chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Apathy, Asthenia, Decreased appetite, Fatigue
Clinical narrative: feeling tired; no motivation without energy; no motivation without energy; no appetite; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer or other non-healthcare professional (Patient).  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient was feeling tired, no motivation without energy and no appetite. It was reported that patient who received her first dose of the Pfizer BioNTech Covid-19 Vaccine and is due for her second dose tomorrow. Caller states she "did not experience any side effects after her first dose", but she has been feeling "tired, no motivation, without energy, and no appetite" since she was vaccinated. Caller states she "eats a little bit sometimes because I know I have to." She asking if/how long she can wait to get her second dose of the Pfizer BioNTech Covid-19 Vaccine given how she is feeling and her side effects could be worsened after a second dose of the vaccine, or if she could experience new side effects. The Pfizer-BioNTech COVID-19 Vaccine vaccination series is 2 doses given 3 weeks apart. If you receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series. The caller has questions about the covid 19 vaccine. The caller already received the first dose and is due tomorrow, 17Aug2021, for the second dose. The caller wants to know if she can wait 1-2 more weeks before getting the second dose. The caller doesn't think the 3 weeks is long enough for her body to recover before the second dose since she has been run down. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Paraesthesia
Clinical narrative: tingling in feet and hands; This is a spontaneous report from a Pfizer sponsored Program COVAX US Support from a contactable consumer reported for a female patient (her sister). A female patient of unspecified age received first dose of bnt162b2 (Pfizer Covid-19 vaccine, Solution for injection, Batch/lot number: Not Provided, Expiry date: not provided), via an unspecified route on an unspecified date as a single dose for covid-19 immunization. Medical history included rheumatoid arthritis, Hepatitis B and was receiving an infusion for that. Before the vaccine, she also had Covid and had pneumonia, this was before receiving the vaccine. She does not have cancer. The patient concomitant medications were not reported. On an unknown date, patient experienced tingling in feet and hands, she did not specify if it was the right or left, just stated that patient experienced tingling in the feet and hands. She has been seeing many doctors who can't find anything wrong with her. The patient underwent lab test and procedure which included blood work. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Feeding disorder, Investigation, Malaise, Weight
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a female patient of an unspecified age received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 2, single on an unspecified date for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis (diagnosed and receiving an infusion), pneumonia and Covid 19 (she also had Covid and had pneumonia, this was before receiving the vaccine) and ongoing hepatitis B (diagnosed and receiving an infusion) all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included patient previously took bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 1, single on an unspecified date for covid-19 immunisation and experienced tingling in her feet and hands. Caller was a consumer, called regarding her sister (patient), who had the first dose of the Pfizer Covid-19 vaccine. After that, she experienced tingling in her feet and hands did not specify right or left. After patient received the second dose, she had been going downhill, not been able to eat, bloating and gone down to 111 pounds on unspecified date in 2021. Patient saw many doctors who can't find anything wrong with her. Patient does not have cancer and has had blood work. Caller was not sure why patient was going downhill, it because of everything going on, plus the vaccine. Caller was concerned about patient (sister). The patient underwent lab tests and procedures which included investigation: unknown and weight decreased: 111 pounds on unspecified date. At the time of this report, 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: Weight decreased
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a female patient of an unspecified age received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 2, single on an unspecified date for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis (diagnosed and receiving an infusion), pneumonia and Covid 19 (she also had Covid and had pneumonia, this was before receiving the vaccine) and ongoing hepatitis B (diagnosed and receiving an infusion) all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included patient previously took bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 1, single on an unspecified date for covid-19 immunisation and experienced tingling in her feet and hands. Caller was a consumer, called regarding her sister (patient), who had the first dose of the Pfizer Covid-19 vaccine. After that, she experienced tingling in her feet and hands did not specify right or left. After patient received the second dose, she had been going downhill, not been able to eat, bloating and gone down to 111 pounds on unspecified date in 2021. Patient saw many doctors who can't find anything wrong with her. Patient does not have cancer and has had blood work. Caller was not sure why patient was going downhill, it because of everything going on, plus the vaccine. Caller was concerned about patient (sister). The patient underwent lab tests and procedures which included investigation: unknown and weight decreased: 111 pounds on unspecified date. At the time of this report, the outcome of 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, COVID19
Symptoms: Dizziness, Trigeminal neuralgia
Clinical narrative: Dizziness; Trigeminal neuralgia on left side of neck and face; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: not reported) via an unspecified route of administration in left arm on 25Mar2021 at 13:15 (at the age of 62 years) as dose 1, single and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0172) via an unspecified route of administration in left arm on 11May2021 at 16:00 as dose 2, single for COVID-19 immunization in a hospital. Medical history included elevated blood pressure and penicillin allergy. Patient was not tested COVID prior and post vaccination. Concomitant medication included lisinopril (LISINOPRIL) 15mg. Patient did not receive any other vaccine within four weeks. On 08May2021 at 20:00, the patient experienced dizziness, trigeminal neuralgia on left side of neck and face. The adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Steroid blast (7 days prescription) was taken as therapeutic measures as a result of the events. Outcome of the events was recovering.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Extra dose administered, Fatigue, Insomnia
Clinical narrative: sore left arm; sore left hip; Sniffles; Trouble sleeping; Tired; Tender and swollen under left arm; Tender and swollen under left arm; Shot # 3- Booster; Shot # 3- Booster; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 3180), via an unspecified route of administration, administered in Left arm on 16Aug2021 16:30 at the age of 45-years-old as dose 3, single for covid-19 immunisation. Medical history included none. The patient had no known allergies. Concomitant medications included adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported received within 2 weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on an unspecified date as single dose and second dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 6201), via an unspecified route of administration, administered in Left arm on 24Mar2021 08:15 at the age of 44-years-old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Device Date: 17Aug2021. On 16Aug2021 at 16:30, the patient experienced shot # 3- booster (off label use), shot # 3- booster (extra dose administered) and on 16Aug2021 at 21:00, the patient experienced sore left arm, sore left hip, sniffles, trouble sleeping, tired, tender and swollen under left arm. No treatment was received for adverse events. The case was reported as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The outcome of events was unknown.  Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Rhinorrhoea, Swelling
Clinical narrative: sore left arm; sore left hip; Sniffles; Trouble sleeping; Tired; Tender and swollen under left arm; Tender and swollen under left arm; Shot # 3- Booster; Shot # 3- Booster; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 3180), via an unspecified route of administration, administered in Left arm on 16Aug2021 16:30 at the age of 45-years-old as dose 3, single for covid-19 immunisation. Medical history included none. The patient had no known allergies. Concomitant medications included adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported received within 2 weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on an unspecified date as single dose and second dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 6201), via an unspecified route of administration, administered in Left arm on 24Mar2021 08:15 at the age of 44-years-old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Device Date: 17Aug2021. On 16Aug2021 at 16:30, the patient experienced shot # 3- booster (off label use), shot # 3- booster (extra dose administered) and on 16Aug2021 at 21:00, the patient experienced sore left arm, sore left hip, sniffles, trouble sleeping, tired, tender and swollen under left arm. No treatment was received for adverse events. The case was reported as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The outcome of events was unknown.  Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Nausea, Ultrasound Doppler
Clinical narrative: Headaches; Nausea; Muscle cramps; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 45 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Feb2021 (45-year-old at vaccination) as Dose 1, Single for Covid-19 immunization. The patient was non-pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Workplace clinic. The patient's medical history included known allergies of Sulfa, hypertension. The patient's concomitant medication(s) included lisinopril 2.5mg and hydrochlorothiazide 25mg within 2 weeks of vaccination. 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. On 01Jul2021, the patient had experienced headaches, nausea, muscle cramps. Since vaccination the patient was tested for Covid-19. The patient underwent lab test and procedure which include (SARS-CoV-2 test) Nasal swab, Binax: result was negative, Doppler ultrasound: results not provided. These adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received Zofran (unspecified route) as treatment medication for resulted events. Device date was reported as 18Aug2021. The outcome of the events was not recovered. The seriousness of the events was assessed as non-serious by the reporter.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Extra dose administered, Fatigue, Off label use, Pain in extremity
Clinical narrative: low grade fever; extreme left arm pain; extreme fatigue; uncontrolled shaking on exertion; lack of appetite; patient received 3rd dose of vaccine; patient received 3rd dose of vaccine; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 29-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration in arm left on 20Aug2021 at 16:45 (at the age of 29-year-old) as a dose 3, single for COVID-19 immunization. The patient's medical history included ulcerative colitis, autoimmune disease, other medical history: other autoimmune disease (undetermined), known allergies Latex. Past drug event included meclizine and experienced known allergies meclizine, known allergies Latex, meclizine. The patient's concomitant medications in two weeks included vedolizumab (ENTYVIO), methotrexate, prednisone, all were taken for an unspecified indication and others. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 2, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. No other vaccine in four weeks was reported. No covid prior vaccination and covid tested post vaccination was reported as yes. Covid test type post vaccination was Nasal Swab. On 20Aug2021 at 20:00, the patient experienced possible low grade fever, extreme left arm pain, extreme fatigue, uncontrolled shaking on exertion, lack of appetite. Treatment was not received for the events possible low grade fever, extreme left arm pain, extreme fatigue, uncontrolled shaking on exertion, lack of appetite. On 13Aug2021, the patient underwent lab tests and procedures which included Nasal Swab (SARS-CoV-2 test), resulted as negative. The outcome of the events for possible low grade fever, extreme left arm pain, extreme fatigue, uncontrolled shaking on exertion, lack of appetite was not recovered while for the other events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Tremor
Clinical narrative: low grade fever; extreme left arm pain; extreme fatigue; uncontrolled shaking on exertion; lack of appetite; patient received 3rd dose of vaccine; patient received 3rd dose of vaccine; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 29-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration in arm left on 20Aug2021 at 16:45 (at the age of 29-year-old) as a dose 3, single for COVID-19 immunization. The patient's medical history included ulcerative colitis, autoimmune disease, other medical history: other autoimmune disease (undetermined), known allergies Latex. Past drug event included meclizine and experienced known allergies meclizine, known allergies Latex, meclizine. The patient's concomitant medications in two weeks included vedolizumab (ENTYVIO), methotrexate, prednisone, all were taken for an unspecified indication and others. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 2, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. No other vaccine in four weeks was reported. No covid prior vaccination and covid tested post vaccination was reported as yes. Covid test type post vaccination was Nasal Swab. On 20Aug2021 at 20:00, the patient experienced possible low grade fever, extreme left arm pain, extreme fatigue, uncontrolled shaking on exertion, lack of appetite. Treatment was not received for the events possible low grade fever, extreme left arm pain, extreme fatigue, uncontrolled shaking on exertion, lack of appetite. On 13Aug2021, the patient underwent lab tests and procedures which included Nasal Swab (SARS-CoV-2 test), resulted as negative. The outcome of the events for possible low grade fever, extreme left arm pain, extreme fatigue, uncontrolled shaking on exertion, lack of appetite was not recovered while for the other events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Muscle tightness, Myalgia
Clinical narrative: I had severe joint pain the same day with tiredness that lasted over 24hrs. The following day I am having severe muscle pain, the joint pain decreased but the muscle pain seems to be targeting areas; I had severe joint pain the same day with tiredness that lasted over 24hrs. The following day I am having severe muscle pain, the joint pain decreased but the muscle pain seems to be targeting areas; I had severe joint pain the same day with tiredness that lasted over 24hrs. The following day I am having severe muscle pain, the joint pain decreased but the muscle pain seems to be targeting areas; I had severe joint pain the same day with tiredness that lasted over 24hrs. The following day I am having severe muscle pain, the joint pain decreased but the muscle pain seems to be targeting areas; This is a spontaneous report from a contactable other health care professional(patient). A 38-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported), via an unspecified route of administration, administered in Left Arm on 21Aug2021 09:15 (at the age of 38 years old) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization . The patient had not received any other vaccine within 4 weeks. Patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. Medical history included HBP (high blood pressure) hypertension, pain. The patient have had previous history of pain over the years. Concomitant medication in 2 weeks included nifedipine, vitamin d, MULTIVITAMIN (ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate) and elderberry taken for an unspecified indication, start and stop date were not reported. No known allergies was reported. On 21Aug2021 11:00,The patient experienced severe joint pain the same day with tiredness that lasted over 24hrs the following day having severe muscle pain, the joint pain decreased but the muscle pain seems to be targeting areas where the patient had previous history of pain over the years and it was tightening my muscles. The patient had not taken any pain medication to help with the symptoms. The patient did not received any treatment for the events. The outcome of the event arthralgia was recovering, fatigue was recovered on 22Aug2021 and the other events myalgia, muscle tightness were unknown.  Follow up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: My wife had her second shot 2 days ago and she got like a golf form in her armpit; This is a spontaneous report from a contactable consumer (patient's husband). A female patient (reporter's spouse) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 19Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The reporter stated that his wife had her second shot 2 days ago and she got like a golf form in her armpit on an unspecified date in 2021 and should they be worried about that. The clinical outcome for the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Breast pain, Erythema, Polymenorrhoea, Skin warm
Clinical narrative: Large (bigger than a golf ball) lump in my left breast; Lump in her left breast, hot to the touch; Lump in my left breast, hot to the touch ,red; Lump in my left breast, hot to the touch ,red, painful; Menstrual period every two weeks since vaccination; This is a spontaneous report from a contactable consumer (patient). A 45-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0176), dose 2 via an unspecified route of administration, administered in arm left on 08May2021 15:00 (at the age of 45-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously, the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Er8731), dose 1 via an unspecified route of administration, administered in arm left on 17Apr2021, 15:00 (at the age of 45-years-old) as DOSE 1, SINGLE for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 12May2021, the patient experienced large (bigger than a golf ball) lump in her left breast, hot to the touch, red, painful for a week. Now in 2021, had a smaller sore lump and menstrual period every two weeks since vaccination. No treatment was received for the events. Outcome of all events was not recovered.    Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Muscular weakness, Periarthritis
Clinical narrative: Frozen left shoulder after about a month of second doze Pfizer COVID 19 vaccination. My doctor recommended physical therapy, which may also have contributed to in addition to COVID-19 vaccination; COVID-19 vaccination in raising my blood pressure; Left shoulder and arm as well is also experiencing a weakness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9265), via an unspecified route of administration, administered in Arm Left on 05Feb2021 11:45 (at the age of 56-year-old) as dose 2, single for covid-19 immunisation. The patient other medical history was reported as none and concomitant medications were not reported. Patient did not have any known allergies. Patient was not pregnant at the time of vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL1283), via an unspecified route of administration, administered in Arm Left on 15Jan2021 10:30 (at the age of 56-year-old) as dose 1, single for covid-19 immunisation. Patient did not receive any other vaccine in four weeks and did not have any other medications in two weeks. Patient did not have COVID prior vaccination and COVID was not tested post vaccination. The patient experienced frozen left shoulder after about a month of second doze Pfizer COVID-19 vaccination in Mar2021. Her doctor recommended physical therapy, which may also have contributed to in addition to COVID-19 vaccination in raising her blood pressure and ended up taking blood pressure medicine. Left shoulder and arm as well was also experiencing a weakness. The patient underwent lab tests and procedures which included blood pressure measurement: raising my blood pressure on an unspecified date. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment in the form of physical therapy and high blood pressure medicine. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Extra dose administered, Fatigue, Feeling hot
Clinical narrative: reported on (name)that he had received his third booster dose.; reported on (name)that he had received his third booster dose.; experienced fatigue, mild headache, and low appetite; experienced fatigue, mild headache, and low appetite; experienced fatigue, mild headache, and low appetite; nausea; dizziness; warm feeling; This is a spontaneous report from contactable Physician via Pfizer Sales Representative. A male patient of an unspecified age received third booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunisation. Medical history stated patient was immunocompromised due to a prior stem cell transplant on an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, patient received first dose and second dose of BNT162B2 via an unspecified route of administration for covid-19 immunisation. On an unspecified date, patient stated he had received his third booster dose 12 hours after the dose he experienced fatigue, mild headache, and low appetite, 14 hours after the dose he reported experiencing nausea and dizziness and 17 hours after that he had fatigue, a warm feeling and was nauseated. Patient stated events occurred after use of product. Outcome of al the events were unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Off label use
Clinical narrative: reported on (name)that he had received his third booster dose.; reported on (name)that he had received his third booster dose.; experienced fatigue, mild headache, and low appetite; experienced fatigue, mild headache, and low appetite; experienced fatigue, mild headache, and low appetite; nausea; dizziness; warm feeling; This is a spontaneous report from contactable Physician via Pfizer Sales Representative. A male patient of an unspecified age received third booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunisation. Medical history stated patient was immunocompromised due to a prior stem cell transplant on an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, patient received first dose and second dose of BNT162B2 via an unspecified route of administration for covid-19 immunisation. On an unspecified date, patient stated he had received his third booster dose 12 hours after the dose he experienced fatigue, mild headache, and low appetite, 14 hours after the dose he reported experiencing nausea and dizziness and 17 hours after that he had fatigue, a warm feeling and was nauseated. Patient stated events occurred after use of product. Outcome of al the events were unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Extra dose administered, Off label use
Clinical narrative: I have had 3 Pfizer COVID shots; I may have experienced a little pain in my shoulders; Extra dose administered; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient (age at vaccination: 77 years) received third dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FA7485 and expiry date were not reported), via an unspecified route of administration, on 18Aug2021, as a single dose for COVID-19 immunization, second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 23Mar2021, as a single dose for COVID-19 immunization and first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 02Mar2021, as a single dose for COVID-19 immunization. The patient's medical history included idiopathic pulmonary fibrosis in 2012 and polymyalgia rhuematica in 2018. Concomitant medication included prednisone acetate (PREDNISONE). The patient reported that he had 3 Pfizer COVID shots. 1st on 02Mar2021, 2nd on 23Mar2021 and 3rd ('booster') on 18Aug2021. The length of time between the 1st and 3rd was just under 5 months. He was immunocompromised in that he has been on Prednisone for about 3 years. His current dosage was 10 mg per day. The patient asked was there any difference in the shots that he had received and were all 3 the same or was each shot different in some way. If there was a difference in any of those shots, would you please explain. He had no difficulty or side affects with any of the shots (he might have experienced a little pain in his shoulders with the 3rd shot). Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, SARS-CoV-2 test, Vision blurred
Clinical narrative: lost my ability to focus. Vision blurred distance, middle and close.; periods have also been exceptionally heavy every cycle since the vaccine; This is a spontaneous report from a contactable consumer. This 42-year-old female consumer (patient) reported for herself that:  A 42-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 14Apr2021 11:00 (at the age of 42 years old) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store.  Medical history included blood cholesterol increased from an unknown date and unknown if ongoing, strokes rom an unknown date and unknown if ongoing (family history of strokes).   The patient's concomitant medications were not reported.  It was reported that the patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. The patient experienced lost my ability to focus. vision blurred distance, middle and close on 18Apr2021 10:00, periods have also been exceptionally heavy every cycle since the vaccine on 18Apr2021. Caller stated 4 days after the first (only dose caller received) lost ability to focus. Vision blurred distance, middle and close. Lasted about an hour and then reoccurred that night, caller had never experienced this. Caller stated had personal risk factors of potential stroke and the scary/odd loss of vision following  first dose. Caller did not receive the second dose. It was reported that Prolonged Hospitalization was no. Treatment Received was no. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jul2021. (Nasal Swab). The outcome of events was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Extra dose administered, Fatigue, Headache, Illness
Clinical narrative: Caller is a medical assistant and got her third Pfizer covid vaccine and has been sick ever since; headache; nausea; fatigue; joint pain; she got the third dose of the Pfizer COVID-19 vaccine; she got the third dose of the Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable Other HCP (Patient herself). A female patient of an unspecified age received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 (mRNA) VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19Aug2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously received 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 and received 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 2, single for COVID-19 immunisation and states that she has had no problem from the first or second vaccine. On 19Aug2021, she got the third dose of the Pfizer COVID-19 vaccine. On 20Aug2021, the patient experienced caller is a medical assistant and got her third Pfizer COVID vaccine and has been sick ever since, headache, nausea, fatigue and joint pain.  As per the report, she got the third dose of the Pfizer COVID-19 vaccine and stated that she has been sick ever since. She stated that she has had no problem from the first or second vaccine. She stated that she got the vaccine on 19Aug2021 and since 20Aug2021 she has had a headache and nausea Friday-Sunday. She states that she is still have fatigue and joint pain, and that she really hasn't felt right since the third dose. She stated that she didn't have any problems from the first or second dose but the third one threw her for a loop. She wanted to know if this is going to go away or is it something permanent? She stated that she talked to her doctors and they told her to call Pfizer. She stated that she had stuff to treat her symptoms with but it is not doing any good. The outcome of event fatigue and joint pain was not recovered and outcome of all other events was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Off label use
Clinical narrative: Caller is a medical assistant and got her third Pfizer covid vaccine and has been sick ever since; headache; nausea; fatigue; joint pain; she got the third dose of the Pfizer COVID-19 vaccine; she got the third dose of the Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable Other HCP (Patient herself). A female patient of an unspecified age received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 (mRNA) VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19Aug2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously received 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 and received 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 2, single for COVID-19 immunisation and states that she has had no problem from the first or second vaccine. On 19Aug2021, she got the third dose of the Pfizer COVID-19 vaccine. On 20Aug2021, the patient experienced caller is a medical assistant and got her third Pfizer COVID vaccine and has been sick ever since, headache, nausea, fatigue and joint pain.  As per the report, she got the third dose of the Pfizer COVID-19 vaccine and stated that she has been sick ever since. She stated that she has had no problem from the first or second vaccine. She stated that she got the vaccine on 19Aug2021 and since 20Aug2021 she has had a headache and nausea Friday-Sunday. She states that she is still have fatigue and joint pain, and that she really hasn't felt right since the third dose. She stated that she didn't have any problems from the first or second dose but the third one threw her for a loop. She wanted to know if this is going to go away or is it something permanent? She stated that she talked to her doctors and they told her to call Pfizer. She stated that she had stuff to treat her symptoms with but it is not doing any good. The outcome of event fatigue and joint pain was not recovered and outcome of all other events was unknown.    Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bradyphrenia, Dizziness, Extra dose administered, Fatigue, Feeding disorder
Clinical narrative: This is booster.; This is booster.; scalding nerve pain; searing muscle pain; very weak muscles (cant hold phone more than seconds); nausea (unable to eat); profound fatigue; headache; dizzy; slow thinking; unable to eat; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 24Aug2021 as DOSE 3, SINGLE for covid-19 immunisation  .    Medical history included ,chronic obstructive pulmonary disease from, breast cancer female, hypersensitivity.There were no concomitant medications.  The patient previously took bnt162b2 for covid-19 immunisation, bnt162b2 for covid-19 immunisation, theophylline and experienced drug hypersensitivity.  On 24Aug2021 12:00 the patient experienced this is booster (off label use), All systemic, not just arm: scalding nerve pain, searing muscle pain, stiff painful joints, very weak muscles (cant hold phone more than seconds), nausea (unable to eat), profound fatigue, headache, dizzy, slow thinking.The outcome of the events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscular weakness, Myalgia, Nausea, Neuralgia
Clinical narrative: This is booster.; This is booster.; scalding nerve pain; searing muscle pain; very weak muscles (cant hold phone more than seconds); nausea (unable to eat); profound fatigue; headache; dizzy; slow thinking; unable to eat; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 24Aug2021 as DOSE 3, SINGLE for covid-19 immunisation  .    Medical history included ,chronic obstructive pulmonary disease from, breast cancer female, hypersensitivity.There were no concomitant medications.  The patient previously took bnt162b2 for covid-19 immunisation, bnt162b2 for covid-19 immunisation, theophylline and experienced drug hypersensitivity.  On 24Aug2021 12:00 the patient experienced this is booster (off label use), All systemic, not just arm: scalding nerve pain, searing muscle pain, stiff painful joints, very weak muscles (cant hold phone more than seconds), nausea (unable to eat), profound fatigue, headache, dizzy, slow thinking.The outcome of the events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: This is booster.; This is booster.; scalding nerve pain; searing muscle pain; very weak muscles (cant hold phone more than seconds); nausea (unable to eat); profound fatigue; headache; dizzy; slow thinking; unable to eat; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 24Aug2021 as DOSE 3, SINGLE for covid-19 immunisation  .    Medical history included ,chronic obstructive pulmonary disease from, breast cancer female, hypersensitivity.There were no concomitant medications.  The patient previously took bnt162b2 for covid-19 immunisation, bnt162b2 for covid-19 immunisation, theophylline and experienced drug hypersensitivity.  On 24Aug2021 12:00 the patient experienced this is booster (off label use), All systemic, not just arm: scalding nerve pain, searing muscle pain, stiff painful joints, very weak muscles (cant hold phone more than seconds), nausea (unable to eat), profound fatigue, headache, dizzy, slow thinking.The outcome of the events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.