chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blister, Blood blister, Pain, Skin discolouration, Vaccination site erythema
Clinical narrative: redness at the injection site; discoloration; blisters in between her toes; she noticed a blood blister; extremely sore; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in Arm on 28Aug2021 as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. On an unspecified date in Sep2021, the patient experienced redness at the injection site and on an unspecified date in 2021 the patient experienced extremely sore, discoloration, blisters in between her toes and she noticed a blood blister. Therapeutic measures were taken as a result of redness at the injection site. The patient stated she received her first dose of the Pfizer-BioNTech Covid-19 vaccine on 28Aug2021. She stated she had tremendous anxiety about the vaccine and the vaccination provider did it high on her arm. She believed that where they vaccinated her she was surprised she did not have a giant bruise. It was extremely sore, which was fine, and there was no redness initially. A week later, to the day, her fiance noticed at the injection site (of the patient) there was a quarter size red mark but it was not itchy. It was flush with the skin, not swollen, and took a week to fade. It left a light tan mark like if they burned their hand and it healed to turn tan. She called the pharmacist and they said they have gotten reports of that. The discoloration was just how the area healed. She stated on her left toe, medially, the area that makes contact with the pointer and she noticed a blood blister. She stated it could be from shoes or flip flops, but it was a popped blood blister. She stated it was in an odd place where you can get a friction blister. If she didn't get the vaccine, she wouldn't had given it a second thought. She stated she had super sensitive skin but no other blisters or petechiae. She stated she was connecting the dots of the blood blister on her foot being potentially from the vaccine. The doctor was not helpful, but she let it go as that. She wanted to know if that could be from the vaccine or if it was a contraindication to the second dose. Therapeutic measures were taken as a result of redness at the injection site that included, she took Benadryl and used a steroid cream. The patient recovered from the outcome of the events redness at the injection site on an unspecified date and the outcome of the events extremely sore, discoloration, blisters in between her toes, she noticed a blood blister was reported as unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Limb discomfort, Loss of personal independence in daily activities
Clinical narrative: 4 to 5 to 6 days later, he lost range of motion on his arm down to 15%, and can't lift his arm or do anything with that arm unless he holds it straight to his side; 4 to 5 to 6 days later, he lost range of motion on his arm down to 15%, and can't lift his arm or do anything with that arm unless he holds it straight to his side; 4 to 5 to 6 days later, he lost range of motion on his arm down to 15%, and can't lift his arm or do anything with that arm unless he holds it straight to his side; left shoulder was kind of throbbing; This is a spontaneous report from a contactable consumer or other non hcp. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 31Aug2021 as dose 1, single (at the age of 44 year) for COVID-19 immunisation. The patient medical history and medications were not reported. On 31Aug2021, consumer stated that as soon as he came out, his left shoulder was kind of throbbing, but he expected that. "3 to 5 days into it, it started getting worse". On an unspecified date in Sep2021, consumer reported that 4 to 5 to 6 days later, he lost range of motion on his arm down to 15% and can't lift his arm or do anything with that arm unless he holds it straight to his side". Consumer also mentioned that he read on the internet that it may not be from the vaccine but from how the vaccine was administered, as people have administered it incorrectly. Consumer asked if this had been reported as side effect of the Pfizer COVID-19 vaccine and what does he need to do about it and in terms of reporting? Consumer also stated that he was now hesitant to get his second dose of the Pfizer COVID-19 vaccine. Spoke from attached document #1, mentioned "arm pain and muscle pain have been reported as possible side effects of the Pfizer COVID-19 vaccine." The outcome of events was unknown.  The Lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: swelling of the lower edge of his lip that is quarter inch and a half long; swelling of the face; This is a spontaneous report from a contactable consumer (patient himself). A 79-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EP7534; Expiration date: unknown) via an unspecified route of administration on 16Mar2021 (at age of 79-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6198; Expiration date: unknown) via an unspecified route of administration on 23Feb2021 (at age of 78-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced swelling of the lower edge of his lip that is quarter inch and a half long and swelling of the face on Aug2021. It was reported that, the patient had received the both doses of the vaccine in one in February and second in March - 6 weeks ago he experienced swelling of the lower edge of his lip that was quarter inch and a half long - He went to his dermatologist, main hospital in withheld, and his doctor but no one can provide any idea on why he had it - His dermatologist gave something to put on and it was not able to treat it - He will go to withheld in about 2 weeks for consultation - Asking if this has been reported before and what was the percentage of reported cases for swelling of specific body part. Therapeutic measures were taken as a result of adverse event (treatment not specified). This report was not serious. The outcome of both the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, SARS-CoV-2 test
Clinical narrative: Menstrual cycle was 3 weeks late after receiving the first dose; This is a spontaneous report from a non-contactable consumer, the patient. An adult non-pregnant female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On an unknown date, the patient's menstrual cycle was 3 weeks late after receiving the first dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent the COVID-19 test and the result was negative. The clinical outcome of the event menstrual cycle was 3 weeks late after receiving the first dose was unknown at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Persistent genital arousal disorder
Clinical narrative: Condition called PGAD or Persistent Genital Arousal Disorder; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 20Feb2021 at 14:15 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (A-fib), high blood pressure and high cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included losartan (MANUFACTURER UNKNOWN), atenolol (MANUFACTURER UNKNOWN) and flecainide (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 20Jan2021 at 13:30, as a single dose for COVID-19 immunisation. The patient previously received sumatriptan succinate (IMITREX) for an unknown indication on an unknown date and experienced drug allergy. The patient previously received pramipexole dihydrochloride monohydrate (MIRAPEX), rivaroxaban (XARELTO) and hydrocodone bitartrate/ paracetamol (NORCO); all for unknown indications from unknown dates. On 10Mar2021 at 21:45, the patient had a condition called PGAD or persistent genital arousal disorder. It was like being aroused and not in a good way either all the time. It was reported that, it hurt and the patient could not get any relief, it was horrid. The event persistent genital arousal disorder did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event persistent genital arousal disorder. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event condition called PGAD or persistent genital arousal disorder was not resolved at the time of this report.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over body and come backagain next day; Rash all over body and come backagain next day; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Aug2021 at 15:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 08Sep2021, the patient experienced rash all over body and come back again next day, on 09Sep2021. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with diphenhydramine (BENADRYL).  The clinical outcome of the events rash all over body and come back again next day was resolving at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Aug2021 at 15:30 (at the age of 45-year-old), as a single dose for COVID-19 immunisation.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Loss of personal independence in daily activities, Pain
Clinical narrative: weak as a baby kitten/It is got me weak; It is got me weak and I cant do anything; chills; extreme body aches; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received 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 in 2021 (at the age of 80-year-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received the Pfizer covid vaccine 2 weeks ago, was experiencing, chills, extreme body aches (2021), and weak as a baby kitten (Sep2021). Patient wanted to know what to do about the side effects, and how long will they last. Patient stated, it had been 1 week ago today It had got me weak, and I cannot do anything (Sep2021), I sure wish it would leave me. The events were assessed as non-serious. The clinical outcome of events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia, Skin discolouration
Clinical narrative: low grade fever; headache; Has 2 marks on his stomach about the size of a little blueberry/color is still dark; When he presses it, it is painful; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 28Aug2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. He did not have a doctor and never needed to see a doctor and when he got his first dose of the Pfizer COvid-19 Vaccine on 28Aug2021, he had a lot of things happen to him. Who should he go see and where should he go? Who will pay for this if the doctor tells him that the vaccine is the cause of his problem? The patient is worried. In Sep2021, 2 weeks (as reported, not captured in field) after the first dose of the Pfizer Covid-19 Vaccine, he continued to experience low grade fever, headache, and had 2 marks on his stomach about the size of a little blueberry. When he pressed it, it was painful and the color was still dark. The symptoms began 10 days (captured in field) after receiving the vaccine. Lab tests included low grade fever in Sep2021. The outcome of events was unknown.  The lot number for bnt162b2, was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasopharyngitis
Clinical narrative: Real fatigue; Light headache; Cold; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 15Sep2021 at 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (reported as HBP) and asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took promethazine (PHENERGAN), for an unknown indication, from an unspecified date and experienced drug allergy. On 16Sep2021, at 07:00 the patient experienced real fatigue, light headache and cold. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events real fatigue, light headache and cold was not recovered, at the time of this report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation delayed, SARS-CoV-2 test
Clinical narrative: Disruption in menstrual cycle/ very delayed cycle; Unusual cramps; This is a spontaneous report from a contactable healthcare professional, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via intramuscular route of administration on 26Jul2021 at 10:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jul2021, directly after first vaccination, the patient experienced disruption in menstrual cycle, very delayed cycle with unusual cramps. Since the vaccination, the patient had been tested for COVID-19. On 23Aug2021, the patient underwent COVID-19 test and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events disruption in menstrual cycle/ very delayed cycle and unusual cramps were not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0T65) via unspecified route of administration in the right arm on an unspecified date in 2021 (at the age of 36-year-old) as a single dose for COVID-19 immunisation.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Tension headache
Clinical narrative: dizziness; it wasn't a headache but "it felt like tightness in my head"; This is a spontaneous report from a non-contactable consumer (patient). A 55-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication(s) included ranitidine hydrochloride (ACID REDUCER [RANITIDINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. On 06Sep2021, the patient experienced dizziness, it wasn't a headache but "it felt like tightness in my head". Caller reported that 4 days after vaccination on Monday he started having dizziness that got progressively worse, had a really bad day, then it got better and now he is clear of it, caller reports that it wasn't a headache but "it felt like tightness in my head" that presented itself on Monday, continued Tuesday, Wednesday it was the worst and Thursday is started getting better. I didn't have an allergic reaction, but dizziness is not a good thing. Caller reported that he read that dizziness occurs in about 17% of patients. He reports that he counts himself pretty fortunate because he didn't experience a fever or anything. Caller wants to know if he will experience dizziness again if he gets the second Covid vaccine dose. The outcomes of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Pain in extremity
Clinical narrative: she only had a sore arm after the first three doses; she only had a sore arm after the first three doses; Sore arm; This is a spontaneous report from a contactable consumer (Patient's husband) reported for 66-year-old female patient (reporter's wife) via Medical Information Team. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), dose 3 via an unspecified route of administration on 24Aug2021 (at the age of 66 years old) as DOSE 3, SINGLE for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medication included hydrocortisone (HUMERA) for rheumatoid arthritis from an unspecified start date and ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown) on 04Feb2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown) on 26Feb2021 for covid-19 immunisation and patient experienced she only had a sore arm after the first three doses. Reporter was on behalf of his wife who has received four total Pfizer BioNtech covid 19 vaccines. They were on 04Feb2021, 26Feb2021, 24Aug2021 and today respectively. Today she was supposed to get a flu shot and was accidentally given a fourth dose of the Pfzer BioNtech covid 19 vaccine. She has not had any side effects so far. Reporter reports that she only had a sore arm after the first three doses on an unspecified date in Aug2021. Reporter also reports that she has RA and has been on Humera for the past 15 years. Seeking information on safety after this error of the 4th dose. Reporter considered events as non-serious. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eructation, Fatigue, Flatulence, Headache
Clinical narrative: Fast heartbeat; Had a Lot's of gas & burping back to back; Had a Lot's of gas & burping back to back; Joint pain; Muscle pain; Low fever; Headache; Tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Sep2021 at 10:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and it was reported that the patient was vegan and mostly used plant-based medications/natural remedies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received Pfizer vaccine (details unspecified) within four weeks prior to the vaccination. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN) and inhalers (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously took ibuprofen (MANUFACTURER UNKNOWN), amoxicillin (AMOXI) and ibuprofen (MOTRIN) and experienced drug allergy. On an unknown date in Sep2021 the patient experienced besides Joint pain, muscle pain, low fever, fast heartbeat, headache and tiredness. The patient had a lot's of gas and burping back to back that decreased in 2 days. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events Joint pain, muscle pain, low fever, fast heartbeat, headache, tiredness and had a lot's of gas and burping back to back were resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia, Pyrexia
Clinical narrative: Fast heartbeat; Had a Lot's of gas & burping back to back; Had a Lot's of gas & burping back to back; Joint pain; Muscle pain; Low fever; Headache; Tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Sep2021 at 10:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and it was reported that the patient was vegan and mostly used plant-based medications/natural remedies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received Pfizer vaccine (details unspecified) within four weeks prior to the vaccination. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN) and inhalers (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously took ibuprofen (MANUFACTURER UNKNOWN), amoxicillin (AMOXI) and ibuprofen (MOTRIN) and experienced drug allergy. On an unknown date in Sep2021 the patient experienced besides Joint pain, muscle pain, low fever, fast heartbeat, headache and tiredness. The patient had a lot's of gas and burping back to back that decreased in 2 days. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events Joint pain, muscle pain, low fever, fast heartbeat, headache, tiredness and had a lot's of gas and burping back to back were resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Site injection - redness, mild swelling,hot, itchy; Site injection - redness, mild swelling,hot, itchy; Site injection - redness, mild swelling,hot, itchy; Site injection - redness, mild swelling,hot, itchy; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration on 13Sep2021 at 16:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included lymphangioleiomyomatosis (LAM), diabetes type 2 and thyroid cancer. The patient had known allergy to computerized tomography (CT) contrast. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination. Concomitant medications included, varicella zoster vaccine recombinant glycoprotein E (rge) (cho) (SHINGRIX) and pertussis vaccine/ tetanus vaccine toxoid/diphtheria vaccine toxoid (DPT); both  taken on 24Aug2021 for immunisation, dapagliflozin propanediol monohydrate (FARXIGA), sirolimus (MANUFACTURER UNKNOWN), medroxyprogesterone acetate (MEDROXIPROGESTERONE), levothyroxine sodium (SYNTHROID), montelukast sodium (MONTELUCAST), semaglutide (RYBELSUS), fexofenadine hydrochloride (ALLEGRA), ezetimibe (MANUFACTURER UNKNOWN), irbesartan (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received codeine (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN) and paracetamol/ oxycodone hydrochloride/oxycodone terephthalate (PERCOCET); all for unknown indications from unknown dates and experienced drug allergy. On 15Sep2021, the patient experienced site injection - redness, mild swelling, hot, itchy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events site injection - redness, mild swelling, hot, itchy was resolving at the time of this report.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal lymphadenopathy, Joint swelling, Lymphadenopathy, Peripheral swelling, Swelling
Clinical narrative: Right olecranon process swelling; Right axillary Lymphadenopathy; Right abdominal Lymphadenopathy; Right toe swelling; Swelling and lymphadenopathy on theright side of the body; Swelling and lymphadenopathy on the right side of the body; This is a spontaneous report from a contactable physician. A 59-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via intramuscular route of administration in the right arm on 21May2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via unknown route of administration on 30Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 21May2021, the patient experienced right olecranon process swelling, right axillary lymphadenopathy, right abdominal lymphadenopathy, right toe swelling and swelling and lymphadenopathy on the right side of the body. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right olecranon process swelling, right axillary lymphadenopathy, right abdominal lymphadenopathy, right toe swelling and swelling and lymphadenopathy on the right side of the body was unknown at the time of this report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea, SARS-CoV-2 test
Clinical narrative: Period comes every 23-25 days; This is a spontaneous report from a contactable healthcare professional, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El3246) via an unspecified route of administration in the left arm on 21Jan2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation and the patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 29Jan2021 (after two doses of vaccine), the patient's period was coming every 23 to 25 days, prior to the vaccine the patient had a very regular period that came every 30 days on the dot. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient has been tested for COVID-19. On an unknown date in 2021, the patient underwent Id now COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event period comes every 23 to 25 days was not resolved at the time of this report.  The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Mild rash on left chest, same side as injection; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 12Sep2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included cardiovascular disease. It was unknown if the patient had any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 12Sep2021 the patient experienced mild rash on left chest, same side as injection. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken for the event mild rash. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild rash on left chest, same side as injection was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Middle insomnia, Nausea, Restless legs syndrome
Clinical narrative: Awakened from normal sleep by something similar to restless leg syndrome (which "I" don't have) accompanied by pain all over body; Awakened from normal sleep by something similar to restless leg syndrome (which "I" don't have) accompanied by pain all over body; Couldn't find any position that "I" could stay in for more than a few seconds. "I" couldn't tolerate the pressure of the bed on any part of body; Felt acute pain in the rib area of back on both sides; Mild nausea; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the right arm on 14Sep2021 at 10:15 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer survivor, chronic back pain, and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included acetylsalicylic acid (ASPIRIN), paracetamol (TYLENOL), and curcuma longa (TURMERIC), unspecified vitamins and minerals; all taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received hydrochlorothiazide (HCTZ) on an unknown date for unknown indication and experienced drug allergy. On 14Sep2021, the patient experienced mild nausea, which the patient had since getting the shot. On 16Sep2021 at 00:00, the patient was awakened from normal sleep by something similar to restless leg syndrome (which the patient did not have) accompanied by pain all over the body, the patient could not find any position that the patient could stay in for more than a few seconds. The patient could not tolerate the pressure of the bed on any part of the body and the patient felt acute pain in the rib area of the back, on both sides. The patient tried walking in place, back, stretching exercises, etc but nothing worked. The patient finally tried autogenic relaxation focused on the brain, the patient's brain was calm and was able to fall asleep. The patient estimated that this lasted about 30 minutes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event nausea. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events awakened from normal sleep by something similar to restless leg syndrome (which the patient did not have) accompanied by pain all over body, could not find any position that could stay in for more than a few seconds could not tolerate the pressure of the bed on any part of body, felt acute pain in the rib area of back on both sides, and mild nausea was unknown at the time of this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: The pain has been excruciating especially since she received the Covid-19 vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for his mother. A 79-year-old female patient first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EM9809) via an unspecified route of administration, administered in arm right on 06Feb2021 (at age of 79-years) as dose 1, single for covid-19 immunisation (covid prevention) at hospital. The patient medical history included ongoing acute rheumatoid arthritis (being treated for rheumatoid arthritis, taking prednisone and steroid shots in her shoulder). The patient's concomitant medications were a list of medications and infusions of prednisone and another steroid injection (gets the steroid shot every 3 months) both for acute rheumatoid arthritis from unspecified date to 05Feb2021. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. There were no prior vaccinations within 4 weeks and no illness at time of vaccination. Reportedly, the patient had to go off her medication prior to receiving the first Pfizer Covid-19 vaccination on 06Feb2021. The patient 's HCP stopped her prednisone and another steroid injection on the 05Feb2021 and stated, "they took her off her infusions and it's been getting worse and worse." The patient has been having pain in Feb2021 (since being off her medication). The patient was in extreme pain from not having her other meds and the pain had been excruciating especially since she received the Covid-19 vaccine and pain started on 09 or 10Feb2021. She had to get a TORADOL shot for pain (as therapeutic measure). She was seen at the Urgent Care and at the physician's office. The patient was also off her rheumatoid arthritis medications for a year while the doctors were trying to figure out what to start her on and it had been getting worse and worse. On 16Feb2021 she was started on ORICA infusions and the rheumatologist said she should be on this medication and there should be no issues with her getting the shot. She visited the physician office for pain. The patient's second Pfizer Covid-19 vaccine was scheduled 27Feb2021 and steroid shot (in left arm for left and right shoulder) on the 23Feb2021 and the 04Mar2021. No other products administered. She understood that she was unable to have more than 5mg at a balanced rate and no prednisone for 2 weeks after the injection and she was also not able to receive the steroid shots. There were no relevant tests. Reportedly, the case was non-serious. The outcome of event was unknown.  No follow-up attempts were possible. No further information was expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Vaccination site pain
Clinical narrative: Soreness at injection site; Fatigue; Chills; Aches; This is a spontaneous report from a contactable consumer. This contactable 35-years-old male patient reported himself who received second dose of bnt162b2 ((PFIZER-BIONTECH COVID -19 VACCINE, Injection for injection, (Batch/Lot Number: unknown, expiry date: unknown), via an unspecified route of administration, administered in Right Arm on 16Feb2021 01:15 (age at vaccination:35-Year-old) as SINGLE for covid-19 immunization. Medical history included renal cyst from an unknown date and unknown if ongoing. The patient previously took amoxicillin and experienced drug allergy. Concomitant medication(s) included atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Injection for injection, (Batch/Lot Number: unknown, expiry date: unknown) unspecified route of administration on an unspecified date (age at vaccination:35-Year-old) as single, for covid-19 immunization from Workplace clinic. On 17Feb2021 08:00 the patient experienced fatigue, chills, aches (pain) soreness at injection site (vaccination site pain). The patient did not received any treatment for all the events. The outcome of all the events was recovered on unspecific date in Feb2021.  Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Painful swollen lymph nodes on the right supraclavicular area and lower right side of the neck; Painful swollen lymph nodes on the right supraclavicular area and lower right side of the neck; Administration date of second dose was 15Feb2021 and Administration date of first dose was 11Jan2021.; This is a spontaneous report from a contactable physician. A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via intramuscular route of administration, on 15Feb2021 at 13:00 (at the age of 45-year-old), as dose 2, single in right arm for COVID-19 immunization at Public Health Department. The patient's medical history included seasonal allergy and sinusitis. Patient had known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via intramuscular route of administration, on 11Jan2021 at 01:00 PM, as single dose in right arm for COVID-19 immunization. Patient did not receive other vaccine in four weeks after COVID vaccine. Patient took first dose on 11Jan2021 and second dose on 15Feb2021, which was considered as an inappropriate schedule of vaccine administration. On 16Feb2021 at 12:00 AM, 23 hours after second dose of vaccine, the patient experienced painful swollen lymph nodes on the right supraclavicular area and lower right side of the neck. Events led to Physician office visit. The patient received treatment for the events which included hot packs, acetaminophen and doxycycline. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was not resolved.  Information about lot/ batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: A little soreness at the injection site; kind of tired; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history included ongoing dust and dust mites, trees and grass. The patient's concomitant medications were not reported. It was reported that the patient receives an allergy shot every 3 weeks and has done so since 2009. She receives the allergy shot in one arm for dust and dust mites, and another in the other arm for trees and grass. On an unspecified date, the patient also reports that after receiving her first dose, she experienced a little soreness at the injection site and reports feeling kind of tired but states she haven't really experienced anything else. She was okay. She hasn't had anything significant. The patient would like to know if there was any information regarding blood thinners and taking the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: still getting some body aches and pain; still getting some body aches and pain; This is a spontaneous report from a contactable consumer (patient, self-reported). A 74-year-old male patient received 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 12Feb2021, as a single dose for COVID-19 immunization. The patient's medical history included arthritis. Concomitant medications included paracetamol (TYLENOL) and naproxen sodium (ALEVE). The patient explained he was "still getting some body aches and pain" on an unspecified date. He asked was that normal after the shot. He then added he stopped taking his pain medication, "Tylenol and Aleve", one day before the receipt of the first dose of the vaccine and hasn't taken anything since then. He specified he usually took those pain medications for his "arthritis". The patient also asked could he took pain medication such as Tylenol or Aleve with the vaccination. If so, how long before getting the second dose should I stop taking them. Outcome of the events was not reported.  Information on lot/ batch has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Nausea, Pain in extremity
Clinical narrative: fatigue; arm pain; stomach pain, cramping; diarrhea; nausea; This is a spontaneous report from a contactable pharmacist.  A 48-years-old non pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 13Feb2021 11:00 (at age of 48-years-old) at as dose 2, single for covid-19 immunisation. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration left arm on 14Jan2021 as dose 1, single for covid-19 immunization. Medical history included asthma, allergies. The patient was known allergies to dairy, statin drugs and yeast. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On 14Feb2021 08:00 AM, 20 hours after the second vaccine dose I experienced 48 hours of fatigue and arm pain. After this, I started to have severe stomach pain, cramping and some diarrhea. It was not like anything I experienced before. The only thing that relieved the pain and nausea was to lie still. The adverse event resulted in emergency room. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the of reporting, the outcome of the events were not resolved.   Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste; This is a spontaneous report from a contactable consumer (patient). A 32-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: El3247) via an unspecified route of administration, administered in arm right on 16Feb2021 12:30 PM as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included IBS, enlarged mitro valve. The patient had known allergies to peanuts. Concomitant medications/other medications in two weeks included Benadryl. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: El1284) via an unspecified route of administration, administered in arm left on 26JanFeb2021 10:30 AM as DOSE 1, SINGLE for COVID-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 19Feb2021 09:00 PM, the patient experienced metallic taste. The patient did not receive any treatment for the event. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information was expected.