chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Eczema, Rash, Rash papular, Rash pruritic, Sensitive skin
Clinical narrative: Sensitive skin; Delayed reaction; Hives; I got rashes like some of them were little itchy; Eczema; Red bumps; I got rashes like some of them were little itchy; This is a spontaneous report from a contactable consumer. This consumer (patient) of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) for covid-19 immunisation. When probed for the concern, consumer stated, I wanted to report the side effect, I think I got (side effect) from Pfizer (second shot) vaccine (unspecified vaccine) after 3 weeks I got the shot." When paraphrased the concern, consumer stated, "After 3 weeks I got the second shot, my skin goes very sensitive after 3 weeks after I got the shot, it came out as delayed reaction and I got hives, I got rashes like some of them were little itchy and this is going on since I got. I think I am getting better then I get back now its settling down. It was the delayed reaction after 3 weeks, it's like eczema, hives, red bumps. I wanted to know at the peak might possible it feels like going away, I am getting better, I wanted to know people are getting this?" When probed for consumer's Mailing address, consumer stated, "What is this for now? It's going away now, I wanted to report it." In response to file safety report, consumer stated, "Is that a "VAER" (Further not clarified) report? Do you know what, I can't talk any more here now? I have to call back, let me call back." When probed for vaccine LOT#, consumer stated, "No, I don't have with me right now." As consumer was not willing to proceed the call and abruptly hung up. Product details (expiration date, NDC# and UPC#), Pharmacy details and treatment could not be probed over the call. Limited information available over the call and appropriate response could not be provided. The outcome of the events was reported as recovering.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Slow response to stimuli, Urticaria
Clinical narrative: Sensitive skin; Delayed reaction; Hives; I got rashes like some of them were little itchy; Eczema; Red bumps; I got rashes like some of them were little itchy; This is a spontaneous report from a contactable consumer. This consumer (patient) of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) for covid-19 immunisation. When probed for the concern, consumer stated, I wanted to report the side effect, I think I got (side effect) from Pfizer (second shot) vaccine (unspecified vaccine) after 3 weeks I got the shot." When paraphrased the concern, consumer stated, "After 3 weeks I got the second shot, my skin goes very sensitive after 3 weeks after I got the shot, it came out as delayed reaction and I got hives, I got rashes like some of them were little itchy and this is going on since I got. I think I am getting better then I get back now its settling down. It was the delayed reaction after 3 weeks, it's like eczema, hives, red bumps. I wanted to know at the peak might possible it feels like going away, I am getting better, I wanted to know people are getting this?" When probed for consumer's Mailing address, consumer stated, "What is this for now? It's going away now, I wanted to report it." In response to file safety report, consumer stated, "Is that a "VAER" (Further not clarified) report? Do you know what, I can't talk any more here now? I have to call back, let me call back." When probed for vaccine LOT#, consumer stated, "No, I don't have with me right now." As consumer was not willing to proceed the call and abruptly hung up. Product details (expiration date, NDC# and UPC#), Pharmacy details and treatment could not be probed over the call. Limited information available over the call and appropriate response could not be provided. The outcome of the events was reported as recovering.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable consumer (Patient). A 15-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that 14 hours post second dose the patient experienced fever and chills approximately 15 years old. Event took place after use of product. The outcome of the events were unknown.  Information about batch/lot number has been requested
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: Little mild imbalance; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced little mild imbalance. The outcome of the event was resolved on an unspecified date in 2021.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities, Muscle discomfort, Muscular weakness, Myalgia
Clinical narrative: Sore arm; Muscle soreness, like an ache "on and off" and then it went away; Had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group; Picking things up and dropping things; Having a tingling feeling off and on but that went away; Some weakness to her hand on the side of her injection; Feel discomfort at the injection site; Tired; Pain at injection site; This is a spontaneous report from a contactable consumer (patient's friend). A 56-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 18Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Apr2021, from the time patient got the injection she started having a sore arm. On an unknown date in 2021, patient experienced muscle soreness, like an ache on and off and then it went away, had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group, she had 5,6,7 days where she was picking things up and dropping things and reports having a tingling feeling off and on but that went away. Consumer reported that 2 weeks ago the soreness started to come back, same place, same muscle, same ache. Patient was having some weakness to her hand on the side of her injection, Feel discomfort at the injection site, Tired and Pain at injection site. Patient reported that her friends also experienced similar symptoms. The event having a tingling feeling off and on was recovered on an unknown date in 2021. The outcome of rest all the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021684418 same patient/drug/similar event, different patient;US-PFIZER INC-2021687674 same patient/drug/similar event, different patient;US-PFIZER INC-2021687675 same patient/drug/similar event, different patient;US-PFIZER INC-2021687676 same patient/drug/similar event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Vaccination site discomfort, Vaccination site pain
Clinical narrative: Sore arm; Muscle soreness, like an ache "on and off" and then it went away; Had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group; Picking things up and dropping things; Having a tingling feeling off and on but that went away; Some weakness to her hand on the side of her injection; Feel discomfort at the injection site; Tired; Pain at injection site; This is a spontaneous report from a contactable consumer (patient's friend). A 56-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 18Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Apr2021, from the time patient got the injection she started having a sore arm. On an unknown date in 2021, patient experienced muscle soreness, like an ache on and off and then it went away, had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group, she had 5,6,7 days where she was picking things up and dropping things and reports having a tingling feeling off and on but that went away. Consumer reported that 2 weeks ago the soreness started to come back, same place, same muscle, same ache. Patient was having some weakness to her hand on the side of her injection, Feel discomfort at the injection site, Tired and Pain at injection site. Patient reported that her friends also experienced similar symptoms. The event having a tingling feeling off and on was recovered on an unknown date in 2021. The outcome of rest all the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021684418 same patient/drug/similar event, different patient;US-PFIZER INC-2021687674 same patient/drug/similar event, different patient;US-PFIZER INC-2021687675 same patient/drug/similar event, different patient;US-PFIZER INC-2021687676 same patient/drug/similar event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Nausea, Peripheral swelling, Rash
Clinical narrative: Right arm is kind of swollen in two places and a rash; Right arm is kind of swollen in two places and a rash/ bad rash; Had a really bad effect of not being able to breathe while I was sleeping, but it was so bad that I could hear myself gasping for breath; Have little bit of nausea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on 07Jun2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included patient received first dose of BNT162B2 received for Covid-19 immunization and experienced little mild imbalance (it went away). Concern: Consumer stated, "This was the number they gave me to report a possible side effect, this was my second corona vaccine shot (COVID Vaccine), I got on Monday. I did not had any problem with the first one, except for little mild imbalance and then it went away, but with the second one I got Monday, I have seen to have a really bad rash, my right arm was kind of swollen in two places and a rash, I had a really bad, just you can say effect of not being able to breathe while I was sleeping, but it was so bad that I could hear myself gasping for breath when I woke up. And when I woke up I also felt nauseated, I have little bit of nausea now but that's about it. So patient wanted to know were those effects something that will kind of go away or there was something that patient need to go back to where patient got the shot or the doctor". Consumer was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information was the right department who can answer the questions which consumer have. When offered the number for Pfizer Medical information consumer stated, "You know what maybe I will just call them back and see what they say." and hung up the call abruptly. Further information could not be probed as the consumer hung up the call abruptly. Hence limited information available over the call. The outcome of the event have little bit of nausea was not recovered and outcome of other events was unknown.  Information on the lot/batch number has been requested
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: After having the covid vaccine she felt more tired and no strength; After having the covid vaccine she felt more tired and no strength; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for a 26-year old female patient that she received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation; tofacitinib citrate (XELJANZ), oral from 2018 (Batch/Lot number was not reported; Expiration Date: 30Jun2023) and ongoing, at 5 mg, twice a day for an unspecified indication. The patient medical history was not reported. Concomitant medications included baclofen (BACLOFEN); empagliflozin, metformin hydrochloride (SYNJARDY); levothyroxine sodium (LEVOTHYROXINE SODIUM); paracetamol, tramadol hydrochloride (TRAMADOL HCL AND ACETAMINOPHEN); lisinopril (LISINOPRIL); gabapentin (GABAPENTIN); fluoxetine (FLUOXETINE); fish oil (FISH OIL); rosuvastatin calcium (ROSUVASTATIN CALCIUM); dulaglutide (TRULICITY); calcium, colecalciferol (CALCIUM +D3) taken for an unspecified indication, start and stop date were not reported. Patient states that after having the covid vaccine she felt more tired and no strength 4 days after receiving the covid vaccine and for a couple days after that. Md unaware. (withheld) any missed doses. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Dry skin, Feeling abnormal, Pain in extremity, Rash erythematous
Clinical narrative: Hurt in his arm; The hair is falling out on the arm; He doesn't feel like his arm is normal; Before the skin was soft and thin/ it feels thick and rough only on the arm; They are red dots and there is some yellow in the middle; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0158), dose 2 via an unspecified route of administration on 09May2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient had the reaction from the first vaccination. He had the first vaccination on 18Apr2021 and the second vaccine was on 09May2021. He had a lot of little dots. They are not pimples. They are dots on the whole arm. They are red dots and there is some yellow in the middle. He mentioned it to the person that gave him the second injection and they said it was normal. He wanted to mention that. He has hurt in his arm and the hair is falling out on the arm. He doesn't feel like his arm is normal. He doesn't feel it as before. Before the skin was soft and thin. Now when he feels it, it feels thick and rough only on the arm. He had the reaction on the first day he had the vaccination. HCP Information: He doesn't have any doctor. He would love anyone to see his arms. He doesn't have medical. Dots on the whole arm: They are going away. Some of them are going away. They are appearing again. He would not say that it has been worse or improving. For example, he can feel a new one there that was going away. They are just coming and going. They appear and disappear. He can feel that his skin is rough and thick. It is not like the arm looks horrible, but it is not either worse or improving. It is both arms.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Lip swelling, Oral mucosal eruption, Rash
Clinical narrative: Rash around mouth; Swollen lips; Spotty rash on neck, arms, under arms, buttocks, and thighs. Rash on arms, buttocks, and thighs are not itchy; This is a spontaneous report from a contactable consumer (patient). A 53-Year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, lot unknown: True, Lot unknown reason: Unable to locate or read the details), dose 2 via an unspecified route of administration, administered in Left Arm on 14Jun2021 11:00 AM (at the age of 53-Year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Hypertension, high cholesterol, GERD. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. There were no known allergies. Concomitant medication(s) (in two weeks) included amlodipine taken for an unspecified indication, start and stop date were not reported; pantoprazole taken for an unspecified indication, start and stop date were not reported; calcium taken for an unspecified indication, start and stop date were not reported; vitamin b complex (VITAMIN B) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VITAMIN C) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot unknown: True, Lot unknown reason: Unable to locate or read the details), dose 1 via an unspecified route of administration, administered in Left Arm on 24May2021 11:00 AM (at the age of 53-Year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced rash around mouth (non-serious) on 15Jun2021 15:00 PM, swollen lips (non-serious) on 15Jun2021 15:00 PM, spotty rash on neck, arms, under arms, buttocks, and thighs. rash on arms, buttocks, and thighs are not itchy (non-serious) on 15Jun2021 15:00 PM. Adverse event:  Rash around mouth with swollen lips (but able to eat with a little discomfort). Spotty rash on neck, arms, under arms, buttocks, and thighs. Rash on arms, buttocks, and thighs are not itchy. Treatment was received for the adverse events (Currently, using Aveeno and applying ointment). Facility type vaccine was Pharmacy or Drug Store. Facility in Country. Adverse event country. The outcome of events was recovering.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Swelling
Clinical narrative: Body, ankles and feet swollen/my body has been swollen specially my ankles and my feet; Body, ankles and feet swollen/my body has been swollen specially my ankles and my feet; Body, ankles and feet swollen/my body has been swollen specially my ankles and my feet; This is a spontaneous report from a contactable consumer or other non hcp.   A patient of unspecified age and gender received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single on an unspecified date for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, The patient experienced body, ankles and feet swollen/my body has been swollen specially my ankles and my feet. "patient was wondering, it was normal for your body to swell up after the vaccine. The patient got it on Monday and the next day patient body has been swollen specially the my ankles and my feet." Consumer was informed about Pfizer Medical Information Department. In response, consumer stated, "So will I be able to call now. I was just going to the "ER" (Further not clarified)." (Further call hung up) As consumer abruptly hung up the call. Product details (LOT#, expiration date, NDC# and UPC#), Pharmacy details and treatment could not be probed over the call. Limited information available over the call and appropriate response could not be provided. The outcome of the events were unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Experienced numbness and tingling after the injection into left deltoid; Experienced numbness and tingling after the injection into left deltoid; This is a spontaneous report from a contactable Pharmacist. A 12-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0217), via an unspecified route of administration in left deltoid, on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration, on an unspecified date as single dose for COVID-19 immunization and had no reaction. On an unspecified date, patient experienced numbness and tingling after the injection into left deltoid and it's still on going. Reporter seriousness for experienced numbness and tingling after the injection into left deltoid was unspecified. Outcome of event was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: sore arm and right now patient is having a hard time trying to raise her arm/ can't lift shoulder and arm hardly; sore arm and right now patient is having a hard time trying to raise her arm/ can't lift shoulder and arm hardly; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of unspecified age reported for herself that received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 09Jun2021, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Jun2021, after the second dose of vaccination, patient experienced sore arm and right now patient is having a hard time trying to raise her arm/ can't lift shoulder and arm hardly. Patient asked if she had any question then what are the option that is should need to go to hospital or go to the emergency room and how long does it going to take. Patient was advised to call nearest physician in case of any emergency. The outcome of both the events was unknown.   Information on batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Facial pain, Pyrexia, Swelling face
Clinical narrative: Feeling a little bit of fever; Fever is very low it's not like high but it's been running since one week; Little bit of swelling on the face; Face swelling is there and she is also having pain on the face; Little bit of swelling on the face; Face swelling is there and she is also having pain on the face; This is a spontaneous report from a contactable consumer or other non hcp (Patient's husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on 05May2021 (Batch/Lot Number: EW0175) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced the fever was very low it was not like high, but it was been running for one week, now the face swelling was there, and she was also having pain on the face today. And wanted to visit doctor. The patient underwent lab tests and procedures which included body temperature: fever on an unspecified date. the outcome the events was unknown.  Follow up attempts are needed; Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: He had his armpit is swollen like a ball; This is a spontaneous report from a contactable consumer (parent) or other non HCP.   A male patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown, Expiration date: unknown), via an intramuscular route on 19Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were 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 on unspecified date as dose 1, single for covid-19 immunisation and had no reaction on previous exposure to vaccine. On 20Jun2021, the patient experienced had his armpit swollen like a ball. Reporter stated he got his 2nd COVID Vaccine and next day morning he had his armpit is swollen like a ball and really very concerned about his son's health. The outcome of the event was not recovered.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: She got a rash on her butt; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that she received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 02Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included herpes zoster, varicella from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Caller states she received her fist dose of the Pfizer COVID-19 vaccine on 02Jun2021 and is due to get her second dose on 23Jun2021, but 2 weeks after receiving the first dose she developed a rash on her butt, she does have a history of Herpes but this rash is different than that, and her husband did research and saw that there has been rare reports of getting shingles from the vaccine and she did have chicken pox as a child. Caller would like to know if it is okay to get the second dose of the vaccine even though she still had the rash, the rash is drying up and getting better but it is still there. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2, formulation: Solution for injection), dose 1 via an unspecified route of administration on 18Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. He was calling about the Covid 19 vaccine. He was asking how long he should have diarrhea. This was his first Covid 19 vaccine and his paperwork says he can have diarrhea, but he just wants to know how long the diarrhea will last. It was been going on since Friday, 18Jun2021. He received his first Covid 19 vaccine on Friday 18Jun2021. Caller stated he had been having diarrhea since 18Jun2021. Caller stated he knew this can be a side effect of the Pfizer Covid-19 vaccine, but he would like to know how long this side effect may last. Caller was asking if he should continue drinking a lot of water. The outcome of the event was not recovered.  Information related to batch/Lot no. was requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: Pityriasis rosea; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 30-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP7533) via an unspecified route of administration in left arm on 10Apr2021 as dose 2, single (at the age of 30-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient medical history was not reported. The concomitant medications included spironolactone (SPIROLACTONE). Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6207) via an unspecified route of administration in right arm on 20Mar2021 as dose 1, single for COVID-19 immunization. Vaccination facility type was reported as Other. Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19, prior to vaccination and was not tested for COVID-19, post vaccination. On 24Apr2021, the patient experienced Pityriasis rosea. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the adverse events. The outcome of the events was not recovered.  Follow-up (23Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: has a rash in both of his armpits that do not itch; This is a spontaneous report from a contactable consumer reported for a male patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Jun2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization.The patient medical history and concomitant medications were not reported. It was reported that both her and her husband received the Pfizer COVID19 Vaccine yesterday. On an unspecified date, her husband had a rash in both of his armpits that do not itch. Caller wants to know if this is normal. Her husband is prescribed Lovenox BID and that did worry her. She states that when she refilled his prescription, she also let the pharmacy know and they advised he should be okay but to follow up with this number as well so that is what she is doing. Patient will be seeing his vascular surgeon this week she states, and they will also make him aware of this reaction/side effect. The event outcome was Unknown.  Caller declined to complete report. Full details not obtained. The caller was provided with phone number and hours of operation, prior to warm transfer.  Information on the lot/batch number has been requested.  Follow-up (23Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia
Clinical narrative: Left side of his arm was numb; Tried to put a Nebulizer on him and he couldn't even breath with it/Trouble breathing; This is a spontaneous report from a contactable consumer (father of patient) or other non hcp. A 20-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 20Jun2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 22Jun2021, the patient developed breathing trouble, he went to an asthma doctor like literally half hour ago and they tried to put a Nebulizer on him, and he couldn't even breath with it. On the same day the patient also experienced numbness of the left side of his arm. The patient was treated for breathing trouble with nebulizer at the asthma doctor and he could not even breath with it. The outcome of the events was reported as unknown at the time of report.  Information on Batch/lot no. has been requested. Further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Ocular discomfort, Tension headache
Clinical narrative: I have a lot of pressure in my face, under my eyes (from the left side of my face to my right). Also pressure around my nose, it's very tender on both side. My entire face feels tight and has a lot of; I have a lot of pressure in my face, under my eyes (from the left side of my face to my right). Also pressure around my nose, it's very tender on both side. My entire face feels tight and has a lot of; I have a lot of pressure in my face, under my eyes (from the left side of my face to my right). Also pressure around my nose, it's very tender on both side. My entire face feels tight and has a lot of; This is a spontaneous report from a contactable consumer (patient herself). This 52-year-old female consumer (patient) reported for herself that received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation was Solution for injection, Lot Number: EW0196), dose 1 via intramuscular in left Arm on 18-JUN-2021 14:30, as single dose for COVID-19 immunization (age at time of vaccination 542 years). The patient was not pregnant. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed COVID-19 Prior to vaccination, Since the vaccination, has the patient been tested for COVID-19 as no. The patient medical history included Allergies, Asthma. The patient concomitant medications included DHEA, Pregnenolone, Iron, Calcium, Multi, Calciferol (Vit D). On 19Jun2021 patient experienced a lot of pressure in face, under her eyes (from the left side of her face to right). Also, pressure around her nose, it was very tender on both sides. Her entire face felt tight and has a lot of pressure. The patient had allergies to Sulfa, Ceclor, Amoxicillin, Tetracycline, Wheat, Soy, Yeast, and she was not taking any treatment. The outcome of all events were not recovered.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Exposure to SARS-CoV-2, Fatigue, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: exposed to Covid-19 between first and second vaccines, tested negative for Covid-19; he felt a little like he was coming down with something; he was not really hungry; tired; This is a spontaneous report from a Contactable consumer. This consumer is reporting for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 28Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the first dose of the vaccine in February and got or was exposed to COVID to someone with the COVID in-between the first and second dose. Patient stated, again, it was the first week and he had a customer he was near but they both had masks on. He was wearing an N95, and she had a medical mask on. They stayed the six feet, and he was not around her long. She told him the next day and texted him that she had it. He got tested one week later. He just had a part of one weekend where he felt a little like he was coming down with something. He was not really hungry and was tired on an unspecified date in 2021. He then tested negative. He got the second dose after testing negative. Then, he periodically got purple spots on his left arm on an unspecified date and right arm joint was tender every once in a while, on an unspecified date and he wanted to make sure or know if that was part of it. He wanted to make sure he was fully vaccinated after being exposed to the virus. A couple of weeks later, on an unspecified date he developed a few dark spots on his left arm where he got the shot. It was on his mid forearm between the forearm and the wrist, on top. And then it would go away and he would get more, it would be different, darker to lighter. It always went away; he did not have any currently at the time of report. He also had on his right arm near the elbow, occasional soreness. Patient was really thankful for the first shot since he was possibly exposed. He never really developed symptoms and he was testing himself regularly like his temperature. Patient reported that his first vaccine was 28Feb2021 and then three weeks later was the second, but he does not have his card. Patient did not really want to report anything other than that he did not experienced anything. The patient underwent lab tests and procedures which included Covid-19 test: negative on an unspecified date in Mar2021. Outcome of all the events was reported as Unknown at this time of the report.   Information upon lot number/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Chills, Pyrexia
Clinical narrative: low grade temperatures; chills like 100 degrees; Weak; This is a spontaneous report from a COVAX US SUPPORT via a contactable reporter (Parent). A 38-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm, on an unspecified date in Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any vaccine within 4 weeks prior vaccinations. The patient took Pfizer covid vaccine because he wanted to be immunized to be inoculated. The reporter (patient's mother) calling on behalf of her son (patient) regarding the Pfizer covid vaccine. Her son recently got the second dose, and he was having adverse effects. She was calling to report. On an unspecified date in Apr201, the patient experienced low grade temperatures, chills like 100 degrees, and weak. She was not sure if its related directly to the vaccine, but she thought it's worth mentioning. Maybe to bring awareness to see if anyone else that had that batch, if anyone else had adverse effects. The first vaccine was in April. The second in May and he was fine with it and about two weeks ago out of the clear blue sky he was weak, dizzy, lightheaded, nauseous and vomiting. He was still weak, easily fatigued, just general malaise. It was medically significant, and it has improved a little. He was just taking supplements, vitamins, and trying to eat more properly. He was drinking a lot of fluids, electrolyte replacement, Pedialyte, and Gatorade. She has been to the Emergency Room with him three times, he's seen doctors and specialist and went to hematologist because of his liver. It went away she didn't have a date. Now it's not serious because it has subsided. He has lasting effects he is still weak. No dizziness noted. Whatever was going on has affected the integrity of his blood we have had blood work done and his liver enzymes were totally abnormal. All the symptoms were gone, vomiting was gone. The weakness fatigue and lost of appetite persists. The events required a visit to emergency room (3 times) and physician office. Outcome of the events was unknown.  Information on Batch/lot no. has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hypoaesthesia
Clinical narrative: she sad slight reaction-numbness in arm and slight chest pain, lasted the 10 minutes while she sat there and then it subsided.; she sad slight reaction-numbness in arm and slight chest pain, lasted the 10 minutes while she sat there and then it subsided.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 02Jun2021 (age at vaccination was 56 years) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Jun2021, immediately following the first vaccine, the patient experienced slight reaction-numbness in arm and slight chest pain, lasted for 10 minutes while she sat there and then it subsided. She received a response which stated that as noted in the fact sheet for recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They referred her to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Her healthcare provider knows her health situation and had access to information that can better help inform this decision. The adverse event resulted in emergency room visit. She was scheduled for 2nd dose tomorrow. The outcome of event was resolved on 02Jun2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Lost of taste; This is a spontaneous report from a contactable consumer (patient's mother).A 12-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unknown route of administration on an unknown date as dose number unknown, single for covid-19 immunization.The patient medical history and concomitant medications were not reported.In Jun2021, the patient experienced loss of taste. The mother reported that, her daughter got the vaccine, and she experienced a loss of taste, it's been about 4 days or so. She was wondering if that was one of the side effects of the shot or maybe she has it or what to do. She called her doctor but they did not know what to tell her. Outcome of event was unknown.   Information on the lot/batch number has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Malaise
Clinical narrative: Chest pain; Not feeling well; This is a spontaneous report from a contactable consumer or other non hcp. The consumer (mother) reported for (daughter) that 12-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 2 via an unspecified route of administration on 22Jun2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration on 01Jun2021 (Batch/Lot number: Not reported) as dose 1, single for covid-19 immunization. On an unknown date, the patient experienced chest pain and not feeling well. It was reported that caller was calling now on behalf of her daughter, she is 12 years old. She had her first dose Pfizer COVID 19 Vaccine 01Jun2021, second dose is 22Jun2021, that is yesterday. After having the second dose of Pfizer Covid 19 Vaccine she was experiencing chest pain and she was complaining about it. The clinical outcome of both events was unknown.  Information regarding the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Cough, Decreased appetite, Eating disorder
Clinical narrative: Itching; extreme tiredness and sleepiness; extreme tiredness and sleepiness; Headache; Muscle pain; Chills; Fever; Nausea; Feeling unwell; can't eat; problems with equilibrium; Cough; Sore throat; has not been eating; This is a spontaneous report from a contactable consumer or other non hcp. A 64-year-old female patient 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, administered in arm left on 14Jun2021 (at the age of 64-year-old) as dose 1, single for COVID-19 immunization. Medical history included immune deficiency (diagnosed 11 years ago), diabetes (diagnosed over 10 years ago). The patient's concomitant medications were not reported. The patient experienced has not been eating, extreme tiredness and sleepiness, headache, muscle pain, chills, fever, nausea, feeling unwell, can't eat, problems with equilibrium, cough, sore throat, all on 20Jun2021, Itching on 21Jun2021. The reporter is calling about the Pfizer covid vaccine on behalf of his wife. The reporter wants to report the patient's side effects. The patient has had complications starting on June 20th with severe, well not, but pretty close to it, symptoms. The patient has not been eating. Event: The patient has chills and keeps getting hot and cold. The patient is having problems with her equilibrium and stumbles and feels like she is drunk and is unbalanced. Outcome of the events was not recovered.   Follow up attempts are needed; Information on lot number/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Nausea
Clinical narrative: Itching; extreme tiredness and sleepiness; extreme tiredness and sleepiness; Headache; Muscle pain; Chills; Fever; Nausea; Feeling unwell; can't eat; problems with equilibrium; Cough; Sore throat; has not been eating; This is a spontaneous report from a contactable consumer or other non hcp. A 64-year-old female patient 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, administered in arm left on 14Jun2021 (at the age of 64-year-old) as dose 1, single for COVID-19 immunization. Medical history included immune deficiency (diagnosed 11 years ago), diabetes (diagnosed over 10 years ago). The patient's concomitant medications were not reported. The patient experienced has not been eating, extreme tiredness and sleepiness, headache, muscle pain, chills, fever, nausea, feeling unwell, can't eat, problems with equilibrium, cough, sore throat, all on 20Jun2021, Itching on 21Jun2021. The reporter is calling about the Pfizer covid vaccine on behalf of his wife. The reporter wants to report the patient's side effects. The patient has had complications starting on June 20th with severe, well not, but pretty close to it, symptoms. The patient has not been eating. Event: The patient has chills and keeps getting hot and cold. The patient is having problems with her equilibrium and stumbles and feels like she is drunk and is unbalanced. Outcome of the events was not recovered.   Follow up attempts are needed; Information on lot number/batch number has been requested.