chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Panic attack
Clinical narrative: heart rate over 100 beats per minute; panic, anxiety attack lasting 1/2-1 hour; panic, anxiety attack lasting 1/2-1 hour; Blood pressure reading 142 over 100; Panic/Anxiety attack lasting 1/2-1 hour with elevated heart rate over 100 beats per minute, reaching 144 beats per minutes at it's worse; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient (not pregnant) received the third dose of BNT162B2 (PFIZER COVID) via an unspecified route of administration on the left arm on 20Oct2021 at 11:00 AM (Lot Number: FF2590) at the age of 77-year-old as single dose for COVID-19 immunization. Medical history included atrial fibrillation and high blood pressure. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Known allergy was none. Concomitant medications included rivaroxaban (XARELTO), nebivolol hydrochloride (BYSTOLIC), amlodipine, olmesartan medoxomil (OLMESAR) and atorvastatin. The patient previously received the second dose and the first dose of BNT162B2, the second dose on 26Feb2021 at 11:00 AM (Batch/Lot Number: EN6203), the first dose on 05Feb2021 at 11:00 AM (Batch/Lot Number: EL9265), both via an unspecified route of administration on the left arm at the age of 77-year-old as single dose for COVID-19 immunization. On 23Oct2021 at 19:30, the patient experienced panic, anxiety attack lasting 1/2-1 hour with elevated heart rate over 100 beats per minute, reaching 144 beats per minutes at it's worse, blood pressure reading 142 over 100. Hospitalization prolonged was none. Treatment was received included Clonazepam 0.5 mg & Amlodipine Besylate 2.5mg. The outcome of events was recovering.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vulvovaginal pruritus
Clinical narrative: Vaginal Itch, severe; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient (not pregnant) receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm, second dose on 26Feb2021 12:00 (at the age of 73 years old) (Lot Number: EN6205), third dose on 08Oct2021 16:15 (at the age of 74 years old) (Lot Number: FH8020), at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (Lot no: Pfizer EL9264) on 05Feb2021 12:15 (at the age of 73 years old) in left arm for covid 19 immunization. The patient experienced vaginal itch, severe on 10Mar2021 12:00. Clinical course: Vaginal itch, severe, started after receiving intials shots. She believed it was side effect from Covid shots. She can confirm it was since her booster shot was 2 weeks ago and the itch is back with a vengence. Event resulted in doctor or other healthcare professional office/clinic visit. Treatment received included: ointment, helps relieve itch, but still there. No covid prior vaccination. No covid tested post vaccination. The outcome of the event was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenitis, Narcolepsy, Neck pain
Clinical narrative: Feelings of narcolepsy for 2 days.; Inflamed and sore lymph nodes in left armpit and clavicle; Inflamed and sore lymph nodes in left armpit and clavicle; Headache in front of head, back of head and neck pain; Headache in front of head, back of head and neck pain; This is a spontaneous report from a non-contactable consumer (patient). This 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 21Oct2021 16:00 (at age of 43-year-old) (Lot Number: FE3590) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in Arm Left on 29Sep2021 (at age of 42-year-old) (Batch/Lot No: 30145BA) for covid-19 immunisation. No other vaccine in four weeks. The patient experienced inflamed and sore lymph nodes in left armpit and clavicle, headache in front of head, back of head and neck pain, feelings of narcolepsy for 2 days. Event start date was 21Oct2021. No Covid prior vaccination.  Covid tested post vaccination. Covid test type post vaccination was nasal swab on 15Oct2021 with unknown results. Event outcome was unknown.  No follow up attempts are possible; No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Feelings of narcolepsy for 2 days.; Inflamed and sore lymph nodes in left armpit and clavicle; Inflamed and sore lymph nodes in left armpit and clavicle; Headache in front of head, back of head and neck pain; Headache in front of head, back of head and neck pain; This is a spontaneous report from a non-contactable consumer (patient). This 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 21Oct2021 16:00 (at age of 43-year-old) (Lot Number: FE3590) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in Arm Left on 29Sep2021 (at age of 42-year-old) (Batch/Lot No: 30145BA) for covid-19 immunisation. No other vaccine in four weeks. The patient experienced inflamed and sore lymph nodes in left armpit and clavicle, headache in front of head, back of head and neck pain, feelings of narcolepsy for 2 days. Event start date was 21Oct2021. No Covid prior vaccination.  Covid tested post vaccination. Covid test type post vaccination was nasal swab on 15Oct2021 with unknown results. Event outcome was unknown.  No follow up attempts are possible; No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: I got the vaccine and now I have Lupus; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received the first dose of BNT162B2 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. On an unspecified date,  8 days after getting the 1st shot, symptoms began, the patient had lupus. The patient stated"I have lots of documentation. Is Pfizer helping people who get lupus from the vaccine". The outcome of events was unknown.  The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during Follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Dyspnoea, Fibrin D dimer, Fibrin D dimer increased, Hypertension
Clinical narrative: shortness of breath/ out of breath; high blood pressure; tachycardia; D-Dimer elevated at 0.68; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). An unspecified age male patient received the third dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 22Oct2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the second dose and the first dose of BNT162B2, both via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. In Oct2021, the patient experienced flu like symptoms. The patient stated "Sunday, yesterday, he was feeling more like normal". On 24Oct2021, the patient experienced shortness of breath, was out of breath, and was rushed to the emergency room. At the emergency room, he was told he had high blood pressure and tachycardia and elevated D Dimer at 0.68 (Caller stated it wasn't really high, since a normal D-Dimer is 0.5.). On 24Oct2021, the people at the ER stated that it was not a pulmonary embolism. They ran tests and they were all normal. In Oct2021, the patient performed CT angiogram because they suspected a pulmonary embolism (PE),  the result was negative for PE. The doctor stated the caller did not have a PE and the doctor could not explain the caller's situation. The report was not related to a study or programme. Caller stateed he had no clotting problems or history of clotting before the vaccine. Caller states that he works as a lab assistant. The patient was wondering if this was a possible side effect. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Investigation, Tachycardia
Clinical narrative: shortness of breath/ out of breath; high blood pressure; tachycardia; D-Dimer elevated at 0.68; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). An unspecified age male patient received the third dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 22Oct2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the second dose and the first dose of BNT162B2, both via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. In Oct2021, the patient experienced flu like symptoms. The patient stated "Sunday, yesterday, he was feeling more like normal". On 24Oct2021, the patient experienced shortness of breath, was out of breath, and was rushed to the emergency room. At the emergency room, he was told he had high blood pressure and tachycardia and elevated D Dimer at 0.68 (Caller stated it wasn't really high, since a normal D-Dimer is 0.5.). On 24Oct2021, the people at the ER stated that it was not a pulmonary embolism. They ran tests and they were all normal. In Oct2021, the patient performed CT angiogram because they suspected a pulmonary embolism (PE),  the result was negative for PE. The doctor stated the caller did not have a PE and the doctor could not explain the caller's situation. The report was not related to a study or programme. Caller stateed he had no clotting problems or history of clotting before the vaccine. Caller states that he works as a lab assistant. The patient was wondering if this was a possible side effect. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Interchange of vaccine products, Nasal congestion, Nasopharyngitis
Clinical narrative: Coughing; Congestion, stuffy nose; patient felt like she has cold/ full blown cold; Headache; Nauseous; patient initially had Johnson and Johnson COVID-19 vaccine as her initial dose for COVID-19 vaccine and on 23 OCT 2021, she got the booster dose of the Pfizer BioNTech COVID-19 vaccine; patient initially had Johnson and Johnson COVID-19 vaccine as her initial dose for COVID-19 vaccine and on 23 OCT 2021, she got the booster dose of the Pfizer BioNTech COVID-19 vaccine; Lupus; This is a spontaneous report from a contactable consumer (patient) reported for self. A 54-year-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm right on 23Oct2021 as DOSE 2 (BOOSTER), SINGLE (at the age of 54years) for covid-19 immunization. Medical history included autoimmune disease from 2021 and ongoing (autoimmune disease diagnosed 2 months ago, patient read online that she needs to get the booster to be fully vaccinated). There were no concomitant medications. Historical vaccine included Johnson COVID-19 vaccine (Initially had Johnson and Johnson COVID-19 vaccine as her initial dose for COVID-19 vaccine) for COVID-19 Immunization. The patient experienced lupus on an unknown date in Oct2021, patient initially had Johnson and Johnson COVID-19 vaccine as her initial dose for COVID-19 vaccine, she got the booster dose of the Pfizer BioNTech COVID-19 vaccine on 23Oct2021, coughing, congestion, stuffy nose, patient felt like she has cold/ full blown cold, headache, nauseous all on 24Oct2021. Patient reported that recently diagnosed with auto immune disorder which was Lupus and was also on medications, able to eat but wave of nausea which comes and goes Therapeutic measures were taken as a result of event lupus. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Systemic lupus erythematosus
Clinical narrative: Coughing; Congestion, stuffy nose; patient felt like she has cold/ full blown cold; Headache; Nauseous; patient initially had Johnson and Johnson COVID-19 vaccine as her initial dose for COVID-19 vaccine and on 23 OCT 2021, she got the booster dose of the Pfizer BioNTech COVID-19 vaccine; patient initially had Johnson and Johnson COVID-19 vaccine as her initial dose for COVID-19 vaccine and on 23 OCT 2021, she got the booster dose of the Pfizer BioNTech COVID-19 vaccine; Lupus; This is a spontaneous report from a contactable consumer (patient) reported for self. A 54-year-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm right on 23Oct2021 as DOSE 2 (BOOSTER), SINGLE (at the age of 54years) for covid-19 immunization. Medical history included autoimmune disease from 2021 and ongoing (autoimmune disease diagnosed 2 months ago, patient read online that she needs to get the booster to be fully vaccinated). There were no concomitant medications. Historical vaccine included Johnson COVID-19 vaccine (Initially had Johnson and Johnson COVID-19 vaccine as her initial dose for COVID-19 vaccine) for COVID-19 Immunization. The patient experienced lupus on an unknown date in Oct2021, patient initially had Johnson and Johnson COVID-19 vaccine as her initial dose for COVID-19 vaccine, she got the booster dose of the Pfizer BioNTech COVID-19 vaccine on 23Oct2021, coughing, congestion, stuffy nose, patient felt like she has cold/ full blown cold, headache, nauseous all on 24Oct2021. Patient reported that recently diagnosed with auto immune disorder which was Lupus and was also on medications, able to eat but wave of nausea which comes and goes Therapeutic measures were taken as a result of event lupus. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Chills, Drug ineffective, Headache
Clinical narrative: vomiting; pain in her stomach; severe headache; sweats; chills; sinuses were messed up; Booster; she had Covid; she had Covid; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received 3rd dose (booster) of BNT162B2 (COMIRNATY, Lot Number: FE3690; Expiration Date: 31May2022), via an unspecified route of administration on 22Oct2021 (at the age of 65-year-old) as single dose for COVID-19 immunization. Medical history included back and neck issues, now her neck was tight. Concomitant medications included she had a practice for her back where she got injections all the time. The injections were trying to fake the nerves in to thinking they were dead. She had this injection at 10:30AM on the same day she received booster shot. The patient previously took 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730) on 27Mar2021 (at the age of 64-year-old) for COVID-19 immunization; 2nd single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734) on 19Apr2021 (at the age of 64-year-old) for COVID-19 immunization. Caller stated she (patient) and her husband both received the Comirnaty booster dose last Friday. Caller said they experienced side effects which she guessed were normal because they were listed on the paper given to them but she still wanted to speak to someone about this because their doctor won't see her. Their doctor was saying she had Covid (in Oct2021). Caller asked if there was any information as to why they would say it was Covid. Caller mentioned she had not been tested and there was no positive test. The symptoms she experienced developed on the same day (on 22Oct2021) were vomiting, pain in her stomach, severe headache, sweats, chills, and her sinuses were messed up. Caller added she couldn't understand why she couldn't go in her doctor's clinic. It was also reported that patient and her husband had the last COVID booster shot on Friday and both were experiencing symptoms that han't gone away. She called her local physician who won't see her because they said she had COVID. Reporter stated she was calling because she wanted to let Pfizer know the symptoms. She guessed they were normal because they were on the paper, but they hadn't gotten any better. Reporter clarified her symptoms started on Friday (on 22Oct2021). It was shortly after she ate. She didn't have any in the clinic where she got it. Started with vomiting, pain in her stomach, severe headache, and sweats. Since then her sinuses were really messed up. She didn't have any problems with sinuses until she got booster shot. She had the chills. Reporter clarified that all symptoms started on 22Oct2021 and had not gone away. Reporter clarified she had not been tested for COVID since the booster. She had had multiple COVID test due to her work in the past. The outcome of the events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Immunisation, Sinus disorder, Vomiting
Clinical narrative: vomiting; pain in her stomach; severe headache; sweats; chills; sinuses were messed up; Booster; she had Covid; she had Covid; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received 3rd dose (booster) of BNT162B2 (COMIRNATY, Lot Number: FE3690; Expiration Date: 31May2022), via an unspecified route of administration on 22Oct2021 (at the age of 65-year-old) as single dose for COVID-19 immunization. Medical history included back and neck issues, now her neck was tight. Concomitant medications included she had a practice for her back where she got injections all the time. The injections were trying to fake the nerves in to thinking they were dead. She had this injection at 10:30AM on the same day she received booster shot. The patient previously took 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730) on 27Mar2021 (at the age of 64-year-old) for COVID-19 immunization; 2nd single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734) on 19Apr2021 (at the age of 64-year-old) for COVID-19 immunization. Caller stated she (patient) and her husband both received the Comirnaty booster dose last Friday. Caller said they experienced side effects which she guessed were normal because they were listed on the paper given to them but she still wanted to speak to someone about this because their doctor won't see her. Their doctor was saying she had Covid (in Oct2021). Caller asked if there was any information as to why they would say it was Covid. Caller mentioned she had not been tested and there was no positive test. The symptoms she experienced developed on the same day (on 22Oct2021) were vomiting, pain in her stomach, severe headache, sweats, chills, and her sinuses were messed up. Caller added she couldn't understand why she couldn't go in her doctor's clinic. It was also reported that patient and her husband had the last COVID booster shot on Friday and both were experiencing symptoms that han't gone away. She called her local physician who won't see her because they said she had COVID. Reporter stated she was calling because she wanted to let Pfizer know the symptoms. She guessed they were normal because they were on the paper, but they hadn't gotten any better. Reporter clarified her symptoms started on Friday (on 22Oct2021). It was shortly after she ate. She didn't have any in the clinic where she got it. Started with vomiting, pain in her stomach, severe headache, and sweats. Since then her sinuses were really messed up. She didn't have any problems with sinuses until she got booster shot. She had the chills. Reporter clarified that all symptoms started on 22Oct2021 and had not gone away. Reporter clarified she had not been tested for COVID since the booster. She had had multiple COVID test due to her work in the past. The outcome of the events was not recovered.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache, Insomnia, Pain
Clinical narrative: chest pain; No sleep whole night.; pain; Feeling severe head ache; This is a spontaneous report from a contactable consumer (patient) reported for himself.  A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 24Oct2021 12:00 (Lot Number: FF2590) (age at vaccination 30-year-old) as dose 2, single for covid-19 immunisation at Pharmacy or Drug Store. The patient had no allergies. The patient relevant medical history and concurrent conditions was reported as no. There were no concomitant medications. The patient received historical vaccine (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (age at vaccination 30-year-old) dose 1 via an unspecified route of administration, administered in arm left on 30Sep2021 at 06:00 pm (Lot Number: 301308A) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not received any other medications the patient received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies. The patient experienced chest pain, no sleep whole night, pain and feeling severe headache on 24Oct2021 at 14:00. It was reported that feeling severe headache and chest pain. No sleep whole night. Took tylenol but no use. Not slept whole night and still pain is continuing. He don't know what to do. Seriousness criteria were reported as no. The patient did not received treatment for events. Therapeutic measures were taken as a result of chest pain and feeling severe headache. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pruritus, Rash, Swelling
Clinical narrative: Swelling; Rashes/ Outbreaks all over my body; Joints are hurting; Paining; Itching; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported that patient had taken the shot and on an unspecified date, patient was having swelling, patient was having rashes, outbreaks, and stuff (further not clarified) all over body. Patient joints were hurting. Patient further reported that patient was trying to figure out what patient could do to help with the swelling, paining, and itching. The clinical outcome for the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: her arm above the elbow began to cause pain up to her shoulder, within a few days, from her left elbow to and over her shoulder was painful; her arm above the elbow began to cause pain up to her shoulder, within a few days, from her left elbow to and over her shoulder was painful; her neck was beginning to hurt; This is a spontaneous report from contactable consumer (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27Mar2021 11:00 (Lot Number: ER2613, at the age of 62-year-old) as single dose for covid-19 immunization. Medical history included interstitial lung dis, post-traumatic stress disorder (PTSD). Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); clonazepam; hydrochlorothiazide (HYDRODIURIL); paracetamol (TEMPERINE); omeprazole (PRILOSEC). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Mar2021 at 11:00 am (lot number: EN6199, at the age of 62-year-old) as single dose for covid-19 immunization. Day after second vaccine (28Mar2021) her arm above the elbow began to cause pain up to her shoulder, within a few days, from her left elbow to and over her shoulder was painful, it came and went from hurting only a little to hurting to the extent of topical cream and 2 Ibuprofen and 2 Tylenol to ease the pain. Her PM doctor hadn't addressed it, a stay at the hospital in Apr2021, they wouldn't address it either, now her neck was beginning to hurt. No treatment for "neck was beginning to hurt". The patient was not pregnant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (nasal swab) on 10Apr2021. The outcome of the events was not recovered.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Pityriasis rosea, Rash
Clinical narrative: Pityriasis rosea; Rash; This is a spontaneous report from a contactable consumer (patients mother) reported for a patient (reporter's son) that:  A 12-year-old male patient received first dose of BNT162B2 (COMIRNATY; Solution for injection; Lot number: unknown) via an unspecified route of administration on 09Jun2021 (age at the time of vaccination: 12 years) as dose 1, single for COVID-19 immunization. Medical history of the patient were not reported. Family history included history of auto-immune disorder. Concomitant medications were not reported. On an unspecified date in 2021, few days after receiving first dose of vaccination patient experienced rash, pityriasis rosea that lasted beyond the 40-day mark. Patient was directed to not give his 2nd vaccination while he was still having this auto-immune rash. Patient have a history of auto-immune disorders in family and wanted to see if it was recommended if he did have a small auto-immune response to receive the second dose. The rash lasted for almost 2 months. Reporter mentioned that they saw the doctor on 06Jul2021, 10Jul2021, and another doctor in August. They both said it was pityriasis rosea and to report to Pfizer if he should get the 2nd vaccination. Reporter (mother) highest concern was that he had an auto-immune response rash. The rash itself was not a big deal, but we have a very strong auto-immune history in our family. Reporter (mother) have 2 auto-immune diseases and just wanted to make sure they were making an informed decision." Outcome of the events were resolved on an unspecified date in 2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Deafness unilateral
Clinical narrative: Sudden total hearing loss in left ear; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received third dose of bnt162b2 via an unspecified route of administration, administered in left arm on 15Oct2021 at 15:30 (Batch/Lot number was not reported, unable to locate or read the details) at age of 49-year-old as single booster dose for covid-19 immunisation; first dose of influenza vaccine inact split 3v (AFLURIA), via an unspecified route of administration, administered in right arm on 15Oct2021 (Batch/Lot number was not reported) at age of 49-year-old as single dose for an unspecified indication. The patient previously took first dose of bnt162b2 (Batch/Lot number was unknown) via an unspecified route of administration, administered in left arm on 21Dec2020 at 16: 30 at age of 48-year-old for covid-19 immunisation, second dose of bnt162b2 (Batch/Lot number was unknown) via an unspecified route of administration, administered in left arm on 25Jan2021 at 13: 00 at age of 48-year-old for covid-19 immunisation. The patient had known allergies with Codeine. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Concomitant medication included omeprazole. The patient experienced sudden total hearing loss in left ear on 23Oct2021 at 23:30. Seriousness criteria were reported as disabling/ incapacitating. The event was resulted in Doctor or other healthcare professional office clinic visit Emergency room department or urgent care Disability or permanent damage. Treatment included high dose steroid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of event was not recovered.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Ear pain, Headache, Heart rate increased, Muscle twitching
Clinical narrative: looked like he got bells palsey; heart rate was extraordinarily high; my face just fell and I got a headache; slept for a straight 36 hours; massive ear ache; eye starting twitching; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER COVID 19) via an unspecified route of administration on the left arm on 11Feb2021 at 15:00 (Lot Number: EL3302) at the age of 68-year-old as single dose for COVID-19 immunization. Medical history included meningioma, they found a meningioma that was about 10 years old (who knew). Known allergy was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient performed COVID test (Nasal Swab) post vaccination on 18Mar2021 and result was negative. The patient didn't receive other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included hydrochlorothiazide, mecobalamin (VITAMIN B12 [MECOBALAMIN]) and women's Vitamins. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the right arm on 11Jan2021 at 10:00 AM (Batch/Lot Number: EN6201) at the age of 68-year-old as single dose for COVID-19 immunization and the patient eye started twitching of and on and got an ear ache towards the end of month for 4 days. In Feb2021, few days later, the patient eye starting twitching again for a couple of weeks. In Mar2021, toward the end of the month, the  patient got another massive ear ache. The patient was not sick. On 15Mar2021, the patient slept for a straight 36 hours. O n17Mar2021, the patient felt better and then on 18Mar2021 at 10 AM, the patient told  her sister to take he to emergency her face just fell and got a headache. In Mar2021, went to clinic nearby, PA told her to go to hospital it looked like he got bells palsey and her heart rate was extraordinarily high. Kept her in hospital for 3 days brought blood pressure down and set her up with a neurologist, cardiologist and neurosurgeon. Neurologist was at a seminar and said they talked about vaccine waking up the bells palsy virus. The events resulted in doctor or other healthcare professional office/clinic visit. The events of palsy bells and heart rate high resulted in hospitalization for 3 days. No treatment was received. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sleep disorder
Clinical narrative: looked like he got bells palsey; heart rate was extraordinarily high; my face just fell and I got a headache; slept for a straight 36 hours; massive ear ache; eye starting twitching; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER COVID 19) via an unspecified route of administration on the left arm on 11Feb2021 at 15:00 (Lot Number: EL3302) at the age of 68-year-old as single dose for COVID-19 immunization. Medical history included meningioma, they found a meningioma that was about 10 years old (who knew). Known allergy was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient performed COVID test (Nasal Swab) post vaccination on 18Mar2021 and result was negative. The patient didn't receive other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included hydrochlorothiazide, mecobalamin (VITAMIN B12 [MECOBALAMIN]) and women's Vitamins. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the right arm on 11Jan2021 at 10:00 AM (Batch/Lot Number: EN6201) at the age of 68-year-old as single dose for COVID-19 immunization and the patient eye started twitching of and on and got an ear ache towards the end of month for 4 days. In Feb2021, few days later, the patient eye starting twitching again for a couple of weeks. In Mar2021, toward the end of the month, the  patient got another massive ear ache. The patient was not sick. On 15Mar2021, the patient slept for a straight 36 hours. O n17Mar2021, the patient felt better and then on 18Mar2021 at 10 AM, the patient told  her sister to take he to emergency her face just fell and got a headache. In Mar2021, went to clinic nearby, PA told her to go to hospital it looked like he got bells palsey and her heart rate was extraordinarily high. Kept her in hospital for 3 days brought blood pressure down and set her up with a neurologist, cardiologist and neurosurgeon. Neurologist was at a seminar and said they talked about vaccine waking up the bells palsy virus. The events resulted in doctor or other healthcare professional office/clinic visit. The events of palsy bells and heart rate high resulted in hospitalization for 3 days. No treatment was received. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Headache, Hyperacusis, Hypoaesthesia
Clinical narrative: severe headache; Nausea; Body ache/whole body hurts; Fatigue; muscular/ bone pain; muscular/ bone pain; right leg was numb; Annoyed by a minimal noise even listening to people speak; This is a spontaneous report from a contactable other HCP (patient). A 45-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 01Oct2021 15:00 (Lot Number: 23183) at age of 45 years old as single dose for covid-19 immunisation. There was no medical history.   There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took bnt162b2 (lot number=30130BA) dose 1 on 10Sep2021 in Left arm at age of 45 years old for covid-19 immunisation, amoxillin and experienced drug hypersensitivity. The patient was concerned because her body/immune system was very sensitive, Anyways... she received first dose on 10Sep2021, no complications.  Second dose 01Oct2021 (Friday)vaccine was received around 3pm, two hours later she started to get a severe headache, nausea, body ache, fatigue at the same time feeling annoyed by a minimal noise even listening to people speak, as time went by she felt worst, the whole weekend was a nightmare, pain more pain, headache was worst took Tylenol didn't help. She was told the headache was going to go away within two day. Well not in her case. She was persistently experiencing headache along muscular/ bone pain, her whole body hurts. She supposed to get better as time goes by, not in her case. This weekend 22Oct2021-24Oct2021 she woke up 22Oct2021 in the middle of the night with an extreme pain in right are, also right leg was numb. The events resulted in [Disability or permanent damage]. The patient had covid test post vaccination on 15Oct2021: covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test result=negative. The outcome of events was not recovered.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug 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
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, SARS-CoV-2 test
Clinical narrative: severe headache; Nausea; Body ache/whole body hurts; Fatigue; muscular/ bone pain; muscular/ bone pain; right leg was numb; Annoyed by a minimal noise even listening to people speak; This is a spontaneous report from a contactable other HCP (patient). A 45-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 01Oct2021 15:00 (Lot Number: 23183) at age of 45 years old as single dose for covid-19 immunisation. There was no medical history.   There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took bnt162b2 (lot number=30130BA) dose 1 on 10Sep2021 in Left arm at age of 45 years old for covid-19 immunisation, amoxillin and experienced drug hypersensitivity. The patient was concerned because her body/immune system was very sensitive, Anyways... she received first dose on 10Sep2021, no complications.  Second dose 01Oct2021 (Friday)vaccine was received around 3pm, two hours later she started to get a severe headache, nausea, body ache, fatigue at the same time feeling annoyed by a minimal noise even listening to people speak, as time went by she felt worst, the whole weekend was a nightmare, pain more pain, headache was worst took Tylenol didn't help. She was told the headache was going to go away within two day. Well not in her case. She was persistently experiencing headache along muscular/ bone pain, her whole body hurts. She supposed to get better as time goes by, not in her case. This weekend 22Oct2021-24Oct2021 she woke up 22Oct2021 in the middle of the night with an extreme pain in right are, also right leg was numb. The events resulted in [Disability or permanent damage]. The patient had covid test post vaccination on 15Oct2021: covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test result=negative. The outcome of events was not recovered.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug 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
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest discomfort, Dizziness, Feeling hot
Clinical narrative: almost fainted; blood pressure elevation to 150/90; felt entire body was on fire; tremors; seeing black spots; dizziness; pressure on chest; palpitations; This is a spontaneous report from a contactable nurse (patient). A 46-year-old non-pregnant female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 23Oct2021 09:00 (at the age of 46-year-old) (Lot Number: FE3590) as single dose for covid-19 immunisation. Medical history included Hypothyroidism, known allergies: Flagyl, Benadryl, Latex, Pork and kale. Concomitant medications included levothyroxine. The patient experienced almost fainted, blood pressure elevation to 150/90, felt entire body was on fire, tremors, seeing black spots, dizziness, pressure on chest, palpitations on 23Oct2021 09:30. Blood pressure elevation to 150/90 (baseline B/P is 110/60), she felt entire body was on fire, tremors, was seeing black spots, almost fainted, dizziness, pressure on chest and palpitations. AE resulted in Doctor or other healthcare professional office/clinic visit. Unknown if treatment received. The outcome of the events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Presyncope, Tremor, Visual impairment
Clinical narrative: almost fainted; blood pressure elevation to 150/90; felt entire body was on fire; tremors; seeing black spots; dizziness; pressure on chest; palpitations; This is a spontaneous report from a contactable nurse (patient). A 46-year-old non-pregnant female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 23Oct2021 09:00 (at the age of 46-year-old) (Lot Number: FE3590) as single dose for covid-19 immunisation. Medical history included Hypothyroidism, known allergies: Flagyl, Benadryl, Latex, Pork and kale. Concomitant medications included levothyroxine. The patient experienced almost fainted, blood pressure elevation to 150/90, felt entire body was on fire, tremors, seeing black spots, dizziness, pressure on chest, palpitations on 23Oct2021 09:30. Blood pressure elevation to 150/90 (baseline B/P is 110/60), she felt entire body was on fire, tremors, was seeing black spots, almost fainted, dizziness, pressure on chest and palpitations. AE resulted in Doctor or other healthcare professional office/clinic visit. Unknown if treatment received. The outcome of the events was not recovered.
Sex: F
Vaccine: FLUX, HEP, PNC13, VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: she has severe reactions to vaccines, anaphylaxis; This is a spontaneous report from a contactable nurse (patient). A 71-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunisation; hepatitis b vaccine (manufacturer unknown) via an unspecified route of administration on an unspecified date for an unspecified indication; influenza vaccine (manufacturer unknown) via an unspecified route of administration on an unspecified date for an unspecified indication; varicella zoster vaccine (manufacturer unknown) via an unspecified route of administration on an unspecified date for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced severe reactions to vaccines, anaphylaxis on an unspecified date. The patient said she had a history of a lot of crazy allergies she was allergic to everything under the sun including the Hepatitis B vaccine after her second dose of that one she couldn't have the third one. She hadn't had the Flu shot in 20 years and also cant get the Pneumonia vaccine or Shingles vaccine anything like that she had severe reactions to them anaphylaxis. The outcome of event was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information expected.; Sender's Comments: A possible causal association between administration of PREVNAR 13 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Near death experience, Red blood cell count, Red blood cell count decreased
Clinical narrative: Red blood cell counts took a dump; he was bleeding internally; almost died after the Covid Vaccine; This is a spontaneous report from a contactable consumer (patient's daughter). An 85-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had the Covid Vaccine and his red blood cell counts took a dump afterwards. He was bleeding internally and almost died after the Covid Vaccine. Patient's cardiologist told him not to get the booster dose of the vaccine.  The patient was not the same since the vaccine, he cannot go grocery shopping anymore. He was receiving iron transfusions. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cardiac flutter, Cardiomegaly, Condition aggravated
Clinical narrative: her blood pressure going up and flutters in her chest and stuff, then had the vaccine as well and it was more intensified since the vaccine; her blood pressure going up and flutters in her chest and stuff, then had the vaccine as well and it was more intensified since the vaccine; heart was slightly enlarged; blood pressure was up; This is a spontaneous report from a contactable consumer(patient). A 57-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included covid-19 from 25Nov2020, blood pressure increased, cardiac flutter from 2020.   The patient's concomitant medications were not reported. The patient was wondering since she did have COVID and then probably a couple months later noticed her blood pressure going up and flutters in her chest and stuff, then had the vaccine as well and it was more intensified in 2021 since the vaccine. She said that they said her heart was slightly enlarged in 2021 and could be because her blood pressure was up in 2021. She said her blood pressure was back down to her normal level. She did not have her vaccine card with her, so she was not sure when she had her vaccine, she thought it was in April. She had COVID in the end of November, before 01Dec, so maybe 25Nov, it was right around Thanksgiving. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.