chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vaccination complication
Clinical narrative: Muscle aches; Tingling sensation; Itching only on the arm that the injection administered."I" have noticed very tiny bumps that may be the cause of the itchiness;; This is a spontaneous report from a contactable consumer, the patient. A patient of unknown age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the arm left on 12Mar2021 at 12:00 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin d nos (VITAMIN D), daily multi vitamins (MANUFACTURER UNKNOWN) and ascorbic acid (VITAMIN C) for unknown indication from unknown date and unknown if ongoing. On 13Mar2021, the patient experienced muscle aches, tingling, and itching only on the arm that the injection was administered. The tingling sensation went from upper arm to fingertips and subsided after about 3 weeks. The patient continue to experience achiness in upper arm muscle and itching in the same upper arm area. Both of these side effects are felt throughout the upper arm beyond the actual injection site. (The patient had noticed very tiny bumps that may be the cause of the itchiness; when patient scratch them, they scab but seem take some time to heal up. The patient had not experienced this anywhere else on body nor experienced it prior to injection.) Again, patient had experienced these conditions only on the arm that the vaccine was administered. It had been close to eight weeks since first and only vaccine injection. Because of these ongoing side effects, patient chosen not to get the second injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tingling, itching only on the arm that the injection administered and upper arm muscle aches was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Paraesthesia, Rash pruritic
Clinical narrative: Muscle aches; Tingling sensation; Itching only on the arm that the injection administered."I" have noticed very tiny bumps that may be the cause of the itchiness;; This is a spontaneous report from a contactable consumer, the patient. A patient of unknown age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the arm left on 12Mar2021 at 12:00 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin d nos (VITAMIN D), daily multi vitamins (MANUFACTURER UNKNOWN) and ascorbic acid (VITAMIN C) for unknown indication from unknown date and unknown if ongoing. On 13Mar2021, the patient experienced muscle aches, tingling, and itching only on the arm that the injection was administered. The tingling sensation went from upper arm to fingertips and subsided after about 3 weeks. The patient continue to experience achiness in upper arm muscle and itching in the same upper arm area. Both of these side effects are felt throughout the upper arm beyond the actual injection site. (The patient had noticed very tiny bumps that may be the cause of the itchiness; when patient scratch them, they scab but seem take some time to heal up. The patient had not experienced this anywhere else on body nor experienced it prior to injection.) Again, patient had experienced these conditions only on the arm that the vaccine was administered. It had been close to eight weeks since first and only vaccine injection. Because of these ongoing side effects, patient chosen not to get the second injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tingling, itching only on the arm that the injection administered and upper arm muscle aches was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Starting the day after vaccination, developed diffuse painful tingling in entire body.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody negative, Blood creatine phosphokinase normal, Blood magnesium normal, Blood phosphorus normal
Clinical narrative: Starting the day after vaccination, developed diffuse painful tingling in entire body.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone normal, C-reactive protein normal, Chlamydia test negative, Computerised tomogram head normal, Double stranded DNA antibody
Clinical narrative: Starting the day after vaccination, developed diffuse painful tingling in entire body.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Glycosylated haemoglobin, HIV test negative, Hepatitis B test negative, Laboratory test normal
Clinical narrative: Starting the day after vaccination, developed diffuse painful tingling in entire body.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lipase normal, Liver function test normal, Metabolic function test normal, Pain, Paraesthesia
Clinical narrative: Starting the day after vaccination, developed diffuse painful tingling in entire body.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Protein urine absent, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Sexually transmitted disease test, Treponema test negative
Clinical narrative: Starting the day after vaccination, developed diffuse painful tingling in entire body.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis normal, Vitamin B12 normal, Vitamin B6 normal, Vitamin D
Clinical narrative: Starting the day after vaccination, developed diffuse painful tingling in entire body.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Nausea, SARS-CoV-2 test positive, Upper respiratory tract infection
Clinical narrative: slight swelling in throat and face; slight swelling in throat and face; Heart beats fast; very dizzy; cannot focus; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient received the first dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine, Formulation: Solution for injection, Batch/Lot Number: EW0169, Expiration Date: Unknown) via an unspecified route of administration, administered in Left Arm on 30Apr2021 10:50 (at the age of 49-year-old) as DOSE 1, SINGLE for COVID-19 immunization administered. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, ongoing polyarteritis nodosa from an unknown date, Infection under right breast from an unknown date and unknown if ongoing, has had about a month. Concomitant medication(s) included azathioprine (MANUFACTURER UNKNOWN) taken for polyarteritis from an unspecified date and ongoing, has been taking 6 years; ongoing insulin aspart (NOVOLOG), ongoing metformin (MANUFACTURER UNKNOWN) has been taking about 20 years, ongoing insulin glargine (BASAGLAR); all three taken for diabetes mellitus from an unspecified date. The patient previously received Cefalexin (MANUFACTURER UNKNOWN) for an unspecified indication from an unknown date, (Finished antibiotic Cefalexin about a week ago). Prior vaccination within 4 weeks was reported as none. On 30Apr2021 11:45, the patient experienced slight swelling in throat and face, heart beats fast, very dizzy, cannot focus. The patient did not receive any treatment for the events. The event did not result in visit to physician office. The outcome of events slight swelling in throat and face and cannot focus was unknown. The outcome of event heart beats fast and very dizzy was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disturbance in attention, Dizziness, Heart rate increased, Pharyngeal swelling, Swelling face
Clinical narrative: slight swelling in throat and face; slight swelling in throat and face; Heart beats fast; very dizzy; cannot focus; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient received the first dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine, Formulation: Solution for injection, Batch/Lot Number: EW0169, Expiration Date: Unknown) via an unspecified route of administration, administered in Left Arm on 30Apr2021 10:50 (at the age of 49-year-old) as DOSE 1, SINGLE for COVID-19 immunization administered. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, ongoing polyarteritis nodosa from an unknown date, Infection under right breast from an unknown date and unknown if ongoing, has had about a month. Concomitant medication(s) included azathioprine (MANUFACTURER UNKNOWN) taken for polyarteritis from an unspecified date and ongoing, has been taking 6 years; ongoing insulin aspart (NOVOLOG), ongoing metformin (MANUFACTURER UNKNOWN) has been taking about 20 years, ongoing insulin glargine (BASAGLAR); all three taken for diabetes mellitus from an unspecified date. The patient previously received Cefalexin (MANUFACTURER UNKNOWN) for an unspecified indication from an unknown date, (Finished antibiotic Cefalexin about a week ago). Prior vaccination within 4 weeks was reported as none. On 30Apr2021 11:45, the patient experienced slight swelling in throat and face, heart beats fast, very dizzy, cannot focus. The patient did not receive any treatment for the events. The event did not result in visit to physician office. The outcome of events slight swelling in throat and face and cannot focus was unknown. The outcome of event heart beats fast and very dizzy was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Headache, Hypersensitivity
Clinical narrative: Patient is a 58 year old female who began having shortness of breath, nausea, extreme headache and coughing 10 min after receiving her JJ COVID-19 vaccination.  She was brought in to the Urgent Care, noted to be having an allergic reaction and was immediately given 50 mg of Benadryl, 8 mg of ondansetron and observed for 5 min.  She continued having worsening symptoms with coughing and shortness of breath, 125 mg of Solu-Medrol were given IM and she was placed on 15 L O2 non-rebreather mask. The patient reported feeling progressive throat tightening and chest tightness and her coughing fits increased.  Epinephrine 0.3 mg was administered to the left lateral thigh and the EMS system was activated.  After the epinephrine her symptoms improved, however did not fully resolved.  EMS arrived  Within 10 min and received report transporting the patient to ER for further evaluation.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Throat tightness
Clinical narrative: Patient is a 58 year old female who began having shortness of breath, nausea, extreme headache and coughing 10 min after receiving her JJ COVID-19 vaccination.  She was brought in to the Urgent Care, noted to be having an allergic reaction and was immediately given 50 mg of Benadryl, 8 mg of ondansetron and observed for 5 min.  She continued having worsening symptoms with coughing and shortness of breath, 125 mg of Solu-Medrol were given IM and she was placed on 15 L O2 non-rebreather mask. The patient reported feeling progressive throat tightening and chest tightness and her coughing fits increased.  Epinephrine 0.3 mg was administered to the left lateral thigh and the EMS system was activated.  After the epinephrine her symptoms improved, however did not fully resolved.  EMS arrived  Within 10 min and received report transporting the patient to ER for further evaluation.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Condition aggravated, Insomnia, Irritability, Migraine
Clinical narrative: Migraines; Increased Blood Pressure (out of the ordinary, beyond usual or customary); Irritability (out of character); Insomnia; Edema (out of the ordinary, beyond usual or customary); This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 02Aug2021 at 11:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included general hypertension and optical migraines. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Aug2021, the patient experienced migraines, increased blood Pressure (out of the ordinary, beyond usual or customary), irritability (out of character), insomnia and edema (out of the ordinary, beyond usual or customary). On an unknown date in Aug2021, the patient underwent blood pressure and the result was increased. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraines, increased blood Pressure (out of the ordinary, beyond usual or customary), irritability (out of character), insomnia and edema (out of the ordinary, beyond usual or customary) was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oedema
Clinical narrative: Migraines; Increased Blood Pressure (out of the ordinary, beyond usual or customary); Irritability (out of character); Insomnia; Edema (out of the ordinary, beyond usual or customary); This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 02Aug2021 at 11:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included general hypertension and optical migraines. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Aug2021, the patient experienced migraines, increased blood Pressure (out of the ordinary, beyond usual or customary), irritability (out of character), insomnia and edema (out of the ordinary, beyond usual or customary). On an unknown date in Aug2021, the patient underwent blood pressure and the result was increased. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraines, increased blood Pressure (out of the ordinary, beyond usual or customary), irritability (out of character), insomnia and edema (out of the ordinary, beyond usual or customary) was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Insomnia, Irritability, Migraine
Clinical narrative: Migraines; Increased Blood Pressure (out of the ordinary, beyond usual or customary); Irritability (out of character); Insomnia; Edema (out of the ordinary, beyond usual or customary); This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 02Aug2021 at 11:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included general hypertension and optical migraines. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Aug2021, the patient experienced migraines, increased blood Pressure (out of the ordinary, beyond usual or customary), irritability (out of character), insomnia and edema (out of the ordinary, beyond usual or customary). On an unknown date in Aug2021, the patient underwent blood pressure and the result was increased. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraines, increased blood Pressure (out of the ordinary, beyond usual or customary), irritability (out of character), insomnia and edema (out of the ordinary, beyond usual or customary) was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Muscle tightness, Pain in jaw, Trismus
Clinical narrative: Right side of my face got tight and was having spasms; I had some hives; The right side of my face got tight; This is a spontaneous report from a contactable healthcare professional, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Aug2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) and a lot of allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Aug2021, the patients right side of face got tight and she was having spasms and had some hives. It got worse for at least the following 3 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events right side of face got tight and she was having spasms and had some hives was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Musculoskeletal stiffness, Urticaria
Clinical narrative: Right side of my face got tight and was having spasms; I had some hives; The right side of my face got tight; This is a spontaneous report from a contactable healthcare professional, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Aug2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) and a lot of allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Aug2021, the patients right side of face got tight and she was having spasms and had some hives. It got worse for at least the following 3 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events right side of face got tight and she was having spasms and had some hives was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Coordination abnormal, Inflammation, Migraine, Nausea
Clinical narrative: Severe migraine attack on 24Aug; Vertigo; unilateral weakness; high levels of inflammation; headache; tongue tingling and lip numbness; lip numbness; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: FC3182) via an unspecified route of administration in left arm on 21Aug2021 at 08:45 (at the age of 41-year-old) as single dose for COVID-19 immunization at Pharmacy or Drug Store. Medical history of the patient included Arthritis. Other medications in two weeks included Magnesium Citrate, B12, Vitamin D. Patient did not receive any other vaccine in four weeks. Patient had no COVID prior vaccination and was not tested for COVID post vaccination. Patient previously took Amoxicillin, Levaquin and experienced allergy. On 24Aug2021, patient experienced severe migraine attack with vertigo and unilateral weakness, headache. Migraine lessened within a day to a low grade that would not dissipate. By the following week patient had tongue tingling and lip numbness on an unspecified date in Aug2021. Patient was administered with dexamethasone injections in neck and upper right side of back due to the high levels of inflammation which knocked out the migraine but left the tongue and lip tingling for two days, along with a regular headache. Chiropractor and doctor think vaccine triggered an inflammatory response in my neck and upper back. Patient asked if she could have the same or worse inflammation with shot two. AE resulted in visit to doctor or other healthcare professional office/clinic visit. Corrective treatment in response to events included dexamethasone injections. Outcome of the events were recovering.   Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Vertigo
Clinical narrative: Severe migraine attack on 24Aug; Vertigo; unilateral weakness; high levels of inflammation; headache; tongue tingling and lip numbness; lip numbness; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: FC3182) via an unspecified route of administration in left arm on 21Aug2021 at 08:45 (at the age of 41-year-old) as single dose for COVID-19 immunization at Pharmacy or Drug Store. Medical history of the patient included Arthritis. Other medications in two weeks included Magnesium Citrate, B12, Vitamin D. Patient did not receive any other vaccine in four weeks. Patient had no COVID prior vaccination and was not tested for COVID post vaccination. Patient previously took Amoxicillin, Levaquin and experienced allergy. On 24Aug2021, patient experienced severe migraine attack with vertigo and unilateral weakness, headache. Migraine lessened within a day to a low grade that would not dissipate. By the following week patient had tongue tingling and lip numbness on an unspecified date in Aug2021. Patient was administered with dexamethasone injections in neck and upper right side of back due to the high levels of inflammation which knocked out the migraine but left the tongue and lip tingling for two days, along with a regular headache. Chiropractor and doctor think vaccine triggered an inflammatory response in my neck and upper back. Patient asked if she could have the same or worse inflammation with shot two. AE resulted in visit to doctor or other healthcare professional office/clinic visit. Corrective treatment in response to events included dexamethasone injections. Outcome of the events were recovering.   Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Headache, Hypoaesthesia oral, Inflammation, Migraine
Clinical narrative: Severe migraine attack on 24Aug; Vertigo; unilateral weakness; high levels of inflammation; headache; tongue tingling and lip numbness; lip numbness; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: FC3182) via an unspecified route of administration in left arm on 21Aug2021 at 08:45 (at the age of 41-year-old) as single dose for COVID-19 immunization at Pharmacy or Drug Store. Medical history of the patient included Arthritis. Other medications in two weeks included Magnesium Citrate, B12, Vitamin D. Patient did not receive any other vaccine in four weeks. Patient had no COVID prior vaccination and was not tested for COVID post vaccination. Patient previously took Amoxicillin, Levaquin and experienced allergy. On 24Aug2021, patient experienced severe migraine attack with vertigo and unilateral weakness, headache. Migraine lessened within a day to a low grade that would not dissipate. By the following week patient had tongue tingling and lip numbness on an unspecified date in Aug2021. Patient was administered with dexamethasone injections in neck and upper right side of back due to the high levels of inflammation which knocked out the migraine but left the tongue and lip tingling for two days, along with a regular headache. Chiropractor and doctor think vaccine triggered an inflammatory response in my neck and upper back. Patient asked if she could have the same or worse inflammation with shot two. AE resulted in visit to doctor or other healthcare professional office/clinic visit. Corrective treatment in response to events included dexamethasone injections. Outcome of the events were recovering.   Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Vertigo
Clinical narrative: Severe migraine attack on 24Aug; Vertigo; unilateral weakness; high levels of inflammation; headache; tongue tingling and lip numbness; lip numbness; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: FC3182) via an unspecified route of administration in left arm on 21Aug2021 at 08:45 (at the age of 41-year-old) as single dose for COVID-19 immunization at Pharmacy or Drug Store. Medical history of the patient included Arthritis. Other medications in two weeks included Magnesium Citrate, B12, Vitamin D. Patient did not receive any other vaccine in four weeks. Patient had no COVID prior vaccination and was not tested for COVID post vaccination. Patient previously took Amoxicillin, Levaquin and experienced allergy. On 24Aug2021, patient experienced severe migraine attack with vertigo and unilateral weakness, headache. Migraine lessened within a day to a low grade that would not dissipate. By the following week patient had tongue tingling and lip numbness on an unspecified date in Aug2021. Patient was administered with dexamethasone injections in neck and upper right side of back due to the high levels of inflammation which knocked out the migraine but left the tongue and lip tingling for two days, along with a regular headache. Chiropractor and doctor think vaccine triggered an inflammatory response in my neck and upper back. Patient asked if she could have the same or worse inflammation with shot two. AE resulted in visit to doctor or other healthcare professional office/clinic visit. Corrective treatment in response to events included dexamethasone injections. Outcome of the events were recovering.   Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: pt admitted to hosp with SOB (worsening past 3-4 days) and positive for COVID, O2 sats 85% @ home; on 5 L via NC now; eventually placed on BiPAP and prone positioning; required intubation due to worsening condition and O2 requirement increasing; intubated; pt remained gravely ill; condition worsened; placed pt on comfort care; pt died in the hospital; COVID pneumonia
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Death, Dyspnoea, Endotracheal intubation
Clinical narrative: pt admitted to hosp with SOB (worsening past 3-4 days) and positive for COVID, O2 sats 85% @ home; on 5 L via NC now; eventually placed on BiPAP and prone positioning; required intubation due to worsening condition and O2 requirement increasing; intubated; pt remained gravely ill; condition worsened; placed pt on comfort care; pt died in the hospital; COVID pneumonia
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Positive airway pressure therapy, Prone position, SARS-CoV-2 test positive
Clinical narrative: pt admitted to hosp with SOB (worsening past 3-4 days) and positive for COVID, O2 sats 85% @ home; on 5 L via NC now; eventually placed on BiPAP and prone positioning; required intubation due to worsening condition and O2 requirement increasing; intubated; pt remained gravely ill; condition worsened; placed pt on comfort care; pt died in the hospital; COVID pneumonia
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: neck pain on left side which is the same side where she got the vaccine; very strong hip pain on both sides; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0158, expiry date: Jul2021) via an unspecified route of administration in the left arm on 09Apr2021 (vaccination at the age of 36-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. Patient's Medical History (including any illness at time of vaccination) was none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect Additional Administered Vaccines If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. Caller stated that she received the flu vaccine in October. It was reported that the patient got the first dose Pfizer covid -19 vaccine on 09Apr2021 and the patient started having hip pain, she said in Spanish, very strong hip pain on both sides. The patient also reported neck pain on the left side which was the same side where she got the vaccine. It was stated that the patient tried some massage and putting some creams to stop the pain. It was conformed that the cream the patient used was Biofreeze (lot number 22650). Caller states her neck pain was getting worse. The patient did not require any visit to emergency Room/physician office but she wants to go see her doctor. It was also stated that the patient does not have any insurance and wants to cancel her second dose of Pfizer COVID-19 vaccine. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fatigue; headache; fever; chills; This is a spontaneous report received from a contactable consumer. This consumer reported for a 50-year-old male patient received second dose of 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 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had previously received first dose of 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 1, SINGLE for COVID-19 immunization. On an unspecified date right after the second dose the patient experienced fatigue, headache, fever and chills. He got gradually better the next day. The outcome of all events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: fatigue; headache; fever; chills; This is a spontaneous report received from a contactable consumer. This consumer reported for a 50-year-old male patient received second dose of 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 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had previously received first dose of 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 1, SINGLE for COVID-19 immunization. On an unspecified date right after the second dose the patient experienced fatigue, headache, fever and chills. He got gradually better the next day. The outcome of all events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Vaccine breakthrough infection
Clinical narrative: diagnosed positive for COVID 10 days before hosp admission; presented to hosp with increasing abdominal pain; hx of ulcerative colitis; sent to ICU; pain was ongoing with etiology unknown; no UTI; underwent subtotal abdominal colectomy and end ileostomy for ulcerative colitis; pt's status worsened in ICU, experienced hypotension despite pressors given; comfort care instituted and pt extubated; pt expired in the hosp
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, Colectomy, Colitis ulcerative, Condition aggravated
Clinical narrative: diagnosed positive for COVID 10 days before hosp admission; presented to hosp with increasing abdominal pain; hx of ulcerative colitis; sent to ICU; pain was ongoing with etiology unknown; no UTI; underwent subtotal abdominal colectomy and end ileostomy for ulcerative colitis; pt's status worsened in ICU, experienced hypotension despite pressors given; comfort care instituted and pt extubated; pt expired in the hosp
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Hypotension, Ileostomy, Intensive care, SARS-CoV-2 test positive
Clinical narrative: diagnosed positive for COVID 10 days before hosp admission; presented to hosp with increasing abdominal pain; hx of ulcerative colitis; sent to ICU; pain was ongoing with etiology unknown; no UTI; underwent subtotal abdominal colectomy and end ileostomy for ulcerative colitis; pt's status worsened in ICU, experienced hypotension despite pressors given; comfort care instituted and pt extubated; pt expired in the hosp
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Appendicectomy, Appendicitis perforated, Blood test, Body temperature increased, Computerised tomogram
Clinical narrative: Had her appendix removed; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 16Sep2021 (Lot Number: FC3183) as dose 1, single (at the age of 69 years old) for COVID-19 immunization. Medical history included COVID from unspecified date. There were no concomitant medications. Weight was 63.96 kg and height was 173 cm. The patient had her appendix removed on 18Sep2021 at 19:05. Stated that she was reading the paper when she got first vaccine for Pfizer. Stated that she had wanted to know what to do about side effects. Stated that she called and talked to pharmacy that got vaccine 16Sep2021 and two days later was in urgent care and had appendix removed. Stated that three days later called doctor for after surgery appointment. Stated that she reported side effects to FDA and CDC. Stated that she was told to call Pfizer. Stated that the doctor told her to have the vaccine. Stated that she did not have it previously because she had a paper that said she had antibodies. Stated that she went to the doctor and had a couple of more tests done. No further details provided. Stated that she had a paper that she got 6 months prior and was a blood donor who was told that she may have had COVID before and had antibodies. Stated that on 25Aug2021, about two months ago she had her wellness check and the test showed no antibodies so she was told to go and get the vaccine. It was for the first dose. Clarified that it was the Pfizer BioNTech. Stated that she was transferred from urgent care to the hospital where she stayed for three days. The patient was hospitalized for had her appendix removed from 18Sep2021 to 21Sep2021. There were no history of previous immunization with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer suspect. Did not require a visit to emergency room or physician office. No prior vaccinations (within 4 weeks) or any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The patient underwent lab tests and procedures which included tests: unknown result on unspecified date and wellness check test: no antibodies on 25Aug2021. Therapeutic measures were taken as a result of had her appendix removed. The outcome of the event was recovering.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Had her appendix removed; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 16Sep2021 (Lot Number: FC3183) as dose 1, single (at the age of 69 years old) for COVID-19 immunization. Medical history included COVID from unspecified date. There were no concomitant medications. Weight was 63.96 kg and height was 173 cm. The patient had her appendix removed on 18Sep2021 at 19:05. Stated that she was reading the paper when she got first vaccine for Pfizer. Stated that she had wanted to know what to do about side effects. Stated that she called and talked to pharmacy that got vaccine 16Sep2021 and two days later was in urgent care and had appendix removed. Stated that three days later called doctor for after surgery appointment. Stated that she reported side effects to FDA and CDC. Stated that she was told to call Pfizer. Stated that the doctor told her to have the vaccine. Stated that she did not have it previously because she had a paper that said she had antibodies. Stated that she went to the doctor and had a couple of more tests done. No further details provided. Stated that she had a paper that she got 6 months prior and was a blood donor who was told that she may have had COVID before and had antibodies. Stated that on 25Aug2021, about two months ago she had her wellness check and the test showed no antibodies so she was told to go and get the vaccine. It was for the first dose. Clarified that it was the Pfizer BioNTech. Stated that she was transferred from urgent care to the hospital where she stayed for three days. The patient was hospitalized for had her appendix removed from 18Sep2021 to 21Sep2021. There were no history of previous immunization with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer suspect. Did not require a visit to emergency room or physician office. No prior vaccinations (within 4 weeks) or any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The patient underwent lab tests and procedures which included tests: unknown result on unspecified date and wellness check test: no antibodies on 25Aug2021. Therapeutic measures were taken as a result of had her appendix removed. The outcome of the event was recovering.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Appendix disorder, Investigation, Physical examination
Clinical narrative: Had her appendix removed; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 16Sep2021 (Lot Number: FC3183) as dose 1, single (at the age of 69 years old) for COVID-19 immunization. Medical history included COVID from unspecified date. There were no concomitant medications. Weight was 63.96 kg and height was 173 cm. The patient had her appendix removed on 18Sep2021 at 19:05. Stated that she was reading the paper when she got first vaccine for Pfizer. Stated that she had wanted to know what to do about side effects. Stated that she called and talked to pharmacy that got vaccine 16Sep2021 and two days later was in urgent care and had appendix removed. Stated that three days later called doctor for after surgery appointment. Stated that she reported side effects to FDA and CDC. Stated that she was told to call Pfizer. Stated that the doctor told her to have the vaccine. Stated that she did not have it previously because she had a paper that said she had antibodies. Stated that she went to the doctor and had a couple of more tests done. No further details provided. Stated that she had a paper that she got 6 months prior and was a blood donor who was told that she may have had COVID before and had antibodies. Stated that on 25Aug2021, about two months ago she had her wellness check and the test showed no antibodies so she was told to go and get the vaccine. It was for the first dose. Clarified that it was the Pfizer BioNTech. Stated that she was transferred from urgent care to the hospital where she stayed for three days. The patient was hospitalized for had her appendix removed from 18Sep2021 to 21Sep2021. There were no history of previous immunization with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer suspect. Did not require a visit to emergency room or physician office. No prior vaccinations (within 4 weeks) or any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The patient underwent lab tests and procedures which included tests: unknown result on unspecified date and wellness check test: no antibodies on 25Aug2021. Therapeutic measures were taken as a result of had her appendix removed. The outcome of the event was recovering.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Cardiac stress test, Diastolic dysfunction, Dizziness, Dyspnoea
Clinical narrative: myocarditis; arrhythmia has gotten worse; diastolic dysfunction; shortness of breath; heart palpitations; upset stomach; brain fog; vertigo; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6205) at the age of 73-years, via an unspecified route of administration in left arm on 27Feb2021 at single dose for COVID-19 immunization, at public health clinic. Medical history included mildly elevated cholesterol; allergy to sulfa; prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Concomitant medication included rosuvastatin calcium (CRESTOR) to control mildly elevated cholesterol. The patient historically received first single dose of BNT162B2 (lot number: Em9810) in left arm on 06Feb2021 (at the age of 73-years) for COVID-19 Immunization. The patient previously received ciprofloxin and had allergy. It was reported that symptoms began within a few days. 1st was heart palpitations then upset stomach requiring medication, now shortness of breath, at a times brain fog and vertigo. Also more recently the arrhythmia had gotten worse. After ECG, ECHO, Holter, stress test and MRI- diagnosed with myocarditis, diastolic dysfunction and arrhythmia. The events occurred on 06Mar2021. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included starting steroids and rest protocol. On 29Jun2021, COVID-19 PCR test (nasal swab) was negative. Outcome of the events was not recovered.