chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: Felt she was going to pass out; Began experiencing a hot, flushed and tingly sensation to her whole arm/whole body went completely hot and flush and tingly; Began experiencing a hot, flushed and tingly sensation to her whole arm/whole body went completely hot and flush and tingly; Began experiencing a hot, flushed and tingly sensation to her whole arm/whole body went completely hot and flush and tingly; Heart was beating fast and hard; The back of her nose, throat, and tongue was tingly and hot; The back of her nose, throat, and tongue was tingly and hot; The back of her nose, throat, and tongue was tingly and hot; The back of her nose, throat, and tongue was tingly and hot; The back of her nose, throat, and tongue was tingly and hot; This is a spontaneous report from a contactable consumer (patient, reported for herself). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, administered in left arm on 29Jul2021 12:45 (at the age of 48 years old) as dose 1, single for covid-19 immunization. Medical history included a fib (atrial fibrillation as one isolated event) from an unknown date to an unknown date; patient had a cardiac ablation in 2018; and allergy to penicillin from an unknown date and unknown if ongoing. The patient had no family history. Concomitant medication included aspirin [acetylsalicylic acid] at 81 mg taken for an unspecified indication, start and stop date were not reported. Patient had no prior vaccinations (within 4 weeks). The patient had no history of all previous immunization with the Pfizer vaccine suspect product. Most recent vaccine was administered at military facility. Patient received her first dose of the Pfizer Covid-19 Vaccine on 29Jul2021.  As soon as it was injected, she began experiencing a hot, flushed and tingly sensation to her whole arm.  She went and sat down and the feeling went to her entire body, then to her nose, throat, and tongue.  Her heart was beating fast and hard.  She felt she was going to pass out.  Everything subsided after 10 minutes and went away. Patient further reported that when the lady put the needle in the patient's arm and pushed the medicine the patient's arm went hot and tingly. The patient sat down for a minute and then her whole body went completely hot and flush and tingly. The back of the patient's nose, throat, and tongue was tingly. Then it felt like the patient's heart started beating fast and hard. Patient asked if this was normal. These events happened within 5 minutes of the patient getting the shot. Behind the patient's nose, throat and tongue was also hot. Patient asked if she could get the second dose. The events were non-serious as per reporter. The events did not require emergency room or physician office visits. The outcome of the events was reported as recovered on 29Jul2021.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium decreased, Blood test, Computerised tomogram, Migraine
Clinical narrative: little low on potassium; migraine/migraine headaches/migraine hurt so bad; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm (reported as left shoulder) on 16Jul2021 13:00 (Batch/Lot Number: FA6780; Expiration Date: 2021 (reported as Aug2021 or Sep2021) (at the age of 48-year-old) as dose 1, single for COVID-19 immunization. The vaccination facility type was pharmacy/drug store. The patient had no previous immunization with BNT162B2. There were no other vaccines administered on same date with BNT162B2. The patient did not receive any other vaccinations within four weeks prior to the first administration date of BNT162B2. The patient had no medical history (as reported). Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL; reported as Adderall Extended Release) taken for an unspecified indication from an unspecified start date and ongoing; fluoxetine (FLUOXETINE) taken for an unspecified indication from an unspecified start date and ongoing; both taken by the patient for about 10 years. The patient reported that she received her first dose of the Pfizer COVID-19 vaccine on 16Jul2021 and she developed a migraine that would not go away so she got scared and went to the ER on she thinks 26Jul2021. She stated that she never really gets migraines. In the ER, she had a CAT Scan and blood work and she did not have a blood clot. She was given medication thru her IV which helped but felt better for a day or so and now they migraines were back. She was wondering if this has been reported and how long was it going to last for. The patient reported that she received the first dose of the Covid 19 vaccine on 16Jul2021. She didn't have any side effects for 2 days, but after those 2 days (18Jul2021), she developed migraine headaches. She's never had migraines before, and she ended up in the emergency department because the migraine hurt so bad. The patient asked how long these migraines should last and if it was something that was being reported. Her headaches started on 18Jul2021 or 19Jul2021. She went to the emergency department on 26Jul2021. She had a CT scan and a blood draw. The CT scan came back that she was fine. For her blood draw, she was a little low on potassium but everything else was in range. In the emergency department she was given something in her IV to cure the migraine and she was good for about a day. Now the migraines were back, and they were persisting. The outcome of migraine/migraine headaches was not recovered. The outcome of low potassium was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Sinusitis bacterial, Thyroid function test
Clinical narrative: Her family physician put her on an antibiotic, Biaxin for what she thought might be a sinus infection; sore throat; fatigue; headaches; This is a spontaneous report from a contactable consumer (patient).  This 71-year-old female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW0158) on 14Apr2021, probably in the late morning, at the age of 70 years, in left arm, as the second single dose, for COVID-19 immunisation. The first dose of BNT162B2 vaccine was administered on 18Mar2021, at the age of 70 years, lot: EN6208, in left arm with no adverse event. Medical history included seasonal allergy (had been taking medications for all these for 10 years or at least 8 years), allergy, cholesterol, blood pressure, upper respiratory issues and thyroid. Prior vaccinations (within 4 weeks): no. Family medical history relevant to AE(s): no. Ongoing concomitant medications included guaifenesin (MUCINEX) at 1200 mg twice daily, for allergy, atorvastatin calcium at 10 mg once daily, for cholesterol, irbesartan at 150 mg once daily, for blood pressure, spironolactone at 100 mg once daily, for facial hair growth, desloratadine, pseudoephedrine sulfate (CLARINEX-D) at 120/2.5 once daily, for allergy. On 29Jun2021 the patient began having a sore throat, fatigue and headaches and wondered if that could be related to the vaccine. They all started at the same time and she was still experiencing them at the time of report. She had been to the physician, her family physician, and to the health care clinic and has had no results. They had stayed pretty much the same. One day, she feels better, then the next day it went down worse. After a few days, she felt good and had one good day, then it went down again. Her family physician put her on an antibiotic Biaxin for what she thought might be a sinus infection. She was on her second round of that, which will make it 20 days when she was done. Tests: her thyroid was out of adjustment on her last thyroid test. The events did not require ER visit. The events had not yet resolved.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Atrial fibrillation, Dyspnoea, Impaired work ability, Palpitations
Clinical narrative: shortness of breath; developed atrial fibrillation of the heart; Heart pounding; Screwing up my ability to work; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization.  Medical history and concomitant medications were not reported.  The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 19Feb2021 (Batch/Lot number was not reported). He then had angiogram done the end of Feb2021 due to shortness of breath and COPD noted in 2021. It was stated that his cardiologist stated that his heart looked health like a 40 year old  (as his heart and arteries were in excellent shape). The patient then had the 2nd dose on 12Mar2021. He was then in the hospital in Apr2021 due to shortness of breath noted in 2021. In Apr2021, he developed atrial fibrillation of the heart. The patient stated that his cardiologist was a monkey and he does not check anything and just prescribes medication and it was really becoming a pain in the neck. The patient just wanted to know if it atrial fibrillation was a possible side effect or direct link to the vaccine. His doctor was not giving him information on the medication he was taking and its making him felt terrible and he wanted to see if we have any information that he can point his new cardiologist in the right direction when he finds one. It was also mentioned that the he was having 4-6 events of heart pounding a day and it was screwing up his ability to work. Outcome of the events were unknown.  Information regarding the batch/lot number has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Peripheral swelling, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 15-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm at the age of 15 years old on 30Jul2021 11:00 (Batch/Lot Number: FA7485) as dose 1, single for covid-19 immunisation. Medical history included seasonal allergies. Concomitant medications included CLARITIN taken for an seasonal allergies start and stop date were not reported; VITAMIN C taken for an unspecified indication, start and stop date were not reported. On 31Jul2021, the patient experienced hives that spread to her entire body. The hives spread on her thigh to left calf, to entire body except her bottom but stated they may have been there too. The patient stated she felt like she had been bit by bugs however she had not gone outside. On Sunday, she had one episode and today, she had one episode. It also started around 11:00. The patient also reported that the palms of her hands were getting very swollen and tight to the touch started on Sunday (01Aug2021) and it was also around 11:00. Since the hives were so itchy, burning, and painful, she called the doctor, the office was so overwhelmed that they called a nurse, that told her to give her Benadryl, Pepcid, and Calamine Lotion. It seemed to work, she gave Benadryl 15 ml the second time, the 3rd time, and her hives started to dissipate but other places pop up, she woke up and 10 minutes after again with the hives, she started takin Benadryl. The last time she took Benadryl was until yesterday, but today she had an occurrence, at 11 o' clock an hour ago, the Clorox wipes swelled up her hands. The patient recovered from the event the palm of her hand swollen and became tight to the tough. The outcome of the event urticaria was not recovered, while the outcome of the event swelling of hands was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Ear infection, Illness
Clinical narrative: Hearing loss; Ear infection; Got really sick; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 1, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Pfizer vaccine and got really sick. He lost more of his hearing (hearing loss) and had severe ear infection; doctor confirmed that it was from the shot. Patient was asking if he should get the second shot. Patient was advised to contact the primary care provider for any medical advice. The physician and neurologist agreed. Outcome of the events was unknown.  Information on lot/batch number has been confirmed.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Headache, Herpes simplex, Immune system disorder, Lip injury
Clinical narrative: anxiety/ I started feeling, little shaky, little nervous, like anxious; bottom lip broke out; the vaccine affected her immune system; I have a slight headache; It's breaking out, and it's breaking out like Herpes simplex; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Jul2021, (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included psychogenic seizures from an unknown date and unknown if ongoing.The patient concomitant medications were not reported. Caller stated she was doing really well until yesterday specifically last night (01Aug2021) she felt anxiety and her bottom lip broke out (patient started feeling, little shaky, little nervous, like anxious). Caller stated it was almost as if she chewed on it and she may have but she did not know if she did. Caller stated she generally did not have the same kind of anxiety she was experiencing but she could feel anxiety and she was diagnosed with psychogenic seizure disorder because she was abused as a child. Caller stated when she was younger she had a lot of anxiety and she worked through it with therapy and it seemed to subside. Caller stated maybe it was just the way the vaccine affected her immune system as to why she felt anxiety. Caller stated she knows people who have had COVID-19 and they felt like they were not functioning correctly but there was nothing in the brain wrong but she thinks they call them long haulers or something like that. On an unspecified date in 2021, the patient experienced bottom lip broke out, the vaccine affected her immune system, have a slight headache, it was breaking out and breaking out like herpes simplex but it was not that bad. Consumer meant it was just slightly swollen. The clinical outcome of the events were unknown.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Burning sensation
Clinical narrative: Constant pain in armpit; Burning sensation in armpit; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on an unknown date in 2021, as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease, blood pressure high (HBP treated) and asthma. The patient had known allergies to sulfa (sulfonamide allergy). Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient received unspecified concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 02Feb2021 at 10:00 as a single dose for COVID-19 immunisation. On 05Apr2021, the patient experienced constant pain and burning sensation in armpit, even 5 months after the second and last shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events constant pain and burning sensation in armpit was not resolved at the time of this report.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in left leg and toes; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old, non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the arm left on 10Jul2021 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other medications in two weeks prior to the vaccination. The patient received DEPOPROVERA medication (reported as other vaccine received with in four weeks prior to COVID vaccine) for an unknown indication from 26Jul2021 and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the arm left on an unknown date in 2021 as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. On 31Jul2021 at 22:00, the patient experienced tingling in left leg and toes. No therapeutic measures were taken as a result of the event. The clinical outcome of the event tingling in left leg and toes was not recovered at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: This is a spontaneous report from a contactable consumer (caregiver/patient's mother). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 14Jul2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included exposure to covid-19 in 2021. Reporter stated that her 16 year old daughter got her first dose of the Pfizer BioNTech Covid-19 vaccine on 14Jul2021, and is scheduled for her second dose on 04Aug2021. She tested positive for Covid after coming into contact with someone who was suspected of having it on 17Jul2021. Reported asked Can she get that second dose then? Reporter stated that she was not sure if her daughter will be able to get her second dose from the same vaccination site as the first, and is wondering how she should handle that. The patient underwent lab tests and procedures which included sars-cov-2 test positive in 2021. Outcome of the event covid-19 was unknown.  The lot number for the vaccine, (BNT162B2) was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hypersensitivity, Inflammation, Paraesthesia
Clinical narrative: Allergic reactions to the vaccine; Heart inflammation; Anxiety; Needles in her heart at the bottom part; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient experienced allergic reactions to the vaccine, heart inflammation, anxiety, needles in her heart at the bottom part on an unspecified date in Mar2021. Patient had the Pfizer-BioNTech COVID-19 Vaccine back in Mar2021 and said she cannot take the second dose. She already consulted an allergist, and the other allergist did not have an appointment right away and they had to go on a trip and had to postpone it. She was asking what type of doctor should she saw since time has passed already. She did not know if she should go to a primary health care provider, allergist, general care provider or internals. She was in a bad situation for 7 weeks and had been requested to get the vaccine again and she has this conflict. She had allergic reactions to the vaccine, heart inflammation, anxiety, needles in her heart at the bottom part that had cleared now. The reported seriousness of the case was non-serious. The outcome of events was resolved in 2021.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Singles; This is a spontaneous report from a contactable consumer. A 78-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Jan2021 (at the age of 78-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Jan2021 (at the age of 78-years-old); 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. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced shingles. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse event and received unspecified treatment. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was resolved with sequelae on an unknown date.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Antibody test, Cold sweat, Cough
Clinical narrative: Metallic Taste; Taste Reduced/loss of taste; Sore arm and neck; Sore arm and neck; Cold Sweats; over heating about 3-5days; Loss of sense of smell; Runny Nose; Cough; Stuffed up ears; Headache; Fever; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0187), intramuscular, administered in left arm deltoid (Left Shoulder) on 07Jul2021 at 08:15 (at the age of 46-years-old) as DOSE 2, SIN-GLE for covid-19 immunisation.  The patient medical history included Hashimoto's disease since 2009-ongoing, vitiligo from 2007-ongoing and thyroid disorder. The patient's concomitant medication(s) included metformin orally taken for metabolic disorder from 2020 (ongoing), levothyroxine orally taken for thyroid disorder from 2011-ongoing, L-thyroxine 10 orally taken for thyroid disorder from 2011-ongoing, naltrexone 4.5 mg orally taken for autoimmune regulation from 2014-ongoing, ketoconazole (KETO [KETOCONAZOLE]) orally taken for Diet from 2020 - ongoing and ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) orally taken for Supplement from 2020-ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: FW0186), via intramuscular route in left shoulder on 16Jun2021 at 08:15 (at the age of 45-year-old) as single dose for COVID-19 immunization and 16Jun2021 at 08:25 experienced metallic taste then no taste left side of tongue numb, lasted 1 day and also sore arm/ Loss of taste, Numbness of tongue on left. On 07Jul2021 at 08:25, the patient experienced metallic taste, then reduced taste/ Loss of taste, sore arm and neck, cold sweats and overheating about 3-5days, loss sense of smell, runny nose, cough, stuffed up ears, headache, many symptoms still persist after 6 weeks later and fever. The patient underwent lab tests and procedures which included antibody test: result negative on Apr2020, Rapid test: result negative on May2021. Treatment was unknown. The outcome of the events loss of taste, loss of smell, fever, cough, runny nose, stuffed ears recovering and rest all not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Ear discomfort, Headache, Neck pain, Pain in extremity
Clinical narrative: Metallic Taste; Taste Reduced/loss of taste; Sore arm and neck; Sore arm and neck; Cold Sweats; over heating about 3-5days; Loss of sense of smell; Runny Nose; Cough; Stuffed up ears; Headache; Fever; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0187), intramuscular, administered in left arm deltoid (Left Shoulder) on 07Jul2021 at 08:15 (at the age of 46-years-old) as DOSE 2, SIN-GLE for covid-19 immunisation.  The patient medical history included Hashimoto's disease since 2009-ongoing, vitiligo from 2007-ongoing and thyroid disorder. The patient's concomitant medication(s) included metformin orally taken for metabolic disorder from 2020 (ongoing), levothyroxine orally taken for thyroid disorder from 2011-ongoing, L-thyroxine 10 orally taken for thyroid disorder from 2011-ongoing, naltrexone 4.5 mg orally taken for autoimmune regulation from 2014-ongoing, ketoconazole (KETO [KETOCONAZOLE]) orally taken for Diet from 2020 - ongoing and ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) orally taken for Supplement from 2020-ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: FW0186), via intramuscular route in left shoulder on 16Jun2021 at 08:15 (at the age of 45-year-old) as single dose for COVID-19 immunization and 16Jun2021 at 08:25 experienced metallic taste then no taste left side of tongue numb, lasted 1 day and also sore arm/ Loss of taste, Numbness of tongue on left. On 07Jul2021 at 08:25, the patient experienced metallic taste, then reduced taste/ Loss of taste, sore arm and neck, cold sweats and overheating about 3-5days, loss sense of smell, runny nose, cough, stuffed up ears, headache, many symptoms still persist after 6 weeks later and fever. The patient underwent lab tests and procedures which included antibody test: result negative on Apr2020, Rapid test: result negative on May2021. Treatment was unknown. The outcome of the events loss of taste, loss of smell, fever, cough, runny nose, stuffed ears recovering and rest all not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Temperature intolerance
Clinical narrative: Metallic Taste; Taste Reduced/loss of taste; Sore arm and neck; Sore arm and neck; Cold Sweats; over heating about 3-5days; Loss of sense of smell; Runny Nose; Cough; Stuffed up ears; Headache; Fever; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0187), intramuscular, administered in left arm deltoid (Left Shoulder) on 07Jul2021 at 08:15 (at the age of 46-years-old) as DOSE 2, SIN-GLE for covid-19 immunisation.  The patient medical history included Hashimoto's disease since 2009-ongoing, vitiligo from 2007-ongoing and thyroid disorder. The patient's concomitant medication(s) included metformin orally taken for metabolic disorder from 2020 (ongoing), levothyroxine orally taken for thyroid disorder from 2011-ongoing, L-thyroxine 10 orally taken for thyroid disorder from 2011-ongoing, naltrexone 4.5 mg orally taken for autoimmune regulation from 2014-ongoing, ketoconazole (KETO [KETOCONAZOLE]) orally taken for Diet from 2020 - ongoing and ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) orally taken for Supplement from 2020-ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: FW0186), via intramuscular route in left shoulder on 16Jun2021 at 08:15 (at the age of 45-year-old) as single dose for COVID-19 immunization and 16Jun2021 at 08:25 experienced metallic taste then no taste left side of tongue numb, lasted 1 day and also sore arm/ Loss of taste, Numbness of tongue on left. On 07Jul2021 at 08:25, the patient experienced metallic taste, then reduced taste/ Loss of taste, sore arm and neck, cold sweats and overheating about 3-5days, loss sense of smell, runny nose, cough, stuffed up ears, headache, many symptoms still persist after 6 weeks later and fever. The patient underwent lab tests and procedures which included antibody test: result negative on Apr2020, Rapid test: result negative on May2021. Treatment was unknown. The outcome of the events loss of taste, loss of smell, fever, cough, runny nose, stuffed ears recovering and rest all not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Pain, SARS-CoV-2 test, Subchorionic haemorrhage
Clinical narrative: a major bleeding event; subchorionic hemorrhage; severe cramping pain; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus/baby. This is the mother report.  A 36-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 12Apr2021 17:00 (Batch/Lot Number: EW0153) as dose 1, single for Covid-19 immunization. Medical history included anxiety and irritable bowel from an unknown date and unknown if ongoing. Patient is pregnant at the time of vaccination. Last menstrual period was 23Nov2020. Concomitant medications included minerals nos, vitamins nos (PRENATAL VITAMINS) and cetirizine hydrochloride (ZYRTEC ALLERGY) both taken for an unspecified indication, start and stop date were not reported. On 13Apr2021 18:00, 25 hours after first dose vaccination, the patient had severe cramping pain that felt like labor. The patient went to the ER for a major bleeding event. The patient had a subchorionic hemorrhage during her pregnancy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was advised to bed rest as was given magnesium as treatment for the events. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100987373 baby case
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This is a spontaneous report from a Pfizer-sponsored program COVAX Support. A non-contactable consumer reported for a male patient. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical and concomitant medication history were reported. It was mentioned that caller has a 1st dose schedule tomorrow (31Jul2021) for COVID-19 vaccine. Caller asking if blood clot was a potential risk once caller got the vaccine. Caller stated that, her uncle got the 1st dose and after the vaccine a few days later he experienced a blood clot. Caller refused to provide any information about patient (uncle). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch can not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Crohn's disease, Feeling abnormal
Clinical narrative: Crohns disease flare up; Coughing; patient did not felt good after getting second dose of covid vaccine; This is a solicited report based on the information received by Pfizer from Company (Mfr. Control No. : 21K-163-3993563-00).  from the marketing program facilitated collect received from a contactable consumer (the patient) .     A 68-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose  for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 0.4 mL, Citrate free for Crohn's disease  .  Medical history included hernia repair on 2016 , ongoing Crohn's disease.     There were no concomitant medications. On an unknown date the patient received the first dose of BNT162B2 vaccine without any complication. The patient experienced Crohns disease flare up  (medically significant) on 12Jul2021 with outcome of not recovered , coughing  (non-serious) on 2021 with outcome of unknown , patient did not felt good after getting second dose of covid vaccine  (non-serious) on 2021 with outcome of unknown.  The action taken in response to the events , for adalimumab was unknown.  The reporter assessed the causality between the event not feeling well and the vaccine as probable, the causality  between cough and the vaccine was not reported; the causality between Crohn's disease flare up and the vaccine as reasonable possible.  The reporter' s assessment of the causal relationship of the event cough with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction positive, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Became COVID symptomatic on 29Jul2021,  Had positive PCR on 30Jul2021; Became COVID symptomatic on 29Jul2021,  Had positive PCR on 30Jul2021; This is a spontaneous report from a contactable physician (patient).   A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection), via an unspecified route of administration in left arm on 12Mar2021 (Batch/Lot Number: EN6207) as dose 2, and first dose via an unspecified route of administration in left arm on 19Feb2021 (Batch/Lot Number: EN6207) as dose 1, single for COVID-19 immunization (at the age of 48-year-old). Medical history included hypertension. Concomitant medication(s) (in two weeks) included nadolol and verapamil hydrochloride taken for an unspecified indication. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient experienced became covid symptomatic on 29Jul2021, had positive pcr on 30Jul2021 (vaccination failure) (medically significant), nausea, congestion, fever, cough, malaise, headache on 29Jul2021. It was reported that patient received both vaccines. Became COVID symptomatic on 29Jul2021, Had positive PCR on 30Jul2021. Have had moderate symptoms, including congestion, fever, cough, malaise, headache, nausea. The events resulted in doctor or other healthcare professional office/clinic visit. Hospitalization was not prolonged. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 29Jul2021 Nasal Swab, SARS CoV2 RNA NAAT. Patient received symptomatic COVID treatment for the events. The outcome of the events was recovering at the time of last observation.; Sender's Comments: Based on the information currently available the lack of efficacy of the vaccine BNT162B2 cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling in my right thigh just above the knee; This is a spontaneous report from a contactable consumer, the patient. This case is for vaccine first dose. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration on 02Mar2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced swelling in right thigh just above the knee on an unspecified date in Mar2021. Patient stated, "I was treated for swelling in my right thigh just above the knee on 16Mar2021. I have been advised by medical personnel to notify your company and provide the information stated above". The patient was hospitalized for swelling in right thigh just above the knee from 16Mar2021 to an unknown date. Therapeutic measures were taken as a result of swelling in my right thigh just above the knee. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary embolism, Thrombosis
Clinical narrative: pulmonary embolism; blood clot(s) in right leg from ankle to groin; This is a spontaneous report from a contactable consumer (patient).A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6204), via an unspecified route of administration on 26Mar2021, as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6198), via an unspecified route of administration on 02Mar2021, as dose 1, single for covid-19 immunization and experienced swelling in my right thigh just above the knee. On 07May2021, after second dose, the patient experienced pulmonary embolism (hospitalization, medically significant) and blood clots in right leg from ankle to groin (hospitalization, medically significant). Discharge report stated no evidence of deep venous thrombosis. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Itching and redness in different locations, like her shoulder, lower back, side, elbow, arm and rib cage; Itching and redness in different locations, like her shoulder, lower back, side, elbow, arm and rib cage; random patches of itching and redness in different locations; This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ZW0187), dose 1 via an unspecified route of administration, administered in right arm on 01Jul2021 (at the age of 48-years-old) at a single dose for covid-19 immunization.  Medical history included brain operation from 2017 for cysts on her brain, the last was in 2017.  There were no concomitant medications.  The patient experienced patches and  itching 1-2 days after her first dose. Patient reported it was random patches of itching and redness in different locations, like shoulder, lower back, side, elbow, and arm. She stated it was random, and little patches were also around her rib cage . Patient said it lasted for a couple weeks after she had her first vaccine on 01Jul2021. Events were treated with calamine lotion. The outcome of the events was reported as recovered in Jul2021.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: right arm aches all the time; My right arm aches all the time, have limited Tom in Right arm.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 21May2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, and sulfonamide allergy. 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. Concomitant medications included insulin lispro (HUMALOG), insulin detemir (LEVEMIR), metformin (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN) and insulin (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient previously took bupropion hydrochloride (WELLBUTRIN) from an unknown date for an unspecified indication and experienced drug allergy. On 21May2021, the patient experienced "my right arm aches all the time, have limited Rom in Right arm". The events did not result in 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events "my right arm aches all the time, have limited Rom in Right arm" was not recovered.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Feeling hot, Pruritus, Skin mass
Clinical narrative: Itchy, hot and burning red lump the size of a half dollar.; Itchy, hot and burning red lump the size of a half dollar.; Itchy, hot and burning red lump the size of a half dollar.; Itchy, hot and burning red lump the size of a half dollar.; Itchy, hot and burning red lump the size of a half dollar.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 21Jul2021 at 10:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19.  The patient received unspecified medications within two weeks of the COVID-19 vaccination. The patient previously took duloxetine hydrochloride (CYMBALTA) and experienced a drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21Jul2021 at 11:00, the patient experienced itchy, hot and burning red lump the size of a half dollar. The patient reported that she started to feel it within "15-20 afterwards". She thought it was the band aid that made her arm feel that way. The patient reported that she still had a small lump and it was a little red and itchy but tolerable (at the time of reporting). 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 outcomes of the events itchy, hot and burning red lump the size of half a dollar were resolving at the time of this report.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Very swollen node on right-side of neck; This is a spontaneous report from a non-contactable consumer, the parent. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 20Apr2021 (at the age of 16-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 11May2021 (at the age of 16-years-old) 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 20Apr2021, the patient developed a very swollen node on right-side of neck after the first shot. This lasted for several weeks and did not start to slowly diminish until several weeks after the second shot. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event very swollen node on right-side of neck was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema, SARS-CoV-2 test
Clinical narrative: Edema /swelling; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the arm left on 15Apr2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome, interstitial cystitis, hypothyroid and migraine with aura. 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 amoxicillin, clavulanic acid (AUGMENTIN) and steroid dose pack (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the arm left on 24Mar2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 09:00, the patient experienced edema/swelling that had not resolved. The patient had been to her nephrologist, cardiologist, and endocrinologist and no one could find a reason for the edema. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 27May2021, the patient underwent nasal swab COVID-19 test and the result was negative. Therapeutic measures were taken as a result of event and included treatment with furosemide (LASIX). The clinical outcome of the event edema /swelling was not resolved at the time of this report.