chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: sore arm. Cannot raise above my head; Sore arm; numbness and tingling of lips and tongue; numbness and tingling of lips and tongue; Back began to itch; Slight headache; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN5318) via an unspecified route of administration on the left arm on 01Feb2021 14:30 at a single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, IBS, indigestion, heart burn, colon polys removed, Morton neuroma, torn meniscus left and right, total hyst with bilat oophorectomy and tonsils removed, Shellfish allergy and many medication allergies. Concomitant medication included metoprolol, hydrochlorothiazide, colecalciferol (VIT D3), zinc and pyridoxine hydrochloride (B6). The patient previously took epipen for shellfish allergy. Sat in waiting area 15 minutes as directed. After leaving in car about 10 min. Into ride home she experienced numbness and tingling of lips and tongue on 01Feb2021 15:00. Eventually subsided by 5 pm. Back began to itch, no rash nor hives subsided in about 10 min. Sore arm started about 17:00. Slight headache during night and sore arm continued esp. to lay on left arm impossible. At 8:18 a.m. still sore arm. Cannot raise above my head. No swelling in arm at injection site. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events numbness and tingling of lips and tongue and Back began to itch was recovered on 01Feb2021 while outcome of the other events was not recovered.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia oral, Mobility decreased, Pain in extremity, Paraesthesia oral
Clinical narrative: sore arm. Cannot raise above my head; Sore arm; numbness and tingling of lips and tongue; numbness and tingling of lips and tongue; Back began to itch; Slight headache; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN5318) via an unspecified route of administration on the left arm on 01Feb2021 14:30 at a single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, IBS, indigestion, heart burn, colon polys removed, Morton neuroma, torn meniscus left and right, total hyst with bilat oophorectomy and tonsils removed, Shellfish allergy and many medication allergies. Concomitant medication included metoprolol, hydrochlorothiazide, colecalciferol (VIT D3), zinc and pyridoxine hydrochloride (B6). The patient previously took epipen for shellfish allergy. Sat in waiting area 15 minutes as directed. After leaving in car about 10 min. Into ride home she experienced numbness and tingling of lips and tongue on 01Feb2021 15:00. Eventually subsided by 5 pm. Back began to itch, no rash nor hives subsided in about 10 min. Sore arm started about 17:00. Slight headache during night and sore arm continued esp. to lay on left arm impossible. At 8:18 a.m. still sore arm. Cannot raise above my head. No swelling in arm at injection site. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events numbness and tingling of lips and tongue and Back began to itch was recovered on 01Feb2021 while outcome of the other events was not recovered.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Gait disturbance, Illness, Impaired work ability, Influenza like illness
Clinical narrative: couldn't walk; could not move her legs, her waist, and her hips; This is a spontaneous report from a contactable consumer, the patient. This 55-year-old  female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  2 , single dose via an unspecified route of administration for COVID-19 vaccination on 14Jan2021. Medical history and concomitant medication were not reported.  On 15Jan2021, the patient couldn't walk and could not move her legs, her waist, and her hips. This has never happened before. It has been a month since the incident happened and it has not been resolved. She has been in the hospital for 6 days now receiving physical therapy and is waiting for a follow up appointment from her doctor. She is using a walker to assist her in walking. The clinical outcomes of events couldn't walk and could not move her legs, her waist, and her hips is  not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Pain, Pain in extremity, SARS-CoV-2 test negative, Tenderness
Clinical narrative: couldn't walk; could not move her legs, her waist, and her hips; This is a spontaneous report from a contactable consumer, the patient. This 55-year-old  female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  2 , single dose via an unspecified route of administration for COVID-19 vaccination on 14Jan2021. Medical history and concomitant medication were not reported.  On 15Jan2021, the patient couldn't walk and could not move her legs, her waist, and her hips. This has never happened before. It has been a month since the incident happened and it has not been resolved. She has been in the hospital for 6 days now receiving physical therapy and is waiting for a follow up appointment from her doctor. She is using a walker to assist her in walking. The clinical outcomes of events couldn't walk and could not move her legs, her waist, and her hips is  not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait inability, Movement disorder
Clinical narrative: couldn't walk; could not move her legs, her waist, and her hips; This is a spontaneous report from a contactable consumer, the patient. This 55-year-old  female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  2 , single dose via an unspecified route of administration for COVID-19 vaccination on 14Jan2021. Medical history and concomitant medication were not reported.  On 15Jan2021, the patient couldn't walk and could not move her legs, her waist, and her hips. This has never happened before. It has been a month since the incident happened and it has not been resolved. She has been in the hospital for 6 days now receiving physical therapy and is waiting for a follow up appointment from her doctor. She is using a walker to assist her in walking. The clinical outcomes of events couldn't walk and could not move her legs, her waist, and her hips is  not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Arthralgia, Blood test, Chest X-ray, Condition aggravated
Clinical narrative: couldn't walk; could not move her legs, her waist, and her hips; This is a spontaneous report from a contactable consumer, the patient. This 55-year-old  female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  2 , single dose via an unspecified route of administration for COVID-19 vaccination on 14Jan2021. Medical history and concomitant medication were not reported.  On 15Jan2021, the patient couldn't walk and could not move her legs, her waist, and her hips. This has never happened before. It has been a month since the incident happened and it has not been resolved. She has been in the hospital for 6 days now receiving physical therapy and is waiting for a follow up appointment from her doctor. She is using a walker to assist her in walking. The clinical outcomes of events couldn't walk and could not move her legs, her waist, and her hips is  not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Electromyogram, Gait disturbance, Headache, Magnetic resonance imaging
Clinical narrative: couldn't walk; could not move her legs, her waist, and her hips; This is a spontaneous report from a contactable consumer, the patient. This 55-year-old  female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  2 , single dose via an unspecified route of administration for COVID-19 vaccination on 14Jan2021. Medical history and concomitant medication were not reported.  On 15Jan2021, the patient couldn't walk and could not move her legs, her waist, and her hips. This has never happened before. It has been a month since the incident happened and it has not been resolved. She has been in the hospital for 6 days now receiving physical therapy and is waiting for a follow up appointment from her doctor. She is using a walker to assist her in walking. The clinical outcomes of events couldn't walk and could not move her legs, her waist, and her hips is  not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Movement disorder, Pain, Pain in extremity, Swelling, Vomiting
Clinical narrative: couldn't walk; could not move her legs, her waist, and her hips; This is a spontaneous report from a contactable consumer, the patient. This 55-year-old  female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  2 , single dose via an unspecified route of administration for COVID-19 vaccination on 14Jan2021. Medical history and concomitant medication were not reported.  On 15Jan2021, the patient couldn't walk and could not move her legs, her waist, and her hips. This has never happened before. It has been a month since the incident happened and it has not been resolved. She has been in the hospital for 6 days now receiving physical therapy and is waiting for a follow up appointment from her doctor. She is using a walker to assist her in walking. The clinical outcomes of events couldn't walk and could not move her legs, her waist, and her hips is  not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inadvertently received both doses of the COVID vaccine 6 days apart; This is a spontaneous report from a contactable nurse. An 86-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (unsure which arm administered to or time, patient thought could be right arm) on 02Feb2021 at single dose for COVID-19 immunisation. Medical history included dementia. There were no concomitant medications. The patient previously took BNT162B2 for COVID-19 immunisation on 27Jan2021. The patient inadvertently received both doses of the bnt162b2 6 days apart on 02Feb2021.  Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: He was released from his job on 01Jan2021 and was supposed to get the second COVID vaccination on 06Jan2021 but he did not and never got his second shot; tested positive for COVID/Got covid Jan 9th to 23rd; tested positive for COVID/Got covid Jan 9th to 23rd; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. He was released from his job on 01Jan2021 and was supposed to get the second COVID vaccination on 06Jan2021 but he did not and never got his second shot. He then tested positive for COVID on 18Jan2021. It was reported that the patient got COVID from 09Jan2021 to 23Jan2021. The outcome of events was unknown.    Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: He was released from his job on 01Jan2021 and was supposed to get the second COVID vaccination on 06Jan2021 but he did not and never got his second shot; tested positive for COVID/Got covid Jan 9th to 23rd; tested positive for COVID/Got covid Jan 9th to 23rd; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. He was released from his job on 01Jan2021 and was supposed to get the second COVID vaccination on 06Jan2021 but he did not and never got his second shot. He then tested positive for COVID on 18Jan2021. It was reported that the patient got COVID from 09Jan2021 to 23Jan2021. The outcome of events was unknown.    Information on the lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Magnetic resonance imaging, Retching
Clinical narrative: Very dizzy (room spinning falling)/ Dizziness; Dry heaves; Briefly queasy; Brief feeling of coming down with cold; Sinus swelling; Quickly fatigued still here a week later; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration at the right arm on 23Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included environmental allergies (many), gastrooesophageal reflux disease, atrial tachycardia, blood pressure abnormal, cholecystectomy, hysterectomy, retinopexy, cellulitis, sepsis and pneumonia from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications included diltiazem, dexlansoprazole (DEXILANT), flecainide, hctz , and triamterene. The patient previously received and experienced allergies from ciprofloxacin hydrochloride (CIPRO), cefalexin (KEFLEX), tetracycline, sulfamethoxazole, trimethoprim (BACTRIM), glycopyrronium bromide (ROBINUL), doxycycline (DORYX), loratadine (CLARITIN), tetracycline hydrochloride (SUMYCIN), lisinopril and clindamycin hydrochloride (CLEOCIN). On the day of shot, on  23Jan2021 10:15 had a brief feeling of coming down with cold. Next day on 24Jan2021, the patient experienced briefly queasy, 3rd day fine, 4th day very dizzy (room spinning falling) and dry heaves. The patient also experienced dizziness, sinus swelling, and fatigued still here a week later. She took weekly immunotherapy shots for her multiple allergies. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 28Jan2021. Therapeutic measure was taken for all the events. Clinical outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Nasopharyngitis, Nausea, Retching
Clinical narrative: Very dizzy (room spinning falling)/ Dizziness; Dry heaves; Briefly queasy; Brief feeling of coming down with cold; Sinus swelling; Quickly fatigued still here a week later; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration at the right arm on 23Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included environmental allergies (many), gastrooesophageal reflux disease, atrial tachycardia, blood pressure abnormal, cholecystectomy, hysterectomy, retinopexy, cellulitis, sepsis and pneumonia from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications included diltiazem, dexlansoprazole (DEXILANT), flecainide, hctz , and triamterene. The patient previously received and experienced allergies from ciprofloxacin hydrochloride (CIPRO), cefalexin (KEFLEX), tetracycline, sulfamethoxazole, trimethoprim (BACTRIM), glycopyrronium bromide (ROBINUL), doxycycline (DORYX), loratadine (CLARITIN), tetracycline hydrochloride (SUMYCIN), lisinopril and clindamycin hydrochloride (CLEOCIN). On the day of shot, on  23Jan2021 10:15 had a brief feeling of coming down with cold. Next day on 24Jan2021, the patient experienced briefly queasy, 3rd day fine, 4th day very dizzy (room spinning falling) and dry heaves. The patient also experienced dizziness, sinus swelling, and fatigued still here a week later. She took weekly immunotherapy shots for her multiple allergies. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 28Jan2021. Therapeutic measure was taken for all the events. Clinical outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Sinus disorder
Clinical narrative: Very dizzy (room spinning falling)/ Dizziness; Dry heaves; Briefly queasy; Brief feeling of coming down with cold; Sinus swelling; Quickly fatigued still here a week later; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration at the right arm on 23Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included environmental allergies (many), gastrooesophageal reflux disease, atrial tachycardia, blood pressure abnormal, cholecystectomy, hysterectomy, retinopexy, cellulitis, sepsis and pneumonia from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications included diltiazem, dexlansoprazole (DEXILANT), flecainide, hctz , and triamterene. The patient previously received and experienced allergies from ciprofloxacin hydrochloride (CIPRO), cefalexin (KEFLEX), tetracycline, sulfamethoxazole, trimethoprim (BACTRIM), glycopyrronium bromide (ROBINUL), doxycycline (DORYX), loratadine (CLARITIN), tetracycline hydrochloride (SUMYCIN), lisinopril and clindamycin hydrochloride (CLEOCIN). On the day of shot, on  23Jan2021 10:15 had a brief feeling of coming down with cold. Next day on 24Jan2021, the patient experienced briefly queasy, 3rd day fine, 4th day very dizzy (room spinning falling) and dry heaves. The patient also experienced dizziness, sinus swelling, and fatigued still here a week later. She took weekly immunotherapy shots for her multiple allergies. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 28Jan2021. Therapeutic measure was taken for all the events. Clinical outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Mouth swelling, Swelling face, Urticaria
Clinical narrative: Did not feel well. Had hives in the morning the morning the next day, post vaccination.  Patient was given an epipen shot for allergic reaction.  Patient was released and not hospitalized.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Malaise, Urticaria
Clinical narrative: Did not feel well. Had hives in the morning the morning the next day, post vaccination.  Patient was given an epipen shot for allergic reaction.  Patient was released and not hospitalized.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Purpura
Clinical narrative: acute Idiopathic purpura (ITP)/Hospitalized twice for critically low platelets.; This is a spontaneous report from a contactable consumer.   A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809) on 07Feb2021 at 08:45 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 08Feb2021 the patient developed idiopathic thrombocytopenic purpura (ITP) within 24 hours from vaccination.  She was hospitalized twice for critically low platelets. The event was considered from as life threatening illness. The patient continued follow up almost daily with her hematologist. Continued IVIG infusions multiple times per week in outpatient clinic. The patient underwent SARS-CoV-2 test which resulted negative on 09Feb2021. The patient had not yet recovered from the event.   Information about Batch/Lot is requested.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Epistaxis, Immune thrombocytopenia, Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: acute Idiopathic purpura (ITP)/Hospitalized twice for critically low platelets.; This is a spontaneous report from a contactable consumer.   A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809) on 07Feb2021 at 08:45 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 08Feb2021 the patient developed idiopathic thrombocytopenic purpura (ITP) within 24 hours from vaccination.  She was hospitalized twice for critically low platelets. The event was considered from as life threatening illness. The patient continued follow up almost daily with her hematologist. Continued IVIG infusions multiple times per week in outpatient clinic. The patient underwent SARS-CoV-2 test which resulted negative on 09Feb2021. The patient had not yet recovered from the event.   Information about Batch/Lot is requested.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immune thrombocytopenia, Platelet count, SARS-CoV-2 test
Clinical narrative: acute Idiopathic purpura (ITP)/Hospitalized twice for critically low platelets.; This is a spontaneous report from a contactable consumer.   A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809) on 07Feb2021 at 08:45 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 08Feb2021 the patient developed idiopathic thrombocytopenic purpura (ITP) within 24 hours from vaccination.  She was hospitalized twice for critically low platelets. The event was considered from as life threatening illness. The patient continued follow up almost daily with her hematologist. Continued IVIG infusions multiple times per week in outpatient clinic. The patient underwent SARS-CoV-2 test which resulted negative on 09Feb2021. The patient had not yet recovered from the event.   Information about Batch/Lot is requested.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Migraine, Pruritus
Clinical narrative: Itching head to toes; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 04Feb2021 16:45 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Allergies to medications, food, or other products: pantoprazole sodium sesquihydrate (PAN), codein, clarithromycin (BIAXIN), atropine, pethidine hydrochloride (demerol). The patient experienced itching head to toes (non-serious) on 05Feb2021 with outcome of recovered. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Itching head to toes; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 04Feb2021 16:45 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Allergies to medications, food, or other products: pantoprazole sodium sesquihydrate (PAN), codein, clarithromycin (BIAXIN), atropine, pethidine hydrochloride (demerol). The patient experienced itching head to toes (non-serious) on 05Feb2021 with outcome of recovered. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: ringing in ears / the ringing has gotten worse; This case was reported by a consumer and described the occurrence of ringing in ears in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number T79D7, expiry date 1st October 2022) for prophylaxis.   On 4th February 2021, the patient received the 1st dose of Shingrix (intramuscular). On 5th February 2021, 1 days after receiving Shingrix, the patient experienced ringing in ears. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the ringing in ears was not recovered/not resolved.   The reporter considered the ringing in ears to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix and on following morning patient experienced ringing in ears. It was stated that on same day afternoon about 2:30 it got so bad and patient contacted to her doctor. The doctor advised the patient to visit ENT,and doctor also called in a prescription for steroids. Patient took steroids and it helped her a little but later in the morning the ringing gotten worse. Reporter considered event was related to the vaccine use. Reporter stated that patient had appointment with an ENT on the day of reporting. The event was reported to the CDC( centers of disease control and prevention ) by the pharmacy. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: ringing in ears / the ringing has gotten worse; This case was reported by a consumer and described the occurrence of ringing in ears in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number T79D7, expiry date 1st October 2022) for prophylaxis.   On 4th February 2021, the patient received the 1st dose of Shingrix (intramuscular). On 5th February 2021, 1 days after receiving Shingrix, the patient experienced ringing in ears. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the ringing in ears was not recovered/not resolved.   The reporter considered the ringing in ears to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix and on following morning patient experienced ringing in ears. It was stated that on same day afternoon about 2:30 it got so bad and patient contacted to her doctor. The doctor advised the patient to visit ENT,and doctor also called in a prescription for steroids. Patient took steroids and it helped her a little but later in the morning the ringing gotten worse. Reporter considered event was related to the vaccine use. Reporter stated that patient had appointment with an ENT on the day of reporting. The event was reported to the CDC( centers of disease control and prevention ) by the pharmacy. The reporter consented to follow up.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Wheezing
Clinical narrative: PATIENT DOES NOT KNOW WHICH VACCINE WAS RECEIVED. Patient vaccine status cannot be tracked. She either received Moderna or Pfizer. Apparently, the patient left the building where she received the vaccine and immediately became disoriented and combative and developed respiratory distress. She was brought in by ambulance to ER. While in the ambulance, she was given 0.3mg epinephrine IM. While in the ambulance, she was placed on 4L of oxygen via nasal cannula. She was also given multiple DuoNeb treatments as well as Benadryl 25mg IV one time, Pepcid 20mg IV one time, and 10mg Decadron  IV one time. She had a chest x-ray performed, which showed pulmonary vascular congestion. She had COVID-19 testing as well as influenza A and B and RSV by PCR, which were all negative. She had a CBC, which showed a leukocytosis of 14.7; however, was otherwise unremarkable. She had a complete metabolic panel, which was essentially unremarkable with the exception of mild elevation of glucose. She had troponins which were elevated, the first was 0.064, second 0.366. She had an ABG that showed pH 7.35, pCO2 of 47, PO2 of 148, bicarbonate 26. Patient will be admitted to the Hospitalist service for further workup and treatment.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aggression, Blood bicarbonate normal, Blood glucose increased, Blood pH normal, Chest X-ray abnormal
Clinical narrative: PATIENT DOES NOT KNOW WHICH VACCINE WAS RECEIVED. Patient vaccine status cannot be tracked. She either received Moderna or Pfizer. Apparently, the patient left the building where she received the vaccine and immediately became disoriented and combative and developed respiratory distress. She was brought in by ambulance to ER. While in the ambulance, she was given 0.3mg epinephrine IM. While in the ambulance, she was placed on 4L of oxygen via nasal cannula. She was also given multiple DuoNeb treatments as well as Benadryl 25mg IV one time, Pepcid 20mg IV one time, and 10mg Decadron  IV one time. She had a chest x-ray performed, which showed pulmonary vascular congestion. She had COVID-19 testing as well as influenza A and B and RSV by PCR, which were all negative. She had a CBC, which showed a leukocytosis of 14.7; however, was otherwise unremarkable. She had a complete metabolic panel, which was essentially unremarkable with the exception of mild elevation of glucose. She had troponins which were elevated, the first was 0.064, second 0.366. She had an ABG that showed pH 7.35, pCO2 of 47, PO2 of 148, bicarbonate 26. Patient will be admitted to the Hospitalist service for further workup and treatment.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disorientation, Influenza A virus test negative, Influenza virus test negative, Leukocytosis, PCO2 increased
Clinical narrative: PATIENT DOES NOT KNOW WHICH VACCINE WAS RECEIVED. Patient vaccine status cannot be tracked. She either received Moderna or Pfizer. Apparently, the patient left the building where she received the vaccine and immediately became disoriented and combative and developed respiratory distress. She was brought in by ambulance to ER. While in the ambulance, she was given 0.3mg epinephrine IM. While in the ambulance, she was placed on 4L of oxygen via nasal cannula. She was also given multiple DuoNeb treatments as well as Benadryl 25mg IV one time, Pepcid 20mg IV one time, and 10mg Decadron  IV one time. She had a chest x-ray performed, which showed pulmonary vascular congestion. She had COVID-19 testing as well as influenza A and B and RSV by PCR, which were all negative. She had a CBC, which showed a leukocytosis of 14.7; however, was otherwise unremarkable. She had a complete metabolic panel, which was essentially unremarkable with the exception of mild elevation of glucose. She had troponins which were elevated, the first was 0.064, second 0.366. She had an ABG that showed pH 7.35, pCO2 of 47, PO2 of 148, bicarbonate 26. Patient will be admitted to the Hospitalist service for further workup and treatment.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: PO2 increased, Pulmonary congestion, Respiratory distress, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: PATIENT DOES NOT KNOW WHICH VACCINE WAS RECEIVED. Patient vaccine status cannot be tracked. She either received Moderna or Pfizer. Apparently, the patient left the building where she received the vaccine and immediately became disoriented and combative and developed respiratory distress. She was brought in by ambulance to ER. While in the ambulance, she was given 0.3mg epinephrine IM. While in the ambulance, she was placed on 4L of oxygen via nasal cannula. She was also given multiple DuoNeb treatments as well as Benadryl 25mg IV one time, Pepcid 20mg IV one time, and 10mg Decadron  IV one time. She had a chest x-ray performed, which showed pulmonary vascular congestion. She had COVID-19 testing as well as influenza A and B and RSV by PCR, which were all negative. She had a CBC, which showed a leukocytosis of 14.7; however, was otherwise unremarkable. She had a complete metabolic panel, which was essentially unremarkable with the exception of mild elevation of glucose. She had troponins which were elevated, the first was 0.064, second 0.366. She had an ABG that showed pH 7.35, pCO2 of 47, PO2 of 148, bicarbonate 26. Patient will be admitted to the Hospitalist service for further workup and treatment.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin increased, White blood cell count increased
Clinical narrative: PATIENT DOES NOT KNOW WHICH VACCINE WAS RECEIVED. Patient vaccine status cannot be tracked. She either received Moderna or Pfizer. Apparently, the patient left the building where she received the vaccine and immediately became disoriented and combative and developed respiratory distress. She was brought in by ambulance to ER. While in the ambulance, she was given 0.3mg epinephrine IM. While in the ambulance, she was placed on 4L of oxygen via nasal cannula. She was also given multiple DuoNeb treatments as well as Benadryl 25mg IV one time, Pepcid 20mg IV one time, and 10mg Decadron  IV one time. She had a chest x-ray performed, which showed pulmonary vascular congestion. She had COVID-19 testing as well as influenza A and B and RSV by PCR, which were all negative. She had a CBC, which showed a leukocytosis of 14.7; however, was otherwise unremarkable. She had a complete metabolic panel, which was essentially unremarkable with the exception of mild elevation of glucose. She had troponins which were elevated, the first was 0.064, second 0.366. She had an ABG that showed pH 7.35, pCO2 of 47, PO2 of 148, bicarbonate 26. Patient will be admitted to the Hospitalist service for further workup and treatment.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Muscle twitching
Clinical narrative: immediately after vaccine injection upper body went into convulsion, uncontrolled jerking and tremor of all extremities. Difficulty Breathing
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dyskinesia, Dyspnoea, Electrocardiogram, Immediate post-injection reaction
Clinical narrative: immediately after vaccine injection upper body went into convulsion, uncontrolled jerking and tremor of all extremities. Difficulty Breathing
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan thyroid gland, Seizure, Tremor, Urine analysis, X-ray
Clinical narrative: immediately after vaccine injection upper body went into convulsion, uncontrolled jerking and tremor of all extremities. Difficulty Breathing
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: lost the ability's to get drunk from Gin or  Wine/The affects of drinking or getting drunk is not longer possible; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Lot number: EL9265) via an unspecified route of administration on 30Jan2021 09:00 at single dose on left arm, for covid-19 immunisation. Medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. After taken first dose, within 4 days the patient lost the ability's to get drunk from Gin or Wine. He said he was not joking. He enjoyed a good drink of wine and or liquor. The affects of drinking or getting drunk was not longer possible. The event occurred on 03Feb2021 20:00. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alcohol intolerance
Clinical narrative: lost the ability's to get drunk from Gin or  Wine/The affects of drinking or getting drunk is not longer possible; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Lot number: EL9265) via an unspecified route of administration on 30Jan2021 09:00 at single dose on left arm, for covid-19 immunisation. Medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. After taken first dose, within 4 days the patient lost the ability's to get drunk from Gin or Wine. He said he was not joking. He enjoyed a good drink of wine and or liquor. The affects of drinking or getting drunk was not longer possible. The event occurred on 03Feb2021 20:00. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram head
Clinical narrative: Diagnosed with Bell's Palsy; This is a spontaneous report from a contactable nurse (patient). This 35-year-old female (no pregnant) patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration in right arm at age of 34-year-old on 11Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension, supraventricular tachycardia, premenstrual dysphoric disorder. None Known allergies. No Covid prior vaccination. No other vaccine in four weeks. Concomitant medication in two weeks included Losartan, Spironolactone, Metoprolol, sertraline hydrochloride (ZOLOFT). The patient was diagnosed with bell's palsy on 16Feb2021. Event resulted in Emergency room/department or urgent care. Steroids and anti-virals received for the event. The outcome of event was not recovered. No COVID tested post vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported Bell's palsy cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Diagnosed with Bell's Palsy; This is a spontaneous report from a contactable nurse (patient). This 35-year-old female (no pregnant) patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration in right arm at age of 34-year-old on 11Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension, supraventricular tachycardia, premenstrual dysphoric disorder. None Known allergies. No Covid prior vaccination. No other vaccine in four weeks. Concomitant medication in two weeks included Losartan, Spironolactone, Metoprolol, sertraline hydrochloride (ZOLOFT). The patient was diagnosed with bell's palsy on 16Feb2021. Event resulted in Emergency room/department or urgent care. Steroids and anti-virals received for the event. The outcome of event was not recovered. No COVID tested post vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported Bell's palsy cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, Headache, Immediate post-injection reaction, Nausea
Clinical narrative: tingling on her mouth; had some tingling on her mouth and face; This is a spontaneous report from a contactable physician reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient called and stated she sent in a report on the report line already. She was going to her HCP today at 11:30AM and added she got the first dose on 29Jan2021 and one and one half hours later she had some tingling on her mouth and face that lasted about two hours. She has a lot of drug allergies and she told them and they kept her for 30 minutes. She added she was a physician and she read on the CDC website and it sounded like she had an allergic reaction. She was dismayed now as the recommendation looks like she should not get the second dose but that information was dated Dec2020. She was asking if we have any more current information regarding recommendations for receiving the second dose and confirmed she has no new events to report today and she did previously provide all product information including lot number. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: tingling on her mouth; had some tingling on her mouth and face; This is a spontaneous report from a contactable physician reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient called and stated she sent in a report on the report line already. She was going to her HCP today at 11:30AM and added she got the first dose on 29Jan2021 and one and one half hours later she had some tingling on her mouth and face that lasted about two hours. She has a lot of drug allergies and she told them and they kept her for 30 minutes. She added she was a physician and she read on the CDC website and it sounded like she had an allergic reaction. She was dismayed now as the recommendation looks like she should not get the second dose but that information was dated Dec2020. She was asking if we have any more current information regarding recommendations for receiving the second dose and confirmed she has no new events to report today and she did previously provide all product information including lot number. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Paraesthesia, Paraesthesia oral
Clinical narrative: tingling on her mouth; had some tingling on her mouth and face; This is a spontaneous report from a contactable physician reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient called and stated she sent in a report on the report line already. She was going to her HCP today at 11:30AM and added she got the first dose on 29Jan2021 and one and one half hours later she had some tingling on her mouth and face that lasted about two hours. She has a lot of drug allergies and she told them and they kept her for 30 minutes. She added she was a physician and she read on the CDC website and it sounded like she had an allergic reaction. She was dismayed now as the recommendation looks like she should not get the second dose but that information was dated Dec2020. She was asking if we have any more current information regarding recommendations for receiving the second dose and confirmed she has no new events to report today and she did previously provide all product information including lot number. The outcome of the events was recovering.