chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypoaesthesia oral, SARS-CoV-2 test
Clinical narrative: Dizziness; tiredness,; numbness of tongue; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old female patient received BNT162b2 (Pfizer-Biotech COVID-19 Vaccine, Batch/Lot Number: Ew0161), via an unspecified route of administration in the Right Arm on 21Apr2021 11:15 as a single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication desvenlafaxine. The patient experienced dizziness, tiredness, and numbness of tongue on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Apr2021. Outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Polymenorrhoea, SARS-CoV-2 test, Uterine disorder
Clinical narrative: excess uterine clotting; enlarged lymph nodes in the auxiliary of left arm.; two uterine cycles every moth; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received the first dose of (Solution for injection), via an unspecified route of administration, administered in Arm Left on 14Jan2021 10:00 (received at the age of 32-years-old) as SINGLE DOSE for covid-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccine in four weeks prior to receiving. Medical history included covid-19 from Nov2020 to an unknown date. The patient was not pregnant and had no known allergies. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and multivitamin. Within 48 hours, on 15Jan2021 10:00 AM, the patient had enlarged lymph nodes in the auxiliary of left arm. 16 days after the vaccine, on 30Jan2021, she started having excess uterine clotting and have been having two uterine cycles every month since the vaccine (Jan2021). She stated that she had COVID-19 in Nov2020 and her cycles were normal. She has been checked with her doctor and refereed to a GYN for further testing. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on Apr2021.  The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received therapeutic measures in response to the adverse events. Outcome of the events was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Insomnia, Malaise, Nasal congestion
Clinical narrative: Congestion; Dizziness; sore throat; slight headache/her head was pounding; ringing in head headache; feeling sick; had a hard time going to sleep; This is a spontaneous report from a contactable consumer (patient).   A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 09:30 (Lot Number: ER8729) as single dose for covid-19 immunisation. There were no medical history or concomitant medications. The patient previously received the first dose of BNT162B2 lot number- EM0204 on 18Mar2021 for Covid-19 immunization and experienced Sore arm. She previously received shingles shot and hurt for a long time. There were no additional vaccines administered on same date of bnt162b2.  She received the second shot on 08Apr2021 at 09:30, initially provided as 14Apr2021. She had a ringing in her head and a slight headache that she has had maybe since the time she got the shot. She blew it off as she was just working. Then she started feeling sick in Apr2021. The slight headache started from the morning she had the shot, 08Apr2021, but she went to work. The ringing in her head was annoying. She still had this and would not say it has improved. The headache and ringing in her head were together. She felt she heard it more at times. Sometimes she can ignore it and it was ok but at night, she has had a hard time going to sleep in Apr2021. It was worsening. The ringing in the head was so horrible at night because it was so quiet. She was still feeling a little sick. She then had a sore throat on 17Apr2021. The sore throat got really bad that night but she took medication for it and got better. She had a sore throat and her head was pounding and a ringing in her head that won't go away. The doctor gave her antibiotics and nose spray and cough medicine.  She didn't think anything was helping, and she wondered if it was a reaction to the shot. Her throat was still a little sore, she thought it went away but this morning 21Apr2021 she was starting feel it again and she felt a little congestion and she still has couple days of antibiotics she was taking. it was persisting. She had head pounding on 18Apr2021 morning: it was pounding like noises. While on hold the loud music was felt like pounding. This was not all the time. She had dizziness started 18Apr2021 morning as soon as she got out of bed. This was still going on occasionally, when she leans over. She had to do a lot of leaning over and therefore has not been to work in 2 weeks since getting the shot. When she straightens up, it went away. This was concerning and not normal, it's persisting. All the events did not require a visit to Emergency Room . The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Tinnitus
Clinical narrative: Congestion; Dizziness; sore throat; slight headache/her head was pounding; ringing in head headache; feeling sick; had a hard time going to sleep; This is a spontaneous report from a contactable consumer (patient).   A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 09:30 (Lot Number: ER8729) as single dose for covid-19 immunisation. There were no medical history or concomitant medications. The patient previously received the first dose of BNT162B2 lot number- EM0204 on 18Mar2021 for Covid-19 immunization and experienced Sore arm. She previously received shingles shot and hurt for a long time. There were no additional vaccines administered on same date of bnt162b2.  She received the second shot on 08Apr2021 at 09:30, initially provided as 14Apr2021. She had a ringing in her head and a slight headache that she has had maybe since the time she got the shot. She blew it off as she was just working. Then she started feeling sick in Apr2021. The slight headache started from the morning she had the shot, 08Apr2021, but she went to work. The ringing in her head was annoying. She still had this and would not say it has improved. The headache and ringing in her head were together. She felt she heard it more at times. Sometimes she can ignore it and it was ok but at night, she has had a hard time going to sleep in Apr2021. It was worsening. The ringing in the head was so horrible at night because it was so quiet. She was still feeling a little sick. She then had a sore throat on 17Apr2021. The sore throat got really bad that night but she took medication for it and got better. She had a sore throat and her head was pounding and a ringing in her head that won't go away. The doctor gave her antibiotics and nose spray and cough medicine.  She didn't think anything was helping, and she wondered if it was a reaction to the shot. Her throat was still a little sore, she thought it went away but this morning 21Apr2021 she was starting feel it again and she felt a little congestion and she still has couple days of antibiotics she was taking. it was persisting. She had head pounding on 18Apr2021 morning: it was pounding like noises. While on hold the loud music was felt like pounding. This was not all the time. She had dizziness started 18Apr2021 morning as soon as she got out of bed. This was still going on occasionally, when she leans over. She had to do a lot of leaning over and therefore has not been to work in 2 weeks since getting the shot. When she straightens up, it went away. This was concerning and not normal, it's persisting. All the events did not require a visit to Emergency Room . The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Ultrasound scan, X-ray
Clinical narrative: My cleaning lady said she is having pain in her lower leg, that she is going through the exact same thing; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that, her cleaning lady said she was having pain in her lower leg, that she was going through the exact same thing on an unspecified date. The patient underwent lab tests and procedures which included ultrasound scan and x-ray on unknown date. Now they want a neve conduction test and MRI. The event was considered as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Patient had fever and chills during the night after 2nd dose; Patient had fever and chills during the night after 2nd dose; This is a spontaneous report from a non-contactable consumer (Patient) via company representative. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of (BNT162B2) for via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. On an unspecified date, patient had fever and chills during the night after 2nd dose. Event took place after use of product. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: first shot, just some soreness of her arm; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration on 18Mar2021 (Batch/Lot Number: EM0204) as single dose for COVID-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient received her first shot on 18Mar2021. She had nothing really with the first shot, just some soreness of her arm. The outcome of the events was recovered on 21Mar2021.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Felt very sick; This is a spontaneous report from a non-contactable consumer (patient's parent). A male patient an unspecified age received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient was felt very sick. The outcome of the event unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Fatigue; disjointed thoughts and speech; disjointed thoughts and speech; chills; headache; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received second dose 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 single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced Fatigue, disjointed thoughts and speech, chills and headache after 2nd COVID vaccine. Awareness Date was 25Apr2021. The event outcome of unknown. Event took place after use of product. Reporter does not wish to be contacted for follow-up.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: Felt a lot of pain; This is a solicited report by a contactable consumer (patient) based on information received by Pfizer from Manufacturer Report Number: UNT-2021-007034). This case is a solicited report received on 16Apr2021, from a consumer via (specialty pharmacy). This 47-year-old, 125-lb, female, patient began therapy with Orenitram (treprostinil diethanolamine), on 17Jan2020 for primary pulmonary arterial hypertension. The patient was supplied with Orenitram 2.5 mg and the current dose was reported as 2.5 mg, every 8 hours (q8h) via oral (PO) route. On 27Mar2021, the patient felt a lot of pain from COVID vaccination (pain, hospitalization). Co-suspect medication included: Covid-19 vaccine. Concomitant medications included: Opsumit (macitentan) and Adcirca (tadalafil). Relevant medical history included: primary pulmonary arterial hypertension. On 27Mar2021, 1 year 2 months 11 days after initiating PO (Orally) Orenitram, the patient was hospitalized because she felt a lot of pain from COVID vaccination. The patient received 2nd COVID vaccination on 25Mar2021. She was discharged on 04Apr2021. Action taken with PO (Orally) Orenitram dose for the event of pain was not reported. Action taken with Covid-19 vaccine dose for the event of pain was not applicable. At the time of reporting the outcome of the event of pain was unknown. The reporter did not provide causality for the event of pain. Comment: The company has assessed the serious adverse event of pain as not related to oral treprostinil. The event was likely related to COVID vaccination in view of the safety profiles of current COVID vaccines.  The reporter's assessment of the causal relationship of the pain with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The event pain is considered related to suspect product COVID 19 vaccine (unspecified), in view of the safety profiles of current COVID vaccines. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Feeling abnormal, Hot flush
Clinical narrative: had strange vision issues where I am dizzy and then I see spots and distortion of what is in front of me off and on; extreme dizziness and tiredness; extreme dizziness and tiredness; infectious mononucleosis; had a lot of brain fog; extreme lethargy to the point of wanting to sleep it off every single day no matter how long she slept; sore all over her body like her joints are sore all over her body; sore all over her body like her joints are sore all over her body; hot flashes like when she went into menopause in the past; all she wanted to do was sleep all the time; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Apr2021 09:15 (Batch/Lot Number: ew0153) as single dose for covid-19 immunisation.  Medical history included hot flush from an unknown date and unknown if ongoing (went into menopause in the past), menopause from an unknown date and unknown if ongoing menopause.  The patient previously took Tequin and experienced allergy. Patient reported of taking daily vitamins and supplements in 2 weeks timeframe of vaccination. There were no other vaccines in 4 weeks. Patient did not have COVID prior to vaccination. On Day 1, 11Apr2021 at 09:15 am, the patient experienced extreme dizziness and tiredness. Day two and on, patient still getting the side effects. Patient stated "I felt like I have mono". She expressed that  she was "dog tired" every single day. She reported of also had a lot of brain fog. She had extreme lethargy to the point of wanting to sleep it off every single day no matter how long she slept. Patient reported of also experienced "strange vision issues where I am dizzy and then I see spots and distortion of what is in front of me off and on". The patient was sore all over her body like her joints are sore all over her body. She experienced hot flashes like when she went into menopause in the past. All of these symptoms come and go but the lethargy and brain fog continued and has not gone away now 12 days has past since she got her first shot. She stated that all she wanted to do was sleep all the time. The outcome of events was not recovered. No treatment was received. Patient did not test for COVID post vaccination.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Infectious mononucleosis, Lethargy, Pain, Somnolence, Visual impairment
Clinical narrative: had strange vision issues where I am dizzy and then I see spots and distortion of what is in front of me off and on; extreme dizziness and tiredness; extreme dizziness and tiredness; infectious mononucleosis; had a lot of brain fog; extreme lethargy to the point of wanting to sleep it off every single day no matter how long she slept; sore all over her body like her joints are sore all over her body; sore all over her body like her joints are sore all over her body; hot flashes like when she went into menopause in the past; all she wanted to do was sleep all the time; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Apr2021 09:15 (Batch/Lot Number: ew0153) as single dose for covid-19 immunisation.  Medical history included hot flush from an unknown date and unknown if ongoing (went into menopause in the past), menopause from an unknown date and unknown if ongoing menopause.  The patient previously took Tequin and experienced allergy. Patient reported of taking daily vitamins and supplements in 2 weeks timeframe of vaccination. There were no other vaccines in 4 weeks. Patient did not have COVID prior to vaccination. On Day 1, 11Apr2021 at 09:15 am, the patient experienced extreme dizziness and tiredness. Day two and on, patient still getting the side effects. Patient stated "I felt like I have mono". She expressed that  she was "dog tired" every single day. She reported of also had a lot of brain fog. She had extreme lethargy to the point of wanting to sleep it off every single day no matter how long she slept. Patient reported of also experienced "strange vision issues where I am dizzy and then I see spots and distortion of what is in front of me off and on". The patient was sore all over her body like her joints are sore all over her body. She experienced hot flashes like when she went into menopause in the past. All of these symptoms come and go but the lethargy and brain fog continued and has not gone away now 12 days has past since she got her first shot. She stated that all she wanted to do was sleep all the time. The outcome of events was not recovered. No treatment was received. Patient did not test for COVID post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Fibroblast growth factor 23, Product administered to patient of inappropriate age
Clinical narrative: 01-month-old male patient; fgf; This is a spontaneous report from a non-contactable health care professional. A 1-month-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 06Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fgf (as reported) on Apr2021. The outcome of the event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot been obtained.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the event, experiencing fgf cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Limb mass, Pain, Pyrexia
Clinical narrative: low grade fever; lump in the arm underneath skin; body aches and pains; chills; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (reported as COVID 19 vaccine), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced Low graded fever, Lump in arm underneath Skin, Body aches and pain, Chills on an unspecified date. He was concerned because it was still going on. The outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: had pain at injection site; fatigue; This is a spontaneous report from a non contactable consumer. This consumer (sister of patients mother) reported for a 17-year-old female patient. A 17-year-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, The patient had pain at injection site and fatigue. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site swelling
Clinical narrative: Patient described experiencing swelling and a large lump at the injection site on her arm after the vaccination was administered.; Patient described experiencing swelling and a large lump at the injection site on her arm after the vaccination was administered.; This is a spontaneous report received from a contactable pharmacist. A 45-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via intramuscular route of administration, administered in Arm Left on 19Apr2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Apr2021, the patient experienced swelling and a large lump at the injection site on her arm after the vaccination was administered. The outcome of the event was recovered on 21-Apr-2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Ear pain, Head discomfort, Headache, Pain
Clinical narrative: Head pressure; pain where Botox injected; Extreme pain and pressure; Dizziness; Vertigo; Headache; Ear pain; This is a spontaneous report from a contactable consumer or other non-HCP. A 50-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8729), via an unspecified route of administration in left arm on 09Apr2021 as single dose for covid-19 immunization. Medical history included migraine, Graves' disease, hypothyroidism and blood pressure measurement. Historical vaccine included BNT162B2 for Covid-19 immunization. Concomitant medications included botox, propranolol, emgality galcanezumab levothyroxine and prednisone. On 10Apr2021, the patient experienced extreme pain and pressure, dizziness, vertigo, headache, ear pain patient had head pressure and pain where botox injected. Consumer stated, I was calling to report a reaction to a medication to the second COVID Vaccine. So, migraine suffer (Later clarified as medical history) and I take numerous medications to prevent migraine. One of the interactions that I experienced is Botox injection with and the second COVID vaccine, I had a reaction. Consumer stated, it was not immediate, it was the day after and it would have been, it was Saturday. So, 10Apr2021. Consumer stated, it doesn't have any expiration date. I dont see expiration. There was a date printed here April 2nd. Wherever I received my Botox injection, I received Botox injection in my shoulders, in my neck, left side of my (incomplete sentence), the temples in the face, the upper face. I have extreme pain and pressure. Consumer stated, "After it was getting worse it started getting better, the pressure and pain with causing me dizziness, vertigo and a headache and ear pain I went into my primary doctor and she gave a prescription of steroid, Prednisone 20 mg (treatment) and it started with 3 tablet by mouth for 3 days then it went to 2 tablet by mouth for 3 days then it went 1 tablet by mouth for 3 days and then it went to half a tablet for 3 days. Severe head pressure and upper head pressure. Caller would like to report the reaction she experienced after the 2nd dose. Caller has migraine and experienced pain where Botox injected and also experienced head pressure. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Head pressure; pain where Botox injected; Extreme pain and pressure; Dizziness; Vertigo; Headache; Ear pain; This is a spontaneous report from a contactable consumer or other non-HCP. A 50-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8729), via an unspecified route of administration in left arm on 09Apr2021 as single dose for covid-19 immunization. Medical history included migraine, Graves' disease, hypothyroidism and blood pressure measurement. Historical vaccine included BNT162B2 for Covid-19 immunization. Concomitant medications included botox, propranolol, emgality galcanezumab levothyroxine and prednisone. On 10Apr2021, the patient experienced extreme pain and pressure, dizziness, vertigo, headache, ear pain patient had head pressure and pain where botox injected. Consumer stated, I was calling to report a reaction to a medication to the second COVID Vaccine. So, migraine suffer (Later clarified as medical history) and I take numerous medications to prevent migraine. One of the interactions that I experienced is Botox injection with and the second COVID vaccine, I had a reaction. Consumer stated, it was not immediate, it was the day after and it would have been, it was Saturday. So, 10Apr2021. Consumer stated, it doesn't have any expiration date. I dont see expiration. There was a date printed here April 2nd. Wherever I received my Botox injection, I received Botox injection in my shoulders, in my neck, left side of my (incomplete sentence), the temples in the face, the upper face. I have extreme pain and pressure. Consumer stated, "After it was getting worse it started getting better, the pressure and pain with causing me dizziness, vertigo and a headache and ear pain I went into my primary doctor and she gave a prescription of steroid, Prednisone 20 mg (treatment) and it started with 3 tablet by mouth for 3 days then it went to 2 tablet by mouth for 3 days then it went 1 tablet by mouth for 3 days and then it went to half a tablet for 3 days. Severe head pressure and upper head pressure. Caller would like to report the reaction she experienced after the 2nd dose. Caller has migraine and experienced pain where Botox injected and also experienced head pressure. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: Head pressure; pain where Botox injected; Extreme pain and pressure; Dizziness; Vertigo; Headache; Ear pain; This is a spontaneous report from a contactable consumer or other non-HCP. A 50-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8729), via an unspecified route of administration in left arm on 09Apr2021 as single dose for covid-19 immunization. Medical history included migraine, Graves' disease, hypothyroidism and blood pressure measurement. Historical vaccine included BNT162B2 for Covid-19 immunization. Concomitant medications included botox, propranolol, emgality galcanezumab levothyroxine and prednisone. On 10Apr2021, the patient experienced extreme pain and pressure, dizziness, vertigo, headache, ear pain patient had head pressure and pain where botox injected. Consumer stated, I was calling to report a reaction to a medication to the second COVID Vaccine. So, migraine suffer (Later clarified as medical history) and I take numerous medications to prevent migraine. One of the interactions that I experienced is Botox injection with and the second COVID vaccine, I had a reaction. Consumer stated, it was not immediate, it was the day after and it would have been, it was Saturday. So, 10Apr2021. Consumer stated, it doesn't have any expiration date. I dont see expiration. There was a date printed here April 2nd. Wherever I received my Botox injection, I received Botox injection in my shoulders, in my neck, left side of my (incomplete sentence), the temples in the face, the upper face. I have extreme pain and pressure. Consumer stated, "After it was getting worse it started getting better, the pressure and pain with causing me dizziness, vertigo and a headache and ear pain I went into my primary doctor and she gave a prescription of steroid, Prednisone 20 mg (treatment) and it started with 3 tablet by mouth for 3 days then it went to 2 tablet by mouth for 3 days then it went 1 tablet by mouth for 3 days and then it went to half a tablet for 3 days. Severe head pressure and upper head pressure. Caller would like to report the reaction she experienced after the 2nd dose. Caller has migraine and experienced pain where Botox injected and also experienced head pressure. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 2 via an unspecified route of administration as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical Vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The caller reported that his sons are 23 and 25. Caller reported that both of his sons received both doses of the Pfizer Covid-19 vaccine. Caller reported that his sons both had sore arms for about a day and that their pain went away immediately. The outcome of the event was recovered in 2021.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Caller reported that his sons both had sore arms; This is a spontaneous report from a contactable consumer or other non hcp. A 23-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6201; Expiration Date: unknown), dose 2 via an unspecified route of administration on left arm on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. Historical Vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's concomitant medications were not reported. Caller reported that his sons are 23 and 25. Caller reported that both of his sons received both doses of the Pfizer Covid-19 vaccine.  Caller reported that his sons both had sore arms for about a day and that their pain went away immediately. The outcome of the events was recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Influenza like illness, Pyrexia
Clinical narrative: anticipated fever; flu like symptoms; pain in elbow joint/occasionally he feels elbow pain; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient received first dose on unspecified date for COVID-19 immunization no adverse effect after first dose. Medical history and concomitant medications were not reported. The patient mentioned that post the second PfiZer COVID vaccine along with the anticipated fever and flu like symptoms the patient experienced pain in elbow joint on unspecified date that lasted for 3 days and a month later occasionally he feels elbow pain. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Migraine, Nausea, Photophobia
Clinical narrative: Migraine; light sensitive; Extremely nauseous; Extremely dizzy; Headache; This is a spontaneous report from a contactable consumer. This consumer reported similar events for herself and her husband. This is 2nd of 2 reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced migraine, light sensitive, extremely nauseous, extremely dizzy, and headache but he was able to sleep at night. (These events were reported as "similar side effects" with the patient's spouse.). The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021477842 same reporter, drug, and event, different patient
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable consumer (Patient) reported two reports for herself and her son. This is one of the two reports. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 28Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the 2nd dose of the Pfizer covid vaccine yesterday on 28Apr2021. She and her son have a fever in Apr2021. Caller also stated 'Tylenol' didn't really work for her. The outcome of the event was unknown.                                  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021481479 same reporter, product and AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Myalgia
Clinical narrative: muscle pain increased after the second dose; her anxiety increased after the second dose; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not provided) via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunisation. Medical history included spinal cord disorder, anxiety, muscle pain and breast cancer (survivor for 33 years). Concomitant medications included blood pressure (unspecified),blood thinner (unspecified), pain medication and anxiety medication. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not provided) via an unspecified route of administration on 12Feb2021 as a single dose for COVID-19 immunization and experienced injection site swelling. On an unspecified date in 2021, patient had anxiety and muscle pain increased after the second dose. The patient wanted to know if other people experienced the same adverse reaction as she did. The outcome for the events were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache
Clinical narrative: felt dizzy; Headache; she had chill; This is a spontaneous report from a contactable consumer (patient) received from Pfizer sponsored program. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 23Apr2021, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date. On 24Apr2021 (Saturday), the patient experienced chills. On 25Apr2021 (Sunday), she had a very light headache. On 26Apr2021 (Monday), she had a severe headache and felt dizzy. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Pyrexia, SARS-CoV-1 test positive
Clinical narrative: she felt very sick; chills; fever; This is a spontaneous report received from a Pfizer sponsored program COVAX US Support.   A non-contactable consumer (patient) reported for herself that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history includes that she had tested positive to COVID before receiving the 1st vaccine. The concomitant medications were not reported. Caller wanted to know was it ok not to show up for her 2nd appointment because after receiving her 1st dose of the vaccine she felt very sick and had the chills and fever on an unspecified date. At home she took her temperature and it was 99 but when she went to the doctor office it was 97. She read online that she didn't really need the 2nd dose or the vaccine if she already tested positive for COVID. The patient underwent lab tests and procedures which included body temperature: 99, body temperature: 97, SARS-CoV-1 test positive: positive on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Lymphatic disorder
Clinical narrative: lymph level is extremely high/Elevated Lymph levels on blood work; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient (unknown age) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 04Apr2021 as SINGLE DOSE for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On an unspecified date patient had her lab work done and her lymph level was extremely high. Elevated Lymph levels on blood work. The response which the patient received included a review of the prescribing Information for Pfizer Covid Vaccine did not find information regarding elevated lymph. As the Prescribing Information did not include all adverse reactions that have been reported or that may occur, the patient was advised to consult with her doctor/healthcare provider about what she had experienced/experiencing. Because her doctor/healthcare provider is most familiar with her medical condition, clinical history, how her treatment has been conducted and any relevant information to her specific case, her doctor/healthcare provider was in the best position to advise her about the appropriate action to take. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Sinusitis
Clinical narrative: sinus infection; asking if Doxycycline with interfere or interact with the vaccine; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,/Lot number: not reported), dose 1 via an unspecified route of administration on 15Apr2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. on an unspecified date,the patient experienced sinus infection, asking if doxycycline with interfere or interact with the vaccine. Question: Caller is a consumer, asking if Doxycycline with interfere or interact with the vaccine. Caller reports that she received her first vaccine dose on 15Apr2021 and is scheduled for her second dose on 05May2021 but since her first dose she has been diagnosed with a sinus infection and was prescribed Doxycycline antibiotic. She reports "I read on the fact sheet that you shouldn't take other vaccines when getting the covid vaccine and I want to know if it is safe to take my antibiotic for 10 days if I'm planning to get my second shot". Caller reports that she already talked to her doctors PA wh'o advised her that it was ok to take the antibiotic, but she stated "He's new and I don't trust him yet".  Caller also asks "When can I restart my other medicine" reporting that she was advised to hold her medications, no specific medicine specified, but wasn't told when to restart them. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, SARS-CoV-2 antibody test, Vomiting
Clinical narrative: She had diarrhea, vomiting, and stomach pain from the 1st dose; She had diarrhea, vomiting, and stomach pain from the 1st dose; She had diarrhea, vomiting, and stomach pain from the 1st dose; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 08Apr2021 (at 56-years age) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had diarrhea, vomiting, and stomach pain from the 1st dose and went to doctor on 08Apr2021. They were still ongoing. When patient had blood work done, she had positive antibodies for COVID and the office stated she would have to wait until the end of may to get the second dose. Patient was supposed to get her second dose on 29Apr2021. Patient was asking how she can reschedule her second appointment. The outcome of the event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A  male patient received both doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on an unknown date (received second dose day before yesterday as per report) as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included clopidogrel bisulfate (PLAVIX) as an anticoagulant therapy. After both doses, the patient experienced sore arm. Patient was unaware at the time of his injections that he should mention taking an anti-coagulant. The outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Chills, Hyperhidrosis, Hypersensitivity
Clinical narrative: Woke up with chills; Sweat through an undershirt; The arm that they gave the shot in at the injection site got red; Had arthritic stuff in fingers; Late reaction; This is a spontaneous report from a contactable consumer (patient). A male patient (age reported as 77) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date not reported) via an unspecified route of administration on 20Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 26Apr2021, patient blood drawn in general (results unknown). Last night, 28Apr2021 into 29Apr2021 (as reported), the arm that they gave the shot in at the injection site got red. Patient took Tylenol this morning and that subsided. He had arthritic stuff in fingers, but the Tylenol helped and woke up with chills, and his fellow golfers had the chills too, but he also sweat through an undershirt. Patient was scheduled for the second dose on 11May2021 and was just a little anxious of whether to delay it because of a late reaction. The case was non serious. Outcome for the event the arm that they gave the shot in at the injection site got red was recovered on 29Apr2021, had arthritic stuff in fingers was recovering, and for remaining was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.