chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Incoherent, Loss of personal independence in daily activities, Lyme disease, Magnetic resonance imaging head
Clinical narrative: Migraines/insane migraines; felt fainting; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 24Sep2021 16:00 (Lot number was not reported) as single dose (at age of 40-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. On unknown date in Sep2021 patient experienced fainting and on 24Sep2021 she experienced migraines/insane migraines. Patient stated that she received second dose of Pfizer covid vaccine on 24Sep2021 and began having Migraines, they come in waves and are getting worse. Patient asked if this side effect had been reported and how long to expect it to last. Patient reported she was normally healthy no issues. Patient stated that she had called her family doctor and where she got the second shot, she got this past Friday around 4pm, 24Sep2021. Since getting the second shot she has been getting insane migraines, and she had never even had a headache before. They are debilitation and she felt like they were progressively getting worse. The day of the report was the 4th or 5th day she had been dealing with this. The day of the report she felt fainting and almost fell. She wanted to know if this going end and how long will it last. Patient had not recovered from migraine, while outcome of the other mentioned event was unknown.  The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation irregular, Metabolic function test, Serum ferritin, Sleep disorder, Thyroxine
Clinical narrative: Migraines/insane migraines; felt fainting; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 24Sep2021 16:00 (Lot number was not reported) as single dose (at age of 40-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. On unknown date in Sep2021 patient experienced fainting and on 24Sep2021 she experienced migraines/insane migraines. Patient stated that she received second dose of Pfizer covid vaccine on 24Sep2021 and began having Migraines, they come in waves and are getting worse. Patient asked if this side effect had been reported and how long to expect it to last. Patient reported she was normally healthy no issues. Patient stated that she had called her family doctor and where she got the second shot, she got this past Friday around 4pm, 24Sep2021. Since getting the second shot she has been getting insane migraines, and she had never even had a headache before. They are debilitation and she felt like they were progressively getting worse. The day of the report was the 4th or 5th day she had been dealing with this. The day of the report she felt fainting and almost fell. She wanted to know if this going end and how long will it last. Patient had not recovered from migraine, while outcome of the other mentioned event was unknown.  The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo, Vitamin B12
Clinical narrative: Migraines/insane migraines; felt fainting; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 24Sep2021 16:00 (Lot number was not reported) as single dose (at age of 40-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. On unknown date in Sep2021 patient experienced fainting and on 24Sep2021 she experienced migraines/insane migraines. Patient stated that she received second dose of Pfizer covid vaccine on 24Sep2021 and began having Migraines, they come in waves and are getting worse. Patient asked if this side effect had been reported and how long to expect it to last. Patient reported she was normally healthy no issues. Patient stated that she had called her family doctor and where she got the second shot, she got this past Friday around 4pm, 24Sep2021. Since getting the second shot she has been getting insane migraines, and she had never even had a headache before. They are debilitation and she felt like they were progressively getting worse. The day of the report was the 4th or 5th day she had been dealing with this. The day of the report she felt fainting and almost fell. She wanted to know if this going end and how long will it last. Patient had not recovered from migraine, while outcome of the other mentioned event was unknown.  The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back disorder, Gait disturbance, Inappropriate schedule of product administration, Inflammation
Clinical narrative: having really bad problems with her back; trouble walking; 1st dose 19Jan2021, 2nd dose 05Feb2021; inflammatory response; lymphedema in her left arm; fluid in her left shoulder; severe joint pain; Diagnosed with spinal stenosis; This is a spontaneous report from a contactable consumer (patient)   A 76-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 (Batch/Lot Number: EN9581) as DOSE 2, SINGLE, and dose 1 via an unspecified route of administration, administered in Arm Left on 19Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  Age at vaccination for both doses was 76 years old. Medical history included breast cancer from 2008 to an unknown date.  The patient's concomitant medications were not reported.  The patient experienced inappropriate schedule of product administration on an unspecified date with outcome of unknown, inflammatory response on Feb2021 with outcome of unknown, lymphedema in her left arm on Feb2021 with outcome of not recovered, fluid in her left shoulder on Feb2021 with outcome of not recovered, severe joint pain on Feb2021 with outcome of not recovered, having really bad problems with her back on an unspecified date with outcome of unknown, trouble walking on an unspecified date with outcome of unknown, diagnosed with spinal stenosis  on 2021 with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on Sep2021. Details were reported as follows: She had an inflammatory response.  She states she developed lymphedema in her left arm; fluid and pain in her left shoulder.  States she was having really bad problems with her back and went to the spine institute and they said she had spinal stenosis.  States that the spinal stenosis wasn't caused by the Covid Vaccine; was something she probably already had, the vaccine just brought it to the forefront. Says she didn't think she would want to take the third dose of the vaccine because the second one caused her 6 months of agony.  States she went to her doctor and had her antibodies drawn about 2 weeks ago and they were negative.  States her Covid shot must've worn off. States that the inflammatory reaction began in the first part of February.  Says she has mostly recovered from the lymphedema and fluid but she can actually touch that arm and still feel where the shot was given and it is still sore. It is a narrowing of her spinal cord and they don't want to operate and risk her becoming paralyzed.  They can give her steroid shots three times a year to help with the pain.  She had one of those shots this year, but she doesn't want to get them on a regular basis if she can help it. The events required a physician office visit.; Sender's Comments: Based on the available information and the reported event spinal stenosis most possibly related to age and not related to suspect product BNT162B2.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Joint effusion, Lymphoedema, SARS-CoV-2 antibody test, Spinal stenosis
Clinical narrative: having really bad problems with her back; trouble walking; 1st dose 19Jan2021, 2nd dose 05Feb2021; inflammatory response; lymphedema in her left arm; fluid in her left shoulder; severe joint pain; Diagnosed with spinal stenosis; This is a spontaneous report from a contactable consumer (patient)   A 76-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 (Batch/Lot Number: EN9581) as DOSE 2, SINGLE, and dose 1 via an unspecified route of administration, administered in Arm Left on 19Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  Age at vaccination for both doses was 76 years old. Medical history included breast cancer from 2008 to an unknown date.  The patient's concomitant medications were not reported.  The patient experienced inappropriate schedule of product administration on an unspecified date with outcome of unknown, inflammatory response on Feb2021 with outcome of unknown, lymphedema in her left arm on Feb2021 with outcome of not recovered, fluid in her left shoulder on Feb2021 with outcome of not recovered, severe joint pain on Feb2021 with outcome of not recovered, having really bad problems with her back on an unspecified date with outcome of unknown, trouble walking on an unspecified date with outcome of unknown, diagnosed with spinal stenosis  on 2021 with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on Sep2021. Details were reported as follows: She had an inflammatory response.  She states she developed lymphedema in her left arm; fluid and pain in her left shoulder.  States she was having really bad problems with her back and went to the spine institute and they said she had spinal stenosis.  States that the spinal stenosis wasn't caused by the Covid Vaccine; was something she probably already had, the vaccine just brought it to the forefront. Says she didn't think she would want to take the third dose of the vaccine because the second one caused her 6 months of agony.  States she went to her doctor and had her antibodies drawn about 2 weeks ago and they were negative.  States her Covid shot must've worn off. States that the inflammatory reaction began in the first part of February.  Says she has mostly recovered from the lymphedema and fluid but she can actually touch that arm and still feel where the shot was given and it is still sore. It is a narrowing of her spinal cord and they don't want to operate and risk her becoming paralyzed.  They can give her steroid shots three times a year to help with the pain.  She had one of those shots this year, but she doesn't want to get them on a regular basis if she can help it. The events required a physician office visit.; Sender's Comments: Based on the available information and the reported event spinal stenosis most possibly related to age and not related to suspect product BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: developed COVID-19 infection, two days after vaccination; This is a spontaneous report from a Pfizer-sponsored program received from a contactable pharmacist. A 91-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on Aug2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed COVID-19 infection two days after vaccination in Aug2021. The pharmacist reported that the patient received the first dose of the vaccine then afterwards, in the earlier part of August, he developed COVID-19 infection. The pharmacist wanted to know if the patient should proceed with the second dose, and what was the waiting period in between both doses. Outcome of the event was unknown.    The lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID19 on 05Sep2021 or 06Sep2021; tested positive for COVID19 on 05Sep 2021 or 06Sep2021; This is a spontaneous report from a program from a contactable consumer (patient). A 39-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on Mar2021 (Lot number was not reported) as single dose (at age of 39-year-old), and first dose was administered via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose, both for covid-19 immunisation. Medical history included ongoing obesity. Concomitant medications were not reported. In Sep2021 (reported as on 05Sep2021 or 06Sep2021) the patient was tested positive for covid19. The patient underwent laboratory tests and procedures which included sars-cov-2 test positive in Sep2021 (reported as on 05Sep2021 or 06Sep2021). It was reported that patient already received both doses of the Pfizer BioNTech COVID19 vaccine and the second dose was around late Mar2021. Patient tested positive for COVID19 on 05Sep2021 or 06Sep2021 and has fully recovered. It was reported that six months before the time of the report, patient had his second dose of the Pfizer Covid Vaccine. It has been 3 weeks since he got the Covid Virus. Reporter stated she was wanting to know when patient could take the booster vaccine. Patient tested positive around the 05Sep2021 or 06Sep2021 and he has fully recovered. No treatment was received for the event. Patient recovered on unknown date.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Headache, Malaise
Clinical narrative: Feeling kind of ill; Arm was really sore; Sluggish; Body aches; Fever (low grade, then 103 and 104 F); Nausea; Vomiting; Diarrhea; Hurting chills; Headache; Muscle aches; This is a spontaneous report from a contactable consumer (patient).  A 41-year-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration, on 21Aug2021 (lot number: FC3184; Expiry Date: 31Oct2021), at the age of 41 years old, as 1st single dose, for COVID-19 immunisation. The patient's medical history was not provided. Concomitant drugs included XANAX and AMBIEN. There was no prior vaccination within 4 weeks of getting the Pfizer vaccine. The patient woke up on the following morning, on 22Aug2021, and started feeling kind of ill, her arm was really sore, she was just sluggish, with low grade fever, body aches, and as the days progressed the symptoms kept getting worse, she had nausea, vomiting, diarrhea, hurting chills, body aches, muscle aches, headache, and for 2 or 3 days she started running fever like a 103 F to 104 F and then fever 100-101F. According to the patient, no treatment was needed for the events. The outcome of the events was not specified.   Follow-up attempts are completed. No further information is expected. Linked Report(s): US-PFIZER INC-202101286731 similar report from same reporter.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Feeling kind of ill; Arm was really sore; Sluggish; Body aches; Fever (low grade, then 103 and 104 F); Nausea; Vomiting; Diarrhea; Hurting chills; Headache; Muscle aches; This is a spontaneous report from a contactable consumer (patient).  A 41-year-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration, on 21Aug2021 (lot number: FC3184; Expiry Date: 31Oct2021), at the age of 41 years old, as 1st single dose, for COVID-19 immunisation. The patient's medical history was not provided. Concomitant drugs included XANAX and AMBIEN. There was no prior vaccination within 4 weeks of getting the Pfizer vaccine. The patient woke up on the following morning, on 22Aug2021, and started feeling kind of ill, her arm was really sore, she was just sluggish, with low grade fever, body aches, and as the days progressed the symptoms kept getting worse, she had nausea, vomiting, diarrhea, hurting chills, body aches, muscle aches, headache, and for 2 or 3 days she started running fever like a 103 F to 104 F and then fever 100-101F. According to the patient, no treatment was needed for the events. The outcome of the events was not specified.   Follow-up attempts are completed. No further information is expected. Linked Report(s): US-PFIZER INC-202101286731 similar report from same reporter.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Vomiting
Clinical narrative: Feeling kind of ill; Arm was really sore; Sluggish; Body aches; Fever (low grade, then 103 and 104 F); Nausea; Vomiting; Diarrhea; Hurting chills; Headache; Muscle aches; This is a spontaneous report from a contactable consumer (patient).  A 41-year-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration, on 21Aug2021 (lot number: FC3184; Expiry Date: 31Oct2021), at the age of 41 years old, as 1st single dose, for COVID-19 immunisation. The patient's medical history was not provided. Concomitant drugs included XANAX and AMBIEN. There was no prior vaccination within 4 weeks of getting the Pfizer vaccine. The patient woke up on the following morning, on 22Aug2021, and started feeling kind of ill, her arm was really sore, she was just sluggish, with low grade fever, body aches, and as the days progressed the symptoms kept getting worse, she had nausea, vomiting, diarrhea, hurting chills, body aches, muscle aches, headache, and for 2 or 3 days she started running fever like a 103 F to 104 F and then fever 100-101F. According to the patient, no treatment was needed for the events. The outcome of the events was not specified.   Follow-up attempts are completed. No further information is expected. Linked Report(s): US-PFIZER INC-202101286731 similar report from same reporter.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: I got Covid from someone who got vaccinated; I got Covid from someone who got vaccinated; This is a spontaneous report from a non contactable consumer. An unspecified age and gender patient received an unknown dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient stated: "I was watching a video from (name)today. They were questioning 2 college athletes who said they don't want to take the jab. They preferred their own immunity versus taking the vaccine. They don't want any side effects from the vaccine. Indian doctors took ivermectin and they did not get sick.  So they did not pull out your Pfizer vaccine but instead pulled out ivermectin. I don't trust your medicine. My system is strong enough to beat it by itself. You did not get it the way you said you got it.  You did not make it. Moderna gave you their concoction and you just backed it off to 30 mcg. It should not exist because it is damaging to aquatic life. It is highly poisonous and dangerous. People take it and they pee it out and it kills fish and they die. You have put down hydrochloroquine, zinc, you won't give nobody vitamin D or C, you stick them in a room for 7 days in a hospital when they are feeling bad. Why would you want to kill somebody. Think about that. I got Covid from someone who got vaccinated (caller did not provide name of vaccination or manufacturer). I recovered in 4 days". The outcome of event s was recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Erythema, Pruritus, Thermal burn
Clinical narrative: skin inflammation; redness when exposed to direct or indirect sunlight even with spf 85; Skin burns; itches on face and neck; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8733) via an unspecified route of administration in Arm Left on 28Mar2021 at 14:45 (at 64 years) as single dose for covid-19 immunisation. Medical history included hypothyroid. No known allergies. Covid prior vaccination and no covid tested post vaccination. Concomitant medications included clopidogrel bisulfate (PLAVIX) and bupropion hydrochloride (WELLBUTRIN) both taken for an unspecified indication and hypothyroid medications (unspecified).  Previously on 07Mar2021 at 15:30 (at 64 years) the patient took the first dose of the vaccine (lot EN6206) in Left arm for covid-19 immunisation. On 22May2021 patient experienced skin inflammation, redness, skin burns and itches on face and neck. Clinical course was reported as follows: on 22May2021 extreme reaction to mosquito bites, skin inflammation and redness when exposed to direct or indirect sunlight even with spf 85. Looked like 2nd degree burns. Skin burns and itches on face and neck whenever outside. Events resulted in doctor or other healthcare professional office/clinic visit and were serious due to disability or permanent damage.Steroid cream was given as treatment. The final outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Pain, Uterine cyst, Uterine inflammation
Clinical narrative: they removed two cysts; an severe inflammation to the Uterus; pain; This is a spontaneous report from a contactable consumer who reported for the wife who was enrolled in a Pfizer-sponsored program; this report regards an event under BNT162B2.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 23Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient took the vaccine on 23Aug2021 and 3 days later (Aug2021) she ended up in the Emergency Room with a severe inflammation to the uterus, pain and they removed two cysts. 30 days has gone by and she had this problem once again, and the Emergency Room can't find anything wrong. This was a reaction to the vaccine shot. The final outcome of the events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: PE; This is a spontaneous report from a contactable other health care professional (HCP). A 39-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included deep vein thrombosis (DVT), pulmonary embolism (PE). Patient had not covid prior vaccination. It was reported that patient received concomitant medications within two weeks of vaccination, no details reported. It was unknown if patient received any other vaccines within four weeks prior to the COVID-19 vaccine. On 28Sep2021 patient experienced pulmonary embolism (PE). Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. It was unknown if patient was treated for the event. It was unknown if patient was covid tested post vaccination. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely 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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hypomenorrhoea, Menstruation delayed, Menstruation irregular
Clinical narrative: irregular/menstrual cycle has been unbalanced, It has been on and off/ when it did come, it was not a normal cycle; my menstrual cycle was about to start and it was three weeks delayed/ cycle was started on the 10Sep2021; it was like a heavy cycle with heavy blood clots; normally my cycles are heavy but they were light; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0217), via an unspecified route of administration, administered in Arm Right on 24Aug2021 at the age of 45-year-old as dose 1, single for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medications included amlodipine and losartan. The patient experiencing irregular and menstrual cycle has been unbalanced. It has been on and off. Patient got the vaccine on 24Aug2021, the same day when menstrual cycle was about to start and it was three weeks delayed. The cycle was started on the 10Sep2021 and it was not a normal cycle. Normally her cycles are heavy, but they were light. On 27Sep2021 it was like a heavy cycle with heavy blood clots. So, it is like starting like the first day of her menstrual. On same day patient talked to the doctor who advised should monitor it for 7 days and if still is happening then patient need to consult again or if she is using more than like a pad or the tampons fill with up the blood within an hour, then patient advised to go to the urgent care of the hospital. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Ear discomfort, Oropharyngeal pain, Pruritus, Throat irritation
Clinical narrative: I have been itchy like hives; I have been itchy like hives; ears started itching and ringing; Anaphylactic reaction; ears started itching and ringing; my ears are burning; my throat was irritated/sore throat; Sore throat; This is a spontaneous report from a contactable nurse. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FF2587), via an unspecified route of administration, in right deltoid on 27Sep2021 17:30 (at the age of 58-years-old) as dose 1, single for COVID-19 immunization. Medical history was reported as none. Concomitant medication included moxifloxacin hydrochloride (AVELOX). The patient experienced anaphylactic reaction, ears started itching and ringing, ears are burning, my throat was irritated /sore throat, itchy like hives, ears started itching and ringing on 27Sep2021 18:00, i have been itchy like hives on an unspecified date. The patient was hospitalized for the events. Therapeutic measures were taken as a result of the events included Benadryl, Medrol pack and prednisolone. The outcome of the events was unknown.; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of events anaphylactic reaction, tinnitus, ear discomfort, throat irritation, oropharyngeal pain, urticaria and pruritus cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Urticaria
Clinical narrative: I have been itchy like hives; I have been itchy like hives; ears started itching and ringing; Anaphylactic reaction; ears started itching and ringing; my ears are burning; my throat was irritated/sore throat; Sore throat; This is a spontaneous report from a contactable nurse. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FF2587), via an unspecified route of administration, in right deltoid on 27Sep2021 17:30 (at the age of 58-years-old) as dose 1, single for COVID-19 immunization. Medical history was reported as none. Concomitant medication included moxifloxacin hydrochloride (AVELOX). The patient experienced anaphylactic reaction, ears started itching and ringing, ears are burning, my throat was irritated /sore throat, itchy like hives, ears started itching and ringing on 27Sep2021 18:00, i have been itchy like hives on an unspecified date. The patient was hospitalized for the events. Therapeutic measures were taken as a result of the events included Benadryl, Medrol pack and prednisolone. The outcome of the events was unknown.; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of events anaphylactic reaction, tinnitus, ear discomfort, throat irritation, oropharyngeal pain, urticaria and pruritus cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Eye pain, Eye swelling, Lacrimation increased, Ocular hyperaemia
Clinical narrative: her right eyeball is bloody; her right eyeball is bloody, red, swollen and painful; her right eyeball is bloody, red, swollen and painful; her right eyeball is bloody, red, swollen and painful; eye watering; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 27Sep2021 10:00 (Lot Number: FF2587) as DOSE 1, SINGLE for COVID-19 immunization at the age of 72 years old. Medical history included breast cancer and lymph nodes were removed from an unknown date. There were no concomitant medications. The patient experienced right eyeball is bloody, red, swollen and painful, eye watering, and swollen still on 28Sep2021 07:30. The patient feels hesitant to get the second injection, as she doesn't want this to happen again. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: I have a stroke in July; This is a spontaneous report from a contactable consumer (patient). A 78-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration at the age of 78-year-old on 25Mar2021 (Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history included High blood pressure (on High blood pressure medicine), blood disorder (on blood thinners), immunisation. Concomitant medications included influenza vaccine taken for immunisation, start and stop date were not reported; acetylsalicylic acid (ASPIRIN) taken for an unspecified indication, start and stop date were not reported; on blood thinners medication (unspcified), on High blood pressure medicine (unspcified). The patient previously took first dose bnt162b2 (The LOT# for first is EL9266) at the age of 78-year-old on 26Feb2021 for COVID-19 immunisation and experienced arm is sore. The patient experienced 'I have a stroke in july' in Jul2021. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Heavy menstrual bleeding, Oligomenorrhoea, Weight
Clinical narrative: when menstrual cycle came on 10Sep2021, it was like a light period and then today it was like a normal period, heavy cycle with heavy blood clots; when menstrual cycle came on 10Sep2021, it was like a light period and then today it was like a normal period, heavy cycle with heavy blood clots; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FD0809), via an unspecified route of administration in right arm on 14Sep2021 (at the age of 45-years-old) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications included amlodipine taken for high blood pressure; losartan taken for high blood pressure. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0217), via an unspecified route of administration in right arm on 24Aug2021 (at the age of 45-years-old) as dose 1, single for COVID-19 immunization and experienced menstrual cycle has been unbalanced; It has been on and off and menstruation was three weeks delayed. The patient experienced when menstrual cycle came on 10Sep2021, it was like a light period and then today it was like a normal period, heavy cycle with heavy blood clots on 27Sep2021. It was reported that patient received second dose of Vaccine on 14Sep2021 but ever since she received the first dose, her menstrual cycle has been unbalanced. It has been on and off. So, basically, she got the first vaccine on 24Aug2021, the same day when her menstrual cycle was about to start, and it was three weeks delayed. And then when it did come, it was not a normal cycle. Like normally her cycles are heavy but they were light. The cycle was started on 10Sep2021. And on the day of this report, it was like a heavy cycle with heavy blood clots. So, it was like starting like the first day of menstrual. Patient talked to the doctor on the day of this report, and today patient should monitor it for 7 days and so, she said that it sounds like it is just starting like a fresh menstrual. So, patient will wait for 7 days and if still is happening then patient need to come and re-seen and then if she is using more than like a pad or the tampons fill with up the blood within an hour. Then patient need to go to the urgent care of the hospital. Outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Oedema, SARS-CoV-2 test
Clinical narrative: His edema started to get worse; This is a spontaneous report from a contactable consumer (patient's wife). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6208), via an unspecified route of administration, administered in the left arm on 13Mar2021 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization. Medical history included diabetic, hypertension, edema, and allergy to not fresh seafood. The patient received unspecified medications in two weeks prior to the COVID-19 vaccine. The patient did not receive other vaccines within four weeks of the COVID-19 vaccine. The patient's wife reported that after the patient got his first vaccine in March his edema started to get worse. The event was considered life-threatening. On an unspecified date, the patient received the second single dose of BNT162B2 (lot number: ER8737) administered in the left arm. On 02Sep2021, the patient got his third single dose of BNT162B2 (lot number: FC3182) administered in the left arm. Therapeutic measure was not taken as result of the event. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): negative on 01Sep2021. The outcome of the event was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Biopsy, Body temperature, COVID-19
Clinical narrative: Covid symptoms again; Besides losing taste and smell for 3 months; Besides losing taste and smell for 3 months; fever of 105.2; the vaccine induced skin issues; psoriasis; This is a spontaneous report from a contactable consumer or other non-HCP.    A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0153), via an unspecified route of administration, administered in Left Arm on 15Apr2021 02:30 as DOSE 1, SINGLE for covid-19 immunization.  Medical history included thyroid disorder, hypertension, migraine, covid-19 If covid prior vaccination: Yes. On 22Apr2021 the patient experienced covid symptoms again. besides losing taste and smell for 3 months, fever of 105.2, the vaccine induced skin issues, psoriasis. The patient underwent lab tests and procedures which included biopsy: psoriasis on 22Apr2021 now she has had a spot biopsied and she now have psoriasis , body temperature: 105.2 on 22Apr2021 fever of 105.2 for 3 days. Therapeutic measures were taken as a result of covid symptoms again, besides losing taste and smell for 3 months, besides losing taste and smell for 3 months, fever of 105.2, the vaccine induced skin issues, psoriasis. The outcome of all events was recovering.    Follow-Up (01Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Pyrexia, Skin disorder
Clinical narrative: Covid symptoms again; Besides losing taste and smell for 3 months; Besides losing taste and smell for 3 months; fever of 105.2; the vaccine induced skin issues; psoriasis; This is a spontaneous report from a contactable consumer or other non-HCP.    A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0153), via an unspecified route of administration, administered in Left Arm on 15Apr2021 02:30 as DOSE 1, SINGLE for covid-19 immunization.  Medical history included thyroid disorder, hypertension, migraine, covid-19 If covid prior vaccination: Yes. On 22Apr2021 the patient experienced covid symptoms again. besides losing taste and smell for 3 months, fever of 105.2, the vaccine induced skin issues, psoriasis. The patient underwent lab tests and procedures which included biopsy: psoriasis on 22Apr2021 now she has had a spot biopsied and she now have psoriasis , body temperature: 105.2 on 22Apr2021 fever of 105.2 for 3 days. Therapeutic measures were taken as a result of covid symptoms again, besides losing taste and smell for 3 months, besides losing taste and smell for 3 months, fever of 105.2, the vaccine induced skin issues, psoriasis. The outcome of all events was recovering.    Follow-Up (01Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, Hypoaesthesia, Skin disorder
Clinical narrative: New onset diagnosed alopecia Areata within 11 days of vaccine.; 2 large bald patches on the scalp as well as overall thinning; 2 large bald patches on the scalp as well as overall thinning; Fist signs were 6-7 days out; This is a spontaneous report from a contactable consumer (Patient). A 17-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ew0150), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jul2021 at 14:00 (Age at vaccination: 17 years) as dose 1, single for covid-19 immunisation. Medical history was reported as None. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. Patient did not test covid post vaccination. Patient did not had allergies. The patient reported  fist signs were 6-7 days out (hypoaesthesia) on 27Jul2021 and reported new onset diagnosed alopecia areata within 11 days of vaccine, 2 large bald patches on the scalp as well as overall thinning 02Aug2021. Adverse events resulted Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of new onset diagnosed alopecia areata within 11 days of vaccine, 2 large bald patches on the scalp as well as overall thinning, fist signs were 6-7 days out. Steroid injectons in scalp, topical steroid was received as a result of events. Patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ew0176), dose 2 via an unspecified route of administration, administered in Arm Left on 11Aug2021 at 02:00 PM. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myocarditis, Pain
Clinical narrative: Myocarditis; headache; body aches; joint pain; Fatigue; This is a spontaneous report from a non-contactable consumer or other non hcp.     A 36-years-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 07Sep2021 09:00 (Lot Number: FC3181) as single dose (at the age of 36) for covid-19 immunisation. Medical history was none. No known allergies. There were no concomitant medications. No other vaccine in four weeks. The patient experienced myocarditis on 14Sep2021 18:15, headache on 14Sep2021 18:15, body aches on 14Sep2021 18:15, joint pain on 14Sep2021 18:15, fatigue on 14Sep2021 18:15. No treatment received. No covid prior vaccination. Unknown if covid tested post vaccination. The events outcome was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Defaecation urgency, Diarrhoea haemorrhagic, SARS-CoV-2 test
Clinical narrative: bloody diarrhea; foul-smelling stools; abdominal urgency for 1 month; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Apr2021 (Lot Number: ER6955), at the age of 55-year-old, as dose 2, single for COVID-19 immunization. The vaccine was administered at Pharmacy or Drug Store. The patient did not receive other vaccine in four weeks. Medical history included hyperthyroidism and hypercholesterolaemia and COVID-19 prior to vaccination. The patient was not pregnant. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=8731, as reported) via an unspecified route of administration on 28Mar2021, at the age of 55-year-old, at single dose for COVID-19 immunization. The patient had known allergies to methimazole: she previously took methimazole and had allergy. On 10Aug2021 the patient experienced bloody diarrhea, foul-smelling stools, abdominal urgency for 1 month. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. No treatment was administered for the events. It was reported that the patient recovered with lasting effects from the events. Abdominal urgency recovered with sequelae in Sep2021, the other events recovered with sequelae on an unspecified date. The patient was tested for Covid-19 post vaccination on 07Sep2021 and the test result was negative.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscular weakness, Myalgia, Rheumatoid arthritis
Clinical narrative: Since the Covid shot I was diagnosed with RA.; severely fatigued; headaches; muscle weakness/soreness; muscle weakness/soreness; This is a spontaneous report from a contactable consumer (patient herself).  This 44-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FC3183), via an unspecified route of administration administered in the left arm, on 17Sep2021 14:30 (at the age of 44-year-old) at single dose for COVID-19 immunisation, administered at clinic. No relevant medical history was provided. The patient did not have COVID-19 before the vaccination. Past drug history included benzylpenicillin potassium (PENICILLIN). Relevant concomitant medications included gabapentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Sep2021, the patient was diagnosed with rheumatoid arthritis (RA). From 18Sep2021, the patient was severely fatigued, she had headaches, muscle weakness/soreness, joint pain and joint swelling. The patient was not treated for the events. No COVID-19 test was done post vaccination. The patient had not recovered from the events.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: Confirmed Miscarriage; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Sep2021 07:15 (Lot Number: FP8448) at the age of 29-year-old, as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine was administered in four weeks. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=FP8448) via an unspecified route of administration, administered in Arm Left on 26Aug2021 at 08:00 AM at the age of 29-year-old at single dose for COVID-19 immunisation. The patient had confirmed miscarriage on 26Sep2021. The event resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Abortion spontaneous 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.