chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Pain on arm of injection; fatigue; chills; fever; muscle aches; This is a spontaneous report from a contactable other health professional (patient). A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular (left arm) on 19Jan2021 17:30 at single dose for Covid-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced pain on arm of injection, fatigue, chills, fever, and muscle aches on 20Jan2021 (07:00 AM). There was no treatment received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Rash macular, Swelling face
Clinical narrative: broke out in hives on her face, arms, and chest; warm feeling; Itching; face was really swollen; face was really swollen and red; skin was blotchy; This is a spontaneous report from a contactable consumer reported for herself. A 64-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) at single dose via an unknown route at right arm on 16Jan2021 about 11:00 for vaccination against Covid. No additional vaccines administered on same date of the Pfizer Suspect. Medical history included anxiety, high blood pressure, and ongoing physical urticaria (with no investigation assessment) where if she gets warm her arms itch and she breaks out in a little bit of hives, but never to this extent. Concomitant drugs included lisinopril at 20mg, 1 tablet by mouth once daily for high blood pressure, and sertraline at 50mg, 1 tablet by mouth once daily for anxiety, both ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as "none". No other vaccines given the same day and none 4 weeks prior. No history of problems with vaccines in past. Prior Vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine was "none". No events following prior vaccinations. Family medical history relevant to the event was reported as "none". Patient reported an adverse event/side effect to the Covid vaccine, and was not sure if she should go ahead with the second dose or not. Patient received the vaccine on 16Jan2021 (reported as Saturday as of 18Jan2021) about 11am and at 5pm she started getting a warm feeling and changed to cooler clothing. Patient started itching and then broke out in hives on her face, arms, and chest. Patient used a cool cloth to face to cool off and sat under the fan. Her daughter got her some diphenhydramine hydrochloride (BENADRYL) within that 15minutes and about 20-30 minutes of taking the diphenhydramine hydrochloride it was calming down. Patient only took 1 diphenhydramine hydrochloride to help and that took care of it. This was the only occurrence. Her face was really swollen and red, she looked like she was sun burnt, skin was blotchy, but she didn't have any trouble with breathing or heart palpitations. The event onset date was 16Jan2021. The events did not require a visit to Emergency Room/ Physician Office. No relevant tests performed. Outcome of the events was resolving.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: broke out in hives on her face, arms, and chest; warm feeling; Itching; face was really swollen; face was really swollen and red; skin was blotchy; This is a spontaneous report from a contactable consumer reported for herself. A 64-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) at single dose via an unknown route at right arm on 16Jan2021 about 11:00 for vaccination against Covid. No additional vaccines administered on same date of the Pfizer Suspect. Medical history included anxiety, high blood pressure, and ongoing physical urticaria (with no investigation assessment) where if she gets warm her arms itch and she breaks out in a little bit of hives, but never to this extent. Concomitant drugs included lisinopril at 20mg, 1 tablet by mouth once daily for high blood pressure, and sertraline at 50mg, 1 tablet by mouth once daily for anxiety, both ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as "none". No other vaccines given the same day and none 4 weeks prior. No history of problems with vaccines in past. Prior Vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine was "none". No events following prior vaccinations. Family medical history relevant to the event was reported as "none". Patient reported an adverse event/side effect to the Covid vaccine, and was not sure if she should go ahead with the second dose or not. Patient received the vaccine on 16Jan2021 (reported as Saturday as of 18Jan2021) about 11am and at 5pm she started getting a warm feeling and changed to cooler clothing. Patient started itching and then broke out in hives on her face, arms, and chest. Patient used a cool cloth to face to cool off and sat under the fan. Her daughter got her some diphenhydramine hydrochloride (BENADRYL) within that 15minutes and about 20-30 minutes of taking the diphenhydramine hydrochloride it was calming down. Patient only took 1 diphenhydramine hydrochloride to help and that took care of it. This was the only occurrence. Her face was really swollen and red, she looked like she was sun burnt, skin was blotchy, but she didn't have any trouble with breathing or heart palpitations. The event onset date was 16Jan2021. The events did not require a visit to Emergency Room/ Physician Office. No relevant tests performed. Outcome of the events was resolving.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood grouping, Erythema, Fatigue, Feeling hot
Clinical narrative: headache; severe neck and shoulder pain; severe neck and shoulder pain; intense fatigue; arm was first very achy; shooting pain; redness; "hot" to touch; This is a spontaneous report from a contactable healthcare professional reporting for herself. A female patient of an unknown age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient reported that her blood type was O positive. The patient previously received the first dose of BNT162B2 on an unknown date. On an unknown date, the first day after receiving the second dose of vaccination, the patient experienced headache, severe neck and shoulder pain, and intense fatigue like jetlag x10. On an unknown date, the patient experienced her arm was first very achy, then shooting pain, burning pain, and the past two days, redness, and very "hot" to touch. There was no cellulitis and no sign of infection.  The patient was on day 4 and still experienced fatigue. The outcome of the other events headache, severe neck and shoulder pain, arm was achy, shooting pain, burning pain, redness, and "hot" to touch was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Pain, Pain in extremity
Clinical narrative: headache; severe neck and shoulder pain; severe neck and shoulder pain; intense fatigue; arm was first very achy; shooting pain; redness; "hot" to touch; This is a spontaneous report from a contactable healthcare professional reporting for herself. A female patient of an unknown age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient reported that her blood type was O positive. The patient previously received the first dose of BNT162B2 on an unknown date. On an unknown date, the first day after receiving the second dose of vaccination, the patient experienced headache, severe neck and shoulder pain, and intense fatigue like jetlag x10. On an unknown date, the patient experienced her arm was first very achy, then shooting pain, burning pain, and the past two days, redness, and very "hot" to touch. There was no cellulitis and no sign of infection.  The patient was on day 4 and still experienced fatigue. The outcome of the other events headache, severe neck and shoulder pain, arm was achy, shooting pain, burning pain, redness, and "hot" to touch was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Tremor
Clinical narrative: chills with shaking; chills with shaking; joint pain; muscle pain; fatigue; swelling at injection site; pain at injection site; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EA9899, via an unspecified route of administration on Arm Left from 19Jan2021 08:15 to 19Jan2021 08:15 as single dose for COVID-19 immunisation. The patient took first dose of the BNT162B2 vaccine on an unspecified date. Medical history included asthma, penicillin (PCN) allergy, environmental allergies, and major depression. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), and lamotrigine (LAMICTAL). On 19Jan2021 20:00, the patient experienced chills with shaking, joint pain, muscle pain, fatigue, swelling at injection site, and pain at injection site. The outcome of the events was recovering. Prior to vaccination and since the vaccination, was the patient was not diagnosed with COVID-19. No treatment was received for the events.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: chills with shaking; chills with shaking; joint pain; muscle pain; fatigue; swelling at injection site; pain at injection site; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EA9899, via an unspecified route of administration on Arm Left from 19Jan2021 08:15 to 19Jan2021 08:15 as single dose for COVID-19 immunisation. The patient took first dose of the BNT162B2 vaccine on an unspecified date. Medical history included asthma, penicillin (PCN) allergy, environmental allergies, and major depression. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), and lamotrigine (LAMICTAL). On 19Jan2021 20:00, the patient experienced chills with shaking, joint pain, muscle pain, fatigue, swelling at injection site, and pain at injection site. The outcome of the events was recovering. Prior to vaccination and since the vaccination, was the patient was not diagnosed with COVID-19. No treatment was received for the events.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: first injection caused arm and shoulder pain (in the arm that was injected) for about 2 days; first injection caused arm and shoulder pain (in the arm that was injected) for about 2 days; This is a spontaneous report from a contactable physician (patient himself). A male patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the arm on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has received both of the Pfizer Covid19 vaccine doses, 3 weeks apart. He stated the first injection caused arm and shoulder pain (in the arm that was injected) for about 2 days. The outcome of the events was recovered on unspecified date. The second injection did not cause any adverse events. He felt fine and does not wish to be further contacted.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Pain
Clinical narrative: soreness; fatigue; slight heaviness; This is a spontaneous report from a contactable other health professional. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in the left arm, on 13Jan2021 17:15 at SINGLE DOSE for COVID-19 immunization.  Medical history included Acid reflux. Patient received the first doe of BNT162B2 on 23Dec2021 for COVID-19 immunization There were no concomitant medications. On an unspecified date, the patient experienced soreness, fatigue and slight heaviness but still feel off today (16Jan2021). The outcome of events was recovering. Patient did not receive any treatment due to events.  Information about lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Left hand got red and itchy; Left hand got red and itchy; This is a spontaneous report from a contactable healthcare professional (patient). An 84-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3247), via an unspecified route of administration in the left arm on 20Jan2021 10:00 at a single dose for covid-19 immunization. Medical history included allergies Penicillin and allergies: sulphur IV dye. Concomitant medication included omeprazole (PRILOSEC), levothyroxine sodium (SYNTHROID) and amlodipine besylate. The patient previously took augmentin [amoxicillin;clavulanic acid] and Sulphur where patient experienced allergies. On 20Jan2021 21:30, the patient experienced left hand got red and itchy. The patient was not diagnosed with covid-19 prior vaccination and has not been tested for covid-19 since the vaccination. The patient did not receive treatment for the event. The outcome of the events was not recovered.
Age: 27.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Flushing, Pruritus
Clinical narrative: the patient felt itchy; flushed; This is a spontaneous report from a contactable pharmacist.  A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular in left arm on 10Jan2021 at single dose for COVID-19 immunization; and diphenhydramine hcl, via an unspecified route of administration from an unspecified date at unknown dose for premedication. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously had first dose of BNT162B2, lot number: EL0140, via intramuscular in left arm on 20Dec2020 at single dose for COVID-19 immunization and experienced itching. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was pre-medicated with diphenhydramine prior to the second dose of the COVID-19 vaccine. 9 minutes after the vaccination on 10Jan2021, the patient felt itchy and flushed then received oral dexamethasone as treatment for the events. The patient was sent out with oral dexamethasone home. The outcome of the events was recovering. The action taken in response to diphenhydramine hcl for the events was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Hypoaesthesia oral, Hypoaesthesia teeth, Pain in extremity
Clinical narrative: mild numbness of teeth and tongue; mild numbness of teeth and tongue; heaviness of head; I was very tired; arm pain lasted 2 days; This is a spontaneous report from a contactable Other HCP. This Other HCP reported himself that the  58-year-old male patient received second dose of bnt162b2 (COVID 19, Pfizer), via Intramuscular on 11Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. Medical history included history of mitral valve repair and pacemaker. Known allergies was not known. Concomitant medications included  Metoprolol 25 mg, Baby aspirin 81 mg, Antihistamine( Certizine hidrocloride 10mg,Costco brand). The patient previously took first dose of bnt162b2 (COVID 19, Pfizer), via Intramuscular on 21Dec2020 10:00 AM on Left arm at single dose for covid-19 immunisation. No other vaccine in four weeks. Side effect occurred after his 2nd dose (11Jan2021) he was feeling mild numbness of teeth and tongue heaviness of head after 30 minutes of vaccine. It lasted 5-6 hours, also he was very tired, and arm pain lasted 2 days. The events started from 11Jan2021 10:00 AM. The outcome of the events feeling mild numbness of teeth and tongue, heaviness of head was recovered on 11Jan2021. The outcome of the other event was recovered in Jan2021. No Covid prior vaccination. Covid tested post vaccination. covid test post vaccination included Rapid test on 09Jan2021 with covid test result: Negative.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: mild numbness of teeth and tongue; mild numbness of teeth and tongue; heaviness of head; I was very tired; arm pain lasted 2 days; This is a spontaneous report from a contactable Other HCP. This Other HCP reported himself that the  58-year-old male patient received second dose of bnt162b2 (COVID 19, Pfizer), via Intramuscular on 11Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. Medical history included history of mitral valve repair and pacemaker. Known allergies was not known. Concomitant medications included  Metoprolol 25 mg, Baby aspirin 81 mg, Antihistamine( Certizine hidrocloride 10mg,Costco brand). The patient previously took first dose of bnt162b2 (COVID 19, Pfizer), via Intramuscular on 21Dec2020 10:00 AM on Left arm at single dose for covid-19 immunisation. No other vaccine in four weeks. Side effect occurred after his 2nd dose (11Jan2021) he was feeling mild numbness of teeth and tongue heaviness of head after 30 minutes of vaccine. It lasted 5-6 hours, also he was very tired, and arm pain lasted 2 days. The events started from 11Jan2021 10:00 AM. The outcome of the events feeling mild numbness of teeth and tongue, heaviness of head was recovered on 11Jan2021. The outcome of the other event was recovered in Jan2021. No Covid prior vaccination. Covid tested post vaccination. covid test post vaccination included Rapid test on 09Jan2021 with covid test result: Negative.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (reported as 53; unit unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tired (reported as on the 1st shot) on an unspecified. The patient did not have did not have COVID prior to vaccination. The outcome of event was unknown.   No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Gastrooesophageal reflux disease, Headache, Myalgia
Clinical narrative: shaking chills; fever; severe headache; body aches (muscle / joint); body aches (muscle / joint); nausea; reflux; This is a spontaneous report from a contactable other hcp. A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) , via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shaking chills, severe headache, body aches (muscle / joint), fever, nausea, reflux on an unspecified date. The patient did not have did not have COVID prior to vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: shaking chills; fever; severe headache; body aches (muscle / joint); body aches (muscle / joint); nausea; reflux; This is a spontaneous report from a contactable other hcp. A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) , via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shaking chills, severe headache, body aches (muscle / joint), fever, nausea, reflux on an unspecified date. The patient did not have did not have COVID prior to vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: sluggish and wanting to sleep all day; Sneezing; stuffy head; Low grade fever; Chills; bad headache; arm hurts; The initial case was missing the following minimum criteria- No Adverse Effect. Upon receipt of follow-up information on 19Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided - "has not received information card "), via an unspecified route of administration on 17Jan2021 at single dose on the left arm for COVID-19 immunization (reported as "Why was the patient taking Covid-19 vaccine (Verbatim): works in a group home ").  Medical history included ongoing heart murmur since 2019. There were no concomitant medications. There were no investigation assessment. The patient experienced low-grade fever, chills and a bad headache on 17Jan2021. Patient was sluggish and wanting to sleep all day on 18Jan2021. Patient took Tylenol for a headache. It did not work so she took sumatriptan. The patient was also sneezing on 18Jan2021. Patient reported that she sweated the fever out. She had chills at night. The headache was lingering off and on but was mild. She sneezed all day on Monday (18Jan2021). She has not sneezed yet today but she has a stuffy head on 18Jan2021. Patient clarified that she took Acetaminophen Rapid Pain Relief instead of Tylenol. She took two 500mg tablets (UPC: 3225152303, Lot: 91670159AA, Expiry: Aug2022). Patient also reported that her arm hurts on 17Jan2021. She was unable to provide the Lot number. She will receive the information card after she receives the second dose. She had a picture of the card but it was not very clear. Outcome of the events arm hurts, headache, stuffy head  was recovering (also reported as ongoing), for chills, low grade fever was recovered on 18Jan2021, for sluggish and wanting to sleep all day was recovered on 19Jan2021 while for other event was unknown.  Information about batch/lot number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Sneezing, Upper respiratory tract congestion
Clinical narrative: sluggish and wanting to sleep all day; Sneezing; stuffy head; Low grade fever; Chills; bad headache; arm hurts; The initial case was missing the following minimum criteria- No Adverse Effect. Upon receipt of follow-up information on 19Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided - "has not received information card "), via an unspecified route of administration on 17Jan2021 at single dose on the left arm for COVID-19 immunization (reported as "Why was the patient taking Covid-19 vaccine (Verbatim): works in a group home ").  Medical history included ongoing heart murmur since 2019. There were no concomitant medications. There were no investigation assessment. The patient experienced low-grade fever, chills and a bad headache on 17Jan2021. Patient was sluggish and wanting to sleep all day on 18Jan2021. Patient took Tylenol for a headache. It did not work so she took sumatriptan. The patient was also sneezing on 18Jan2021. Patient reported that she sweated the fever out. She had chills at night. The headache was lingering off and on but was mild. She sneezed all day on Monday (18Jan2021). She has not sneezed yet today but she has a stuffy head on 18Jan2021. Patient clarified that she took Acetaminophen Rapid Pain Relief instead of Tylenol. She took two 500mg tablets (UPC: 3225152303, Lot: 91670159AA, Expiry: Aug2022). Patient also reported that her arm hurts on 17Jan2021. She was unable to provide the Lot number. She will receive the information card after she receives the second dose. She had a picture of the card but it was not very clear. Outcome of the events arm hurts, headache, stuffy head  was recovering (also reported as ongoing), for chills, low grade fever was recovered on 18Jan2021, for sluggish and wanting to sleep all day was recovered on 19Jan2021 while for other event was unknown.  Information about batch/lot number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature increased, Cough, Headache
Clinical narrative: Elevated temperature (almost 100); Feel weak and shaky; Feel weak and shaky; Coughing; Nasal congestion; Headache; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (Vaccine location: left arm) on 20Jan2021 11:45 for COVID-19 immunization. Facility where the recent COVID-19 vaccine was administered: Other-Drive thru vaccine POD. Medical history included Hashimoto's thyroiditis, allergies to penicillin, and sinus infection. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Other medication the patient received within 2 weeks of vaccination included doxycycline 'hydroxylate' for a sinus infection. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021 12:00, the patient had an elevated temperature (almost 100), felt weak and shaky, coughing and nasal congestion, and a headache. The events were considered as non-serious by the reporter. No treatment was received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events.  No follow-up attempts are possible; information about batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nervousness
Clinical narrative: Elevated temperature (almost 100); Feel weak and shaky; Feel weak and shaky; Coughing; Nasal congestion; Headache; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (Vaccine location: left arm) on 20Jan2021 11:45 for COVID-19 immunization. Facility where the recent COVID-19 vaccine was administered: Other-Drive thru vaccine POD. Medical history included Hashimoto's thyroiditis, allergies to penicillin, and sinus infection. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Other medication the patient received within 2 weeks of vaccination included doxycycline 'hydroxylate' for a sinus infection. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021 12:00, the patient had an elevated temperature (almost 100), felt weak and shaky, coughing and nasal congestion, and a headache. The events were considered as non-serious by the reporter. No treatment was received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events.  No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) from a contactable consumer reported (patient). This female patient of unspecified age received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunisation. Medical history was unknown. Concomitant medications were none. The patient got first covid19 vaccine on 28Dec2020. She tested positive for the covid virus on 29Dec2020. She was scheduled to get second vaccine today (18Jan2021) but she did not get it since she did not know if she should. She had been negative for the covid virus for one week. She was asking when she should get second dose. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on entire trunk of body; This is a spontaneous report from a contactable physician (reported for herself).  A 38-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL3302, expiry date not reported), via an unspecified route of administration on 19Jan2021 08:30 at a single dose in the left arm for COVID-19 immunization. Medical history included penicillin allergy (rash as a child). The patient was not pregnant at the time of the vaccination. Prior to vaccination, patient was not diagnosed with COVID-19.  The patient's concomitant medications were not reported. Patient had the first dose of BNT162B2 (Pfizer brand; lo EL1284) for COVID-19 immunization on 29Dec2020 08:30 AM, in the left arm. The patient did not receive any other medications within 2 weeks of vaccination and any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rash on entire trunk of body on 20Jan2021 20:00. No treatment received in response to the event. The event was reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event rash on entire trunk of body.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache; fever; chills; This is a spontaneous report from a contactable nurse reported for a consumer.  A 31-year-old female patient received second dose bnt162b2 (BNT162B2, reported as Pfizer COVID 19 vaccine, lot number unknown), intramuscular on 20Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient  previously received first dose BNT162B2 on 30Dec2020 for COVID-19 immunization (other vaccine 4 weeks prior Covid-19 vaccine).  The patient experienced headache, fever and chills, all on 20Jan2021. The patient did not received treatment for these events. These events did not result in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, was not congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient tested positive 6 days after the 1st dose; patient tested positive 6 days after the 1st dose; This is a spontaneous report from a Pfizer-sponsored Program, Pfizer. A contactable physician reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive 6 days after the 1st dose. The patient asked about the ingredients of COVID-19 Vaccine. The outcome of the event was unknown.  Information on the batch/lot number has been requested.; 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.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Lethargy
Clinical narrative: very weak and almost passed out on Wednesday; very weak and almost passed out on Wednesday; joint pain; body aches; chills; extreme fatigue; very lethargic; pain that ran down my arm up into neck; pain that ran down my arm up into neck; This is a spontaneous report from a contactable Nurse. A patient of unspecified age and gender(Age: 59, Unit: Unspecified) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 and experienced fatigue sore arm. After shot 2, the patient experienced joint pain, body aches, chills, extreme fatigue and very lethargic, pain that ran down my arm up into neck. The patient got shot on Monday, symptoms were on Tuesday, the patient was very weak and almost passed out on Wednesday. The patient did not have COVID 19 before and did not take paracetamol(TYLENOL). The outcome of the events was unknown.     Information on the Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Presyncope
Clinical narrative: very weak and almost passed out on Wednesday; very weak and almost passed out on Wednesday; joint pain; body aches; chills; extreme fatigue; very lethargic; pain that ran down my arm up into neck; pain that ran down my arm up into neck; This is a spontaneous report from a contactable Nurse. A patient of unspecified age and gender(Age: 59, Unit: Unspecified) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 and experienced fatigue sore arm. After shot 2, the patient experienced joint pain, body aches, chills, extreme fatigue and very lethargic, pain that ran down my arm up into neck. The patient got shot on Monday, symptoms were on Tuesday, the patient was very weak and almost passed out on Wednesday. The patient did not have COVID 19 before and did not take paracetamol(TYLENOL). The outcome of the events was unknown.     Information on the Lot/Batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Malaise, Nausea
Clinical narrative: not feeling well that day; The next morning I was tired because I didnt get good sleep the night before; severe chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283; expiration date: unknown), intramuscularly left deltoid on 12Jan2021 10:50 at a single dose for prevention (covid-19 immunization). Medical history included cystitis interstitial and headache. There were no concomitant medications. The patient didn't receive other vaccines in the last 4 weeks. The patient reported that she had her first dose on 12Jan2021 around 10am and she experienced severe chills where she could not get warm and nausea the night of 13Jan2021, about 10pm. It lasted approximately 8 hours. She probably had a temperature, but she was shaking so much, she did not check. She could not get warm. The next day, she was tired, and probably because she could not sleep the night before. The tiredness was back to normal on 14Jan2021 at 8pm. She was awake the whole night until 8am. The chills stopped and she was very, very tired. Around 8pm on 14Jan2021, she felt like her normal self and it was amazing. She was not feeling well that day (unspecified date). She is due for her second dose on 02Feb2021. She added that she had severe chill ("couldn't get warm") and nausea then the next morning, she was tired because she didn't get good sleep the night before and then felt like herself the following day. The nausea stopped 8 hours afterwards. The tiredness was back to normal on 14Jan2021 at 8pm. She mentioned that she was treated for interstitial cystitis before she took the vaccine. She began to experience a headache prior to receiving the vaccination and called the hotline to see if it was COVID. They did not want to test her since she did not have any other symptoms. She got tested for COVID on 18Jan2021, and it came back negative. She inquired if she can take 25mg of diphenhydramine (BENADRYL) and acetaminophen (TYLENOL) prior to her receiving her second dose to prevent side effects. Treatment was received by the patient. The outcome of the event feeling unwell was unknown while the outcome of the other events was recovered on 14Jan2021 20:00.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: not feeling well that day; The next morning I was tired because I didnt get good sleep the night before; severe chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283; expiration date: unknown), intramuscularly left deltoid on 12Jan2021 10:50 at a single dose for prevention (covid-19 immunization). Medical history included cystitis interstitial and headache. There were no concomitant medications. The patient didn't receive other vaccines in the last 4 weeks. The patient reported that she had her first dose on 12Jan2021 around 10am and she experienced severe chills where she could not get warm and nausea the night of 13Jan2021, about 10pm. It lasted approximately 8 hours. She probably had a temperature, but she was shaking so much, she did not check. She could not get warm. The next day, she was tired, and probably because she could not sleep the night before. The tiredness was back to normal on 14Jan2021 at 8pm. She was awake the whole night until 8am. The chills stopped and she was very, very tired. Around 8pm on 14Jan2021, she felt like her normal self and it was amazing. She was not feeling well that day (unspecified date). She is due for her second dose on 02Feb2021. She added that she had severe chill ("couldn't get warm") and nausea then the next morning, she was tired because she didn't get good sleep the night before and then felt like herself the following day. The nausea stopped 8 hours afterwards. The tiredness was back to normal on 14Jan2021 at 8pm. She mentioned that she was treated for interstitial cystitis before she took the vaccine. She began to experience a headache prior to receiving the vaccination and called the hotline to see if it was COVID. They did not want to test her since she did not have any other symptoms. She got tested for COVID on 18Jan2021, and it came back negative. She inquired if she can take 25mg of diphenhydramine (BENADRYL) and acetaminophen (TYLENOL) prior to her receiving her second dose to prevent side effects. Treatment was received by the patient. The outcome of the event feeling unwell was unknown while the outcome of the other events was recovered on 14Jan2021 20:00.
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: Bronchitis; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Asking if it's safe to take the second dose even if he was advised to take steroids due to his bronchitis. As per the caller he was scheduled 27Jan2021 for his second dose. The outcome pf event was unknown.   Information about lot and batch number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Really bad headache; Muscle pain; Joint pain; Fatigue; Swollen glands; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 18Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient said she received the first dose of Covid-19 vaccine yesterday 18th of January 2021. She stated she was experiencing a really bad headache, muscle pain, joint pain, extreme fatigue and swollen glands the night of 18Jan2021 after she took the first dose of Covid-19 vaccine. She was asking how long this effect lasts. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Sore arm; shaking chills; This is a spontaneous report from a non-contactable consumer.  A 38-year-old female patient (not pregnant) received her second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot/batch number and expiry date not reoorted), via an unspecified route of administration on 19Jan2021 12:00 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She received her first dose of bnt162b2 on 29Dec2020 12:00. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with Covid-19 prior to vaccination. The patient experienced sore arm and shaking chills (reported as non-serious) on 20Jan2021. No treatment was given. The outcome of events was recovered.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Neck pain
Clinical narrative: Slight fever/ her temperature usually runs 97 and currently is 99.4; joint pain because her hips hurt/ her hips were really sore; Chills; Arm pain; Headache/ pain at the base of the head/ pain in her head; Neck pain; Shoulder pain; pain everywhere; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ16R6), intramuscular in the left arm on 17Jan2021 09:30 at single dose for COVID-19 prophylaxis.  The patient medical history was not reported.  There were no concomitant medications. The historical vaccine included the first dose of BNT162B2 on 26Dec2020 at her 60-year-old for COVID-19 prophylaxis. The patient was a physical therapist (non- Healthcare Professional), she received the second dose and was having almost every side effects. She experienced arm pain started night around 17Jan2021 17:00; headache, pain at the base of the head, neck pain, shoulder pain, pain everywhere on 17Jan2021; chills that she couldn't get rid of on 17Jan2021 19:00; slight fever, and overall feeling tough, joint pain because her hips hurt on 18Jan2021. At 17:00-19:00 on 17Jan2021 and stated that she could not tolerate her head being upright. She stated that she went to bed at 19:00. Pain in her head, neck, and shoulders is a little better because she can actually sit up now and hold her head up. She said that her temperature usually ran 97 and currently was 99.4. She said that she did not take her temperature on 17Jan2021 and did not get up until 13:00 and stated that she took it when she got up on18Jan2021. She noticed joint pain when she got up on 18Jan2021, her hips were really sore. Chills started at night, when she went to bed she had the chills around 19:00 17Jan2021. The outcome of pain in her head, neck, and shoulders was recovering, of the other events was not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Slight fever/ her temperature usually runs 97 and currently is 99.4; joint pain because her hips hurt/ her hips were really sore; Chills; Arm pain; Headache/ pain at the base of the head/ pain in her head; Neck pain; Shoulder pain; pain everywhere; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ16R6), intramuscular in the left arm on 17Jan2021 09:30 at single dose for COVID-19 prophylaxis.  The patient medical history was not reported.  There were no concomitant medications. The historical vaccine included the first dose of BNT162B2 on 26Dec2020 at her 60-year-old for COVID-19 prophylaxis. The patient was a physical therapist (non- Healthcare Professional), she received the second dose and was having almost every side effects. She experienced arm pain started night around 17Jan2021 17:00; headache, pain at the base of the head, neck pain, shoulder pain, pain everywhere on 17Jan2021; chills that she couldn't get rid of on 17Jan2021 19:00; slight fever, and overall feeling tough, joint pain because her hips hurt on 18Jan2021. At 17:00-19:00 on 17Jan2021 and stated that she could not tolerate her head being upright. She stated that she went to bed at 19:00. Pain in her head, neck, and shoulders is a little better because she can actually sit up now and hold her head up. She said that her temperature usually ran 97 and currently was 99.4. She said that she did not take her temperature on 17Jan2021 and did not get up until 13:00 and stated that she took it when she got up on18Jan2021. She noticed joint pain when she got up on 18Jan2021, her hips were really sore. Chills started at night, when she went to bed she had the chills around 19:00 17Jan2021. The outcome of pain in her head, neck, and shoulders was recovering, of the other events was not recovered.