chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Blood pressure increased, Dehydration, Dry throat, Fatigue
Clinical narrative: asthma attack; throat began to tighten / throat remained constricted; feel itchy; Dryness of throat; hives; extreme fatigue; nausea; mild fever; high BP; dehydrated; This is a spontaneous report form a contactable consumer (patient herself). A 23-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0179) via an unspecified route of administration in right arm on 26May2021 10:00 as dose 2, single (at the age of 23-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient medical history included asthma. Patient was highly allergic to wasp venom, mild allergy to other insect venom. The concomitant medications included ascorbic acid (VITAMIN C ACID). Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0171) via an unspecified route of administration in right arm on 05May2021 11:00 as dose 1, single for COVID-19 immunization. Patient did not have any reaction upon first dose. On 26May2021 at 10:10, 10 minutes after receiving vaccine patient experienced dryness of throat which was ignored on account of hot weather. Approximately 20 minutes after receiving vaccine, throat began to tighten and she began to feel itchy. Within 10 minutes afterwards, she experienced an asthma attack which she treated with a Ventolin inhaler. However, her throat remained constricted and hives began to develop. She dissolved 2000 mg of vitamin C in water and drank it after which these symptoms began to recede. She also took 1 dose of Histal medication. Over the following 36 hours she experienced extreme fatigue and nausea, accompanied by a mild fever and persistent itching. She visited centre for diagnosis and was informed that she had a high BP and was dehydrated. She was released 4 hours later and placed on steroids to aid in combatting any remaining histamines. Patient received treatment as ventolin, steroids, Benadryl. The reported seriousness was life threatening. The adverse event resulted in emergency room/department or urgent care. The outcome of the events was recovering.  Follow up attempts are needed. Further information has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Pyrexia, Throat tightness, Urticaria
Clinical narrative: asthma attack; throat began to tighten / throat remained constricted; feel itchy; Dryness of throat; hives; extreme fatigue; nausea; mild fever; high BP; dehydrated; This is a spontaneous report form a contactable consumer (patient herself). A 23-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0179) via an unspecified route of administration in right arm on 26May2021 10:00 as dose 2, single (at the age of 23-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient medical history included asthma. Patient was highly allergic to wasp venom, mild allergy to other insect venom. The concomitant medications included ascorbic acid (VITAMIN C ACID). Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0171) via an unspecified route of administration in right arm on 05May2021 11:00 as dose 1, single for COVID-19 immunization. Patient did not have any reaction upon first dose. On 26May2021 at 10:10, 10 minutes after receiving vaccine patient experienced dryness of throat which was ignored on account of hot weather. Approximately 20 minutes after receiving vaccine, throat began to tighten and she began to feel itchy. Within 10 minutes afterwards, she experienced an asthma attack which she treated with a Ventolin inhaler. However, her throat remained constricted and hives began to develop. She dissolved 2000 mg of vitamin C in water and drank it after which these symptoms began to recede. She also took 1 dose of Histal medication. Over the following 36 hours she experienced extreme fatigue and nausea, accompanied by a mild fever and persistent itching. She visited centre for diagnosis and was informed that she had a high BP and was dehydrated. She was released 4 hours later and placed on steroids to aid in combatting any remaining histamines. Patient received treatment as ventolin, steroids, Benadryl. The reported seriousness was life threatening. The adverse event resulted in emergency room/department or urgent care. The outcome of the events was recovering.  Follow up attempts are needed. Further information has been requested.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Hypertension, Migraine, Pain
Clinical narrative: Migraine; Fever; Headache; Body ache; Chills; Blood pressure high; This is a spontaneous report from a contactable consumer or other non HCP (patient, self-reporting). A 44-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0177, Expiration Date: 31Aug2021), via an unspecified route of administration in arm on 07Jun2021 as dose 2, single for COVID-19 immunisation. The patient medical history included thyroid disorder, coeliac disease, blood clotting disorder. Concomitant medication included levothyroxine taken for thyroid disorder. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, LOT#EW0182, Expiration date: 21Aug2021), via an unspecified route of administration on 14May2021 as single dose for COVID-19 immunization and no reaction was experienced. On 07Jun2021, the patient experienced migraine, fever, headache, body ache, chills, blood pressure high. Patient stated, he just wanted to report the side effect. Patient reported that "I received the second vaccine on 07Jun2021 and I had Migraine, 12 hours after the (second shot) shot, it started with fever, headache, body ache, chills for 2 days and then after the 2 days headaches did not go away and had just got progressively worst, he went to my Primary Care Doctor and he gave to me the Migraine medication. Patient added, I never had Migraines. This was the first time I have ever had. That was also a side effect my blood pressure was high right now but Doctor said it was because of the headache". Therapeutic measures were taken as a result of migraine. The outcome of the events fever, body ache, chills was recovered on 09Jun2021, outcome of events headache, blood pressure high was not recovered and unknown for other events.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Migraine; Fever; Headache; Body ache; Chills; Blood pressure high; This is a spontaneous report from a contactable consumer or other non HCP (patient, self-reporting). A 44-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0177, Expiration Date: 31Aug2021), via an unspecified route of administration in arm on 07Jun2021 as dose 2, single for COVID-19 immunisation. The patient medical history included thyroid disorder, coeliac disease, blood clotting disorder. Concomitant medication included levothyroxine taken for thyroid disorder. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, LOT#EW0182, Expiration date: 21Aug2021), via an unspecified route of administration on 14May2021 as single dose for COVID-19 immunization and no reaction was experienced. On 07Jun2021, the patient experienced migraine, fever, headache, body ache, chills, blood pressure high. Patient stated, he just wanted to report the side effect. Patient reported that "I received the second vaccine on 07Jun2021 and I had Migraine, 12 hours after the (second shot) shot, it started with fever, headache, body ache, chills for 2 days and then after the 2 days headaches did not go away and had just got progressively worst, he went to my Primary Care Doctor and he gave to me the Migraine medication. Patient added, I never had Migraines. This was the first time I have ever had. That was also a side effect my blood pressure was high right now but Doctor said it was because of the headache". Therapeutic measures were taken as a result of migraine. The outcome of the events fever, body ache, chills was recovered on 09Jun2021, outcome of events headache, blood pressure high was not recovered and unknown for other events.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Redness above the bandaid; This is a spontaneous report for a non-contactable consumer (patient mother). A unspecified age male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via intramuscular route of administration, on an unknown date, as a 2nd dose, single for COVID-19 Immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccination included first dose of BNT162B2 for COVID-19 immunisation. On an unknown date, within minutes of vaccination, the patient experienced redness above the band aid and then it went away after 5 minutes. The consumer stated she read about on proper preparation/dilution instructions such as she knows it was good for 6 hours in the vial after dilution and to keep it away from light. The consumer just wanted to ensure it was done right and she was not sure if nurse inverted it. She will follow up with the nurse who administered vaccine but wanted to ask manufacturer. Asked if the vial needs to be inverted 10 times gently prior to each dose being drawn up in syringe and whether pfizer gives the instructions to facilities and also in the case of if someone inverted it prior to drawing up dose in syringe (after already been inverted) would Pfizer want to know that. Consumer added that she knows for some facilities they leave the diluted vial exposed to light, she was unclear which facility. Consumer also stated that they did not inserted the entire needle for his son, they inserted it almost all the way because of concern hitting bone with his small arm. She was told by nurse that they usually do that with kids. The outcome of the event erythema was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Rhinorrhoea
Clinical narrative: chills; runny nose; joint pain in knees and little bit in elbows; This is a spontaneous report from a contactable consumer (patient). Follow-up #1 (PRD/SRD 18Jun2021) and Follow-up #2 (PRD 18Jun2021/SRD 21Jun2021) received from a contactable consumer was processed together with initial information.  A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8737), via an unspecified route of administration on 03Apr2021 as first dose, single for COVID-19 immunization. On an unspecified date, the patient experienced chills and little bit of a runny nose, later she experienced joint pain in knees and little bit in elbows. The outcome of the events was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Joint swelling
Clinical narrative: 3-4 days after the first dose the wife's joints were swollen and inflamed then after 3-4 days the left knee also became swollen and inflamed; 3-4 days after the first dose the wife's joints were swollen and inflamed then after 3-4 days the left knee also became swollen and inflamed; This is a spontaneous report from a contactable consumer (Patient's husband) via medical information team. A 56-year-old female (Reporter's wife) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose 1 via an unspecified route of administration on 28May2021 as single dose for COVID-19 immunization. Medical history was not reported. Family history included diabetes and high blood pressure (patient's mother). He thinks the patient's mother is starting to get dementia and is getting to the stage where she is aggressive and lies all the time. Concomitant medications were none. No prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. In May2021, 3-4 days after the first dose the wife's joints were swollen and inflamed then after 3-4 days the left knee also became swollen and inflamed. The inflammation and swelling was all related to joints and mobility. It was the same as the wrist, the patient's left knee was starting to get swollen. He treated the swollen and inflamed joints for the patient with ibuprofen, Tylenol, icing at night, and he also wrapped it. Swelling and inflammation went away within 3-4 days. The patient went to the clinic after her joint issues. The clinic staff gave the patient a cortisone shot and it relieved the pain and everything for a little bit. Now the patient's joint pain has come back again 3 other times. It seems like every time the patient gets the Covid shot, she starts swelling up in the joints. Patient's joint inflammation and swelling went away a little then came back into the knees within probably 3-4 days after that. The patient's joint inflammation and swelling went away before she received the second dose of the Covid-19 vaccine. She got the first Cortisone shot and can't get any others right now. She has to wait 3 months before getting another Cortisone shot. Events required a visit to physician office. The outcome of events was recovered in May2021.  Follow up needed, further information has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Carney complex, Limb discomfort, Lymphadenopathy, Metabolic function test, Urine analysis
Clinical narrative: swollen glands in arm and neck; the glands were very uncomfortable under his left arm; This is a spontaneous report from a consumer (patient) via Pfizer.   A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: ER8729 and Expire Date: unknown) via unspecified route of administration, in left (upper) arm on 07Apr2021 13:45 in the afternoon (age at vaccination: 64 years) as DOSE 2, SINGLE for Covid-19 immunisation. Patient's medical history included diabetes and immune system disorder (immune system is not the same) from an unspecified date and unknown if ongoing. Since he was diabetic so he was skeptical to get the vaccine because he knew his immune system is not the same as most people. Concomitant medications were none. Patient previously received first dose of vaccine (Lot no: ER2613, expiry date: unknow) via unspecified route of administration, in left (upper) arm on 17Mar2021, as single dose for Covid-19 Immunisation. There were no other vaccinations taken within four weeks prior to the first administration date of the suspect vaccine. After second dose, on 08Apr2021 the patient reported he had swollen glands under his arm and neck. It was reported that when it first started swelling, it wasn't extremely painful but the glands were very uncomfortable under his left arm and then after a few days it got better but then on the 5th or 6th day all the glands got swollen. He confirmed that was still ongoing, it had pretty much been persisting the same since that 6th day after the shot. He said it had been almost 10 weeks. He went to his GP and they took one look and did a blood test and a urine test and it was all normal and because this was such a new thing no one knows what to do. Since the blood test and urine test was negative the patient was sent to the ENT and he looked at his under arm and neck and said come back in a month if he still has it, this is why he was calling because no doctor knows what to do with it. The patient underwent lab test on 30Apr2021 which included CNC, CMP and urine test, results of which were negative. The sample was collected on 30Apr2021 the report was given on 01May2021. The adverse event resulted in visit of physician's office. Patient believed that his other 2 sisters got the Pfizer shot, and they had no reactions and they also have immune compromised systems. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Adverse reaction, Nausea, Pyrexia, Vomiting
Clinical narrative: fever and chills; vomiting, a lot of vomit about 20 times; wheezing; he had stomach ache and sharp pain in his stomach; very, very nauseous; Worse side effects; This is a spontaneous report from a contactable consumer (Reporter Mother of the patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date 2, single dose for COVID-19 immunization. No medical and concomitant medication history were reported. After the 2nd dose vaccine patient had worse side effects, fever and chills, common side effects. It was states she gave him Advil and patient was able to sleep and 4 hours after the Advil he woke up vomiting. Patient had a lot of vomit about 20 times, almost 20 times. In the morning patient started wheezing, had a stomach ache and sharp pains in stomach. Patient was very nauseous. He had a lot of pain in his stomach. Reporter states that the doctor, was no help to her. She was very worried, today patient woke up better, no more vomit, no more stomach ache. She saw on the news, about 1 boy who had the same side effects, inflammation in his heart. Patient was better now but she did not know if patient has Myocarditis now because the Boy in the news had the same side effects as her son and also had vomiting and stomach ache. She just needs to know what she needs to do. Is this a normal side effect. She would just like to know what to do for her son. She canceled her doctor because she told her that her son had no side effects from COVID-19 vaccine. The outcome of the events were unknown.    Information on batch/lot no. has been requested. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021581782 similar report from same reporter
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: fever and chills; vomiting, a lot of vomit about 20 times; wheezing; he had stomach ache and sharp pain in his stomach; very, very nauseous; Worse side effects; This is a spontaneous report from a contactable consumer (Reporter Mother of the patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date 2, single dose for COVID-19 immunization. No medical and concomitant medication history were reported. After the 2nd dose vaccine patient had worse side effects, fever and chills, common side effects. It was states she gave him Advil and patient was able to sleep and 4 hours after the Advil he woke up vomiting. Patient had a lot of vomit about 20 times, almost 20 times. In the morning patient started wheezing, had a stomach ache and sharp pains in stomach. Patient was very nauseous. He had a lot of pain in his stomach. Reporter states that the doctor, was no help to her. She was very worried, today patient woke up better, no more vomit, no more stomach ache. She saw on the news, about 1 boy who had the same side effects, inflammation in his heart. Patient was better now but she did not know if patient has Myocarditis now because the Boy in the news had the same side effects as her son and also had vomiting and stomach ache. She just needs to know what she needs to do. Is this a normal side effect. She would just like to know what to do for her son. She canceled her doctor because she told her that her son had no side effects from COVID-19 vaccine. The outcome of the events were unknown.    Information on batch/lot no. has been requested. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021581782 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Cough, Dysphonia, Dyspnoea, Flushing
Clinical narrative: Patient stated she felt like I can breathe in but I cant breathe out; Flushing; Clammy skin; Coughing; wheezing; Voice changes; This is a spontaneous report from a contactable Nurse. An adult female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0162), dose 1 intramuscular on 27May2021 as single dose for covid-19 immunisation. Medical history included allergy to eggs, dust, feathers and roach feces all from an unknown date and unknown if ongoing. The patients concomitant medications were not reported. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. On 27May2021, the patient experienced flushing, clammy skin, coughing, wheezing, dyspnea, voice changes, patient stated she felt like she could breathe in but could not breathe out. The reporter classified the events as non-serious and stated the events result emergency room/department or urgent care. Therapeutic measures were taken as a result of the events with Epinephrine, 0.3 mg, intramuscular (IM) for 2 doses and Benadryl, 50 mg, IM. The outcome of the events was unknown.; Sender's Comments: Based on strong temporal relationship the reported events flushing, clammy skin, coughing, wheezing, dyspnea, voice changes, patient stated she felt like "I can breathe in but I can't breathe out" are assessed as possibly related to the usage of the vaccine BNT612B2. Also consider the possible contributory effect of the patient's medical history. 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
Symptoms: Wheezing
Clinical narrative: Patient stated she felt like I can breathe in but I cant breathe out; Flushing; Clammy skin; Coughing; wheezing; Voice changes; This is a spontaneous report from a contactable Nurse. An adult female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0162), dose 1 intramuscular on 27May2021 as single dose for covid-19 immunisation. Medical history included allergy to eggs, dust, feathers and roach feces all from an unknown date and unknown if ongoing. The patients concomitant medications were not reported. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. On 27May2021, the patient experienced flushing, clammy skin, coughing, wheezing, dyspnea, voice changes, patient stated she felt like she could breathe in but could not breathe out. The reporter classified the events as non-serious and stated the events result emergency room/department or urgent care. Therapeutic measures were taken as a result of the events with Epinephrine, 0.3 mg, intramuscular (IM) for 2 doses and Benadryl, 50 mg, IM. The outcome of the events was unknown.; Sender's Comments: Based on strong temporal relationship the reported events flushing, clammy skin, coughing, wheezing, dyspnea, voice changes, patient stated she felt like "I can breathe in but I can't breathe out" are assessed as possibly related to the usage of the vaccine BNT612B2. Also consider the possible contributory effect of the patient's medical history. 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Dizziness postural, Fatigue, Feeling abnormal
Clinical narrative: experienced tiredness; dizziness; nausea; Sometimes she cannot get up, feels like someone is pushing her back down; Worried about getting the second dose of the Covid 19 Vaccination; States it is really bad and strange; The inside of her head will start spinning; Caller mentions her dizziness again. States sometimes she cannot get up because it feels like someone is pushing her down; She has not been driving for 5 days now because the dizziness comes suddenly; Soreness in arm; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 05Jun2021 (Batch/Lot Number: EW0191) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history included Historical Vaccine INFLUENZA VACCINES; she gets the flu shot every year with no adverse events. The patient's concomitant medications were not reported. The patient experienced dizziness and Nausea on 13Jun2021, experienced tiredness on 17Jun2021, she has not been driving for 5 days now because the dizziness comes suddenly, soreness in arm and worried about getting the second dose of the coved 19 vaccination, states it is really bad and strange and the inside of her head will start spinning on Jun2021, sometimes she cannot get up, feels like someone is pushing her back down on 13Jun2021, caller mentions her dizziness again. states sometimes she cannot get up because it feels like someone is pushing her down on Jun2021. Upon the follow-up received on 18Jun2021 reporter gave consent to contact. NDC number and expiry date of Covid 19 Vaccination were unknown. Vaccination Facility Type was Pharmacy/Drug Store. Vaccine was not Administered at admin Facility. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No AE required as visit to Emergency Room or Physician office. There was no prior vaccination within 4 weeks. There was no Family Medical History Relevant to AE and no Relevant Tests were performed. Outcome of event for the event soreness in arm was recovered on an unspecified date, Outcome of the events nausea, dizziness and sometimes she cannot get up, feels like someone is pushing her back down was not recovered and unknown other events.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Movement disorder, Nausea, Pain in extremity, Vertigo
Clinical narrative: experienced tiredness; dizziness; nausea; Sometimes she cannot get up, feels like someone is pushing her back down; Worried about getting the second dose of the Covid 19 Vaccination; States it is really bad and strange; The inside of her head will start spinning; Caller mentions her dizziness again. States sometimes she cannot get up because it feels like someone is pushing her down; She has not been driving for 5 days now because the dizziness comes suddenly; Soreness in arm; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 05Jun2021 (Batch/Lot Number: EW0191) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history included Historical Vaccine INFLUENZA VACCINES; she gets the flu shot every year with no adverse events. The patient's concomitant medications were not reported. The patient experienced dizziness and Nausea on 13Jun2021, experienced tiredness on 17Jun2021, she has not been driving for 5 days now because the dizziness comes suddenly, soreness in arm and worried about getting the second dose of the coved 19 vaccination, states it is really bad and strange and the inside of her head will start spinning on Jun2021, sometimes she cannot get up, feels like someone is pushing her back down on 13Jun2021, caller mentions her dizziness again. states sometimes she cannot get up because it feels like someone is pushing her down on Jun2021. Upon the follow-up received on 18Jun2021 reporter gave consent to contact. NDC number and expiry date of Covid 19 Vaccination were unknown. Vaccination Facility Type was Pharmacy/Drug Store. Vaccine was not Administered at admin Facility. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No AE required as visit to Emergency Room or Physician office. There was no prior vaccination within 4 weeks. There was no Family Medical History Relevant to AE and no Relevant Tests were performed. Outcome of event for the event soreness in arm was recovered on an unspecified date, Outcome of the events nausea, dizziness and sometimes she cannot get up, feels like someone is pushing her back down was not recovered and unknown other events.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Have pain/Aches and pains all day; Headache/head was killing; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0196), via an unspecified route of administration in right arm on 17Jun2021 (at the age of 66-year-old) as dose 2, single for COVID-19 immunization. The patient was taking the Pfizer COVID vaccine to try not to get COVID work in the business with a lot of people. The patient's medical history was none. Concomitant medications included blood pressure pill and vitamins NOS every day. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178), via injection in right arm on 27May2021 (at the age of 66-year-old) as dose 1, single for COVID-19 immunization. Patients medical history (including any illness at time of vaccination) was none. Family medical history relevant to adverse events was none. Prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine was none. Additional vaccines administered on same date of the Pfizer suspect was none. No adverse events following prior vaccinations. Patient stated she has received the Pfizer COVID vaccine and wanted to know if she could take something for pain, most specifically for a headache. She stated, "her head was killing her on an unspecified date in 2021." Reporter stated she was calling about the Pfizer COVID Vaccine. She stated she just has a question on what she could take for pain after receiving the COVID vaccine yesterday. Reporter stated she was having pain, so she was taking off work today and that was why she was home today. Reporter stated it really just her head. She has aches and pain all day and night all the time anyways. She stated it was on 18Jun2021 about 02:10 am almost exactly 12 hours after the second dose. Reporter stated that it was worse this morning. Reporter stated the outcome of having pain was the same. The adverse events did not require emergency room visit and physician office visit. No relevant tests. No investigation assessment. The outcome of the event pain was not resolved and unknown for the other event.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood pressure measurement, Cold sweat, Dizziness, Heart rate
Clinical narrative: Patient exhibited a seizure like episode that lasted approximately 15 seconds.; feel dizzy; pale and clammy skin; pale and clammy skin; This is a spontaneous report from a contactable other hcp (nurse). An adolescent non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162 and expiry date: unknown), dose 1 via intramuscular on 08Jun2021 as dose 1, single for covid-19 immunisation. The patient's medical history included syncope when patient was younger (had syncopal episode after a vaccination). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies. On 08Jun2021 the patient experienced exhibited a seizure like episode that lasted approximately 15 seconds. Patient was placed on the ground in a supine position where she regained consciousness. Patient with clammy and pale skin. Attempted to put patient in chair, once in chair she began to feel dizzy and was placed back on the ground in a supine position. Patient was able to sit up on the ground and was given juice and crackers. Patient continued to have pale and clammy skin. Alert and oriented x 3. EMS arrived and patient transported to hospital. The patient underwent lab tests and procedures which included Blood sugar at 14:13 was 92, at 14:05 BP was 122/69, at 14:10 BP was 122/58, at 14:05 heart rate was 100, at 14:05 respiratory rate was 18 on 08Jun2021. The outcome of all the events was unknown.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. . The case will be reassessed once new information is available  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
Symptoms: Pallor, Respiratory rate, Seizure like phenomena
Clinical narrative: Patient exhibited a seizure like episode that lasted approximately 15 seconds.; feel dizzy; pale and clammy skin; pale and clammy skin; This is a spontaneous report from a contactable other hcp (nurse). An adolescent non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162 and expiry date: unknown), dose 1 via intramuscular on 08Jun2021 as dose 1, single for covid-19 immunisation. The patient's medical history included syncope when patient was younger (had syncopal episode after a vaccination). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies. On 08Jun2021 the patient experienced exhibited a seizure like episode that lasted approximately 15 seconds. Patient was placed on the ground in a supine position where she regained consciousness. Patient with clammy and pale skin. Attempted to put patient in chair, once in chair she began to feel dizzy and was placed back on the ground in a supine position. Patient was able to sit up on the ground and was given juice and crackers. Patient continued to have pale and clammy skin. Alert and oriented x 3. EMS arrived and patient transported to hospital. The patient underwent lab tests and procedures which included Blood sugar at 14:13 was 92, at 14:05 BP was 122/69, at 14:10 BP was 122/58, at 14:05 heart rate was 100, at 14:05 respiratory rate was 18 on 08Jun2021. The outcome of all the events was unknown.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. . The case will be reassessed once new information is available  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
Symptoms: Herpes dermatitis
Clinical narrative: Outbreak of Herpes; This is a spontaneous report from a non-contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced outbreak of herpes. The patient wanted to know if she can take valacyclovir for an outbreak of Herpes after being vaccinated with the Pfizer Covid vaccine. The outcome of the event was unknown. There was no product quality complaint (PQC) present.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vulvovaginal burning sensation
Clinical narrative: couple days after started having some burning on her vaginal area, mainly on the outside of her vagina; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 15Jun2021 (age at vaccination: 52 years) (Batch/Lot Number: EW0155) as DOSE 1, SINGLE for covid-19 immunization. The patient past medical history included high cholesterol (patient stated cholesterol medication is 145 mg once in the morning), irregular heartbeat, allergy, migraine (she used to take Topamax for migraines) and sinuses. Stated she took high cholesterol pills, nose spray, and sinus pills. No family medical history relevant to adverse event. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Concomitant medication included Loratadine (Has been taking for years) taken for sinusitis, fluticasone propionate (FLONASE ALLERGY RELIEF) (Has been taking for years, only takes when the fall is starting) taken for allergy and sinus. No additional vaccines administered on same date of the pfizer suspect. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. Several years ago, may have been in her middle-forties, there was adverse event prior vaccinations due to flu shot of unknown brand and it made her more sick and she felt like dying, her body shut off. On an unspecified date, it was reported a couple days after started having some burning on her vaginal area, mainly on the outside of her vagina. She wanted to know if this is caused by the vaccine or if it had been reported before. The patient received the first dose of the vaccine on 15Jun2021 and a couple days after started having some burning on her vaginal area, mainly on the outside of her vagina. She wanted to know if this is caused by the vaccine or if it had been reported before. Adverse event did not required emergency room and physician office visit. Patient stated the shot was easy, her daughter got the second one, the Pfizer, she was more tired than usual but she okay now, her daughter got the second shot at the same time as the patient got her first one. Patient clarified this was her first dose. Investigations/Treatment: she was going to wait a couple of days, because she read on some of these, that sometimes, by it being so early, and she just got it, and sometimes can take a few days to do what it's got to do. There were no relevant tests. The event outcome was not recovered.  Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: A heavy feeling in her chest afterward that lasted approximately 2 weeks; This is a spontaneous report from a contactable pharmacist via Medical Information Team. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 14May2021 as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, the patient experienced a heavy feeling in her chest afterward that lasted approximately 2 weeks. Pharmacist was calling about a 77-year-old female who came in for her 2nd dose of the Pfizer BioNTech Covid-19 vaccine. In fact, she waited an extra week to come get her 2nd dose due to that symptom persisting. Pharmacist was wondering if there was any reason, she cannot get the second dose today. She reported that she does not have HCP and that this has not been formally diagnosed. The outcome of the event was recovered on an unspecified date in 2021.   Information on the lot/batch number has been requested.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Investigation, Loss of personal independence in daily activities, SARS-CoV-2 test
Clinical narrative: severe chest pressure; shortness of breath/cant breathe / not breathing normally; unable to dance or even walk; This is a spontaneous report from a contactable consumer (patient).   A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0180), via an unspecified route of administration, administered in Right arm on 05Jun2021 at 13:00 at the age of 13-years-old as dose 2, single dose for covid-19 immunisation. Medical history included Bechet's disease from an unknown date and unknown if ongoing, allergy to sesame seeds, she also carries the antibody for crest syndrome but does not have the disease or diagnosis (crest syndrome) from an unknown date and unknown if ongoing. Concomitant medications included colchicine (COLCHICINE) taken for an unspecified indication, vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, iron; vitamins nos (IRON; VITAMINS NOS) taken for an unspecified indication, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication on unspecified date. The patient previously took Omnicef omni-pac, and first dose of previous vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Eq0170), via an unspecified route of administration, administered in Left arm on 14May2021 at 16:00 at the age of 13-years-old as single dose for covid-19 immunisation. 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. The patient has been tested for COVID-19 since the vaccination. On 13Jun2021 at 8:00 AM, 8 days post vaccination, the patient had severe chest pressure and shortness of breath. Previously she was significantly athletic and danced 30-40 hours a week, now she was unable to dance or even walk without feeling like she cannot breathe.  ER in  said they have had 2 other cases with similar symptoms 8-10 days post vaccination. Her labs checked out okay, but she is not breathing normally. The patient received treatment for adverse events with Mortin, Tylenol, steroids and breathing treatments. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care was not specified. The patient underwent lab tests and procedures which included labs (Investigation): okay on an unspecified date and Nasal Swab (sars-cov-2 test): negative on 16Jun2021 (). Device Date: 18Jun2021. The outcome of events was not recovered.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, SARS-CoV-2 test
Clinical narrative: severe chest pressure; shortness of breath/cant breathe / not breathing normally; unable to dance or even walk; This is a spontaneous report from a contactable consumer (patient).   A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0180), via an unspecified route of administration, administered in Right arm on 05Jun2021 at 13:00 at the age of 13-years-old as dose 2, single dose for covid-19 immunisation. Medical history included Bechet's disease from an unknown date and unknown if ongoing, allergy to sesame seeds, she also carries the antibody for crest syndrome but does not have the disease or diagnosis (crest syndrome) from an unknown date and unknown if ongoing. Concomitant medications included colchicine (COLCHICINE) taken for an unspecified indication, vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, iron; vitamins nos (IRON; VITAMINS NOS) taken for an unspecified indication, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication on unspecified date. The patient previously took Omnicef omni-pac, and first dose of previous vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Eq0170), via an unspecified route of administration, administered in Left arm on 14May2021 at 16:00 at the age of 13-years-old as single dose for covid-19 immunisation. 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. The patient has been tested for COVID-19 since the vaccination. On 13Jun2021 at 8:00 AM, 8 days post vaccination, the patient had severe chest pressure and shortness of breath. Previously she was significantly athletic and danced 30-40 hours a week, now she was unable to dance or even walk without feeling like she cannot breathe.  ER in  said they have had 2 other cases with similar symptoms 8-10 days post vaccination. Her labs checked out okay, but she is not breathing normally. The patient received treatment for adverse events with Mortin, Tylenol, steroids and breathing treatments. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care was not specified. The patient underwent lab tests and procedures which included labs (Investigation): okay on an unspecified date and Nasal Swab (sars-cov-2 test): negative on 16Jun2021 (). Device Date: 18Jun2021. The outcome of events was not recovered.