chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Fatigue, Hallucination, Headache
Clinical narrative: I received the injection around 11:30am on Saturday, 8/21. Beginning about 7pm that evening, I started feeling very fatigued and soon after began having chills. I went to bed around 9pm and woke up several times during the night with intense nausea. I also experienced waves of chills and sweating all night and very vivid, realistic dreams. The dreams were so real and mundane that I?m not entirely certain still if they were dreams or me sleep walking/hallucinating. The next day I had extreme fatigue and both head and body aches - I felt as though I had been in a car accident. No additional nausea or chills/sweats all day Sunday, but just very intense fatigue and all over body aches. I took my temperature under my arm with my baby?s thermometer (it was all I had) and it read 104. I?m not certain of the accuracy though. I took extra strength Tylenol as frequently as the directions allowed and slept for most of the day and all night Sunday. Once I woke up Monday morning around 9am, I felt completely normal again.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypersomnia, Nausea, Pain, Pyrexia
Clinical narrative: I received the injection around 11:30am on Saturday, 8/21. Beginning about 7pm that evening, I started feeling very fatigued and soon after began having chills. I went to bed around 9pm and woke up several times during the night with intense nausea. I also experienced waves of chills and sweating all night and very vivid, realistic dreams. The dreams were so real and mundane that I?m not entirely certain still if they were dreams or me sleep walking/hallucinating. The next day I had extreme fatigue and both head and body aches - I felt as though I had been in a car accident. No additional nausea or chills/sweats all day Sunday, but just very intense fatigue and all over body aches. I took my temperature under my arm with my baby?s thermometer (it was all I had) and it read 104. I?m not certain of the accuracy though. I took extra strength Tylenol as frequently as the directions allowed and slept for most of the day and all night Sunday. Once I woke up Monday morning around 9am, I felt completely normal again.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Somnambulism
Clinical narrative: I received the injection around 11:30am on Saturday, 8/21. Beginning about 7pm that evening, I started feeling very fatigued and soon after began having chills. I went to bed around 9pm and woke up several times during the night with intense nausea. I also experienced waves of chills and sweating all night and very vivid, realistic dreams. The dreams were so real and mundane that I?m not entirely certain still if they were dreams or me sleep walking/hallucinating. The next day I had extreme fatigue and both head and body aches - I felt as though I had been in a car accident. No additional nausea or chills/sweats all day Sunday, but just very intense fatigue and all over body aches. I took my temperature under my arm with my baby?s thermometer (it was all I had) and it read 104. I?m not certain of the accuracy though. I took extra strength Tylenol as frequently as the directions allowed and slept for most of the day and all night Sunday. Once I woke up Monday morning around 9am, I felt completely normal again.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Injection site erythema, Respiratory tract congestion
Clinical narrative: 16 days after the shot, large red patch resembling a bullseye appeared at injection site. No itching so far. Have had other problems but they have been attributed to cancer medication or cancer itself. Have also developed a slight cough and congestion the last week
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Headache, Hyperhidrosis, Hypoaesthesia, Pain
Clinical narrative: Headaches , backache , painful  side pains, numbness and tingling in toes , profusely sweating
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Headaches , backache , painful  side pains, numbness and tingling in toes , profusely sweating
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Cardiac disorder, Disability, Gastrointestinal disorder, Nervous system disorder
Clinical narrative: Headaches , backache , painful  side pains, numbness and tingling in toes , profusely sweating
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Pain
Clinical narrative: Dull Chest Pain
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: Severe sharp pain with numbness and weakness on back/outside part of right thigh
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Exposure during pregnancy, Joint swelling
Clinical narrative: Received Pfizer vaccine at 35 weeks pregnant. The estimated due date is 9/8/21. Pain and swelling in joints of hands. Feels like what I assume would be arthritis. Worse in the night and morning and gets better during the day.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Swollen red hot bump and rash on arm at injection site. Very itchy. From the IPV.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Rash papular
Clinical narrative: Swollen red hot bump and rash on arm at injection site. Very itchy. From the IPV.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Paraesthesia
Clinical narrative: Right thumb went numb and tingled.  Left thumb and index finger has sensation of pins and needles feeling.  Tiredness...
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I feel like I'm having tendon problems since having the vaccines.   I thought I should let someone know.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Cardiac monitoring, Dizziness, Electrocardiogram normal, Fatigue
Clinical narrative: I had previously experienced  significant elevated blood pressure following the original Shingles (live) vaccine for about a week following the vaccine (180/103 and I am usually around 118/65). Doctor encouraged me to get the new Shingrix vaccines stating it was no longer a live virus and was much more effective so I did.  The week following the vaccine #1 I was at a dog show when I noticed I felt very groggy and had trouble thinking clearly. I put this off to not having eaten breakfast. Over the next few weeks I felt more tired than usual and was at work and stood up to help the Dr. (I am a dental assistant) and suddenly felt extremely dizzy, like I might pass out. This continued for the next 10-15 minutes and when we took my BP it was 185/108--highly unusual for me. I was taken to the ER where they ran several tests, bloodwork, EKG, etc. which all came back as normal and my BP gradually went back down to a more normal range. The elevated BP continued for 2-3 weeks (I was told to check it 2x/day). I also wore a monitor to record my heart rhythms for 2 wks to verify that I had no abnormal cardiac activity. I remembered having had elevated BP after receiving the original vaccine and while we can't be certain we are suspecting that this was again a longer, more drawn out reaction to the Shingrix vaccine. My MD has advised me not to get the 2nd dose due to the potential of this being a reaction to the vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension, Somnolence, Thinking abnormal, Urine analysis normal
Clinical narrative: I had previously experienced  significant elevated blood pressure following the original Shingles (live) vaccine for about a week following the vaccine (180/103 and I am usually around 118/65). Doctor encouraged me to get the new Shingrix vaccines stating it was no longer a live virus and was much more effective so I did.  The week following the vaccine #1 I was at a dog show when I noticed I felt very groggy and had trouble thinking clearly. I put this off to not having eaten breakfast. Over the next few weeks I felt more tired than usual and was at work and stood up to help the Dr. (I am a dental assistant) and suddenly felt extremely dizzy, like I might pass out. This continued for the next 10-15 minutes and when we took my BP it was 185/108--highly unusual for me. I was taken to the ER where they ran several tests, bloodwork, EKG, etc. which all came back as normal and my BP gradually went back down to a more normal range. The elevated BP continued for 2-3 weeks (I was told to check it 2x/day). I also wore a monitor to record my heart rhythms for 2 wks to verify that I had no abnormal cardiac activity. I remembered having had elevated BP after receiving the original vaccine and while we can't be certain we are suspecting that this was again a longer, more drawn out reaction to the Shingrix vaccine. My MD has advised me not to get the 2nd dose due to the potential of this being a reaction to the vaccine.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, SARS-CoV-2 test
Clinical narrative: Gout flair up; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 10Jun2021 at 13:15 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19.The patient had no known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC) for allergy from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Jun2021, two days after vaccination, the patient experienced gout flair up. Therapeutic measures were not taken as a result of the event. The event 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 an unknown date, the patient underwent nasal swab test and the result was unknown. The clinical outcome of the event gout flair up was not recovered at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Headache; Tired; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 12Jun2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not have any known allergies. The patient did not receive any medication within two weeks of 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Jun2021, the patient experienced headache, tired and sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events headache, tired and sore arm were recovered on an unknown date in Jun2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus  in right ear.  Constant...never goes away.; This is a spontaneous report from a non-contactable consumer, the patient. A 55-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 55-year-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 an unknown date in Mar2021 the patient experienced Tinnitus in right ear, which was Constant and it never gone away. The event resulted in doctor or other healthcare professional office/clinic visit, The clinical outcome of the event Tinnitus in right ear was not resolved .  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: palpitations, heart racing only at night; This is a spontaneous report from a contactable consumer reporting for herself. A 60-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL3247; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 05Mar2021 15:00 (at the age of 60-years-old) as dose 1, single for covid-19 immunization at other facility. The patient was not pregnant at the time of vaccination. Medical history included gastrooesophageal reflux disease (severe acid reflux disease, GERD) from an unknown date and unknown if ongoing. Concomitant medications in 2 weeks included esomeprazole sodium (NEXIUM) and levothyroxine taken for an unspecified indication, start and stop date were not reported. Known allergies, other vaccine in four weeks, covid prior vaccination included none. The patient experienced palpitations, heart racing only at night on 22Apr2021 00:30 (12:30 AM). The patient did not receive any treatment for the event. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 03May2021 (covid test post vaccination). Clinical outcome was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes
Clinical narrative: Herpes outbreak in anal area; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an intramuscular route of administration  in the left arm on 09Apr2021 at 12:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and known allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an intramuscular route of administration  in the left arm on 19Mar2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not received any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 12:00, the patient experienced herpes outbreak in anal area. The patient had not had an outbreak in 20 years and never in that area. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with acyclovir. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event herpes outbreak in anal area was recovered on an unknown date.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dandruff, Herpes zoster, Lacrimation increased, Miliaria, Neuralgia
Clinical narrative: Eye began watering non-stop; lesions appeared on side of neck/more lesions appeared on ears; scalp itching; dandruff; nerve pain; Shingles/shingles outbreak on my neck./determined to be disseminated shingles scalp, neck, ears, right eye; Originally thought it was heat rash/heat rash still present/heat rash on back of neck; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0176), via an unspecified route of administration in the left upper arm on 01May2021 at 10:30 (at the age of 43-year-old), dose 2, single for COVID-19 immunisation. Medical history included sinus problems, allergies to penicillin. Concomitant medications included fluticasone propionate (FLONASE) and loratadine (CLARITINE). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0162) administered via an unspecified route of administration in the left upper arm on 09Apr2021 at 15:30 (at the age of 43-year-old), dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at public health department. Around 5May2021 to 8May2021, the patient noticed heat rash on back of neck. On 08May2021, the patient had shingles. On 15May2021, about two weeks later, the patient noticed scalp itching, but she figured it was product dandruff. On 26May2021, the patient had shingles outbreak started on her neck. Originally thought it was heat rash. On 08Jun2021, the patient's eye began watering nonstop. The heat rash was still present and lesions appeared on side of neck. The patient was prescribed with antibiotics (z-pack) and steroid eye drops. By the end of week more lesions appeared on ears. Determined to be disseminated shingles on scalp, neck, ears and right eye. The patient received 2 rounds of Valtrex 3g for the events and also received gabapentin for nerve pain missed work on neck, right eye (as reported). Symptoms returned three weeks after finishing the medications. If known side effect would have went for treatment earlier. The patient stated that she missed seven days of work without pay and mentioned that she still would have recommend the vaccine, but people need to be aware it can stir things up. The events were reported as serious (persistent /significant disability /incapacity) and resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible; No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin lesion
Clinical narrative: Eye began watering non-stop; lesions appeared on side of neck/more lesions appeared on ears; scalp itching; dandruff; nerve pain; Shingles/shingles outbreak on my neck./determined to be disseminated shingles scalp, neck, ears, right eye; Originally thought it was heat rash/heat rash still present/heat rash on back of neck; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0176), via an unspecified route of administration in the left upper arm on 01May2021 at 10:30 (at the age of 43-year-old), dose 2, single for COVID-19 immunisation. Medical history included sinus problems, allergies to penicillin. Concomitant medications included fluticasone propionate (FLONASE) and loratadine (CLARITINE). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0162) administered via an unspecified route of administration in the left upper arm on 09Apr2021 at 15:30 (at the age of 43-year-old), dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at public health department. Around 5May2021 to 8May2021, the patient noticed heat rash on back of neck. On 08May2021, the patient had shingles. On 15May2021, about two weeks later, the patient noticed scalp itching, but she figured it was product dandruff. On 26May2021, the patient had shingles outbreak started on her neck. Originally thought it was heat rash. On 08Jun2021, the patient's eye began watering nonstop. The heat rash was still present and lesions appeared on side of neck. The patient was prescribed with antibiotics (z-pack) and steroid eye drops. By the end of week more lesions appeared on ears. Determined to be disseminated shingles on scalp, neck, ears and right eye. The patient received 2 rounds of Valtrex 3g for the events and also received gabapentin for nerve pain missed work on neck, right eye (as reported). Symptoms returned three weeks after finishing the medications. If known side effect would have went for treatment earlier. The patient stated that she missed seven days of work without pay and mentioned that she still would have recommend the vaccine, but people need to be aware it can stir things up. The events were reported as serious (persistent /significant disability /incapacity) and resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible; No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart Palpitations; This is a spontaneous report from a non contactable pharmacist, the patient. A 32-year-old male patient received 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. Medical history was not reported. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24May2021, the patient experienced heart palpitations. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of reported event. The clinical outcome of the event heart palpitations was recovering 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This is a spontaneous report based on the information received by Pfizer from Novartis Pharmaceuticals Corporation (Reference ID: NVSC2020US319232_OS). A contactable consumer (patient) reported that an 83-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm was sore. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia oral, Pyrexia
Clinical narrative: Woke up with dizzy; Wake up with fever; Numbness across body especially legs and toes.; This is a spontaneous report from a contactable consumer. A 12-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the arm left on 16Jun2021 at 10:15 as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medications. The patient had no known allergies. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 25May2021 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 17Jun2021 at 06:00, the patient reported that she woke up dizzy, with fever and numbness across body, especially legs and toes. 6 hours after waking dizziness was less intense but toes and calves are still somewhat numb but feeling was improved. Therapeutic measures were not taken as a result of these 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 event woke up with dizziness, numbness and fever was recovering at the time of this report.   The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: Very fatigued; Low grade fever 100.5F; Chills; Upset stomach; This is a spontaneous report from a contactable consumer. A 13-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG6207), via intramuscular route of administration in the left arm on 16Jun2021 at 09:30 (at the age of 13-years-old), as a single dose for COVID-19 immunisation. Medical history included ADHD. The patient did not have any allergies to medications, food or other products. Concomitant medications included methylphenidate hydrochloride (RITALIN) and levocetirizine dihydrochloride (XYZAL); both from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG6207), via intramuscular route of administration in the left arm on an unknown date in May2021 at 15:00 (at the age of 13-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 17Jun2021 at 01:30, the patient experienced very fatigued, low-grade fever 100.5F, chills and upset stomach. 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. On 17Jun2021 at 01:30, the patient underwent lab test and procedure which included body temperature and the result was shown as 100.5 F. The clinical outcome of the events very fatigued, low-grade fever 100.5F, chills and upset stomach were resolving at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fatigue
Clinical narrative: Fatigue for two months with some dizziness.; Fatigue for two months with some dizziness.; balance with yoga and pilates is off; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 03Apr2021 at 11:15 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included Sjogren's syndrome, migraine and sulfonamide allergy. Concomitant medications included ubidecarenone (COQ10), vitamin d nos (VIT D), ascorbic acid (VIT C), curcuma longa rhizome (TURMERIC) and biotin (MANUFACTURER UNKNOWN) all from an unknown date and unknown if ongoing for an unknown indication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 13Mar2021 at 11:15 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. 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. On 04Apr2021, the patient experienced fatigue for two months with some dizziness, unusual for her, usually had lots of energy and her balance was great, forced herself to do her usual routine, but felt fatigued and balance with yoga and pilates was off. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events fatigue for two months with some dizziness and balance with yoga and pilates was off was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Inflammation, Rash pruritic, Vaccination site pain
Clinical narrative: Rash with itching; Pain at injection site.; Pain and inflammation increasing on day 3.; Dose 1: 28May2021; Dose 2: 14Jun2021; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Jun2021 at 10:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28May2021 at 11:00, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Jun2021 at 10:00, 24 hours after vaccination, the patient experienced rash with itching and pain at injection site. The patient stated that the pain and inflammation was increasing on day 3. 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 rash with itching and pain at injection site and inflammation 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Body aches, pains, tiredness; Body aches, pains, tiredness; This is a spontaneous report from a contactable consumer or other non-health care professional re-ported for female patient (reporter's niece). A 23-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot num-ber was not reported), via an unspecified route of administration (at the age of 23-years), adminis-tered in arm on 23May2021 as dose 2, single for COVID-19 immunization. Medical history included none and family history of diabetes mellitus the patient dad was diabetic, but caller does not know for sure from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient historical vaccine included 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 (at the age of 23-years), on an unspecified date as dose 1, single for COVID-19 immunization and stated that it was maybe 3 weeks before the second dose and experienced no reac-tion on previous exposure to drug. On an unspecified date, the patient experienced body aches, pains, tiredness. Reporter also mentioned that his niece developed minor adverse events after the second dose of the vaccine. Caller was not sure when this started for the patient but caller states that it did not go away completely right away but the patient told the caller that she is getting better, not getting worse. The adverse event does not result in emergency room and physician office. Reporter was calling for his niece had the second dose of the Pfizer COVID-19 vaccine 10 days ago. The day before yesterday, his niece had an appointment for the hepatitis B vaccine. By mistake, the pharmacist had administered the Pfizer COVID19 vaccine to his niece and now his niece is experiencing adverse events that are similar to the adverse events she has experienced during her Pfizer COVID-19 vaccine second dose. Reporter wanted to know how safe having a third dose of the Pfizer COVID-19 vaccine was and he wanted to know what to do at this point. The patient was taking Pfizer Covid 19 vaccine as preventative. The clinical outcome for the events was reported as recovering.  Information regarding the Lot/Batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in left hand; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01May2021 at 14:30(at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Patient had no known allergies. The patient received other medications in two to three weeks, names unspecified. 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 01May2021 at 18:00, the patient experienced numbness in left hand. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event numbness in left hand was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: shoulder pain; decrease range of motion on shoulder; This is a spontaneous report from a contactable nurse, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in the right arm on 13Jan2021 at 10:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included graves' disease. The patient previously took  nitrofurantoin (MACROBID) for an unknown indication on an unknown date and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via an unspecified route of administration in the left arm on 23Dec2020 at 20:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any medicines within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Jan2021, the patient experienced shoulder pain and decrease range of motion on shoulder which was persisting 6 months after getting COVID-19 vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. 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 outcomes of the events of shoulder pain and decrease range of motion on shoulder was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Knot above  collarbone; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old patient of unknown gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Jun2021 at 12:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. The patient previously took tetanus shot vaccine on an unknown date and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN EXTRA STRENGTH) and paracetamol (TYLENOL); both for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Jun2021, the patient experienced knot above collarbone. It was unknown whether the patient received any treatment for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event knot above collarbone was unknown at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast tenderness, Lymphadenopathy
Clinical narrative: There was sharp pain through the breast; breast is still tender two months later.; Enlarged lymph nodes under the arm and in breast on the side the shot was given; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 10:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 10:00. the patient experienced enlarged lymph nodes under the arm and in breast on the side the shot was given. There was sharp pain through the breast and breast was still tender two months later. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event sharp pain through the breast, breast was still tender and enlarged lymph nodes under the arm and in breast was not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache; Body aches; chills; This is a spontaneous report from a contactable consumer. A 15-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via intramuscular route of administration in the left arm on 16Jun2021 at 09:15 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Patient had nut allergy to hazelnuts, pistachios and cashews.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via intramuscular route of administration in the left arm on 26May2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Patient did not had any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Jun2021 at 22:00, the patient experienced body aches, chills and headache. The patient did not receive any treatment for the reported events. 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 not been tested for COVID-19. The clinical outcome of the events of body aches, chills and headache was recovered on an unknown date in Jun2021.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Pain site; Tiredness; Headache; Muscle pain; Feeling unwell; Arm pain; Nausea; Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on an unknown date in 2021, as a single dose for COVID-19 immunisation. Medical history of the patient was reported as none. The patient had no known allergies. Concomitant medications included anxiety medications (MANUFACTURER UNKNOWN), on an unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on an unknown date in 2021 at 14:00, 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 16Jun2021 at 00:00, the patient experienced pain site, tiredness, headache, muscle pain, feeling unwell, arm pain, nausea, fever and chills. . Therapeutic measures were not taken as a result of these 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 pain site, tiredness, headache, muscle pain, feeling unwell, arm pain, nausea, fever and chills was not recovered at the time of this report.   The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Pain site; Tiredness; Headache; Muscle pain; Feeling unwell; Arm pain; Nausea; Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on an unknown date in 2021, as a single dose for COVID-19 immunisation. Medical history of the patient was reported as none. The patient had no known allergies. Concomitant medications included anxiety medications (MANUFACTURER UNKNOWN), on an unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on an unknown date in 2021 at 14:00, 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 16Jun2021 at 00:00, the patient experienced pain site, tiredness, headache, muscle pain, feeling unwell, arm pain, nausea, fever and chills. . Therapeutic measures were not taken as a result of these 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 pain site, tiredness, headache, muscle pain, feeling unwell, arm pain, nausea, fever and chills was not recovered at the time of this report.   The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea, Vomiting
Clinical narrative: Fatigue; Feeling unwell; Nausea; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 14-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0180) via an unspecified route of administration in the left arm on 16Jun2021 at 12:15 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included sertraline hydrochloride (ZOLOFT) and doxycycline (MANUFACTURER UNKNOWN); for unknown indication from unknown date and unknown if ongoing. The patient previously received azithromycin (MANUFACTURER UNKNOWN) 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 16Jun2021 at 16:00, the patient experienced fatigue, feeling unwell, nausea and vomiting. 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 fatigue, feeling unwell, nausea and vomiting were 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.