronic pain from C7; Was also having protein in urine; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization.  Medical history included the patient had neck surgery and several falls before.  The patient's concomitant medications were not reported. The patient got Pfizer 1st shot 22Mar2021 though had the virus and Doctor did not want her to have the antibody test. End up in hospital. Had terrible cough and Doctor ended giving antibiotic. Had heart check and Electrocardiogram (EKG) done. Was having heart palpitation. She saw a diabetes Doctor and nephrologist. Was ready to have back surgery 05May. Also had fatigue cough slept for 2 days and had loss of breath. Called CDC and told her it was normal and her body was building the immune system. Additionally Doctor saw fluid on her chest. Surgeon told her she had swollen lymph nodes. Now she felt better but still have the cough. She was having different type of pain other from her chronic pain from C7. She went to the ER had 3 abnormal EKG and glycemia was at 500 and A1C at 10 which used to be at 8, never saw this before. Did not have a heart attack. Right side of her foot is tingling and swollen. When legs swell has aching in right arm and from the clavicles to the chest. Left arm feels same way. Went for pre-op and surgery was cancelled due to all those bad results. Was also having protein in urine but now everything is good. Had genetic testing  but everything was negative. Also still having coughing and lost of breath. Doctor wanted her to take the 2nd dose. The outcome of the event coughing and lost of breath was not recovered, of other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia, Retinal vein occlusion
Clinical narrative: Central retinal vein occlusion of right eye; Fewer; headache; pain throughout body; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0173), dose 2 via an unspecified route of administration, administered in right arm on 07May2021 16:00 as 2nd dose, single for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161) administered in left arm on 16Apr2021 00:00 for COVID-19 Immunization. There is no other vaccine in four weeks, no other medications in four weeks, no covid prior vaccination, no covid tested post vaccination, no known allergies, no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced central retinal vein occlusion of right eye, Fewer, headache, pain through-out body, fatigue on 08May2021. The adverse event resulted in emergency room/department or urgent care, disability or permanent damage. The outcome of the events was recovered with lasting effects (resolved with Sequel).   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Haematochezia, Myalgia, Pain, Rash
Clinical narrative: blood in stool; upset stomach; rash; muscle pain and aches all over body; muscle pain and aches all over body; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 27Mar2021 10:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization; acetylsalicylic acid (BABY ASPIRIN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Lot unknown reason: Not available/provided to reporter at the time of report completion. Prior to vaccination, the patient was diagnosed with COVID-19. No Known allergies. No other medical history. The patient's concomitant medications included Baby Aspirin. No other vaccine in four weeks.  2 weeks after 1st vaccine on 08Apr2021 3:30 PM a rash started to appear with muscle pain and aches all over body. On 17Apr2021 started with upset stomach. On 21Apr2021 started to notice blood in stool and its been like that ever since. Adverse event started on 08Apr2021 3:30 PM. No treatment received for the events. The patient was taking the following medications; baby aspirin, tylenol, goli gummies, benadryl, melatonin, oesto plex for 3 days only. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Bone pain, Dyspnoea, Facial pain, Haemorrhage
Clinical narrative: bleeding; headaches; facial pain; hot flushes; breathlessness; severe body aches; upset stomach; skull pain; numbness in lips; blurred vision; This is a spontaneous report received  from a contactable consumer (patient). A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 04May2021 17:30 (Batch/Lot Number: EW0165) (age at vaccination: 31 years old) as single dose for COVD-19 immunisation. The patient had received dose 1 of BNT162b2 on 13Apr2021 17:00 (Batch/lot number: EW0162) administered in left arm for COVID-19 immunization. The patient had no relevant history, no prior drug, no known allergies. The patient's concomitant medications were not reported. No other vaccines received within 4 weeks prior to the COVID vaccine. The patient had not had COVID prior to the vaccination, unknown if tested post the vaccination. The patient experienced severe headaches, facial pain, hot flushes, bleeding, breathlessness, severe body aches, upset stomach, skull pain, numbness in lips, blurred vision. Event onset date wsa 07May2021 at 08:00. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It's unknown if any treatment was received for the events. The events were not resolved.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Hypoaesthesia oral, Pain, Vision blurred
Clinical narrative: bleeding; headaches; facial pain; hot flushes; breathlessness; severe body aches; upset stomach; skull pain; numbness in lips; blurred vision; This is a spontaneous report received  from a contactable consumer (patient). A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 04May2021 17:30 (Batch/Lot Number: EW0165) (age at vaccination: 31 years old) as single dose for COVD-19 immunisation. The patient had received dose 1 of BNT162b2 on 13Apr2021 17:00 (Batch/lot number: EW0162) administered in left arm for COVID-19 immunization. The patient had no relevant history, no prior drug, no known allergies. The patient's concomitant medications were not reported. No other vaccines received within 4 weeks prior to the COVID vaccine. The patient had not had COVID prior to the vaccination, unknown if tested post the vaccination. The patient experienced severe headaches, facial pain, hot flushes, bleeding, breathlessness, severe body aches, upset stomach, skull pain, numbness in lips, blurred vision. Event onset date wsa 07May2021 at 08:00. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It's unknown if any treatment was received for the events. The events were not resolved.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Haemoptysis, Lymphadenopathy, Pyrexia
Clinical narrative: Coughing up blood, after second vaccine; Feverish, after second vaccine; Lymph nodes swollen, with bruising under arm, after second vaccine; Under arm bruised, after second vaccine; This is a spontaneous report from a contactable nurse (patient's grandmother). A 24-year-old female patient received bnt162b2 (Pfizer Covid shot), dose 2 (at the age of 24 years) via an unspecified route of administration, administered in left deltoid on 09May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included ongoing polycystic ovaries from a couple of years ago and allergic to peanut butter from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received the first shot of bnt162b2 one month ago (Apr2021) for COVID-19 immunization. The patient experienced coughing up blood, feverish, lymph nodes swollen, with bruising under arm/under arm bruised all on 11May2021 after second vaccine. Outcome of events was unknown. The events did not require a visit to Emergency Room or Physician Office; no treatment was given. Events coughing up blood, feverish, lymph nodes swollen were reported as serious medically significant, event under arm bruised was non-serious.  Information on Lot/Batch number was requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a close 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: She can not taste cumin; This is a spontaneous report from a contactable consumer (Patient). A 67-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: ER8736), via an unspecified route of administration, administered in arm right on 27Apr2021 at 10:10 (at the age of 67-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no previous history of immunization with the Pfizer vaccine. Patient had no additional vaccines administered on same date. Patient did not have any other vaccine four weeks prior vaccinations. On 07May2021, patient cannot taste cumin (spice). Patient clarified that her sense of taste was not gone, can taste other things, but she cannot taste cumin.  She has not tried cumin again, however, she could still taste bunch of things. Patient took Pfizer COVID vaccine to improve her chances of life. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Cognitive disorder, Dysarthria, Dyspnoea, Head discomfort
Clinical narrative: 50% loss of vision; Tingling on one side of body; Experienced Transient Ischemic Attack 1 week after vaccine 2nd dose (April 27, 2021).; Strong pressure in head; loss of ability to support body in RL; Slurred  speech; Difficulty in breathing; Cognitive difficulties; Extreme headache; This is a spontaneous report from a contactable consumer (patient) reported for himself that a 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL7533) via an unspecified route of administration, administered in Arm Left on 20Apr2021 14:00 as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Lot number EL8727) in the Left arm on 29Mar2021 16:00 at the age of 40 years for covid-19 immunisation. No known allergies. No vaccines were received within 4 weeks prior to the COVID vaccine. Healthy and no prior adverse event history.  The patient experienced transient ischemic attack 1 week after vaccine 2nd dose, strong pressure in head, loss of ability to support body in RL, slurred speech, difficulty breathing, cognitive difficulties, extreme headache on 27Apr2021 16:30; visited emergency department.  2nd incident 02May2021- 50% loss of vision, tingling on one side of body, slurred speech, cognitive difficulties, extreme headache. The adverse events resulted in emergency room and healthcare professional office visit. Patient was treated with headache medications. It was reported that patient was recovered from events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered in 2021.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Loss of personal independence in daily activities, Paraesthesia, Transient ischaemic attack
Clinical narrative: 50% loss of vision; Tingling on one side of body; Experienced Transient Ischemic Attack 1 week after vaccine 2nd dose (April 27, 2021).; Strong pressure in head; loss of ability to support body in RL; Slurred  speech; Difficulty in breathing; Cognitive difficulties; Extreme headache; This is a spontaneous report from a contactable consumer (patient) reported for himself that a 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL7533) via an unspecified route of administration, administered in Arm Left on 20Apr2021 14:00 as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Lot number EL8727) in the Left arm on 29Mar2021 16:00 at the age of 40 years for covid-19 immunisation. No known allergies. No vaccines were received within 4 weeks prior to the COVID vaccine. Healthy and no prior adverse event history.  The patient experienced transient ischemic attack 1 week after vaccine 2nd dose, strong pressure in head, loss of ability to support body in RL, slurred speech, difficulty breathing, cognitive difficulties, extreme headache on 27Apr2021 16:30; visited emergency department.  2nd incident 02May2021- 50% loss of vision, tingling on one side of body, slurred speech, cognitive difficulties, extreme headache. The adverse events resulted in emergency room and healthcare professional office visit. Patient was treated with headache medications. It was reported that patient was recovered from events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered in 2021.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysmenorrhoea, Heavy menstrual bleeding, Pain, Tremor
Clinical narrative: Bad mensural cramps; Full body shakes; vomiting; dizzy; heavy period; pain; This is a spontaneous report from a contactable consumer (patient reported for herself). A 28-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 (pending clarification) via an unspecified route of administration, administered in Arm Left on 28Apr2021 13:00 at the age of 28 years old (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. On 09May2021 5:00, the patient experienced Bad mensural cramps, Full body shakes, vomiting, dizzy, heavy period two weeks after 2nd dose. Ended up in the emergency room.  Still in pain 3 days later. The adverse events result in Emergency room/department or urgent care. No treatment. Seriousness criteria was hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovered with sequel in May2021.  Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Bad mensural cramps; Full body shakes; vomiting; dizzy; heavy period; pain; This is a spontaneous report from a contactable consumer (patient reported for herself). A 28-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 (pending clarification) via an unspecified route of administration, administered in Arm Left on 28Apr2021 13:00 at the age of 28 years old (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. On 09May2021 5:00, the patient experienced Bad mensural cramps, Full body shakes, vomiting, dizzy, heavy period two weeks after 2nd dose. Ended up in the emergency room.  Still in pain 3 days later. The adverse events result in Emergency room/department or urgent care. No treatment. Seriousness criteria was hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovered with sequel in May2021.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Facial paralysis, Fatigue, Herpes ophthalmic, Hypoaesthesia
Clinical narrative: Left side face numb, droopy; Huge cluster of cold sores left side face. Mouth and eye; Lips cherry red; Huge cluster of cold sores left side face. Mouth and eye; Left side face numb, droopy; Loss appetite; Kidney pain; mild body aches; tired and not wanting to do anything; simply not feeling well,; This is a spontaneous report from a contactable other hcp (patient). A 40-year-old female non-pregnant patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at age of 40 years old as single dose for covid-19 immunization. Medical history included Asthma, allergies, Herpes Virus and Penicillin allergies. Concomitant medications included montelukast sodium (SINGULAIR); fluticasone propionate, salmeterol (WIXELA INHUB); salbutamol sulfate (PROVENTIL HFA); cetirizine hydrochloride (ZYRTEC ALLERGY); budesonide (RHINOCORT ALLERGY). No other vaccines received within 4 weeks prior to the COVID vaccine. No covid prior vaccination. Covid tested not done post vaccination. The patient previously took Amoxicillin and experienced allergies, first dose of bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) (Lot number: EW0185) on 08May2021 10:13 AM at Right arm as single dose for covid-19 immunization. Adverse events occurred after 1st dose from 09May2021 07:00 AM included mild body aches, no arm pain, tired and not wanting to do anything after few days, simply not feeling well, loss appetite and kidney pain. Acyclovir was received as treatment and not recovered. After 2nd dose, lips were cherry red next day. By end of day, huge cluster of cold sores left side face, mouth and eye. Left side face was numb, droopy. The patient still had no will do anything but didn't feel sick. Loss appetite and kidney pain progressed from time 1st dose to 2nd.  The outcome of the events was unknown.   Information on lot number/batch number was requested.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the event so facial droopy, huge cluster of cold sores left side face, mouth and eye 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.,Linked Report(s) : 2021530924 same patient/reporter/drug, different AE/dose
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lip erythema, Malaise, Oral herpes, Pain, Renal pain
Clinical narrative: Left side face numb, droopy; Huge cluster of cold sores left side face. Mouth and eye; Lips cherry red; Huge cluster of cold sores left side face. Mouth and eye; Left side face numb, droopy; Loss appetite; Kidney pain; mild body aches; tired and not wanting to do anything; simply not feeling well,; This is a spontaneous report from a contactable other hcp (patient). A 40-year-old female non-pregnant patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at age of 40 years old as single dose for covid-19 immunization. Medical history included Asthma, allergies, Herpes Virus and Penicillin allergies. Concomitant medications included montelukast sodium (SINGULAIR); fluticasone propionate, salmeterol (WIXELA INHUB); salbutamol sulfate (PROVENTIL HFA); cetirizine hydrochloride (ZYRTEC ALLERGY); budesonide (RHINOCORT ALLERGY). No other vaccines received within 4 weeks prior to the COVID vaccine. No covid prior vaccination. Covid tested not done post vaccination. The patient previously took Amoxicillin and experienced allergies, first dose of bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) (Lot number: EW0185) on 08May2021 10:13 AM at Right arm as single dose for covid-19 immunization. Adverse events occurred after 1st dose from 09May2021 07:00 AM included mild body aches, no arm pain, tired and not wanting to do anything after few days, simply not feeling well, loss appetite and kidney pain. Acyclovir was received as treatment and not recovered. After 2nd dose, lips were cherry red next day. By end of day, huge cluster of cold sores left side face, mouth and eye. Left side face was numb, droopy. The patient still had no will do anything but didn't feel sick. Loss appetite and kidney pain progressed from time 1st dose to 2nd.  The outcome of the events was unknown.   Information on lot number/batch number was requested.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the event so facial droopy, huge cluster of cold sores left side face, mouth and eye 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.,Linked Report(s) : 2021530924 same patient/reporter/drug, different AE/dose
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Rash, Rash pruritic, Ulcer
Clinical narrative: Rash got worse/The rash is painful and itchy all over my body at this time; The rash is painful and itchy all over my body at this time; Sores were open and seeping; Sever bruising all over my body; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in left arm at the age of 55-year-old on 27Apr2021 17:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was a facility.  Medical history included allergy, blood pressure abnormal, Sulfonamide allergy. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included calcium; ascorbic acid (VIT C); ergocalciferol (VIT D), unspecified medicine for blood pressure abnormal and unspecified medicine for allergy. The patient previously took first dose bnt162b2 for COVID-19 immunisation and 48 hours after the first vaccine patient developed a rash starting on patient's arms, moved to patient's back, then patient's chest and neck. Went to the doctor and received a steroid shot for the itchy rash. The rash got worse by 4/4, returned to the doctor for additional treatment. Patient was given Triamcinolone Acetonide to apply to the rash. Patient was told if patient wanted the 2nd vaccine they could not provide further treatment. Patient received the 2nd vaccine on 27Apr2021 and 48 hours later the rash got worse on 29Apr2021 17:00. Patient had been to ER once because the sores were open and seeping in 2021 and the doctor's office 4 times, receiving 3 steroid shots in total. On 10May2021 patient returned to the doctor with sever bruising all over patient's body in addition to the rash in 2021. The rash is painful and itchy all over patient's body at this time in 2021. sores were open and seeping resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Other events were resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of events (steroid shot, triamcinolone acetonide cream). The outcome of events was not recovered.   Information on the lot/batch number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: diagnosed with a Deep Vein Thrombosis since the clot was in his vein/Arm starting swelling specifically in his wrist and forearm; This is a spontaneous report initially directly from a contactable consumer (the patient), and then received from a Pfizer sponsored program. A 48-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0164) via an unspecified route of administration, administered in left shoulder on 20Apr2021 at age of 48-year-old at singe dose for COVID-19 immunization. The patient had no medical history (including any illness at time of vaccination). No family medical history relevant to AE(s). The patient did not receive any concomitant medications (reported as "the patient did not receive other products"). No relevant tests. No prior vaccinations (within 4 weeks). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150) via an unspecified route of administration in his left shoulder on 30Mar2021 at age of 48-year-old for COVID-19 immunization and experienced no adverse event. Caller stated he was calling about the COVID 19 vaccine. Caller stated he got the second dose about 3 weeks ago and about 10 days or 11 days after the second dose (01May2021) his arm starting swelling specifically in his wrist and forearm. Caller stated he went to the emergency room and there was a blood clot found in his left arm. Caller stated he was diagnosed with a deep vein thrombosis since the clot was in his vein. Caller stated everything was going better but the emergency room doctor told him he should probably report this to Pfizer to let Pfizer know. Caller clarified that he was released from the emergency room and was never admitted to the hospital. Treatment received for the event included blood thinner. The event required a visit to emergency room, and the caller stated he went to physician office today. The outcome of the event was recovering.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chapped lips, Dehydration, Ear pain, Eczema
Clinical narrative: Dehydrated; Lost her electrolytes; Her lips were cracked; Eczema; exhausted and she couldn't leave the bed; Hallucinating; Violent dreams; Strange aches in one of her arms and one ear; Strange aches in one of her arms and one ear; Has not had the same energy; This is a spontaneous report from a contactable consumer (patient). A 90-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Feb2021 (Batch/Lot Number: EL9261; Expiration Date: May2021) at the age of 90-years-old as single dose for covid-19 immunization. Medical history included allergies to Shellfish, penicillin, sulfa, mercury, and latex, the patient has been tested positive on 08Jan2021 for covid-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot Number: EL9261; Expiration Date: May2021) on 26Jan2021 at the age of 90-years-old for covid-19 immunization and experienced exhausted, weak, so lethargic she could barely move, had chills, and she lost her sense of taste. For second dose: Most of these symptoms began on 16Feb2021 around 6:00 - 7:00 pm. The patient was exhausted and she couldn't leave the bed, started 16Feb2021, improved. The patient was hallucinating, started 16Feb2021, improved. The patient had chills, started 16Feb2021, improved. On an unknown date in Feb2021, the patient was dehydrated to the point to where her lips were cracked, the patient was so dehydrated and couldn't get enough water she drank so much water that she lost her electrolytes which was why she was hospitalized. The patient was hospitalized on 28Feb2021 and released on 01Mar2021, they gave her an IV for treatment. The patient had violent dreams, started 16Feb2021, improved. The patient had strange aches in one of her arms and one ear, started 16Feb2021, improved. The patient has not had the same energy since the shots on 16Feb2021, she's going to physical therapy for this. The patient had eczema, started 28Feb2021, ongoing. The outcome of the events eczema was not recovered, the outcome of the event dehydrated, lost her electrolytes and lips were cracked and 'has not had the same energy' was unknown, the outcome of the other events Hallucinating, Violent dreams, 'Strange aches in one of her arms and one ear', 'exhausted and she couldn't leave the bed' was recovering.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Electrolyte imbalance, Fatigue, Hallucination, Nightmare, Pain in extremity
Clinical narrative: Dehydrated; Lost her electrolytes; Her lips were cracked; Eczema; exhausted and she couldn't leave the bed; Hallucinating; Violent dreams; Strange aches in one of her arms and one ear; Strange aches in one of her arms and one ear; Has not had the same energy; This is a spontaneous report from a contactable consumer (patient). A 90-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Feb2021 (Batch/Lot Number: EL9261; Expiration Date: May2021) at the age of 90-years-old as single dose for covid-19 immunization. Medical history included allergies to Shellfish, penicillin, sulfa, mercury, and latex, the patient has been tested positive on 08Jan2021 for covid-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot Number: EL9261; Expiration Date: May2021) on 26Jan2021 at the age of 90-years-old for covid-19 immunization and experienced exhausted, weak, so lethargic she could barely move, had chills, and she lost her sense of taste. For second dose: Most of these symptoms began on 16Feb2021 around 6:00 - 7:00 pm. The patient was exhausted and she couldn't leave the bed, started 16Feb2021, improved. The patient was hallucinating, started 16Feb2021, improved. The patient had chills, started 16Feb2021, improved. On an unknown date in Feb2021, the patient was dehydrated to the point to where her lips were cracked, the patient was so dehydrated and couldn't get enough water she drank so much water that she lost her electrolytes which was why she was hospitalized. The patient was hospitalized on 28Feb2021 and released on 01Mar2021, they gave her an IV for treatment. The patient had violent dreams, started 16Feb2021, improved. The patient had strange aches in one of her arms and one ear, started 16Feb2021, improved. The patient has not had the same energy since the shots on 16Feb2021, she's going to physical therapy for this. The patient had eczema, started 28Feb2021, ongoing. The outcome of the events eczema was not recovered, the outcome of the event dehydrated, lost her electrolytes and lips were cracked and 'has not had the same energy' was unknown, the outcome of the other events Hallucinating, Violent dreams, 'Strange aches in one of her arms and one ear', 'exhausted and she couldn't leave the bed' was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date not provided) via an unspecified route of administration on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller reported that someone he knew, the patient, who did not wait the recommended 15 minutes after receiving the Covid-19 vaccine. Caller reported that after leaving the vaccination facility, the patient passed out in his car and hit 2 parked cars. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Deep vein thrombosis, Pneumonia, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Developed acute respiratory failure; COVID like pneumonia/ tested negative 5 times for COVID; Right lower extremity DVT; she also developed small PE; This is a spontaneous report from a contactable physician. A 73-year-old male patient received bnt162b2 (unspecified trade name), dose 1 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included Chronic atrial fibrillation, chronic obstructive pulmonary disease, cerebrovascular accident with residual weakness. The patient's concomitant medications were not reported. No covid prior vaccination. Covid tested not done post vaccination. The patient previously took erythromycin and experienced allergies. After patient initially had the COVID vaccine at the END of February she developed acute respiratory failure due to COVID like pneumonia, tested negative 5 times for COVID. She also developed small PE and right lower extremity DVT. Treatment of Enoxiparin received. The adverse event result in emergency room/department or urgent care visit, and Prolongation of existing hospitalization (vaccine received during existing hospitalization). Number of days in hospitalization was 4. The outcome of the events was recovering.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a causal association between the reported events and Bnt162b2 cannot be fully excluded. Case will be reassessed when additional 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 RAs, Ethics Committees, and investigators, as appropriate.,Linked Report(s) : 2021532932 same patient/drug, different dose/AE
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Inappropriate schedule of product administration, Off label use
Clinical narrative: Developed acute respiratory failure; COVID like pneumonia/ tested negative 5 times for COVID; Right lower extremity DVT; she also developed small PE; This is a spontaneous report from a contactable physician. A 73-year-old male patient received bnt162b2 (unspecified trade name), dose 1 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included Chronic atrial fibrillation, chronic obstructive pulmonary disease, cerebrovascular accident with residual weakness. The patient's concomitant medications were not reported. No covid prior vaccination. Covid tested not done post vaccination. The patient previously took erythromycin and experienced allergies. After patient initially had the COVID vaccine at the END of February she developed acute respiratory failure due to COVID like pneumonia, tested negative 5 times for COVID. She also developed small PE and right lower extremity DVT. Treatment of Enoxiparin received. The adverse event result in emergency room/department or urgent care visit, and Prolongation of existing hospitalization (vaccine received during existing hospitalization). Number of days in hospitalization was 4. The outcome of the events was recovering.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a causal association between the reported events and Bnt162b2 cannot be fully excluded. Case will be reassessed when additional 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 RAs, Ethics Committees, and investigators, as appropriate.,Linked Report(s) : 2021532932 same patient/drug, different dose/AE
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Deep vein thrombosis, Pneumonia, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: developed right upper extremity DVT; 1st dose, 25Feb2021/ 2nd dose, 08May2021; 1st dose, 25Feb2021/ 2nd dose, 08May2021; This is a spontaneous report from a contactable physician. A 73-year-old male patient received bnt162b2, via an unspecified route of administration on 08May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. Medical history included Chronic A fib, COPD, CVA with residual weakness, Known allergies: erythromycin. The patient's concomitant medications were not reported. The patient previously received the bnt162b2, at the age of 73-year-old, via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization and experienced acute respiratory failure due to COVID like pneumonia, small PE and right lower extremity DVT. Within few days (May2021) she developed right upper extremity DVT despite being on Apixaban and being compliant with it. This event resulted in Emergency room/department or urgent care, Hospitalization (4 days). The patient received the Enoxiparin as treatment for this event. The outcome of the event Deep venous thrombosis arm was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the Deep vein thrombosis and the vaccine (BNT162B2 )cannot be excluded. The case will be reassessed once new information is available. "The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate."
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Inappropriate schedule of product administration, Off label use
Clinical narrative: developed right upper extremity DVT; 1st dose, 25Feb2021/ 2nd dose, 08May2021; 1st dose, 25Feb2021/ 2nd dose, 08May2021; This is a spontaneous report from a contactable physician. A 73-year-old male patient received bnt162b2, via an unspecified route of administration on 08May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. Medical history included Chronic A fib, COPD, CVA with residual weakness, Known allergies: erythromycin. The patient's concomitant medications were not reported. The patient previously received the bnt162b2, at the age of 73-year-old, via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization and experienced acute respiratory failure due to COVID like pneumonia, small PE and right lower extremity DVT. Within few days (May2021) she developed right upper extremity DVT despite being on Apixaban and being compliant with it. This event resulted in Emergency room/department or urgent care, Hospitalization (4 days). The patient received the Enoxiparin as treatment for this event. The outcome of the event Deep venous thrombosis arm was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the Deep vein thrombosis and the vaccine (BNT162B2 )cannot be excluded. The case will be reassessed once new information is available. "The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate."