chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Wheezing
Clinical narrative: some trouble breathing; just a little wheezy at first; started not feeling well; Blood pressure reading high; Heart rate increased; A spontaneous report was received from a consumer who was also a 50 years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced some trouble breathing, started not feeling well, just a little wheezy at first, blood pressure increased and heart rate increased.  The patient's medical history included asthma and interstitial lung disease. Products known to have been used by the patient included were "oxygen tank" and "nebulizer medicines".  The patient received their first of two planned doses of mRNA-1273 (Batch number: 031L20A) on 19 Feb 2021, approximately one day prior to the onset of the symptoms intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 19 Feb 2021 about 8 minutes after the shot, patient experienced not feeling well, breathing trouble, wheezy, high blood pressure and heart rate. Patient blood pressure shot up to 210/112, heart rate was 160.  On 19 Feb 2021, patient ended up in the hospital with IV steroids and other meds, she went home on 20 Feb 2021. On 22 Feb 2021, her breathing was worse and did not feel well and she was back in the hospital. On 26 Feb 2021 patient was discharged from the hospital.  Action taken with the drug in response to the events were not reported.  The outcome of the event, some trouble breathing was considered as not recovered. The outcome of events,just a little wheezy at first and started not feeling well, blood pressure increased and heart rate increased were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: potential Bell's palsy; A spontaneous report was received from a 84-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was diagnosed with Bell's palsy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 07-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. Approximately around 25-FEB-2021, the patient's face started to droop. She was unable to close her eyes. The patient went to the emergency room. The patient was diagnosed with potential Bell's palsy and was prescribed prednisone. The patient was asked to follow-up with the physician.  On 07-MAR-2021, the patient received their second of two planned doses of mRNA-1273 (lot number: unknown) intramuscular for prophylaxis of COVID-19 infection. The patient had an appointment with her physician on 15-MAR-2021.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event potential bell's palsy was unknown.  The reporter did not provide the assessment for the event, Bell's palsy.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Patient got very sick and was hospitalized; A spontaneous report was received from a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and patient got very sick and was hospitalized.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.  On an unknown date, the patient reported that that after receiving her first dose of the Moderna vaccine, the patient got very sick and had to be hospitalized. No further information was provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event, patient got very sick and was hospitalized was unknown.  The reporter did not provide an assessment for the event patient got very sick and was hospitalized.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Diplegia, Tenderness, Tremor
Clinical narrative: Could not move their legs; Legs were shaky shaky shaky/Hands were trembling and shaking; Tender arm; A spontaneous report was received from a consumer concerning a 96-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced not being able to move her legs, legs were shaky, hands were trembling and arm was tender.  The patient's medical history included dementia. Concomitant medications were not mentioned.   On 04 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 031120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06 Mar 2021, approximately a day prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Mar 2021, prior to receiving mRNA-1273, the patient could not move her legs and  noticed her legs were shaky. Patients daughter had to help her to get up. Hands were trembling and shaking (could not drink from a glass of water and had to use a straw).  it affected her muscles; her legs were like jelly. She is in mild mid-stage of dementia but it had no impact on that level. She only had a tender arm after the first dose. Treatment for the events was not mentioned.   Action taken with mRNA-1273 in response to the events is not applicable as both doses of the vaccine have been taken.   The events, legs were shaky,hands were trembling, were considered resolved on 08 Mar 2021 and outcome of arm tenderness was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Very sick; A spontaneous report was received from a consumer concerning a patient (age and gender unknown), who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hospitalization for being very sick and with some underlying sickness.  The patient's medical history was not reported. Concomitant medications were not mentioned.   On an unmentioned date, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the reporter stated that after receiving second dose of the vaccine the patient was in hospital and very sick.  Treatment for the events was not mentioned.   Action taken with mRNA-1273 in response to the events is not applicable as both doses of the vaccine have been taken.   The outcome of the events, very sick with underlying sickness, was considered unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; A spontaneous report was received from a consumer concerning a 64-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy (facial paralysis).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Mar 2021, at 13:00, four hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient had had Bell's palsy and had to go to the emergency room (ER). They went to the emergency room (ER) because they though the patient was having a stroke. Treatment details included IV (intravenous) medication.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event of Bell's palsy was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Muscle spasms, Papule, Swollen tongue, Vaccination site erythema
Clinical narrative: tongue swelling; fingers cramping up; flu like symptoms; white dot big as dime solid white; swelling in her arm; arm  red; pain all the way down to arm; A spontaneous report was received from a consumer concerning a 62-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tongue swelling,  white dot big as dime solid white (papule), fingers cramping up (muscle spasms), flu like symptoms, vaccination site swelling, vaccination site erythema and  vaccination site pain.  The patient's medical history was not provided. Concomitant medications reported were levothyroxine, lisinopril , premarin 0.625, omeprazole, valacyclovir, d-amphetamine salt.  On 05-Mar-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced swelling in her arm, . arm red, white dot big as dime solid white, tongue swelling, pain all the way down to arm , fingers cramping up, flu like symptoms.  On 07-Mar-2021 the patient reported to the hospital, was evaluated by a physician who took blood and advised her to go home and take diphenhydramine. Treatment details included tylenol and benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, tongue swelling,white dot big as dime solid white,fingers cramping up, flu like symptoms, vaccination site swelling, vaccination site erythema and vaccination site pain, was considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: tongue swelling; fingers cramping up; flu like symptoms; white dot big as dime solid white; swelling in her arm; arm  red; pain all the way down to arm; A spontaneous report was received from a consumer concerning a 62-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tongue swelling,  white dot big as dime solid white (papule), fingers cramping up (muscle spasms), flu like symptoms, vaccination site swelling, vaccination site erythema and  vaccination site pain.  The patient's medical history was not provided. Concomitant medications reported were levothyroxine, lisinopril , premarin 0.625, omeprazole, valacyclovir, d-amphetamine salt.  On 05-Mar-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced swelling in her arm, . arm red, white dot big as dime solid white, tongue swelling, pain all the way down to arm , fingers cramping up, flu like symptoms.  On 07-Mar-2021 the patient reported to the hospital, was evaluated by a physician who took blood and advised her to go home and take diphenhydramine. Treatment details included tylenol and benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, tongue swelling,white dot big as dime solid white,fingers cramping up, flu like symptoms, vaccination site swelling, vaccination site erythema and vaccination site pain, was considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hallucination, Nausea, Vomiting
Clinical narrative: Hallucinations; Dizziness; Fatigue; Nausea; Vomiting; A spontaneous report was received from a consumer, concerning her husband, a 77-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hallucinations, dizziness, fatigue, nausea and vomiting.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) via unknown route for prophylaxis of COVID-19 infection. On 01 Mar 2021, approximately three days prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 03 Mar 2021, after second dose of vaccine, the patient experienced nausea and vomiting, fatigue, dizziness, and hallucinations. The event hallucinations were considered to be medically significant. The patient was also not been out bed for seven days. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable.    The outcome of the events, hallucinations, dizziness, fatigue, nausea and vomiting were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (dizziness, fatigue, nausea, and vomiting), a causal relationship cannot be excluded. Very limited information regarding these event (hallucination) has been provided at this time. Medical history and concomitant medications are required for assessment. However, further information has been requested. However, fatigue, nausea, and vomiting are expected for mRNA1273.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Hospitalized with AFIB; A spontaneous report was received from a consumer concerning a  female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: hospitalized with AFIB (atrial fibrillation).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Hospitalized with AFIB.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event(s), hospitalized with afib was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Seizure
Clinical narrative: Headache; Mild seizure; A spontaneous report was received from a consumer concerning a 51-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events mild seizure, headache.  The patient's medical history included seizures. Concomitant medications reported were oxcarbazepine 300 mg three tablets twice daily and topiramate 100 mg one tablet twice daily, both were used for an unknown indication.  On 10 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 002A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 10 Mar 2021, Patient reported that approximately 30 minutes later after receiving the vaccine, she had a mild seizure that lasted a few seconds. Patient stated she sat still and let it pass.Patient stated she now has a headache. No treatment information was provided.  The seriousness criterion for the event mild seizure was medically significant.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, mild seizure and headache was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram
Clinical narrative: gasping air issues/ severe breathing issues; A spontaneous report was received from a consumer concerning a 66-year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced gasping air issues or severe breathing issues (gasping).  The patient's medical history was not reported. Concomitant product use was not reported.  On 19 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 20 Feb 2021, next day of receiving vaccine, patient experienced gasping air issues and had went to the emergency room because of severe breathing issues.   He was admitted into the hospital and on 22 Feb 2021, they had put him on a pacemaker. He also had a little bump on electrocardiogram (EKG). His second shot was scheduled on 16 Mar 2021.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, gasping was recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Chills, Fatigue
Clinical narrative: Chills; Fatigue; Bell's palsy; A spontaneous report was received from a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills and bell's palsy.  The patient's medical history was not provided.  Concomitant medications include daily vitamin.  On 15-JAN-2021, prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly for prophylaxis of COVID-19 infection. A few hours after receiving  the Covid-19 vaccine, the patient had chills for a day. On 08-FEB-2021, 25 days after receiving the vaccine, the patient experienced bell's palsy on her left side of the face. On 12-FEB-2021, the patient received her second of two planned doses of mRNA-1273 (lot/batch: 043L20A) intramuscularly on left arm for prophylaxis of COVID-19 infection.  Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not applicable as the patient already received the second dose of the vaccine.   The outcome of event(s), chills was recovered and the outcome for the event bell's palsy was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; A spontaneous report was received from a consumer concerning a 76-year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed fever (pyrexia).  The patient's medical history was not reported. Concomitant products included chemotherapy.  On 25 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 002A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Feb 2021, next day of receiving vaccine, the patient developed fever and was taken to the emergency room and subsequently admitted on 02 Mar 21 for the fever. Treatment for the event included were antibiotics.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the event is not applicable.  The outcome of event, fever was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Deep vein thrombosis, Dyspnoea, Fatigue, Pulmonary embolism
Clinical narrative: Difficulty breathing; Chest pains; Blood clots in both of her lungs; Blood clots in both legs; Tired/ wiped out; A spontaneous report was received from a consumer (patient's daughter), concerning a 75-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced difficulty breathing (dyspnoea), chest pains, blood clots in both of her lungs (pulmonary embolism), blood clots in both legs (deep vein thrombosis), tired/ wiped out (fatigue).   No medical history was reported. No concomitant medications were reported.  On 03 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided).  On 03 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient was completely wiped out for a couple of days following the vaccine. She was very tired and out of it. On an unknown date, over the weekend, the patient had difficulty breathing. On 08 Mar 2021, in the morning, the patient was hospitalized for chest pains and difficulty breathing. On the same day lab data revealed that she had blood clots in both of her lungs. On an unknown date, the patient had clots in both legs as well. She was hospitalized for a week and was in rehabilitation being monitored. The reporter also informed that the patient will be hospitalized until 18 Mar 2021 for the clots in both legs. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The outcome of the events of difficulty breathing (dyspnoea), chest pains, blood clots in both of her lungs (pulmonary embolism), blood clots in both legs (deep vein thrombosis), tired/ wiped out (fatigue) was unknown.  The reporter did not provide assessment for the events of difficulty breathing (dyspnoea), chest pains, blood clots in both of her lungs (pulmonary embolism), blood clots in both legs (deep vein thrombosis), tired/ wiped out (fatigue). Follow-up received on 16 Mar 2021 included hospitalization end date, date of first dose of vaccine.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Asthenia, Back pain, Body temperature, Body temperature increased
Clinical narrative: Ground Glass Opaque lung problem; Weak; nausea; diff.breathing; pain on rt.side waist around to back,down to lower belly; slight temp almost 100; pain on rt.side waist around to back,down to lower belly; pain on rt.side waist around to back,down to lower belly; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Left Arm on 22Jan2021 10:45 am as SINGLE DOSE for covid-19 immunisation. Medical history included overweight, sleep apnoea syndrome and ongoing shortness of breath. Concomitant medication included levothyroxine strength 125 mcg; triamterene; colecalciferol (VIT.D3) and thiamine (VITAMIN B1). The patient previously took tylenol and experienced drug intolerance (Known allergies: Cannot tolerate anything but Tylenol). No other vaccine in four weeks. Facility type vaccine was Workplace clinic. The patient experienced weak (asthenia) on 23Jan2021 15:00, nausea on 23Jan2021 15:00, diff. breathing (dyspnoea) on 23Jan2021 15:00, pain on rt.side waist around to back, down to lower belly (pain) on an unspecified date in 2021, ground glass opaque lung problem (lung opacity) on an unspecified date, slight temp almost 100 (body temperature increased) on an unspecified date in 2021 and pain on rt.side waist around to back, down to lower belly both on an unspecified date in 2021. AE resulted in [Emergency room/department or urgent care]. Treatment was received for these events (Levofloxacin 500mg). It was reported that Weak, nausea, diff. breathing, urgent care on Fri. 05Feb2021, with pain on rt. side waist around to back, down to lower belly. Contrast Cat Scan showed no signs where pain was, but found Ground Glass Opaque lung problem. Is it safe to take #2 vaccine I'm on oxygen now, slight temp almost 100, usually 97. There was no covid prior vaccination. Patient has covid tested post vaccination as SARS-COV-2 test: negative (Nasopharyngeal) on 05Feb2021. The outcome of events was not recovered.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Lung opacity, Nausea, Pain
Clinical narrative: Ground Glass Opaque lung problem; Weak; nausea; diff.breathing; pain on rt.side waist around to back,down to lower belly; slight temp almost 100; pain on rt.side waist around to back,down to lower belly; pain on rt.side waist around to back,down to lower belly; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Left Arm on 22Jan2021 10:45 am as SINGLE DOSE for covid-19 immunisation. Medical history included overweight, sleep apnoea syndrome and ongoing shortness of breath. Concomitant medication included levothyroxine strength 125 mcg; triamterene; colecalciferol (VIT.D3) and thiamine (VITAMIN B1). The patient previously took tylenol and experienced drug intolerance (Known allergies: Cannot tolerate anything but Tylenol). No other vaccine in four weeks. Facility type vaccine was Workplace clinic. The patient experienced weak (asthenia) on 23Jan2021 15:00, nausea on 23Jan2021 15:00, diff. breathing (dyspnoea) on 23Jan2021 15:00, pain on rt.side waist around to back, down to lower belly (pain) on an unspecified date in 2021, ground glass opaque lung problem (lung opacity) on an unspecified date, slight temp almost 100 (body temperature increased) on an unspecified date in 2021 and pain on rt.side waist around to back, down to lower belly both on an unspecified date in 2021. AE resulted in [Emergency room/department or urgent care]. Treatment was received for these events (Levofloxacin 500mg). It was reported that Weak, nausea, diff. breathing, urgent care on Fri. 05Feb2021, with pain on rt. side waist around to back, down to lower belly. Contrast Cat Scan showed no signs where pain was, but found Ground Glass Opaque lung problem. Is it safe to take #2 vaccine I'm on oxygen now, slight temp almost 100, usually 97. There was no covid prior vaccination. Patient has covid tested post vaccination as SARS-COV-2 test: negative (Nasopharyngeal) on 05Feb2021. The outcome of events was not recovered.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Ground Glass Opaque lung problem; Weak; nausea; diff.breathing; pain on rt.side waist around to back,down to lower belly; slight temp almost 100; pain on rt.side waist around to back,down to lower belly; pain on rt.side waist around to back,down to lower belly; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Left Arm on 22Jan2021 10:45 am as SINGLE DOSE for covid-19 immunisation. Medical history included overweight, sleep apnoea syndrome and ongoing shortness of breath. Concomitant medication included levothyroxine strength 125 mcg; triamterene; colecalciferol (VIT.D3) and thiamine (VITAMIN B1). The patient previously took tylenol and experienced drug intolerance (Known allergies: Cannot tolerate anything but Tylenol). No other vaccine in four weeks. Facility type vaccine was Workplace clinic. The patient experienced weak (asthenia) on 23Jan2021 15:00, nausea on 23Jan2021 15:00, diff. breathing (dyspnoea) on 23Jan2021 15:00, pain on rt.side waist around to back, down to lower belly (pain) on an unspecified date in 2021, ground glass opaque lung problem (lung opacity) on an unspecified date, slight temp almost 100 (body temperature increased) on an unspecified date in 2021 and pain on rt.side waist around to back, down to lower belly both on an unspecified date in 2021. AE resulted in [Emergency room/department or urgent care]. Treatment was received for these events (Levofloxacin 500mg). It was reported that Weak, nausea, diff. breathing, urgent care on Fri. 05Feb2021, with pain on rt. side waist around to back, down to lower belly. Contrast Cat Scan showed no signs where pain was, but found Ground Glass Opaque lung problem. Is it safe to take #2 vaccine I'm on oxygen now, slight temp almost 100, usually 97. There was no covid prior vaccination. Patient has covid tested post vaccination as SARS-COV-2 test: negative (Nasopharyngeal) on 05Feb2021. The outcome of events was not recovered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, Decreased appetite, Dizziness
Clinical narrative: Fever of 3 degrees; extreme fatigue; nausea; dizziness; loss of appetite; loss of smell/taste; loss of smell/taste; sore throat; This is a spontaneous report from a contactable consumer.  A 72-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 06Feb2021 (Batch/Lot number was not reported) at 72-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did have COVID prior to the vaccination. Medical history included penicillin allergy, Brazil nuts allergy, COVID-19 (recovered from COVID 11 days prior); all from an unknown date and unknown if ongoing. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; citalopram (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; famotidine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. On 07Feb2021 at 04:00, the patient experienced fever of 3 degrees (non-serious), extreme fatigue (non-serious), nausea (non-serious), dizziness (non-serious), loss of appetite (non-serious), loss of smell/taste (non-serious), sore throat (non-serious); which the patient described as "like a mini COVID storm." There was no treatment received due to the events. The patient underwent lab tests and procedures which included body temperature: 3 degrees on 07Feb2021. The clinical outcome of the events was recovered in Feb2021. The patient was not tested for COVID post vaccination.   The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever of 3 degrees; extreme fatigue; nausea; dizziness; loss of appetite; loss of smell/taste; loss of smell/taste; sore throat; This is a spontaneous report from a contactable consumer.  A 72-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 06Feb2021 (Batch/Lot number was not reported) at 72-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did have COVID prior to the vaccination. Medical history included penicillin allergy, Brazil nuts allergy, COVID-19 (recovered from COVID 11 days prior); all from an unknown date and unknown if ongoing. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; citalopram (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; famotidine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. On 07Feb2021 at 04:00, the patient experienced fever of 3 degrees (non-serious), extreme fatigue (non-serious), nausea (non-serious), dizziness (non-serious), loss of appetite (non-serious), loss of smell/taste (non-serious), sore throat (non-serious); which the patient described as "like a mini COVID storm." There was no treatment received due to the events. The patient underwent lab tests and procedures which included body temperature: 3 degrees on 07Feb2021. The clinical outcome of the events was recovered in Feb2021. The patient was not tested for COVID post vaccination.   The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Myalgia, Pain in extremity
Clinical narrative: Low grade fever (100.1F); Achy joints; headache; sore arm, especially at injection site; sore arm, especially at injection site; muscle aches; This is a spontaneous report from a contactable healthcare professional (the patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration in the left arm on 12Feb2021 10:45 (at the age of 44-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: vitamin C and ibuprofen (ADVIL), both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration in the left arm on 22Jan2021 13:45 (at the age of 44-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Feb2021 06:00, the patient experienced low grade fever (100.1F), achy joints, headache, sore arm, especially at injection site, and muscle aches. The clinical course was as follows: Low grade fever (100.1 F), achy joints, headache and sore arm, especially at injection site, at 06:00 on 13Feb2021. Low grade fever lasted for about 10 hours, took ADVIL, which brought temperature to normal level (98.8 F). Slight headache still remained on 14Feb2021, but ADVIL relieved that. Fever and muscle aches dissipated by morning of 14Feb2021. No treatment was received for achy joints, sore arm, especially at injection site, and muscle aches. The clinical outcome of the events fever and muscle aches was recovered on 14Feb2021, and for other events was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Low grade fever (100.1F); Achy joints; headache; sore arm, especially at injection site; sore arm, especially at injection site; muscle aches; This is a spontaneous report from a contactable healthcare professional (the patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration in the left arm on 12Feb2021 10:45 (at the age of 44-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: vitamin C and ibuprofen (ADVIL), both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration in the left arm on 22Jan2021 13:45 (at the age of 44-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Feb2021 06:00, the patient experienced low grade fever (100.1F), achy joints, headache, sore arm, especially at injection site, and muscle aches. The clinical course was as follows: Low grade fever (100.1 F), achy joints, headache and sore arm, especially at injection site, at 06:00 on 13Feb2021. Low grade fever lasted for about 10 hours, took ADVIL, which brought temperature to normal level (98.8 F). Slight headache still remained on 14Feb2021, but ADVIL relieved that. Fever and muscle aches dissipated by morning of 14Feb2021. No treatment was received for achy joints, sore arm, especially at injection site, and muscle aches. The clinical outcome of the events fever and muscle aches was recovered on 14Feb2021, and for other events was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: chills; moderate headache; fatigue; This is a spontaneous report from a contactable nurse, the patient. A 66-year-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: unknown), via an unspecified route of administration in the left arm on 08Feb2021 at 15:45 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included gluten allergies and celiac. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were none. The patient did not have any other vaccines within 4 weeks of the vaccination. On 11Feb2021 at 23:30, the patient experienced chills, moderate headache and fatigue. The events started to resolve on 13Feb2021, but the patient continued to have a very mild intermittent headache. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of chills and fatigue resolved on Feb2021, while moderate headache resolved with sequel on Feb2021.   Information on the lot/batch number has been requested
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Electrocardiogram, Malaise, Scan
Clinical narrative: Dizzy; not feeling well; Constant noise started in my head, sometimes on right, sometimes on left, most of the time my entire head/a "shush"ing sound, like steam evaporating from a teakettle letting out steam; This is a spontaneous report from a contactable consumer, the patient. A 91-years-old  female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown),via an unspecified route of administration in the left arm on 27Jan2021 at 15:00 (at the age of 91-years-old) as a single dose,  for COVID-19 immunisation. The patient had no known medical history or allergies.The vaccine was administered at a Nursing Home/ Facility. Concomitant medications  included macrogol 3350 (MIRALAX) and  losartan potassium (LOSARTAN POTASSIUM) 25 mg.  Historical Vaccine includes  BNT162B2, Dose 1; Administration date: 06Jan2021 at 03:00,  Lot Number Not Provided, in the left arm. On 31Jan2021 at 12:00 the patient experienced dizziness, malaise and tinnitus. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The clinical course was reported as follows. About 4 days after Second shot, on '31JAN2021 at 12:00' patient started to get dizzy and not feeling well. Constant noise started in my head, sometimes on right, sometimes on left, most of the time my entire head. It is like a "shush"ing sound, like steam evaporating from a teakettle letting out steam. This has been for 2 weeks. The patient went to the Emergency Room and/or Doctors Office and was checked, vital signs normal, had scan of head and stomach, EKG and bloodwork. No treatment was given for the events.The noise has never subsided in the past 3 weeks. . The patient underwent lab tests and procedures which included blood test: unknown results on and unknown date,  electrocardiogram: unknown results on an unknown date, Scan of head and stomach  unknown results on an unknown date and  vital signs measurement: normal on an unknown date. The clinical outcome of the event dizzy, malaise and tinnitus was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vital signs measurement
Clinical narrative: Dizzy; not feeling well; Constant noise started in my head, sometimes on right, sometimes on left, most of the time my entire head/a "shush"ing sound, like steam evaporating from a teakettle letting out steam; This is a spontaneous report from a contactable consumer, the patient. A 91-years-old  female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown),via an unspecified route of administration in the left arm on 27Jan2021 at 15:00 (at the age of 91-years-old) as a single dose,  for COVID-19 immunisation. The patient had no known medical history or allergies.The vaccine was administered at a Nursing Home/ Facility. Concomitant medications  included macrogol 3350 (MIRALAX) and  losartan potassium (LOSARTAN POTASSIUM) 25 mg.  Historical Vaccine includes  BNT162B2, Dose 1; Administration date: 06Jan2021 at 03:00,  Lot Number Not Provided, in the left arm. On 31Jan2021 at 12:00 the patient experienced dizziness, malaise and tinnitus. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The clinical course was reported as follows. About 4 days after Second shot, on '31JAN2021 at 12:00' patient started to get dizzy and not feeling well. Constant noise started in my head, sometimes on right, sometimes on left, most of the time my entire head. It is like a "shush"ing sound, like steam evaporating from a teakettle letting out steam. This has been for 2 weeks. The patient went to the Emergency Room and/or Doctors Office and was checked, vital signs normal, had scan of head and stomach, EKG and bloodwork. No treatment was given for the events.The noise has never subsided in the past 3 weeks. . The patient underwent lab tests and procedures which included blood test: unknown results on and unknown date,  electrocardiogram: unknown results on an unknown date, Scan of head and stomach  unknown results on an unknown date and  vital signs measurement: normal on an unknown date. The clinical outcome of the event dizzy, malaise and tinnitus was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive for Covid-19/patient vaccinated first dose 21Jan2021; she tested positive for Covid-19/temperature rose to 98.7; This is a spontaneous report from a contactable consumer (patient). A 70 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249), via an unspecified route of administration on left arm on 21Jan2021 (at the age of 70 -years-old), single dose for COVID-19 immunization. Medical history included hypertension. The patient's concomitant medication included unspecified hypertension medicine. The patient received the first dose of the Pfizer-BioNTech Covid-19 Vaccine last 21Jan2021, and was originally scheduled to receive the 2nd dose on 11Feb2021. However, she tested positive for Covid-19 on February 4, 2021 performed via swab in the mouth, under the tongue and the tonsils. She said she had been in quarantine ever since. She also mentioned that her temperature rose to 98.7, and had to take two tylenol for it. The patient has continued isolation/quarantine, has not gone around anyone. She is by herself and does not go around other people anyway. She feels fine. She did not get the second dose of Pfizer COVID-19 Vaccine as scheduled on 11Feb2021. She wanted to stay in quarantine as she is supposed to. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 49 (units unknown) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 24Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 24Jan2021 and tested positive for COVID-19 on 14Feb2021. The patient called to ask whether the second dose of the vaccine would cause harm to her since she now had COVID-19. The patient stated that according to her doctors, they were unable to give her information on whether she could get the second dose or not. The patient wanted to know "if she could not get the second dose today, when could she get it?" She stated that she was married to someone who was negative for COVID-19. The patient asked if "she got the COVID-19 vaccine and tested positive later on, would that cause harm?" The clinical outcome of the event "COVID-19 confirmed by positive COVID-19 test" was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives inside [her] forearm; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number unknown, via an unspecified route of administration on 06Feb2021 as a single dose for COVID-19 immunization.  The patient had the first dose of BNT162B2 as COVID-19 immunisation on unspecified date, and lot number.  Medical history and concomitant medication were not reported.  On 06Feb2021 the patient experienced hives on opposite arm of injection arm.  She said she had not realized up until 1 hour after the injection that she had "hives inside [her] forearm". She added the hives got "more and more and are spreading from the interior of [her] forearm to her elbow, shoulder blade, and the tip of [her] finger".  Treatment included Benadryl for two days and "it doesn't help" and therefore, she stopped taking.  It's been 9 days now. It is still spreading.  The outcome of hives was not recovered.  Information on the lot/batch number has been requested.