chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram, Dyspnoea, Electrocardiogram, Electrocardiogram abnormal
Clinical narrative: EKG which showed some abnormal activity; resting heart rate rose to 113, and remained between 110-113 for 48 hours/her resting heart rate was elevated around 110-115; she felt slightly short of breath; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140 and expiration date Mar2021), intramuscular (top of her right arm) first dose on 29Dec2020 11:00 at single dose for Covid-19 immunization.  The patient's medical history included ongoing allergic to contrast dye, allergic to dust, and covid from Apr2020.  There were no concomitant medications.  The patient had the first dose of the Pfizer covid vaccine and she had an uncommon reaction. She received the first dose of the covid vaccine on 29Dec2020 around 11am. 24 hours after receiving the vaccine on 30Dec2020 around 11am she felt slightly short of breath and her resting heart rate was rose to 113, and remained between 110-113, elevated around 110-115. Her heart rate stayed elevated for about 2 hours. She called her doctor and she was instructed to go to urgent care where they did an EKG which showed some abnormal activity. Reports she has no history of cardiac issues in the past. The doctor at urgent care recommended for her to be transported by ambulance to emergency room to rule out a pulmonary embolism. Her heart rate remained elevated and while she was in the ER she had an EKG, lab test, chest x-ray, and nuclear cat scan since she is allergic to iv contrast dye. Her cardiac enzymes were negative. She did not have a pulmonary embolism. Her d-dimer was 1,131. She confirms she was not admitted. She has an apple watch and was told to monitor her heart rate. She was instructed to call # if she experienced shortness of breath.  The patient heart rate remained elevated for the next 48 hours and she did not start to feel normal and recovered completely around noon on 01Jan2021. She just had a follow up with her primary doctor. She asked if she should get the second dose of the vaccine. Her doctor consulted with the allergist and stated she should call Pfizer to ask if she should receive the second dose.  Vaccination Facility Type was Nursing home where she works. No additional vaccines administered. No prior vaccinations within 4 weeks.  The outcome of the events heart rate increased and dyspnoea was recovered on 01Jan2021 and unknown for the remaining event.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Investigation, Myocardial necrosis marker, X-ray
Clinical narrative: EKG which showed some abnormal activity; resting heart rate rose to 113, and remained between 110-113 for 48 hours/her resting heart rate was elevated around 110-115; she felt slightly short of breath; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140 and expiration date Mar2021), intramuscular (top of her right arm) first dose on 29Dec2020 11:00 at single dose for Covid-19 immunization.  The patient's medical history included ongoing allergic to contrast dye, allergic to dust, and covid from Apr2020.  There were no concomitant medications.  The patient had the first dose of the Pfizer covid vaccine and she had an uncommon reaction. She received the first dose of the covid vaccine on 29Dec2020 around 11am. 24 hours after receiving the vaccine on 30Dec2020 around 11am she felt slightly short of breath and her resting heart rate was rose to 113, and remained between 110-113, elevated around 110-115. Her heart rate stayed elevated for about 2 hours. She called her doctor and she was instructed to go to urgent care where they did an EKG which showed some abnormal activity. Reports she has no history of cardiac issues in the past. The doctor at urgent care recommended for her to be transported by ambulance to emergency room to rule out a pulmonary embolism. Her heart rate remained elevated and while she was in the ER she had an EKG, lab test, chest x-ray, and nuclear cat scan since she is allergic to iv contrast dye. Her cardiac enzymes were negative. She did not have a pulmonary embolism. Her d-dimer was 1,131. She confirms she was not admitted. She has an apple watch and was told to monitor her heart rate. She was instructed to call # if she experienced shortness of breath.  The patient heart rate remained elevated for the next 48 hours and she did not start to feel normal and recovered completely around noon on 01Jan2021. She just had a follow up with her primary doctor. She asked if she should get the second dose of the vaccine. Her doctor consulted with the allergist and stated she should call Pfizer to ask if she should receive the second dose.  Vaccination Facility Type was Nursing home where she works. No additional vaccines administered. No prior vaccinations within 4 weeks.  The outcome of the events heart rate increased and dyspnoea was recovered on 01Jan2021 and unknown for the remaining event.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Vaccination site bruising, Vaccination site pain
Clinical narrative: her left, upper arm became bruised and sore; her left, upper arm became bruised and sore/muscle soreness, like from a flu shot; half of the vaccine came out at the injection site and she did not receive the full dose.; This is a spontaneous report from a Pfizer from a contactable nurse reporting for self. This 42-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: 31May2021) via unspecified route of administration on 06Jan2021 at single dose in left upper arm for COVID-19 immunisation. Medical history and concomitant medications were none. The patient previously received her first dose of BNT162B2 (Lot Number: EJ1685) on 18Dec2020 IM in her right deltoid muscle at single dose for COVID-19 immunisation at age of 42-year-old. She said when she received her first dose, the person who administered the shot used a 3-finger width distance from her right shoulder bone when administering the vaccine into her right deltoid muscle. She said after receiving the first dose, it was about 9 hours later before her right shoulder hurt. The patient received the second dose on 06Jan2021. She said at least half of the vaccine came out of her arm (came out at the injection site), so she did not receive the full second dose.  She said when she received her second dose, the person who administered the vaccine used only a 2- finger width distance from her left shoulder, and administered the vaccine very high up on her left arm. She said her left, upper arm became bruised and sore within an hour after receiving the second dose of vaccine. She said her left arm is still hurting today, clarifying she had a muscle soreness, like from a flu shot. The events did not require a visit to emergency room or physician office. The outcome of events was not recovered. The reporter considered the relatedness of vaccine to all events was related, and considered event her left, upper arm became bruised and sore/ muscle soreness, like from a flu shot as not serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Nausea, Pain in extremity
Clinical narrative: nausea/Nauseated; severe diarrhea; Her arm is sore; She is not feeling well; This is a spontaneous report from a contactable other HCP (patient).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 11:00 at single dose for COVID-19 immunisation.  The patient medical history and the concomitant medications were not reported. She worked in a hospital. She got the vaccine at 11:00 and within an hour she had severe diarrhea. She hasn't thrown up. It is like a bowel prep. She was nauseated, not really bad but it was annoying. She can smell. She was not weak. Her arm was sore but that was normal. Following administration of the vaccine she experienced severe diarrhea and now nausea. She can't take Imodium, so she took Kaopectate. She was out for breakfast and then this happened. She has never had anything happen like this before. She was not feeling well. The onset date of events was 07Jan2021. She reported that the diarrhea was now gone. The outcome of diarrhea was recovered, of other events was unknown. Treatment received for nausea and diarrhea.   Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Night sweats, Pain
Clinical narrative: Chills; Night sweats; Body aches; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL1284) intramuscular in left arm on 05Jan2021 at 14:00 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On 06Jan2021 at 19:00, the patient experienced chills, night sweats and body aches. No treatment given.The outcome of the events was recovering.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Fever over 100 F; brief body aches and chills; brief body aches and chills; This is a spontaneous report from a contactable other HCP reporting for a patient. A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EJ1658/expiration date: unknown), via intramuscular route of administration, on 17Dec2020 at 05:30 PM (at the age of 32 years old) as a single dose in the right arm and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL3249/expiration date: unknown), via intramuscular route of administration, on 06Jan2021 at 03:45 PM (at the age of 32 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021, the patient experienced fever over 100*F, brief body aches and chills. Treatment was received for the events fever over 100*F, brief body aches and chills included acetaminophen (TYLENOL). The outcome of the events fever over 100*F, brief body aches and chills was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Eye pruritus, Rhinorrhoea
Clinical narrative: burning and itching sensation in his eyes; burning and itching sensation in his eyes; runny nose; This is a spontaneous report from a contactable consumer (patient). This male patient of an unspecified age (Age-92, Unit-Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient has received the first dose of the vaccine on an unspecified date (reported as today) at 10:35am. He mentioned that nothing happened during the 30 min observation period for allergic reactions. Then at around 4pm, he experienced a burning and itching sensation in his eyes and had a runny nose. Outcome of the events was unknown.  Information about Lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: chills; body aches; headache; nausea; dry heaves; fatigue; This is a spontaneous report from a contactable Nurse. This Nurse reported for self that the 55-year-old female patient received second dose of bnt162b2 (BNT162B2, brand:ELI,, Batch/lot number: 283), via Intramuscular on Left arm on 06Jan2021 03:30 PM at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Known allergies to medications, food, or other products: Penicillin, sulfa drugs and Hypothyroid, genital herpes. Concomitant medications included the patient received within 2 weeks of vaccination: levothyroxine, Valacyclovir. The patient previously took first dose of bnt162b2 (BNT162B2, brand: EK, Batch/lot number: 5730), by injection via Intramuscular on Arm Right on 16Dec2020 03:30 PM at single dose for covid-19 immunisation. Facility type vaccine was Hospital. No other vaccine in fourweeks. At approximately 12 hours post injection chills, body aches, headache, nausea, dry heaves, fatigue from 07Jan2021 03:30 AM. No covid prior vaccination. No covid tested post vaccination. 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. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: chills; body aches; headache; nausea; dry heaves; fatigue; This is a spontaneous report from a contactable Nurse. This Nurse reported for self that the 55-year-old female patient received second dose of bnt162b2 (BNT162B2, brand:ELI,, Batch/lot number: 283), via Intramuscular on Left arm on 06Jan2021 03:30 PM at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Known allergies to medications, food, or other products: Penicillin, sulfa drugs and Hypothyroid, genital herpes. Concomitant medications included the patient received within 2 weeks of vaccination: levothyroxine, Valacyclovir. The patient previously took first dose of bnt162b2 (BNT162B2, brand: EK, Batch/lot number: 5730), by injection via Intramuscular on Arm Right on 16Dec2020 03:30 PM at single dose for covid-19 immunisation. Facility type vaccine was Hospital. No other vaccine in fourweeks. At approximately 12 hours post injection chills, body aches, headache, nausea, dry heaves, fatigue from 07Jan2021 03:30 AM. No covid prior vaccination. No covid tested post vaccination. 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. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: I  just had a sore in the left arm the next day; This is a spontaneous report from a contactable Nurse (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiration date not reported), intramuscular on the left arm on 28Dec2020 07:00 at single dose for COVID-19 immunization. Medical history included allergies to PCN/Sulfa. Concomitant medications included calcium and an unspecified allergy pill. The patient reported that she  just had a sore in the left arm the next day on 29Dec2020 and there were no other problems. No treatment was given for the event. The event was reported as non-serious. The patient had no prior COVID vaccination and did not test positive for COVID post vaccination. The patient recovered from the event on an unspecified date.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal oedema, Rhinalgia
Clinical narrative: Mild Tenderness of Nose; Slight Swelling of Nose; This is a spontaneous report from a contactable Other HCP (patient). A 40-year-old female patient received the first dose of BNT162B2 (lot number: EJ1685), intramuscular from  05Jan2021 10:00 at single dose in the right arm for COVID-19 immunization. There were no medical history and concomitant medications. On 06Jan2021 16:00, the patient experienced mild tenderness of nose and slight swelling of nose. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications in two weeks. 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 outcome of the events was recovering.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Skin burning sensation
Clinical narrative: I lost all the hair at the top of my head. I was already slowly balding/ thinning. Two weeks after the injection my scalp felt like it was on fire and the hair started falling out in clumps easily.; I lost all the hair at the top of my head. I was already slowly balding/ thinning. Two weeks after the injection my scalp felt like it was on fire and the hair started falling out in clumps easily.; This is a spontaneous report from a contactable Other-HCP (patient). A 29-year-old male patient received BNT162B2 (Lot/Batch number and expiry date unknown), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history included High blood pressure and depression, both from unknown date. Concomitant medication included venlafaxine and lamotrigine. On 30Dec2020, the patient lost all the hair at the top of her head. He was already slowly balding/thinning. Two weeks after the injection, his scalp felt like it was on fire and the hair started falling out in clumps easily. The hair has not grown back. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Dyspnoea, Fatigue, Hypoaesthesia, Limb discomfort
Clinical narrative: trouble breathing-  feeling like she "had yawn or having to take a deep breath; legs felt super heavy when I tried to walk; fatigue; Numbness and tingling in L-arm (opposite from vaccine given) which lasted for 20 minutes, then tingling went to feet up to thigh (5-10 min)/Tingling sensation continued to her tongue (3 minutes) then to her R-arm and to the top of her head; Numbness and tingling in L-arm; This is a spontaneous report from a contactable Other-HCP. This Other HCP reported for self that the female patient of unknown age who received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Arm right on 30Dec2020 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient reports that she got the vaccine 30Dec2020 2 days after felt great, day 3 and 4 fatigue (fatigue on days 3 and 4 after dose). Then 06Jan2021 reports trouble breathing-feeling like she "had yawn or having to take a deep breath,". She reports having Sars-Cov-2 infection previous to this experience. She was tested for Sars-Cov-2 infection, had Covid in the past and had a chest X-ray, both negative. Numbness and tingling in L-arm (opposite from vaccine given) which lasted for 20 minutes, then tingling went to feet up to thigh (Didn't last long 5-10 min) then reported her "legs felt super heavy when I tried to walk". Tingling sensation continued to her tongue (3 minutes) then to her R-arm tingly and to the top of her head. She states she is "getting better" and is "fine now" but wanted to know if this is a reported AE and how long it might last. She is asking for guidance on getting the second dose after her experience. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: trouble breathing-  feeling like she "had yawn or having to take a deep breath; legs felt super heavy when I tried to walk; fatigue; Numbness and tingling in L-arm (opposite from vaccine given) which lasted for 20 minutes, then tingling went to feet up to thigh (5-10 min)/Tingling sensation continued to her tongue (3 minutes) then to her R-arm and to the top of her head; Numbness and tingling in L-arm; This is a spontaneous report from a contactable Other-HCP. This Other HCP reported for self that the female patient of unknown age who received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Arm right on 30Dec2020 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient reports that she got the vaccine 30Dec2020 2 days after felt great, day 3 and 4 fatigue (fatigue on days 3 and 4 after dose). Then 06Jan2021 reports trouble breathing-feeling like she "had yawn or having to take a deep breath,". She reports having Sars-Cov-2 infection previous to this experience. She was tested for Sars-Cov-2 infection, had Covid in the past and had a chest X-ray, both negative. Numbness and tingling in L-arm (opposite from vaccine given) which lasted for 20 minutes, then tingling went to feet up to thigh (Didn't last long 5-10 min) then reported her "legs felt super heavy when I tried to walk". Tingling sensation continued to her tongue (3 minutes) then to her R-arm tingly and to the top of her head. She states she is "getting better" and is "fine now" but wanted to know if this is a reported AE and how long it might last. She is asking for guidance on getting the second dose after her experience. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash pruritic
Clinical narrative: Vaccine received Monday 04Jan, severe headache afterwards. Tuesday 05Jan, full body itchy rash. Unchanged with use of benadryl.; Vaccine received Monday 04Jan, severe headache afterwards. Tuesday 05Jan, full body itchy rash. Unchanged with use of benadryl.; This is a spontaneous report from a contactable healthcare professional. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date not reported), via an unspecified route of administration in the left arm on 04Jan2021 14:00 at a single dose for COVID-19 immunisation. Medical history included depression and celiac disease. Concomitant medications included sertraline hydrochloride (ZOLOFT), omeprazole, calcium, and lactobacillus acidophilus (ACIDOPHILUS). The patient previously took amoxicillin, gluten and experienced allergies. It was reported that the patient had a vaccine received on Monday 04Jan2021, and experienced severe headache afterwards. On Tuesday 05Jan2021, the patient experienced full body itchy rash. These were unchanged with the use of Benadryl. Clinical outcome of the events was not recovered.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Malaise, Myalgia
Clinical narrative: Low grade fever 99-100's; Muscle aches; Fatigue; Chills; Malaise; This is a spontaneous report from a contactable Physician (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EK5730/expiration date: unknown), via unknown route of administration, on 18Dec2020 at 02:00 PM (at the age of 43 years old) as a single dose in the left arm and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL0130/expiration date: unknown), via unknown route of administration, on 06Jan2021 at 03:45 PM (at the age of 43 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included hypertension (HTN) and GERD. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Metoprolol, Hydrochloride, Acetylsalicylic acid (ASPIRIN), Omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 12:00 PM, the patient experienced low-grade fever 99-100's, muscle aches, fatigue, chills, malaise. Treatment was received for the events low grade fever 99-100's, muscle aches, fatigue, chills, malaise included ibuprofen (ADVIL), acetaminophen (TYLENOL), rest and fluid. The outcome of the events fever 99-100's, muscle aches, fatigue, chills, malaise was recovering. Patient underwent COVID-19 PCR test which was pending result. Since the vaccination, the patient had not been tested for COVID-19.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Low grade fever 99-100's; Muscle aches; Fatigue; Chills; Malaise; This is a spontaneous report from a contactable Physician (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EK5730/expiration date: unknown), via unknown route of administration, on 18Dec2020 at 02:00 PM (at the age of 43 years old) as a single dose in the left arm and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL0130/expiration date: unknown), via unknown route of administration, on 06Jan2021 at 03:45 PM (at the age of 43 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included hypertension (HTN) and GERD. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Metoprolol, Hydrochloride, Acetylsalicylic acid (ASPIRIN), Omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 12:00 PM, the patient experienced low-grade fever 99-100's, muscle aches, fatigue, chills, malaise. Treatment was received for the events low grade fever 99-100's, muscle aches, fatigue, chills, malaise included ibuprofen (ADVIL), acetaminophen (TYLENOL), rest and fluid. The outcome of the events fever 99-100's, muscle aches, fatigue, chills, malaise was recovering. Patient underwent COVID-19 PCR test which was pending result. Since the vaccination, the patient had not been tested for COVID-19.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Headache, Neck pain, Pain
Clinical narrative: In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; This is a spontaneous report from a contactable other HCP (patient). A 36-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231), intramuscularly on 06Jan2021 14:45 at single dose in Left arm for COVID-19 immunisation. No Pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Irritable bowel syndrome.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included fluticasone propionate, ethinylestradiol, norethisterone (WERA). The patient experienced In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4 on 07Jan202105:30 AM. No treatment received for the adverse events. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; This is a spontaneous report from a contactable other HCP (patient). A 36-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231), intramuscularly on 06Jan2021 14:45 at single dose in Left arm for COVID-19 immunisation. No Pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Irritable bowel syndrome.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included fluticasone propionate, ethinylestradiol, norethisterone (WERA). The patient experienced In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4 on 07Jan202105:30 AM. No treatment received for the adverse events. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome was unknown.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness postural, Myalgia, Off label use
Clinical narrative: Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; first dose of BNT162B2 on 16Dec2020 12:00, second dose on 05Jan2021 15:00; first dose of BNT162B2 on 16Dec2020 12:00, second dose on 05Jan2021 15:00; This is a spontaneous report from a contactable Physician (patient). This 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 05Jan2021 15:00 (lot number: EK9231) at single dose in Arm Left for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Migraines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included paracetamol (TYLENOL), ibuprofen (ADVIL) occasionally as needed. The patient previously received first dose of BNT162B2 intramuscularly on 16Dec2020 12:00 at 31-year-old (lot number: EH9899) at single dose in Arm Left for COVID-19 immunisation. The patient experienced Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing on 06Jan2021 03:00 AM. The outcome of Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing was recovering. Tylenol, Advil, Bed Rest was received for the adverse events Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing as treatment. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Product use issue, Vaccination site pain
Clinical narrative: Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; first dose of BNT162B2 on 16Dec2020 12:00, second dose on 05Jan2021 15:00; first dose of BNT162B2 on 16Dec2020 12:00, second dose on 05Jan2021 15:00; This is a spontaneous report from a contactable Physician (patient). This 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 05Jan2021 15:00 (lot number: EK9231) at single dose in Arm Left for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Migraines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included paracetamol (TYLENOL), ibuprofen (ADVIL) occasionally as needed. The patient previously received first dose of BNT162B2 intramuscularly on 16Dec2020 12:00 at 31-year-old (lot number: EH9899) at single dose in Arm Left for COVID-19 immunisation. The patient experienced Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing on 06Jan2021 03:00 AM. The outcome of Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing was recovering. Tylenol, Advil, Bed Rest was received for the adverse events Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing as treatment. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscular weakness, Nausea, Off label use
Clinical narrative: muscle weakness; fatigue; nausea; headaches; fever; This was a 17 day interval between doses; This was a 17 day interval between doses; This is a spontaneous report from a contactable consumer (patient). This 28-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported.  The patient previously received first dose of BNT162B2 on 21Dec2020 at single dose for COVID-19 immunisation. She received her first dose of Covid vaccine on 21Dec2020 and second dose of Covid vaccine on 06Jan2021. This was a 17 day interval between doses. After receiving second dose of COVID vaccine, she has been experiencing muscle weakness all over, fatigue, nausea, headaches, and fever. The outcome was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: muscle weakness; fatigue; nausea; headaches; fever; This was a 17 day interval between doses; This was a 17 day interval between doses; This is a spontaneous report from a contactable consumer (patient). This 28-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported.  The patient previously received first dose of BNT162B2 on 21Dec2020 at single dose for COVID-19 immunisation. She received her first dose of Covid vaccine on 21Dec2020 and second dose of Covid vaccine on 06Jan2021. This was a 17 day interval between doses. After receiving second dose of COVID vaccine, she has been experiencing muscle weakness all over, fatigue, nausea, headaches, and fever. The outcome was unknown.    Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Dental restoration failure, Investigation
Clinical narrative: Her bones were hurting her; hip was hurting more/ pain in hip; Dental implants and bridge fell out; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar event for two patients. This is the 1st of two reports. A 75-years-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Batch/lot number: EK5730), via an unspecified route of administration on 16Dec2020 at single dose for covid-19 immunization (reported as works with COVID patients on daily basis). Medical history included hypertension, hip replacement from an accident four years before 07Jan2021 in December (Dec2016). The patient was not overweight, exercises, was older, but considered in good health. The patient's concomitant medications were not reported. The past vaccine event included weak after the Flu shot. Couple weeks after first vaccine, before new year (Dec2020), dental implants came out.  The patient clarified she was referring to dental implants had no pain, had a bridge in her mouth on the left lower side. Felt something was bothering her. Noticed her bridge lifted up and her implants fell out. Had to go to doctor's and had it removed. Everything was moving. She was very uncomfortable. Surgery cost her almost $3,000. Surgery was 3 days before 07Jan2021 (04Jan2021) for her implants and bridge. Had to use bone graft. Her bones were hurting her. After COVID-19 Vaccine, her hip was hurting more. She stated the pain in hip beginning up to one week as of 07Jan2021. The had labs in Dec2020 and everything was ok. The event outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021011233 same reporter/drug, similar event with different patients
Sex: M
Vaccine: COVID19
Symptoms: Dental restoration failure
Clinical narrative: Dental implant fell out; This is a spontaneous report from a contactable nurse. This nurse reported similar event for two patients. This is the 2nd of two reports.  A male patient of an unspecified age received bnt162b2 (also reported as COVID-19 Vaccine, lot no. and expiry date were 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 dental implant fell out on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021011228 same reporter/drug, similar event with different patients
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Vomiting
Clinical narrative: By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; This is a spontaneous report from a contactable nurse (patient). This 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020 09:00 at single dose in Arm Right for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Migraines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included nortriptyline, bupropion, magnesium sulfate, fish oil , ca. The patient experienced By 2am extreme headache, by 4 am vomiting, chills, to sleep till 5p, headache, chills and muscle aches on 24Dec2020 02:00 AM, Back to normal in 72 hours. The outcome was recovered. No treatment received for the adverse events. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain
Clinical narrative: Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm soreness at injection site; This is a spontaneous report from a contactable Nurse (patient). This 40-year-old female Nurse reported for herself received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Elt9899/expiration date: unknown), via unknown route of administration, on 17Dec2020 at 07:45 PM (at the age of 40 years old) as a single dose in the left arm and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Eh9899/expiration date: unknown), via unknown route of administration, on 07Jan2021at 06:30 AM (at the age of 40 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included asthma. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Albuterol inhaler. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 03:00 PM, the patient experienced body chills, extreme fatigue, arm soreness at injection site. No treatment was received for the events body chills, extreme fatigue, arm soreness at injection site. The outcome of the events body chills, extreme fatigue, arm soreness at injection site was unknown. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Mass, Vaccination site pain
Clinical narrative: arm pain from the injection site up to her shoulder; "penny-sized lump" above her collarbone (on the same side she was vaccinated on) which is painful to the touch and "feels like it is full of fluid"; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first Pfizer covid vaccine on 31Dec2020; and 7 days later (07Jan2021), the patient experienced arm pain from the injection site up to her shoulder and also reported "penny-sized lump" above her collarbone (on the same side she was vaccinated on) which was painful to the touch and "feels like it is full of fluid". The patient asked if these effects were normal and if she should receive the second dose of the vaccine. The outcome of the events was unknown.  Information of lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: Rash; This is a spontaneous report from a contactable physician (patient herself). A 38-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on left arm on 05Jan2021 08:15 at single dose for covid-19 immunization, administered at hospital. Medical history included asthma. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced rash within 12 hours on 05Jan2021. The reported event was non-serious. The patient underwent lab tests and procedures which included nasal swab-PCR on 07Jan2021 with pending result. Therapeutic measures were taken as a result of rash with steroid cream and antihistamine. The outcome of the event was not recovered.  No follow-up attempts are possible; Information on the lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Headache, Hypotension, Pruritus
Clinical narrative: temperature of 99.5; Excessive/Severe itching from head to toe/itching has progressively gotten worse; experiencing slight headaches; low blood pressure; This is a spontaneous report from a contactable other-HCP (patient). A 25-years-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot: EL1284) via an unspecified route of administration on 29Dec2020 12:30 at single dose for COVID-19 immunisation. The patient was allegic to Sulfa products and Nickel products. Concomitant medication included bupropion hydrochloride (WELLBUTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020 08:00 AM, the patient experienced excessive/severe itching from head to toe that started 2 days after the vaccine was administered. The itching has progressively gotten worse. She had also been experiencing slight headaches, low blood pressure, and temperature of 99.5 on 31Dec2020 08:00. Events resulted in doctor or other healthcare professional office/clinic visit. The patient received Medrol Dose pack as treatment. Events outcome was not recovered.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: temperature of 99.5; Excessive/Severe itching from head to toe/itching has progressively gotten worse; experiencing slight headaches; low blood pressure; This is a spontaneous report from a contactable other-HCP (patient). A 25-years-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot: EL1284) via an unspecified route of administration on 29Dec2020 12:30 at single dose for COVID-19 immunisation. The patient was allegic to Sulfa products and Nickel products. Concomitant medication included bupropion hydrochloride (WELLBUTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020 08:00 AM, the patient experienced excessive/severe itching from head to toe that started 2 days after the vaccine was administered. The itching has progressively gotten worse. She had also been experiencing slight headaches, low blood pressure, and temperature of 99.5 on 31Dec2020 08:00. Events resulted in doctor or other healthcare professional office/clinic visit. The patient received Medrol Dose pack as treatment. Events outcome was not recovered.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Motion sickness
Clinical narrative: I'm feeling like I have motion sickness.; This is a spontaneous report from a contactable other healthcare professional.   A 61-year-old male patient received bnt162b2, lot El0143, via an unspecified route of administration in the right arm on 06Jan2021 14:00 at single dose for covid-19 immunisation. The patient's medical has no relevant medical history. Patient has allergies to medications, food, or other products. The patient's concomitant medications were not reported. On an 07Jan2021 05:00, the patient felt like he has a motion sickness. The outcome of the event was recovering. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.