chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood follicle stimulating hormone normal, Blood prolactin normal, Blood test normal, Blood thyroid stimulating hormone, Dysmenorrhoea
Clinical narrative: I have not had a period due to taking birth control for almost 2 years. I got the first shot on July 12th and started my period on July 28th. This period was heavy, passed quarter sized clots, painful cramps and lasted 7 days. I stopped bleeding for 5 days then started bleeding again with the same pain, flow, and clots. This lasted 6 days. I stopped bleeding for 5 days and then started bleeding again  for 6 days.  I have stopped bleeding now for a week.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Pain, Ultrasound pelvis normal
Clinical narrative: I have not had a period due to taking birth control for almost 2 years. I got the first shot on July 12th and started my period on July 28th. This period was heavy, passed quarter sized clots, painful cramps and lasted 7 days. I stopped bleeding for 5 days then started bleeding again with the same pain, flow, and clots. This lasted 6 days. I stopped bleeding for 5 days and then started bleeding again  for 6 days.  I have stopped bleeding now for a week.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Menstruation irregular, Pain, Pain in extremity
Clinical narrative: Headache that started about 1 hour after the shot and lasted over night Severe arm pain that radiated down my arm and through my middle finger; started shortly after the injection and continued for nearly three days; discomfort that woke me from sleep The two and a half weeks after the shot my menstrual cycle started. This was 2 weeks early than expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Headache that started about 1 hour after the shot and lasted over night Severe arm pain that radiated down my arm and through my middle finger; started shortly after the injection and continued for nearly three days; discomfort that woke me from sleep The two and a half weeks after the shot my menstrual cycle started. This was 2 weeks early than expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Rash
Clinical narrative: Patient received her first MODERNA COVID vaccine shot on 08/12/21 and was due for her second shot after 28 days on 09/09/21. But mistakenly worker administered her the second shot on 09/02/21. She called complaining about being sick and with a rash. The other symptoms seem to have subsided but her rash remains. Though she said she is feeling better than before. I asked her to call her doctor and check with the pharmacy again in a day or two.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient reported getting pfizer at a different pharmacy, did not have card, after administration system revealed the first dose was moderna.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2nd shot too early
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood test, Computerised tomogram abdomen, Computerised tomogram head
Clinical narrative: Massive migraine headache for 12 days starting Aug 16.  Never had them before.  Acetaminophen helped but then got migraine relief OTC and it knocked it back.   Slight fever 1-2 degrees.  Had full panel of blood work done on Aug 23, 2021.  Liver enzymes (AST and ALT were 500 to 1000% over the normal range.  Six other blood tests were out of normal range, HDL cholesterol, triglycerides, white blood count, red blood count, Hematocrit, and platelet count.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatic enzyme, Migraine
Clinical narrative: Massive migraine headache for 12 days starting Aug 16.  Never had them before.  Acetaminophen helped but then got migraine relief OTC and it knocked it back.   Slight fever 1-2 degrees.  Had full panel of blood work done on Aug 23, 2021.  Liver enzymes (AST and ALT were 500 to 1000% over the normal range.  Six other blood tests were out of normal range, HDL cholesterol, triglycerides, white blood count, red blood count, Hematocrit, and platelet count.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: After 1 st shot my arm was red and hot but then went away, after 2nd shot had something and it went away, 2 or so weeks ago I got this itchy weird rash, on my arms feet, legs and one on my shoulder, it was a rash I never experienced, it was patchy, itchy, had bubbles, looked almost like poison ivy but different
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: received pfizer as 2nd dose, 1st dose was moderna
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Dyspnoea, Pulmonary thrombosis
Clinical narrative: Patient received dose and had no immediate problems. While patient was waiting she complained of shortness of breath. I had the patient sit down and drink some water. The symptoms continued to get worse over the course of 5 minutes. At 10 minutes after the dose was given I retrieved the patient's spouse. At 10 minutes I administered 1 dose of 0.3mg epinephrine into the left outer thigh. I gave the other dose pen to the patient's spouse and sent them to the nearest emergency department. As they left I notified the ED that they would be arriving shortly.  Later about 1 hour later I called the patient to follow up at which point the patient informed me the ED personnel had taken chest x-rays and found a blood clot in her lungs. She was currently being treated for the blood clot and could breath easily. She explained to me that the doctors supposed she may have had an active COVID 19 infection recently and was asymptomatic until she came in today. It is my opinion that the vaccine did not cause the clot and that it happened to show up by chance.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient came into the store on Sunday 9/5 to technician to recieve vaccine. Patient came in by himself and presented his drivers license. He told the technician that this was his first vaccine when she asked him. She automatically dropped for pfizer due to habit since that had been what they had been doing all day. She said so you want pfizer is that correct? And the patient specifically said no I want the moderna vaccine. We verified drivers license and asked for ins card. Patient said he did not have it but went to the car to look. When he came back he said he could not find his card and so the technician tried to look it up by his social security number and it came back no coverage so we ran on the no ins plan. Today, Tues 9/8 patient's mom called and said that they had just left the pharmacy and gotten their second pfizer vaccine and they said that we had put in that he got a moderna shot on Sunday. Mom said that son was not at the pharmacy on sunday and there was no way he got it. At this point, I started researching and pulled his record and printed a screen shot of the person at the counter at the time his shot was dropped. The mom said that they were in the parking lot and were coming in the store, but they never showed up. Unsure if son admitted to making a mistake or what but tried to call the number we had for the patient with no answer.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Palpitations
Clinical narrative: A few hours after the vaccine I started feeling my heart racing and shortness of breath. I have felt this feeling every day since the vaccination.  The day after I was driving and felt my heart racing and then felt dizzy and lightheaded as if I was going to faint while driving on the road.  I started to breathe deeply and pulled over until I felt regulated.  My heart palpitations have not ceased.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Ear discomfort, Feeling abnormal, Flushing
Clinical narrative: Sudden onset of chest tightness, flushing, headache, stuffy ears, muscle weakness, brain fog, bladder urgency, throat tightness, shortness of breath, difficulty breathing.  Initially, I took 50mg of liquid, diphenhydramine, Allegra, and Ketotifen.  When it was difficult to breathe, I used my epi-pen and called 911. Treated with IV benadryl, solumedrol, and nebulized epinephrine in the ambulance.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Micturition urgency, Muscular weakness, Throat tightness, Tryptase
Clinical narrative: Sudden onset of chest tightness, flushing, headache, stuffy ears, muscle weakness, brain fog, bladder urgency, throat tightness, shortness of breath, difficulty breathing.  Initially, I took 50mg of liquid, diphenhydramine, Allegra, and Ketotifen.  When it was difficult to breathe, I used my epi-pen and called 911. Treated with IV benadryl, solumedrol, and nebulized epinephrine in the ambulance.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Cardiac monitoring, Computerised tomogram, Deep vein thrombosis, Fibrin D dimer
Clinical narrative: NO ADVERSE EVENTS IMMEDIATELY AFTER VACCINE. PATIENT RETURNED STATING HE DEVELOPED A BLOOT CLOT.  HE PRESENTED PAPERWORK STATING TREATMENT FOR A DVT IN HIS ARM AT THE INJECTION SITE.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Metabolic function test, Thrombosis, Ultrasound scan
Clinical narrative: NO ADVERSE EVENTS IMMEDIATELY AFTER VACCINE. PATIENT RETURNED STATING HE DEVELOPED A BLOOT CLOT.  HE PRESENTED PAPERWORK STATING TREATMENT FOR A DVT IN HIS ARM AT THE INJECTION SITE.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthma, Dyspnoea, Dyspnoea exertional, Injection site pruritus
Clinical narrative: Shortly after getting my first vaccination I had a sore shoulder/arm and body aches.  This continued to get worse during the week, I started getting short of breath and more winded when doing any activity.  My heart would race and pound extra hard.  Exactly a week after my shot I began to get extremely itchy from the injection site, which was spreading up my arm into my neck area.  This also made it more difficult for me to breath.  I took multiple doses of Benadryl at home which seemed to stop symptoms from getting worse.  So I decided to not go to the ER.  I contacted my provider about what to do for the next vaccine dose  later that week.  I did not get the 2nd dose due to the difficulty breathing from the first dose.  I still have asthma like symptoms since this whole ordeal which has required follow up appointments.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Palpitations, Product dose omission issue, Pruritus
Clinical narrative: Shortly after getting my first vaccination I had a sore shoulder/arm and body aches.  This continued to get worse during the week, I started getting short of breath and more winded when doing any activity.  My heart would race and pound extra hard.  Exactly a week after my shot I began to get extremely itchy from the injection site, which was spreading up my arm into my neck area.  This also made it more difficult for me to breath.  I took multiple doses of Benadryl at home which seemed to stop symptoms from getting worse.  So I decided to not go to the ER.  I contacted my provider about what to do for the next vaccine dose  later that week.  I did not get the 2nd dose due to the difficulty breathing from the first dose.  I still have asthma like symptoms since this whole ordeal which has required follow up appointments.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary function test
Clinical narrative: Shortly after getting my first vaccination I had a sore shoulder/arm and body aches.  This continued to get worse during the week, I started getting short of breath and more winded when doing any activity.  My heart would race and pound extra hard.  Exactly a week after my shot I began to get extremely itchy from the injection site, which was spreading up my arm into my neck area.  This also made it more difficult for me to breath.  I took multiple doses of Benadryl at home which seemed to stop symptoms from getting worse.  So I decided to not go to the ER.  I contacted my provider about what to do for the next vaccine dose  later that week.  I did not get the 2nd dose due to the difficulty breathing from the first dose.  I still have asthma like symptoms since this whole ordeal which has required follow up appointments.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: redness, noticeable swelling, itching, warm, no pain  - started within 24 hrs, still occurring.  Recommended benedryl
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: On the day of the vaccination, everything was fine, just a little pain, redness in the area and I felt hot the next day. everything was the same until day 4, when I had a strong swelling in the arm. Itching and the heat of the injected area was hard to handle.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: On the day of the vaccination, everything was fine, just a little pain, redness in the area and I felt hot the next day. everything was the same until day 4, when I had a strong swelling in the arm. Itching and the heat of the injected area was hard to handle.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swollen tongue
Clinical narrative: Tongue swells on and off since April. Multiple painful spots. Resolve onto white circles within 24 hours. Ent referral could not dx Not allergy as can be triggered without food. Bizarre and annoying immune response.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: experiencing unbearable pain on the arm where she got injected; This spontaneous report from contactable consumer (patient) via medical information department.  A 69-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, on unspecified date (age at vaccination: 69 years), as a dose 2, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient reported that she has been experiencing unbearable pain on the arm where she got the injection. Patient wanted to know if this was normal, or this has been reported before. Outcome for the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: lightheaded; tired; fuzzy-minded; weak feeling; This is a spontaneous report from a contactable consumer (Patient). A 75-years-old female patient 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, administered on 26Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. On an unspecified date patient experienced lightheaded, tired. On 30Aug2021 patient experienced fuzzy-minded, weak feeling. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Pyrexia
Clinical narrative: cold chills; fevers between 101°-104°F; feeling like she couldn't wake up; This is a spontaneous report from a contactable consumer or other non hcp.    A 56-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 30Aug2021 as single for COVID-19 immunisation. The patient medical history and patient's concomitant medications were not reported. Historical vaccine included first dose BNT162B2 via an unspecified routed of administration on 09Aug2021 Dose 1, Single for COVID-19 immunisation.  On 31Aug2021 the patient experienced cold , fever between 101-104 degree Fahrenheit, feeling like she couldn't wake up. Therapeutic measures were taken as a result of cold chills, fevers between 101 degree-104 degree Fahrenheit feeling like she couldn't wake up. The patient underwent lab tests and procedures which included body temperature as 101-104 degree Fahrenheit. The outcome of events cold, feeling like she couldn't wake up recovered on an unspecified date in 2021 and the outcome of event fever between 101 -104 degree Fahrenheit was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Dizziness, Dyspepsia, Nausea, Pain in extremity
Clinical narrative: dizzy; nauseous; bad ingestion; She couldnt get out of bed; arm pain; This is a spontaneous report from a contactable consumer or other non hcp(patient).A 53-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number- not reported), via an unspecified route of administration(age at vaccination 53 years) on 29Aug2021 as DOSE 2, SINGLE for covid-19 immunization.The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (COMIRNATY, solution for injection,Lot number-not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. It was reported that patient had the 2nd dose of the Comirnaty vaccine on 29Aug2021. After that,patient had arm pain on 29Aug2021.The next morning on 30Aug2021 she felt dizzy, she couldn't get out of bed, nauseous, with bad indigestion. Her indigestion, dizziness, and intermittent nausea were still ongoing.She was asking for more information as she will be flying some time so she was concerned about that.She asked if since dizziness was listed as one of the signs of severe allergic reaction, would that mean that her body was rejecting the vaccine.She also asked how long will her symptoms last.Clarified that dizziness doesn't necessarily indicate a severe allergic reaction, only it was listed as one of its signs. The outcome of all events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Vertigo
Clinical narrative: Vertigo; diarrhea; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on an unspecified date (age at vaccination: unspecified), as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was experiencing vertigo and diarrhoea after the first injection but debilitating after the second injection. The patient formally requested the document for the product. Outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature fluctuation, Chills, Fatigue
Clinical narrative: I get a temperature;  I feel temperature off and on; I feel flushed; Itching; Hives; Pain injection site; Tiredness; Headache; Muscle pain; Chills; Joint pain; Injection site is swelling; little bit of nausea the first day; Arm pain; I get a temperature; low grade temperature; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot Number: FD8448) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have the severe side effects, but the patient had it done on Sunday around 09:40 (date not reported) and had itching and hives, pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, injection site was swelling, little bit of nausea the first day and arm pain. The patient got a little bit of low grade temperature, it started out as 99.4 on the evening of 31Aug2021 then it was at 101 on 01Sep2021. The patient felt temperature off and on and suspected a temperature but it went away and patient was back to normal. The patient did not know if it was going to be on and off, patient felt flushed, then would get a temperature, then it would go away. The outcome of the event low grade temperature was recovered in Sep2021 and the other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Flushing, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: I get a temperature;  I feel temperature off and on; I feel flushed; Itching; Hives; Pain injection site; Tiredness; Headache; Muscle pain; Chills; Joint pain; Injection site is swelling; little bit of nausea the first day; Arm pain; I get a temperature; low grade temperature; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot Number: FD8448) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have the severe side effects, but the patient had it done on Sunday around 09:40 (date not reported) and had itching and hives, pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, injection site was swelling, little bit of nausea the first day and arm pain. The patient got a little bit of low grade temperature, it started out as 99.4 on the evening of 31Aug2021 then it was at 101 on 01Sep2021. The patient felt temperature off and on and suspected a temperature but it went away and patient was back to normal. The patient did not know if it was going to be on and off, patient felt flushed, then would get a temperature, then it would go away. The outcome of the event low grade temperature was recovered in Sep2021 and the other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Urticaria, Vaccination site pain, Vaccination site swelling
Clinical narrative: I get a temperature;  I feel temperature off and on; I feel flushed; Itching; Hives; Pain injection site; Tiredness; Headache; Muscle pain; Chills; Joint pain; Injection site is swelling; little bit of nausea the first day; Arm pain; I get a temperature; low grade temperature; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot Number: FD8448) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have the severe side effects, but the patient had it done on Sunday around 09:40 (date not reported) and had itching and hives, pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, injection site was swelling, little bit of nausea the first day and arm pain. The patient got a little bit of low grade temperature, it started out as 99.4 on the evening of 31Aug2021 then it was at 101 on 01Sep2021. The patient felt temperature off and on and suspected a temperature but it went away and patient was back to normal. The patient did not know if it was going to be on and off, patient felt flushed, then would get a temperature, then it would go away. The outcome of the event low grade temperature was recovered in Sep2021 and the other events was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Caller is a consumer who received both doses of the Pfizer Biontech COVID19 vaccine on January and got COVID19 infection this August; Caller is a consumer who received both doses of the Pfizer Biontech COVID19 vaccine on January and got COVID19 infection this August; This is a spontaneous report from a Sponsored Program. This 72-year-old male consumer reported for himself.  A 72-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date in Jan2021 (72-year-old at the time of vaccination) as dose 1, single, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date in Jan2021 (72-year-old at the time of vaccination) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in Aug2021, the patient got COVID19 infection. The patient also stated that he had received a regencov infusion which was an antibody that also boosts immunity. The patient wanted to know if he should receive the booster dose when it comes available in September or if he should wait longer than September. The patient underwent lab tests and procedures which included COVID-19: positive on unspecified date on Aug2021. The outcome of the events were unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: ache; I had fever chills; She herself experience the sore arm after taking the first dose; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 08Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm after taking the first dose leading to pain in extremity on 08Aug2021 with outcome of unknown, she had fever chills causing pyrexia on 30Aug2021 with outcome of unknown and body ache on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of this. The patient took Tylenol and was concerned about side effect with vaccine regimen.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Pain
Clinical narrative: difficulty breathing; tight feeling in chest; pain with regular/deep breathing; dizziness; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. After first dose of Pfizer COVID 19 vaccine, on an unspecified date, the patient experienced tight feeling in chest, difficulty breathing, pain with regular/deep breathing and dizziness on first day. Noted that cardiologist was not confident if the patient should take the second dose. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Started to feel cramping in extremities, like light charlie horses; Slight pains in forearms; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 27Aug2021 at 11:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included gluten sensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included cranberry vitamin (MANUFACTURER UNKNOWN), elderberry with zinc (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and multi (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 28Aug2021, the patient started to feel cramping in her extremities, like light charlie horses and then felt in the tops of her feet, hands at times, calves and some slight pains in forearms. The events resulted in emergency room/department visit 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 events. The clinical outcome of the events started to feel cramping in extremities, like light charlie horses and slight pains in forearms was not resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle sore on upper right part of her back; This is a spontaneous report from contactable consumer (patient).   A 71-years-old female patient received bnt162b2 (Pfizer BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 17Aug2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient has been experienced muscle sore on upper right part of her back since 25Aug2021. She received the 1st dose of the vaccine on 17Aug2021 and had it on her left arm-It usually occurs some time in a day but not 24/7. Patient took Ibuprofen once a day that started 2 days ago but skipped today as she will have her 2nd dose on 07Sep2021- Asking if this is a general reaction from the vaccine. Therapeutic measures were taken as a result of muscle sore on upper right part of her back. The outcome of the event was unknown.  The lot number for the vaccine, was not provided and will be requested during follow up.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Lack of energy; Lymph node on shot arm swollen and tender; Fever/fever (98.7); Lymph node on shot arm swollen and tender; Slept for 17 hours; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308A) via an unspecified route of administration in the right arm on 31Aug2021 at 17:30 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse and sleep apnea. The patient had no known allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included flu shot (influenza vaccine) (MANUFACTURER UNKNOWN) on an unknown date of 2021 (reported as the day before) for immunisation; simvastatin (MANUFACTURER UNKNOWN) and clobetasol propionate (CLOP); for unknown indications from unknown dates and unknown if ongoing. On 01Sep2021, first day after shot, the patient experienced a fever, slept for 17 hours and lymph node on shot arm was swollen and tender. On 02Sep2021 (reported as second day), the patient ran fever (98.7 unspecified units). The patient also experienced lack of energy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever/fever (98.7 unspecified units), slept for 17 hours, lymph node on shot arm swollen and tender and lack of energy were resolving at the time of the report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Lack of energy; Lymph node on shot arm swollen and tender; Fever/fever (98.7); Lymph node on shot arm swollen and tender; Slept for 17 hours; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308A) via an unspecified route of administration in the right arm on 31Aug2021 at 17:30 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse and sleep apnea. The patient had no known allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included flu shot (influenza vaccine) (MANUFACTURER UNKNOWN) on an unknown date of 2021 (reported as the day before) for immunisation; simvastatin (MANUFACTURER UNKNOWN) and clobetasol propionate (CLOP); for unknown indications from unknown dates and unknown if ongoing. On 01Sep2021, first day after shot, the patient experienced a fever, slept for 17 hours and lymph node on shot arm was swollen and tender. On 02Sep2021 (reported as second day), the patient ran fever (98.7 unspecified units). The patient also experienced lack of energy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever/fever (98.7 unspecified units), slept for 17 hours, lymph node on shot arm swollen and tender and lack of energy were resolving at the time of the report.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Never experience bleeding during the period because of  IUD but did after receiving both vaccine shots; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 16Jul2021 at 19:00 (at the age of 27-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis and penicillin 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 medication included levonorgestrel (MIRENA) intra uterine device (IUD) for an unknown indication from an unknown date and unknown if ongoing. On 17Jul2021 at 12:00, the patient experienced bleeding during her period. It was reported that the patient had never experienced bleeding during her period because of  the IUD but did after receiving both vaccine shots. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event never experienced bleeding during the period because of IUD but did after receiving both vaccine shots was not resolved at the time of the report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Vision blurred
Clinical narrative: Woke up with blurred vision; Felt heart racing; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Apr2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient felt that her heart was racing for 3 weeks after the vaccine. Recently on 13Aug2021, the patient woke up with blurred vision and looked up if this could be a side effect, and it was. The patient also reported that it had been 3 weeks and her eyesight was still blurred which happened over night. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events felt heart racing and woke up with blurred vision was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Swelling face
Clinical narrative: Swelling on right side face; Swelling on right side face and right side ear lobe; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EC3180) via an unspecified route of administration in the right arm on 06Aug2021 at 18:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included two premature baby. The patient had known allergy to sulfa antibiotics. 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 21Aug2021 at 08:00, the patient experienced swelling on right side face and right-side ear lobe. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and the patient had an appointment for biopsy. The clinical outcome of the events swelling on right side face and swelling on right side ear lobe was not recovered at the time of this report.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: Diarrhea; Sore arm; Runny nose; Headache; Low grade fever; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 30Aug2021 at 08:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received cefaclor (CECLOR) for an unknown indication on an unknown date and experienced drug allergy. On 30Aug2021 at 13:00, the patient experienced runny nose, headache, low grade fever and sore arm within 8 hours of vaccine at 16:30. On 01Sep2021, day three after the vaccine, the patient experienced diarrhea. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 02Sep2021, the patient underwent polymerase chain reaction (PCR) test and the result was pending. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events runny nose, headache, low grade fever, sore arm and diarrhea was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Diarrhea; Sore arm; Runny nose; Headache; Low grade fever; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 30Aug2021 at 08:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received cefaclor (CECLOR) for an unknown indication on an unknown date and experienced drug allergy. On 30Aug2021 at 13:00, the patient experienced runny nose, headache, low grade fever and sore arm within 8 hours of vaccine at 16:30. On 01Sep2021, day three after the vaccine, the patient experienced diarrhea. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 02Sep2021, the patient underwent polymerase chain reaction (PCR) test and the result was pending. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events runny nose, headache, low grade fever, sore arm and diarrhea was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dyspnoea, Pleurisy
Clinical narrative: Chest pain; Back pain; Trouble breathing; Pleurisy; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 31Aug2021 at 16:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 10Aug2021 at 16:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 01Sep2021 at 09:30, the patient experienced chest and back pain and trouble breathing and the patient was presented to emergency room (ER) on 01Sep2021 at approximately 10:30. It was reported that the patient was diagnosed with pleurisy as a result of the immune response from the vaccine. The events resulted 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 taken as a result of the events and included treatment with unspecified medication. The clinical outcome of the events chest and back pain, trouble breathing and pleurisy was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: Headaches; Joint pain; fevers off and on; Feeling yucky; Cough; Swets; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 18Aug2021 at 18:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos, blood pressure high, allergy to sugarcane, very sensitive to soy (allergy). Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atenolol (TENORMIN), amlodipine besilate (NORVASC), progesterone (MANUFACTURER UNKNOWN) and thyroid medication (unspecified); all taken from an unknown dates for unknown indications and unknown if ongoing. The patient previously received cefalexin (KEFLEX) and hydromorphone hydrochloride (DILAUDID) on unknown dates for unknown indications and experienced drug allergy. On 21Aug2021 the patient experienced headaches, joint pain, fevers off and on (reported as an), feeling yucky, cough, sweats. The events 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 events. The clinical outcome of the events headaches, joint pain, fevers off and on, feeling yucky, cough and sweats were not resolved at the time of this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headaches; Joint pain; fevers off and on; Feeling yucky; Cough; Swets; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 18Aug2021 at 18:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos, blood pressure high, allergy to sugarcane, very sensitive to soy (allergy). Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atenolol (TENORMIN), amlodipine besilate (NORVASC), progesterone (MANUFACTURER UNKNOWN) and thyroid medication (unspecified); all taken from an unknown dates for unknown indications and unknown if ongoing. The patient previously received cefalexin (KEFLEX) and hydromorphone hydrochloride (DILAUDID) on unknown dates for unknown indications and experienced drug allergy. On 21Aug2021 the patient experienced headaches, joint pain, fevers off and on (reported as an), feeling yucky, cough, sweats. The events 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 events. The clinical outcome of the events headaches, joint pain, fevers off and on, feeling yucky, cough and sweats were not resolved at the time of this report.