chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bradykinesia, Fall, Influenza like illness
Clinical narrative: He started walking more slow and he became very weak; He started walking more slow and he became very weak; They looked for flu like things; He fell a couple times; This is a spontaneous report from a contactable consumer. A 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 23Jan2021 (86-year-old at the time of vaccination) (Batch/Lot number: EL8982,  number/Expiry date: Unknown) as single dose for Covid-19 immunization. The patient's medical history included diabetes for about 25 years and hypertension. Concomitant medication: Reporter stated, "He was on 3 pills one was for blood pressure, he took one for sugar, and one for potassium correct, he take these 3." Reporter stated: "he was calling to report the side effects that happened to the patient, after he get the Pfizer vaccine." Reporter stated, "He had his first injection and after that injection, it was noticed that he started walking more slow and he became very weak. He always had been a walker. And that was not normal for him, he was very healthy. All events were reported yesterday, first was an ER visit, the doctor said they had no explanation, they asked what is causing that, the weakness, he used to drive, he did daily walks, was active, it all started after the first injection, but at the time, no one knew to look for fatigue, they looked for flu like things, and he fell a couple times. Reporter stated, "Yes, he had both diabetes and hypertension, but doctor was absent because he had diabetes for about 25 years and when aunt told them that she thought that it was related to the vaccines then they just said they have no idea." Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Cough, Eye disorder
Clinical narrative: Tiredness and aches and pains; I had, my chest was burning, I had a horrible cough and pain in my back sort of like in my shoulder blade both of them; In my left eye and it is colorful it's red, blue and yellow; It's like making eyelashes on it in different colors and it does not stay in one spot and it float; Tiredness and aches and pains; I had, my chest was burning, I had a horrible cough and pain in my back sort of like in my shoulder blade both of them; I had, my chest was burning, I had a horrible cough and pain in my back sort of like in my shoulder blade both of them; I had a horrible cough and pain in my back sort of like in my shoulder blade both of them; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER/BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date: Not reported), via an unspecified route of administration on Jun2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated, I got the Pfizer on, I want to say this Wednesday but it could have been Thursday now I'm confused but you know I'm going through the symptoms, tiredness and aches and pains but would be, you know I had, my chest was burning, I had a horrible cough and pain in my back sort of like in my shoulder blade both of them and then the one thing that I'm most concerned about is I got like a 'blood' (Not further clarified hence not captured in tab) in one of, in my left eye and it is colourful it's red, blue and yellow and it's look like a half of the sea like in cove and little it's like making eyelashes on it in different colors and it does not stay in one spot and it float. I never had this before I mean is there anything that would you think would cause. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Eyelash discolouration, Fatigue, Pain
Clinical narrative: Tiredness and aches and pains; I had, my chest was burning, I had a horrible cough and pain in my back sort of like in my shoulder blade both of them; In my left eye and it is colorful it's red, blue and yellow; It's like making eyelashes on it in different colors and it does not stay in one spot and it float; Tiredness and aches and pains; I had, my chest was burning, I had a horrible cough and pain in my back sort of like in my shoulder blade both of them; I had, my chest was burning, I had a horrible cough and pain in my back sort of like in my shoulder blade both of them; I had a horrible cough and pain in my back sort of like in my shoulder blade both of them; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER/BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date: Not reported), via an unspecified route of administration on Jun2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated, I got the Pfizer on, I want to say this Wednesday but it could have been Thursday now I'm confused but you know I'm going through the symptoms, tiredness and aches and pains but would be, you know I had, my chest was burning, I had a horrible cough and pain in my back sort of like in my shoulder blade both of them and then the one thing that I'm most concerned about is I got like a 'blood' (Not further clarified hence not captured in tab) in one of, in my left eye and it is colourful it's red, blue and yellow and it's look like a half of the sea like in cove and little it's like making eyelashes on it in different colors and it does not stay in one spot and it float. I never had this before I mean is there anything that would you think would cause. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: experiencing bilateral lung blood clots; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration in Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was experiencing bilateral lung blood clots (medically significant) in 2021 with outcome of unknown.    Information on the batch/lot number has been requested.; Sender's Comments: Based on description given in the narrative, there is reasonable possibility of causal association between the event Pulmonary thrombosis and the suspect BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Dizziness, Fatigue, Feeling hot
Clinical narrative: High fever; He was having a fever and he ended up sweating it out on the bed, he was not even making the signs; Actually woke up in a furrow of water that came out of his body with a 102 degree fever; Sore throat; Teeth hurt; Teeth ache; Teeth all hurting; Pain on my teeth; Body ache; High fever; He was having a fever and he ended up sweating it out on the bed, he was not even making the signs; Actually woke up in a furrow of water that came out of his body with a 102 degree fever; Fatigue all over body; Sweaty sweat all over body, dripping sweat; I broke out with sweat and sweaty palms and forehead; Really sweaty; Woke up super-hot like the whole bed was wet; Got sick; Feeling tired all over, Very tired; We were really hot at night, it is like burning inside; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; This is a spontaneous report from a contactable consumer. There were 2 reporters on the call reporting for themselves. This is the second case out of the two cases where reporter handed over the phone to her Fiancée (Consumer) and he is reporting for himself.   This consumer (patient) reported for himself that a 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0191), via an unspecified route of administration on 19Jun2021 at 16:15 (at the age of 46-year-old), as dose 1, single in deltoid left, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no family medical history. On an unspecified date, the patient experienced high fever; he was having a fever and he ended up sweating it out on the bed, he was not even making the signs; actually woke up in a furrow of water that came out of his body with a 102 degree fever; sore throat; teeth hurt; teeth ache; teeth all hurting; pain on my teeth; body ache; fatigue all over body; sweaty sweat all over body, dripping sweat; I broke out with sweat and sweaty palms and forehead; really sweaty; woke up super-hot like the whole bed was wet; got sick; feeling tired all over, very tired. Patient was really hot at night, it was like burning inside; and extremely very hot, very thirsty, and dizzy, kind of tired, fatigue. Patient received treatment for the events. Treatment medications included Tylenol 500mg and Advil 200mg and Naproxen 500mg, once every 12 hours, twice a day. Patient had to take Nyquil and half a Benadryl to help fall asleep because of the pain on his teeth, and sore throat. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical outcome of all events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: High fever; He was having a fever and he ended up sweating it out on the bed, he was not even making the signs; Actually woke up in a furrow of water that came out of his body with a 102 degree fever; Sore throat; Teeth hurt; Teeth ache; Teeth all hurting; Pain on my teeth; Body ache; High fever; He was having a fever and he ended up sweating it out on the bed, he was not even making the signs; Actually woke up in a furrow of water that came out of his body with a 102 degree fever; Fatigue all over body; Sweaty sweat all over body, dripping sweat; I broke out with sweat and sweaty palms and forehead; Really sweaty; Woke up super-hot like the whole bed was wet; Got sick; Feeling tired all over, Very tired; We were really hot at night, it is like burning inside; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; This is a spontaneous report from a contactable consumer. There were 2 reporters on the call reporting for themselves. This is the second case out of the two cases where reporter handed over the phone to her Fiancée (Consumer) and he is reporting for himself.   This consumer (patient) reported for himself that a 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0191), via an unspecified route of administration on 19Jun2021 at 16:15 (at the age of 46-year-old), as dose 1, single in deltoid left, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no family medical history. On an unspecified date, the patient experienced high fever; he was having a fever and he ended up sweating it out on the bed, he was not even making the signs; actually woke up in a furrow of water that came out of his body with a 102 degree fever; sore throat; teeth hurt; teeth ache; teeth all hurting; pain on my teeth; body ache; fatigue all over body; sweaty sweat all over body, dripping sweat; I broke out with sweat and sweaty palms and forehead; really sweaty; woke up super-hot like the whole bed was wet; got sick; feeling tired all over, very tired. Patient was really hot at night, it was like burning inside; and extremely very hot, very thirsty, and dizzy, kind of tired, fatigue. Patient received treatment for the events. Treatment medications included Tylenol 500mg and Advil 200mg and Naproxen 500mg, once every 12 hours, twice a day. Patient had to take Nyquil and half a Benadryl to help fall asleep because of the pain on his teeth, and sore throat. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical outcome of all events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Thirst, Toothache
Clinical narrative: High fever; He was having a fever and he ended up sweating it out on the bed, he was not even making the signs; Actually woke up in a furrow of water that came out of his body with a 102 degree fever; Sore throat; Teeth hurt; Teeth ache; Teeth all hurting; Pain on my teeth; Body ache; High fever; He was having a fever and he ended up sweating it out on the bed, he was not even making the signs; Actually woke up in a furrow of water that came out of his body with a 102 degree fever; Fatigue all over body; Sweaty sweat all over body, dripping sweat; I broke out with sweat and sweaty palms and forehead; Really sweaty; Woke up super-hot like the whole bed was wet; Got sick; Feeling tired all over, Very tired; We were really hot at night, it is like burning inside; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; This is a spontaneous report from a contactable consumer. There were 2 reporters on the call reporting for themselves. This is the second case out of the two cases where reporter handed over the phone to her Fiancée (Consumer) and he is reporting for himself.   This consumer (patient) reported for himself that a 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0191), via an unspecified route of administration on 19Jun2021 at 16:15 (at the age of 46-year-old), as dose 1, single in deltoid left, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no family medical history. On an unspecified date, the patient experienced high fever; he was having a fever and he ended up sweating it out on the bed, he was not even making the signs; actually woke up in a furrow of water that came out of his body with a 102 degree fever; sore throat; teeth hurt; teeth ache; teeth all hurting; pain on my teeth; body ache; fatigue all over body; sweaty sweat all over body, dripping sweat; I broke out with sweat and sweaty palms and forehead; really sweaty; woke up super-hot like the whole bed was wet; got sick; feeling tired all over, very tired. Patient was really hot at night, it was like burning inside; and extremely very hot, very thirsty, and dizzy, kind of tired, fatigue. Patient received treatment for the events. Treatment medications included Tylenol 500mg and Advil 200mg and Naproxen 500mg, once every 12 hours, twice a day. Patient had to take Nyquil and half a Benadryl to help fall asleep because of the pain on his teeth, and sore throat. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical outcome of all events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable other hcp. It was reported that the Registered Nurse called as follow-up to previous report she filed on behalf of her wife who is the patient in report 1 of 2.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported, Expiry date: Not Provided) via an unspecified route of administration,administered in Arm on 01May2021 as dose 1,Single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. On an unspecified day in 2021, the patient experienced sore arm.During that report caller reported information about her-self. The patient in this report is the caller. She reported she had both doses of Pfizer Covid-19 Vaccine and had no reaction other than a sore arm that went away. She had them do the second dose in the dominant arm so the next time it was less of a problem, she could work it. She has not reported this information for herself previously. She reported that is a common occurrence, most injections get that effect, she was not concerned with that and declined to complete report. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported, Expiry date: Not Provided) via an unspecified route of administration, administered in Arm on an unspecified date as dose 2, 0.3 mg single for COVID-19 immunization.The consumer asked why they did not put down the dosage information for her first dose; She had an emergency came there agreed to provide her second dose and they put down for dose: 0.3mg for the injection to her arm; she wondered why they did not put that for the first dose. NDC number was not provided.There was not product complaint to the report. There was no medical information request. This wasn't an Other report. Outcome of the event was recovered on an unspecified day in 2021.  Information about lot/batch number is requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysphonia, Oropharyngeal pain
Clinical narrative: Joint pain; sore throat; Hoarseness; This is a spontaneous report from a contactable consumer or other non-HCP (patient's daughter).  A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Apr2021 (at the age of 51-years-old) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not reported), dose 1 via an unspecified route of administration on 27Apr2021 as dose 1, single for covid-19 immunisation. The patient received the vaccine in Mar2021 or Apr2021. The patient has been experiencing hoarseness/sore throat (voice was horse) which started 3 months ago (in 2021), since then and joint pain a week after her Pfizer shot in Apr2021. The reporter would like more information about the side effects, reclarified the hoarseness and joint pain and asked were these common side effects, and what should be the next steps, treatment. The patient went to the doctor about these issues, and they could not find a solution. This has been ongoing for 3 months, and she was a normally well person, with no health issues. She asked what the next steps for her side effects response were, provided disclaimer that Pfizer does not provide treatment recommendations or clinical interventions.The patient required the physician office visit for the adverse events. The outcome of the events was not recovered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Metabolic function test, Thyroid function test, Tinnitus
Clinical narrative: Tinnitus worsened; This is a spontaneous report from a contactable consumer (patient Herself). A 44-year-old female consumer received first dose BNT162B2(Pfizer COVID 19 vaccine, solution for injection, lot number ER8732), via unspecified route of administration on 12Apr2021 09:00 in left arm for 1st dose, single for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history included ongoing high blood pressure, ongoing thyroid problems from an unspecified date of 2012, acute asthma and overweight. The patient concomitant medications was not provided. She had acute asthma and was afraid if she got COVID that she would be sick. The patient received both doses of the Pfizer COVID 19 vaccine. She reports after receiving the first dose of the vaccine on 03May2021 she had severe tinnitus and hearing loss and constant ring in the. She had a few episodes and didn't know what it was. It got a little better and then she got the second dose, and it has gotten worse after that. She saw her doctor and he mentioned that he saw lots of patients that their blood pressure and hearing were affected. Caller does not have any patient details to provide. Her doctor told her to report this, and she could go to a specialist if she wanted to. Her doctor didn't know what to do. The doctor is still documenting what his patients are telling him. She saw the doctor on Friday. He did a full blood work panel including a CBC, metabolic panel, thyroid panel. She had a full blood work panel since she has had issues. She wanted to make sure there was nothing in her blood that was alarming other than the hearing loss and tinnitus. They called this morning and said everything was normal and to report it and she can go to a specialist if she wants to. The outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer. This report 2 of 3. This case is for the 2nd stepdaughter.  A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC number: Unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Family History included Rheumatoid Arthritis (mom). The patient's concomitant medications were not reported. The reporter does not believe she had any other vaccines, but she does not know. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC number: Unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Reporter does not know when she had her first dose of the vaccine. It was the Pfizer version and believes she had her second dose, but she was not 100% sure. She does not know in which arm she got it. The reporter has 2 stepdaughters. They both received the Pfizer Covid Vaccine, and they both have developed shingles on an unspecified date. It was quite a few weeks after they got the injection. The reporter was not sure of the timing. They suspect it may be related to the vaccine. She is a nurse. She got the Covid Vaccine before most people in her country. She wanted to get protected for herself as well as for her clients. The reporter thinks it was a few months later that she developed Shingles. The reporter thought it was strange that the patient and her sister both had shingles at such a young age. The reporter does not really remember when the Shingles started for her. It was about 2 or 3 months ago. It has resolved. The reporter does not know when it resolved. It was unknown if event required a visit to Emergency Room or Physician Office. The outcome of event was recovered on an unknown date.  Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021797564 similar report from same reporter/event/drug, different patient
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Syncope
Clinical narrative: fainted/Fainted after first dose; Lightheaded, after first vaccine.; Headache, after first vaccine.; Fatigue, and tiredness, after first vaccine; Brainfog, after first vaccine; This is a spontaneous report from Pfizer sponsored program COVAX US Support. A contactable consumer (patient) reported that a 34-year-old male patient received first dose of BNT162B2 on Apr2021 (at age of 34-year-old) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Agent states Caller reports some adverse events experienced with his first dose of the Pfizer Covid 19 vaccine. Agent states, that the Caller, is inquiring about the second dose. Agent states the Caller had his first dose 2 months ago. Agent states the Caller reports one hour after the vaccine, he became lightheaded, and 3 hours later, he fainted. Agent states the Caller mentioned he had a few other effects, but those two were his most prevalent ones. Caller states that he had other symptoms, that are normal after the vaccine, but reclarified that he had a headache, fatigue and tiredness, and brain fog. Caller asks, is it safe for him to get the second vaccine, Caller asks why did he faint, Caller wants to know, how can he be safe, if he takes the second vaccine, Caller reports that he does not have a doctor, and he hasn't seen a doctor in about 20 years. Caller states he always feels fine, and has never fainted, before this event. The outcome of event faint and lightheaded was unknown. The outcome of other events was recovered.   Information about batch/Lot number had been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Leg was hurting a little bit; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0187) via an unspecified route of administration in right arm on 06Jun2021 in morning as 1st dose, single for Covid-19 immunization. Patients medical history was not reported. Patients concomitant medications included pantoprazole and she reported takes Levothyroxine sodium, Levoxine or something like that, it is 75. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. On 06Jun2021 patients leg was hurting a little bit faced the same day, she took the vaccine. Reporter stated, he was speaking on behalf of his wife. She took the Pfizer shot, she got the first shot, and she was supposed to go back on day of reporting, she went to get the second shot and they asked her if she had any symptoms and she said that her leg was hurting a little bit. Event was improved because they only hurt for one day. Patient did not receive any treatment for the event. The outcome of event was recovering at the time of reporting.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: A week later I developed ringing in my ears which has persisted till today.; This is a spontaneous report from a contactable consumer (patient) patient of unspecified age and gender received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number, and Expiration date was not reported), via an unspecified route of administration on 29Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Apr2021, (a week later), patient developed ringing in his/her ears which had persisted till today. It had been terrible. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Cerebrovascular accident
Clinical narrative: cerebral stroke; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program.  A 70-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  Medical history included palpitations from an unknown date and unknown if ongoing (6 Weeks prior to getting her first dose), the patient had a history of anaphylaxis with sulfa drugs but did not specify the type of sulfa medication. The patient's concomitant medications were not reported.  The patient experienced cerebral stroke on 07Apr2021. The patient underwent lab tests and procedures which included antibody test: have antibodies (as reported) on an unspecified date. The patient outcome of the event was unknown.    The information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Dysstasia, Exercise tolerance decreased, Fatigue, Gait disturbance
Clinical narrative: Severe right groin pain; Difficulty walking; exercise is extremely limited; Quite painful; Weakness in legs and muscles; Very tired; heart seems taxed; Standing become laborious; Headache; Received BNT162B2 of first dose on 15Apr2021 at 15:15 and second dose on 05Jun2021 at 15:15; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 05Jun2021 at 15:15 (Lot number: EL3247) as single dose for COVID-19 immunization. The patient medical history was not reported. Family medical history included thyroid med use, arthritis, increased blood pressure. Concomitant medications reported as none. None of prior vaccinations. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 15Apr2021 at 15:15 (Lot number: EL9265) as single dose for COVID-19 immunization that patient had a severe ear problem/cannot hear. On 06Jun2021, the patient experienced severe right groin pain - difficulty walking, exercise was extremely limited and quite painful; weakness in legs/muscles; very tired (heart seems taxed). This seemed to come in 'out-of-the-blue' standing becomes laborious (patient cannot seem to go on a walk anymore); headaches. One day patient would see some improvement but, the next was another story. Patient was taking Tylenol. Overall it was getting better-sort of (xtra with regular strength). Exactly 1 month to the day of 2nd vaccination (Pfizer) that this ghostly ailment came on, the right side of my body. Patient had called her GP & was scheduled for a blood test. Also, patient had scheduled an orthopaedic visit (neighbour recommended) at end of month. Patient was sleeping more, moving slow and trying to figure out how to help herself. Isometric exercise helped sometimes. Events resulted in physician office visit. Treatment received for events including Tylenol xtra strength and reg. strength. Outcome of the event "received BNT162B2 of first dose on 15Apr2021 at 15:15 and second dose on 05Jun2021 at 15:15" was unknown, while of the other events was not recovered. Seriousness criteria was assessed by the reporting consumer as persistent/ significant disability/incapacity.   Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Groin pain, Headache, Inappropriate schedule of product administration, Muscular weakness, Pain
Clinical narrative: Severe right groin pain; Difficulty walking; exercise is extremely limited; Quite painful; Weakness in legs and muscles; Very tired; heart seems taxed; Standing become laborious; Headache; Received BNT162B2 of first dose on 15Apr2021 at 15:15 and second dose on 05Jun2021 at 15:15; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 05Jun2021 at 15:15 (Lot number: EL3247) as single dose for COVID-19 immunization. The patient medical history was not reported. Family medical history included thyroid med use, arthritis, increased blood pressure. Concomitant medications reported as none. None of prior vaccinations. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 15Apr2021 at 15:15 (Lot number: EL9265) as single dose for COVID-19 immunization that patient had a severe ear problem/cannot hear. On 06Jun2021, the patient experienced severe right groin pain - difficulty walking, exercise was extremely limited and quite painful; weakness in legs/muscles; very tired (heart seems taxed). This seemed to come in 'out-of-the-blue' standing becomes laborious (patient cannot seem to go on a walk anymore); headaches. One day patient would see some improvement but, the next was another story. Patient was taking Tylenol. Overall it was getting better-sort of (xtra with regular strength). Exactly 1 month to the day of 2nd vaccination (Pfizer) that this ghostly ailment came on, the right side of my body. Patient had called her GP & was scheduled for a blood test. Also, patient had scheduled an orthopaedic visit (neighbour recommended) at end of month. Patient was sleeping more, moving slow and trying to figure out how to help herself. Isometric exercise helped sometimes. Events resulted in physician office visit. Treatment received for events including Tylenol xtra strength and reg. strength. Outcome of the event "received BNT162B2 of first dose on 15Apr2021 at 15:15 and second dose on 05Jun2021 at 15:15" was unknown, while of the other events was not recovered. Seriousness criteria was assessed by the reporting consumer as persistent/ significant disability/incapacity.   Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Insomnia, Tinnitus
Clinical narrative: slight hearing loss; I started with ringing in my ears; unable to sleep; This is a spontaneous report from a contactable consumer (patient). An 82-year-old-female consumer (no pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the left arm  on 26Mar2021 at 02:00 PM (Lot Number: ER8732) at the age of 82-year-old as single dose for COVID-19 immunization. Medical history included history of high blood pressure. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 05Mar2021 at 02:00 PM (Lot Number: EN6204) at the age of 82-year-old as single dose for COVID-19 immunization and no reaction on previous exposure to drug. The patient previously took Percocet (PERCOCET [OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE; PARACETAMOL]) used for unknown indication and experienced drug allergy and took codeine used for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received BP Medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 08:00 AM, the patient started with ringing in ears (head) that had never stopped since that day. The patient unable to sleep since that day due to the constant noise. The patient had been to primary care Dr. and also an ENT Dr. The patient not deaf but do had slight hearing loss. The events all result in doctor or other healthcare professional office/clinic visit and the events of hearing loss and ringing in ears also result in disability permanent damage. The treatment was received with Steroids x 10 days. The outcome of event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Condition aggravated
Clinical narrative: RA Flare-up; extremely painful pain in my lower back; extremely painful pain in sacroiliac joint; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown) at single dose for COVID-19 immunisation and experienced a couple of rashes and rheumatoid arthritis (RA) flare-up. The patient previously took Xeljanz for RA since 2017. The patient experienced RA flare-up and extremely painful pain in lower back and sacroiliac joint. The clinical course was reported as: The patient was unsure why the patient received this letter regarding Enbrel. The patient contacted Pfizer in Mar2021 when the patient was informed that funding on Xeljanz rebate program had run out, so the patient had to apply for another rebate program, which the patient got accepted into until the end of the year. The patient had not been on Enbrel for over 15 years. The patient had been on Xeljanz since 2017. It worked for RA. After the first and second Covid-19 vaccines from Pfizer, the patient was told to not take Xeljanz for a week. The patient got off of Xeljanz for 5 days after the first shot and on day 6 after the second shot, the patient had a RA flare-up and had to contact the rheumatologist who put the patient on a prednisone burst; 15mg for 2 days, 10mg for 2 days and 5 mg for two days. This was on days 7 through 12 after the second vaccination and was due to the fact that the patient had been off of Xeljanz for 6 days. The patient did get a couple of rashes after the first Covid-19 shot and extremely painful pain in lower back and sacroiliac joint, beginning the afternoon of the second shot and continuing, but fading over the next 10 days. This was reported and the patient went to the doctor for it as well. All of this, however, had nothing to do with Enbrel. The outcome of event RA flare-up was unknown. The outcome of events pain in lower back and sacroiliac joint was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rheumatoid arthritis
Clinical narrative: RA flare-up; rashes; This is a spontaneous report from a contactable consumer (patient). This unknown age female patient received first dose of covid-19 vaccine BNT162B2 on an unspecific date at single dose for covid-19 immunization. Medical history was rheumatoid arthritis. Concomitant drug was tofacitinib citrate (XELJANZ) for rheumatoid arthritis. After first dose from Pfizer, she was told to not take tofacitinib citrate for a week. She got off of tofacitinib citrate for 5 days after the first shot and on day 6 after the second shot, she had an RA flare-up and had to contact the rheumatologist who put her on a prednisone burst; 15 mg for 2 days, 10mg for 2 days and 5mg for two days. She did get a couple of rashes after the first covid-19 shot. This was reported and she went to the doctor for it as well. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness, Fatigue
Clinical narrative: Fever/Fever of 103; Chills; Weak; Dizzy; Tiredness; Headache; Muscle pain; This is a spontaneous report from a contactable consumer reported for granddaughter.   A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Solution for injection, via an unspecified route of administration on 27Jun2021 (Batch/Lot number was not reported) as dose 2, single (at an unknown age) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received BNT162B2 as first dose at an unknown age for COVID-19 Immunization and she didn't really have a reaction with first.  The patient was having fever of 103 after the second shot. She had her second shot yesterday (27Jun2021). She was okay yesterday, there was no reaction. She just had her fever today (28Jun2021). She had been pushing fluids and giving tylenol.  The patient also experienced chills, weak, dizzy, tiredness, headache, muscle pain in Jun2021. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever/Fever of 103; Chills; Weak; Dizzy; Tiredness; Headache; Muscle pain; This is a spontaneous report from a contactable consumer reported for granddaughter.   A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Solution for injection, via an unspecified route of administration on 27Jun2021 (Batch/Lot number was not reported) as dose 2, single (at an unknown age) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received BNT162B2 as first dose at an unknown age for COVID-19 Immunization and she didn't really have a reaction with first.  The patient was having fever of 103 after the second shot. She had her second shot yesterday (27Jun2021). She was okay yesterday, there was no reaction. She just had her fever today (28Jun2021). She had been pushing fluids and giving tylenol.  The patient also experienced chills, weak, dizzy, tiredness, headache, muscle pain in Jun2021. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dysstasia, Haemorrhage, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: prolonged menstrual period and menstrual bleeding.; her menstrual period involved bleeding a bunch of blood; severe stomach ache; she also stated that her feet are swollen and she can barely stand; she also stated that her feet are swollen and she can barely stand; heavy bleeding; This is a spontaneous report from a contactable consumer reported for herself. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Jun2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated that, she got her first dose of the Pfizer Covid-19 Vaccine on 05Jun2021. The next day, 06Jun2021, she started experiencing severe stomachache which lasted for a week. It comes and goes, and still experiences this from time to time. She also stated that, on unknown date in Jun2021 her feet were swollen, and she could barely stand. On unknown date in Jun2021, she had heavy bleeding. She also stated that her menstrual period started on 12Jun2021 and until today 28Jun2021, she still had her period. She also mentioned that her menstrual period involved bleeding a bunch of blood. She spoke with her doctor and was prescribed Transaxemic Acid, 650MG twice every 8 hours (Total of 1300MG/8 hours) which she continued to take to relieve heavy bleeding. She also stated that she had no prior history of heavy bleeding. Caller was concerned that she might be contraindicated in getting the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine because of her prolonged menstrual period and menstrual bleeding. The patient wanted to know if the symptoms that she was experiencing were among the commonly reported adverse events of the Pfizer BioNTech covid-19 Vaccine. The patient saw similar accounts of prolonged menstrual period and menstrual bleeding with stomachache on google and she would like this to be raised for attention. The patient still did not have her 2nd dose of the Pfizer BioNTech Covid-19 Vaccine, the patient would like to know if she could still get her 2nd dose beyond the 21st day. The event heavy bleeding was assessed as serious (medically significant). Therapeutic measures were taken as a result of the events heavy bleeding, prolonged menstrual period and menstrual bleeding and her menstrual period involved bleeding a bunch of blood. The outcome of the events, severe stomachache, prolonged menstrual period and menstrual bleeding and her menstrual period involved bleeding a bunch of blood was not resolved while the outcome of other events was unknown. No PQC involved.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: prolonged menstrual period and menstrual bleeding.; her menstrual period involved bleeding a bunch of blood; severe stomach ache; she also stated that her feet are swollen and she can barely stand; she also stated that her feet are swollen and she can barely stand; heavy bleeding; This is a spontaneous report from a contactable consumer reported for herself. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Jun2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated that, she got her first dose of the Pfizer Covid-19 Vaccine on 05Jun2021. The next day, 06Jun2021, she started experiencing severe stomachache which lasted for a week. It comes and goes, and still experiences this from time to time. She also stated that, on unknown date in Jun2021 her feet were swollen, and she could barely stand. On unknown date in Jun2021, she had heavy bleeding. She also stated that her menstrual period started on 12Jun2021 and until today 28Jun2021, she still had her period. She also mentioned that her menstrual period involved bleeding a bunch of blood. She spoke with her doctor and was prescribed Transaxemic Acid, 650MG twice every 8 hours (Total of 1300MG/8 hours) which she continued to take to relieve heavy bleeding. She also stated that she had no prior history of heavy bleeding. Caller was concerned that she might be contraindicated in getting the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine because of her prolonged menstrual period and menstrual bleeding. The patient wanted to know if the symptoms that she was experiencing were among the commonly reported adverse events of the Pfizer BioNTech covid-19 Vaccine. The patient saw similar accounts of prolonged menstrual period and menstrual bleeding with stomachache on google and she would like this to be raised for attention. The patient still did not have her 2nd dose of the Pfizer BioNTech Covid-19 Vaccine, the patient would like to know if she could still get her 2nd dose beyond the 21st day. The event heavy bleeding was assessed as serious (medically significant). Therapeutic measures were taken as a result of the events heavy bleeding, prolonged menstrual period and menstrual bleeding and her menstrual period involved bleeding a bunch of blood. The outcome of the events, severe stomachache, prolonged menstrual period and menstrual bleeding and her menstrual period involved bleeding a bunch of blood was not resolved while the outcome of other events was unknown. No PQC involved.    Information on the lot/batch number has been requested.