chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Memory impairment, Transient ischaemic attack
Clinical narrative: started seeing strange things- saw things that weren't there. The yellow wall in his bedroom came up but had all kinds of art work on it, the ceiling and doors too; couldn't remember things; Weird things happened in my brain; lost his vision while driving; CT scan  it did show hardening of the arteries in his brain ,was told had a TIA (Transient Ischemic Attack) or some kind of a stroke; had issues with confusion as well; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 06Apr2021 as 2nd dose, single dose (at the age of 78-year-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 as 1st dose for COVID-19 immunization. On 02May2021 (26 days later), patient lost his vision while driving and it came back good enough to drive within a half hour (medically significant) and when it recovered on 02May2021, patient started seeing strange things, saw things that were not there. The yellow wall in his bedroom came up but had all kinds of artwork on it, the ceiling and doors too (medically significant), patient couldn't remember things, had weird things happened in his brain. Patient stated that it didn't go away entirely until about 10 days later. Patient also had issues with confusion as well. Patient stated that he thinks he was back to normal now. A computed tomography (CT) scan was completed a week or so earlier and it did show hardening of the arteries in his brain. Patient saw his primary care physician and was referred to a neurologist. On unspecified date of May-2021, patient was told he had a transient ischemic attack (TIA) or some kind of a stroke (medically significant). Patient had a Magnetic resonance elastography (MRE) (like a Magnetic resonance imaging (MRI) of the brain) yesterday (27May2021), but it had not been read yet. Patient asked if he was the only one that had done this or had other people had this problem, even two or three people or he was an isolated case and in response it was stated that, unable to find information about his symptoms in resources and the Product Information (PI) for the vaccine does not contain information reporting his symptoms (vision loss, memory loss, confusion, hallucinations) as side effects of the vaccine. The outcome of had a TIA (Transient Ischemic Attack) or some kind of a stroke was unknown, for lost his vision while driving was recovered on 02May2021 while recovered for rest of the events on May2021.  Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Chills, Crying, Dysphagia
Clinical narrative: like an affected brain function; intense chills/ severe chills so bad that she thought that she was going to have a convulsion.; intense chills/ severe chills so bad that she thought that she was going to have a convulsion.; symptoms like those for the flu/flu like symptoms; redness in her eyes; problems focusing her vision; pain in the eyes and very hard pain on the eft side of her skull that went down to the neck.; very hard pain on the eft side of her skull that went down to the neck.; pain in the eyes and very hard pain on the eft side of her skull that went down to the neck.; not thinking properly/her thinking processand her logic were affected; the muscular tone of the tongue was affected affecting her speech and swallowing; the muscular tone of the tongue was affected affecting her speech and swallowing; the muscular tone of the tongue was affected affecting her speech and swallowing; cry; This is a spontaneous report from a contactable consumer (Patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Feb2021 (lot number: not reported) as second dose, single for COVID-19 Immunization. Patient had received first dose of vaccine Pfizer BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Jan2021 (at the age of 78-years-old) for COVID-19 Immunization and she was feeling fine. The patient medical history and concomitant medications were not reported. On 25Feb2021, 5 days after the administration of the second dose of the vaccine,  patient experienced symptoms related with her eyes, her nervous system and symptoms like those for the flu, Ophthalmological symptoms like redness in her eyes, problems focusing her vision, pain in the eyes and very hard pain on the left side of her skull that went down to the neck and Neurological symptoms like an affected brain function, not thinking properly, the muscular tone of the tongue was affected affecting her speech and swallowing, these symptoms always on the left side of her head. The patient reported that the flu like symptoms were intense chills, so much that she could not get warmed even when she used very warm material, she took her body temperature and she found it to be normal, then she experienced severe chills so bad that she thought that she was going to have a convulsion, then she started to feel afraid and she started to cry, noticing that her thinking process and her logic were affected. Patient visited multiple specialists like Neurologists, Ophthalmologists, and Physicians for the events. The patient underwent lab tests and procedures which included body temperature: normal on an unspecified date in Feb2021. The outcome of the events was reported as recovered on 23May2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Influenza like illness, Mental impairment, Neck pain, Ocular hyperaemia
Clinical narrative: like an affected brain function; intense chills/ severe chills so bad that she thought that she was going to have a convulsion.; intense chills/ severe chills so bad that she thought that she was going to have a convulsion.; symptoms like those for the flu/flu like symptoms; redness in her eyes; problems focusing her vision; pain in the eyes and very hard pain on the eft side of her skull that went down to the neck.; very hard pain on the eft side of her skull that went down to the neck.; pain in the eyes and very hard pain on the eft side of her skull that went down to the neck.; not thinking properly/her thinking processand her logic were affected; the muscular tone of the tongue was affected affecting her speech and swallowing; the muscular tone of the tongue was affected affecting her speech and swallowing; the muscular tone of the tongue was affected affecting her speech and swallowing; cry; This is a spontaneous report from a contactable consumer (Patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Feb2021 (lot number: not reported) as second dose, single for COVID-19 Immunization. Patient had received first dose of vaccine Pfizer BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Jan2021 (at the age of 78-years-old) for COVID-19 Immunization and she was feeling fine. The patient medical history and concomitant medications were not reported. On 25Feb2021, 5 days after the administration of the second dose of the vaccine,  patient experienced symptoms related with her eyes, her nervous system and symptoms like those for the flu, Ophthalmological symptoms like redness in her eyes, problems focusing her vision, pain in the eyes and very hard pain on the left side of her skull that went down to the neck and Neurological symptoms like an affected brain function, not thinking properly, the muscular tone of the tongue was affected affecting her speech and swallowing, these symptoms always on the left side of her head. The patient reported that the flu like symptoms were intense chills, so much that she could not get warmed even when she used very warm material, she took her body temperature and she found it to be normal, then she experienced severe chills so bad that she thought that she was going to have a convulsion, then she started to feel afraid and she started to cry, noticing that her thinking process and her logic were affected. Patient visited multiple specialists like Neurologists, Ophthalmologists, and Physicians for the events. The patient underwent lab tests and procedures which included body temperature: normal on an unspecified date in Feb2021. The outcome of the events was reported as recovered on 23May2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Speech disorder, Thinking abnormal, Tongue disorder, Vision blurred
Clinical narrative: like an affected brain function; intense chills/ severe chills so bad that she thought that she was going to have a convulsion.; intense chills/ severe chills so bad that she thought that she was going to have a convulsion.; symptoms like those for the flu/flu like symptoms; redness in her eyes; problems focusing her vision; pain in the eyes and very hard pain on the eft side of her skull that went down to the neck.; very hard pain on the eft side of her skull that went down to the neck.; pain in the eyes and very hard pain on the eft side of her skull that went down to the neck.; not thinking properly/her thinking processand her logic were affected; the muscular tone of the tongue was affected affecting her speech and swallowing; the muscular tone of the tongue was affected affecting her speech and swallowing; the muscular tone of the tongue was affected affecting her speech and swallowing; cry; This is a spontaneous report from a contactable consumer (Patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Feb2021 (lot number: not reported) as second dose, single for COVID-19 Immunization. Patient had received first dose of vaccine Pfizer BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Jan2021 (at the age of 78-years-old) for COVID-19 Immunization and she was feeling fine. The patient medical history and concomitant medications were not reported. On 25Feb2021, 5 days after the administration of the second dose of the vaccine,  patient experienced symptoms related with her eyes, her nervous system and symptoms like those for the flu, Ophthalmological symptoms like redness in her eyes, problems focusing her vision, pain in the eyes and very hard pain on the left side of her skull that went down to the neck and Neurological symptoms like an affected brain function, not thinking properly, the muscular tone of the tongue was affected affecting her speech and swallowing, these symptoms always on the left side of her head. The patient reported that the flu like symptoms were intense chills, so much that she could not get warmed even when she used very warm material, she took her body temperature and she found it to be normal, then she experienced severe chills so bad that she thought that she was going to have a convulsion, then she started to feel afraid and she started to cry, noticing that her thinking process and her logic were affected. Patient visited multiple specialists like Neurologists, Ophthalmologists, and Physicians for the events. The patient underwent lab tests and procedures which included body temperature: normal on an unspecified date in Feb2021. The outcome of the events was reported as recovered on 23May2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: His left armpit got big and swollen. He thinks it's  swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 29-years-old male patient received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0168, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 25May2021 at 09:15 as 1st dose, single for COVID-19 immunisation. The patient medical history was none. The patient's concomitant medications were not reported. There was no history of previous immunization with the Pfizer vaccine that would be considered as suspect. The patient did not administered vaccine on same date of the Pfizer suspect. The patient did not receive any prior vaccinations (within 4 weeks). On 26May2021, evening 19:30-20:00, the patient experienced his left armpit got big and swollen, he thinks its swollen lymph nodes. Response was 6 over all safety summary, lymphadenopathy (0.3%). It had not gone down much. The patient stated that he had a little fact sheet which says it was a lymph node. He asked that was there any way that he could possibly get that to go down and how long it would last. He also asked for specific medication he could take for his swollen lymph nodes. The event did not require a visit to emergency room or physician office. There was no family medical history relevant to adverse event. The patient did not undergo relevant tests. The patient did not receive treatment for the event. The outcome of the event was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Body temperature, Chills, Heart rate
Clinical narrative: Blood pressure fluctuation with the current reading of 89/49 mmHg; Pulse rate and heart rate that is fluctuating to around 106-162 bpm and is currently at 180 bpm now; fever of 102F-103F; chills; SpO2 also keeps fluctuating every 5-10 second with a current reading of 94 , his normal ranges are within 98-99; This is a spontaneous report from a contactable consumer reported for father via medical information team. A 69-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 27May2021 as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant drugs not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as 1st dose, single dose for COVID-19 immunization. On an unspecified time later in May2021, as of the moment, the patient was having fever of 102F-103F and chills. Pulse rate and heart rate that was fluctuating to around 106-162 bpm and was currently at 180 bpm now. He also was experiencing some blood pressure fluctuation with the current reading of 89/49 mmHg, SpO2 also kept fluctuating every 5-10 second with a current reading of 94, his normal ranges were within 98-99. The reporter wanted to know if these were commonly reported side effect after getting the vaccine. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Oxygen saturation decreased, PO2, Pyrexia
Clinical narrative: Blood pressure fluctuation with the current reading of 89/49 mmHg; Pulse rate and heart rate that is fluctuating to around 106-162 bpm and is currently at 180 bpm now; fever of 102F-103F; chills; SpO2 also keeps fluctuating every 5-10 second with a current reading of 94 , his normal ranges are within 98-99; This is a spontaneous report from a contactable consumer reported for father via medical information team. A 69-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 27May2021 as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant drugs not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as 1st dose, single dose for COVID-19 immunization. On an unspecified time later in May2021, as of the moment, the patient was having fever of 102F-103F and chills. Pulse rate and heart rate that was fluctuating to around 106-162 bpm and was currently at 180 bpm now. He also was experiencing some blood pressure fluctuation with the current reading of 89/49 mmHg, SpO2 also kept fluctuating every 5-10 second with a current reading of 94, his normal ranges were within 98-99. The reporter wanted to know if these were commonly reported side effect after getting the vaccine. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report received from a contactable consumer (Patient) and Follow-up information received on 27May2021 was processed together with initial information. A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EWQ179), via an unspecified route of administration on 20May2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included phenazopyridine hydrochloride taken for an unspecified indication, start and stop date were not reported. Patient stated received my first dose of Covid vaccine on this past Thursday, for couple of days I have been experiencing chest pain and I was just wondering is that  normal or is that something to worry about. Patient not received any treatment for event and other Medical condition. No probed for vaccination anatomical site, patient stated, "It was in my arm, I am not sure. Patient stated Yes, I had kind of gone through this process already with somebody else and then I mean within your company (previous department not clarified. hence, captured as initial report in the tab) and they gave me a different phone are you going to be able to help me with the chest pain (treatment) that patient was having or you are just going to take my information? Reporter was informed about Pfizer Medical Information Department. As consumer was not willing to proceed the call. Product details (Expiration date) Pharmacy details and further probing could not be done. Limited information available over the call. The outcome of the events was reported as unknown.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Vomiting
Clinical narrative: feeling dizzy; throwing up; generally feeling horrible; This is a spontaneous report from contactable consumer. This is a male consumer (patient) reported for himself.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/batch Number was not reported) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 Immunisation. Medical history and concomitant medications were not reported. On an unspecified date (after vaccination), the patient experienced feeling dizzy, throwing up and generally feeling horrible after receiving his first dose. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Headache, sudden pain in the head and feels like something is moving inside her head; I felt pain on left side even though I got my vaccine on right side; This is a spontaneous report from a contactable consumer via Pfizer Sponsored Program. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173, Expiry date is Unknown) via an unspecified route of administration in arm right on 08May2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. On 08May2021, the patient experienced headache, sudden pain in the head and feels like something is moving inside her head, felt pain on left side even though I got my vaccine on right side. She is scheduled for 2nd dose on 29May which is the exactly the 3 weeks or 21st day from the 1st dose. However, she would like to know she can still get it or something inside her head she feels like moving. Patient only felt pain on that day When she got the dose, didn't experience after that and experienced it for one day. The events are assessed as non-serious. Outcome of the events are recovered on 08May2021.  Follow up attempts are needed. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Hypopnoea, Malaise, Nasal congestion, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Runny nose; "Sore throat it seems like it's kind of coming and going, I don't really feel it right now"; Congestion; Breathing is kind of off and on; "I am not feeling well, have not feeling well for the last couple of days"; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER- BIONTECH COVID- 19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced runny nose, sore throat it seems like it's kind of coming and going, don't really feel it right now, not feeling well, have not feeling well for the last couple of days, congestion and breathing is kind of off and on. It was reported, the patient was called to report some side effects that is not consistent with, anyway the patient will tell what was experienced. It was reported, the patient took that Pfizer Vaccine. When paraphrased, patient stated, yeah, the breathing was kind of off and on. It was reported, patient can ask a question? patient probably need to talk to somebody really quick about what patient need to do because patient not feeling well, have not feeling well for the last couple of days, patient have been out of work. Patient was provided the number of Pfizer Medical Information Department. When asked for the permission to probe the questions, patient stated, No, just not feel like to talk, not right now not at the time of report. Patient stated, where will get the LOT# and expiration date from? yeah, patient don't have it. Patient was unwilling to answer questions to complete the report, hence limited information available over the call. The outcome of the events was unknown.   Follow up letter has been generated for further information.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Tongue discomfort
Clinical narrative: I feel some weird in my mouth like on my tongue; now on my tongue, on the inside of my mouth, in my throat it is like troubling; I feel some weird in my mouth like on my tongue; now on my tongue, on the inside of my mouth, in my throat it is like troubling; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: Solution for injection), via an unspecified route of administration, administered in arm left on 27May2021 (Batch/Lot Number: Patient reported that "EW971, it looks like. consumer was not very sure about E but it look like E", Expiration Date: unknown) (at the age of 57-year-old) single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that, "I just took the vaccination of Pfizer (confirmed as Covid19 vaccine) and  on an unspecified date I feel some weird in my mouth, like on my tongue. It's something weird, you know, I want to get normal. It's on my teeth and everything that's why I wanted to call you, my mouth is weird like something like hot something in my tongue and full mouth, my lips. Like around 6 we have appointment around 6:30 and we stayed till 7:00 to see any side effect but patient did not know its feel like weird when patient was coming home did you recommend anything or something."  The patient reported that "the main reason why she called was because she was worried because now on her tongue, on the inside of her mouth, in her throat it was like troubling." The patient did not receive any treatment for the events. The outcome of the events was unknown.   Information about batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Sore arm at the site, a little dead arm; Sore arm at the site, a little dead arm; This is a spontaneous report received from a contactable consumer. This consumer (patient's wife) reported for a male patient (reporter's husband). A male patient of an unspecified age received first dose BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20May2021 as, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore arm at the site and a little dead arm. Caller had called with questions and stated she and her husband got the vaccine, the first dose, 20May2021. States the side effects they each had was a sore arm at the site, a little dead arm Friday and Saturday felt good. Caller declined to make a report. States she didn't know that it was necessary and she didn't know where to call as her primary care physician was at a loss and can only answer questions using what she had heard from other patients. The outcome of the events was recovered on MAY-2021.  Information about Lot/Batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: After two weeks hives still have hem daily; This is a spontaneous report received from a contactable consumer(patient). A 75-old-year non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection; Lot number and Expiration date not provided) via unspecified route of administration in right arm on 05Apr2021 at 03:00 PM (at the age of 74-years-old) as single for covid-19 immunization. The patient medical history included Diabetic removal of gall bladder skin; the patient has yeast coruscation as known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Diabetic meds insulin vitamins within 2 weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021 at 12:00, the patient experienced After two weeks hives still have hem daily. The patient did not receive any treatment. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling, Rash
Clinical narrative: Enlarged lymph nodes, swollen legs, and rash on both legs; Enlarged lymph nodes, swollen legs, and rash on both legs; Enlarged lymph nodes, swollen legs, and rash on both legs; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration in right arm on 24Apr2021 at 01:45 PM (Batch/Lot Number: EW0169) as single dose for COVID-19 immunization. Medical history included essential hypertension, benign and penicillin allergy. Concomitant medications included ASPIRIN 81MG (Acetylsalicylic acid) 81MG tablet, ATORVASTATIN (Atorvastatin) 40 mg tablet and DILTIAZEM (Diltiazem). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had not been tested since the vaccination. On 28Apr2021, the patient experienced enlarged lymph nodes, swollen legs and rash on both legs. Ciprofloxacin was taken as treatment for the events. Outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature increased, Cough, Feeding disorder
Clinical narrative: Got sick and she has trouble even getting up off the couch to walk. She is so weak.; She has been having temperatures now for over a week and now having any way it goes from 100 to 102 something; Headache; Nauseated; Got sick and she has trouble even getting up off the couch to walk. She is so weak; Got sick and she has trouble even getting up off the couch to walk. She is so weak; Got sick and she has trouble even getting up off the couch to walk. She is so weak; She started to cough also her lung started to sound like gurgling.; Now she started to cough also her lung started to sound like gurgling; She cannot eat; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19May2021 as unknown, single dose for COVID 19 immunisation. Medical history and concomitant medications were not reported. On 20May2021 patient got sick, and she had trouble even getting up off the couch to walk. She was so weak. She was having temperatures now for over a week and now any way it goes from 100 to 102 something. She had severe headache going. Also, she could not eat. She was nauseated. She started to cough, also her lung started to sound like gurgling. Outcome of the events were unknown.  Follow-up attempts are needed; information about lot/batch number can be obtained
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Headache, Illness, Lung disorder, Movement disorder
Clinical narrative: Got sick and she has trouble even getting up off the couch to walk. She is so weak.; She has been having temperatures now for over a week and now having any way it goes from 100 to 102 something; Headache; Nauseated; Got sick and she has trouble even getting up off the couch to walk. She is so weak; Got sick and she has trouble even getting up off the couch to walk. She is so weak; Got sick and she has trouble even getting up off the couch to walk. She is so weak; She started to cough also her lung started to sound like gurgling.; Now she started to cough also her lung started to sound like gurgling; She cannot eat; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19May2021 as unknown, single dose for COVID 19 immunisation. Medical history and concomitant medications were not reported. On 20May2021 patient got sick, and she had trouble even getting up off the couch to walk. She was so weak. She was having temperatures now for over a week and now any way it goes from 100 to 102 something. She had severe headache going. Also, she could not eat. She was nauseated. She started to cough, also her lung started to sound like gurgling. Outcome of the events were unknown.  Follow-up attempts are needed; information about lot/batch number can be obtained
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Got sick and she has trouble even getting up off the couch to walk. She is so weak.; She has been having temperatures now for over a week and now having any way it goes from 100 to 102 something; Headache; Nauseated; Got sick and she has trouble even getting up off the couch to walk. She is so weak; Got sick and she has trouble even getting up off the couch to walk. She is so weak; Got sick and she has trouble even getting up off the couch to walk. She is so weak; She started to cough also her lung started to sound like gurgling.; Now she started to cough also her lung started to sound like gurgling; She cannot eat; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19May2021 as unknown, single dose for COVID 19 immunisation. Medical history and concomitant medications were not reported. On 20May2021 patient got sick, and she had trouble even getting up off the couch to walk. She was so weak. She was having temperatures now for over a week and now any way it goes from 100 to 102 something. She had severe headache going. Also, she could not eat. She was nauseated. She started to cough, also her lung started to sound like gurgling. Outcome of the events were unknown.  Follow-up attempts are needed; information about lot/batch number can be obtained
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness and tingling on my left cheek; numbness and tingling on my left cheek; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 33-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration on 29May2021 at 10:15 (at the age of 33 years) as 1st single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced minor numbness and tingling on his left cheek on 29May2021. The patient received first dose of the Pfizer COVID vaccine and had a minor reaction of numbness and tingling on his left cheek, few (2-3) hours after the vaccine. It was reported that patient did not think that this should be a concern or if it was something that would happen after vaccine and enquired about the side effect, whether it was common and will it go. The outcome of the event was unknown.  Follow up attempts are completed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Headache, Illness, Migraine
Clinical narrative: Vomiting; Massive Migraine; Pain in neck; Dizziness; Headache; Nausea; Made me sick; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0167; Expiration Date: 31Aug2021), via an unspecified route of administration on 20May2021 at 16:30 (at the age of 51-year-old) as 1st dose, single dose in right arm for COVID-19 immunisation at Public Health Department. The patient's medical history included arthritis and gout. The patient had known allergies to amoxicillin. Concomitant medications within 2 weeks of vaccination included allopurinol (ALLOPURINOL) taken for gout, celecoxib (CELEBREX) taken for arthritis, gabapentin (GABAPENTIN), and buprenorphine (BUPRENORPHINE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20May2021 at 22:30, after the first shot of vaccine, the patient experienced massive migraine, pain in neck, dizziness, vomiting, headache, and nausea. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment medication included Sumatriptan Succinate 50mg and then 100 mg (Manufacturer: Aurobindo). On an unspecified date in May2021, the patient reported that the Pfizer shot had made her sick. The patient underwent lab tests and procedures on Apr2021 which included blood test: unknown results and patient had several blood test over the last month. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event made me sick was unknown and clinical outcome of all other events was not resolved.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Vomiting
Clinical narrative: Vomiting; Massive Migraine; Pain in neck; Dizziness; Headache; Nausea; Made me sick; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0167; Expiration Date: 31Aug2021), via an unspecified route of administration on 20May2021 at 16:30 (at the age of 51-year-old) as 1st dose, single dose in right arm for COVID-19 immunisation at Public Health Department. The patient's medical history included arthritis and gout. The patient had known allergies to amoxicillin. Concomitant medications within 2 weeks of vaccination included allopurinol (ALLOPURINOL) taken for gout, celecoxib (CELEBREX) taken for arthritis, gabapentin (GABAPENTIN), and buprenorphine (BUPRENORPHINE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20May2021 at 22:30, after the first shot of vaccine, the patient experienced massive migraine, pain in neck, dizziness, vomiting, headache, and nausea. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment medication included Sumatriptan Succinate 50mg and then 100 mg (Manufacturer: Aurobindo). On an unspecified date in May2021, the patient reported that the Pfizer shot had made her sick. The patient underwent lab tests and procedures on Apr2021 which included blood test: unknown results and patient had several blood test over the last month. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event made me sick was unknown and clinical outcome of all other events was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Pruritus
Clinical narrative: It's itching at the site, it's not a large bite but it's itchy, it's like an elevated pimple; It's itching at the site, it's not a large bite but it's itchy, it's like an elevated pimple; This is a spontaneous report from a contactable consumer (patient herself).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported)via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, she had a question, she received first dose with Pfizer and she was due to receive the second dose on Tuesday and on unspecified date she had tick bite, that she got about 2 or might be 3-4 days ago and it was itching at the site. It was not a large bite but it was itching as like an elevated pimple. She enquired was there any problem with receiving her second dose on Tuesday or not. She stated that her husband and she were due to get their second dose this Tuesday. The outcome of events was unknown.  Information about the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, SARS-CoV-2 test
Clinical narrative: first vax was arm soreness and about a week of fatigue; first vax was arm soreness and about a week of fatigue; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: er8730) via an unspecified route of administration (At the age of vaccination 57-year) in Left Arm on 25Mar2021 08:45 as 1st dose, single dose for COVID-19 immunization. Medical history included fibromyalgia, hypersensitivity Allergies to codeine, levaquin, cipro, sulfa, antibiotics, shrimp. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient experienced first vax was arm soreness and about a week of fatigue. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 14May2021. The seriousness of the event was reported as non-serious. The clinical outcome of the event was not recovered.  Follow-up attempts are needed. Further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on 06May2021 as 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as 1st dose, single dose for COVID-19 immunization. On an unspecified, the patient experienced cough. It was reported that, patient got second shot on May the 6th of this year, and patient was wondering after so many weeks and was just coughing. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chillblains
Clinical narrative: Chilblains on left fingers; This is a spontaneous report from a non-contactable consumer or other non hcp. A 33-years-old non-pregnant adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection),via an unspecified route of administration, administered in Left arm on 26May2021 at 09:00 (at the age of 33y-ears old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history was reported as none. Allergies were reported as None. The patient concomitant medications were not reported. No COVID occurred prior vaccination. No COVID test was taken post vaccination No other vaccine was taken in four weeks of vaccination. No other medications were taken in two weeks of vaccination. On 27May2021at 19:00, the patient experienced chilblains on left fingers. The outcome for the events Recovering/Resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Nausea, Pain in extremity, Pharyngeal swelling
Clinical narrative: Pain in arm; Swollen; Itching; Headache; Nausea; My left nose clogged up; The left side of my throat burns, hurts to swallow and is swollen.; The left side of my throat burns, hurts to swallow and is swollen.; This is a spontaneous report from a contactable consumer (patient).  A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 25May2021 16:30 (at age of 19-year-old during vaccination) as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient had received birth control pills within 2 weeks of vaccination. The Patient had not received any other vaccines within 4 weeks prior to the Covid vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. On 25May2021 12:00 AM, the patient experienced pain in arm, swollen, itching, headache, and nausea for the first few days in the night of. On 29May2021 (Saturday, four days later), her left nose clogged up and the left side of throat burns, hurts to swallow and was swollen. Since the vaccination the patient had not diagnosed with COVID-19. The outcome of the events were unknown.  Information about lot/batch number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Throat irritation
Clinical narrative: Pain in arm; Swollen; Itching; Headache; Nausea; My left nose clogged up; The left side of my throat burns, hurts to swallow and is swollen.; The left side of my throat burns, hurts to swallow and is swollen.; This is a spontaneous report from a contactable consumer (patient).  A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 25May2021 16:30 (at age of 19-year-old during vaccination) as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient had received birth control pills within 2 weeks of vaccination. The Patient had not received any other vaccines within 4 weeks prior to the Covid vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. On 25May2021 12:00 AM, the patient experienced pain in arm, swollen, itching, headache, and nausea for the first few days in the night of. On 29May2021 (Saturday, four days later), her left nose clogged up and the left side of throat burns, hurts to swallow and was swollen. Since the vaccination the patient had not diagnosed with COVID-19. The outcome of the events were unknown.  Information about lot/batch number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Inappropriate schedule of product administration, Loss of personal independence in daily activities
Clinical narrative: had to go to sleep; Could not function correctly; They had headache; body aches; chills; He felt really exhausted and drained.; Pfizer Covid Vaccine first dose Date: 19 Apr 2021/Pfizer Covid Vaccine second dose Date: 03 May 2021; Pfizer Covid Vaccine first dose Date: 19 Apr 2021/Pfizer Covid Vaccine second dose Date: 03 May 2021; This is a spontaneous report from a Pfizer sponsored program COVAX US support.   A contactable 46-year-old male patient reported that who received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot Number and expiry date unknown) via an unspecified route of administration at left arm as a single dose for COVID-19 Immunisation. Past drugs included Lisinopril taken for quite some time, 3 or 4 years, Nifidipine for blood pressure. Historical vaccine BNT162B2 via an unspecified route of administration (Lot Number / Expiry Date was not reported) on 19-APR-2021 as a single dose at left arm for COVID-19 immunisation. On an unknown date patient could not function correctly the day after both shots. They had to go to sleep. He said that the headache, body aches and chills started the same day as the shot after both shots. He felt exhausted and drained. Patient did not visit physician office or emergency room visit due to the event. Outcome of the events were recovered on an unknown date.  Information on the lot/batch number has been requested.