chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cold sweat, Dizziness, Dyspepsia
Clinical narrative: Monday morning 5am i had very bad chest pains, slight heartburn, cold sweats in addition to the dizziness; Monday morning 5am i had very bad chest pains, slight heartburn, cold sweats in addition to the dizziness; Monday morning 5am i had very bad chest pains, slight heartburn, cold sweats in addition to the dizziness; Within 24 hours i felt dizzy.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8730) via an unspecified route of administration in the left arm on 09Apr2021 at 12:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not have any other medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included venlafaxine hydrochloride 150 milligram (EFFEXOR) and naloxone hydrochloride, buprenorphine hydrochloride 16 milligram (SUBOXONE) both from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Within 24 hours on 10Apr2021, the patient felt dizzy. On Monday morning, 12Apr2021 at 05:00 the patient had very bad chest pains, slight heartburn, cold sweats in addition to the dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events within 24 hours felt dizzy, Monday morning at 05:00 the patient had very bad chest pains, slight heartburn, cold sweats in addition to the dizziness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Migraine, Pyrexia
Clinical narrative: Lots of tightness in the chest.; Terrible migraine; Extreme chills; Low fever; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0151) via an unspecified route of administration in the right arm on 11Apr2021 at 09:45 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease. Concomitant medication included loratadine (CLARITIN) from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 21:30, roughly 12 hours after the injection the patient experienced terrible migraine, extreme chills and low fever. Additionally, on 12Apr2021, around 14:00 the following day she started experiencing lots of tightness in the chest. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events terrible migraine, extreme chills, low fever and lots of tightness in the chest were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Pain, Vomiting
Clinical narrative: Body aches; Nausea; Vomit; Diarrhea; Chills; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 09Apr2021 at 14:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included estradiol, progesterone (BIJUVA; hormone replace therapy) from an unknown date for unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 19Mar2021 at 13:45 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021 at 03:30, the patient experienced nausea, vomit, diarrhoea, body aches, and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of nausea, vomit, diarrhoea, body aches, and chills which included treatment with ibuprofen (MANUFACTURER UNKNOWN). The clinical outcomes of nausea, vomit, diarrhea, body aches and chills were recovered with sequelae on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Body aches; Chills; Fever; Extreme fatigue; Nausea; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955), via an unspecified route of administration in the left arm on 29Mar2021 at 12:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included anemia and the patient had a history of allergy to sulfur medication, garlic and dairy intolerance. Concomitant medications included mirtazapine (MANUFACTURER UNKNOWN) and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN) for an unspecified indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 30Mar2021 at 00:00, the patient experienced flu like symptoms such as chills, fever, body aches, extreme fatigue, nausea and headache. The events did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of the events chills, fever, body aches, extreme fatigue, nausea and headache was resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body aches; Chills; Fever; Extreme fatigue; Nausea; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955), via an unspecified route of administration in the left arm on 29Mar2021 at 12:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included anemia and the patient had a history of allergy to sulfur medication, garlic and dairy intolerance. Concomitant medications included mirtazapine (MANUFACTURER UNKNOWN) and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN) for an unspecified indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 30Mar2021 at 00:00, the patient experienced flu like symptoms such as chills, fever, body aches, extreme fatigue, nausea and headache. The events did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of the events chills, fever, body aches, extreme fatigue, nausea and headache was resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Night sweats, Pain in extremity
Clinical narrative: Sudden onset of feeling bad; Feverish (no fever); Bad joint pain; Very tired; Arm hurt a lot more with the 2nd shot; Woke up soaked in sweat, still no fever; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), via an unspecified route of administration in the left arm on 10Apr2021 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included autoimmune, several, graves, thyroid, eye disease and colitis. The patient did not have any allergies to medications, food or other products. Concomitant medications included thyroid (ARMOUR THYROID), sulfasalazine (SULFASALASIN) and alendronate sodium (FOSAMAX); all from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 18Mar2021 at 16:00 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. After the first shot the patient had no problems at all and after second shot at 17:00, Saturday, April 10th, the patient had no problems until 21:30. On 11Apr2021, Sunday evening, the patient experienced sudden onset of feeling bad, feverish (no fever), bad joint pain, very tired. Went to bed, a lot of joint pain. Took 3 tylenol and drank gatorade, went back to bed, and slept 2 hours well. Woke up soaked in sweat, still no fever, drank more gatorade went back to sleep and slept well. The patient woke up on Monday feeling good, normal. Basically for 4 hours of feeling very bad. The patient's arm hurt a lot more with the second shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with 3 tylenol and the patient drank gatorade. The clinical outcome of the events feeling bad, feverish (no fever), bad joint pain, very tired, woke up soaked in sweat and the patient's arm hurt a lot more were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sudden onset of feeling bad; Feverish (no fever); Bad joint pain; Very tired; Arm hurt a lot more with the 2nd shot; Woke up soaked in sweat, still no fever; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), via an unspecified route of administration in the left arm on 10Apr2021 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included autoimmune, several, graves, thyroid, eye disease and colitis. The patient did not have any allergies to medications, food or other products. Concomitant medications included thyroid (ARMOUR THYROID), sulfasalazine (SULFASALASIN) and alendronate sodium (FOSAMAX); all from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 18Mar2021 at 16:00 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. After the first shot the patient had no problems at all and after second shot at 17:00, Saturday, April 10th, the patient had no problems until 21:30. On 11Apr2021, Sunday evening, the patient experienced sudden onset of feeling bad, feverish (no fever), bad joint pain, very tired. Went to bed, a lot of joint pain. Took 3 tylenol and drank gatorade, went back to bed, and slept 2 hours well. Woke up soaked in sweat, still no fever, drank more gatorade went back to sleep and slept well. The patient woke up on Monday feeling good, normal. Basically for 4 hours of feeling very bad. The patient's arm hurt a lot more with the second shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with 3 tylenol and the patient drank gatorade. The clinical outcome of the events feeling bad, feverish (no fever), bad joint pain, very tired, woke up soaked in sweat and the patient's arm hurt a lot more were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hot flush, Pain in extremity, Pyrexia
Clinical narrative: Body hot flashes; Low grade fever; Very sore arm; Feeling run down; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0151) via an unspecified route of administration in the left arm on 11Apr2021 at 13:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8730) via an unspecified route of administration in the left arm on 22Mar2021 at 18:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021 at 05:00, the patient experienced low grade fever, very sore arm, body hot flashes and felt run down. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken for the events. The clinical outcome of the events low grade fever, very sore arm, body hot flashes and felt run down were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Skin rashes all over the body; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old non pregnant (including at time of vaccination) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), at the age of 39-years-old via an unspecified route of administration administered in Arm Left on 22Mar2021 10:30 (Batch/Lot Number: EN6207) as DOSE 1, SINGLE for COVID-19 immunization. No medical history and concomitant medications. On 26Mar2021 21:00 (as reported), the patient experienced skin rashes all over the body after 5 days of taking the first dose of vaccination. It was stated that the rashes were getting worst every day. Then, the primary care physician prescribed steroid and BENADRYL. The event resulted to doctor or other healthcare professional office/clinic visit. The patient then been to urgent care where they administered IV steroids (dexamethasone sodium phosphate), IV BENADRYL and famotidine. The patient was not patient diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination. Outcome of the event was not recovered.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Pain, Vaccination site pain
Clinical narrative: severe nausea; vomiting; pain around the injection site; stinging sensation; dizzy; fatigued; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 11Apr2021 at 13:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included generalised anxiety disorder, smoker (Vaping), overweight, COVID-19 and shellfish allergy. Concomitant medications included escitalopram oxalate (LEXAPRO), and oral contraceptive nos (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 10:00, the patient experienced several unpleasant side effects, most of which were said to be normal. The worst symptom was very severe nausea, as well as vomiting. Also experienced quite a bit of pain around the injection site with a sort of stinging sensation, dizzy and fatigued. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events very severe nausea, vomiting, pain around the injection site with a sort of stinging sensation, dizzy and fatigued was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: severe nausea; vomiting; pain around the injection site; stinging sensation; dizzy; fatigued; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 11Apr2021 at 13:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included generalised anxiety disorder, smoker (Vaping), overweight, COVID-19 and shellfish allergy. Concomitant medications included escitalopram oxalate (LEXAPRO), and oral contraceptive nos (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 10:00, the patient experienced several unpleasant side effects, most of which were said to be normal. The worst symptom was very severe nausea, as well as vomiting. Also experienced quite a bit of pain around the injection site with a sort of stinging sensation, dizzy and fatigued. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events very severe nausea, vomiting, pain around the injection site with a sort of stinging sensation, dizzy and fatigued was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Irregular sleep wake rhythm disorder, Poor quality sleep
Clinical narrative: Since  second dose, unable to enter deep sleep cycle to stay asleep. Sleep was very light and unable to stay asleep. Sometimes waking up early in the morning due to unable to enter deep cycle.; Since  second dose, unable to enter deep sleep cycle to stay asleep. Sleep was very light and unable to stay asleep. Sometimes waking up early in the morning due to unable to enter deep cycle.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 09Apr2021 at 14:00 (at the age of 37years-old) as a single dose for COVID-19 immunisation. Medical history not was reported as no. The patient had no known allergies to any medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluticasone propionate (FLONASE) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 20Mar2021 at 15:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 23:45, since second dose of vaccination, the patient experienced unable to enter deep sleep cycle to stay asleep and sleep was very light and the patient was unable to stay asleep. Sometimes the patient  woke up early in the morning because he was unable to enter deep cycle. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events unable to enter deep sleep cycle to stay asleep and sleep was very light and the patient was unable to stay asleep. Sometimes the patient  woke up early in the morning because he was unable to enter deep cycle was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Groin pain, Pain in extremity, Product administered at inappropriate site, Pyrexia
Clinical narrative: Fever 101; swelled, fist sized raised below the injection site which was on left thigh , 2-3 inch swell around the injection site; Red area just below the injection site whichwas on my left thigh; warm area just below the injection site whichwas on left thigh; Tender area just below the injection site whichwas on left thigh, injection site also tender to touch; Pain extends from groin area; Pain around the side of thigh, down towards knee and to the back of thigh causing difficulty, sitting, walking and moving.; Slight swelling, around the side of thigh, down towards knee and to the back of  thigh causing difficulty sitting, walking and moving.; vaccine administered in inappropriate site; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right thigh on 09Apr2021 at 08:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer in 2008 and COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient has known allergy to oxycodone. Prior to the vaccination, the patient was diagnosed with COVID-19. On 09Apr2021 at 22:00 the patient experienced fever 101, had a swelled, fist sized raised, red, warm and tender area just below the injection site which was on left thigh due to a previous cancer diagnosis that was cleared. There was also a 2-3 inch swell around the injection site, tender to touch and movement. It resembled a bullseye. The pain extended from groin area with slight swelling, around the side of thigh, down towards the knee and to the back of thigh causing difficulty sitting, walking and moving. No therapeutic measures were taken for the events. The events resulted in doctor or other healthcare professional office/clinic visit.  On 09Apr2021, the patient underwent body temperature and the result was 101 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever 101 was recovered on an unknown date in Apr2021; while that of swelled, fist sized raised, red, warm and tender area just below the injection site which was on left thigh, 2-3 inch swell around the injection site, tender to touch and movement, pain extended from  groin area with slight swelling, around the side of thigh, down towards the knee and to the back of thigh causing difficulty sitting, walking and moving was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Fever 101; swelled, fist sized raised below the injection site which was on left thigh , 2-3 inch swell around the injection site; Red area just below the injection site whichwas on my left thigh; warm area just below the injection site whichwas on left thigh; Tender area just below the injection site whichwas on left thigh, injection site also tender to touch; Pain extends from groin area; Pain around the side of thigh, down towards knee and to the back of thigh causing difficulty, sitting, walking and moving.; Slight swelling, around the side of thigh, down towards knee and to the back of  thigh causing difficulty sitting, walking and moving.; vaccine administered in inappropriate site; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right thigh on 09Apr2021 at 08:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer in 2008 and COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient has known allergy to oxycodone. Prior to the vaccination, the patient was diagnosed with COVID-19. On 09Apr2021 at 22:00 the patient experienced fever 101, had a swelled, fist sized raised, red, warm and tender area just below the injection site which was on left thigh due to a previous cancer diagnosis that was cleared. There was also a 2-3 inch swell around the injection site, tender to touch and movement. It resembled a bullseye. The pain extended from groin area with slight swelling, around the side of thigh, down towards the knee and to the back of thigh causing difficulty sitting, walking and moving. No therapeutic measures were taken for the events. The events resulted in doctor or other healthcare professional office/clinic visit.  On 09Apr2021, the patient underwent body temperature and the result was 101 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever 101 was recovered on an unknown date in Apr2021; while that of swelled, fist sized raised, red, warm and tender area just below the injection site which was on left thigh, 2-3 inch swell around the injection site, tender to touch and movement, pain extended from  groin area with slight swelling, around the side of thigh, down towards the knee and to the back of thigh causing difficulty sitting, walking and moving was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: buzzing in ears/tinnitus; light-headedness/dizziness; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the right arm on 25Mar2021 at 18:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, blood pressure high and depression. Concomitant medications included metformin (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN) and thyroid (ARMOUR THYROID) taken for unknown indication and unknown if its ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the right arm on 03Mar2021 at 18:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient previously received amoxicillin (AMOXYL) taken for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 07:00, about 2 weeks after second dose of the vaccine, the patient woke up and had a buzzing in her ears as well as light-headedness/dizziness. It happened constantly and have never had issues with tinnitus or dizziness before but this was non-stop. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events buzzing in ears/tinnitus and light-headedness/dizziness were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Back disorder, Blood glucose, Blood glucose increased, Chills
Clinical narrative: diabetic & sugar levels were very high since shot; diabetic & sugar levels were very high since shot; Nose bleeds; Severe headaches; Nausea; Exhaustion; Irritability; Depression worsened; white "bumps" near eyes; Chills; Extreme agitation; Back feels twisted keeping her from sleep; Back feels twisted keeping her from sleep; Loss of appetite; itching in both feet 1st week; Nose running constantly; can't stand light in her eyes; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 01Apr2021 14:45 (Batch/Lot Number: ER8737) as dose 1, single (at the age of 62-years-old) for COVID-19 immunisation. Medical history included chronic kidney disease stage II, carpal tunnel syndrome, degenerative arthritis, high cholesterol, high blood pressure (BP), agoraphobia, anxiety, depression, Hashimoto's disease and diabetes. The patient has unspecified concomitant medications (reported as "many to list"). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took morphine and lisinopril and experienced allergies: anaphylaxis. She has 3 pages of adverse reactions to meds (unspecified). On 02Apr2021 at 15:00 the patient started to have the adverse events. The patient was still having severe headaches, nausea, exhaustion, irritability, anxiety, depression worsened, nose bleeds, white "bumps" near eyes, chills, diabetic & sugar levels were very high since shot. Extreme agitation. Back feels twisted keeping her from sleep. Loss of appetite. The patient would not be taking second dose. 12 days later she still felt the same. She was extremely cautious and had not left home except for labs for three times since the virus began. Nose running constantly, had itching in both feet 1st week. Headache was unbearable and she can't stand light in her eyes. The patient no longer had nosebleeds after 6 days. The patient added that were minor but definitely not the norm. No treatment was received for the adverse events. The patient recovered from the nosebleeds after 6 days (08Apr2021). The patient recovered from itching in both feet 1st week in Apr2021. The patient has not recovered from the remaining events.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Decreased appetite, Depression, Epistaxis, Fatigue
Clinical narrative: diabetic & sugar levels were very high since shot; diabetic & sugar levels were very high since shot; Nose bleeds; Severe headaches; Nausea; Exhaustion; Irritability; Depression worsened; white "bumps" near eyes; Chills; Extreme agitation; Back feels twisted keeping her from sleep; Back feels twisted keeping her from sleep; Loss of appetite; itching in both feet 1st week; Nose running constantly; can't stand light in her eyes; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 01Apr2021 14:45 (Batch/Lot Number: ER8737) as dose 1, single (at the age of 62-years-old) for COVID-19 immunisation. Medical history included chronic kidney disease stage II, carpal tunnel syndrome, degenerative arthritis, high cholesterol, high blood pressure (BP), agoraphobia, anxiety, depression, Hashimoto's disease and diabetes. The patient has unspecified concomitant medications (reported as "many to list"). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took morphine and lisinopril and experienced allergies: anaphylaxis. She has 3 pages of adverse reactions to meds (unspecified). On 02Apr2021 at 15:00 the patient started to have the adverse events. The patient was still having severe headaches, nausea, exhaustion, irritability, anxiety, depression worsened, nose bleeds, white "bumps" near eyes, chills, diabetic & sugar levels were very high since shot. Extreme agitation. Back feels twisted keeping her from sleep. Loss of appetite. The patient would not be taking second dose. 12 days later she still felt the same. She was extremely cautious and had not left home except for labs for three times since the virus began. Nose running constantly, had itching in both feet 1st week. Headache was unbearable and she can't stand light in her eyes. The patient no longer had nosebleeds after 6 days. The patient added that were minor but definitely not the norm. No treatment was received for the adverse events. The patient recovered from the nosebleeds after 6 days (08Apr2021). The patient recovered from itching in both feet 1st week in Apr2021. The patient has not recovered from the remaining events.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Irritability, Nausea, Photophobia
Clinical narrative: diabetic & sugar levels were very high since shot; diabetic & sugar levels were very high since shot; Nose bleeds; Severe headaches; Nausea; Exhaustion; Irritability; Depression worsened; white "bumps" near eyes; Chills; Extreme agitation; Back feels twisted keeping her from sleep; Back feels twisted keeping her from sleep; Loss of appetite; itching in both feet 1st week; Nose running constantly; can't stand light in her eyes; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 01Apr2021 14:45 (Batch/Lot Number: ER8737) as dose 1, single (at the age of 62-years-old) for COVID-19 immunisation. Medical history included chronic kidney disease stage II, carpal tunnel syndrome, degenerative arthritis, high cholesterol, high blood pressure (BP), agoraphobia, anxiety, depression, Hashimoto's disease and diabetes. The patient has unspecified concomitant medications (reported as "many to list"). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took morphine and lisinopril and experienced allergies: anaphylaxis. She has 3 pages of adverse reactions to meds (unspecified). On 02Apr2021 at 15:00 the patient started to have the adverse events. The patient was still having severe headaches, nausea, exhaustion, irritability, anxiety, depression worsened, nose bleeds, white "bumps" near eyes, chills, diabetic & sugar levels were very high since shot. Extreme agitation. Back feels twisted keeping her from sleep. Loss of appetite. The patient would not be taking second dose. 12 days later she still felt the same. She was extremely cautious and had not left home except for labs for three times since the virus began. Nose running constantly, had itching in both feet 1st week. Headache was unbearable and she can't stand light in her eyes. The patient no longer had nosebleeds after 6 days. The patient added that were minor but definitely not the norm. No treatment was received for the adverse events. The patient recovered from the nosebleeds after 6 days (08Apr2021). The patient recovered from itching in both feet 1st week in Apr2021. The patient has not recovered from the remaining events.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rhinorrhoea, Skin disorder
Clinical narrative: diabetic & sugar levels were very high since shot; diabetic & sugar levels were very high since shot; Nose bleeds; Severe headaches; Nausea; Exhaustion; Irritability; Depression worsened; white "bumps" near eyes; Chills; Extreme agitation; Back feels twisted keeping her from sleep; Back feels twisted keeping her from sleep; Loss of appetite; itching in both feet 1st week; Nose running constantly; can't stand light in her eyes; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 01Apr2021 14:45 (Batch/Lot Number: ER8737) as dose 1, single (at the age of 62-years-old) for COVID-19 immunisation. Medical history included chronic kidney disease stage II, carpal tunnel syndrome, degenerative arthritis, high cholesterol, high blood pressure (BP), agoraphobia, anxiety, depression, Hashimoto's disease and diabetes. The patient has unspecified concomitant medications (reported as "many to list"). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took morphine and lisinopril and experienced allergies: anaphylaxis. She has 3 pages of adverse reactions to meds (unspecified). On 02Apr2021 at 15:00 the patient started to have the adverse events. The patient was still having severe headaches, nausea, exhaustion, irritability, anxiety, depression worsened, nose bleeds, white "bumps" near eyes, chills, diabetic & sugar levels were very high since shot. Extreme agitation. Back feels twisted keeping her from sleep. Loss of appetite. The patient would not be taking second dose. 12 days later she still felt the same. She was extremely cautious and had not left home except for labs for three times since the virus began. Nose running constantly, had itching in both feet 1st week. Headache was unbearable and she can't stand light in her eyes. The patient no longer had nosebleeds after 6 days. The patient added that were minor but definitely not the norm. No treatment was received for the adverse events. The patient recovered from the nosebleeds after 6 days (08Apr2021). The patient recovered from itching in both feet 1st week in Apr2021. The patient has not recovered from the remaining events.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Chest discomfort, Diarrhoea, Headache, Myalgia
Clinical narrative: Headache; Muscle aches; Fever; Vomiting; Diarrhea; Swollen fingers; swollen hands/feet; Heavy chest; High blood sugars; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735), via an unspecified route of administration in the left arm on 09Apr2021 at 12:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus, celiac disease, sarcoidosis, migraine, sulfonamide allergy and spice allergy (dill). Concomitant medications included insulin glargine (TOUJEO), lisinopril (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), ondansetron (ZOFRAN) and insulin aspart (NOVALOG); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the right arm on 19Mar2021 at 12:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. The patient previously took morphine (MANUFACTURER UNKNOWN), prochlorperazine edisylate (COMPAZINE), metoclopramide (REGLAN) and tizanidine (MANUFACTURER UNKNOWN); all on unknown dates for unspecified indications and experienced allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 16:30, the patient experienced headache, muscle aches, fever, vomiting, diarrhea, swollen fingers/hands/feet, heavy chest and high blood sugars. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events headache, muscle aches, fever, vomiting, diarrhea, swollen fingers/hands/feet, heavy chest and high blood sugars were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Swelling, Vomiting
Clinical narrative: Headache; Muscle aches; Fever; Vomiting; Diarrhea; Swollen fingers; swollen hands/feet; Heavy chest; High blood sugars; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735), via an unspecified route of administration in the left arm on 09Apr2021 at 12:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus, celiac disease, sarcoidosis, migraine, sulfonamide allergy and spice allergy (dill). Concomitant medications included insulin glargine (TOUJEO), lisinopril (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), ondansetron (ZOFRAN) and insulin aspart (NOVALOG); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the right arm on 19Mar2021 at 12:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. The patient previously took morphine (MANUFACTURER UNKNOWN), prochlorperazine edisylate (COMPAZINE), metoclopramide (REGLAN) and tizanidine (MANUFACTURER UNKNOWN); all on unknown dates for unspecified indications and experienced allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 16:30, the patient experienced headache, muscle aches, fever, vomiting, diarrhea, swollen fingers/hands/feet, heavy chest and high blood sugars. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events headache, muscle aches, fever, vomiting, diarrhea, swollen fingers/hands/feet, heavy chest and high blood sugars were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm, Vaccination site swelling
Clinical narrative: Swelling in injection site; warm to touch; itchy; red patch (Covid arm); This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 09Apr2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 19Mar2021 at 10:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 19:00, the patient experienced swelling in injection site, warm to touch, itchy, red patch (COVID arm). The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling in injection site, warm to touch, itchy, red patch (COVID arm) was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: After I received the shot the tingling intensified; After I received the shot the tingling intensified along with the numbness; This is a spontaneous report from a contactable consumer. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration on the left arm on 12Apr2021 at 13:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, hypothyroidism, a compound fracture many years before and cholesterol. The patient received concomitant medications within two weeks of vaccination. The patient had known allergies to amoxicillin and food extenders. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Apr2021 at 13:45 the After patient received the vaccine the tingling intensified along with the numbness. The tingling is going from the tip of my pinky finger to just above my elbow. I had been over 3 hours since I received shot and the intensity of tingling has not subsided. It's like when you lay on a body part too long and it "goes to sleep" and feels tingly. Well this tingly and numbness never goes away. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events tingling sensation and numbness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.