chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Ear discomfort, Eustachian tube obstruction, Tinnitus
Clinical narrative: my ears built up tremendous pressure behind them/My ears were sensitive to the slightest pressure change; my Eustachian tubes collapsed; I developed tinnitus in both ears; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 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, patient did receive the first dose of the vaccine, within 7 hours his/her ears built up tremendous pressure behind them. Eustachian tubes collapsed and patient had to continually try to pop his/her ears for 2 weeks. His/her ears were sensitive to the slightest pressure change. Patient had to pop the ears frequently. Shortly after eustachian tubes collapsed, patient developed tinnitus in both ears. It has not gone away. Patient had never had any problems with the ears prior to receiving this vaccine so he/she had made the assumption, this was the result of the vaccine. Patient decided not to take the second dose. For fear, the side effects would worsen. Outcome of tinnitus was not recovered, and outcome of other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Palpitations
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced chills and a racing heart on an unspecified date. The outcome of events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site discomfort, Vaccination site joint movement impairment
Clinical narrative: felt discomfort at the injection site; felt like she had to support her arm to lift it and it was painful; have some soreness; felt like she had to support her arm to lift it and it was painful; This is a spontaneous report from a contactable pharmacist (the patient). 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 provided), via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided.  Patient reported she has experienced this with Flu vaccine (FLU ARIX) (GlaxoSmithKline). Patient does not have an NDC, Lot or expiration date, reporter stated she had the vaccine in September 2020 or the first of October 2020. On an unspecified date, the patient felt discomfort at the injection site, she felt like she had to support her arm to lift it and it was painful. Patient stated that vaccine is mandatory and she generally does have some soreness. Investigation assessment was not Provided. Patient stated that her Pfizer NDC number was the same as for the previous reports filed. 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: Pain, Pain in extremity, Vaccination site discomfort, Vaccination site pain
Clinical narrative: felt discomfort at the injection site; felt like she had to support her arm to lift it and it was painful; have some soreness; Pain at the injection site; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 07Jan2021 as single dose for COVID-19 immunization. The patient medical history included, first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Dec2020 as single dose for COVID-19 immunization; Flu vaccine (FLU ARIX) for an unspecified indication on an unspecified date in September 2020 or the first of October 2020. Patient's concomitant medications were not reported. Reporter stated that she knew she got her vaccine, Pfizer Covid 19vaccine, for sure, because she felt discomfort at the injection site, she reported that she got her first vaccine on 16Dec2020 and the second vaccine on 07Jan2021. Reporter stated she felt like she had to support her arm to lift it and it was painful and Pain at the injection site. Reporter stated it was almost as bad after the second vaccine. Patient stated that she had experienced this with the Flu vaccine and the brand was Flu Arix. Reporter stated states she had the vaccine in September 2020 or the first of October 2020. Patient stated that the vaccine is mandatory and she generally does have some soreness. The outcome of all the events were unknow.  No Follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Skin irritation, Urticaria
Clinical narrative: my hives were getting very irritating; little rashes and kind of hives on my body; growing inwards; little rashes and kind of hives on my body; growing inwards; itching and hives on my wrist and my feet and it's like kind of growing toward my back; rashes I mean it's kind of red; This is a spontaneous report from a contactable consumer, the patient. This 24-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733; Expiration Date: 31Jul2021), via an unspecified route of administration on 26Mar2021 (at the age of 24-year-old) as single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient stated, "I wanted to call and report side effects so I got my vaccine on the 26Mar2021 and since Sunday (18Apr2021) I have been getting like little rashes and kind of hives on my body so started on my wrist just like growing inwards. Just wanted to report like it was itching and hives on my wrist and my feet and it's like kind of growing towards my back as well so I mean I can breath and everything, it's not like that I have like an anaphylactic reaction but I can, like it's very itchy and irritating. I am still getting like hives and rashes I mean it's kind of red, but it still growing a little bit. I did take like one antihistamine Zyrtec 10 mg only once a day yesterday (20Apr2021) for the little rashes and kind of hives, because my hives were getting very irritating. My second shot is scheduled for this Friday that's on 23Apr2021." Patient reported his height as 6 feet 1 inch (185 cm) and weight should be like 190 pounds on an unspecified date. The clinical outcomes of the events, "rashes I mean it's kind of red", "little rashes and kind of hives on my body; growing inwards", "itching and hives on my wrist and my feet and it's like kind of growing toward my back" and "my hives were getting very irritating" were not resolved as of 21Apr2021.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Migraine, Myalgia, Nausea
Clinical narrative: Muscle Aches; Migraine; Nausea; Constipation; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) at the age of 21-year-old, as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she had the following symptoms including Muscle Aches, Migrane, Nausea, and constipation starting from 24-72 hours after her injection. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder pain after first dose; This is a spontaneous report from a non-contactable consumer. This consumer reported events for two patients. This is first of two reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shoulder pain after first dose on an unspecified date. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021452678 same reporter and drug, different patient and event
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report from contactable consumer (patient). A patient of unspecified age and gender received first dose of 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 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced piercing headache after first dose on an unspecified date. The outcome of event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm, doesn't hurt, just sore; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: unknown), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunization. The patient medical history included ongoing blood disorder. The patient's concomitant medication included ongoing warfarin as a blood thinner before her first dose. The patient experienced sore arm, doesn't hurt, just sore on an unspecified date. The outcome of the event was unknown. Patient wanted to be sure that it was okay that she was on blood thinner and can take second dose.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Platelet count, Platelet count decreased
Clinical narrative: platelet count dropped down to 126 within a couple of weeks; Pain in left leg; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received BNT162B2, dose 2 via an unspecified route of administration, administered in arm left on 18Apr2021 10:15 (Lot Number: EW0164) as single dose for COVID-19 immunisation. Medical history included overweight, seasonal allergies and temple headaches. Concomitant medication included ongoing hydrochlorothiazide taken for blood pressure high. The patient previously received first dose of  BNT162B2 on 12Mar2021 at 3:00 pm (Lot Number: EN6208), at the age of 54-years-old, in her left arm, for COVID-19 immunization. Temple headaches started before the first dose. Did have a temple headache before, but they seemed worse after first vaccine. The patient experienced sore arm on 18Apr2021 and pain in left leg on 19Apr2021. The patient got the second COVID vaccine on 18Apr2021 (Sunday), a couple of days ago. She noticed that her left leg is sort of painful. She had soreness in her arm Sunday and yesterday, but it's better now. Her questions were about the pain in her left leg. She was wondering if this is part of the muscle ache problem or is it probably something different? was there a way to know the difference on if this is from the vaccine or something else. Yesterday morning, her leg felt fine. In the afternoon it started to feel a little achy. It wasn't anything bad. She took Tylenol which seemed to work. Her leg really bothered her this morning since she woke up this way. She got the first COVID vaccine on 12Mar2021, and on the 17Mar2021, she went to get her blood work done. Her platelet count was down to 148. It is supposed to be 150. Her doctor told her to hold off on the second until they rechecked her platelets. She went and got blood work done again and they dropped down to 126 within a couple of weeks. The events didn't result emergency room or physician office visit. The patient underwent lab tests and procedures which included platelet count 148 on 17Mar2021 and platelet count: 126 on an unknown date. Treatment of the event pain in left leg included Tylenol. The outcome of the event sore arm was recovering. The outcome of the event pain in left leg was not recovered. The outcome of the other event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test with symptoms within 7 days from 1st vaccination; This is a spontaneous report from a contactable female consumer (patient's mother). This is 1 of 3 cases from the same family, and refers to the daughter. A  female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, via an unspecified route of administration, on 15Apr2021, at the age  years old, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the BNT162b2 vaccination on the same day of her old mother and father with whom she was living. Within 7 days after the vaccination (exact date unspecified), the patient began to experience a temperature and a cough that lasted for 3 days. The patient was therefore tested for COVID-19, and tested positive, always on an unspecified date within 7 days from the vaccination. The patient had not recovered from the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021453064 same reporter, same product, different patients, similar events;US-PFIZER INC-2021448634 same reporter, same product, different patients, similar events
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Cough, Exposure to SARS-CoV-2
Clinical narrative: Exposure to COVID-19 (via daughter); cough; Body temperature abnormal; This is a spontaneous report from a contactable consumer (patient's wife). A 64-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 15Apr2021 (Lot Number: EW0162), as single dose, for COVID-19 immunisation. Medical history included ongoing hypertension, ongoing blood cholesterol increased, ongoing diabetes mellitus. Concomitant medication included losartan (unknown manufacturer) for hypertension. The patient experienced exposure to COVID-19 (via daughter) (non-serious) on an unspecified date with outcome of unknown, body temperature abnormal (non-serious) on 21Apr2021 with outcome of unknown, cough (non-serious) on an unspecified date with outcome of unknown.  No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Pain, Pyrexia
Clinical narrative: First day fatigue, second day intense body aches, dizziness, and fever. Third day diarrhea and ringing in the ears. Pulsating tinnitus has continued on for two weeks with progression after other symptoms have subsided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: First day fatigue, second day intense body aches, dizziness, and fever. Third day diarrhea and ringing in the ears. Pulsating tinnitus has continued on for two weeks with progression after other symptoms have subsided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Lymphadenopathy, Swelling
Clinical narrative: Right clavicle/neck/shoulder pain, swelling, inflammation (supraclavicular lymphadenopathy)
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Sneezing
Clinical narrative: sick; chills; tired; sneezing like crazy; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she had been sick due to the reaction to her COVID vaccine, chills, tired and sneezing like crazy. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Fever 102, rigors, aches , muscle pain, fatigue
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Itchy, red swollen skin in patchy area around the injection site. Appeared nearly 8 days after the injection and remains active.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Headache, Pain
Clinical narrative: Headache, Fatigue within an hour, 8 hours after Achiness all over, Chills, Fever, Racing Heartbeat, Headache comes and goes, sleepiness, then too hot can't sleep Took 2 Ibuprofen, 2 x 30 suedo-effedrin  , ate bagel and cream cheese, 1/2 a banana 3x2000 D3 vitamin Trying to sleep now
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Sleep disorder, Somnolence
Clinical narrative: Headache, Fatigue within an hour, 8 hours after Achiness all over, Chills, Fever, Racing Heartbeat, Headache comes and goes, sleepiness, then too hot can't sleep Took 2 Ibuprofen, 2 x 30 suedo-effedrin  , ate bagel and cream cheese, 1/2 a banana 3x2000 D3 vitamin Trying to sleep now
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hemiplegic migraine, Hypoaesthesia, Hypoaesthesia oral, Magnetic resonance imaging
Clinical narrative: Within an hour half of my body went numb My tongue went numb and I was in the emergency room unable to speak with what appeared to be the worst hemiplegic migraine in my life.  The feeling has not returned in my left hand side of my body or my tongue.  I am told the second vaccine injection will be worse.  Then I was misdiagnosed with muscular sclerosis after an MRI was done and damage was found to my brain.  I could not be more angry
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Piloerection
Clinical narrative: Fever; Headache; Sweating; Feeling nauseous; A bit of chills; Goosebumps; This is a spontaneous report from a contactable consumer (the patient) via medical information team. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) through an unspecified route of administration on an unspecified date for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported feeling "normal side effects" which included a bit of chills, goosebumps, fever, headache, sweating, and feeling nauseous after the first dose. 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: Pyrexia
Clinical narrative: Fever; Headache; Sweating; Feeling nauseous; A bit of chills; Goosebumps; This is a spontaneous report from a contactable consumer (the patient) via medical information team. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) through an unspecified route of administration on an unspecified date for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported feeling "normal side effects" which included a bit of chills, goosebumps, fever, headache, sweating, and feeling nauseous after the first dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Peripheral swelling, Swelling, Vascular rupture
Clinical narrative: She would say like broken vessels on her underpits of her left hand, left fingers, she was sorry, so in the fingers of her left hand.; she felt her legs were swollen like inflamed; she felt her legs were swollen like inflamed; she had a little bit of blood coming out of her nose; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0161; Expiration Date: Jul2021) via an unspecified route of administration, administered in arm left on 21Apr2021 16:00 at single dose for COVID-19 immunisation at the age of 39-year-old. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium. The patient received the first dose of BNT162B2 on 30Mar2021 for COVID-19 immunization at the age of 39-year-old. Consumer stated, "She had the 2nd dose of the Pfizer Vaccine yesterday at 4 pm and today when she woke up she felt like she did not even know how to say, She would say like broken vessels on her underpits of her left hand, left fingers, she was sorry, so in the fingers of her left hand. It happened in her left hand. It's the 1st time she had something like this and also she felt her legs were swollen like inflamed and she had a little bit of blood coming out of her nose, it was fine when she cleaned her nose she felt little bit of blood, she had not seen of those symptoms or the side-effects of the vaccine, she did not know if it was something she should be concerned about or what?". When paraphrased the above concern, consumer stated, "She didn't see the symptoms yesterday she just realized those things this morning when she woke up like 2-3 hours ago and she was aware of them." Event onset date was 22Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash-on torso; 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: EW0158), dose 2 intramuscularly, administered in Arm Left on 09Apr2021 12:43 as a single dose for COVID-19 immunization. Medical history included ongoing high cholesterol. There was none relevant test. The patient previously took first dose of bnt162b2 (lot number: GP6955) via intramuscular on 18Mar2021 10:40 am, in left arm for COVID-19 immunization. 2nd day after shot on 19Mar2021, the patient developed sore arm, non-serious, with recovered outcome, no treatment received for it. After the first shot, side effect "just a sore arm" which did not affect daily activities." Prior vaccination: None. Concomitant medication included pravastatin taken for high cholesterol from an unspecified start date and ongoing; estradiol (ESTRADIOL TRANSDERMAL) taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced rash-on torso on 10Apr2021 after second shot, lasted 3 days. This is a non-serious event, without any treatment for it. The outcome of event was recovered on 13Apr2021.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: dizzy; weakness; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included seizure from an unknown date and unknown if ongoing , respiratory issues from an unknown date and unknown if ongoing , chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. Additionally patient stated "she was very unhealthy and that she had a lot of health issues".  The patient's concomitant medications were not reported.  The patient experienced dizzy on an unspecified date with outcome of unknown , weakness on an unspecified date with outcome of unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Vaccination site pain
Clinical narrative: A sore arm and neck but has always had neck issues; A sore arm and neck but has always had neck issues; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced a sore arm and neck but has always had neck issues (neck pain). The outcome of the events sore arm and neck issues was unknown.  No follow-up attempts are needed. Further information for lot/batch number can not be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: she had heard of tingling and numbness in hands.; she had heard of tingling and numbness in hands.; This is the spontaneous report from a contactable consumer. A contactable consumer reported similar events for 2 patients. This is first of 2 reports. This consumer reported that:  A patient of unspecified age and gender 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. Caller stated when she got the vaccine on Sunday the nurse said 2 people the day before, 10Apr2021, complained of tingling in their hands and this was the first time she had heard of tingling and numbness in hands. The nurse was unsure how they made out. Outcome of events 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-2021454473 Same reporter/product/events, different patient
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: breakthrough bleeding for 5 days; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: not reported), via an unspecified route of administration in the left arm on 03Apr2021 at 06:30 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history included allergies (unspecified), she did not have a menstrual cycle in 7 years because she had an intrauterine device in place. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications include ongoing levonorgestrel (MIRENA) intrauterine delivery system. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: unknown) on 13Mar2021 at 18:30 (at the age of 49-years-old) in the left arm for COVID-19 immunization. There were no other vaccinations within 4 weeks of the vaccine. On 06Apr2021 at 05:00, the patient experienced breakthrough bleeding for 5 days. The patient was not treated for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of breakthrough bleeding was resolved on an unspecified date.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Pain, Pyrexia
Clinical narrative: aching; feeling crappy; feeling lousy/feeling sick almost 3 weeks after 1st dose; have a low grade fever; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot number and expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 21Apr2021, 3 weeks after receiving first dose, patient experienced aching, feeling lousy, had a low-grade fever, feeling crappy and sick. The outcome of the events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, Pyrexia, SARS-CoV-2 test
Clinical narrative: he was diagnosed with Covid; he started not feeling well; fever; This is a spontaneous report from a contactable consumer (patient's mother). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 18Apr2021 at single dose for COVID-19 immunisation. Medical history included cold induced asthma. The patient's concomitant medications were not reported. It was reported that the patient got the vaccine last Sunday. On 21Apr2021 (Wednesday), he started not feeling well and he was diagnosed with COVID. She asked, will the vaccine still work on him. The patient also had a fever on Apr2021. The patient underwent lab tests and procedures which included COVID-19: positive on 21Apr2021. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: she woke up with a swollen lip; This is a spontaneous report from a contactable consumer (Patient herself). A 21-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown. Expiration date: Unknown) via unspecified route of administration on an unknown date at SINGLE DOSE for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown. Expiration date: Unknown) via unspecified route of administration on an unknown date at SINGLE DOSE for COVID-19 Immunization. The patient got her second dose about 3 weeks ago, yesterday she woke up with a swollen lip, that looks like it's ballooning on the left side. 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, UNK
Symptoms: Ear infection, Ear pruritus
Clinical narrative: Ear infection; Ear was itchy; This is a spontaneous report from a contactable consumer (patient). This female patient with unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Mar2021 at single dose for COVID-19 immunization, hydrocortisone, neomycin sulfate, polymyxin b sulfate (CORTISPORIN) from unspecified date at unknown dose for unknown indication. Medical history included occasional dizziness. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 02Mar2021 for COVID-19 immunization.  On 24Mar2021 after her second dose, the patient experienced one ear infection and had to go to doctor, was prescribed an anti-biotic, she was put on cefuroxime axetil (CEFTIN). The patient stated she didn't think the vaccination caused the ear infection. Her ear was itchy on 24Mar2021, nothing painful, no fever, nothing like that and she overlooked them (symptoms of ear infection). Action taken for hydrocortisone, neomycin sulfate, polymyxin b sulfate was unknown. The outcome of events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Herpes virus infection, Oral herpes
Clinical narrative: A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration on 16Apr2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had a reaction that caused herpes virus to flare up. It's a bad flare up and was all over lips and chin. It happened a day after patient received the first dose on 17Apr2021. This symptom that was a result of the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Paraesthesia
Clinical narrative: having tingling in both of her hands; jittery feeling in hands like she had drank a bunch of coffee; This is a spontaneous report from a contactable consumer (patient herself). A 34-year-old female patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Unknown, Lot Number: ER8737, Expiry date: Unknown), via an unspecified route of administration on left arm, on 30Mar2021 at 12.30 as a single dose for COVID-19 immunization. Medical history and concomitant medications of the patient were none. The patient had no other condition. There was no family history. Patient did not receive any other vaccine within 4 weeks prior to the first dose of vaccination. Also, no other vaccine was administered on the same day of vaccination. On 21Apr2021 (3 weeks after the first dose), in morning patient experienced tingling in both of her hands that have been constant since it started on and occasionally in feet and down arm. The patient had no emergency room visit or not visited physician's office. It is not bad enough where it is preventing her from doing anything but not typical for her to experience this constantly. She also experienced jittery feeling in hands like she had drunk a bunch of coffee, on 21Apr2021, which was recovered on the same day. she feels like she's experienced it before, like pre-vaccine, that's why she is not sure if it is from the vaccine or not. she didn't pay much attention to it, until it didn't go away. About 2 days ago it became constant. Patient did not receive second dose of vaccine till 23Apr2021. The outcome of the event jittery feeling in hands like she had drunk a bunch of coffee was recovered and the outcome of the event having tingling in both of her hands was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: tiredness; headaches; This is a spontaneous report from a contactable consumer (Patient's mother). A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch number: Unknown, Expiry date: Unknown) via an unspecified route of administration on 20Apr2021 as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tiredness and headaches, its been roughly 2 days with side effects and patient taking Motrin yesterday and today. The outcome of the events unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: experience pain/stiffness; stiffness; This is a spontaneous report from a contactable other health professional and a consumer (patient). A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunization; tofacitinib citrate (XELJANZ XR), orally from Jan2020 to an unspecified date, at 11 mg, daily for rheumatoid arthritis. The patient medical history included flare-up. The patient's concomitant medications were not reported. The patient held tofacitinib citrate 7 days post second Covid vaccine. Within 4 days of being off tofacitinib citrate he started to experience pain/stiffness. Flare-up pre existing precipitated switch to tofacitinib citrate. Flare up had improved in the last 6 weeks since tofacitinib citrate started to work. MD was aware. The action taken in response to the events tofacitinib citrate was post therapy. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills; Fever; Soreness in the body; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, lot number and expiry date were unknown), via an unspecified route of administration on 21Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient has experienced chills, fever, and soreness in the body in Apr2021. She would like to know if this side effects have been reported. The events were reported as non-serious. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: tooth pain; This is a spontaneous report from a Pfizer sponsored program via medical information team. A contactable consumer (patient's husband) reported that a 60-year-old female patient (reporter's wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, on 07Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was developing tooth pain in Apr2021 and went to the dentist. She was prescribed amoxicillin 500mg capsules yesterday (22Apr2021), and she already took 1000mg last night. She was taking Amoxicillin 500mg three times daily. Patient was scheduled for the second dose this coming Wednesday, 28Apr2021. Reporter asked if it is okay for her to receive the second dose. Event required physician office visit. 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: Axillary pain, Chest discomfort, Nausea, Peripheral swelling, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: en0158) via an unspecified route of administration on 13Apr2021 as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included ongoing gabapentin daily for back. Patient received first vaccine dose and in the first day she experienced nausea and some chest tightness on 13Apr2021. These symptoms went away but she also reported having soreness to her arm at the injection site and under her armpit in Apr2021. She couldn't lift the arm, it hurt to lift it so she put an ice pack on it because it was really swollen. The pain was under her armpit and on the top of her arm right where the vaccine was given. It was still swollen but a little better this morning reporting that she is putting ice on it, rubbing alcohol on it, massaging it. She asked if this was a swollen lymph node and if that is a sign that the shot is working. The outcome of events nausea and some chest tightness was recovered in Apr2021; for other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site discomfort
Clinical narrative: Tiredness; Discomfort at jab site; This is a spontaneous report from a contactable other HCP received via a sales representative. A 16-years-old male patient received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tiredness and discomfort at jab site on an unspecified date. 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: Vaccination site mass, Vaccination site swelling
Clinical narrative: she is still experiencing injection site swelling; she still has a red round spot that feels like a lump; This is spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, on 20Apr2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. It was reported that patient presented all the symptoms mentioned in the fact sheet the day after the administration that was on an unknown date in Apr2021. Reportedly, most of them went away after a day but she is still experiencing injection site swelling and she still has a red round spot that feels like a lump. The patient would like to know if putting a warm cloth on it will help. 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: Arthralgia
Clinical narrative: joint pain and extra twist; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took the first dose of BNT162B2 on an unspecified date for covid-19 immunisation. The patient (consumer's wife) had a few days of joint pain and extra twist. Her b friend weak or so of being very tired, arm joint pain also. The outcome of event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness on the injection site; This is a spontaneous report from a Pfizer-sponsored Program. A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 17Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took valium and hydrocodone. She was asking if she can take Valium and Hydrocodone because she always took those medicines even before getting the vaccine. The patient experienced soreness on the injection site on an unspecified date in Apr2021. The outcome of event was unknown.    No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Pain in extremity
Clinical narrative: arm was sore; fibromalagi; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program.  A female patient of an unspecified age received first dose of bnt162b2, via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had the first dose of the Covid vaccine she did not have problems except her arm was sore. She did have fibromalagi. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fibromyalgia, Oropharyngeal pain
Clinical narrative: Her throat started hurting; She did have fibromalagi. her fibro flared up worse than she has ever had it.; She did have fibromalagi. her fibro flared up worse than she has ever had it.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received second dose of bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on 18Apr2021 as single dose for COVID-19 immunization. The patient's medical history included fibromyalgia from unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced her throat started hurting, her fibro flared up worse than she has ever had it on an unspecified date. Caller stated when she had the first dose of the Covid vaccine she did not have problems except her arm was sore. She did have fibromyalgia. She had her second dose last Sunday on 18Apr2021. Her throat started hurting and her fibro flared up worse than she has ever had it. She wanted to know if she need to go to her doctor or what to do. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Vaccination site pain
Clinical narrative: has soreness and hurting at the injection site; right arm pain and burning getting pretty unbearable; from arm down to forearm; right arm pain and burning getting pretty unbearable; from arm down to forearm; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 13Apr2021 (Lot Number: ER8731) as SINGLE DOSE for COVID-19 immunization. The patient's medical history was none and concomitant medications were not reported.  On 13Apr2021, the patient experienced soreness and hurting at the injection site and mentioned right arm pain and burning getting pretty unbearable; and that pain was radiating from arm down to forearm. Tylenol and Advil were considered as therapeutic measures. The outcome was not recovered for the reported events.  No follow-up attempts are needed. No further information is expected.