chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: all died within the 5 weeks after there first shot; This is spontaneous report from a contactable consumer. This the third case out of six cases.   An elderly male patient of unspecified age received 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 an unspecified date of 2021 as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. On unknown date the patient died within the 5 weeks after the first vaccination. It was not reported if an autopsy was performed. The patient was in a residential home with 5 other elderly residents. He/she died in sleep.  Information related Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021617030 same reporter, same vaccine, same adverse event, different patient.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: all died within the 5 weeks after there first shot; This is spontaneous report from a contactable consumer. This the fifth case out of six cases.   An elderly patient of unspecified age received 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 an unspecified date of 2021 as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. On unknown date the patient died within the 5 weeks after the first vaccination. It was not reported if an autopsy was performed. The patient was in a residential home with 5 other elderly residents. He/she died in sleep.  Information related Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021617030 same reporter, same vaccine, same adverse event, different patient.; Reported Cause(s) of Death: all died within the 5 weeks after there first shot
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Upper Arm Right on 25 May 2021 (Batch/Lot Number: EW0187) as single dose for COVID-19 immunisation. Medical history included allergy. Concomitant medication(s) included cetirizine hydrochloride (CETIRIZINE) at 10 mg once daily taken for allergy, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for allergy, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Upper Arm Right on 27Apr2021 for COVID-19 immunisation. It was reported that the patient got Pfizer Vaccine (first and second shot), on Tuesday and the patient had under her arm like a pretty big knot. The patient stated the event started Today (27May2021). The patient just had a question about her COVID-19 Pfizer vaccine, about the side effects, is it normal to have a lump under your armpit (Further clarified as side effect after getting the vaccine). It was just persisting. The patient did not take any treatment for the event. Outcome of the event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: All died within the 5 weeks after first shot; This is a spontaneous report from a contactable consumer. This consumer reported similar events for six patients. This is the fourth of six reports.   An elderly patient of an unknown gender and age received 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 an unspecified date of 2021, as single dose for COVID-19 immunization. The patient' s medical history and concomitant medications were not reported. On unknown date, in 2021, the patient died within the 5 weeks after the first vaccination. It was not reported if an autopsy was performed.  The patient was in a residential home with 5 other elderly residents. He/she died in sleep.  The information on the lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021617030 same reporter/SD/AE, different  patients; Reported Cause(s) of Death: All died within the 5 weeks after first shot
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dysphagia, Laboratory test, Lip disorder, Oral disorder
Clinical narrative: Diarrhea; Food gets stuck in his throat it's hard to swallow; It is like his mouth doesn't work right; His lips won't close and water spills out; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8730), via an unspecified route of administration in left arm on 24Mar2021 as single dose for COVID-19 immunization. The patient's medical history included occasional headache. The patient's concomitant medications were not reported. The patient previously took aspirin. Historical vaccine of the patient included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6202) via an unspecified route of administration (at 68-year-old) on 24Feb2021 for COVID-19 immunization. On an unknown date in Mar2021 patient had diarrhea since his second shot and all the tests his doctor performed had come back negative. He mentioned that diarrhea was a side effect of this vaccine and he was wondering if you have a cure for this or was this now his life. There was a couple other issues that had come up around that same time (Mar2021) and he was unsure if they were related and he had not talked to his doctor about them yet because he had been more concerned with the diarrhea but sometimes when he was eating, food seemed to get stuck in his throat and then it was hard to swallow so he tried to drink and then it was like his mouth does not work right and his lips would not close and water spills out. On 28May2021 the patient reported that it was actually a very bad day. He mentioned that diarrhea was persistent for 4 weeks and then it almost went away for a week or two and now was back and bad as ever. The outcome of events was not recovered.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Headache
Clinical narrative: severe headache by night time; got a light nosebleed; This is a spontaneous report from a contactable consumer (patient himself). A 45-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8737; Expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 07May2021 as single dose for COVID-19 immunization. Patient medical history included food allergy, allergic to aspirin and shellfish, everybody got COVID-19 in the house from, local anaesthesia from 07May2021 to 07May2021, Caller stated he had a dental cleaning that same morning as the vaccine with anesthesia that was local, from 07May2021 to 07May2021. Patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was not provided. The patient had not any other products. The patient had not received any other vaccines within 4 weeks of COVID vaccine. The patient's concomitant medications were not reported. The caller reported that he was about to get his second dose of the vaccine and the nurse asked about his first dose. On 07May2021 after first dose he had a severe headache by nighttime about an hour later which lasted for 4 days. Caller stated the nosebleed started on the same day 07May2021 as receiving the vaccine around 10:00-10:30 which lasted until Sunday. The pharmacist asked him to call us to see if he could get the second dose. They did not know what could happen to him with his second dose because of this. He stated he was really allergic to aspirin and shellfish too and didn't know if that was the problem. The caller wanted to know if shellfish was a part of the vaccine. It was enquired that, Pfizer-BioNTech COVID-19 Vaccine contain aspirin or not. Patient was not visited to Emergency Room/ Physician Office. Reporter seriousness for headache and nosebleed was Unspecified. AE(s) following prior vaccinations was not provided. Caller stated he just took Tylenol for side effects and went to bed. Patient had not any relevant tests. The outcome of event headache was recovered on 09May2021 and nosebleed on 10May2021.  Information about lot/batch number available, no further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Dyspnoea, Headache
Clinical narrative: Headache; Chills; Feeling unwell; Tightness in chest; Wheezing; A lot of coughing; Lungs hurt and are kind of sore; It makes breathing difficult; This is a spontaneous report from a contactable consumer (patient) reported for himself.  A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, on 19may2021 (at the age of 55-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, on 28apr2021. The patient medical history includes type 2 diabetes and patient is not a smoker. Concomitant medications were not reported. On 22may2021, 3 days after the second vaccination, the patient experienced headache, chills, feeling unwell, tightness in the chest, a lot of coughing, wheezing, lungs hurt and kind of sore and breathing difficulty. The coughing is usually dry with something coming up occasionally, but it's not much. It's been a lot of coughing and he was feeling rundown. He wants to know if this was normal after having the shot a week ago. The patient stated that his lungs begin to hurt after coughing a lot and it makes breathing difficult. He is a non-smoker, so it has nothing to do with smoking. He has tightness in the chest from coughing and his lungs are kind of sore. It just comes on and he feels fine for a while. But it just comes on and sticks with him for a while. Patient stated headache started on Saturday afternoon and it kept with him till Wednesday. After ibuprofen it stayed down but, occasionally it is off and on. It has gotten better. He had it for 3 days straight and it will come back and then it is gone away again. Patient also stated that chills happened once or twice and not sure on the day the chills stopped. Patient stated that he was at work and for a while and started feeling unwell on 22may2021 morning. And he starts with the coughing, it just comes and goes. His blood sugar has been okay. Patient received ibuprofen as treatment option for the events (headache). The seriousness of the events was unspecified. The outcome of the events headache was recovering and outcome of all other events was mentioned as unknown.  No follow-up attempts possible. No further information expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pulmonary pain, Wheezing
Clinical narrative: Headache; Chills; Feeling unwell; Tightness in chest; Wheezing; A lot of coughing; Lungs hurt and are kind of sore; It makes breathing difficult; This is a spontaneous report from a contactable consumer (patient) reported for himself.  A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, on 19may2021 (at the age of 55-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, on 28apr2021. The patient medical history includes type 2 diabetes and patient is not a smoker. Concomitant medications were not reported. On 22may2021, 3 days after the second vaccination, the patient experienced headache, chills, feeling unwell, tightness in the chest, a lot of coughing, wheezing, lungs hurt and kind of sore and breathing difficulty. The coughing is usually dry with something coming up occasionally, but it's not much. It's been a lot of coughing and he was feeling rundown. He wants to know if this was normal after having the shot a week ago. The patient stated that his lungs begin to hurt after coughing a lot and it makes breathing difficult. He is a non-smoker, so it has nothing to do with smoking. He has tightness in the chest from coughing and his lungs are kind of sore. It just comes on and he feels fine for a while. But it just comes on and sticks with him for a while. Patient stated headache started on Saturday afternoon and it kept with him till Wednesday. After ibuprofen it stayed down but, occasionally it is off and on. It has gotten better. He had it for 3 days straight and it will come back and then it is gone away again. Patient also stated that chills happened once or twice and not sure on the day the chills stopped. Patient stated that he was at work and for a while and started feeling unwell on 22may2021 morning. And he starts with the coughing, it just comes and goes. His blood sugar has been okay. Patient received ibuprofen as treatment option for the events (headache). The seriousness of the events was unspecified. The outcome of the events headache was recovering and outcome of all other events was mentioned as unknown.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fear of injection, Headache, Malaise, Pruritus, Rash
Clinical narrative: she felt like she had covid again; she is scared to get the second dose; horrible headaches; rash; hives; itching; She did not feel well; This is a spontaneous report from Pfizer sponsored program. A contactable female consumer (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 immunisation. Medical history included covid and monoclonal antibodies (I ended up getting a mononucleo (presumably monoclonal antibody) infusion and it saved my life) in Jan2021 and Autoimmune disorder. Concomitant medications were not reported. The patient reported, received first dose of Pfizer's COVID vaccine and didn't feel well after the vaccine. She had horrible headaches and rash or hives and was itching afterwards. She took some Benadryl and was ok. She felt like she had COVID again and had COVID in January. The doctor told her to get the vaccine but terrified of getting the 2nd dose after the symptoms having with the first dose. She has autoimmune issues. She was asking if she gets the second dose, will her side effects be worse? States she is terrified of getting the second dose after the symptoms she had from the first dose. The outcome of reported events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Urticaria
Clinical narrative: she felt like she had covid again; she is scared to get the second dose; horrible headaches; rash; hives; itching; She did not feel well; This is a spontaneous report from Pfizer sponsored program. A contactable female consumer (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 immunisation. Medical history included covid and monoclonal antibodies (I ended up getting a mononucleo (presumably monoclonal antibody) infusion and it saved my life) in Jan2021 and Autoimmune disorder. Concomitant medications were not reported. The patient reported, received first dose of Pfizer's COVID vaccine and didn't feel well after the vaccine. She had horrible headaches and rash or hives and was itching afterwards. She took some Benadryl and was ok. She felt like she had COVID again and had COVID in January. The doctor told her to get the vaccine but terrified of getting the 2nd dose after the symptoms having with the first dose. She has autoimmune issues. She was asking if she gets the second dose, will her side effects be worse? States she is terrified of getting the second dose after the symptoms she had from the first dose. The outcome of reported events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 04May2021 as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received his both doses of the Pfizer covid vaccine and experienced only tiredness with first dose in May 2021. He got the second vaccine on Tuesday, 25May2021, he felt sleepy and tired that evening. He received the vaccine at lunch time. The next day after the vaccine he had a sore throat and a hot flash in his head that night. He had pizza and 2 beers and 2 beer have not effective him this way before but he experienced heavy heart, pain in the chest, fast heartbeat, he does not feel good. He will be traveling and wanted to know about side effects. He felt that his chest was heavy and it's a little bit uncomfortable. After second dose, not sure if his blood pressure is high or low. He was feeling all this pain after the Covid 19 vaccine. He was asking what kind of medicine he can take or what can he do. He provided an email as his phone is not reliable. He did not provide an address as he is getting ready to move. Patient stated that Yesterday, 27May2021, he was feeling good but today in the morning he had a high rate of his heart beat. A couple beers never affected him in this way. He did check his heart beat with his hand and it felt much higher than normal. He also had a headache. He cannot relate how he was feeling to drinking 2 beers. He was asking if these are side effects of the Covid 19 vaccine. He had read online that these can be side effects. He called Pfizer for support this is to complicated, maybe he can buy some pills or medicine. He also would like to measure his blood pressure because he had a headache. He will go to Urgent Care for a check up, the Urgent Care is across the street. While transferring the call patient stated he was at the urgent care and did not wishes to speak at this time. he stated he was ok. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness, Nausea, Oropharyngeal discomfort, Retching
Clinical narrative: throwing up, not actually vomiting food, more like bile; coughing; her throat it's very loud and grainy; gagging and spitting up a little bit, not really expelling anything but having the gag reflex; nauseated; ill; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration, administered in Arm Left on 27May2021 as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.Concomitant medication included ergocalciferol (CALCIFEROL VIT D), piroxicam (FOCUS) taken for an unspecified indication from an unspecified start date and ongoing. Patient did not like to take medicines and things, but because of all of everything going on this last year reporter decided patient needed to start taking these vitamins to stay as fit as they could. After receiving her 2n dose yesterday (27May2021) at noon, She was okay last night and during the night but at 05:30am this morning was was nauseated and trying to vomit but she is not expelling anything really, maybe some phlegm, have some gag reflex, She is kind of throwing up, not really expelling anything but having the gag reflex. she was also coughing. About 05:30-06:00. She is not critically ill. Outcome she is very loud when she is doing this but that is a common effect with her. When she clears her throat it's very loud and grainy and spell of the coughing and gagging and spitting up a little bit, not actually vomiting food, more like bile. The outcome of events was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: throwing up, not actually vomiting food, more like bile; coughing; her throat it's very loud and grainy; gagging and spitting up a little bit, not really expelling anything but having the gag reflex; nauseated; ill; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration, administered in Arm Left on 27May2021 as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.Concomitant medication included ergocalciferol (CALCIFEROL VIT D), piroxicam (FOCUS) taken for an unspecified indication from an unspecified start date and ongoing. Patient did not like to take medicines and things, but because of all of everything going on this last year reporter decided patient needed to start taking these vitamins to stay as fit as they could. After receiving her 2n dose yesterday (27May2021) at noon, She was okay last night and during the night but at 05:30am this morning was was nauseated and trying to vomit but she is not expelling anything really, maybe some phlegm, have some gag reflex, She is kind of throwing up, not really expelling anything but having the gag reflex. she was also coughing. About 05:30-06:00. She is not critically ill. Outcome she is very loud when she is doing this but that is a common effect with her. When she clears her throat it's very loud and grainy and spell of the coughing and gagging and spitting up a little bit, not actually vomiting food, more like bile. The outcome of events was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling, Swelling
Clinical narrative: Swollen arm/arm had swollen up; Swollen arm, It was also warm and hot/it is warm, has heat to it; it is hot and warm; It was long, swelling is like the shape of a football/swelling is from the shoulder and started to go downward; This is a spontaneous report from a contactable consumer (Patient's husband). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN0186), via unspecified route of administration in the Left arm, on 18May2021 at 12:00 PM (at the age of 55-year-old), as a single for COVID-19 immunisation. Medical history and concomitant medications were not reported. There was no family medical history relevant to AE. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not received any additional Vaccines administered on same date of the Pfizer Suspect.  The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 27May2021, Yesterday around the afternoon her arm had swollen up, it is warm a little, has heat to it and it was long (clarified it was long as for the swelling is in shape of like a football). The swelling was from the shoulder and started to go downward. They tried to put an ice pack on it because it was hot and warm. They were wanting to know if there was anything to worry about and what are the side effects if she would experience and whether she need to pay attention especially, since it was been 9 days of vaccination. And whether the patient wanted to go hospital or it would be fine. The reporter also stated that he also wanted to take the shot but had worries on how safe it is for him to take it for himself. The adverse event does not resulted in Emergency Room or Physician Office. There was none relevant tests. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Potentiating drug interaction, Swelling face
Clinical narrative: facial swelling; She would like to know if Accutane will interfere with the efficacy of the Pfizer COVID vaccine?; This is a spontaneous report received from a Pfizer sponsored program COVAX US support. A contactable consumer or other non healthcare professional. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number/ Expiration was not reported), via an unspecified route of administration on 28May2021 as 1st dose single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included isotretinoin (ACCUTANE) taken for an un-specified indication, start and stop date were not reported. Caller's son was scheduled for Pfizer's COVID vaccine first dose today, 28May2021. Her son started Accutane 2 days ago and was currently experiencing side effects of facial swelling this morning. She would like to know if Accutane will interfere with the efficacy of the Pfizer COVID vaccine. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Dry throat, Dyspnoea
Clinical narrative: Dryness in his throat/ extremely, extremely sore and dry throat; Headaches; Feeling terrible; Fever; Chills; Chest pain; Oppression in his chest that does not allow him to breathe normally/ pressure in his chest not letting him breathe normally; Sore throat/ extremely, extremely sore and dry throat; Chest pain is like a pressure; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 43-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 27May2021 09:00 as 2nd dose, single dose (at the age of 43-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. Patient mentions that yesterday (27May2021) he got the second dose of the Pfizer covid vaccine at 9 am and since then he had fever, chills, sore throat, chest pain like a pressure in his chest, oppression in his chest that does not allow him to breathe normally. On 28Feb2021, experienced dryness in his throat (extremely sore and dry throat), headache, feeling terrible. He wants to report the situation. Patient what should he do, does he need to go to a hospital.  Communication included Advising patient to seek medical attention or the care of a doctor. The outcome of the events was unknown.   No further information is provided or obtained. Information on lot/Batch number has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Dryness in his throat/ extremely, extremely sore and dry throat; Headaches; Feeling terrible; Fever; Chills; Chest pain; Oppression in his chest that does not allow him to breathe normally/ pressure in his chest not letting him breathe normally; Sore throat/ extremely, extremely sore and dry throat; Chest pain is like a pressure; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 43-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 27May2021 09:00 as 2nd dose, single dose (at the age of 43-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. Patient mentions that yesterday (27May2021) he got the second dose of the Pfizer covid vaccine at 9 am and since then he had fever, chills, sore throat, chest pain like a pressure in his chest, oppression in his chest that does not allow him to breathe normally. On 28Feb2021, experienced dryness in his throat (extremely sore and dry throat), headache, feeling terrible. He wants to report the situation. Patient what should he do, does he need to go to a hospital.  Communication included Advising patient to seek medical attention or the care of a doctor. The outcome of the events was unknown.   No further information is provided or obtained. Information on lot/Batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Contusion, Hyperhidrosis, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer- sponsored program. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN0164; Expiration Date: Aug 2021), via an unspecified route of administration, administered in Arm Left on 14May2021 14:00 as 1st dose, single dose for COVID-19 immunization. Medical history included COVID-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported. The patient experienced she developed a rash on her neck on 15May2021, fever on 15May2021 21:00, there were bruises on her ankles on (she visited physician office), chills on May2021, hot sweat like on 15May2021 07:00. She wanted to know if this has happened to other people after receiving, the vaccine she also wants to know if she should still receive the 2nd dose of the Pfizer-BioNTech COVID-19 Vaccine after having a side effect with the 1st dose. Patient stated she saw online about the rash; she notices she had a very faint rash on her neck and didn't really bother her; that went away pretty quickly. The chills and the fever, she knew that this was a side effect, and it didn't last long at all. The patient underwent lab tests and procedures which included blood test normal on 17May2021 for blood work. The outcome of event she developed a rash on her neck recovered on 19May2021 and fever on 16May2021. The outcome of contusion was not recovered, the outcome of chills and hot sweat like was unknown. Follow-up attempts are needed. Further information is expected. .
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a Pfizer- sponsored program. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN0164; Expiration Date: Aug 2021), via an unspecified route of administration, administered in Arm Left on 14May2021 14:00 as 1st dose, single dose for COVID-19 immunization. Medical history included COVID-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported. The patient experienced she developed a rash on her neck on 15May2021, fever on 15May2021 21:00, there were bruises on her ankles on (she visited physician office), chills on May2021, hot sweat like on 15May2021 07:00. She wanted to know if this has happened to other people after receiving, the vaccine she also wants to know if she should still receive the 2nd dose of the Pfizer-BioNTech COVID-19 Vaccine after having a side effect with the 1st dose. Patient stated she saw online about the rash; she notices she had a very faint rash on her neck and didn't really bother her; that went away pretty quickly. The chills and the fever, she knew that this was a side effect, and it didn't last long at all. The patient underwent lab tests and procedures which included blood test normal on 17May2021 for blood work. The outcome of event she developed a rash on her neck recovered on 19May2021 and fever on 16May2021. The outcome of contusion was not recovered, the outcome of chills and hot sweat like was unknown. Follow-up attempts are needed. Further information is expected. .
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Dizziness, Loss of personal independence in daily activities, Nausea, Pain in extremity
Clinical narrative: Patient who was inadvertently given an entire undiluted vial for her second shot; Patient who was inadvertently given an entire undiluted vial for her second shot; dizziness; nausea; sore arm; He had to call out of work; This is a spontaneous report from a contactable pharmacist. A 39-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0167 and Expiration Date: Aug2021, NDC number was not reported), via an unspecified route of administration, administered in left arm on 28May2021 as 2nd dose, 0.3 mL, single dose (at the age of 39-years-old) for covid-19 immunisation. Patient had no medical history, and no concomitant medications were used by patient. Patient had no prior vaccinations. Patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, as 1st dose, single dose (at the age of 39-years-old) for covid-19 immunisation. On 28May2021, patient inadvertently given an entire undiluted vial for her second shot vaccine. On an unspecified date of May2021, patient had dizziness, nausea, a sore arm and had to call out of work for 3 days. The outcome of all the events was unknown.  Additional information is requested
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient who was inadvertently given an entire undiluted vial for her second shot; Patient who was inadvertently given an entire undiluted vial for her second shot; dizziness; nausea; sore arm; He had to call out of work; This is a spontaneous report from a contactable pharmacist. A 39-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0167 and Expiration Date: Aug2021, NDC number was not reported), via an unspecified route of administration, administered in left arm on 28May2021 as 2nd dose, 0.3 mL, single dose (at the age of 39-years-old) for covid-19 immunisation. Patient had no medical history, and no concomitant medications were used by patient. Patient had no prior vaccinations. Patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, as 1st dose, single dose (at the age of 39-years-old) for covid-19 immunisation. On 28May2021, patient inadvertently given an entire undiluted vial for her second shot vaccine. On an unspecified date of May2021, patient had dizziness, nausea, a sore arm and had to call out of work for 3 days. The outcome of all the events was unknown.  Additional information is requested
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Ear pain, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: having "allergies" with symptoms including pain in her ears, throat, and has red eyes; having "allergies" with symptoms including pain in her ears, throat, and has red eyes; having "allergies" with symptoms including pain in her ears, throat, and has red eyes; having "allergies" with symptoms including pain in her ears, throat, and has red eyes; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient experienced having allergies with symptoms including pain in her ears, throat, and has red eyes. It was reported that the patient has been scheduled for an appointment for her second dose of vaccine today ( day of reporting) but her allergies were really bad. She has red eyes and other symptoms, she wanted to know if she can go ahead and get the second dose (3weeks) or should she wait an get it next week. The patient also wants to know if she can change her appointment to Tuesday. The outcome of events was unknown.   Follow-up attempts were needed, further information was expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pigmentation disorder
Clinical narrative: Yellow spots on his upper right chest on the same side that he received the injection; Age at vaccination 14 years; This is a spontaneous report from a contactable consumer (patient's father).   A 14-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0191), first dose via intramuscular route of administration, administered in right arm on 26May2021 at 10:00 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma but controlled from an unknown date and unknown if ongoing. No known allergies were reported. The patient's concomitant medications were not reported. This report not related to study or programme. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported that the patient received COVID-19 vaccine at the age 14-year-old (off label use). The patient's father stated that on 28May2021 at 06:00 his son had a side effect from taking the vaccine. The patient broked out with; and he had yellow spots on his upper right chest on the same side that he received the injection. No treatment received for the event yellow spots on his upper right chest. The outcome of the event off label use was unknown and other event outcome was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Hypersensitivity, Ocular discomfort, Ocular hyperaemia, Scleral disorder
Clinical narrative: it was an allergic reaction to the vaccine; left eye swollen; white part of the left eye turned yellow; left eye is red; pressure to the left eye; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot Number: EW0178; Expiration Date: 01Aug2021), via an unspecified route of administration, in arm left on 26May2021 at 11:00 (at time of vaccination was 35-years) as single dose for COVID-19 immunization. The patient had no relevant medical history. The patient did not receive any other vaccines within four weeks prior to COVID-19 Vaccine. The concomitant medications were not reported. On 27May2021 at 08:00, the patient had allergic reaction to the vaccine and experienced left eye swollen, white part of the left eye turned yellow, left eye is red, pressure to the left eye. The clinical course included: reporter stated that she got the Covid vaccine yesterday first round. Stated that her left eye was swollen and turned to yellow eye. Stated that it was the same side she got the shot on. Stated that her doctor told her that it was an allergic reaction to the vaccine and prescribed steroids. Stated that the pharmacist recommended not to get the second dose. The events left eye swollen, white part of left eye turning yellow resulted in Physician office visit. The outcome of the events was resolving.  Information on Lot/Batch number is available; Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body ache; This is a spontaneous report from a contactable consumer or non-Health Care Professional. A patient of unspecified age and gender received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on 01May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported.The patient's concomitant medications were not reported. Patient took Second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported on 22May2021 for covid-19 immunization. The reporter stated, the patient first shot was on 01May2021 and patient did not have any symptoms, mean just body ache but that was all. The first shot did not gave me any problem. The outcome of event body ache was unknown.  Information about lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Flushing, Infection, Pruritus
Clinical narrative: Anaphylactic reaction; itching/generalized  pruritus/ some prickly the itching; shortness a breath; hives; skin rash; body flushed; Iv infection; This is a spontaneous report from a contactable other healthcare professional (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EL1284), via an unspecified route of administration, in Arm Left on 12Jan2021 at 17:00 as 0.3ml, single for covid-19 immunization. Medical history included asthma. The patient concomitant medications were not reported. On 19Jan2021, the patient had anaphylactic reaction. The anaphylactic reaction started within minute lasted upto 6 hours with shortness a breadth and was on prednisolone for six days (40mg). The sign and symptoms of the anaphylactic reaction included: vital sign was normal; itching began with in minute and IV infection and body flushed; began to get treated with antihistamines for her hives and precaution. The patient had hives and its thing (unbelievable); then difficulty breathing without wheeze. She had generalized itching and some prickly; the itching was at times like if her body was of hive (generalized pruritus with skin rash). The patient received treatment with Benadryl 6 mg above and pro air - prednisone for 6 days and then with a prescribed. No 2nd dose. The patient did not require any medical intervention; all prescribed her allergy for fused me to go to hospital too much condition. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of reported events Anaphylaxis, rash, urticaria, dyspnea  and pruritis and flushing cannot be excluded. But also consider medical history of  asthma  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Anaphylactic reaction; itching/generalized  pruritus/ some prickly the itching; shortness a breath; hives; skin rash; body flushed; Iv infection; This is a spontaneous report from a contactable other healthcare professional (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EL1284), via an unspecified route of administration, in Arm Left on 12Jan2021 at 17:00 as 0.3ml, single for covid-19 immunization. Medical history included asthma. The patient concomitant medications were not reported. On 19Jan2021, the patient had anaphylactic reaction. The anaphylactic reaction started within minute lasted upto 6 hours with shortness a breadth and was on prednisolone for six days (40mg). The sign and symptoms of the anaphylactic reaction included: vital sign was normal; itching began with in minute and IV infection and body flushed; began to get treated with antihistamines for her hives and precaution. The patient had hives and its thing (unbelievable); then difficulty breathing without wheeze. She had generalized itching and some prickly; the itching was at times like if her body was of hive (generalized pruritus with skin rash). The patient received treatment with Benadryl 6 mg above and pro air - prednisone for 6 days and then with a prescribed. No 2nd dose. The patient did not require any medical intervention; all prescribed her allergy for fused me to go to hospital too much condition. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of reported events Anaphylaxis, rash, urticaria, dyspnea  and pruritis and flushing cannot be excluded. But also consider medical history of  asthma  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.