chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Hypoaesthesia, Immediate post-injection reaction, Joint range of motion decreased, Magnetic resonance imaging
Clinical narrative: the vaccine may have been administered into sub-acromial space; the vaccine may have been administered into sub-acromial space; Seemed to be higher on arm; soreness; Continued having progressed symptoms of decreased ROM; n/t (numbness and tingling); n/t (numbness and tingling); weakness; frozen shoulder; This is a spontaneous report from a contactable Nurse reporting for herself. A 30-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231), on 22Dec2020 at 15:30 at single dose in left arm, for COVID-19 immunisation. Age at vaccination was 30-year-old. No other vaccine was given within 4 weeks prior to the COVID vaccine. COVID was not tested prior or post vaccination. Medical history included type 1 diabetes mellitus, migraines, postural orthostatic tachycardia syndrome. The patient had known allergies to morphine and tomatoes. Concomitant medications included insulin aspart (NOVOLOG), topiramate (TROKENDI), metoprolol (METOPROLOL). The patient reported seemed to be higher on arm; immediately had soreness informed this was normal. Continued having progressed symptoms of decreased range of motion (ROM), n/t (numbness and tingling), weakness. Was evaluated on 31Dec2020 for this by an Orthopedic provider at employment. X-rays obtained at that time. Based off exam, he (orthopedic) reported other patient's having similar issues with this after being administered a vaccine and reporting frozen shoulder. Informed the patient the vaccine may have been administered into sub-acromial space. Strongly recommended magnetic resonance imaging (MRI); obtained the same day on 31Dec2020. Informed the patient this was the case and recommended a follow-up visit to discuss surgery. He was not able to provide injection to help with relief due to 2nd vaccine on 12Jan2021. He strongly recommended a different administration site on 12Jan2021. The events started on 22Dec2020 at 15:30, resulted in doctor or other healthcare professional office/clinic visit, and were considered serious for disability or permanent damage. The events had not resolved.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Paraesthesia, Periarthritis, Product administered at inappropriate site, X-ray abnormal
Clinical narrative: the vaccine may have been administered into sub-acromial space; the vaccine may have been administered into sub-acromial space; Seemed to be higher on arm; soreness; Continued having progressed symptoms of decreased ROM; n/t (numbness and tingling); n/t (numbness and tingling); weakness; frozen shoulder; This is a spontaneous report from a contactable Nurse reporting for herself. A 30-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231), on 22Dec2020 at 15:30 at single dose in left arm, for COVID-19 immunisation. Age at vaccination was 30-year-old. No other vaccine was given within 4 weeks prior to the COVID vaccine. COVID was not tested prior or post vaccination. Medical history included type 1 diabetes mellitus, migraines, postural orthostatic tachycardia syndrome. The patient had known allergies to morphine and tomatoes. Concomitant medications included insulin aspart (NOVOLOG), topiramate (TROKENDI), metoprolol (METOPROLOL). The patient reported seemed to be higher on arm; immediately had soreness informed this was normal. Continued having progressed symptoms of decreased range of motion (ROM), n/t (numbness and tingling), weakness. Was evaluated on 31Dec2020 for this by an Orthopedic provider at employment. X-rays obtained at that time. Based off exam, he (orthopedic) reported other patient's having similar issues with this after being administered a vaccine and reporting frozen shoulder. Informed the patient the vaccine may have been administered into sub-acromial space. Strongly recommended magnetic resonance imaging (MRI); obtained the same day on 31Dec2020. Informed the patient this was the case and recommended a follow-up visit to discuss surgery. He was not able to provide injection to help with relief due to 2nd vaccine on 12Jan2021. He strongly recommended a different administration site on 12Jan2021. The events started on 22Dec2020 at 15:30, resulted in doctor or other healthcare professional office/clinic visit, and were considered serious for disability or permanent damage. The events had not resolved.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Nausea, Neck pain, Pain
Clinical narrative: Initially what seemed like a muscle spasm involving entire left arm/neck/chest. Followed by tiredness. Approximately 2.5hrs later developed generalized muscle aches, tired, chills.  Next morning muscle aches were less, new headache and dizziness. took Tylenol which helped, about 5 hrs later symptoms worsened, improved with sleep and Tylenol.   Awoke this morning with some chest pain similar to initial response, some headache and dizziness, improved with Tylenol,  now returning (noon).  occasionally feels like I need to take a deep breath.  I believe its mostly muscular pain gets a little worse with deep breathing.  Sent home from work day of vaccine, worked partial days next 2 days
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pulse abnormal
Clinical narrative: Initially what seemed like a muscle spasm involving entire left arm/neck/chest. Followed by tiredness. Approximately 2.5hrs later developed generalized muscle aches, tired, chills.  Next morning muscle aches were less, new headache and dizziness. took Tylenol which helped, about 5 hrs later symptoms worsened, improved with sleep and Tylenol.   Awoke this morning with some chest pain similar to initial response, some headache and dizziness, improved with Tylenol,  now returning (noon).  occasionally feels like I need to take a deep breath.  I believe its mostly muscular pain gets a little worse with deep breathing.  Sent home from work day of vaccine, worked partial days next 2 days
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Initially what seemed like a muscle spasm involving entire left arm/neck/chest. Followed by tiredness. Approximately 2.5hrs later developed generalized muscle aches, tired, chills.  Next morning muscle aches were less, new headache and dizziness. took Tylenol which helped, about 5 hrs later symptoms worsened, improved with sleep and Tylenol.   Awoke this morning with some chest pain similar to initial response, some headache and dizziness, improved with Tylenol,  now returning (noon).  occasionally feels like I need to take a deep breath.  I believe its mostly muscular pain gets a little worse with deep breathing.  Sent home from work day of vaccine, worked partial days next 2 days
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Impaired work ability, Muscle spasms, Myalgia, Painful respiration
Clinical narrative: Initially what seemed like a muscle spasm involving entire left arm/neck/chest. Followed by tiredness. Approximately 2.5hrs later developed generalized muscle aches, tired, chills.  Next morning muscle aches were less, new headache and dizziness. took Tylenol which helped, about 5 hrs later symptoms worsened, improved with sleep and Tylenol.   Awoke this morning with some chest pain similar to initial response, some headache and dizziness, improved with Tylenol,  now returning (noon).  occasionally feels like I need to take a deep breath.  I believe its mostly muscular pain gets a little worse with deep breathing.  Sent home from work day of vaccine, worked partial days next 2 days
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Vertigo
Clinical narrative: The day after vaccine administration, pt was still experiencing vertigo, spinning and headache.; The day after vaccine administration, pt was still experiencing vertigo, spinning and headache.; This is a spontaneous report from a non-contactable other healthcare professional (hcp). A 27-year-old female patient receive first dose of bnt162b2 (Pfizer BioNTech COVID vaccine, lot number: EL0140), intramuscularly on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. There is unknown if any other vaccine received in four weeks. The patient experienced the day after vaccine administration, patient was still experiencing vertigo, spinning and headache, all on 31Dec2020 the day after vaccine administration. The outcome of events was unknown. This is a non-serious report. It's unknown if patient was diagnosed with COVID-19 or tested for COVID-19 since the vaccination. The adverse did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'.   No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Paraesthesia, Urticaria
Clinical narrative: I received the vaccine.  I was sitting with another group of nurses maybe about five minutes after the vaccine talking.  One of the nurses noticed I had a red area on my left forearm.  After, I started to feel strange, body tingling, light headed, my heart started racing,  I broke out in Hives on the left arm, neck, back, ear, side of face.  It felt like I could not swallow on left side.  Was brought  to ER was put on oxygen, given 125 solu-medrol IV, Benadryl 50mg IV, and Pepcid IV and 1liter of fluid.   Was in observation for two and half hours,  improved.  Was send home on five days worth of steroids and Pepcid
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Electrocardiogram, Feeling abnormal, Injection site erythema
Clinical narrative: I received the vaccine.  I was sitting with another group of nurses maybe about five minutes after the vaccine talking.  One of the nurses noticed I had a red area on my left forearm.  After, I started to feel strange, body tingling, light headed, my heart started racing,  I broke out in Hives on the left arm, neck, back, ear, side of face.  It felt like I could not swallow on left side.  Was brought  to ER was put on oxygen, given 125 solu-medrol IV, Benadryl 50mg IV, and Pepcid IV and 1liter of fluid.   Was in observation for two and half hours,  improved.  Was send home on five days worth of steroids and Pepcid
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Paraesthesia, Urticaria
Clinical narrative: I received the vaccine.  I was sitting with another group of nurses maybe about five minutes after the vaccine talking.  One of the nurses noticed I had a red area on my left forearm.  After, I started to feel strange, body tingling, light headed, my heart started racing,  I broke out in Hives on the left arm, neck, back, ear, side of face.  It felt like I could not swallow on left side.  Was brought  to ER was put on oxygen, given 125 solu-medrol IV, Benadryl 50mg IV, and Pepcid IV and 1liter of fluid.   Was in observation for two and half hours,  improved.  Was send home on five days worth of steroids and Pepcid
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dysphagia, Dyspnoea, Oropharyngeal discomfort, Pyrexia
Clinical narrative: anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation.  Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip.  Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN).  The patient previously took erythromycin, morphine and experienced drug hypersensitivity.  The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021.  The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation.  Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip.  Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN).  The patient previously took erythromycin, morphine and experienced drug hypersensitivity.  The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021.  The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Chills, Cough, Dizziness, Headache
Clinical narrative: anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation.  Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip.  Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN).  The patient previously took erythromycin, morphine and experienced drug hypersensitivity.  The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021.  The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Oropharyngeal pain, Pharyngeal paraesthesia, Pruritus, Pyrexia
Clinical narrative: anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation.  Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip.  Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN).  The patient previously took erythromycin, morphine and experienced drug hypersensitivity.  The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021.  The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Tachycardia, Throat tightness, Wheezing
Clinical narrative: anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation.  Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip.  Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN).  The patient previously took erythromycin, morphine and experienced drug hypersensitivity.  The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021.  The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Muscular weakness, Pain, Photosensitivity reaction
Clinical narrative: headache; chills; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) intramuscular (right deltoid) on 05Jan2021 at 13:00 at a single dose, for COVID-19 prophylaxis. Patient has no relevant medical history. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular (left deltoid) on 15Dec2020, at 13:00 for COVID-19 immunization. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient received the second dose of his COVID-19 vaccine yesterday on 05Jan2021. He said that he had no side effects with the first dose except for injection site pain. He received the first dose on 15Dec2020. After receiving the second dose, he has a headache, chills, and muscle aches. He had more symptoms than he had with the first dose. His symptoms started last night and continued this morning. Headache started around 02:00 06Jan2021 while chills started around 22:00 on 05Jan2021. He stated that the chills resolved sometime in the early morning 06Jan2021.  Muscle aches started around 22:00 05Jan2021. Patient reported that both of his COVID-19 vaccines had the same lot number. The patient did not require emergency room visit. Patient received ibuprofen, naproxen, and acetaminophen for his headache and muscle aches. Outcome of the event chills was recovered on 06Jan2021, while for other events was not recovered.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: headache; chills; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) intramuscular (right deltoid) on 05Jan2021 at 13:00 at a single dose, for COVID-19 prophylaxis. Patient has no relevant medical history. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular (left deltoid) on 15Dec2020, at 13:00 for COVID-19 immunization. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient received the second dose of his COVID-19 vaccine yesterday on 05Jan2021. He said that he had no side effects with the first dose except for injection site pain. He received the first dose on 15Dec2020. After receiving the second dose, he has a headache, chills, and muscle aches. He had more symptoms than he had with the first dose. His symptoms started last night and continued this morning. Headache started around 02:00 06Jan2021 while chills started around 22:00 on 05Jan2021. He stated that the chills resolved sometime in the early morning 06Jan2021.  Muscle aches started around 22:00 05Jan2021. Patient reported that both of his COVID-19 vaccines had the same lot number. The patient did not require emergency room visit. Patient received ibuprofen, naproxen, and acetaminophen for his headache and muscle aches. Outcome of the event chills was recovered on 06Jan2021, while for other events was not recovered.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: headache; chills; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) intramuscular (right deltoid) on 05Jan2021 at 13:00 at a single dose, for COVID-19 prophylaxis. Patient has no relevant medical history. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular (left deltoid) on 15Dec2020, at 13:00 for COVID-19 immunization. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient received the second dose of his COVID-19 vaccine yesterday on 05Jan2021. He said that he had no side effects with the first dose except for injection site pain. He received the first dose on 15Dec2020. After receiving the second dose, he has a headache, chills, and muscle aches. He had more symptoms than he had with the first dose. His symptoms started last night and continued this morning. Headache started around 02:00 06Jan2021 while chills started around 22:00 on 05Jan2021. He stated that the chills resolved sometime in the early morning 06Jan2021.  Muscle aches started around 22:00 05Jan2021. Patient reported that both of his COVID-19 vaccines had the same lot number. The patient did not require emergency room visit. Patient received ibuprofen, naproxen, and acetaminophen for his headache and muscle aches. Outcome of the event chills was recovered on 06Jan2021, while for other events was not recovered.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Hypersensitivity, Urticaria
Clinical narrative: Date of symptom onset ? 1/1/21?  Symptoms - ? patient reports she began with abd pain, and itchiness to head, face and ear that progressed to generalized hives.  Patient denies any changes in hygiene products and NKDA or food allergies per patient.   Last day of work and shift - ?  Home remedies? -   patient took Benadryl after onset of symptoms and reported resolution of hives approx. 30 mins after medication.  Patient reports she spoke with her PCP and scheduled for allergy testing today (1/12) at 1:30 PM.   Any improvement? ? yes Recommendation? Patient asking if she should get her 2nd dose as scheduled tomorrow.  Patient encouraged to attend her allergy appointment today and to consult with her MD today for recommendations whether or not to receive 2nd dose. Patient provided with HR support phone number if she needs to cancel/reschedule her 2nd vaccine appointment after MD recommendations.  Patient encouraged to call vaccine support line if she has adverse reactions after 2nd vaccine dose.  Patient verbalized back understanding and denied further questions at this time.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Pruritus, Urticaria
Clinical narrative: Date of symptom onset ? 1/1/21?  Symptoms - ? patient reports she began with abd pain, and itchiness to head, face and ear that progressed to generalized hives.  Patient denies any changes in hygiene products and NKDA or food allergies per patient.   Last day of work and shift - ?  Home remedies? -   patient took Benadryl after onset of symptoms and reported resolution of hives approx. 30 mins after medication.  Patient reports she spoke with her PCP and scheduled for allergy testing today (1/12) at 1:30 PM.   Any improvement? ? yes Recommendation? Patient asking if she should get her 2nd dose as scheduled tomorrow.  Patient encouraged to attend her allergy appointment today and to consult with her MD today for recommendations whether or not to receive 2nd dose. Patient provided with HR support phone number if she needs to cancel/reschedule her 2nd vaccine appointment after MD recommendations.  Patient encouraged to call vaccine support line if she has adverse reactions after 2nd vaccine dose.  Patient verbalized back understanding and denied further questions at this time.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: Patient complained of itching starting on her legs, which went upwards; Redness on her arms, neck, face; Redness on her arms, neck, face; Redness on her arms, neck, face; Itching up to her scalp; Dry cough; Rash; This is a spontaneous report from a contactable nurse (patient).   A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the left arm, on 26Dec2020, at 09:00 AM, for COVID-19 immunisation. COVID-19 vaccine was administered at hospital. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included asthma, hypertension, hypothyroidism, penicillin allergy, food allergy (melon and pineapple) and latex allergy. Concomitant medications, received within 2 weeks of vaccination, included omalizumab (XOLAIR), levothyroxine sodium (LEVOXYL), levocetirizine dihydrochloride (XYZAL), losartan and formoterol fumarate, mometasone furoate (DULERA). After covid vaccination, the patient was advised to stay 30 minutes for observation. On 26Dec2020 at 09:15, less than 15 minutes later, the patient complained of itching starting on her legs, which went upwards. The patient took 25 mg oral diphenhydramine hydrochloride (BENADRYL). She noted to have redness on her arms, neck, face, itching up to her scalp. By then she started to have a dry cough, removed her mask, nurse who was with her called for a rapid response team. Patient's epi pen was used, they then started IV and pushed emergency meds and transported to ED. Emergency room/department or urgent care was required. Another dose of epinephrine IM and additional meds were given. Placed on oxygen via non-rebreather with albuterol. Epinephrine drip started. Stabilized after 3 hours, stayed in observation for 12 hours then discharged to home. Around the clock 50 mg diphenhydramine hydrochloride (BENADRYL) at home x 2 days, then levocetirizine (ZYXAL) thrice daily x 7 days to control itching and redness/rash. Other treatment included steroids, pepcid. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19 (PCR, Nasal Swab) on 26Dec2020 and the result was negative. Clinical outcome of the adverse events was recovering at time of this report.   Information on the lot/batch number has been requested.; Sender's Comments: Based on a close temporal association, a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Erythema, Pruritus, Rash, SARS-CoV-2 test negative
Clinical narrative: Patient complained of itching starting on her legs, which went upwards; Redness on her arms, neck, face; Redness on her arms, neck, face; Redness on her arms, neck, face; Itching up to her scalp; Dry cough; Rash; This is a spontaneous report from a contactable nurse (patient).   A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the left arm, on 26Dec2020, at 09:00 AM, for COVID-19 immunisation. COVID-19 vaccine was administered at hospital. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included asthma, hypertension, hypothyroidism, penicillin allergy, food allergy (melon and pineapple) and latex allergy. Concomitant medications, received within 2 weeks of vaccination, included omalizumab (XOLAIR), levothyroxine sodium (LEVOXYL), levocetirizine dihydrochloride (XYZAL), losartan and formoterol fumarate, mometasone furoate (DULERA). After covid vaccination, the patient was advised to stay 30 minutes for observation. On 26Dec2020 at 09:15, less than 15 minutes later, the patient complained of itching starting on her legs, which went upwards. The patient took 25 mg oral diphenhydramine hydrochloride (BENADRYL). She noted to have redness on her arms, neck, face, itching up to her scalp. By then she started to have a dry cough, removed her mask, nurse who was with her called for a rapid response team. Patient's epi pen was used, they then started IV and pushed emergency meds and transported to ED. Emergency room/department or urgent care was required. Another dose of epinephrine IM and additional meds were given. Placed on oxygen via non-rebreather with albuterol. Epinephrine drip started. Stabilized after 3 hours, stayed in observation for 12 hours then discharged to home. Around the clock 50 mg diphenhydramine hydrochloride (BENADRYL) at home x 2 days, then levocetirizine (ZYXAL) thrice daily x 7 days to control itching and redness/rash. Other treatment included steroids, pepcid. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19 (PCR, Nasal Swab) on 26Dec2020 and the result was negative. Clinical outcome of the adverse events was recovering at time of this report.   Information on the lot/batch number has been requested.; Sender's Comments: Based on a close temporal association, a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling abnormal, Feeling cold, Headache, Heart rate increased
Clinical narrative: fever; tachycardia; This is a spontaneous report from a contactable nurse.  A female patient of an unspecified age (pregnancy status not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on 03Jan2021 as a single dose for COVID-19 immunization. Indication. Medical history and concomitant medications were not reported. I was not known if the patient received other vaccinations in last 4 weeks or if she took any medications in the past 2 weeks. It was not reported if the patient had been tested for COVID-19 prior to the vaccination.  The patient reported fever, tachycardia following administration of vaccine. She was scheduled to receive second dose 30Jan2021 and was questioning safety of second administration. The clinical outcome of the fever and tachycardia was not reported. It was unknown if the patient was tested for COVID-19 after the vaccination.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Pyrexia, Tremor
Clinical narrative: fever; tachycardia; This is a spontaneous report from a contactable nurse.  A female patient of an unspecified age (pregnancy status not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on 03Jan2021 as a single dose for COVID-19 immunization. Indication. Medical history and concomitant medications were not reported. I was not known if the patient received other vaccinations in last 4 weeks or if she took any medications in the past 2 weeks. It was not reported if the patient had been tested for COVID-19 prior to the vaccination.  The patient reported fever, tachycardia following administration of vaccine. She was scheduled to receive second dose 30Jan2021 and was questioning safety of second administration. The clinical outcome of the fever and tachycardia was not reported. It was unknown if the patient was tested for COVID-19 after the vaccination.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tachycardia
Clinical narrative: fever; tachycardia; This is a spontaneous report from a contactable nurse.  A female patient of an unspecified age (pregnancy status not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on 03Jan2021 as a single dose for COVID-19 immunization. Indication. Medical history and concomitant medications were not reported. I was not known if the patient received other vaccinations in last 4 weeks or if she took any medications in the past 2 weeks. It was not reported if the patient had been tested for COVID-19 prior to the vaccination.  The patient reported fever, tachycardia following administration of vaccine. She was scheduled to receive second dose 30Jan2021 and was questioning safety of second administration. The clinical outcome of the fever and tachycardia was not reported. It was unknown if the patient was tested for COVID-19 after the vaccination.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The swelling started on 31Dec2020 like a knot under the skin at the site of the injection; Soreness in her arm; Redness; This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (left arm), on 29Dec2020 at 13:00 at a single dose, for COVID-19 immunization. Medical history included Modular Sponge Kidney stage one (being monitored; this predates her vaccination), Gastrooesophageal reflux disease (GERD), and high cholesterol. Family history included diabetes. Concomitant medications included dexlansoprazole (DEXILANT) from an unspecified date and ongoing for 10 years for GERD, ongoing estrogens conjugated, medroxyprogesterone acetate (PREMPRO) for hormone replacement therapy, pravastatin from an unspecified date and ongoing for 2 years and ezetimibe from an unspecified date and ongoing for six months both taken for high cholesterol. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a drug store.This pharmacy tech received the vaccine on 29Dec2020 at 1300 in the left arm and then had some of the soreness, redness, swelling, and a large knot that grew to the size of a 50 cent piece. It went away and then it came back. She noticed the soreness in her arm and redness at the site on 30Dec2020. The swelling started on 31Dec2020 like a knot under the skin at the site of the injection which grew to the size of a 50-cent piece. The knot went away by the 02Jan2021. Then it started to come back yesterday 05Jan2021 with a knot; and today 06Jan2021 it is also red again and the size of a quarter. Patient is planning to have the second dose on 19Jan2021. She has not treated herself in any way other than rubbing the site. The events did not require emergency or physician visit. Outcome of the events was not recovered.  Information on the batch/lot number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: The swelling started on 31Dec2020 like a knot under the skin at the site of the injection; Soreness in her arm; Redness; This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (left arm), on 29Dec2020 at 13:00 at a single dose, for COVID-19 immunization. Medical history included Modular Sponge Kidney stage one (being monitored; this predates her vaccination), Gastrooesophageal reflux disease (GERD), and high cholesterol. Family history included diabetes. Concomitant medications included dexlansoprazole (DEXILANT) from an unspecified date and ongoing for 10 years for GERD, ongoing estrogens conjugated, medroxyprogesterone acetate (PREMPRO) for hormone replacement therapy, pravastatin from an unspecified date and ongoing for 2 years and ezetimibe from an unspecified date and ongoing for six months both taken for high cholesterol. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a drug store.This pharmacy tech received the vaccine on 29Dec2020 at 1300 in the left arm and then had some of the soreness, redness, swelling, and a large knot that grew to the size of a 50 cent piece. It went away and then it came back. She noticed the soreness in her arm and redness at the site on 30Dec2020. The swelling started on 31Dec2020 like a knot under the skin at the site of the injection which grew to the size of a 50-cent piece. The knot went away by the 02Jan2021. Then it started to come back yesterday 05Jan2021 with a knot; and today 06Jan2021 it is also red again and the size of a quarter. Patient is planning to have the second dose on 19Jan2021. She has not treated herself in any way other than rubbing the site. The events did not require emergency or physician visit. Outcome of the events was not recovered.  Information on the batch/lot number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Back pain, Dizziness, Lymphadenopathy, Myalgia
Clinical narrative: fever, rash, lymphadenopathy
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Neck pain, Pyrexia, Spinal pain
Clinical narrative: fever, rash, lymphadenopathy
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood electrolytes normal, Full blood count, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: fever, rash, lymphadenopathy
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Bone pain, Chest pain, Dizziness, Headache
Clinical narrative: fever, rash, lymphadenopathy
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy, Myalgia, Myopathy, Nausea, Pulmonary pain
Clinical narrative: fever, rash, lymphadenopathy
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Spinal pain
Clinical narrative: fever, rash, lymphadenopathy
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Dizzy, light headed,and left arm numb.  Laid down, felt better after laying down Monitored heart rate 68 , no shortness of breath and color was pink.  once symptoms were gone, was released and informed if any further symptoms to go to ER.