chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Inappropriate schedule of product administration
Clinical narrative: received the Pfizer Covid vaccine on 22Apr2021, and 02May2021; Arthritis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 22Apr2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 02May2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced inappropriate schedule of product administration on 02May2021 and arthritis on an unspecified date in 2021. She stated she taking Leflunomide 10mg daily for arthritis. She wanted to know if " A third "booster shot was necessary since she was on immunosuppressants?  The use of a 3rd or booster dose was not recommended or authorized and Pfizer does not suggest the use of the vaccine in any manner other than as described in the authorized EUA Prescribing Information. Therapeutic measures were taken as a result of arthritis with Leflunomide. The outcome of events was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Odynophagia, Pyrexia, Thyroiditis subacute
Clinical narrative: subacute thyroiditis; neck pain; odynophagia; pyrexia; This is a spontaneous report from a contactable consumer or other non-HCP. A 39-years-old female patient (Pregnant: Unknown) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (Age of vaccination: Unknown) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE , Solution injection, Lot number/Expiration date: Unknown) for covid-19 immunization The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced subacute thyroiditis, neck pain, odynophagia, pyrexia. Therapeutic measures were taken as a result of subacute thyroiditis, neck pain, odynophagia, pyrexia. The outcome of event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Ear infection, Erythema, Lymphadenopathy, Mammogram
Clinical narrative: Diagnosed with non lactation mastitis; Lump and red area on right breast; Lump and red area on right breast; One day after second dose hard, hot red lump that hurt where injected; One day after second dose hard, hot red lump that hurt where injected; One day after second dose hard, hot red lump that hurt where injected; Mouth sores; Ear infection; Swollen glands; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 2021 (Batch/Lot Number: Ew0198); at the age of 42-years-old, as dose 2, single for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 11Jun2021 6:00 PM, at the age of 42-years-old, as dose 1, single for COVID-19 immunization. Concomitant medication included fluoxetine hydrochloride (PROZAC); esomeprazole (ESOMEPRAZOLE); ciclosporin (RESTASIS); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jul2021 07:30AM, the patient experienced lump and red area on right breast. Diagnosed with non-lactation mastitis. One day after second dose, hard, hot red lump that hurt where injected. 3 weeks after 2nd shot mouth sores, ear infection, swollen glands and sore throat. The patient received antibiotics and pending ultrasound and mammogram. The patient was not diagnosed or tested for COVID-19. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mastitis, Oral pain, Oropharyngeal pain, Ultrasound scan, Vaccination site discolouration
Clinical narrative: Diagnosed with non lactation mastitis; Lump and red area on right breast; Lump and red area on right breast; One day after second dose hard, hot red lump that hurt where injected; One day after second dose hard, hot red lump that hurt where injected; One day after second dose hard, hot red lump that hurt where injected; Mouth sores; Ear infection; Swollen glands; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 2021 (Batch/Lot Number: Ew0198); at the age of 42-years-old, as dose 2, single for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 11Jun2021 6:00 PM, at the age of 42-years-old, as dose 1, single for COVID-19 immunization. Concomitant medication included fluoxetine hydrochloride (PROZAC); esomeprazole (ESOMEPRAZOLE); ciclosporin (RESTASIS); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jul2021 07:30AM, the patient experienced lump and red area on right breast. Diagnosed with non-lactation mastitis. One day after second dose, hard, hot red lump that hurt where injected. 3 weeks after 2nd shot mouth sores, ear infection, swollen glands and sore throat. The patient received antibiotics and pending ultrasound and mammogram. The patient was not diagnosed or tested for COVID-19. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: Diagnosed with non lactation mastitis; Lump and red area on right breast; Lump and red area on right breast; One day after second dose hard, hot red lump that hurt where injected; One day after second dose hard, hot red lump that hurt where injected; One day after second dose hard, hot red lump that hurt where injected; Mouth sores; Ear infection; Swollen glands; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 2021 (Batch/Lot Number: Ew0198); at the age of 42-years-old, as dose 2, single for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 11Jun2021 6:00 PM, at the age of 42-years-old, as dose 1, single for COVID-19 immunization. Concomitant medication included fluoxetine hydrochloride (PROZAC); esomeprazole (ESOMEPRAZOLE); ciclosporin (RESTASIS); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jul2021 07:30AM, the patient experienced lump and red area on right breast. Diagnosed with non-lactation mastitis. One day after second dose, hard, hot red lump that hurt where injected. 3 weeks after 2nd shot mouth sores, ear infection, swollen glands and sore throat. The patient received antibiotics and pending ultrasound and mammogram. The patient was not diagnosed or tested for COVID-19. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Gastrointestinal pain, Rash
Clinical narrative: i had severe gastrointestinal paying; intestinal pain; bad skin rash on my chest and then maybe a week later on my face; This is a spontaneous report received from a non-contactable consumer (Patient). A 55-year-old female patient received second dose of BNT162 (PFIZER-BIONTECH COVD-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 16Apr2021 (at the age of 55-year-old) as single dose for covid-19 immunisation. The patient medical history was not reported and there were no concomitant medications. Patient historic vaccine included first dose of BNT162 (PFIZER-BIONTECH COVD-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation.On 21May2021, the patient had severe gastrointestinal paying, intestinal pain and bad skin rash on her chest and then maybe a week later on her face. Patient reported that, after the second vaccination she had severe gastrointestinal pain that she couldn't attribute to anything else her husband and she had the same vaccine at the same time he also had that gastrointestinal pain but then she would say several weeks after that vaccination she got a really bad skin rash on her chest and then may be a week later on her face that the dermatologist really couldn't distrubute to anything and she thought perhaps it might have something to do with the Pfizer vaccination so she just wanted to report it um she have gotten several different ointments that have finally worked on the rash and the gastrointestinal pain had subsided. Therapeutic measures were taken as a result of adverse events. The events were recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Cardiac function test, Chest pain, Headache
Clinical narrative: Severe anxiety; Chest pain; Left arm and shoulder pain; Left arm and shoulder pain; Pain in neck; Headaches; This is a spontaneous report received from a contactable other HCP (patient) reported for himself. A 45-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: ER8732) via an unspecified route of administration, administered in Arm Left on 12Apr2021 14:00 as single dose for covid-19 immunisation. The patient did not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Medical history included blood pressure increased from an unknown date and unknown if ongoing. Concomitant medication(s) included candesartan (CANDESARTAN) taken for an unspecified indication, start and stop date were not reported. On 15May2021 the patient experienced severe anxiety, chest pain, left arm and shoulder pain, left arm and shoulder pain, pain in neck, headaches. The patient underwent lab tests and procedures which included cardiac function test: unknown results in 2021. The patient did receive any treatment for the adverse events. Treatment received for the adverse event with Heart test, Neuro visit, Psychiatrist visit. The clinical outcome of the events was not recovered. Therapeutic measures were taken as a result of severe anxiety, chest pain, left arm and shoulder pain, left arm and shoulder pain, pain in neck, headaches.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Severe anxiety; Chest pain; Left arm and shoulder pain; Left arm and shoulder pain; Pain in neck; Headaches; This is a spontaneous report received from a contactable other HCP (patient) reported for himself. A 45-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: ER8732) via an unspecified route of administration, administered in Arm Left on 12Apr2021 14:00 as single dose for covid-19 immunisation. The patient did not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Medical history included blood pressure increased from an unknown date and unknown if ongoing. Concomitant medication(s) included candesartan (CANDESARTAN) taken for an unspecified indication, start and stop date were not reported. On 15May2021 the patient experienced severe anxiety, chest pain, left arm and shoulder pain, left arm and shoulder pain, pain in neck, headaches. The patient underwent lab tests and procedures which included cardiac function test: unknown results in 2021. The patient did receive any treatment for the adverse events. Treatment received for the adverse event with Heart test, Neuro visit, Psychiatrist visit. The clinical outcome of the events was not recovered. Therapeutic measures were taken as a result of severe anxiety, chest pain, left arm and shoulder pain, left arm and shoulder pain, pain in neck, headaches.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: It started while she was very sore; Now has a headache; Feeling tired; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, NDC number and expiry date were not reported) via an unspecified route of administration on 21Jul2021 as a single dose for covid-19 immunization. The patient's medical history, investigation assessment and concomitant medications were not reported. The report was related to a study or programme. The patient experienced headache, felt tired and she was very sore on an unknown date in Jul2021. She wondered how long the events will last. She asked if the same thing will happen with the second one, she was kind of hesitant to get it. She stated that maybe she will wait and see her doctor. The outcome of all the events was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Hypoaesthesia, Limb discomfort, Musculoskeletal discomfort
Clinical narrative: started feeling or hearing popping sensation in the left shoulder and Severe pain in the shoulder and arm was reported as worsened.; Severe pain in the shoulder and arm; Severe pain in the shoulder and arm; tips of the fingers in the left hand were numb; started feeling or hearing popping sensation in the left shoulder; cannot use the arm to get dressed, shower, lift arm in certain angles, or push and pull; This is a spontaneous report from a contactable consumer. A 46-Year-old female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0150 and expiry date Jul2021) via an unspecified route of administration on 17Apr2021 in left arm (at 46-year-old), as dose 1, single for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing and overweight from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received DPT and experienced anaphylaxis. It was mentioned no investigation assessment was done. The prior vaccinations (within 4 weeks), event following prior vaccinations, family medical history and relevant tests were reported as none. On 17Apr2021 almost immediately after the vaccination the patient's tips of the fingers in the left hand were numb and started feeling or hearing popping sensation in the left shoulder. It went away within an hour, it felt weird. She recovered completely and treatment was reported as none, it resolved on its own. On 18Apr2021 the patient experienced severe pain in the shoulder and arm. On an unknown date in Apr2021 she could not use the arm to get dressed, shower, lift arm in certain angles, or push and pull. No treatment was received, the doctor recommended that she continued to move the arm somewhat so she would not get frozen shoulder. She got an x-ray that showed no fracture or dislocation.It was mentioned that started feeling or hearing popping sensation in the left shoulder and Severe pain in the shoulder and arm was reported as worsened (condition aggravated). The patient did not require emergency room visit, but she visited physician office. On an unknown date in 2021 tips of the fingers in the left hand were numb recovered. The other events had not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, X-ray
Clinical narrative: started feeling or hearing popping sensation in the left shoulder and Severe pain in the shoulder and arm was reported as worsened.; Severe pain in the shoulder and arm; Severe pain in the shoulder and arm; tips of the fingers in the left hand were numb; started feeling or hearing popping sensation in the left shoulder; cannot use the arm to get dressed, shower, lift arm in certain angles, or push and pull; This is a spontaneous report from a contactable consumer. A 46-Year-old female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0150 and expiry date Jul2021) via an unspecified route of administration on 17Apr2021 in left arm (at 46-year-old), as dose 1, single for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing and overweight from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received DPT and experienced anaphylaxis. It was mentioned no investigation assessment was done. The prior vaccinations (within 4 weeks), event following prior vaccinations, family medical history and relevant tests were reported as none. On 17Apr2021 almost immediately after the vaccination the patient's tips of the fingers in the left hand were numb and started feeling or hearing popping sensation in the left shoulder. It went away within an hour, it felt weird. She recovered completely and treatment was reported as none, it resolved on its own. On 18Apr2021 the patient experienced severe pain in the shoulder and arm. On an unknown date in Apr2021 she could not use the arm to get dressed, shower, lift arm in certain angles, or push and pull. No treatment was received, the doctor recommended that she continued to move the arm somewhat so she would not get frozen shoulder. She got an x-ray that showed no fracture or dislocation.It was mentioned that started feeling or hearing popping sensation in the left shoulder and Severe pain in the shoulder and arm was reported as worsened (condition aggravated). The patient did not require emergency room visit, but she visited physician office. On an unknown date in 2021 tips of the fingers in the left hand were numb recovered. The other events had not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: gets dizzy; This is a spontaneous report from a contactable consumer. This consumer reported for 80-year-old female patient (friend's neighbor). An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), 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. The patient experienced gets dizzy on an unspecified date. She stated the other day she was talking to her friend and her friend said she knows 3 people who have also had similar symptoms as her husband and they all have had the Pfizer vaccine as well. Mentions that her friend's female neighbor is 80. Reporter stated she doesn't know about the neighbor; the friend just said the neighbor gets dizzy too. This report is for the friend's neighbor, the 3rd of the 3 people. She confirms she received the Pfizer COVID 19 Vaccine. Reporter asked if there were any studies being done on the long-term effects of dizziness with the vaccine. Reporter is a consumer. Reporter is calling on behalf of her husband. Reporter and husband received their first dose of the Pfizer COVID 19 vaccine on 09JAN2021 and their second dose 30JAN2021. She reports that her husband began getting headaches, nausea, and dizziness two months ago. They have visited several specialists who cannot determine anything wrong. She said the reason she decided to call was because I was telling a friend of mine about my husband and she knows three other people who are also having dizziness; two have passed out more than once and the other one gets dizzy; all four have had the Pfizer vaccine. Reporter wants to know if there are any studies being done on the long-term effects of dizziness and the vaccine. Caller reports,  that she had a sore arm after receiving the vaccine. Reporter is a 74-year-old female; her husband is a 74-year-old male. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, X-ray
Clinical narrative: I had slight rash from the first one; I haven't got the second one; This is a spontaneous report from a contactable consumer. A 58-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EW0191), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included antidepressant therapy from an unknown date and unknown if ongoing mild Antidepressant. Concomitant medications included escitalopram (ESCITALOPRAM) taken for antidepressant therapy, start and stop date were not reported. On an unspecified date of Jun2021 consumer stated, Yes, I am at the health department to get a second Pfizer Vaccine (Pfizer Covid Vaccine) and I had slight rash from the first one and so they gave me this number to see, if it's okay to vaccinate me with the second dose and I had the first dose on June nineteenth (19Jun). consumer stated, how long do I have, I don't know. I haven't got the second one that's why I am calling you. I am here at the health department and wanted to get the second shot, but they won't unless you say it's okay. Consumer stated, the nurse at the Health Department said to call this number. I am trying to get my second dose, but they won't give it to me unless you say it's okay. Consumer stated, Yes, I take an antidepressant. It's Escitalopram (Not clarified hence not captured in tab) I didn't know I would be question on my medical stuff here, so I don't have my medical file. It's a generic. I take a mild Antidepressant. It's spelled ETC. Consumer stated, I had a general X-ray last week. The first vaccine it was in, it was like a sealed syringe. The patient did not receive any other vaccination within 4 weeks prior to vaccination. The patient underwent lab tests and procedures which included x-ray: unknown on an unspecified date of 2021. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dyspepsia, Hyperhidrosis
Clinical narrative: My girlfriend is also feeling like her stomach is burning, but it could be from having to poop all the time; hot and cold with sweats; hot and cold with sweats; chills; This is a spontaneous report from a contactable consumer. A 67-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 21Jul2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reported that reporter and his girlfriend (withheld) got it at the same 21Jul2021, and my girlfriend is going through the same thing. We got at the same time. My girlfriend is also feeling like her stomach is burning, but it could be from having to poop all the time. Wanted to know if anyone else reported anything like this. On an unspecified date in 2021, the patient experienced my girlfriend is also feeling like her stomach is burning, but it could be from having to poop all the time, hot and cold with sweats, chills. Th outcomes of events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lethargy, Loss of personal independence in daily activities, Migraine, Muscle spasms
Clinical narrative: Loss of blood flow in left arm; Swelling at injection site; Inability to lift arm (injection site); Rash at injection site; Tingling in left hand; Muscle spasms in left side; Migraine; Vomiting; Diarrhea; Neck pain; Lethargy; Ringing in ears; Inability to complete normal daily tasks; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), via an unspecified route of administration, administered in the left arm on 24Jul2021 16:00 (at the age of 30-years-old) as dose 1, single for COVID-19 immunization. Medical history included anxiety, white wine allergy, depression, and post-traumatic stress disorder (PTSD). Concomitant medications included escitalopram oxalate (LEXAPRO) and alprazolam (XANAX). The patient previously took orphenadrine (K FLEX) and midazolam hydrochloride (VERSED) and experienced drug allergy with both. The patient previously received TDAP/DTAP vaccine and experienced vaccine allergy. The patient did not receive any other vaccines within 4 weeks of the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed COVID-19 infection. Since the vaccination, the patient has not been tested for COVID-19. On 24Jul2021 17:00 (1 hour after the vaccination), the patient experienced loss of blood flow in left arm, swelling at injection site, inability to lift arm (injection site), rash at injection site, tingling in left hand, muscle spasms in left side, migraine, vomiting, diarrhea, neck pain, lethargy, ringing in ears, and inability to complete normal daily tasks. Therapeutic measures were not taken as result of the events. 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Paraesthesia, Tinnitus, Vaccination site ischaemia, Vaccination site movement impairment
Clinical narrative: Loss of blood flow in left arm; Swelling at injection site; Inability to lift arm (injection site); Rash at injection site; Tingling in left hand; Muscle spasms in left side; Migraine; Vomiting; Diarrhea; Neck pain; Lethargy; Ringing in ears; Inability to complete normal daily tasks; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), via an unspecified route of administration, administered in the left arm on 24Jul2021 16:00 (at the age of 30-years-old) as dose 1, single for COVID-19 immunization. Medical history included anxiety, white wine allergy, depression, and post-traumatic stress disorder (PTSD). Concomitant medications included escitalopram oxalate (LEXAPRO) and alprazolam (XANAX). The patient previously took orphenadrine (K FLEX) and midazolam hydrochloride (VERSED) and experienced drug allergy with both. The patient previously received TDAP/DTAP vaccine and experienced vaccine allergy. The patient did not receive any other vaccines within 4 weeks of the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed COVID-19 infection. Since the vaccination, the patient has not been tested for COVID-19. On 24Jul2021 17:00 (1 hour after the vaccination), the patient experienced loss of blood flow in left arm, swelling at injection site, inability to lift arm (injection site), rash at injection site, tingling in left hand, muscle spasms in left side, migraine, vomiting, diarrhea, neck pain, lethargy, ringing in ears, and inability to complete normal daily tasks. Therapeutic measures were not taken as result of the events. 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling, Vomiting
Clinical narrative: Loss of blood flow in left arm; Swelling at injection site; Inability to lift arm (injection site); Rash at injection site; Tingling in left hand; Muscle spasms in left side; Migraine; Vomiting; Diarrhea; Neck pain; Lethargy; Ringing in ears; Inability to complete normal daily tasks; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), via an unspecified route of administration, administered in the left arm on 24Jul2021 16:00 (at the age of 30-years-old) as dose 1, single for COVID-19 immunization. Medical history included anxiety, white wine allergy, depression, and post-traumatic stress disorder (PTSD). Concomitant medications included escitalopram oxalate (LEXAPRO) and alprazolam (XANAX). The patient previously took orphenadrine (K FLEX) and midazolam hydrochloride (VERSED) and experienced drug allergy with both. The patient previously received TDAP/DTAP vaccine and experienced vaccine allergy. The patient did not receive any other vaccines within 4 weeks of the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed COVID-19 infection. Since the vaccination, the patient has not been tested for COVID-19. On 24Jul2021 17:00 (1 hour after the vaccination), the patient experienced loss of blood flow in left arm, swelling at injection site, inability to lift arm (injection site), rash at injection site, tingling in left hand, muscle spasms in left side, migraine, vomiting, diarrhea, neck pain, lethargy, ringing in ears, and inability to complete normal daily tasks. Therapeutic measures were not taken as result of the events. 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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: that she had a sore arm after receiving the vaccine.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 74-years), administered in arm right on 09Jan2021 as dose 1, single for COVID-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Jan2021 as dose 2, single for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced that she had a sore arm after receiving the vaccine. She stated that she received both doses of the Pfizer vaccine in January and did not have any side effects, maybe a little sore arm, but nothing else. She confirmed that she received the Pfizer Covid 19 Vaccine. She was not having any symptoms at all. It was not anything, she always gets a sore arm when she gets a shot. A little sore arm: She would guess, but it was not anything that she even thought about. She just expected it to begin with, it was not horrific. She has recovered completely. She probably recovered later that night, but it was very minor. She and husband received their first dose of the Pfizer covid 19 vaccine on 09Jan2021 and their second dose 30Jan2021. She reported that her husband began getting headaches, nausea, and dizziness two months ago. They have visited several specialists who cannot determine anything wrong. She said the reason she decided to call was because I was telling a friend of mine about my husband and she knows three other people who are also having dizziness; two have passed out more than once and the other one gets dizzy; all four have had the Pfizer vaccine. She wanted to know if there are any studies being done on the long term effects of dizziness and the vaccine. She reported that she had a sore arm after receiving the vaccine. The patient was taking Pfizer Covid 19 Vaccine because they were worried about the virus. The clinical outcome for the events was reported as recovered on an unspecified date in Jan2021.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Investigation, Loss of consciousness
Clinical narrative: passed out more than once; dizziness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for four patients. This is the second of four reports.   A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has been getting dizzy and he passes out. He has had all kinds of testing also and they can't find anything wrong with him either. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100951538 same reporter and product, similar event, different patients
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Investigation, Loss of consciousness
Clinical narrative: has passed out three different times; dizziness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for four patients. This is the third of four reports.  A 7-decade-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced dizziness and has passed out three different times on an unspecified date. Consumer reported that her friend's boyfriend, who's 65, maybe 66, has had dizziness, and has passed out three different times. The consumer's friend stated that her boyfriend has gone to various doctors and had various tests and they can't find anything. The outcome of the events was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100951538 same reporter/drug, similar events, different patient
Sex: M
Vaccine: COVID19
Symptoms: Headache, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: couldn't get out of bed for 3 days; nasty headache; fever; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that after receiving the first dose of vaccine on an unspecified date the patient couldn't get out of bed for 3 days and he had a nasty headache and a fever for 3 days. The outcome of the events was recovered.   The lot number for the vaccine, [Pfizer BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Hypoaesthesia, Nausea, Pain
Clinical narrative: Nausea; Diarrhea; sporadic numbness and pain; Dizziness; Immediate numbness in whole arm; continued for 3 days then sporadic numbness; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Jul2021 at 16:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included eczema, asthma, sunscreen sensitivity, reaction to food coloring (red dye) and allergy to chemicals (cleaning products). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jul2021 at 16:00 the patient experienced numbness in whole arm and dizziness. On 24Jul2021, the patient experienced sporadic numbness and pain. On 25Jul2021, the patient experienced diarrhea and nausea. Therapeutic measures were not taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of numbness in whole arm, dizziness, sporadic numbness and pain, diarrhea and nausea was recovering at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Musculoskeletal discomfort, Pain in extremity, X-ray
Clinical narrative: In her right arm she has a similar popping in the shoulder; She cannot use the arm to get dressed, shower, lift arm in certain angles, or push and pull.; Severe pain in the shoulder and arm; Severe pain in the shoulder and arm; This is a spontaneous report from a contactable consumer (patient herself). A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0164; Expiration Date: Aug2021), via an unspecified route of administration, administered in right arm on 07May2021 (age at vaccination: 46 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included hypertension and overweight. The patient's concomitant medications were not reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0150) an unspecified route of administration, administered in left arm on 17Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. On an unknown date in May2021, the patient in her right arm had a similar popping in the shoulder, she cannot use the arm to get dressed, shower, lift arm in certain angles, or push and pull, severe pain in the shoulder and arm. She thought it was a side effect of the vaccine. She went to see the doctor on 27May2021. She cannot use the arm to get dressed, shower, lift arm in certain angles, or push and pull. The patient did not require emergency room visit. The patient did not have any prior vaccinations within 4 weeks. The patient on an unknown date in 2021, underwent x-ray which showed no fracture or dislocation. The outcome of musculoskeletal discomfort was recovering; Loss of personal independence in daily activities was unknown; Arthralgia and pain in extremity was recovered on an unknown date in 2021.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Computerised tomogram, Disorientation, Disturbance in attention, Hyperacusis
Clinical narrative: The sound attenuates in both loadness and pitch from day to day/Sound in my head that does not go away; Disorientation; loss of memory; inability to focus; It iterferes with sleep and ability to complete complicated tasks.; It iterferes with sleep and ability to complete complicated tasks.; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 27Mar2021 13:00 (Batch/Lot Number: ER2613) as dose 1, single for covid-19 immunisation. Medical history included fibromyalgia, acid reflux, osteoarthritis, attention deficit disorder and allergy. Concomitant medication not reported. On 30Mar2021 at 12:00, the patient experienced disorientation, loss of memory, inability to focus started day after first immunization and has continued. The sound attenuates in both loudness and pitch from day to day.  It interferes with sleep and ability to complete complicated tasks. The sound in her head that does not go away and about 5 days after the first covid-19 immunization, booster caused sound to be loader. He patient underwent CT Scan and MRI, but results were not provided. The patient received pain management medication. The outcome of the events was not recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging, Sleep disorder
Clinical narrative: The sound attenuates in both loadness and pitch from day to day/Sound in my head that does not go away; Disorientation; loss of memory; inability to focus; It iterferes with sleep and ability to complete complicated tasks.; It iterferes with sleep and ability to complete complicated tasks.; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 27Mar2021 13:00 (Batch/Lot Number: ER2613) as dose 1, single for covid-19 immunisation. Medical history included fibromyalgia, acid reflux, osteoarthritis, attention deficit disorder and allergy. Concomitant medication not reported. On 30Mar2021 at 12:00, the patient experienced disorientation, loss of memory, inability to focus started day after first immunization and has continued. The sound attenuates in both loudness and pitch from day to day.  It interferes with sleep and ability to complete complicated tasks. The sound in her head that does not go away and about 5 days after the first covid-19 immunization, booster caused sound to be loader. He patient underwent CT Scan and MRI, but results were not provided. The patient received pain management medication. The outcome of the events was not recovered.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sever joint pain of the knees, hips, elbows and wrists.; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: fa7484) via an unspecified route of administration in the left arm on 26Jul2021 at 01:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food, or other products. The patient did not receive any medications within two 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Jul2021 at 03:30 the patient experienced severe joint pain of the knees, hips, elbows and wrists. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events severe joint pain of the knees, hips, elbows and wrists was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscle twitching, Photophobia, SARS-CoV-2 test
Clinical narrative: vision problems (blurriness and sensitivity like a bright light is being shined directly into your eyes).; vision problems (blurriness and sensitivity like a bright light is being shined directly into your eyes).; Vertigo; shaking and twitching (I'm not cold); shaking and twitching (I'm not cold); Pain at the injection sight; mild head ache; fatigue; This is a spontaneous report from a contactable other health professional (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 19Jul2021 18:00 (Lot Number: ER8736; at the age of 40-years) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included allergy to onion and lavender. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 20Jul2021 07:00, the patient experienced vertigo and vision problems (blurriness and sensitivity like a bright light is being shined directly into your eyes); was shaking and twitching (I'm not cold as reported). The other symptoms were normal side effects like pain at the injection sight, mild head ache, and a little fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. Blurring of vision was considered medically significant. Therapeutic measures were taken as the result of the events which included treatment with Zofran; blood test (to be scheduled). The patient also had Covid-19  test on 21Jul2021 which came negative. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported blurring of vision cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.