chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Headache, Malaise
Clinical narrative: severe chills; fever; all over body aches; shooting pain in joints and back of head; headache/shooting pain in back of head; shortness of breath; general malaise; This is a spontaneous report from a contactable consumer (patient). This 34-year-old female patient (non pregnant) received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: Ew0153) on 09Apr2021at 10:30 via an unspecified route of administration in the left arm as DOSE 2, SINGLE for COVID-19 immunisation (age at vaccination:34-years-old). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient did not have Covid prior vaccination neither covid tested post vaccination. The patient's other medical history included: OCD, and complex PTSD. Patient reported known allergy to Nickel. Patient took Celexa and lorazepam within 2 weeks of vaccination. Previously the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: En6207) on 19Mar2021at 10:15 via an unspecified route of administration in the left arm as DOSE 1, SINGLE for COVID-19 immunisation. Patient did not have any past drug history.On 09Apr2021, at 22:00 the patient experienced severe chills, fever, all over body aches, shooting pain in joints and back of head, headache, shortness of breath, and general malaise. Patient did not receive any treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: severe chills; fever; all over body aches; shooting pain in joints and back of head; headache/shooting pain in back of head; shortness of breath; general malaise; This is a spontaneous report from a contactable consumer (patient). This 34-year-old female patient (non pregnant) received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: Ew0153) on 09Apr2021at 10:30 via an unspecified route of administration in the left arm as DOSE 2, SINGLE for COVID-19 immunisation (age at vaccination:34-years-old). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient did not have Covid prior vaccination neither covid tested post vaccination. The patient's other medical history included: OCD, and complex PTSD. Patient reported known allergy to Nickel. Patient took Celexa and lorazepam within 2 weeks of vaccination. Previously the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: En6207) on 19Mar2021at 10:15 via an unspecified route of administration in the left arm as DOSE 1, SINGLE for COVID-19 immunisation. Patient did not have any past drug history.On 09Apr2021, at 22:00 the patient experienced severe chills, fever, all over body aches, shooting pain in joints and back of head, headache, shortness of breath, and general malaise. Patient did not receive any treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis, Rash macular, Rash pruritic, Skin discolouration, Urticaria
Clinical narrative: 2 days after the 1st shot upper body, arms, and thighs developed itchy rashes/hives.; A number of tiny blood red dots on skin; 2 days after the 1st shot upper body, arms, and thighs developed itchy rashes/hives.; skin inflammation; The rashes slowly faded, but left a few dark color skin marks; This is a spontaneous report from a contactable consumer, the patient. This is first of two reports. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Feb2021 at 10:30 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Patient had no medical history and had no known allergy to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 19Feb2021 at 12:00, 2 days after the 1st shot, the patient experienced upper body, arms, and thighs developed itchy rashes/hives and a number of tiny blood red dots on the patient's skin. The rashes slowly faded, but left a few dark color skin marks. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with antihistamine Allegra D, but it wasn't effective and 10 days later he saw his doctor and was prescribed triamcinolone acetonide cream, which helped to calm the patient's skin inflammation. The clinical outcome of the events upper body, arms, and thighs developed itchy rashes/hives and a number of tiny blood red dots on the patient's skin was recovered with sequelae on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Inappropriate schedule of product administration, Pain
Clinical narrative: 3/19 (2nd first shot) - chills and feverup to 102.4 before taking tylenol -fever gone w/in 24 hours - body achescontinued for another 24 hrs (backpain); 3/19 (2nd first shot) - chills and feverup to 102.4 before taking tylenol -fever gone w/in 24 hours - body achescontinued for another 24 hrs (backpain); 3/19 (2nd first shot) - chills and feverup to 102.4 before taking tylenol -fever gone w/in 24 hours - body achescontinued for another 24 hrs (backpain); Back pain; none after first shot on 12Mar" (refrigeration issue - had to have first shot again on 19Mar; none after first shot on 12Mar" (refrigeration issue - had to have first shot again on 19Mar; none after first shot on 12Mar" (refrigeration issue - had to have first shot again on 19Mar; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 09:30 (at the age of 55-year-old and non-pregnant at the time of vaccination) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included pre-diabetic and high blood pressure. The patient had no known allergies. Concomitant medications included losartan and metformin. It was reported that the patient had received other vaccines within four weeks prior to the vaccination. The patient also received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6205) via an unspecified route of administration in the left arm on 12Mar2021 (at the age of 55-year-old and non-pregnant at the time of vaccination) as DOSE 1, SINGLE for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported by the patient that "none after first shot on 12Mar" (refrigeration issue - had to have first shot again on 19Mar). On 19Mar2021 (after second shot), the patient experienced chills and fever up to 102.4 before taking TYLENOL. The event fever gone within 24 hours body aches continued for another 24 hours (back pain). Therapeutic measures were taken as a result of the events and included treatment with TYLENOL. The outcome of the event fever up to 102.4 was recovered in 2021, however the chills, body aches and back pain was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue, Pyrexia
Clinical narrative: 3/19 (2nd first shot) - chills and feverup to 102.4 before taking tylenol -fever gone w/in 24 hours - body achescontinued for another 24 hrs (backpain); 3/19 (2nd first shot) - chills and feverup to 102.4 before taking tylenol -fever gone w/in 24 hours - body achescontinued for another 24 hrs (backpain); 3/19 (2nd first shot) - chills and feverup to 102.4 before taking tylenol -fever gone w/in 24 hours - body achescontinued for another 24 hrs (backpain); Back pain; none after first shot on 12Mar" (refrigeration issue - had to have first shot again on 19Mar; none after first shot on 12Mar" (refrigeration issue - had to have first shot again on 19Mar; none after first shot on 12Mar" (refrigeration issue - had to have first shot again on 19Mar; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 09:30 (at the age of 55-year-old and non-pregnant at the time of vaccination) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included pre-diabetic and high blood pressure. The patient had no known allergies. Concomitant medications included losartan and metformin. It was reported that the patient had received other vaccines within four weeks prior to the vaccination. The patient also received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6205) via an unspecified route of administration in the left arm on 12Mar2021 (at the age of 55-year-old and non-pregnant at the time of vaccination) as DOSE 1, SINGLE for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported by the patient that "none after first shot on 12Mar" (refrigeration issue - had to have first shot again on 19Mar). On 19Mar2021 (after second shot), the patient experienced chills and fever up to 102.4 before taking TYLENOL. The event fever gone within 24 hours body aches continued for another 24 hours (back pain). Therapeutic measures were taken as a result of the events and included treatment with TYLENOL. The outcome of the event fever up to 102.4 was recovered in 2021, however the chills, body aches and back pain was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Approximately 8 hours after receiving the first dose, my torso, arms, neck, and face began to itch; My hands were swollen; This is a spontaneous report from a non-contactable consumer (patient). A 38-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number: Not reported), via an unspecified route of administration, administered in Arm Left on 20Mar2021 09:00 (at the age of 38 years-old) as single dose for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: Sulfur of all types in medications, foods, health and beauty products, etc, food allergy from an unknown date and unknown if ongoing. Concomitant medication(s) included calcium, vitamin d, flonase, Zyrtec taken for an unspecified indication, start and stop date were not reported. On 20Mar2021, the patient experienced approximately 8 hours after receiving the first dose, my torso, arms, neck, and face began to itch, my hands were swollen. Therapeutic measures were taken as a result of approximately 8 hours after receiving the first dose, my torso, arms, neck, and face began to itch, my hands were swollen included treatment with benadryl. The clinical outcome of the events my torso, arms, neck, and face began to itch, My hands were swollen was recovered/resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Feeling abnormal
Clinical narrative: still tired; 2nd shot: fri woke in horrible pain all joints and muscles; 2nd shot: fri woke in horrible pain all joints and muscles; Barley walk; chills; beginning of fever; brain fog; This is a spontaneous report from a contactable consumer (patient). A 48-year-old-female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP6955 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 01Apr2021 at 04:30 PM (age at vaccination: 48 years), as dose 2, single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included tachycardia, iron deficiency anemia, and known allergies: Omitted. Concomitant medications included motropolol, acetylsalicylic acid (BABY ASPRIN), curcuma longa (TURMERIC), magnesium, and vita. Past drug included amoxicillin and had known allergies: amoxicillin. Historical vaccine included first dose of BNT162B2 (PFIZ-ER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 11Mar2021 at 01:30 PM, as dose 1, single dose for COVID-19 immunization at hospital and had breast pain right breast for days. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 02Apr2021, the patient had 2nd shot: fri woke in horrible pain all joints and muscles. Barley walk. By 2:30, chills and beginning of fever. By 5pm, she had 105.5 fever while on Motrin. Fever bt 102.8 and 103.8 through the night while alternating tylonal and Motrin every 3 hours. Saturday no fever, brain fog, exhaustion. Sunday still tired and muscle weakness. Monday still not feeling really gut- no energy. Now it was Friday, day 8 and still feel off with throat/ breath. She could breathe deeply, but slight cough and tightness at base of throat. The patient did not receive any treatment for the events. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Myalgia, Pyrexia
Clinical narrative: still tired; 2nd shot: fri woke in horrible pain all joints and muscles; 2nd shot: fri woke in horrible pain all joints and muscles; Barley walk; chills; beginning of fever; brain fog; This is a spontaneous report from a contactable consumer (patient). A 48-year-old-female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP6955 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 01Apr2021 at 04:30 PM (age at vaccination: 48 years), as dose 2, single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included tachycardia, iron deficiency anemia, and known allergies: Omitted. Concomitant medications included motropolol, acetylsalicylic acid (BABY ASPRIN), curcuma longa (TURMERIC), magnesium, and vita. Past drug included amoxicillin and had known allergies: amoxicillin. Historical vaccine included first dose of BNT162B2 (PFIZ-ER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 11Mar2021 at 01:30 PM, as dose 1, single dose for COVID-19 immunization at hospital and had breast pain right breast for days. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 02Apr2021, the patient had 2nd shot: fri woke in horrible pain all joints and muscles. Barley walk. By 2:30, chills and beginning of fever. By 5pm, she had 105.5 fever while on Motrin. Fever bt 102.8 and 103.8 through the night while alternating tylonal and Motrin every 3 hours. Saturday no fever, brain fog, exhaustion. Sunday still tired and muscle weakness. Monday still not feeling really gut- no energy. Now it was Friday, day 8 and still feel off with throat/ breath. She could breathe deeply, but slight cough and tightness at base of throat. The patient did not receive any treatment for the events. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Back pain, Chills, Fatigue
Clinical narrative: loss of smell and taste; loss of smell and taste; fatigue; body aches; chills; headache; backache; This is a spontaneous report from a contactable consumer (patient) forwarded as an Adverse Event by the team on 09Apr2021. A patient of unspecified age and gender received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on 27Mar2021 as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included non-small cell lung cancer. Concomitant medications included keytruda taken for non-small cell lung cancer on an unspecified date. Previously patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date for covid-19 immunisation. The patient experienced chills, headache and backache on 28Mar2021, fatigue and body aches on 29Mar2021, loss of smell and taste on 30Mar2021. The clinical course reported as follows, it was reported that patient received the Pfizer second vaccine on 27Mar2021. The next day experienced chills and a headache and backache. Two days later fatigue and body aches. The third day loss of smell and taste. All days afebrile. Negative Covid testing as well. Taste and smell are not back over 9 days. Patient was on Keytruda for non-small cell lung cancer every six weeks. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unspecified date. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, SARS-CoV-2 test
Clinical narrative: loss of smell and taste; loss of smell and taste; fatigue; body aches; chills; headache; backache; This is a spontaneous report from a contactable consumer (patient) forwarded as an Adverse Event by the team on 09Apr2021. A patient of unspecified age and gender received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on 27Mar2021 as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included non-small cell lung cancer. Concomitant medications included keytruda taken for non-small cell lung cancer on an unspecified date. Previously patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date for covid-19 immunisation. The patient experienced chills, headache and backache on 28Mar2021, fatigue and body aches on 29Mar2021, loss of smell and taste on 30Mar2021. The clinical course reported as follows, it was reported that patient received the Pfizer second vaccine on 27Mar2021. The next day experienced chills and a headache and backache. Two days later fatigue and body aches. The third day loss of smell and taste. All days afebrile. Negative Covid testing as well. Taste and smell are not back over 9 days. Patient was on Keytruda for non-small cell lung cancer every six weeks. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unspecified date. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in joints; This is a spontaneous report from a contactable consumer, the patient. This is the first of two reports. A 76-year-old male patient received the first dose of BNT162b2 (Pfizer BioNTech Covid-19 mrna vaccine; Lot number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 13:00 (at the age of vaccination 76-year-old) as a dose 1, single for COVID-19 immunisation. Medical history included Crohn's disease, acid reflux, sluggish artery, and heart disease-stent. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had taken other medications (unspecified) within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took atorvastatin on an unknown date for unknown indication and experienced drug allergy. Since the vaccination, the patient had not been tested for COVID-19. On 27Feb2021 at 11:00, the patient experienced pain in joints that were normal. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of pain in joints which included treatment with meloxicam (MOBIC). The clinical outcome of the event pain in joints was unknown at the time of this report.  No follow-up attempts are needed. No further information was expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Ultrasound scan
Clinical narrative: My throat swelled up like a balloon; This is a spontaneous report from a contactable consumer (patient) and other HCP. A 73-year-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in the left arm on an unspecified date (at the age of 73 years old) as dose 2, single for COVID-19 immunisation at hospital. Patient was not pregnant at the of vaccination. Medical history included cardiac and kidney issues, Known allergies: Yes. Patient previously took bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in the left arm on an unspecified date (at the age of 73 years old) as dose 1, single for COVID-19 immunisation and experienced sore arm, swelling at shot site. Other medications were given within 2 weeks. No other vaccines were given within 4 weeks. On 01Apr2021 12:00, the patient experienced my throat swelled up like a balloon. The patient underwent lab tests and procedures which included ultrasound scan as doctor ordered ultrasound to be sure it was nothing else. Therapeutic measures were taken as a result of my throat swelled up like a balloon and included with treatment 2 different ultrasounds to check thyroid and gland. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. AE resulted to doctor or other healthcare professional office/clinic visit. The clinical outcome of the event was reported as recovering.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath while climbing stairs; This is a spontaneous report from a contactable consumer (patient's mother).  A 28-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) via an unspecified route of administration on 12Apr2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced shortness of breath while climbing stairs. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Illness, Oropharyngeal pain
Clinical narrative: She said she's generally ill; sore throat; tiredness as well as joint pain after getting the vaccine; tiredness as well as joint pain after getting the vaccine; This is a spontaneous report from contactable consumer (patient) via a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration on 28Mar2021 as dose 1, single for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient would like to know how long a vaccine recipient could be experiencing side effects. She said she was generally ill. She received the first dose on 28Mar2021, and she had been experiencing sore throat, tiredness as well as joint pain after getting the vaccine. The outcome of events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Hypoaesthesia, Palpitations
Clinical narrative: Headache; A few heart palpitations- this was sporadic and did not last long; numbness of left side and marked numbness of left thumb and up left forearm; Strong skin tingling all over body; Knee joints  felt like they were on fire; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6204) via an unspecified route of administration in the left arm on 18Mar2021 at 13:00 (at the age of 51-years-old and non-pregnant at the time of vaccination) as a DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications included estradiol and lisinopril. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 18Mar2021, the patient reported that she experienced a headache which started immediately after the first shot. In Mar2021, the patient experienced strong skin tingling all over the body, no fever, her knee joints felt like they were on fire, fatigue, headache, a few heart palpitations that were sporadic and did not last long, numbness of left side and marked numbness of left thumb and up left forearm. The patient reported that all the symptoms were mostly gone within 3 days. The patient did not receive any treatment for the events. The outcome of the events was resolved in Mar2021.  No follow-up attempts are needed. No further information was expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Headache; A few heart palpitations- this was sporadic and did not last long; numbness of left side and marked numbness of left thumb and up left forearm; Strong skin tingling all over body; Knee joints  felt like they were on fire; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6204) via an unspecified route of administration in the left arm on 18Mar2021 at 13:00 (at the age of 51-years-old and non-pregnant at the time of vaccination) as a DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications included estradiol and lisinopril. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 18Mar2021, the patient reported that she experienced a headache which started immediately after the first shot. In Mar2021, the patient experienced strong skin tingling all over the body, no fever, her knee joints felt like they were on fire, fatigue, headache, a few heart palpitations that were sporadic and did not last long, numbness of left side and marked numbness of left thumb and up left forearm. The patient reported that all the symptoms were mostly gone within 3 days. The patient did not receive any treatment for the events. The outcome of the events was resolved in Mar2021.  No follow-up attempts are needed. No further information was expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lymphadenopathy, Palpitations, Paraesthesia, Vaccination site mass
Clinical narrative: shortness of breath; Redness at injection site; Large knot at injection site; Tingle down to my finger tips on arm with injection; Swollen lymph glands in the armpit of arm with injection; Heart palpitations; This is a spontaneous report received from a contactable consumer (Patient).   A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EW0158) via an unspecified route of administration, administered in left arm on 08Apr2021 11:00 (at the age of 42-year-old) as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included diabetes, high blood pressure from an unspecified date and unknown if ongoing. Patient received concomitant medications within 2 weeks of vaccination. Patient had no known allergies to medications, food, or other products. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: ER2613) via an unspecified route of administration, administered in Left arm on 19Mar2021 11:00 (at the age of 42-year-old) as dose 1, single for COVID-19 immunization. It was reported that on 09Apr2021 14:00 patient experienced Redness at injection site, large knot at injection site, Tingle down to my fingertips on arm with injection, Swollen lymph glands in the armpit of arm with injection, Heart palpitations and shortness of breath. Events were not serious. Patient did not receive treatment for the adverse event. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: shortness of breath; Redness at injection site; Large knot at injection site; Tingle down to my finger tips on arm with injection; Swollen lymph glands in the armpit of arm with injection; Heart palpitations; This is a spontaneous report received from a contactable consumer (Patient).   A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EW0158) via an unspecified route of administration, administered in left arm on 08Apr2021 11:00 (at the age of 42-year-old) as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included diabetes, high blood pressure from an unspecified date and unknown if ongoing. Patient received concomitant medications within 2 weeks of vaccination. Patient had no known allergies to medications, food, or other products. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: ER2613) via an unspecified route of administration, administered in Left arm on 19Mar2021 11:00 (at the age of 42-year-old) as dose 1, single for COVID-19 immunization. It was reported that on 09Apr2021 14:00 patient experienced Redness at injection site, large knot at injection site, Tingle down to my fingertips on arm with injection, Swollen lymph glands in the armpit of arm with injection, Heart palpitations and shortness of breath. Events were not serious. Patient did not receive treatment for the adverse event. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Joint range of motion decreased, Pyrexia, Vaccination site pain
Clinical narrative: tiredness; Limited range of motion of arm without pain; Pain at injection site; fever of 99.4 usually 97.5; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 09Apr2021 at 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, asthma, osteoarthritis, blood pressure high and COVID-19 from an unknown date and unknown if ongoing. The patient previously had wheat and sulfa and experienced allergy. Concomitant medications included Fluticasone Propionate/Salmeterol and salbutamol sulfate (ALBUTEROL SULFA), both from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 11Mar2021 at 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation and experienced severe headache, pain at injection site, limited range of motion of arm without pain. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 17:00, the patient experienced fever of 99.4 (units unspecified) usually 97.5 (units unspecified), pain at injection site, limited range of motion of arm without pain, tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of fever of 99.4 (units unspecified) usually 97.5 (units unspecified), pain at injection site, limited range of motion of arm without pain, tiredness and included treatment with acetaminophen, Biofreeze spray. The patient underwent lab tests and procedures which included body temperature 99.4 (units unspecified) on 09Apr2021. The clinical outcome of the events fever of 99.4 (units unspecified) usually 97.5 (units unspecified), pain at injection site, limited range of motion of arm without pain, tiredness was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Mass, Pruritus, Vaccination site urticaria
Clinical narrative: Large hive/welt the size of a fist over the vaccine site in my left arm for 2+weeks; Hot; Itchy; Had large lump underneath; This is a spontaneous report from a contactable consumer(patient) or other non hcp. A 44-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 16Mar2021 13:00 as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included hypertension, drug hypersensitivity for Sulfa. Concomitant medication(s) included losartan (LOSARTAN) and zolpidem (ZOLPIDEM). The patient previously took keflex [cefalexin monohydrate] and experienced drug hypersensitivity.The patient experienced large hive/welt the size of a fist over the vaccine site in his left arm for 2 plus weeks, hot, itchy and had large lump underneath on Apr2021. The events outcome was reported as not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; chills; extreme body aches; This is a spontaneous report from a contactable nurse. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 18Mar2021 at 14:30 as a single dose for COVID-19 immunisation. Medical history included diabetes, hypothyroidism, mild asthma, extreme sensitivity to medications which was being monitored by an immunologist, COVID-19 and the patient had penicillin allergy from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (UNITHROID), insulin degludec (TRESIBA), metformin (MANUFACTURER UNKNOWN) and deflazacort (PRANDIN), all taken for unspecified indications from unknown dates. The patient previously took vancomycin, augmentin, bactrim, keflex and macrodantin and experienced drug allergy with all of these. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021, the day after the shot, the patient experienced fever, chills and extreme body aches for 24 to 48 hours. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 12Apr2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. The clinical outcome of the events fever, chills and extreme body aches were resolved on 21Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: fever; chills; tired; achy body& muscles; headache; This is a spontaneous report from a non-contactable consumer. This consumer reported for herself that,  A 49-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: ER8729), dose 2 via an unspecified route of administration, administered in arm left on 08Apr2021 16:45 as dose 2, single for covid-19 immunisation (age at the vaccination 49 years old). Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot: ER2613), dose 1 via an unspecified route of administration, administered in arm left on 18Mar2021 17:00 as dose 1, single for covid-19 immunisation, the patient experienced tired. Medical history included asthma, post-traumatic stress disorder and fibromyalgia from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. She also had known allergies to Sulfa, Vicodin and Dilaudid. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for an unspecified indication, start and stop date were not reported; formoterol fumarate, mometasone furoate (DULERA) taken for an unspecified indication, start and stop date were not reported. The patient previously took vicodin and experienced drug hypersensitivity, dilaudid and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation and experienced fatigue. It was reported that, after the second shot on 08Apr2021 following morning on 09Apr2021 04:00 patient experienced fever of 104.1 F, chills, tired, achy body & muscles and headache. She did not receive any treatment for the events. Lab data included, on 09Apr2021 patient experienced fever of 104.1 F. Patient did not take any other vaccine in four weeks. She did not have covid prior to vaccination. She was not tested for covid post vaccination. The outcome for the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; chills; tired; achy body& muscles; headache; This is a spontaneous report from a non-contactable consumer. This consumer reported for herself that,  A 49-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: ER8729), dose 2 via an unspecified route of administration, administered in arm left on 08Apr2021 16:45 as dose 2, single for covid-19 immunisation (age at the vaccination 49 years old). Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot: ER2613), dose 1 via an unspecified route of administration, administered in arm left on 18Mar2021 17:00 as dose 1, single for covid-19 immunisation, the patient experienced tired. Medical history included asthma, post-traumatic stress disorder and fibromyalgia from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. She also had known allergies to Sulfa, Vicodin and Dilaudid. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for an unspecified indication, start and stop date were not reported; formoterol fumarate, mometasone furoate (DULERA) taken for an unspecified indication, start and stop date were not reported. The patient previously took vicodin and experienced drug hypersensitivity, dilaudid and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation and experienced fatigue. It was reported that, after the second shot on 08Apr2021 following morning on 09Apr2021 04:00 patient experienced fever of 104.1 F, chills, tired, achy body & muscles and headache. She did not receive any treatment for the events. Lab data included, on 09Apr2021 patient experienced fever of 104.1 F. Patient did not take any other vaccine in four weeks. She did not have covid prior to vaccination. She was not tested for covid post vaccination. The outcome for the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: 5 days after 1st dose started to itch on torso - started to abate till got the 2nd shot- am still having itching issues; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 80-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9809, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 25Feb2021 at 13:45 pm (age at vaccination was 80 years) as dose 1, single for COVID-19 immunization. The patient's medical history included known allergies to sulfa and penicillin. The patient received concomitant medications or other medications within 2 weeks of vaccination. The patient previously took macrobid [nitrofurantoin] and experienced allergy. The facility where the most recent COVID-19 vaccine was administered was 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. On 02Mar2021, 5 days after 1st dose, the patient started to itch on torso. It started to abate till got the 2nd shot. The patient was still having itching issues. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment with topical creams. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6208, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 25Mar2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The case was assessed as non-serious. The outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hypersomnia, Pyrexia
Clinical narrative: chills; low grade fever; sleeping; He was tired; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date after 2 weeks of vaccination patient experienced sleeping on his, chills, low grade fever, tired. Patient had side effects were within the first 3 days which was normal. Patient had low grade fever and chills for 5 days. The outcome of the events was unknown.  No Follow-up attempts are possible. Information about lot/batch number cannot be Obtained.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Severe joint and muscle pain; Severe joint and muscle pain; tiredness; headache; This is a spontaneous report from a contactable consumer (patient) and other HCP. A 71-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FN6200), via an unspecified route of administration, administered in arm left on 28Feb2021 at 09:30 AM (at the age of 71-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included diabetes, hx breast cancer, arthritis and allergy to xray contrast ionic and non-ionic. The patient received concomitant medication in two weeks which included metformin taken for an unspecified indication, start and stop date were not reported. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6199), via an unspecified route of administration, administered in arm left on 06Mar2021 as dose 2, single for COVID-19 immunization. The patient previously took valium, rocephin and experienced drug allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID prior vaccination. No COVID tested post vaccination. On 05Mar2021, the patient experienced severe joint and muscle pain, tiredness, daily headache about 1 week after 1st injection and continued past 2nd injection up until 12Apr. No treatment was received in response to the adverse events. The outcome of all the events was recovering.  No follow-up attempts are possible. No further information is expected.