chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hypoaesthesia, Influenza like illness, Myalgia
Clinical narrative: mild flu-like symptoms; Diffuse myalgias, more severe on both right and left arm; Numbness in lower legs evening of vaccine; Felt mild headache; foggy feeling this night; This is a spontaneous report from a contactable healthcare professional, reporting for a patient. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EK9231), intramuscular in the right arm on 30Dec2020 at 09:45 (at the age of 26-years-old) as a single dose for Covid-19 vaccination. Medical history included Covid-19 prior to the vaccination on an unknown date. The patient was not pregnant at the time of vaccination. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. On 30Dec2020 at 19:30, the patient experienced diffuse myalgias, more severe on both right and left arm and numbness in lower legs the evening of the vaccine; felt mild headache and foggy feeling that night as well. The second day on 31Dec2020, the patient experienced mild flu-like symptoms such as weakness, fatigue, and myalgias. Therapeutic measures were taken for the myalgia, hypoaesthesia, headache, feeling abnormal and influenza like illness which included Tylenol. The clinical outcome of the events myalgia, hypoaesthesia, headache, feeling abnormal and influenza like illness was recovered on an unknown date.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: headache; arm soreness for 3 days; fever and back pain that began Thursday; fever and back pain that began Thursday; nausea; body aches for 2 weeks; This is a spontaneous report from a contactable consumer, the patient.  A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 (at the age of 36-years-old) as a single dose for COVID-19 vaccination.  Medical history was not reported. The patient's concomitant medications were not reported.  On an unknown date the patient experienced headache, arm soreness, body aches for 2 weeks, fever, back pain and nausea. The patient reported feeling absolutely horrible, which felt like it is escalating sometimes per patient. The patient stated that it was initially just arm soreness for 3 days then all other symptoms including fever and back pain that began Thursday (date unknown), and now a headache, per the patient "before it was just soreness, body aches for 2 weeks, nausea". The patient is completing daily check-ins on the website name.  She has a copy of the Fact Sheet for Recipients and Caregivers. The clinical outcome of the headache, arm soreness for 3 days, fever, back pain, nausea and body aches for 2 weeks was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; arm soreness for 3 days; fever and back pain that began Thursday; fever and back pain that began Thursday; nausea; body aches for 2 weeks; This is a spontaneous report from a contactable consumer, the patient.  A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 (at the age of 36-years-old) as a single dose for COVID-19 vaccination.  Medical history was not reported. The patient's concomitant medications were not reported.  On an unknown date the patient experienced headache, arm soreness, body aches for 2 weeks, fever, back pain and nausea. The patient reported feeling absolutely horrible, which felt like it is escalating sometimes per patient. The patient stated that it was initially just arm soreness for 3 days then all other symptoms including fever and back pain that began Thursday (date unknown), and now a headache, per the patient "before it was just soreness, body aches for 2 weeks, nausea". The patient is completing daily check-ins on the website name.  She has a copy of the Fact Sheet for Recipients and Caregivers. The clinical outcome of the headache, arm soreness for 3 days, fever, back pain, nausea and body aches for 2 weeks was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Lymphadenopathy, Tongue disorder
Clinical narrative: red splotches on tongue and bumps around edge of tongue day after injection; mild-moderate headache; moderate tiredness; Dizziness the first 30 minutes; swollen lymph nodes starting 1-2 hours after injection, lasting approx. 6 hours; red splotches on tongue and bumps around edge of tongue day after injection; This is a spontaneous report from a contactable consumer, the patient.  A 74-year-old patient of unknown gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1284), via an unspecified route of administration in the right arm on 02Jan2021 at 11:00 (at the age of 74-years-old) as a single dose for COVID-19 vaccination.  Medical history included fibromyalgia, bronchiectasis, Degen. Scoliosis, spinal stenosis, peptic esophogitus grade II, osteoarthritis and benign nodules in both upper lobes of lungs (Pulmonary scarring-bilateral lower lobes). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had allergies (unspecified) to medications, food, or other products. The patient's concomitant medications were not reported; however it was reported the patient did receive other medications (unspecified) within 2 weeks of the vaccination.  The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  The patient experienced dizziness the first 30 minutes on 02Jan2021; swollen lymph nodes starting 1-2 hours after injection, lasting approx. 6 hours on 02Jan2021; red splotches on tongue on 02Jan2021 and bumps around edge of tongue day after injection on 03Jan2021; mild-moderate headache on 02Jan2021 and on 02Jan2021 moderate tiredness lasting 2 days+. The patient did not receive any treatment for the events. The clinical outcome of the dizziness the first 30 minutes, swollen lymph nodes starting 1-2 hours after injection, lasting approx. 6 hours, red splotches on tongue and bumps around edge of tongue day after injection, mild-moderate headache and moderate tiredness was recovering.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Tongue erythema
Clinical narrative: red splotches on tongue and bumps around edge of tongue day after injection; mild-moderate headache; moderate tiredness; Dizziness the first 30 minutes; swollen lymph nodes starting 1-2 hours after injection, lasting approx. 6 hours; red splotches on tongue and bumps around edge of tongue day after injection; This is a spontaneous report from a contactable consumer, the patient.  A 74-year-old patient of unknown gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1284), via an unspecified route of administration in the right arm on 02Jan2021 at 11:00 (at the age of 74-years-old) as a single dose for COVID-19 vaccination.  Medical history included fibromyalgia, bronchiectasis, Degen. Scoliosis, spinal stenosis, peptic esophogitus grade II, osteoarthritis and benign nodules in both upper lobes of lungs (Pulmonary scarring-bilateral lower lobes). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had allergies (unspecified) to medications, food, or other products. The patient's concomitant medications were not reported; however it was reported the patient did receive other medications (unspecified) within 2 weeks of the vaccination.  The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  The patient experienced dizziness the first 30 minutes on 02Jan2021; swollen lymph nodes starting 1-2 hours after injection, lasting approx. 6 hours on 02Jan2021; red splotches on tongue on 02Jan2021 and bumps around edge of tongue day after injection on 03Jan2021; mild-moderate headache on 02Jan2021 and on 02Jan2021 moderate tiredness lasting 2 days+. The patient did not receive any treatment for the events. The clinical outcome of the dizziness the first 30 minutes, swollen lymph nodes starting 1-2 hours after injection, lasting approx. 6 hours, red splotches on tongue and bumps around edge of tongue day after injection, mild-moderate headache and moderate tiredness was recovering.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Fever 100.4, chills, joint pain, fatigue, Diarrhea
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vaccination site pain, Vaccination site swelling
Clinical narrative: Headache; nausea; tiredness; site injection swelling; site injection pain; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 28Dec2020 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 28Dec2020, the patient experienced headache, nausea, tiredness, injection site swelling and injection site pain. Treatment was not received for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events headache, nausea, tiredness, injection site swelling, and injection site pain were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I was given a vaccine on Dec17th, on Dec21st I tested positive for Covid; I was given a vaccine on Dec17th, on Dec21st I tested positive for Covid; This is a spontaneous report from a contactable nurse. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. There was no relevant medical history. The patient's concomitant medications were not reported. The patient was given a vaccine on 17Dec2020, the on 21Dec2020, the patient tested positive for COVID. The outcome of the event was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Dyspnoea, Feeling hot
Clinical narrative: could not breath; had a "warm liquid running through her body" feeling/same sensation stated again today, 04Jan; dryness in the throat; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 31Dec2020at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she received the Pfizer covid vaccine on 31Dec2020 and she could not breath and had a "warm liquid running through her body" feeling that went away after some time. She said she has the same sensation stated again today, 04Jan2021 and this time it's not going away. She said it's been 10-15 minutes with this and also have dryness in the throat. She wanted to know if this was  normal. The patient said she was going to the emergency room.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate decreased, Hypoaesthesia
Clinical narrative: Elevated blood pressure (155/95); decrease in heart rate (55); Face & tongue went numb; Face & tongue went numb; Residual ringing in left ear; This is a spontaneous report from a contactable physician, the patient. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 22Dec2020 at 16:00 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history included seasonal allergies and allergies/asthma, from unknown dates and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and montelukast sodium (SINGULAIR). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 22Dec2020 at 16:00, the patient experienced elevated blood pressure of 155/95 (normal was 110/60), a decrease in heart rate which was 55, face and tongue went numb and residual ringing in the left ear. The patient was treated for the events with diphenhydramine (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events elevated blood pressure of 155/95 (normal was 110/60), a decrease in heart rate which was 55, face and tongue went numb and residual ringing in the left ear was resolved with sequel.   Information on lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Tinnitus
Clinical narrative: Elevated blood pressure (155/95); decrease in heart rate (55); Face & tongue went numb; Face & tongue went numb; Residual ringing in left ear; This is a spontaneous report from a contactable physician, the patient. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 22Dec2020 at 16:00 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history included seasonal allergies and allergies/asthma, from unknown dates and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and montelukast sodium (SINGULAIR). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 22Dec2020 at 16:00, the patient experienced elevated blood pressure of 155/95 (normal was 110/60), a decrease in heart rate which was 55, face and tongue went numb and residual ringing in the left ear. The patient was treated for the events with diphenhydramine (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events elevated blood pressure of 155/95 (normal was 110/60), a decrease in heart rate which was 55, face and tongue went numb and residual ringing in the left ear was resolved with sequel.   Information on lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: No reaction on previous exposure to drug, Pruritus
Clinical narrative: Symptoms - ? Patient reports itchiness to bilateral hands approximately 25 mins after vaccination, denies rash.  Patient reports she struggles with allergies and prophylactically medicated prior to first dose with 50 mg of Benadryl and Xytal.  Patient reports no adverse reaction after 1st vaccine.  Patient reports she prophylactically medicated last night as well but only took 25 mg and no Xytal, patient endorses she believes that is the difference in her symptoms between the first and second dose.  Patient endorses allergies to high dose Vitamin D (50,000 units).  Patient denies difficulty breath or SOB at this time.  Patient reports she is able to move freely at this time. Last day of work and shift - ? currently working at home today Home remedies? -   50 mg Benadryl at 08:00 and Pepcid and Xytal at 11:20 (did not disclose dosage) Any improvement? ? Patient reports mild improvement Recommendation? Patient encouraged to take allergy medication as directed and to call vaccine support if symptoms worsen.  Patient educated to call 911 or seek immediate care if any airway issues or difficulty breathing.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Dysphagia, Hypoaesthesia oral, Paraesthesia oral, Throat tightness
Clinical narrative: Tip of tongue was burning, weird metallic taste in mouth, entire tongue numb and tingly , throat closing, hard to swallow. received 50 mg Benadryl po
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: Tip of tongue was burning, weird metallic taste in mouth, entire tongue numb and tingly , throat closing, hard to swallow. received 50 mg Benadryl po
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Hypoaesthesia, Muscular weakness
Clinical narrative: burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swelling in left arm; tingling swelling in left arm; pain left groin left leg with muscle weakness; pain left groin left leg with muscle weakness; vomiting; tiredness; weak; This is a spontaneous report from a contactable Nurse. This 57-year-old female Nurse (patient) received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on 29Dec2020 08:00 (at the age of 57-years) as single dose, Intramuscular in left arm for COVID-19 immunization. Medical history included allergies to penicillin. Prior to vaccination, the patient was diagnosed with COVID-19.  The patient was not pregnant. Concomitant drugs included ASA (ASA), Famotidine (FAMOTIDINE), ergocalciferol (VIT D), ascorbic acid (VIT C), zinc (ZINC), magnesium (MAGNESIUM). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not test for COVID-19 after vaccination.  On 29Dec2020 15:00 the patient experienced 'Burning Upper Nose/Throat', 'Heart Racing', 'Headache', 'Numbness', 'Tingling Swelling in Left Arm', 'Pain Left Groin Left Leg with Muscle' 'Weakness', 'Vomiting', 'Weak', and 'Tiredness'.  The patient did not received treatment as a result of the event.  The outcome of event 'Burning Upper Nose/Throat' was recovered on unspecified date, 'Heart Racing' was recovered on an unspecified date,  'Headache' was recovered on unspecified date, 'Numbness' was recovered on unspecified date, 'Tingling Swelling in Left Arm' was recovered on unspecified date, 'Pain Left Groin Left Leg with Muscle' was recovered on unspecified date, 'Weakness' was recovered on unspecified date, 'Vomiting' was recovered on unspecified date, 'Weak' was recovered on unspecified date, and 'Tiredness' was recovered on unspecified date.   Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal discomfort, Pain in extremity, Palpitations, Paraesthesia, Peripheral swelling
Clinical narrative: burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swelling in left arm; tingling swelling in left arm; pain left groin left leg with muscle weakness; pain left groin left leg with muscle weakness; vomiting; tiredness; weak; This is a spontaneous report from a contactable Nurse. This 57-year-old female Nurse (patient) received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on 29Dec2020 08:00 (at the age of 57-years) as single dose, Intramuscular in left arm for COVID-19 immunization. Medical history included allergies to penicillin. Prior to vaccination, the patient was diagnosed with COVID-19.  The patient was not pregnant. Concomitant drugs included ASA (ASA), Famotidine (FAMOTIDINE), ergocalciferol (VIT D), ascorbic acid (VIT C), zinc (ZINC), magnesium (MAGNESIUM). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not test for COVID-19 after vaccination.  On 29Dec2020 15:00 the patient experienced 'Burning Upper Nose/Throat', 'Heart Racing', 'Headache', 'Numbness', 'Tingling Swelling in Left Arm', 'Pain Left Groin Left Leg with Muscle' 'Weakness', 'Vomiting', 'Weak', and 'Tiredness'.  The patient did not received treatment as a result of the event.  The outcome of event 'Burning Upper Nose/Throat' was recovered on unspecified date, 'Heart Racing' was recovered on an unspecified date,  'Headache' was recovered on unspecified date, 'Numbness' was recovered on unspecified date, 'Tingling Swelling in Left Arm' was recovered on unspecified date, 'Pain Left Groin Left Leg with Muscle' was recovered on unspecified date, 'Weakness' was recovered on unspecified date, 'Vomiting' was recovered on unspecified date, 'Weak' was recovered on unspecified date, and 'Tiredness' was recovered on unspecified date.   Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Vomiting
Clinical narrative: burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swelling in left arm; tingling swelling in left arm; pain left groin left leg with muscle weakness; pain left groin left leg with muscle weakness; vomiting; tiredness; weak; This is a spontaneous report from a contactable Nurse. This 57-year-old female Nurse (patient) received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on 29Dec2020 08:00 (at the age of 57-years) as single dose, Intramuscular in left arm for COVID-19 immunization. Medical history included allergies to penicillin. Prior to vaccination, the patient was diagnosed with COVID-19.  The patient was not pregnant. Concomitant drugs included ASA (ASA), Famotidine (FAMOTIDINE), ergocalciferol (VIT D), ascorbic acid (VIT C), zinc (ZINC), magnesium (MAGNESIUM). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not test for COVID-19 after vaccination.  On 29Dec2020 15:00 the patient experienced 'Burning Upper Nose/Throat', 'Heart Racing', 'Headache', 'Numbness', 'Tingling Swelling in Left Arm', 'Pain Left Groin Left Leg with Muscle' 'Weakness', 'Vomiting', 'Weak', and 'Tiredness'.  The patient did not received treatment as a result of the event.  The outcome of event 'Burning Upper Nose/Throat' was recovered on unspecified date, 'Heart Racing' was recovered on an unspecified date,  'Headache' was recovered on unspecified date, 'Numbness' was recovered on unspecified date, 'Tingling Swelling in Left Arm' was recovered on unspecified date, 'Pain Left Groin Left Leg with Muscle' was recovered on unspecified date, 'Weakness' was recovered on unspecified date, 'Vomiting' was recovered on unspecified date, 'Weak' was recovered on unspecified date, and 'Tiredness' was recovered on unspecified date.   Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Erythema, Headache, Lymphadenopathy, Myalgia
Clinical narrative: HEAD ACHE, MUSCULAR ACHES, FEVER, CHEST PAIN AND IRREGULAR HEART RATE, EDEMA, ITCH, ERYTHEMA, ENLARGEMENT OF LYMPH NODE
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema, Pruritus
Clinical narrative: HEAD ACHE, MUSCULAR ACHES, FEVER, CHEST PAIN AND IRREGULAR HEART RATE, EDEMA, ITCH, ERYTHEMA, ENLARGEMENT OF LYMPH NODE
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pain, Pyrexia
Clinical narrative: dry cough; felt feverish; body aches; This is a spontaneous report from a contactable consumer. A 22-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first vaccine on 30Dec2020. Around 4 days, in Jan2021, after getting the first vaccine, she started getting body aches, she felt feverish but didn't have a fever, and also a dry cough. She knows from reading the fact sheet that symptoms should resolve after a couple of days. She states her symptoms happened after a couple of days. Caller's question is if the symptoms are from the vaccine or should she get tested for something else. The outcome of the events was unknown.  Information about Lot/Batch has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003818 pfizer
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone decreased, Lipids, Throat tightness
Clinical narrative: TSH level has been borderline hypothyroidism; Almost feel like somebody is gently holding my throat, so I could still breathe, talk, eat but I had the feeling that my throat was being kind of squished; This is a spontaneous report from a contactable nurse. A 64-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), via an unspecified route of administration in right deltoid on an unspecified date at a single dose for covid-19 immunization. Medical history included hypertension and high cholesterol. Concomitant medication included evolocumab (REPATHA) for high cholesterol and two unspecified medications for hypertension. The got the first dose of Pfizer Vaccine for COVID, and for about 3 or 4 almost 5 days afterwards, she felt like somebody, it almost feel like somebody was gently holding her throat, so she could still breathe, talk, eat but had the feeling that throat was being kind of squished. The patient had her lipid panel liver and TSH level done because of the Repatha and TSH level has been borderline hypothyroidism, so she haven't really been on medicine for it but it might be. The patient added that the events had certainly correlated with the vaccine. She didn't have the events until she got the vaccine, so she feel like it was and then her concern was it wouldn't be safe to take the second one. The patient did not visit emergency room and physician office because of the issue 'feel like somebody was gently holding her throat' and all she did was take Benadryl at night. The outcome of the events was unknown.; Sender's Comments: The causal relationship between bnt162b2 and the event hypothyroidism cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: site pain, Joint pain, hives, fever, lymph node swelling and painful.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: site pain, Joint pain, hives, fever, lymph node swelling and painful.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Influenza virus test negative, Pain, Pyrexia
Clinical narrative: test positive for COVID-19/fever, chills, body aches, joint pain; test positive for COVID-19/fever, chills, body aches, joint pain; This is a spontaneous report from a contactable other HCP. A 35-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5703), via an unspecified route of administration in left arm on 15Dec2020 17:30 at a single dose for covid-19 immunization. Administration was done in the hospital. Medical history included seronegative rheumatoid arthritis and allergies to latex and actemra. Concomitant medication included tofacitinib citrate (XELJANZ), and ibuprofen. Eight days after vaccination, on 23Dec2020 at 13:30, the patient came down with fever, chills, body aches, joint pain. The patient was initially tested negative for COVID (nasal swab) and influenza on 27Dec2020 but did test positive for COVID-19 on 29Dec2020 (nasal swab). The patient stated that she knew that the vaccine did not cause COVID however as she was on immunosuppressants (Xeljanz), she wanted to record this information. There was no treatment included for the events. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: test positive for COVID-19/fever, chills, body aches, joint pain; test positive for COVID-19/fever, chills, body aches, joint pain; This is a spontaneous report from a contactable other HCP. A 35-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5703), via an unspecified route of administration in left arm on 15Dec2020 17:30 at a single dose for covid-19 immunization. Administration was done in the hospital. Medical history included seronegative rheumatoid arthritis and allergies to latex and actemra. Concomitant medication included tofacitinib citrate (XELJANZ), and ibuprofen. Eight days after vaccination, on 23Dec2020 at 13:30, the patient came down with fever, chills, body aches, joint pain. The patient was initially tested negative for COVID (nasal swab) and influenza on 27Dec2020 but did test positive for COVID-19 on 29Dec2020 (nasal swab). The patient stated that she knew that the vaccine did not cause COVID however as she was on immunosuppressants (Xeljanz), she wanted to record this information. There was no treatment included for the events. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore at injection site; This is a spontaneous report from a non-contactable consumer reporting for a patient. This 53-year-old male received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on an unknown date (at the age of 53-years) as single dose, at unspecified route of administration for immunization. Medical history was unknown.  Allergies were unknown. Concomitant drugs were unknown. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19.  It was unknown if the patient received any other vaccines within 4 weeks prior to BNT162B2.  On an unspecified date, the patient experienced 'sore at injection site'.  It was unknown if the patient received treatment as a result of the event.  The outcome of event 'sore at injection site' was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest pain, Dizziness, Dyspnoea, Hypotension
Clinical narrative: severe dizziness; aches; chest pain; palpitations; extremely low blood pressure; fever; shortness of breath; This is a spontaneous report from a non-contactable nurse, the patient. A 38-year-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EK9231; Expiration date was not reported), via an unspecified route of administration in the left arm on 29Dec2020 at 09:15 (at the age of 38-years) as a single dose for COVID-19 immunization. Medical history included allergy to bee stings. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took cefzil and experienced allergies. On an unspecified date, the patient experienced severe dizziness, shortness of breath, chest pain, palpitations, extremely low blood pressure, fever, and aches. The patient was seen in the emergency department for the events. Therapeutic measures for the events included medications and IV fluids; both not further specified. The outcome of the event severe dizziness, shortness of breath, chest pain, palpitations, extremely low blood pressure, fever, and aches was recovered.    No follow up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Pyrexia
Clinical narrative: severe dizziness; aches; chest pain; palpitations; extremely low blood pressure; fever; shortness of breath; This is a spontaneous report from a non-contactable nurse, the patient. A 38-year-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EK9231; Expiration date was not reported), via an unspecified route of administration in the left arm on 29Dec2020 at 09:15 (at the age of 38-years) as a single dose for COVID-19 immunization. Medical history included allergy to bee stings. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took cefzil and experienced allergies. On an unspecified date, the patient experienced severe dizziness, shortness of breath, chest pain, palpitations, extremely low blood pressure, fever, and aches. The patient was seen in the emergency department for the events. Therapeutic measures for the events included medications and IV fluids; both not further specified. The outcome of the event severe dizziness, shortness of breath, chest pain, palpitations, extremely low blood pressure, fever, and aches was recovered.    No follow up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, SARS-CoV-2 test positive
Clinical narrative: COVID-19 rapid POC test positive; COVID-19 rapid POC test positive; the amount of vaccine given as 1 cc; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs). A contactable nurse (patient) reported that a 52-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EH9899), via an unspecified route of administration on 17Dec2020 at 1 mL, single dose for COVID-19 immunization. Medical history included ongoing hypertension diagnosed when she was 33 years old. There were no concomitant medications. The patient got the vaccine on 17Dec2020. The patient stated that the amount of vaccine given was 1 cc. She took a COVID-19 rapid POC test on the 28Dec2020 and tested positive. She wanted to know if she should have the second dose of the vaccine. The outcome of the events was unknown.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19 rapid POC test positive; COVID-19 rapid POC test positive; the amount of vaccine given as 1 cc; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs). A contactable nurse (patient) reported that a 52-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EH9899), via an unspecified route of administration on 17Dec2020 at 1 mL, single dose for COVID-19 immunization. Medical history included ongoing hypertension diagnosed when she was 33 years old. There were no concomitant medications. The patient got the vaccine on 17Dec2020. The patient stated that the amount of vaccine given was 1 cc. She took a COVID-19 rapid POC test on the 28Dec2020 and tested positive. She wanted to know if she should have the second dose of the vaccine. The outcome of the events was unknown.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, SARS-CoV-2 test positive
Clinical narrative: received the first dose of vaccine.  She then tested positive on a rapid test for Sars-COV-2; received the first dose of vaccine.  She then tested positive on a rapid test for Sars-COV-2; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of unspecified age started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), unspecified route of administration on 17Dec2020 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient received the first dose of vaccine on 17Dec2020.  She then tested positive on a rapid test for Sars-COV-2 on unspecified date.  She was asking if she should receive second dose and what adverse events to expect. Outcome of the event (she received the first dose of vaccine. She then tested positive on a rapid test for Sars-COV-2)  was unknown. Information about lot/Batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: received the first dose of vaccine.  She then tested positive on a rapid test for Sars-COV-2; received the first dose of vaccine.  She then tested positive on a rapid test for Sars-COV-2; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of unspecified age started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), unspecified route of administration on 17Dec2020 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient received the first dose of vaccine on 17Dec2020.  She then tested positive on a rapid test for Sars-COV-2 on unspecified date.  She was asking if she should receive second dose and what adverse events to expect. Outcome of the event (she received the first dose of vaccine. She then tested positive on a rapid test for Sars-COV-2)  was unknown. Information about lot/Batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pt stated that she began to feel light headed after receiving vaccination  VSS, she rested on cot for 30 min and left
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable other health professional. A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, Expiry Date: Mar2021, NDC number: 5926710001), via an unspecified route of administration on 30Dec2020 08:11 at a single dose in right bicep (right arm) for COVID-19 immunisation. Medical history included urinary tract infection from 21Dec2020 to Dec2020 which was resolved and fine after the antibiotic, ongoing eczema (had this condition basically her entire life), ongoing sensitive skin (always had pretty sensitive skin). Concomitant medication not reported. The patient previously took nitrofurantoin (MACROBID [NITROFURANTOIN]) from 24Dec2020 to 28Dec2020. The patient experienced hives on 01Jan2021 09:00 (also reported as "got it last Wednesday morning and broke out in hives the next day"). Patient stated, "I have a question to you. I got the Covid Vaccine, the Pfizer Vaccine on Wednesday morning like around 8 o' clock and this morning I woke up and I broke out hives. I didn't know if in two days, I just want to report my symptoms just to make sure everything is okay." The hives were bad on Friday and took Benadryl and Cortisone cream and it is better now. The hives are not worse; not as bad as it was on the first day. She took about 5 Benadryl throughout the first day: 01Jan2021. Over the last few days she has continued to get small breakouts of hives on pretty much every single spot on her body except for her face; the hives seem to kind of take turns in different areas of the body but have not gone away. She has used Hydrocortisone, lotion and Benadryl for the hives. The outcome of the event was recovering. She is both a sonogram technologist as well as the patient. She asked if she should or should not receive the second dose of Pfizer COVID- 19 Vaccine in response to the hives. She is supposed to get second dose on 19Jan2021; unknown if she will or will not change dose scheduling in response to event at this time.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Disorientation, Fatigue, Feeling hot, Headache
Clinical narrative: 3 hours after I felt hot in the face and mild head ache started. also felt disoriented and weak.  after 2 hours I felt normal. The day after I woke up feeling very tired and weak. I called in sick and rested that day.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability
Clinical narrative: 3 hours after I felt hot in the face and mild head ache started. also felt disoriented and weak.  after 2 hours I felt normal. The day after I woke up feeling very tired and weak. I called in sick and rested that day.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Headache
Clinical narrative: left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection site (4 cm in circumference); Nearly debilitating joint, muscle and body aches and pain; Nearly debilitating joint, muscle and body aches and pain; severe headache; chills; night sweats; weakness; dizziness; lethargy; fever; body aches; nausea; Muscle soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), intramuscularly in the left arm, on 23Dec2020 at 14:30 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, depression, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included atenolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), and simvastatin (MANUFACTURER UNKNOWN). The patient previously took bupropion hydrochloride (WELLBUTRIN) and experienced allergy. The patient did not receive other vaccines within four weeks prior to vaccination. The patient experienced fever, body aches, nausea, and muscle soreness at injection site on 24Dec2020 at 16:00; generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches, severe headache, chills, night sweats, weakness, dizziness, and lethargy on 26Dec2020; and left arm and shoulder pain persisted on 03Jan2021. All of the events were reported as non-serious. The events were described as: Within 24 hours (as reported), fever, body aches, nausea, and muscle soreness at injection site occurred. Then within 72 hours (as reported), generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches and pain for three days with onset of severe headache, fever, chills, night sweats, weakness, dizziness, and lethargy. On Day 11 (as reported), left arm and shoulder joint pain persisted. The patient underwent lab tests and procedures which included nasal swab: negative on 31Dec2020. The patient did not receive any treatment for any of the events. The clinical outcome of all of the events was recovering.