chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Impaired work ability, Lip swelling, Loss of consciousness
Clinical narrative: after the shot I had a red rash, swollen neck and face in lips area within the next few minutes, then I was unable to breath and I remember waking up in the hospital. A few weeks after the event, I was very dizzy and there was really loud ringing in my ears and I would episodes that I would pass out, so there were days that I could not work. This was within two to three weeks after the shot. I took a lot of Benadryl before my next shot and I was okay
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash erythematous, Swelling, Swelling face, Tinnitus
Clinical narrative: after the shot I had a red rash, swollen neck and face in lips area within the next few minutes, then I was unable to breath and I remember waking up in the hospital. A few weeks after the event, I was very dizzy and there was really loud ringing in my ears and I would episodes that I would pass out, so there were days that I could not work. This was within two to three weeks after the shot. I took a lot of Benadryl before my next shot and I was okay
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Diarrhoea, Fall, Gait disturbance, Hyperhidrosis
Clinical narrative: I got sick. I went to the gym after receiving the vaccine, and I didn't feel well. In the afternoon I began sweating profusely. The next morning I tried going to bathroom, but I was weak so I fell and hit my head. I landed hard on my back which resulted in severe back pain. I was taken to the ER and stayed 10 days in there. I was then transferred to a different hospital for 10 more days. I was under home health care for 5 weeks. I went to rehab center  because I was weak from side effects of Covid vaccine. I received physical and speech therapy. 4 months later, I am still under medical care receiving physical therapy under my neurologist. My neurologist referred me to  Clinic for follow up on June 24, 2021.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Pain
Clinical narrative: I got sick. I went to the gym after receiving the vaccine, and I didn't feel well. In the afternoon I began sweating profusely. The next morning I tried going to bathroom, but I was weak so I fell and hit my head. I landed hard on my back which resulted in severe back pain. I was taken to the ER and stayed 10 days in there. I was then transferred to a different hospital for 10 more days. I was under home health care for 5 weeks. I went to rehab center  because I was weak from side effects of Covid vaccine. I received physical and speech therapy. 4 months later, I am still under medical care receiving physical therapy under my neurologist. My neurologist referred me to  Clinic for follow up on June 24, 2021.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Back injury, Back pain, Brain scan abnormal, Fall
Clinical narrative: I got sick. I went to the gym after receiving the vaccine, and I didn't feel well. In the afternoon I began sweating profusely. The next morning I tried going to bathroom, but I was weak so I fell and hit my head. I landed hard on my back which resulted in severe back pain. I was taken to the ER and stayed 10 days in there. I was then transferred to a different hospital for 10 more days. I was under home health care for 5 weeks. I went to rehab center  because I was weak from side effects of Covid vaccine. I received physical and speech therapy. 4 months later, I am still under medical care receiving physical therapy under my neurologist. My neurologist referred me to  Clinic for follow up on June 24, 2021.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Head injury, Hyperhidrosis, Malaise
Clinical narrative: I got sick. I went to the gym after receiving the vaccine, and I didn't feel well. In the afternoon I began sweating profusely. The next morning I tried going to bathroom, but I was weak so I fell and hit my head. I landed hard on my back which resulted in severe back pain. I was taken to the ER and stayed 10 days in there. I was then transferred to a different hospital for 10 more days. I was under home health care for 5 weeks. I went to rehab center  because I was weak from side effects of Covid vaccine. I received physical and speech therapy. 4 months later, I am still under medical care receiving physical therapy under my neurologist. My neurologist referred me to  Clinic for follow up on June 24, 2021.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Extrasystoles, Heart rate irregular, Skin warm, Tremor
Clinical narrative: Shaky; Warm; My face turned red; My hands were shaking; I felt my heart skipping with irregular heart beats; The nurse measured my blood pressure and it was 183/95 with a pulse of 104; This is a Spontaneous report from a Contactable Consumer (patient, self-reported). A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9265 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 03Feb2021 at 08:30 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included hypertension, chronic lymphocytic leukemia, osteoporosis, glaucoma and known allergies: reaction to epinephrine (cannot have Novocain with epinephrine), reaction to histamines and tyramine. Concomitant medications included metoprolol succinate (TOPROL XL), Amlodipine, Levothyroxine, and Atorvastatin. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 03Feb2021, about 7-10 minutes after receiving the shot, she started to feel extremely shaky and warm. Her face turned red, and her hands were shaking. She felt her heart skipping with irregular heartbeats. The nurse measured her blood pressure, and it was 183/95 with a pulse of 104. She was observed for an hour. The patient did not receive treatment for the events. Outcome of the events was recovered on an unknown date in Feb2021.  Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Erythema, Feeling hot, Heart rate, Heart rate irregular
Clinical narrative: Shaky; Warm; My face turned red; My hands were shaking; I felt my heart skipping with irregular heart beats; The nurse measured my blood pressure and it was 183/95 with a pulse of 104; This is a Spontaneous report from a Contactable Consumer (patient, self-reported). A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9265 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 03Feb2021 at 08:30 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included hypertension, chronic lymphocytic leukemia, osteoporosis, glaucoma and known allergies: reaction to epinephrine (cannot have Novocain with epinephrine), reaction to histamines and tyramine. Concomitant medications included metoprolol succinate (TOPROL XL), Amlodipine, Levothyroxine, and Atorvastatin. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 03Feb2021, about 7-10 minutes after receiving the shot, she started to feel extremely shaky and warm. Her face turned red, and her hands were shaking. She felt her heart skipping with irregular heartbeats. The nurse measured her blood pressure, and it was 183/95 with a pulse of 104. She was observed for an hour. The patient did not receive treatment for the events. Outcome of the events was recovered on an unknown date in Feb2021.  Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Nervousness, Tremor
Clinical narrative: Shaky; Warm; My face turned red; My hands were shaking; I felt my heart skipping with irregular heart beats; The nurse measured my blood pressure and it was 183/95 with a pulse of 104; This is a Spontaneous report from a Contactable Consumer (patient, self-reported). A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9265 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 03Feb2021 at 08:30 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included hypertension, chronic lymphocytic leukemia, osteoporosis, glaucoma and known allergies: reaction to epinephrine (cannot have Novocain with epinephrine), reaction to histamines and tyramine. Concomitant medications included metoprolol succinate (TOPROL XL), Amlodipine, Levothyroxine, and Atorvastatin. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 03Feb2021, about 7-10 minutes after receiving the shot, she started to feel extremely shaky and warm. Her face turned red, and her hands were shaking. She felt her heart skipping with irregular heartbeats. The nurse measured her blood pressure, and it was 183/95 with a pulse of 104. She was observed for an hour. The patient did not receive treatment for the events. Outcome of the events was recovered on an unknown date in Feb2021.  Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Exhausted; Feeling Strange; Eye floaters; Dizzy/Dizzy so bad I had crawl so I didn't fall; headache; Nauseaus/nauseous - felt like vomiting; Joint Pain; achy pain/achy all over; Flu; Chills; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL8982) via an unspecified route of administration, administered in arm right on 29Jan2021 14:00 (at the age of 77-years-old) as 1st dose, single; dose 2 (lot no: EL9267) on 19Feb2021 11:00 as 2nd dose, single for COVID-19 immunization. The medical history included digestion problems, ongoing coeliac disease and allergic to gluten, lesion in pancreas. Concomitant medications included vitamin b complex (VITAMIN B), zinc, ascorbic acid (VITAMIN C), cholecalciferol (VITAMIN D), Bifidobacterium lactis (PROBIOTIC BIFIDOBACTERIUM LACTIS). The patient was not pregnant at the time of vaccination. The patient had not received other vaccine in four weeks. On 29Jan2021 18:00 the patient experienced chills; on 29Jan2021 20:00 the patient experienced joint pain achy pain/achy all over, flu; on 29Jan2021 21:00, the patient experienced headache and nauseous/nauseous - felt like vomiting; on 30Jan2021 06:00 the patient experienced eye floaters and dizzy/dizzy so bad I had crawl so I did not fall; on 30Jan2021 08:00, the patient experienced feeling strange; on 05Feb2021 18:00 the patient experienced exhausted. The patient did not take any treatment. The patient was not tested for covid prior vaccination and post vaccination. The outcome of the events was recovered as of 07May2021.  Follow up attempts are completed. No further information is expected.  Follow-up (07May2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A 77-years-old female consumer (patient) reported in response to follow up that reporter contact information was available and "after shot, had some side effects" was coded as event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow up (19May2021): New information received from contactable consumer included: dose 1 vaccination details and medical history (lesions in pancreas), date and time of the events was added.  Follow up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Headache, Influenza like illness, Nausea, Vitreous floaters
Clinical narrative: Exhausted; Feeling Strange; Eye floaters; Dizzy/Dizzy so bad I had crawl so I didn't fall; headache; Nauseaus/nauseous - felt like vomiting; Joint Pain; achy pain/achy all over; Flu; Chills; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL8982) via an unspecified route of administration, administered in arm right on 29Jan2021 14:00 (at the age of 77-years-old) as 1st dose, single; dose 2 (lot no: EL9267) on 19Feb2021 11:00 as 2nd dose, single for COVID-19 immunization. The medical history included digestion problems, ongoing coeliac disease and allergic to gluten, lesion in pancreas. Concomitant medications included vitamin b complex (VITAMIN B), zinc, ascorbic acid (VITAMIN C), cholecalciferol (VITAMIN D), Bifidobacterium lactis (PROBIOTIC BIFIDOBACTERIUM LACTIS). The patient was not pregnant at the time of vaccination. The patient had not received other vaccine in four weeks. On 29Jan2021 18:00 the patient experienced chills; on 29Jan2021 20:00 the patient experienced joint pain achy pain/achy all over, flu; on 29Jan2021 21:00, the patient experienced headache and nauseous/nauseous - felt like vomiting; on 30Jan2021 06:00 the patient experienced eye floaters and dizzy/dizzy so bad I had crawl so I did not fall; on 30Jan2021 08:00, the patient experienced feeling strange; on 05Feb2021 18:00 the patient experienced exhausted. The patient did not take any treatment. The patient was not tested for covid prior vaccination and post vaccination. The outcome of the events was recovered as of 07May2021.  Follow up attempts are completed. No further information is expected.  Follow-up (07May2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A 77-years-old female consumer (patient) reported in response to follow up that reporter contact information was available and "after shot, had some side effects" was coded as event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow up (19May2021): New information received from contactable consumer included: dose 1 vaccination details and medical history (lesions in pancreas), date and time of the events was added.  Follow up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Headache, Influenza, Nausea, Pain
Clinical narrative: Exhausted; Feeling Strange; Eye floaters; Dizzy/Dizzy so bad I had crawl so I didn't fall; headache; Nauseaus/nauseous - felt like vomiting; Joint Pain; achy pain/achy all over; Flu; Chills; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL8982) via an unspecified route of administration, administered in arm right on 29Jan2021 14:00 (at the age of 77-years-old) as 1st dose, single; dose 2 (lot no: EL9267) on 19Feb2021 11:00 as 2nd dose, single for COVID-19 immunization. The medical history included digestion problems, ongoing coeliac disease and allergic to gluten, lesion in pancreas. Concomitant medications included vitamin b complex (VITAMIN B), zinc, ascorbic acid (VITAMIN C), cholecalciferol (VITAMIN D), Bifidobacterium lactis (PROBIOTIC BIFIDOBACTERIUM LACTIS). The patient was not pregnant at the time of vaccination. The patient had not received other vaccine in four weeks. On 29Jan2021 18:00 the patient experienced chills; on 29Jan2021 20:00 the patient experienced joint pain achy pain/achy all over, flu; on 29Jan2021 21:00, the patient experienced headache and nauseous/nauseous - felt like vomiting; on 30Jan2021 06:00 the patient experienced eye floaters and dizzy/dizzy so bad I had crawl so I did not fall; on 30Jan2021 08:00, the patient experienced feeling strange; on 05Feb2021 18:00 the patient experienced exhausted. The patient did not take any treatment. The patient was not tested for covid prior vaccination and post vaccination. The outcome of the events was recovered as of 07May2021.  Follow up attempts are completed. No further information is expected.  Follow-up (07May2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A 77-years-old female consumer (patient) reported in response to follow up that reporter contact information was available and "after shot, had some side effects" was coded as event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow up (19May2021): New information received from contactable consumer included: dose 1 vaccination details and medical history (lesions in pancreas), date and time of the events was added.  Follow up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Vitreous floaters
Clinical narrative: Exhausted; Feeling Strange; Eye floaters; Dizzy/Dizzy so bad I had crawl so I didn't fall; headache; Nauseaus/nauseous - felt like vomiting; Joint Pain; achy pain/achy all over; Flu; Chills; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL8982) via an unspecified route of administration, administered in arm right on 29Jan2021 14:00 (at the age of 77-years-old) as 1st dose, single; dose 2 (lot no: EL9267) on 19Feb2021 11:00 as 2nd dose, single for COVID-19 immunization. The medical history included digestion problems, ongoing coeliac disease and allergic to gluten, lesion in pancreas. Concomitant medications included vitamin b complex (VITAMIN B), zinc, ascorbic acid (VITAMIN C), cholecalciferol (VITAMIN D), Bifidobacterium lactis (PROBIOTIC BIFIDOBACTERIUM LACTIS). The patient was not pregnant at the time of vaccination. The patient had not received other vaccine in four weeks. On 29Jan2021 18:00 the patient experienced chills; on 29Jan2021 20:00 the patient experienced joint pain achy pain/achy all over, flu; on 29Jan2021 21:00, the patient experienced headache and nauseous/nauseous - felt like vomiting; on 30Jan2021 06:00 the patient experienced eye floaters and dizzy/dizzy so bad I had crawl so I did not fall; on 30Jan2021 08:00, the patient experienced feeling strange; on 05Feb2021 18:00 the patient experienced exhausted. The patient did not take any treatment. The patient was not tested for covid prior vaccination and post vaccination. The outcome of the events was recovered as of 07May2021.  Follow up attempts are completed. No further information is expected.  Follow-up (07May2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A 77-years-old female consumer (patient) reported in response to follow up that reporter contact information was available and "after shot, had some side effects" was coded as event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow up (19May2021): New information received from contactable consumer included: dose 1 vaccination details and medical history (lesions in pancreas), date and time of the events was added.  Follow up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Influenza like illness, Nausea, Pain, Sensory disturbance
Clinical narrative: Exhausted; Feeling Strange; Eye floaters; Dizzy/Dizzy so bad I had crawl so I didn't fall; headache; Nauseaus/nauseous - felt like vomiting; Joint Pain; achy pain/achy all over; Flu; Chills; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL8982) via an unspecified route of administration, administered in arm right on 29Jan2021 14:00 (at the age of 77-years-old) as 1st dose, single; dose 2 (lot no: EL9267) on 19Feb2021 11:00 as 2nd dose, single for COVID-19 immunization. The medical history included digestion problems, ongoing coeliac disease and allergic to gluten, lesion in pancreas. Concomitant medications included vitamin b complex (VITAMIN B), zinc, ascorbic acid (VITAMIN C), cholecalciferol (VITAMIN D), Bifidobacterium lactis (PROBIOTIC BIFIDOBACTERIUM LACTIS). The patient was not pregnant at the time of vaccination. The patient had not received other vaccine in four weeks. On 29Jan2021 18:00 the patient experienced chills; on 29Jan2021 20:00 the patient experienced joint pain achy pain/achy all over, flu; on 29Jan2021 21:00, the patient experienced headache and nauseous/nauseous - felt like vomiting; on 30Jan2021 06:00 the patient experienced eye floaters and dizzy/dizzy so bad I had crawl so I did not fall; on 30Jan2021 08:00, the patient experienced feeling strange; on 05Feb2021 18:00 the patient experienced exhausted. The patient did not take any treatment. The patient was not tested for covid prior vaccination and post vaccination. The outcome of the events was recovered as of 07May2021.  Follow up attempts are completed. No further information is expected.  Follow-up (07May2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A 77-years-old female consumer (patient) reported in response to follow up that reporter contact information was available and "after shot, had some side effects" was coded as event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow up (19May2021): New information received from contactable consumer included: dose 1 vaccination details and medical history (lesions in pancreas), date and time of the events was added.  Follow up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Injection site pain
Clinical narrative: Started with fever; body aches; Now severe back pain; stiffness; Makes walking and working very difficult; Nerve pain stemming from lymph node areas (under arms and groin area); Nerve pain stemming from lymph node areas (under arms and groin area); Pain will radiate down my arms and legs; Pain will radiate down my arms and legs; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 35-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 13:30 PM as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient received first dose of BNT162B2 on 23Jan2021 01:30 PM in Left arm (lot number=SMCHD). Medical history included asthma from an unknown date and unknown if ongoing Other medical history: Asthma, rubber sensitivity from an unknown date and unknown if ongoing Known allergies: Latex. The patient's concomitant medications were not reported. The patient experienced started with fever, body aches, now severe back pain, stiffness, makes walking and working very difficult, nerve pain stemming from lymph node areas, pain will radiate down my arms and legs on 11Feb2021 09:00. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Pain, Pyrexia
Clinical narrative: Started with fever; body aches; Now severe back pain; stiffness; Makes walking and working very difficult; Nerve pain stemming from lymph node areas (under arms and groin area); Nerve pain stemming from lymph node areas (under arms and groin area); Pain will radiate down my arms and legs; Pain will radiate down my arms and legs; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 35-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 13:30 PM as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient received first dose of BNT162B2 on 23Jan2021 01:30 PM in Left arm (lot number=SMCHD). Medical history included asthma from an unknown date and unknown if ongoing Other medical history: Asthma, rubber sensitivity from an unknown date and unknown if ongoing Known allergies: Latex. The patient's concomitant medications were not reported. The patient experienced started with fever, body aches, now severe back pain, stiffness, makes walking and working very difficult, nerve pain stemming from lymph node areas, pain will radiate down my arms and legs on 11Feb2021 09:00. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Gait disturbance, Lymph node pain, Musculoskeletal stiffness, Neuralgia
Clinical narrative: Started with fever; body aches; Now severe back pain; stiffness; Makes walking and working very difficult; Nerve pain stemming from lymph node areas (under arms and groin area); Nerve pain stemming from lymph node areas (under arms and groin area); Pain will radiate down my arms and legs; Pain will radiate down my arms and legs; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 35-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 13:30 PM as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient received first dose of BNT162B2 on 23Jan2021 01:30 PM in Left arm (lot number=SMCHD). Medical history included asthma from an unknown date and unknown if ongoing Other medical history: Asthma, rubber sensitivity from an unknown date and unknown if ongoing Known allergies: Latex. The patient's concomitant medications were not reported. The patient experienced started with fever, body aches, now severe back pain, stiffness, makes walking and working very difficult, nerve pain stemming from lymph node areas, pain will radiate down my arms and legs on 11Feb2021 09:00. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Started with fever; body aches; Now severe back pain; stiffness; Makes walking and working very difficult; Nerve pain stemming from lymph node areas (under arms and groin area); Nerve pain stemming from lymph node areas (under arms and groin area); Pain will radiate down my arms and legs; Pain will radiate down my arms and legs; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 35-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 13:30 PM as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient received first dose of BNT162B2 on 23Jan2021 01:30 PM in Left arm (lot number=SMCHD). Medical history included asthma from an unknown date and unknown if ongoing Other medical history: Asthma, rubber sensitivity from an unknown date and unknown if ongoing Known allergies: Latex. The patient's concomitant medications were not reported. The patient experienced started with fever, body aches, now severe back pain, stiffness, makes walking and working very difficult, nerve pain stemming from lymph node areas, pain will radiate down my arms and legs on 11Feb2021 09:00. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Throat irritation
Clinical narrative: post 10m-strange warm feeling in arm that stopped a few minutes later; palms and right side of throat began to itch; rash on chest and hands/rash worse; but like heartburn 60m; itching increased (palm, soles of feet and back of knees worst; general body itching); couldn't sleep; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH, COVID-19 Vaccine, Formulation: solution for injection; Lot Number: EN6201 and Expiration date were not provided), via an unspecified route of administration, administered in Arm Left on 21Feb2021 16:30 as 1ST DOSE, SINGLE for covid-19 immunization. Facility type vaccine: Other. If other vaccine in four weeks: no. Medical history included asthma, atypical trigeminal neuralgia, overweight, small fibroids. Sulfa allergy, Iodine IV contrast allergy. Concomitant medications cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient previously took moxifloxacin hydrochloride (AVALOX), Gadolinium, gabapentin and experienced drug allergy. On 21Feb2021 16:30 the patient experienced post 10m-strange warm feeling in arm that stopped a few minutes later, palms and right side of throat began to itch, rash on chest and hands/rash worse, but like heartburn 60m, itching increased but not intense/ itching continued (soles of feet and back of knees worst; general body itching, couldn't sleep. Therapeutic measures were taken as a result of post 1the patient experienced post 10m-strange warm feeling in arm that stopped a few minutes later, palms and right side of throat began to itch, rash on chest and hands/rash worse, but like heartburn 60m, itching increased but not intense/ itching continued (soles of feet and back of knees worst; general body itching, couldn't sleep. Resulted in: Doctor or other healthcare professional office/clinic visit. Treatment received by the patient were Benadryl, Claritin, and Pepcid. If covid prior vaccination: No. If covid tested post vaccination: No. The outcome of event was recovering.   Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspepsia, Insomnia, Pruritus, Rash, Throat irritation
Clinical narrative: post 10m-strange warm feeling in arm that stopped a few minutes later; palms and right side of throat began to itch; rash on chest and hands/rash worse; but like heartburn 60m; itching increased (palm, soles of feet and back of knees worst; general body itching); couldn't sleep; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH, COVID-19 Vaccine, Formulation: solution for injection; Lot Number: EN6201 and Expiration date were not provided), via an unspecified route of administration, administered in Arm Left on 21Feb2021 16:30 as 1ST DOSE, SINGLE for covid-19 immunization. Facility type vaccine: Other. If other vaccine in four weeks: no. Medical history included asthma, atypical trigeminal neuralgia, overweight, small fibroids. Sulfa allergy, Iodine IV contrast allergy. Concomitant medications cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient previously took moxifloxacin hydrochloride (AVALOX), Gadolinium, gabapentin and experienced drug allergy. On 21Feb2021 16:30 the patient experienced post 10m-strange warm feeling in arm that stopped a few minutes later, palms and right side of throat began to itch, rash on chest and hands/rash worse, but like heartburn 60m, itching increased but not intense/ itching continued (soles of feet and back of knees worst; general body itching, couldn't sleep. Therapeutic measures were taken as a result of post 1the patient experienced post 10m-strange warm feeling in arm that stopped a few minutes later, palms and right side of throat began to itch, rash on chest and hands/rash worse, but like heartburn 60m, itching increased but not intense/ itching continued (soles of feet and back of knees worst; general body itching, couldn't sleep. Resulted in: Doctor or other healthcare professional office/clinic visit. Treatment received by the patient were Benadryl, Claritin, and Pepcid. If covid prior vaccination: No. If covid tested post vaccination: No. The outcome of event was recovering.   Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site warmth
Clinical narrative: post 10m-strange warm feeling in arm that stopped a few minutes later; palms and right side of throat began to itch; rash on chest and hands/rash worse; but like heartburn 60m; itching increased (palm, soles of feet and back of knees worst; general body itching); couldn't sleep; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH, COVID-19 Vaccine, Formulation: solution for injection; Lot Number: EN6201 and Expiration date were not provided), via an unspecified route of administration, administered in Arm Left on 21Feb2021 16:30 as 1ST DOSE, SINGLE for covid-19 immunization. Facility type vaccine: Other. If other vaccine in four weeks: no. Medical history included asthma, atypical trigeminal neuralgia, overweight, small fibroids. Sulfa allergy, Iodine IV contrast allergy. Concomitant medications cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient previously took moxifloxacin hydrochloride (AVALOX), Gadolinium, gabapentin and experienced drug allergy. On 21Feb2021 16:30 the patient experienced post 10m-strange warm feeling in arm that stopped a few minutes later, palms and right side of throat began to itch, rash on chest and hands/rash worse, but like heartburn 60m, itching increased but not intense/ itching continued (soles of feet and back of knees worst; general body itching, couldn't sleep. Therapeutic measures were taken as a result of post 1the patient experienced post 10m-strange warm feeling in arm that stopped a few minutes later, palms and right side of throat began to itch, rash on chest and hands/rash worse, but like heartburn 60m, itching increased but not intense/ itching continued (soles of feet and back of knees worst; general body itching, couldn't sleep. Resulted in: Doctor or other healthcare professional office/clinic visit. Treatment received by the patient were Benadryl, Claritin, and Pepcid. If covid prior vaccination: No. If covid tested post vaccination: No. The outcome of event was recovering.   Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test normal, Decreased appetite, Fatigue, Gait inability
Clinical narrative: syncope; Acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural hematoma up to 7 mm thick; hemorrhagic contusion with edema; hemorrhagic contusion with edema; fatigue; malaise; HA; This is a spontaneous report from a contactable physician. A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 21Feb2021 (Lot Number: EN6200) (at the age of 78-year-old) as single dose for COVID-19 immunisation.  Medical history included hypertension (HTN), hyperlipidemia (HDL) and hypothyroidism, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The patient previously took SSRI, PNC (unknown), sulfa and oxycodone; the patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 31Jan2021 (Batch/Lot Number: EL9265) as single dose for COVID-19 immunisation.  Within 12 hours of vaccine (on 22Feb2021) the patient developed symptoms of fatigue, malaise, headache (HA) and severe and near syncope.  She visited the emergency department (ED) the following day.  Work up at that time including blood work and no imaging.  She was treated with IVFs and discharged.  Symptoms of malaise, fatigue and HA persisted for > 1 week.  A computerized tomogram (CT) of the head was performed on 05Mar2021, this CT showed the following: acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural hematoma up to 7 mm thick; 2X3 left front hemorrhagic contusion with edema. The events required emergency room visit and physician office visit.  Therapeutic measures were taken as a result of the events and includes conservative measures (as reported). The patient outcome of the event was recovered with sequel.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded.  The case will be reassessed if additional information becomes 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: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Somnolence
Clinical narrative: syncope; Acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural hematoma up to 7 mm thick; hemorrhagic contusion with edema; hemorrhagic contusion with edema; fatigue; malaise; HA; This is a spontaneous report from a contactable physician. A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 21Feb2021 (Lot Number: EN6200) (at the age of 78-year-old) as single dose for COVID-19 immunisation.  Medical history included hypertension (HTN), hyperlipidemia (HDL) and hypothyroidism, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The patient previously took SSRI, PNC (unknown), sulfa and oxycodone; the patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 31Jan2021 (Batch/Lot Number: EL9265) as single dose for COVID-19 immunisation.  Within 12 hours of vaccine (on 22Feb2021) the patient developed symptoms of fatigue, malaise, headache (HA) and severe and near syncope.  She visited the emergency department (ED) the following day.  Work up at that time including blood work and no imaging.  She was treated with IVFs and discharged.  Symptoms of malaise, fatigue and HA persisted for > 1 week.  A computerized tomogram (CT) of the head was performed on 05Mar2021, this CT showed the following: acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural hematoma up to 7 mm thick; 2X3 left front hemorrhagic contusion with edema. The events required emergency room visit and physician office visit.  Therapeutic measures were taken as a result of the events and includes conservative measures (as reported). The patient outcome of the event was recovered with sequel.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded.  The case will be reassessed if additional information becomes 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: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Contusion, Fatigue, Haematoma
Clinical narrative: syncope; Acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural hematoma up to 7 mm thick; hemorrhagic contusion with edema; hemorrhagic contusion with edema; fatigue; malaise; HA; This is a spontaneous report from a contactable physician. A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 21Feb2021 (Lot Number: EN6200) (at the age of 78-year-old) as single dose for COVID-19 immunisation.  Medical history included hypertension (HTN), hyperlipidemia (HDL) and hypothyroidism, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The patient previously took SSRI, PNC (unknown), sulfa and oxycodone; the patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 31Jan2021 (Batch/Lot Number: EL9265) as single dose for COVID-19 immunisation.  Within 12 hours of vaccine (on 22Feb2021) the patient developed symptoms of fatigue, malaise, headache (HA) and severe and near syncope.  She visited the emergency department (ED) the following day.  Work up at that time including blood work and no imaging.  She was treated with IVFs and discharged.  Symptoms of malaise, fatigue and HA persisted for > 1 week.  A computerized tomogram (CT) of the head was performed on 05Mar2021, this CT showed the following: acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural hematoma up to 7 mm thick; 2X3 left front hemorrhagic contusion with edema. The events required emergency room visit and physician office visit.  Therapeutic measures were taken as a result of the events and includes conservative measures (as reported). The patient outcome of the event was recovered with sequel.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded.  The case will be reassessed if additional information becomes 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: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Malaise, Oedema, Subarachnoid haemorrhage, Syncope
Clinical narrative: syncope; Acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural hematoma up to 7 mm thick; hemorrhagic contusion with edema; hemorrhagic contusion with edema; fatigue; malaise; HA; This is a spontaneous report from a contactable physician. A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 21Feb2021 (Lot Number: EN6200) (at the age of 78-year-old) as single dose for COVID-19 immunisation.  Medical history included hypertension (HTN), hyperlipidemia (HDL) and hypothyroidism, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The patient previously took SSRI, PNC (unknown), sulfa and oxycodone; the patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 31Jan2021 (Batch/Lot Number: EL9265) as single dose for COVID-19 immunisation.  Within 12 hours of vaccine (on 22Feb2021) the patient developed symptoms of fatigue, malaise, headache (HA) and severe and near syncope.  She visited the emergency department (ED) the following day.  Work up at that time including blood work and no imaging.  She was treated with IVFs and discharged.  Symptoms of malaise, fatigue and HA persisted for > 1 week.  A computerized tomogram (CT) of the head was performed on 05Mar2021, this CT showed the following: acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural hematoma up to 7 mm thick; 2X3 left front hemorrhagic contusion with edema. The events required emergency room visit and physician office visit.  Therapeutic measures were taken as a result of the events and includes conservative measures (as reported). The patient outcome of the event was recovered with sequel.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded.  The case will be reassessed if additional information becomes 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.