chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding, Pain in extremity
Clinical narrative: sore arm; patient received BNT162B2/ breastfeeding a 14 month old; patient received BNT162B2/ breastfeeding a 14 month old; This is a spontaneous report from a contactable consumer (patient). This consumer reported information about mother and baby. This is the mother case. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on left arm on 17Dec2020 07:30 (dose number: 1) as a single dose for COVID-19 immunization. The patient's medical history included uncomplicated vaginal delivery (14 month old has no diagnosis. Was born 41 +5. Mother and baby have no issues postpartum). The patient had no known drug allergies. Concomitant medication were not reported. The patient was not pregnant at the time of vaccination and the facility where the most recent COVID-19 vaccine was administered was a hospital. 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. Since the vaccination, the patient had not been tested for COVID-19. The patient was breastfeeding a 14 month old. The patient was not having symptoms except for a sore arm on 19Dec2020 (12:00AM). The patient did not receive any treatment for the events. The event was assessed as non-serious. The outcome of the event was not recovered.  Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020504610 baby case
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness; This is a spontaneous report from a contactable pharmacist. A 52-year-old male patient started to receive bnt162b2 (BNT162B2, lot number EJ1685), intramuscular from 19Dec2020 10:45 to 19Dec2020 10:45 at a single dose for an unspecified indication. Medical history included hypertension. The patient's concomitant medications were not reported.  The patient experienced lightheadedness on 19Dec2020 11:00 and took ondansetron. The outcome of the event was recovered on 19Dec2020.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: having soreness to her arm at the injection site of the vaccine; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received first dose of bnt162b2 (BNT162B2 lot number and expiry date were not reported), intramuscular on the left arm from an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced having soreness to her arm at the injection site of the vaccine on an unspecified date. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Periorbital swelling, Pruritus
Clinical narrative: puffiness and itchiness around her upper eye/last night she had a puffing, her eyes were puffed; it was itchy and she experienced itchiness everywhere/itchiness around her upper eye; This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EK5730), intramuscular on Dec2020 at single dose for COVID-19 immunization. The patient has no medical history and stated that she had no other medical conditions, stated that she was generally healthy. Concomitant medication included ibuprofen and paracetamol (TYLENOL). The patient received the bnt162b2 and she had a puffing, her eyes were puffed, the upper eye and it was itchy and she experienced itchiness everywhere on an unspecified date in Dec2020. Patient mentioned that there was no rash or hives. She said she took Benadryl and it helped with the puffiness around the eyes, it did help with itchiness but she was still having some itchiness so she wanted to go just ahead and report that to our safety department. Patient clarified that Benadryl helped with the puffiness around her eyes but the itching part was still there, it (Benadryl) helped but not that much. Patient reported that she had a CBC recently and she got her antibodies checked few days before she got the vaccine. Patient reported that there were some mild generalized itchiness. It was just mild right now. Outcome of eyes were puffed was recovering while outcome of itchiness  was not recovered.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: fatigue; fever; body ache; chills; headache; injection site soreness and swelling; injection site soreness and swelling; This is a spontaneous report from a contactable consumer (the patient). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1685), via an unspecified route of administration in the left arm on 18Dec2020 10:15 (at the age of 22-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 18Dec2020 at 20:30, the patient experienced fatigue, fever, body ache, chills, headache, injection site soreness and swelling. The patient did not receive any treatment for the events. The clinical outcome of fatigue, fever, body ache, chills, headache, injection site soreness and swelling, was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fatigue; fever; body ache; chills; headache; injection site soreness and swelling; injection site soreness and swelling; This is a spontaneous report from a contactable consumer (the patient). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1685), via an unspecified route of administration in the left arm on 18Dec2020 10:15 (at the age of 22-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 18Dec2020 at 20:30, the patient experienced fatigue, fever, body ache, chills, headache, injection site soreness and swelling. The patient did not receive any treatment for the events. The clinical outcome of fatigue, fever, body ache, chills, headache, injection site soreness and swelling, was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: body ache; fever; headache; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received bnt162b2 (BNT162B2, lot number and expiration date were not reported), via an unspecified route of administration on 18Dec2020 at a single dose for immunization. Medical history and concomitant medications were not reported. The patient stated that she took the covid vaccine the day before (18Dec2020) and was experiencing body ache, fever and headache on an unspecified date in Dec2020. The outcome of the events was unknown.   Information on batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Pharyngeal swelling, Throat clearing
Clinical narrative: Swelling of throat; lightheaded; right arm injection site arm pain; This is a spontaneous report from a contactable consumer. A 27-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EK5730 expiry date: unknown), via an unspecified route of administration on the right arm on 19Dec2020 09:30 at single dose for immunization. Medical history included cervical spine disc herniations. Concomitant medications included sulfamethoxazole and bisacodyl (DULCOLAX [BISACODYL]). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 19Dec2020 10:00, the patient experienced Swelling of throat, needing to keep clearing my throat, lightheaded, right arm injection site arm pain. The event was considered as non-serious. The patient received BENADRYL as treatment for the events swelling of throat, lightheaded, right arm injection site arm pain. Outcome of the events swelling of throat, lightheaded, right arm injection site arm pain was not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Pain, Pain in jaw
Clinical narrative: Left jaw pain slightly radiating into ear. Pain level 4/10; Left jaw pain slightly radiating into ear. Pain level 4/10; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EK5730, expiration date was not reported), via an unspecified route of administration on the left arm on 18Dec2020 09:30 at single dose for immunisation. Medical history included controlled hypertension (HTN) and allergies to milk products. Concomitant medication included meloxicam (MOBIC), escitalopram oxalate (LEXAPRO) and irbesartan. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 19Dec2020 at 07:00, the patient experienced left jaw pain slightly radiating into ear. Pain level 4/10. No treatment was given for the events. The patient has not been tested for COVID-19 since the vaccination. The patient has not recovered from the events.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pharyngeal erythema
Clinical narrative: swollen lymph node on left side reddened and painful throat (left part)
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: today she has redness around the site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, lot number and expiration date not provided), via an unspecified route of administration on 18Dec2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient took the Covid shot the day before (18Dec2020) and said it was ok, but on the day of the report, 19Dec2020, she has redness around the site. The patient wanted to know if she can put the ice pack around it, and also stated she should have not taken the shot. The outcome of the event was unknown.   Information on the batch/lot number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Heart rate 110; This is a spontaneous report from a contactable nurse. A 39-year-old female patient received bnt162b2 (BNT162B2 lot number and expiration date were not reported) intramuscular at the right arm first dose on 19Dec2020 09:00 at a single dose for immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 19Dec2020 11:00, the patient experienced heart rate 110. No treatment was received for the adverse event. The most recent COVID-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medication was received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has the patient has not been tested for COVID-19. No Allergies to medications, food, or other products. Outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at SINGLE DOSE for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient received almost exactly the covid 19 vaccine 48 hours before 19Dec2020 and now experiencing nausea in Dec2020. The patient wanted to know the time to onset of the side effects. The action taken in response to the event for BNT162B2 was not applicable. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache all day; This is a spontaneous report from a non-contactable physician. A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly in right arm on 19Dec2020 07:30 at single dose for COVID-19 immunization.  Medical history was none.  There was no other vaccine received in four weeks prior to the COVID vaccine, no other medications received in two weeks. The patient experienced headache all day on 19Dec2020 08:30 AM. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility type vaccine was hospital. The outcome of event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hyperhidrosis, SARS-CoV-2 test negative, Tremor
Clinical narrative: extreme diaphoresis; Diarrhea; shaking chills; shaking chills; visual disturbances; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection via an unspecified route of administration in the left arm on 10Dec2020 at 23:30 (at the age of 47-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 11Dec2020 at 00:15, the patient experienced extreme diaphoresis, diarrhea, shaking chills and visual disturbances. No treatment was provided for the events extreme diaphoresis, diarrhea, shaking chills and visual disturbances. The outcome of the events extreme diaphoresis, diarrhea, shaking chills and visual disturbances was recovered in Dec2020. Since the vaccination, the patient had a Nasal Swab, Covid test name post vaccination on 11Dec2020 was negative.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: extreme diaphoresis; Diarrhea; shaking chills; shaking chills; visual disturbances; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection via an unspecified route of administration in the left arm on 10Dec2020 at 23:30 (at the age of 47-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 11Dec2020 at 00:15, the patient experienced extreme diaphoresis, diarrhea, shaking chills and visual disturbances. No treatment was provided for the events extreme diaphoresis, diarrhea, shaking chills and visual disturbances. The outcome of the events extreme diaphoresis, diarrhea, shaking chills and visual disturbances was recovered in Dec2020. Since the vaccination, the patient had a Nasal Swab, Covid test name post vaccination on 11Dec2020 was negative.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: received vaccine @ 725am noted itchy ears back & (R) wrist @744 am denied SOB, difficulty swallowing, nausea rash, hives given Loratadine 10mg @ 7:50 VS BP 110/70 HR 72 O2 sat 98% RA 7:59 reported symptoms resolved
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Inflammation, Pain in jaw, Swelling face
Clinical narrative: almost unmanageable amount of jaw pain/hurting/terrible pain/jaw is sore/the worst pain ever; almost unmanageable amount of jaw pain/hurting/terrible pain/jaw is sore/the worst pain ever; Jaw is sore and swollen; This is a spontaneous report from two contactable other healthcare professionals (HCP, one of them is also the patient). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PF12N EJ1685), intramuscular on 18Dec2020 13:00 at single dose for COVID-19 immunization at a hospital. The patient's medical history included root canal done on 07Dec2020, which was healing nicely with some jaw pain managed effectively with ibuprofen. Sore, easily manageable. Resolving nicely. No known drug allergy. No COVID prior vaccination, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID tested post this vacccination. The patient's concomitant medications within 2 weeks of vaccination included ibuprofen for jaw pain/Sore. No other vaccines in four weeks. It was reported that the patient had an almost unmanageable amount of jaw pain in the "12ish" hours after getting the first dose of vaccine. The patient received the vaccine around 1300 on 18Dec and within an hour (at 1400) it started hurting terribly. So much that he wanted to pull the tooth out with pliars. Terrible, terrible pain all through the night that would not abate at all with ibuprofen and "tylenol number 3". By morning, the patient started feeling better.  Jaw was sore and swollen. Ibuprofen started working again. It seemed to be resolving. The patient saw the dentist urgently that morning and the dentist didn't see anything amiss in the gum line, and had the thought that some systemic response/inflammation in response to the vaccine contributed to this. The patient commented it to be literally among the worst pain he had ever experienced in his life. The outcome of the events was recovered in Dec2020.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Dyspnoea, Headache, Pain
Clinical narrative: chill; temp at 1200 was 100.4 and at 1830 101.7; shortness of breath; body aches; headache; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection via an unspecified route of administration in the right arm on 18Dec2020 at 16:30 (at the age of 59-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient previously took cefadroxil (DURICEF) and experienced allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19 in Apr2020. On 19Dec2020, the patient experienced chill, temp at 1200 was 100.4 and at 1830 101.7, shortness of breath, body aches and headache. No treatment was provided for the events chill, temp at 1200 was 100.4 and at 1830 101.7, shortness of breath, body aches and headache. The outcome of the events chill, temp at 1200 was 100.4 and at 1830 101.7, shortness of breath, body aches and headache was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Injection site erythema, Injection site swelling, Rash
Clinical narrative: erythema and swelling on injection arm below the actual injection site; erythema and swelling on injection arm below the actual injection site; Face and neck rash; This is a spontaneous report from a contactable physician. This physician reported for herself. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 16Dec2020 18:00 at single dose for covid-19 immunization. It was the first dose. The COVID-19 vaccine was administered at Hospital. The patient's vaccine location was left arm. Medical history included hypertension (HTN), and mild asthma, the patient's known allergies included Black pepper, hydroxychloroquine sulfate (PLAQUENIL), hydrochlorothiazide (HCTZ), almond extract. Concomitant medications included Losartan, spironolactone, progesterone, metformin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced face and neck rash, erythema and swelling on injection arm below the actual injection site, adverse event start date was provided as 16Dec2020 06:00 PM. The patient Took fexofenadine 360mg for facial rash. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The outcome of the events was Recovering.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Numbness at the tip of her tongue; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Dec2020 at time of 15:40 at single dose for COVID-19 immunization. Medical history included Irregular heart beat. Concomitant medication included potassium, magnesium; both for irregular heart beat. The patient just had a baby 9 weeks ago, and was breastfeeding. She also mentioned that her daughter just had her 1st round of her vaccines (other vaccines: rota, mmr vaccines, etc.) last week. She wanted to know if it's still okay to nurse her daughter considering that she just had her Covid 19 vaccine this afternoon on 19Dec2020. The patient also wanted to know what was the risk or potential complication of passing her milk, which contained the Covid 19 vaccine, to her daughter. The patient also wanted to know why it was contraindicated to take the Covid 19 vaccine if she has taken other vaccines within the 2 weeks timeframe before getting the Covid 19 vaccine. The patient experienced numbness at the tip of her tongue. Her tongue was numb, just the tip. The patient stated, "I have two things I got my vaccine today at 15:40 for now it is just passing 18:00 anyway. That's all my tongue is numb, no other symptom, nor I am feel tiring. I don't have numbness in my hand or feet anything but there is my tongue is numb." Nurse stated, "Just a tip (of tongue)". The patient stated, "I do have another questions. I had a baby 9 weeks ago so one of the question is asked is that I had not any vaccine over the past two weeks and I have not well my daughter has, she just got her a week ago. So am I okay to breastfeeding?" The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Throat irritation
Clinical narrative: scratchy throat, stiff neck ,
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Headache, dizziness, fatigue; Headache, dizziness, fatigue; Headache, dizziness, fatigue; This is a spontaneous report from a contactable physician.  A 50-years-old female patient  received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE): EJ1685, via an unspecified route of administration, in left arm on 18Dec2020 at 1845 (at the age of 50-years-old) as a single dose for COVID-19 immunization.  Medical history included asthma and an allergy to penicillin. Concomitant medications were not reported.  The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The  patient experienced headache, dizziness, fatigue on 19Dec2020 at 19:00. The patient was not treated for the events. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nervousness, Tachycardia
Clinical narrative: Within 2 minutes of injection, I became tachycardic; shaky; a bit dizzy; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 18Dec2020 07:15 AM at right arm, at SINGLE DOSE for covid-19 immunization. Medical history included anxiety and depression, allergies to IV dye, Bee stings. Concomitant medication included famotidine (PEPCID), diphenhydramine hydrochloride (BENADRYL), ergocalciferol (VIT D), acetylsalicylic acid (BABY ASPIRIN). The patient previously took levofloxacin (LEVAQUIN) and experienced allergy, ceftriaxone sodium (ROCEPHIN) and experienced allergy. The patient was not pregnant at the time of vaccination. Within 2 minutes of injection, the patient became tachycardic, shaky and a bit dizzy from 18Dec2020 07:15AM. These events resulted in Emergency room/department. No treatment was received for these events. Prior to 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 4 weeks prior to the COVID vaccine. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was recovered in Dec2020. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphonia, Flushing, Paraesthesia oral, Throat irritation
Clinical narrative: flushed 15 min post inj. tickle in throat then tongue tingling and raspy voice 20 min post inj.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: flushed 15 min post inj. tickle in throat then tongue tingling and raspy voice 20 min post inj.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue, Throat irritation
Clinical narrative: flushed 15 min post inj. tickle in throat then tongue tingling and raspy voice 20 min post inj.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Vomiting
Clinical narrative: Approx 36 hours after receiving  the vaccine I woke up feeling tired and nauseous; Approx 36 hours after receiving  the vaccine I woke up feeling tired and nauseous; Over the next 6 hours I had chills and vomited profusely  twice.; Over the next 6 hours I had chills and vomited profusely  twice.; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 17:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included sleep apnoea syndrome (OSA), High blood pressure (BP), depression, anxiety, chronic fatigue syndrome (CFS). Concomitant medication included methylphenidate hydrochloride (CONCERTA), bupropion hydrochloride (WELLBUTRIN), chlorthalidone, magnesium. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximate 36 hours after receiving the vaccine she woke up feeling tired and nauseous. Over the next 6 hours she had chills and vomited profusely twice. Adverse event start date provided as 19Dec2020 08:00 AM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Syncope, Tachycardia
Clinical narrative: employee received vaccine at 1525 1535 noted lightheadedness & shaky feeling. Hx of vasovagal responses to injections & blood draws. Denies SOB, difficulty swallowing, nausea (+) hand/fingers tingling - VS- tachycardia to 120, O2 sat 97% became syncopal to ED
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Headache
Clinical narrative: Headache; the patient was pregnant at the time of vaccination, gestational period was 23 weeks; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 18Dec2020 19:45 at single dose for COVID-19 immunization at a hospital. For the patient's medical history, no allergies to medications, food, or other products. For concomitant drugs, no other medications was received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and since the vaccination, the patient been had not tested for COVID-19. It was reported that the patient was pregnant at the time of vaccination, gestational period was 23 weeks. The last menstrual date was reported as 08Jul2020. The patient was due to deliver on 14Apr2021. On 19Dec2020 19:00, the patient experienced headache. No treatment was received for the event headache. The outcome of the event headache was recovering.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Disturbance in attention, Feeling abnormal, SARS-CoV-2 test negative
Clinical narrative: About 30 minutes after injection felt brain fog and had a hard time finding words; About 30 minutes after injection felt brain fog and had a hard time finding words; It's like we were having to concentrate more than usual to do routine stuff; This is a spontaneous report from a contactable consumer (patient himself).  A 44-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number Ej1685), intramuscular on the left arm, as first single dose on 20Dec2020 (at 06:30) for COVID-19 immunisation. The patient did not have a relevant medical history. No relevant concomitant medications were provided. About 30 minutes after injection felt brain fog and had a hard time finding words. Another nurse that got vaccinated at the same time felt the same way. It's like we were having to concentrate more than usual to do routine stuff. The patient was not treated for the events.  The patient did not perform COVID test before vaccination but after vaccination Nasal Swab, Rapid PCR, was Negative. He was recovering from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020504556 same drug, same event and different patient
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: chills; fatigue; headache; arm soreness; nausea; Tingling in lips/mouth; itching; low grade fever; vomiting; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=14-202012170004), via an unspecified route of administration on right arm on 17Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included sertraline hydrochloride (ZOLOFT) and minerals nos, vitamins nos (PRENATAL VITAMIN). The patient experienced tingling in lips/mouth, itching, nausea, vomiting, chills, headache, low grade fever, fatigue, arm soreness on 17Dec2020, all events reported as non-serious. 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 hadn't been tested for COVID-19. The patient did not receive any treatment for all events. The outcome of events was recovered in Dec2020.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pruritus, Pyrexia, Vomiting
Clinical narrative: chills; fatigue; headache; arm soreness; nausea; Tingling in lips/mouth; itching; low grade fever; vomiting; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=14-202012170004), via an unspecified route of administration on right arm on 17Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included sertraline hydrochloride (ZOLOFT) and minerals nos, vitamins nos (PRENATAL VITAMIN). The patient experienced tingling in lips/mouth, itching, nausea, vomiting, chills, headache, low grade fever, fatigue, arm soreness on 17Dec2020, all events reported as non-serious. 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 hadn't been tested for COVID-19. The patient did not receive any treatment for all events. The outcome of events was recovered in Dec2020.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Headache, Peripheral swelling
Clinical narrative: Dizziness, Headache, dry mouth, arm swelling; Dizziness, Headache, dry mouth, arm swelling; Dizziness, Headache, dry mouth, arm swelling; Dizziness, Headache, dry mouth, arm swelling; other vaccine same date vaccine date on 20Dec2020; This is a spontaneous report from a contactable other health professional (patient). A 33-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot umber: Ej1685), intramuscularly on 20Dec2020 08:00 AM at left arm, at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received other vaccine same date on 20Dec2020 (lot number: Ej1686), and experienced dizziness, headache, dry mouth, arm swelling all on 20Dec2020 08:30 AM. No treatment was received for these events dizziness, headache, dry mouth, arm swelling. Prior to 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 4 weeks prior to the COVID vaccine. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events dizziness, headache, dry mouth, arm swelling was not recovered. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Cough, Fatigue, Myalgia
Clinical narrative: chills; myalgias; fatigue; increased cough; This is a spontaneous report from a contactable physician(patient). A 58-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular on 11Dec2020 18:00 at left arm at single dose for COVID-19 immunization. Medical history included COVID-19 diagnosed prior to vaccination and cough. No other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but received other medications within 2 weeks of vaccination. The patient previously took ilosone and experienced allergies. The patient experienced chills, myalgias, fatigue and increased cough on 12Dec2020 14:00. No treatment received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Impaired work ability, Myalgia, Pyrexia
Clinical narrative: Chills; muscle aches; fever; Not able to work; Extreme tiredness; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received the first dose of BNT162B2 (Lot number: eH9899), via an unspecified route of administration, in arm left, on 18Dec2020 17:00 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included heart valve replacement. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. No allergies to medications, food, or other products. No other vaccines were received within 4 weeks prior to the COVID vaccine. The other medication that the patient received within 2 weeks of vaccination was atenolol. The patient experienced chills, muscle aches, fever, not able to work and extreme tiredness on 19Dec2020 06:00 AM. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovered in Dec2020.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: sore arm (right arm where injection was administered); Headache; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old female patient received the first dose of BNT162B2 (lot number: EK5730), via intramuscular in right arm, on 18Dec2020 09:00 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. No allergies to medications, food, or other products. Relevant medical history included Ulcerative Colitis. No other vaccines were received within 4 weeks prior to the COVID vaccine. The medications received within 2 weeks of vaccination included Mercaptopurine, Remicade, Mesalamine and Junel Fe. The patient experienced headache and sore arm (right arm where injection was administered) on 19Dec2020 12:00 PM. No treatment was received for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Lethargy, Pain, Pain in extremity, Paraesthesia
Clinical narrative: lethargic; Right arm pain; body aches; tingling both arms and face; flu like symptoms; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for himself. A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#EL0140) via intramuscular in right arm on 17Dec2020 16:00 at single dose for COVID-19 immunisation. The patient received the vaccine in hospital. The patient had no known allergies or other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced right arm pain, body aches, tingling both arms and face, lethargic, flu like symptoms on 17Dec2020 23:00. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of events was recovered in Dec2020.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Chills; injection site pain/tenderness; body aches; headache; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ett9899), via an unspecified route of administration on 19Dec2020 09:00 on left arm at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient experienced chills, body aches, headache, fatigue, injection site pain/tenderness on 20Dec2020 at 12:00 PM. The treatment of the events included Tylenol. 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 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Immediate post-injection reaction
Clinical narrative: Immediate bitter/metallic taste. Lasted 1 hour post vaccination.; This is a spontaneous report from a non-contactable consumer (patient).  A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 20Dec2020 09:15 at single dose for COVID-19 immunization at a hospital. The patient's medical history was not reported. Concomitant medication included sertraline hydrochloride (ZOLOFT), ergocalciferol (VIT D). The patient previously took butorphanol tartrate (STADOL) and experienced drug allergy (known allergies). No other vaccine in four weeks. No COVID prior vaccination and no COVID tested post vaccination. The patient was not pregnant at the time of vaccination. It was reported that the patient experienced immediate bitter/metallic taste, which lasted 1 hour post vaccination. No treatment was received for the event. The outcome of the event was recovered on recovered on 20Dec2020 10:15.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Slight headache and aches; Slight headache and aches; This is a spontaneous report from a contactable consumer (patient).  This 65-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 19Dec2020 at 14:30 at single dose for COVID-19 immunisation. Vaccination facility type was workplace clinic. The patient did not receive other vaccines in four weeks. Relevant medical history included allergy to latex. Concomitant medication included levothyroxine sodium (SYNTHROID). On an unspecified date, the patient experienced slight headache and aches. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she had not been tested for COVID-19. The outcome of the events was unknown.  The information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Dizziness, Headache, Lethargy
Clinical narrative: Headache; muscle aches /pain; lethargy; dizziness,lightheaded; joint pain; nausea; GI upset; other vaccine same date vaccine date=19Dec2020; This is a spontaneous report from a contactable consumer (patient). This 50-Year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number Unknown, at single dose on 19Dec2020 08:30 AM on left arm at Hospital for COVID-19 immunisation. There was no medical history. The patient had no COVID prior vaccination. The patient did not have COVID tested post vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included clonazepam (KLONOPIN) which was received within 2 weeks of vaccination.  Other vaccine was received on the same date on 19Dec2020. The patient experienced headache, muscle aches /pain, lethargy, dizziness, lightheaded, joint pain, nausea, GI (Gastrointestinal) upset on 20Dec2020 06:00. No treatment was received for all events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain
Clinical narrative: Headache; muscle aches /pain; lethargy; dizziness,lightheaded; joint pain; nausea; GI upset; other vaccine same date vaccine date=19Dec2020; This is a spontaneous report from a contactable consumer (patient). This 50-Year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number Unknown, at single dose on 19Dec2020 08:30 AM on left arm at Hospital for COVID-19 immunisation. There was no medical history. The patient had no COVID prior vaccination. The patient did not have COVID tested post vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included clonazepam (KLONOPIN) which was received within 2 weeks of vaccination.  Other vaccine was received on the same date on 19Dec2020. The patient experienced headache, muscle aches /pain, lethargy, dizziness, lightheaded, joint pain, nausea, GI (Gastrointestinal) upset on 20Dec2020 06:00. No treatment was received for all events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Muscle fatigue, Muscle tightness, Pain
Clinical narrative: muscle fatigue; pain; skin feels tight over the injection site; she could not lift her arm without severe pain; This is a spontaneous report from a contactable Consumer reported for herself.  A 33-year-olfd female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization on unknown date. Relevant medical history and concomitant medications were not reported. On unknown date the patient stated the shot felt like a flu shot at first then at bedtime the muscle fatigue increased and her pain was a 7 out of 10. After taking Tylenol, her pain was a 5-6 out of 10. No rash or redness but the skin feels tight over the injection site. Caller complains of severe soreness. When she woke up, she could not lift her arm without severe pain. The outcome of the events was reported as unknown.   Lot/Batch number has been requested.