chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site discomfort
Clinical narrative: Nausea; Muscle aches; General unwell; Anxiety; Body feels heavy and hard to move; Body feels heavy and hard to move; Arm where injected is very uncomfortable; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 12Jan2021 at a single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Zk5730), via an unspecified route of administration on 22Dec2020 at a single dose on left arm for COVID-19 immunization (at 29 years old). The patient experienced nausea, Muscle aches, General unwell, Anxiety, Body feels heavy and hard to move around, Arm where injected is very uncomfortable on 13Jan2021 01:30 AM. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Left axillary lymphadenopathy; This is a spontaneous report from a contactable physician (patient). A 56-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), intramuscular on the left arm on 11Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical history was reported as none. No known allergies to food, medications or other products. The patient's concomitant medications were not reported. No other vaccines received within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 via the intramuscular route at the left arm for COVID-19 Immunization on 21Dec2020 at 09:00 at the age of 56 years old. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced left axillary lymphadenopathy on 12Jan2021 at 10:00. No treatment was administered for the event. The event was resolving.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Vaccination site pain
Clinical narrative: my arm at the injection site hurt.; couldn't move or lift arm due to the pain; couldn't move or lift arm due to the pain; This is a spontaneous report from a contactable consumer [patient]. A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose at arm for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient woke up the night after the injection and arm at the injection site hurt. couldn't move or lift arm due to the pain. Took 400mg of ibuprofen and can move arm again. The patient was still on 400 mg ibuprofen twice a day for pain. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: Dizziness; headache; Muscle pain/stiffness; Muscle pain/stiffness; This is a spontaneous report from a contactable health professional (patient). A 55-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231, vaccine location: left arm) via an unspecified route of administration on 12Jan2021 05:00 pm at hospital at single dose for COVID-19 immunization. Medical history included high blood pressure and migraine. Concomitant medication in two weeks included atenolol, furosemide, bupropion hydrochloride (WELLBUTRIN), hyoscyamine and magnesium. Patient had not had COVID-19 prior vaccination. Patient had not been tested for COVID-19 post vaccination. The patient was not pregnant. No other vaccine was received in four weeks. The patient previously took first dose of bnt162b2 (lot number El0140, vaccine location: left arm) at the age of 55 years on 22Dec2020 05:15 pm for COVID-19 immunization. Known allergies included tetracycline, montelukast sodium (SINGULAIR), nifedipine, hydrochlorothiazide (HCTZ), erythromycin and sumatriptan. The patient experienced dizziness, headache, muscle pain or stiffness on 12Jan2021 06: 00 pm. No treatment was received for all events. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19, UNK, UNK, UNK, UNK
Symptoms: Drug hypersensitivity, Rash
Clinical narrative: Ended up having a rash or allergies; Ended up having a rash or allergies; This is a spontaneous report from a contactable other health professional (patient) via a Pfizer-sponsored program Pfizer First Connect. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization, doxycycline hyclate; methylprednisolone; methylprednisolone sodium succinate (SOLU-MEDROL); amoxicillin via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient got his first dose on 23Dec2020, due on Tuesday for 2nd dose. No reactions when he took the first shot. The caller was taking different medicines on 10Jan2021 and ended up having a rash or allergies. Gave allergic reaction Amoxicillin, Solu Medrol injection, Doxycycline, Methylprednisolone. The patient wanted to know if he can still be able to get the 2nd dose of vaccine on Tuesday. The action taken in response to the events for doxycycline hyclate was unknown, for methylprednisolone was unknown, for methylprednisolone sodium succinate was unknown, for amoxicillin was unknown. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Oropharyngeal pain
Clinical narrative: muscle pain; sore throat; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable 43-year-old female Nurse (patient) received the first dose of BNT162B2 (Covid-19 vaccine) on an unspecific date at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Caller said she is scheduled for the 2nd dose of Covid-19 vaccine tomorrow. but she is a PUI and has to be on a covid test tomorrow. Caller wanted to know if she still had to take the 2nd dose of covid-19 vaccine, since she's still experiencing muscle pain and sore throat. Mentioned having headache also but gone now. Outcome of the event headache was recovered, for other events was not recovered.   Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache (HA); Slight fever; This is a spontaneous report from a contactable consumer (father-in-law). This consumer reported similar events for two patients. This is the first of two reports.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date), via an unspecified route of administration, on an unspecified date at an unspecified dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache (HA) and slight fever on an unspecified date. The outcome of the event was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021031244 Same reporter, drug, and event, different patient
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Nausea, Pain
Clinical narrative: nausea; like a hundred temperature/high; body aches; headache; fatigue; This is a spontaneous report from a Pfizer-sponsored program. A contactable 34-year-old female patient reported she received first dose bnt162b2 (BNT162B2), via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced like a hundred temperature/high and then nausea but no vomiting on 06Jan2021. And she's currently having body aches, and headache but no vomiting, fatigue since an unknow date in Jan2021. The patient underwent lab tests and procedures which included body temperature: like a hundred temperature/high on 06Jan2021. The patient was better now like a hundred temperature/high was recovering; nausea was not recovered; outcome of other events were unknown.  Information on the Lot/Batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: nausea; like a hundred temperature/high; body aches; headache; fatigue; This is a spontaneous report from a Pfizer-sponsored program. A contactable 34-year-old female patient reported she received first dose bnt162b2 (BNT162B2), via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced like a hundred temperature/high and then nausea but no vomiting on 06Jan2021. And she's currently having body aches, and headache but no vomiting, fatigue since an unknow date in Jan2021. The patient underwent lab tests and procedures which included body temperature: like a hundred temperature/high on 06Jan2021. The patient was better now like a hundred temperature/high was recovering; nausea was not recovered; outcome of other events were unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood testosterone, Blood testosterone decreased
Clinical narrative: low testosterone; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient of unknown age that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on an unknown date at single dose for COVID-19 immunization. Concomitant medications and past drug/medical history were not reported. Caller wanted to know if a patient should stop taking a medication for low testosterone after having gotten the vaccine. Outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: I had a very mild cough; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 06Jan2021 at single dose for COVID-19 immunisation. Medical history included being exposed at home to a symptomatic COVID patient on 04Jan2021.  Concomitant medications were not reported. Patient previously received first dose of BNT162B2 on 16Dec2020 for COVID-19 immunisation. Patient received the second COVID vaccine on 06Jan2021 and had a very mild cough from 06Jan2021 to 09Jan2021. Patient had PCR COVID test on 09Jan2021 and pending result. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: she has a low grade fever; a swollen left node on the neck; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported for self that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. patient got her 1st dose last Dec2020 and is scheduled for the 2nd dose today. She mentioned she has a low grade fever and a swollen left node on the neck. She wants to know if that will contraindicate on taking the vaccine. Outcome of events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: experiencing low-grade fever.; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored. The male patient received first dose of bnt162b2 (BNT162B2), unknown on 09Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced low-grade fever on an unspecified date. It was reported as " had the vaccine yesterday and i had like a really low-grade fever and I was wondering if it was okay to just take some Tylenol for the fever". The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: chills; fatigue; This is a spontaneous report from a contactable physician.  An elderly (reported as 65+ Years) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 21Dec2020 (Lot number: ej1685) via an unspecified route of administration, second dose on 11Jan2021 (Lot number: e21685) via intramuscular, both at single dose for COVID-19 immunisation. Medical history included known allergies to penicillin and erythromycin. The patient's concomitant medications were not reported. The patient experienced chills and fatigue on an unspecified date. No treatment was received for adverse events. The patient received vaccine in hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The outcome of events was recovered on an unspecified date.
Sex: U
Vaccine: COVID19
Symptoms: Cold sweat, Pain
Clinical narrative: felt achy and sore; clammy; This is a spontaneous report from a non-contactable nurse (patient) via Pfizer sales representative. A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Patient was vaccinated by employer. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on an unspecified date. The patient felt achy, clammy and sore in Jan2021. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Headache, Malaise
Clinical narrative: Chills/rigors; back ache; headache; temp was now 101.2; feeling really ill; This is a spontaneous report from a non-contactable consumer.  A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient was feeling really ill from his second vaccine shot, on 09Jan2021, he experienced chills for 12 hours, rigors, back ache, headache. First dose was only arm soreness. It was reported temp was now 101.2 (unit not provided). The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected. Information about Lot/Batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills/rigors; back ache; headache; temp was now 101.2; feeling really ill; This is a spontaneous report from a non-contactable consumer.  A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient was feeling really ill from his second vaccine shot, on 09Jan2021, he experienced chills for 12 hours, rigors, back ache, headache. First dose was only arm soreness. It was reported temp was now 101.2 (unit not provided). The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected. Information about Lot/Batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Headache, Heart rate
Clinical narrative: Body aches; Heaviness in her chest; Pulse is in the 90s; Now her temperature was 101.2 degrees F; Soreness in her left arm; Chills; Not feeling too well/flu-like feeling; Not feeling too well/flu-like feeling; Slight headache / headache; This is a spontaneous report from a contactable consumer (patient).  This 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unknown route, on 10Jan2021 at 15:00 at single dose in the left arm for COVID-19 immunisation. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EZ0140) administered in the upper left arm on 20Dec2020 (at 14:45-15:00) and developed a little headache, soreness and was tired (reported under AER 2021026236). Relevant medical history included thyroid, cholesterol and blood pressure (as reported). The patient was taking concomitant medications for underlying medical history. No other vaccine was received in four weeks. In the evening yesterday she was not feeling too well. She had a slight headache; body aches and she could get rid of the headache. She clarified that last night she felt chilly, she had the chills. By 10am this morning she did not feel well, she had a pretty bad headache and felt like she had a temperature. Her temperature earlier today was 99.4 degrees F and now her temperature was 101.2 degrees F. Her whole body feels like she was having aches, stated it is like a flu-like feeling, she had heaviness in her chest, her pulse will not go out of the 90s. She took her oxygen level and it was between 97-99%. She had also soreness in her left arm. She asked if these are common side effects, or something to be concerned about. Therapeutic measures taken as result of the events included ibuprofen (ADVIL). The outcome of the events was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Influenza like illness, Malaise, Oxygen saturation, Pain
Clinical narrative: Body aches; Heaviness in her chest; Pulse is in the 90s; Now her temperature was 101.2 degrees F; Soreness in her left arm; Chills; Not feeling too well/flu-like feeling; Not feeling too well/flu-like feeling; Slight headache / headache; This is a spontaneous report from a contactable consumer (patient).  This 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unknown route, on 10Jan2021 at 15:00 at single dose in the left arm for COVID-19 immunisation. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EZ0140) administered in the upper left arm on 20Dec2020 (at 14:45-15:00) and developed a little headache, soreness and was tired (reported under AER 2021026236). Relevant medical history included thyroid, cholesterol and blood pressure (as reported). The patient was taking concomitant medications for underlying medical history. No other vaccine was received in four weeks. In the evening yesterday she was not feeling too well. She had a slight headache; body aches and she could get rid of the headache. She clarified that last night she felt chilly, she had the chills. By 10am this morning she did not feel well, she had a pretty bad headache and felt like she had a temperature. Her temperature earlier today was 99.4 degrees F and now her temperature was 101.2 degrees F. Her whole body feels like she was having aches, stated it is like a flu-like feeling, she had heaviness in her chest, her pulse will not go out of the 90s. She took her oxygen level and it was between 97-99%. She had also soreness in her left arm. She asked if these are common side effects, or something to be concerned about. Therapeutic measures taken as result of the events included ibuprofen (ADVIL). The outcome of the events was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Body aches; Heaviness in her chest; Pulse is in the 90s; Now her temperature was 101.2 degrees F; Soreness in her left arm; Chills; Not feeling too well/flu-like feeling; Not feeling too well/flu-like feeling; Slight headache / headache; This is a spontaneous report from a contactable consumer (patient).  This 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unknown route, on 10Jan2021 at 15:00 at single dose in the left arm for COVID-19 immunisation. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EZ0140) administered in the upper left arm on 20Dec2020 (at 14:45-15:00) and developed a little headache, soreness and was tired (reported under AER 2021026236). Relevant medical history included thyroid, cholesterol and blood pressure (as reported). The patient was taking concomitant medications for underlying medical history. No other vaccine was received in four weeks. In the evening yesterday she was not feeling too well. She had a slight headache; body aches and she could get rid of the headache. She clarified that last night she felt chilly, she had the chills. By 10am this morning she did not feel well, she had a pretty bad headache and felt like she had a temperature. Her temperature earlier today was 99.4 degrees F and now her temperature was 101.2 degrees F. Her whole body feels like she was having aches, stated it is like a flu-like feeling, she had heaviness in her chest, her pulse will not go out of the 90s. She took her oxygen level and it was between 97-99%. She had also soreness in her left arm. She asked if these are common side effects, or something to be concerned about. Therapeutic measures taken as result of the events included ibuprofen (ADVIL). The outcome of the events was unknown.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site scab, Vaccination site vesicles
Clinical narrative: blister at the injection site that has turned into a scab; blister at the injection site that has turned into a scab; This is a spontaneous report from a contactable other health professional (nurse practitioner). This other health professional reported similar events for three patients. This is the 3rd of three reports. A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: 30Apr2021), intramuscular at deltoid right on 06Jan2021 at 0.3 mL at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced blister at the injection site that has turned into a scab. The patient outcome of the events was unknown.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left Arm pain; This is a spontaneous report from a contactable consumer.  A 90-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283 expired date 30Apr2021 in left arm  via an unspecified route of administration on 10Jan2021 at a single dose for COVID-19 immunisation. Medical history included arthritis. Concomitant medications were not provided. On 11-JAN-2021 the patient experienced pain in her left arm. She would like to know if she can use a heating pad on it. The event outcome is not recovered and action taken is not applicable.
Sex: F
Vaccine: UNK, COVID19
Symptoms: Insomnia, Pain, Speech disorder, Swelling
Clinical narrative: having speech problems, it's not fluid; Sleeplessness; swelling and hurting for a couple of days after receiving Covid-19 vaccine; swelling and hurting for a couple of days after receiving Covid-19 vaccine; it might be her lithium that the Covid-19 vaccine might have interacted with; This is a spontaneous report from a contactable consumer reporting for herself.  A female patient of an unspecified age received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation ,and  lithium (LITHIUM) , via an unspecified route of administration from an unspecified date at an unknown dose for an unspecified indication .  Medical history included bipolar disorder.   The patient's concomitant medications were not reported.   The patient stated she was having speech problems, it's not fluid  , sleeplessness , swelling and hurting for a couple of days after receiving covid-19 vaccine all the event occurred on an unspecified date with outcome of unknown . The patient suspected a possible interaction  between her lithium and  the Covid-19 vaccine. The patient  didn't expect her psych meds coming up.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: UNK, COVID19
Symptoms: Somnolence
Clinical narrative: having speech problems, it's not fluid; Sleeplessness; swelling and hurting for a couple of days after receiving Covid-19 vaccine; swelling and hurting for a couple of days after receiving Covid-19 vaccine; it might be her lithium that the Covid-19 vaccine might have interacted with; This is a spontaneous report from a contactable consumer reporting for herself.  A female patient of an unspecified age received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation ,and  lithium (LITHIUM) , via an unspecified route of administration from an unspecified date at an unknown dose for an unspecified indication .  Medical history included bipolar disorder.   The patient's concomitant medications were not reported.   The patient stated she was having speech problems, it's not fluid  , sleeplessness , swelling and hurting for a couple of days after receiving covid-19 vaccine all the event occurred on an unspecified date with outcome of unknown . The patient suspected a possible interaction  between her lithium and  the Covid-19 vaccine. The patient  didn't expect her psych meds coming up.  Information on the Lot/Batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Asthenopia, Back pain, Contusion
Clinical narrative: Drowsy; Weak; Pain in the knees/pain in his joints/joint pain from his Legs, Arms, and fingers; Both of his eyes feel tired; could not lift arm; bruised under the arm; back pain; neck pain; could not turn neck; headache; Pain with bending head down; This is a spontaneous report from a contactable consumer.  A 41-year-old male consumer received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm on 11Jan2021 at 07:45 at single dose for COVID-19 immunisation at the age of 40-year-old. Medical history included HIV infection, root canal in Dec2020, COVID-19 in Jun2020 or Jul2020. Concomitant medications were unknown. Vaccination history included first dose of BNT162B2 on 21Dec2020 for COVID-19 immunisation (could not lift arm, bruised under the arm, back pain with his neck he could not turn it, he could not be on his left side where he got the shot on left arm, headache). The patient experienced drowsy, weakness, knee pain, joint pain, could not lift arm, bruised under the arm, back pain, neck pain and could not turn neck, Headache, pain with bending head down, both eyes feel tired. In Jun2020/ Jul2020, the patient resulted positive to SARS-CoV-2 test; then, the patient had 3 negative SARS-CoV-2 test; weight: lost. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: Drowsy; Weak; Pain in the knees/pain in his joints/joint pain from his Legs, Arms, and fingers; Both of his eyes feel tired; could not lift arm; bruised under the arm; back pain; neck pain; could not turn neck; headache; Pain with bending head down; This is a spontaneous report from a contactable consumer.  A 41-year-old male consumer received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm on 11Jan2021 at 07:45 at single dose for COVID-19 immunisation at the age of 40-year-old. Medical history included HIV infection, root canal in Dec2020, COVID-19 in Jun2020 or Jul2020. Concomitant medications were unknown. Vaccination history included first dose of BNT162B2 on 21Dec2020 for COVID-19 immunisation (could not lift arm, bruised under the arm, back pain with his neck he could not turn it, he could not be on his left side where he got the shot on left arm, headache). The patient experienced drowsy, weakness, knee pain, joint pain, could not lift arm, bruised under the arm, back pain, neck pain and could not turn neck, Headache, pain with bending head down, both eyes feel tired. In Jun2020/ Jul2020, the patient resulted positive to SARS-CoV-2 test; then, the patient had 3 negative SARS-CoV-2 test; weight: lost. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, SARS-CoV-2 test positive, Somnolence, Weight
Clinical narrative: Drowsy; Weak; Pain in the knees/pain in his joints/joint pain from his Legs, Arms, and fingers; Both of his eyes feel tired; could not lift arm; bruised under the arm; back pain; neck pain; could not turn neck; headache; Pain with bending head down; This is a spontaneous report from a contactable consumer.  A 41-year-old male consumer received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm on 11Jan2021 at 07:45 at single dose for COVID-19 immunisation at the age of 40-year-old. Medical history included HIV infection, root canal in Dec2020, COVID-19 in Jun2020 or Jul2020. Concomitant medications were unknown. Vaccination history included first dose of BNT162B2 on 21Dec2020 for COVID-19 immunisation (could not lift arm, bruised under the arm, back pain with his neck he could not turn it, he could not be on his left side where he got the shot on left arm, headache). The patient experienced drowsy, weakness, knee pain, joint pain, could not lift arm, bruised under the arm, back pain, neck pain and could not turn neck, Headache, pain with bending head down, both eyes feel tired. In Jun2020/ Jul2020, the patient resulted positive to SARS-CoV-2 test; then, the patient had 3 negative SARS-CoV-2 test; weight: lost. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dehydration, Diarrhoea, Fatigue
Clinical narrative: Diarrhea; Fever; Chills; Muscle ache; first dose on 19Dec2020/ second dose on 08Jan2021 at 08:30; first dose on 19Dec2020/ second dose on 08Jan2021 at 08:30; Headache; fatigued; dehydration; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: PAA156051), on 08Jan2021 at 08:30 at single dose intramuscular in right arm for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), on 19Dec2020 at single dose intramuscular in left arm, with no adverse effects. The second dose of BNT162B2 was administered on day 20 after first dose (unapproved schedule). The patient was taking COVID vaccine since healthcare worker (Recreational Therapist) and was vaccinated at state hospital. Patient age at time of vaccination was 24 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient had no relevant medical history and received no concomitant medications. The patient stated she had fever, chills, muscle aches, diarrhea, headache. She didn't report anything to her doctor. Fever started on 08Jan2021 about 12 hours after getting the second vaccine. Chills started around 7pm and headache in the night of 08Jan2021. Muscle aches started on 08Jan2021 about 8 hours after receiving the second vaccine. Diarrhea started on 09Jan2021. These symptoms lasted all day Saturday 09Jan2021, until the night. By Sunday, 10Jan2021, she was still fatigued but she was pretty much better. She reported she had recovered completely from the symptoms but she does still have a little bit of a headache, but that is probably from dehydration. Headache was resolving at the time of reporting, outcome of dehydration was unknown, other events had resolved in Jan2021.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Off label use, Product use issue, Pyrexia
Clinical narrative: Diarrhea; Fever; Chills; Muscle ache; first dose on 19Dec2020/ second dose on 08Jan2021 at 08:30; first dose on 19Dec2020/ second dose on 08Jan2021 at 08:30; Headache; fatigued; dehydration; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: PAA156051), on 08Jan2021 at 08:30 at single dose intramuscular in right arm for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), on 19Dec2020 at single dose intramuscular in left arm, with no adverse effects. The second dose of BNT162B2 was administered on day 20 after first dose (unapproved schedule). The patient was taking COVID vaccine since healthcare worker (Recreational Therapist) and was vaccinated at state hospital. Patient age at time of vaccination was 24 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient had no relevant medical history and received no concomitant medications. The patient stated she had fever, chills, muscle aches, diarrhea, headache. She didn't report anything to her doctor. Fever started on 08Jan2021 about 12 hours after getting the second vaccine. Chills started around 7pm and headache in the night of 08Jan2021. Muscle aches started on 08Jan2021 about 8 hours after receiving the second vaccine. Diarrhea started on 09Jan2021. These symptoms lasted all day Saturday 09Jan2021, until the night. By Sunday, 10Jan2021, she was still fatigued but she was pretty much better. She reported she had recovered completely from the symptoms but she does still have a little bit of a headache, but that is probably from dehydration. Headache was resolving at the time of reporting, outcome of dehydration was unknown, other events had resolved in Jan2021.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Soreness in the arm; Typical arm swelling; Headache; Tiredness; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  bnt162b2 (BNT162B2), via an unspecified route of administration at single dose on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced soreness in the arm, typical arm swelling, headache, tiredness, all with outcome of unknown.    Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026413 same reporter/drug/AE, different patient
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Headache, Myalgia
Clinical narrative: anterior cervical fusion; Headache; tested positive for COVID-19; tested positive for COVID-19; muscle aches; Loss of taste; Loss of smell; Nausea; sore arm; Tiredness; This is a spontaneous report from a contactable nurse (patient).  A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot  EJ1686, intramuscular in right deltoid on 03Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included ongoing essential tremor started in her 50's.  The patient's concomitant medications were not reported.  The patient did not receive other vaccine within four weeks.  On 03Jan2021 the patient experienced sore arm and tiredness.  On 07Jan2021 the patient experienced anterior cervical fusion and was hospitalized from 07Jan2021 to 09Jan2021. On 08Jan2021 the patient experienced nausea. On 09Jan2021 the patient experienced muscle aches, loss of taste and loss of smell. On unknown date the patient experienced headache. The patient was tested positive to COVID-19 on 11Jan2021. The patient did not visit Physician Office or Emergency Room. Laboratory data included COVID-19 Rapid Test positive on 11Jan2021. The outcome of the events tested positive for COVID-19, and anterior cervical fusion was unknown. The outcome of the events sore arm, tiredness, nausea, muscle aches, headache was resolving. The outcome of the events loss of taste, loss of smell was not resolved.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and COVID-19 test positive on 11Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use.  This 69-year-old female had medical history of ongoing essential tremor started in her 50's.  The reported anterior cervical fusion was most likely due to concurrent disease, and unlikely causally related to the vaccine of BNT162B2.  The case will be reassessed should additional information become 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, SARS-CoV-2 test positive, Spinal fusion surgery
Clinical narrative: anterior cervical fusion; Headache; tested positive for COVID-19; tested positive for COVID-19; muscle aches; Loss of taste; Loss of smell; Nausea; sore arm; Tiredness; This is a spontaneous report from a contactable nurse (patient).  A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot  EJ1686, intramuscular in right deltoid on 03Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included ongoing essential tremor started in her 50's.  The patient's concomitant medications were not reported.  The patient did not receive other vaccine within four weeks.  On 03Jan2021 the patient experienced sore arm and tiredness.  On 07Jan2021 the patient experienced anterior cervical fusion and was hospitalized from 07Jan2021 to 09Jan2021. On 08Jan2021 the patient experienced nausea. On 09Jan2021 the patient experienced muscle aches, loss of taste and loss of smell. On unknown date the patient experienced headache. The patient was tested positive to COVID-19 on 11Jan2021. The patient did not visit Physician Office or Emergency Room. Laboratory data included COVID-19 Rapid Test positive on 11Jan2021. The outcome of the events tested positive for COVID-19, and anterior cervical fusion was unknown. The outcome of the events sore arm, tiredness, nausea, muscle aches, headache was resolving. The outcome of the events loss of taste, loss of smell was not resolved.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and COVID-19 test positive on 11Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use.  This 69-year-old female had medical history of ongoing essential tremor started in her 50's.  The reported anterior cervical fusion was most likely due to concurrent disease, and unlikely causally related to the vaccine of BNT162B2.  The case will be reassessed should additional information become 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: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever/as high as 102.6 tympanic/temperature was 101; This is a spontaneous report from a contactable other HCP.  A 43-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: El3246), intramuscular in left arm on 12Jan2021 09:00 at a single dose for covid-19 immunization. Medical history included diabetes mellitus. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included metformin, rosuvastatin, acyclovir [aciclovir] (ACYCLOVIR), lisinopril, and fenofibrate. The patient previously received the first dose of bnt162b2 on 22Dec2020 09:00 intramuscular in left arm. The patient experienced fever that started at 8pm to 9pm on 12Jan2021. The fever reached as high as 102.6 tympanic. On 14Jan2021 at 7am, temperature was 101. The outcome of the event was not recovered. No treatment was received for the event. This was assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Severe Allergic response; This is a spontaneous report from a contactable nurse. A 36-year-old female nurse reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular at single dose into the left arm on 08Jan2021 at 12:00 PM administered at hospital for COVID-19 immunization. The patient had received the first dose of BNT162B2 intramuscular into left arm on 21Dec2020 at 02:30 PM into left arm. Concomitant drug included Lovenox. Medical history included factor five Leiden and allergy to shellfish. On 08Jan2021 at  01:00 PM the patient experienced a severe allergic response. The patient received two shots of epi pen, round the clock IV steroids, pepcid and Benadryl and was admitted into the hospital. Duration of hospitalization reported as 6. The adverse event resulted in Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reaction cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product. 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: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Lip swelling, Peripheral swelling, Swelling of eyelid, Urticaria
Clinical narrative: Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; This is a spontaneous report from a contactable other health professional (patient). A 27-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) at the age of 26 years old, via intramuscular route in the left arm, on 10Jan2021 at 13:00, at a single dose, for COVID-19 immunization. Medical history included high blood pressure. The patient's concomitant medications were not reported. The patient has no known allergies. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 12Jan2021, at 07:30 A.M., the patient experienced allergic reaction resulting in full body hives, swollen hands, eyelids and lips. The patient did not receive treatment for the events. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pharyngeal swelling, Pyrexia, Rash, Swollen tongue
Clinical narrative: broke out in rash/hives all over; broke out in rash/hives all over; mild tongue swelling; sob throat felt sore and swollen; sob throat felt sore and swollen; swelling at injection site; redness at injection site; itching at injection site; feverish; This is a spontaneous report from a contactable other healthcare professional (patient).  A 33-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number=Ej1685, via an unspecified route of administration on left arm from 07Jan2021 11:00 to 07Jan2021 11:00 at SINGLE DOSE (dose 2) for COVID-19 immunisation. The patient as no known allergies, no other medical history, and no allergies to medications, food, or other products. Historical vaccine includes first dose of BNT162B2 on 18Dec2020, time=12:45 PM, vaccine location=Left arm, lot number=Eh9899.  The patient's concomitant medications were not reported. On 08Jan2021 05:00 AM, the patient experienced post vaccine swelling, redness, itching at injection site and feverish. On 13Jan2021, the patient broke out in rash/hives all over with mild tongue swelling and sob throat felt sore and swollen for a short time. The patient went to physician and received steroid injection and Benadryl.  The outcome of the events was recovering.