chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Headache, Injection site erythema, Pruritus, Pyrexia
Clinical narrative: Noticed a 3 quarters of an inch area at injection site that looks like a mosquito bite that has been scratched; Feel mild itchiness at vaccination site; Redness at the injection site with a diameter of 3/4 inch; This is a spontaneous report from a contactable Consumer. This 68-year-old non-pregnant Caucasian female Consumer received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an Intramuscular injection in left arm on 25Jan2021 at 15:45 as a single dose for COVID-19 immunization. The patients medical history included allergic to penicillin. The patients concomitant medications were not reported. The patient did not undergo any investigations. The patient had not received any additional vaccines on same day of the COVID vaccine. The patient had not received any vaccines with 4 weeks of vaccination. The patient received other unspecified medication with 2 weeks of COVID vaccination. Prior to vaccination the patient was not diagnosed of COVID-19. Post vaccination the patient was not tested for COVID 19. On 02Feb2021 at 14:00, 8 days late, the patient noticed a little bit of itchiness. The patient did not think much of it and the patient did not think it was anything really noticeable, but her husband told her that she had some mild redness. On 03Feb2021, the patient noticed 3 quarters of an inch area that looks like a mosquito bite where it gets bigger and redder as one scratches. The patient not scratching the area, but it looks the patient had a mosquito bite and scratched it. She confirms this was located at the injection site of her left arm. The patient explained that this area at the injection has not got any worse. It was the same. It just started; she did not imagine it was going to get any worse. The patient did not require any emergency room or physician office. The patient did not receive any treatment for the events. While she was sitting on hold waiting to speak to someone, she was reading online and found a doctor that had the same reaction as her except it was with Moderna's vaccine, and the patient also found others that had what they call an 8-day reaction. From reading these articles, it seems she has this reaction because its building up her immune system. The caller just wanted to make sure this is okay and that she can received the second vaccine. Caller states what she read was that it was okay to receive the second vaccine but just to receive the second one in her other arm. Outcome of events was not recovered.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Pain in extremity
Clinical narrative: Asthmatic bronchitis; Arm soreness; This is a spontaneous report from a contactable Consumer (Patient) via Pfizer-sponsored program.  A 74-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and expiration date were unknown,) via unspecified route of administration, on 02Feb2021 (age at vaccination 74-years-old) at single dose for COVID-19 immunization. Patient had asthma before first shot but it was unclear if she was having more trouble now. The patient concomitant medication was not reported. The patient was scheduled for the second dose on 24Feb2021. The patient went to her pulmonologist for regular scheduled appointment for asthma who prescribed her prednisone and an inhaled steroid for her asthmatic bronchitis. The patient does not want to jeopardize the effectiveness of the vaccine so she was wondering if there may be any potential interactions between the steroids and the vaccine. The patient also stated that she had arm soreness for 1.5 days after the vaccine. Patient wanted to know if there was any information regarding the vaccine for patients with osteoporosis. Patient heard that there could be more symptoms/side effects from second dose of the vaccine. No PQC was present. Patient asked if she can have Prolia shot in between the 2 doses or she needs to delay. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Hypersomnia
Clinical narrative: very tired; sleeping alot; dizzy spells; diarrhea; This is a spontaneous report from a contactable consumer. A 74-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 04Feb2021 13:30 (at the age of 74-years) as SINGLE DOSE in Arm Left for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included Lung cancer (lobectomy), copd, emphysema. The patient previously took Pcn (penicillin), codeine, morphine, Indocin and had drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. On 05Feb2021, the patient experienced very tired, sleeping alot, dizzy spells and diarrhea. The patient did not receive any treatment. Since the vaccination the patient had not been tested for COVID-19. The outcome of events was not recovered.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Lump under left armpit which is same side as she received vaccine, lump was about size of a golf and paining.; This is a spontaneous report from a contactable nurse (patient) via information team. A 33-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL0142), via an unspecified route of administration at left arm on 04Feb2021 (at the age of 33-year-old) as a single dose for COVID-19 immunization. The patient had no medical history and concomitant medications. On 05Feb2021, the patient found a lump under her left armpit which was the same side she received the vaccine on. The lump was about the size of golf ball, at first it was not movable but now it was movable, and pain of the lump stayed same as well as the size. The outcome of the event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: Patient white count has been lowered.; This is a spontaneous report from a company program.  A contactable other HCP reported for a patient of unspecified identifiers received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No patient identifiers were provided but the reporter has first but had knowledge of the patient reported on a specific patient. Nurse practitioner reported for patient who got covid vaccine. Patient white count had been lowered. The patient underwent lab tests and procedures which included white blood cell count: lowered on an unspecified date. Outcome of the report was unknown.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Limb discomfort, Myalgia, Renal function test, Vaccination site haemorrhage
Clinical narrative: Arm felt like lead and could not raise it; Stinging sensation at injection site; felt like it stung when she received the first dose. She felt it running into her vein.; When she took the band aid off, instead of a spot, there was an area of blood; muscle pain; This is a spontaneous report from a contactable consumer (Patient) self-reported. A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247 and expiry date: unknown), Injected via an intramuscularly route of administration in left arm on 06Feb2021 at 16:15, as a single dose for COVID-19 immunization. Patient medical history included high blood pressure, diminished kidney and family history like her mother had a breast cancer and father had massive heart attack. Patient concomitant medications included as amlodipine (5mg) daily for high blood pressure start date and stop date was unspecified. Patient did not take it prior to getting the vaccine. Patient did not receive other vaccine in four weeks of vaccination. Patient did not get the adverse events prior vaccinations. Patient experienced felt like it was stung" when received the first dose. Patient could feel warm fluid running through vein on 06Feb2021, and stinging sensation at vaccination site on 06Feb2021 at 16:15 and arm felt like lead and could not raise it on 06Feb2021 at 18:00. When she took the band aid off, instead of a spot, there was an area of blood in Feb2021. And experienced muscle pain in feb2021. Patient took an extra strength Tylenol. The outcome of the event felt like it stung and felt it running into vein and Arm felt like lead and could not raise it was recovering and outcome of the event Stinging sensation at injection site, band aid off, instead of a spot and muscle pain was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm felt like lead and could not raise it; Stinging sensation at injection site; felt like it stung when she received the first dose. She felt it running into her vein.; When she took the band aid off, instead of a spot, there was an area of blood; muscle pain; This is a spontaneous report from a contactable consumer (Patient) self-reported. A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247 and expiry date: unknown), Injected via an intramuscularly route of administration in left arm on 06Feb2021 at 16:15, as a single dose for COVID-19 immunization. Patient medical history included high blood pressure, diminished kidney and family history like her mother had a breast cancer and father had massive heart attack. Patient concomitant medications included as amlodipine (5mg) daily for high blood pressure start date and stop date was unspecified. Patient did not take it prior to getting the vaccine. Patient did not receive other vaccine in four weeks of vaccination. Patient did not get the adverse events prior vaccinations. Patient experienced felt like it was stung" when received the first dose. Patient could feel warm fluid running through vein on 06Feb2021, and stinging sensation at vaccination site on 06Feb2021 at 16:15 and arm felt like lead and could not raise it on 06Feb2021 at 18:00. When she took the band aid off, instead of a spot, there was an area of blood in Feb2021. And experienced muscle pain in feb2021. Patient took an extra strength Tylenol. The outcome of the event felt like it stung and felt it running into vein and Arm felt like lead and could not raise it was recovering and outcome of the event Stinging sensation at injection site, band aid off, instead of a spot and muscle pain was unknown.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain
Clinical narrative: a dark spot like blood lower down on her arm; real sore; This is a spontaneous report from a contactable consumer (patient, self-reported). A 96-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 18:15 (Batch/Lot Number: ENS318) as SINGLE DOSE for Covid-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Medical history included thyroid disorder, blood pressure abnormal, vitamin supplementation, hip fracture (she broke her hip three years ago), neuropathy peripheral, blood cholesterol abnormal, hypertension from an unknown date and unknown if ongoing. Concomitant medications included benazepril (BENAZEPRIL) taken for blood pressure abnormal, 40mg, one in the morning, Oral; levothyroxine (LEVOTHYROXINE) taken for thyroid disorder, 5mg, once daily, Oral; amlodipine (AMLODIPINE) taken for blood pressure abnormal, 10mg, at night, Oral; simvastatin (SIMVASTATIN) taken for blood cholesterol abnormal, 5mg, one at night, Oral; gabapentin (GABAPENTIN) taken for neuropathy peripheral, 100mg, twice daily, Oral, Since unspecified date of Feb2021; ascorbic acid, betacarotene, copper, tocofersolan, zinc (OCUVITE [ASCORBIC ACID;BETACAROTENE;COPPER;TOCOFERSOLAN;ZINC]) taken for vitamin supplementation, once daily, Oral; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, 81mg, once daily, Oral; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication (taking for years), 125mg, once daily, Oral, all concomitant medications start from an unspecified start date and ongoing. Consumer stated she received the first dose of the Pfizer COVID 19 vaccine 04Feb2021 at 1815PM in the left arm. The place where the shot was, was real sore. The next morning (05Feb2021) she noticed a dark spot like blood further down on her arm. It was fading out some now. Stated Saturday the place with the shot hurt real bad and there was this big old place like a bruise on her arm further down. She failed to tell then she had low dose aspirin and was asking could that have caused this. She did call her doctor who advised maybe blood had pooled there from the shot but she did not understand what he was saying. She was scheduled for the next dose of the vaccine on 19Feb2021. Outcome of the event a dark spot like blood lower down on her arm was recovering and real sore was outcome of recovered on 06Feb2021.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Anxiety the next day. It is Tuesday and still feel it; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN), via an unspecified route of administration in left arm on 06Feb2021 12.45 as single dose for covid-19 immunization. Patient was 68-years-old at the time of vaccination. The patient's historical condition included blot clots on warfarin. The patient's concomitant medication included duloxetine hydrochloride (CYMBALTA), mirtazapine, mirtazapine (REMERON) and atorvastatin. On 07Feb2021 12:00 the patient had anxiety and still feel it. Patient was not treated for the adverse event. The outcome of the event was reported as not recovered.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Illness, Myalgia
Clinical narrative: sleepiness; exhaustion; fever (102F); vomiting; Bad Headache; Very sick; Nauseous; muscle problems; This is a spontaneous report from a contactable consumer and Medical Information Team . This consumer reported for a 69-year-old male patient (husband) . This 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: GM9810 and expiry date unknown, Solution for injection), via an unknown route on 03Feb2021 (at the age of 69-years-old) at single dose arm for COVID-19 immunization. The patient received both doses of the vaccine. The patient experienced no symptoms up until last night of 08Feb2021. The patient also had sleepiness, exhaustion, muscle problems, vomiting, and fever (102F). So, that 6days ago and he was tired nothing major. On 09Feb2021,the patient started getting very tired and he slept up until about 03:00 in the morning while he got up the patient was nauseous, very sick ,very high fever 102 F fever and bad headache. Treatment with paracetamol (Tylenol) was initiated. Outcome of the events sleepiness, exhaustion, muscle problems, vomiting, Nauseous, Bad Headache and Very sick was unknown. The action taken in response to the event(s) for BNT162B2 was not applicable.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Somnolence, Vomiting
Clinical narrative: sleepiness; exhaustion; fever (102F); vomiting; Bad Headache; Very sick; Nauseous; muscle problems; This is a spontaneous report from a contactable consumer and Medical Information Team . This consumer reported for a 69-year-old male patient (husband) . This 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: GM9810 and expiry date unknown, Solution for injection), via an unknown route on 03Feb2021 (at the age of 69-years-old) at single dose arm for COVID-19 immunization. The patient received both doses of the vaccine. The patient experienced no symptoms up until last night of 08Feb2021. The patient also had sleepiness, exhaustion, muscle problems, vomiting, and fever (102F). So, that 6days ago and he was tired nothing major. On 09Feb2021,the patient started getting very tired and he slept up until about 03:00 in the morning while he got up the patient was nauseous, very sick ,very high fever 102 F fever and bad headache. Treatment with paracetamol (Tylenol) was initiated. Outcome of the events sleepiness, exhaustion, muscle problems, vomiting, Nauseous, Bad Headache and Very sick was unknown. The action taken in response to the event(s) for BNT162B2 was not applicable.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen painful lymph nodes in under arm, along collarbone, and neck up to base of the skull on the left side.; Swollen painful lymph nodes in under arm, along collarbone, and neck up to base of the skull on the left side.; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: el3247), via an unspecified route of administration in left arm on 05Feb2021 at 08:45 at single dose for COVID-19 immunisation. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: el3247), via an unspecified route of administration in left arm on 15Jan2021 at 08:45 AM at single dose for COVID-19 immunisation. Medical history included allergies to cephalexin and codine. Concomitant medications included ibuprofen (ADVIL). On 06Feb2021 at 08:00 AM, the patient experienced swollen painful lymph nodes in under arm, along collarbone, and neck up to base of the skull on the left side. The patient was not pregnant at the time of vaccination. No treatment was received. The patient was not tested covid-post-vaccination. The outcome of the events was recovering.   Follow up (17Feb2021): This follow up report contains no new medically significant safety information.  Follow up (18Feb2021): This follow up report contains no new medically significant safety information.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 03Feb2021 13:30 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the COVID-19 vaccine yesterday at 13:30. She was experiencing diarrhea all day today (04Feb2021). The outcome of diarrhea was not recovered.     Follow-up attempts are completed; information about lot number cannot be obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Shortness of breath was reported as worsened/Sweating was reported as worsened; shortness of breath; sweating; Tiredness; pulse starts beating very fast at night; This is a spontaneous report from a contactable consumer (patient, self-reported). This 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL8982 and expiry date: on an unknown date in Jun2021), via an unspecified route of administration, in left arm, on 27Jan2021, as a single dose for COVID-19 immunization. Patient's medical history included plugged vessels/veins and high cholesterol. Concomitant medications were not included. On 03Feb2021, the patient experienced shortness of breath, sweating and tiredness. On an unknown date in Feb2021, the patient's pulse starts beating very fast at night. On 09Feb2021, the experienced shortness of breath was reported as worsened, and sweating was reported as worsened. Also, the patient was sweating at night, but even today at work, she was even sweating during the day. On 17Feb2021, the patient was scheduled for the second shot. Outcome of the event dyspnea and hyperhidrosis were not recovered. Outcome of the event fatigue was recovering. Other events heart rate increased and condition aggravated were unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: Shortness of breath was reported as worsened/Sweating was reported as worsened; shortness of breath; sweating; Tiredness; pulse starts beating very fast at night; This is a spontaneous report from a contactable consumer (patient, self-reported). This 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL8982 and expiry date: on an unknown date in Jun2021), via an unspecified route of administration, in left arm, on 27Jan2021, as a single dose for COVID-19 immunization. Patient's medical history included plugged vessels/veins and high cholesterol. Concomitant medications were not included. On 03Feb2021, the patient experienced shortness of breath, sweating and tiredness. On an unknown date in Feb2021, the patient's pulse starts beating very fast at night. On 09Feb2021, the experienced shortness of breath was reported as worsened, and sweating was reported as worsened. Also, the patient was sweating at night, but even today at work, she was even sweating during the day. On 17Feb2021, the patient was scheduled for the second shot. Outcome of the event dyspnea and hyperhidrosis were not recovered. Outcome of the event fatigue was recovering. Other events heart rate increased and condition aggravated were unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: immediate headache; extreme tiredness; dizziness; nausea; This is a spontaneous report from a contactable consumer (patient, self-reported). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry were not provided), via an unspecified route of administration, in right arm, on 06Feb2021 at 01:00 AM, as a single dose for COVID-19 immunization. Patient did not receive other vaccines within 4 weeks prior to COVID vaccination. Patient's medical history included known allergy. Patient received unspecified medications within 2 weeks of vaccination. It was reported that on 06Feb2021 at 01:00 AM, the patient experienced immediate headache followed by extreme tiredness, and dizziness. Patient also had nausea after 3 days which lasted several days. Patient did not have COVID-19 prior vaccination and since the vaccination, the patient was not tested for COVID-19. No treatment was given to the patient for the events. Outcome of the events was recovered on an unknown date in Feb2021.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Insulin resistance
Clinical narrative: My blood sugar was slightly elevated (170mg/dl) 12-24h post injection and severely elevated (200-270 mg/dl) 24-32h after injection; More significantly my body was insulin resistant during that time; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Em9810, expiration date not reported), via an unspecified route of administration in right arm on 08Feb2021 at 09:30 (age at vaccination was 36 years) as a single dose for covid-19 immunization. The facility where most recent COVID-19 vaccine was administered was other. Medical history included type 1 diabetes, asthma and allergy to sulfas. Concomitant medications included aspart (FIASP INSULIN), minerals nos, vitamins nos (CENTRUM), vitamin d nos and cetirizine hydrochloride (ZYRTEC); the patient received all these within 2 weeks of vaccination, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in right arm on 18Jan2021 at 10:30 (Batch/Lot Number: EI3302) as a single dose for covid-19 immunization. The patient was type 1 diabetic. On 08Feb2021 at 20:00 patients blood sugar was slightly elevated (170mg/dl) 12-24h post injection and severely elevated (200-270mg/dl) 24-32h after injection. More significantly his body was insulin resistant during that time. At time of writing, it was 35h past injection and blood sugar has normalized and insulin again started behaving normally. The event was reported as non-serious with no seriousness criteria (Results in death / Life threatening/ Caused/prolonged hospitalization/ Disabling/Incapacitating/ Congenital anomaly/birth defect). The outcome of the events was recovered/resolved in 2021.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Pain
Clinical narrative: minor injection site discomfort; Joint pain; achy all over; weakness; little bit of fever; chills; no appetite; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL82982), via an unspecified route of administration on 02Feb2021 15:00 as SINGLE DOSE in Arm Left for covid-19 immunization. Medical history included: HIV positive, high blood pressure, shoulder replacement, hip replacement and knee replacement. The patient had no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient received first dose of bnt162b2 (Lot Number: EL 3246) on 12Jan2021 at 03:15 AM as SINGLE DOSE in Arm Left for covid-19 immunization and had minor injection site discomfort. Concomitant medications included: dolutegravir sodium (TIVICAY), emtricitabine, tenofovir alafenamide fumarate (DESCOVY), hydrochlorothiazide and rosuvastatin. Prior to the vaccination the patient was not diagnosed with COVID-19. On 03Feb2021 at 08:00, the patient experienced minor injection site discomfort, joint pain, achy all over, weakness, little bit of fever, chills and no appetite. This lasted 1.5 days. The patient did not receive any treatment. The outcome of events recovered on 05Feb2021.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site discomfort
Clinical narrative: minor injection site discomfort; Joint pain; achy all over; weakness; little bit of fever; chills; no appetite; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL82982), via an unspecified route of administration on 02Feb2021 15:00 as SINGLE DOSE in Arm Left for covid-19 immunization. Medical history included: HIV positive, high blood pressure, shoulder replacement, hip replacement and knee replacement. The patient had no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient received first dose of bnt162b2 (Lot Number: EL 3246) on 12Jan2021 at 03:15 AM as SINGLE DOSE in Arm Left for covid-19 immunization and had minor injection site discomfort. Concomitant medications included: dolutegravir sodium (TIVICAY), emtricitabine, tenofovir alafenamide fumarate (DESCOVY), hydrochlorothiazide and rosuvastatin. Prior to the vaccination the patient was not diagnosed with COVID-19. On 03Feb2021 at 08:00, the patient experienced minor injection site discomfort, joint pain, achy all over, weakness, little bit of fever, chills and no appetite. This lasted 1.5 days. The patient did not receive any treatment. The outcome of events recovered on 05Feb2021.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nasopharyngitis
Clinical narrative: severe headache; chills; tired; cold; This is a spontaneous report from a contactable consumer (patient). A 25-Year-Old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot no. EL3248) via unspecified route of administration in left arm on 09Feb2021 at 01:30 PM as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. She was not pregnant at that time. Previously patient received first single dose of BNT162B2 (lot no. EL3248) via unspecified route in left arm on 20Jan2021 01:15 PM for covid-19 immunisation. Patient experienced severe headache, chills, tired on 10Feb2021 at 06:00 AM and cold on feb2021. she felt great the remainder of my vaccination day. The next morning (10Feb2021). she woke up with a severe headache and chills. It should be noted that she only got around 2.5 hours of sleep, causing her to be extremely tired, which could be contributing to the headache. she also tends to be cold a lot of the time. Today seems to be worse than normal, but again, this could be independent of the vaccination. She did not receive treatment for adverse event. No covid prior vaccination. Patient has not tested COVID post vaccination. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bronchitis, Cough, Fatigue, Gait disturbance
Clinical narrative: coughs it is like a bronchitis type thing; coughs it is like a bronchitis type thing; full of phlegm; back started to hurt; tingling to the bottom of her feet; tired; severely sick; she couldn't walk or talk; she couldn't walk or talk; She shrunk; This is a spontaneous report from a contactable consumer (reported for herself). This 76-year-old female BNT162B2 (Pfizer Covid-19 vaccine, solution for injection, Lot number: unknown), via intramuscular route on left arm as a single dose on 06Feb2021 12:15pm, for covid-19 immunization. Medical history included minimal (borderline high blood pressure (since 6 years prior to this report). Concomitant medication included Lisinopril 10 mg once a day orally. On 06Feb2021 About 4 hours later after she got the shot, the patient experienced some tingling to the bottom of her feet with and without walking and felt like needles, then it went away some but not totally, and her back started to hurt. On 10Feb2021, she was coughing and full of phlegm. On an unknown date, since getting the first dose of the covid vaccine she had been severely sick, she could not walk or talk, felt really tired, and she shrunk (weight about 130 pounds). The patient did not have any history of previous immunization with the Pfizer vaccine. She was not administered any additional vaccines on Same Date of the Pfizer Suspect. The events did not require emergency room/ Physician office visit. She did not receive any prior Vaccinations within 4 weeks. There were no relevant tests performed. The patient recovered from the event of tingling on 07Feb2021. The outcome of the event of was event of phlegm was recovering. The outcome of the events of coughing, severely sick, she could not walk or talk, felt really tired, and she shrunk was not reported. She had not recovered from the event of back started to hurt and it had worsened.    Information about Batch/Lot number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Paraesthesia, Productive cough, Speech disorder, Weight decreased
Clinical narrative: coughs it is like a bronchitis type thing; coughs it is like a bronchitis type thing; full of phlegm; back started to hurt; tingling to the bottom of her feet; tired; severely sick; she couldn't walk or talk; she couldn't walk or talk; She shrunk; This is a spontaneous report from a contactable consumer (reported for herself). This 76-year-old female BNT162B2 (Pfizer Covid-19 vaccine, solution for injection, Lot number: unknown), via intramuscular route on left arm as a single dose on 06Feb2021 12:15pm, for covid-19 immunization. Medical history included minimal (borderline high blood pressure (since 6 years prior to this report). Concomitant medication included Lisinopril 10 mg once a day orally. On 06Feb2021 About 4 hours later after she got the shot, the patient experienced some tingling to the bottom of her feet with and without walking and felt like needles, then it went away some but not totally, and her back started to hurt. On 10Feb2021, she was coughing and full of phlegm. On an unknown date, since getting the first dose of the covid vaccine she had been severely sick, she could not walk or talk, felt really tired, and she shrunk (weight about 130 pounds). The patient did not have any history of previous immunization with the Pfizer vaccine. She was not administered any additional vaccines on Same Date of the Pfizer Suspect. The events did not require emergency room/ Physician office visit. She did not receive any prior Vaccinations within 4 weeks. There were no relevant tests performed. The patient recovered from the event of tingling on 07Feb2021. The outcome of the event of was event of phlegm was recovering. The outcome of the events of coughing, severely sick, she could not walk or talk, felt really tired, and she shrunk was not reported. She had not recovered from the event of back started to hurt and it had worsened.    Information about Batch/Lot number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain, Vaccination site swelling
Clinical narrative: The injection site swollen and painful; The injection site swollen and painful; That side felt a little heavy; This is a spontaneous report from a contactable consumer(patient). A 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration at left arm on 09Feb2021 11:30 as single dose for Covid-19 immunization. Patient was 39 years old at the time of vaccination. Medical history included Lupus, autoimmune arthritis, vitamin D deficiency, anemia and high blood pressure. Patient was tested positive for covid-19 prior to vaccination. The patient previously took Reglan and experienced allergy. On 09Feb2021 at 05:30 PM the patient had injection site swollen and painful and that side felt a little heavy. Outcome of the events was recovering.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pains throughout the entire body; This is a spontaneous report from a contactable consumer (patient). A 55-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9269), via an unspecified route of administration in left arm on 03Feb2021 at 11:30 AM as single dose for COVID-19 immunisation. Medical history included atrial fibrillation and hypertension. Concomitant medications included nebivolol hydrochloride (BYSTOLIC) at 10 mg and doxycycline (ORACEA) at 40 mg. The patient did not have allergies to medications, food, or other products. The patient did not received any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 05Feb2021 at 09:00 PM, patient had pains throughout the entire body starting two days after vaccine was given. First pain was in lower left calf; sharp pain. Had experienced pains though out my entire body one and off since (10Feb). The patient was visited emergency room. No treatment was received for the adverse event. The outcome of the event was recovering.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Vaccination site pain
Clinical narrative: Moderate tenderness at injection site; Malaise; Headache; This is a spontaneous report from a contactable nurse, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: en5318) via unknown route on 28Jan2021 09:30 AM as a single dose at left arm for COVID-19 immunisation. The patients medical history was not reported. No drug allergies were reported. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ej1686) via unknown route on 07Jan2021 09:45 AM as a single dose on left arm for Covid-19 immunization. After second dose on 28Jan2021 03:00 PM, the patient experienced moderate tenderness at injection site starting at 6 hours posts vaccine. Next day general malaise and headache for several days. The outcome of the events were recovered on an unknown date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: having a reaction some breaking out(like rashes) (Arm+Upper body+legs); This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 05Feb2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient had the 1st dose vaccine yesterday, having a reaction some breaking out(like rashes) (Arm+Upper body+legs). Wanted to know if she can take Benadryl or go to emergency room. The outcome of the event was unknown.   Information on the Lot/Batch number has been requested
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging, Nausea, Neuralgia, Pain in extremity
Clinical narrative: Severe Headache, left leg tingling, nausea, nerve pain in left leg and arm. All started on 4/13 in the PM and are currently ongoing.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Scan
Clinical narrative: Severe Headache, left leg tingling, nausea, nerve pain in left leg and arm. All started on 4/13 in the PM and are currently ongoing.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Within 72 hours, the pain at shot site intensified; however a rash also started that was very itchy and lasted approximately 17 days.  The pain in the arm lessened considerably, but the itching of the rash seemed worse at night when sleeping.  At night, I would apply Moisturizing Cream, which helped some.  Area was 6 " long & 4" wide.  Since I had no fever or any other symptoms & able to do  household chores, walking exercises, self-care appointment, &  lunch w/a family member, I did not call or report the reaction to my doctor, Dr. (he has recently been told about it).  By Feb. 28 it all stopped. No reaction at all to 2nd Moderna shot on 3/11/2021.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in extremities after 2nd Moderna COVID-19 vaccine shot. Initially felt tingling after first shot half hour after administration in left hand. Felt again half hour after second shot in left hand (10 am). Numbness returning to left hand and feet same day as second shot at 8:30 pm.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Lymphadenopathy, Rash pruritic, Swelling
Clinical narrative: Inflamed, swollen right underarm (onset day 7, not improving) Inflamed, pruritic 2? rash at injection site (onset day 8, not improving)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site swelling, Pain
Clinical narrative: Redness/firm round swelling at injection site in left arm about an hour after appointment. Ache in arm started about an hour later. Diarrhea about 2-3 hours later, however, I have chronic gastrointestinal issues exacerbated by anxiety and this may not be an adverse reaction.  Day 2: distracting/inconvenient ache in arm, redness/swelling at injection site. Slightly itchy. Slight headache.  Day 3:  distractingly itchy. Only slight ache. Redness/swelling reduced slightly.  Slight headache.  Day 4: persistent headache, reduced but not gone by the end of the day. No ache. Itchiness slightly reduced. Redness/swelling slightly reduced.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Redness/firm round swelling at injection site in left arm about an hour after appointment. Ache in arm started about an hour later. Diarrhea about 2-3 hours later, however, I have chronic gastrointestinal issues exacerbated by anxiety and this may not be an adverse reaction.  Day 2: distracting/inconvenient ache in arm, redness/swelling at injection site. Slightly itchy. Slight headache.  Day 3:  distractingly itchy. Only slight ache. Redness/swelling reduced slightly.  Slight headache.  Day 4: persistent headache, reduced but not gone by the end of the day. No ache. Itchiness slightly reduced. Redness/swelling slightly reduced.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nasal congestion
Clinical narrative: Extreme fatigue at hour 8. After hour 10, all over body muscle aches, and head congestion.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tonight started getting really bad tinnitus in my right ear only, and pulsing.  Never had that like this before so loud and pulsing, Checked online and a lot of people are reporting that as a side effect.  it only started an hour ago  so nothing else to report yet, i'm assuming it's temporary.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: I noticed a cluster of bright red splotches on my chest a few days after the 2nd covid shot.  The following day, the clump of red hives-like splotches were more intense. The third and fourth day, the cluster has broken up but there are tiny, paler red spots all across my chest and arms and legs.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeding disorder, Headache, Heavy menstrual bleeding, Muscle spasms
Clinical narrative: Severe headache that lasted several days, extremely heavy period. Soaking overnight pads every fifteen - twenty minutes for three days while still leaking and dripping blood everywhere. Extreme cramps that I would rate at a 10/10 in pain. Absolutely debilitating.  Day four has been soaking overnight pads at a slower rate but still less than an hour per pad. Diarrhea, nausea and vomiting. Unable to keep food down but able to keep water down. No fever.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Severe headache that lasted several days, extremely heavy period. Soaking overnight pads every fifteen - twenty minutes for three days while still leaking and dripping blood everywhere. Extreme cramps that I would rate at a 10/10 in pain. Absolutely debilitating.  Day four has been soaking overnight pads at a slower rate but still less than an hour per pad. Diarrhea, nausea and vomiting. Unable to keep food down but able to keep water down. No fever.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever of 102 F  Fatigue Body aches  started 9am 03/16/2021 lasted 36 hours until 9pm 03/17/2021
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Bronchoscopy normal, Fatigue, Multiple sclerosis
Clinical narrative: Patient received the moderna vaccine (1st dose).  Shortly after was hospitalized for a potential MS flare and was treated with pulse dose steroids, discharged home. He then started to feel progressively fatigued and was readmitted to the hospital on 4/19/21 with a diffuse pneumonitis complicated by hypoxemic respiratory failure. He is currently being treated with IV steroids.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Multiple sclerosis relapse, Neutrophil count normal, Pneumonitis, Respiratory failure
Clinical narrative: Patient received the moderna vaccine (1st dose).  Shortly after was hospitalized for a potential MS flare and was treated with pulse dose steroids, discharged home. He then started to feel progressively fatigued and was readmitted to the hospital on 4/19/21 with a diffuse pneumonitis complicated by hypoxemic respiratory failure. He is currently being treated with IV steroids.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: 9 days after the vaccine I experienced sudden hearing loss in my right ear.  There is a marked difference between the left and right ear, and I am relying on my left ear to hear and function. I am reporting this 48 hours after the onset of the hearing loss. Treatment - prednisone, zyrtec, flonase. Outcome - treatment only began 24 hours ago, so it's too soon to tell.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration
Clinical narrative: Administration date=17Jan2021, dose number=2/administration date=17Dec2020, dose number=1; joint pain throughout my body/continue to experience joint pain mainly in my knees and my ankles; This is a spontaneous report from a contactable other hcp (Patient). A 58-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK4176) via an unspecified route of administration at arm left on 17Jan2021 12:30 as single dose for COVID-19 immunization. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EH989) via an unspecified route of administration at arm right on 17Dec2020 12:30 as single dose for COVID-19 immunization and celexa [celecoxib] and experienced drug hypersensitivity. The patient was not diagnosed with COVID-19 prior to vaccination. The patient medical history was not reported. Concomitant medications included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY), vitamin d nos (VITAMIN D NOS) and latanoprost (LATANOPROST). The patient experienced inappropriate schedule of product administration and joint pain throughout my body and continue to experience joint pain mainly in my knees and my ankles on 19Jan2021 12:00. The outcome of the event joint pain was not recovered, and rest was unknown.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Chills, fever, body ache, nausea, headache
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Oedema peripheral, Pruritus, Ultrasound Doppler normal, Urticaria
Clinical narrative: Approx time frames:  3/10-3/17- soreness and lesions on toes, both feet 3/15-4/1- Purple flushing of toes, numbness, pins and needles 3/20-4/20- Extreme coldness of feet., so much so that it was waking me up at night.  3/22- podiatrist visit- diagnosis chilblains. Prescribed nitro-gel and 325mg aspirin 1x/day for one month took nitro-gel one night- very bad headache, continued aspirin 3/25- took warm bath, felt turbulence in blood vessels of ankle area, toes flushing purple and white. Seemed to improve condition somewhat. 3/29- Second Pfizer 4/4- 4/15- hives and itching all over body 4/12- 4/20 Edema on feet and ankles