chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Extra dose administered, Influenza like illness, Lymphadenopathy
Clinical narrative: fever/back of his head & low grade fever of 100F; development of lymph nodes on his left side, same side where he got the vaccine- characterized to be very painful like someone punched him on the back of his head; got his  3rd/booster dose; got his  3rd/booster dose; low energy; flu-like symptoms; This is a spontaneous report from a contactable consumer (Patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration on 02Sep2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 for covid-19 immunisation. Historical vaccine included bnt162b2 (COMIRNATY) as dose 2 for covid-19 immunisation .The patient experienced got his 3rd/booster dose (off label use) (extra dose administered) on 02Sep2021, fever/back of his head & low grade fever of 100f on 16Sep2021 , low energy, flu-like symptoms in Sep2021, development of lymph nodes on his left side, same side where he got the vaccine- characterized to be very painful like someone punched him on the back of his head on 16Sep2021. The patient underwent lab tests and procedures which included body temperature: 100 fahrenheit on 16Sep2021. 2448-hour post-vaccination- development of fever, low energy, and almost flu-like symptoms. Lasted 2-3 days then went away. >Approximately 2 weeks after (Starting 16Sep) up until today- development of lymph nodes on his left side, same side where he got the vaccine- characterized to be very painful like someone punched him on the back of his head & low-grade fever of 100F. In line with this, caller would like to know if there were any reports similar to his experience specifically on the painful lymph nodes and its development 2 weeks after vaccination. The outcome of the events fever/back of his head & low-grade fever of 100F, development of lymph nodes on his left side, same side where he got the vaccine- characterized to be very painful like someone punched him on the back of his head was not recovered. The outcome of the event low energy, flu-like symptoms, was recovered in Sep2021.  The lot number for BNT162B2 was not provided and will be request during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pyrexia
Clinical narrative: fever/back of his head & low grade fever of 100F; development of lymph nodes on his left side, same side where he got the vaccine- characterized to be very painful like someone punched him on the back of his head; got his  3rd/booster dose; got his  3rd/booster dose; low energy; flu-like symptoms; This is a spontaneous report from a contactable consumer (Patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration on 02Sep2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 for covid-19 immunisation. Historical vaccine included bnt162b2 (COMIRNATY) as dose 2 for covid-19 immunisation .The patient experienced got his 3rd/booster dose (off label use) (extra dose administered) on 02Sep2021, fever/back of his head & low grade fever of 100f on 16Sep2021 , low energy, flu-like symptoms in Sep2021, development of lymph nodes on his left side, same side where he got the vaccine- characterized to be very painful like someone punched him on the back of his head on 16Sep2021. The patient underwent lab tests and procedures which included body temperature: 100 fahrenheit on 16Sep2021. 2448-hour post-vaccination- development of fever, low energy, and almost flu-like symptoms. Lasted 2-3 days then went away. >Approximately 2 weeks after (Starting 16Sep) up until today- development of lymph nodes on his left side, same side where he got the vaccine- characterized to be very painful like someone punched him on the back of his head & low-grade fever of 100F. In line with this, caller would like to know if there were any reports similar to his experience specifically on the painful lymph nodes and its development 2 weeks after vaccination. The outcome of the events fever/back of his head & low-grade fever of 100F, development of lymph nodes on his left side, same side where he got the vaccine- characterized to be very painful like someone punched him on the back of his head was not recovered. The outcome of the event low energy, flu-like symptoms, was recovered in Sep2021.  The lot number for BNT162B2 was not provided and will be request during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Headache, Illness, Malaise
Clinical narrative: really sick; headaches; felt terrible/ not feeling good; throat started to feel funny; couldn't swallow; It felt like it was swelling shut; tired; her arm hurt; This is a spontaneous report from a contactable consumer (patient) reported for herself. This 56-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine, lot number: 301358A) via an unspecified route of administration on 17Sep2021 at 18:00 as single dose for COVID-19 immunization. Medical history included anaphylaxis and allergies, Covid twice: the first time was in Oct2020 - she was sick for a week and on day 8 she had a fever and went to the ER, but she was not hospitalized. The doctor told her she had pneumonia after an xray of her lungs with crackling and she was given antibiotics. On 20Jul2020 she went to the doctor and was tested for Covid, and she had antibodies as well as tested for Covid and it came back positive on 27Jul2021. She had no symptoms but was still told to quarantine. She did two nasal swabs afterwards that came back negative. The second time she didn't even know she had it, they checked her for antibodies, but she was tired of dealing with quarantine. Concomitant medications were unknown. The patient received her first dose of the Pfizer BioNTech Covid 19 vaccine on 17Sep2021 at 18:00. She had a history of anaphylaxis and allergies so she waited 30 minutes. She had no problems at first, but in general she was not feeling good that day or anything. She was tired and her arm hurt on 17Sep2021. That night, she was eating pretzels, around 8-8:30PM her throat started to feel funny like she couldn't swallow, almost like strep. It felt like it was swelling shut, but she could breath. She was still scared. She took Benadryl, and stayed up all night Friday. The next day she was really sick on 18Sep2021, and had terrible headaches that lasted through Sunday. She felt terrible on 18Sep2021. Today she was fine. She will have to go back for the second Pfizer Biotech COVID shot in Oct2021, but she was really afraid. She was tired of dealing with it. She didn't think she's going to get the second dose. Her pharmacist couldn't tell her anything and her doctor told her it could be worse or it could be nothing. So the second vaccine may not give her any side effects, but other times it can be worse. She was leaning towards not getting the second shot but wanted to know if there's any information available on if the second dose will be worse than the first.   It was reported that side effects after the second shot may be more intense than the ones the patient experienced after the first shot. These side effects were normal signs that her body was building protection and should go away within a few days. Outcome of the events really sick and felt terrible/ not feeling good was recovered on 20Sep2021, of the event headaches was recovered on 19Sep2021, of the other events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pain in extremity, Pharyngeal swelling
Clinical narrative: really sick; headaches; felt terrible/ not feeling good; throat started to feel funny; couldn't swallow; It felt like it was swelling shut; tired; her arm hurt; This is a spontaneous report from a contactable consumer (patient) reported for herself. This 56-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine, lot number: 301358A) via an unspecified route of administration on 17Sep2021 at 18:00 as single dose for COVID-19 immunization. Medical history included anaphylaxis and allergies, Covid twice: the first time was in Oct2020 - she was sick for a week and on day 8 she had a fever and went to the ER, but she was not hospitalized. The doctor told her she had pneumonia after an xray of her lungs with crackling and she was given antibiotics. On 20Jul2020 she went to the doctor and was tested for Covid, and she had antibodies as well as tested for Covid and it came back positive on 27Jul2021. She had no symptoms but was still told to quarantine. She did two nasal swabs afterwards that came back negative. The second time she didn't even know she had it, they checked her for antibodies, but she was tired of dealing with quarantine. Concomitant medications were unknown. The patient received her first dose of the Pfizer BioNTech Covid 19 vaccine on 17Sep2021 at 18:00. She had a history of anaphylaxis and allergies so she waited 30 minutes. She had no problems at first, but in general she was not feeling good that day or anything. She was tired and her arm hurt on 17Sep2021. That night, she was eating pretzels, around 8-8:30PM her throat started to feel funny like she couldn't swallow, almost like strep. It felt like it was swelling shut, but she could breath. She was still scared. She took Benadryl, and stayed up all night Friday. The next day she was really sick on 18Sep2021, and had terrible headaches that lasted through Sunday. She felt terrible on 18Sep2021. Today she was fine. She will have to go back for the second Pfizer Biotech COVID shot in Oct2021, but she was really afraid. She was tired of dealing with it. She didn't think she's going to get the second dose. Her pharmacist couldn't tell her anything and her doctor told her it could be worse or it could be nothing. So the second vaccine may not give her any side effects, but other times it can be worse. She was leaning towards not getting the second shot but wanted to know if there's any information available on if the second dose will be worse than the first.   It was reported that side effects after the second shot may be more intense than the ones the patient experienced after the first shot. These side effects were normal signs that her body was building protection and should go away within a few days. Outcome of the events really sick and felt terrible/ not feeling good was recovered on 20Sep2021, of the event headaches was recovered on 19Sep2021, of the other events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jul2021 10:00 (at the age of 63 years) (Batch/Lot Number: FA7484) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. Family Medical History Relevant to Adverse event was none. There were no concomitant medications. Patient stated when received the first shot, "I had some body aches, extreme tired, very, very tired and diarrhea, very tired few days". Reported after the first dose she felt achy and tired for a couple of days; and had diarrhea for a couple of days. That was just a few days of feeling very tired and then she was fully recovered. The events resulted in visit to emergency room. The patient underwent lab tests and procedures which included sars-cov-2 test: negative in 2021. The clinical outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Pleural effusion, Pneumonia, Spinal fracture
Clinical narrative: Feels like he has pneumonia; fell; he slipped between his wheelchair and broke his spine/ broken back; Post vaccination he developed pleural effusion (fluids on the lung).; This is a spontaneous report from a contactable consumer (wife) from a Pfizer Sponsored Program via Regulatory Authority Support. A 73-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) at age of 73-years-old as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date for COVID-19 Immunization. The patient experienced slipped between his wheelchair and broke his spine/ broken back on Apr2021 with outcome of unknown, feels like he has pneumonia on May2021 with outcome of unknown, fell on 08Apr2021 with outcome of unknown, post vaccination he developed pleural effusion on Apr2021 with outcome of not recovered. Clinical course reported as follow: After getting the second COVID 19 vaccine patient developed pleural effusion/built up fluid on lungs/fluid in the pleural area in Apr2021 and the doctors could not figure out where it was coming from. Patient did not have congestive heart failure, he was looked at by 3 heart doctors. No medical conditions before the Covid vaccine, nothing before other than he was wheelchair bound due to needing hip surgery. They were going to do this done but then COVID hit and it was canceled. Since getting the vaccine he slipped between his wheelchair and broke his spine. The doctors didn't do anything about it at first. They thought it was a muscle issue but he kept saying he felt like he broke his back. Then one day he said it felt like he had pneumonia and a broken back and in the beginning May2021 he went to the hospital in beginning of May2021 and he was right, he was hospitalized at that time for it. He fell on 08Apr2021. The patient was hospitalized for he slipped between his wheelchair and broke his spine/ broken back and feels like he has pneumonia from May2021 to May2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Illness, Product dose omission issue
Clinical narrative: if she should get the second dose because its already been 8 or 9 weeks since her first dose; exposed to person's with COVID-19 virus; she was ill; This is a spontaneous report from a contactable consumer (patient). A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: WS2736, expiry date: not reported) via an unspecified route of administration on 26Jul2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, patient exposed to person's with COVID-19 virus, she was ill, if she should get the second dose because its already been 8 or 9 weeks since her first dose. Patient stated she received her first dose of the Pfizer Covid-19 Vaccine on 26Jul2021.  Shortly after, she was exposed to person's with COVID-19 virus. She had the first dose on 26Jul2021 and she was ill after that and was exposed to people with possible expose to COVID-19 virus and she was quarantine after, So she is asking is if she should get the second dose because its already been 8 or 9 weeks since her first dose. She was just exposed to people with the virus and was quarantine. She did not mentioned that she was positive. The outcome of events was unknown.  Follow-up (20Sep2021): New follow-up information from a contactable patient via a Pfizer sponsored program included: lot number of dose, event information added.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Headache, Malaise, Nephrolithiasis, Pyrexia
Clinical narrative: vomiting; Kidney stone; Headache; Fever; not to feel comfortable; Didn't feel well; This is a spontaneous report from a contactable consumer (patient's wife). A 61-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0165), via an unspecified route of administration, administered in arm on 02May2021 17:00 (at the age of 61-year-old) as single dose for COVID-19 immunisation. No prior vaccinations (within 4 weeks) and no AE following prior vaccinations. Medical history included 6 surgeries on legs, and broke his legs from 2019 (fully recovered and did not take medication at all). Concomitant medication was reported as none. The patient previously received 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0162) on 14Apr2021 around 16:00 (at the age of 61-year-old) for COVID-19 Immunization. Patient experienced vomiting on 13May2021 and was rushed to the hospital (in May2021) and diagnosed with a kidney stone on 14May2021. Also, reporter stated that after the 2nd shot her husband (patient) didn't feel well in May2021. Stated that a week after the 2nd vaccine she thought he was dying and he was vomiting and was rushed to the hospital and was diagnosed with a kidney stone. Reporter stated she didn't know if it was related but it had to be. Stated reporter tried to contact the insurance company and the hospital and they denied it and she said it could be possibly related to the vaccine. Patient didn't feel well just after 2 days, he had a headache, fever for 2 days (in May2021) and then started not to feel comfortable (in May2021) and couldn't go to work and was vomiting the night of 13May2021 to the early morning of 14May2021. Reporter stated it scared her she thought he was dying. Stated it was confirmed he had a kidney stone and was nothing dangerous and they gave him medication and said it was 3mm and will come out naturally, and it did come out naturally. All AEs required a visit to emergency room (patient never went to the doctor, they were scared of bills so huge from just the ER). The outcome of the events headache and fever was recovered in May2021, of other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; Kidney stone; Headache; Fever; not to feel comfortable; Didn't feel well; This is a spontaneous report from a contactable consumer (patient's wife). A 61-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0165), via an unspecified route of administration, administered in arm on 02May2021 17:00 (at the age of 61-year-old) as single dose for COVID-19 immunisation. No prior vaccinations (within 4 weeks) and no AE following prior vaccinations. Medical history included 6 surgeries on legs, and broke his legs from 2019 (fully recovered and did not take medication at all). Concomitant medication was reported as none. The patient previously received 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0162) on 14Apr2021 around 16:00 (at the age of 61-year-old) for COVID-19 Immunization. Patient experienced vomiting on 13May2021 and was rushed to the hospital (in May2021) and diagnosed with a kidney stone on 14May2021. Also, reporter stated that after the 2nd shot her husband (patient) didn't feel well in May2021. Stated that a week after the 2nd vaccine she thought he was dying and he was vomiting and was rushed to the hospital and was diagnosed with a kidney stone. Reporter stated she didn't know if it was related but it had to be. Stated reporter tried to contact the insurance company and the hospital and they denied it and she said it could be possibly related to the vaccine. Patient didn't feel well just after 2 days, he had a headache, fever for 2 days (in May2021) and then started not to feel comfortable (in May2021) and couldn't go to work and was vomiting the night of 13May2021 to the early morning of 14May2021. Reporter stated it scared her she thought he was dying. Stated it was confirmed he had a kidney stone and was nothing dangerous and they gave him medication and said it was 3mm and will come out naturally, and it did come out naturally. All AEs required a visit to emergency room (patient never went to the doctor, they were scared of bills so huge from just the ER). The outcome of the events headache and fever was recovered in May2021, of other events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test positive
Clinical narrative: patient tested positive for COVID19, contracted the covid 19 virus; patient tested positive for COVID19, contracted the COVID 19 virus; This is a spontaneous report from Pfizer Sponsored Program via Regulatory Authority Support. A contactable pharmacist via medical information team reported for a patient that: A 65-year-old male patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Not reported) via an unspecified route of administration on an unspecified date as single dose and first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient who got both doses of the COMIRNATY vaccine. On an unspecified date in Jul2021 (2 months ago) patient tested positive for COVID19, contracted the COVID 19 virus. Reporter also queried about the advised timing of the patient to get a booster dose or considering that he already contracted COVID19, was there a need for him to have a booster dose. Administration of More Than a 2-Dose Series (third dose or booster dose) COMIRNATY and Pfizer-BioNTech COVID-19 Vaccine are (administered intramuscularly as a series of 2 doses (0.3 mL each) 3 weeks apart.1 A third dose of the Pfizer-BioNTech COVID-19 vaccine (0.3 mL) administered at least 28 days following the first two doses of this vaccine is authorized for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.2 A booster dose of vaccine is not currently recommended. Use in Patients with Current or Previous Diagnosis of COVID-19. Interim Clinical Considerations for the Use of COVID-19 Vaccines by CDC "People should be offered vaccination regardless of their history of symptomatic or asymptomatic SARS-CoV-2 infection; this includes people with prolonged post-COVID-19symptoms. Data from clinical trials indicate that the currently approved or authorized COVID19 vaccines can be given safely to people with evidence of a prior SARS-CoV-2 infection. Viral testing to assess for acute SARS-CoV-2 infection or serologic testing to assess for prior infection is not recommended for the purposes of vaccine decision-making. Patient underwent lab test and procedures which included COVID19-positive. Outcome of the event was unknown.  Follow up(20Sep2021): Follow up information included information about adverse reactions.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Fell down; This is a spontaneous report from a Pfizer sponsored program Support. A contactable consumer reported for a male patient (Husband). A male patient of an unspecified age received 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 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Patient fell down 3 weeks after the 1st or 2nd Pfizer vaccine dose, reporter could not remember which one. The outcome of the event was unknown.  The lot number was not provided. Information on lot number has been requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Neuralgia
Clinical narrative: shingles; headaches; neuralgia; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date in Mar2021 in the morning (Batch/Lot number was not reported) at age of 66-years-old as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were none. The patient experienced shingles on an unspecified date in 2021 with outcome of unknown; headaches and neuralgia on an unspecified date in 2021 with outcome of recovering, all reported as hospitalization. Clinical course reported as follow: The shingles were on the left side of her face and head. She had two bouts of shingles, with other weird things going on. She could not get the second dose of Pfizer Covid Vaccine until she felt well enough to do so, and was past all of the inflammation issues. She thought she had pretty much recovered completely from the shingles; she just has some residuals of headaches which were initially major headaches that have improved, were just mild on and off headaches; and neuralgia from the shingles which has also improved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hypoaesthesia, Malaise, Pain
Clinical narrative: Leg became numb and one of her toe became numb; Numb and tingling; Felt like a liquid or something going through her body, arm, leg. She was really freaking out; Headache; Not feeling well at all; Got injection on left side and everything seems to be sore and numb on left side; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left on 19Sep2021 16:45 at 58-year-old (Lot Number: FE3592) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (hypersensitive to unknown medication). Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported and an unspecified statin for high cholesterol. Patient did not take any other vaccine within 4 weeks before. The patient experienced leg became numb and one of her toe became numb (medically significant) on 19Sep2021 with outcome of not recovered, numb and tingling (medically significant) on 19Sep2021 with outcome of not recovered, got injection on left side and everything seems to be sore and numb on left side (medically significant) on Sep2021 with outcome of unknown, felt like a liquid or something going through her body, arm, leg. she was really freaking out (medically significant) on 19Sep2021 with outcome of unknown, headache (medically significant) on 19Sep2021 with outcome of unknown, not feeling well at all (non-serious) on Sep2021 with outcome of unknown. Therapeutic measures were taken as a result of leg became numb and one of her toe became numb, numb and tingling, felt like a liquid or something going through her body, arm, leg. she was really freaking out, headache and included treatment with two Benadryl. All the events required physician office visit.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101236214 Same reporter/patient, different drug/events
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Leg became numb and one of her toe became numb; Numb and tingling; Felt like a liquid or something going through her body, arm, leg. She was really freaking out; Headache; Not feeling well at all; Got injection on left side and everything seems to be sore and numb on left side; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left on 19Sep2021 16:45 at 58-year-old (Lot Number: FE3592) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (hypersensitive to unknown medication). Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported and an unspecified statin for high cholesterol. Patient did not take any other vaccine within 4 weeks before. The patient experienced leg became numb and one of her toe became numb (medically significant) on 19Sep2021 with outcome of not recovered, numb and tingling (medically significant) on 19Sep2021 with outcome of not recovered, got injection on left side and everything seems to be sore and numb on left side (medically significant) on Sep2021 with outcome of unknown, felt like a liquid or something going through her body, arm, leg. she was really freaking out (medically significant) on 19Sep2021 with outcome of unknown, headache (medically significant) on 19Sep2021 with outcome of unknown, not feeling well at all (non-serious) on Sep2021 with outcome of unknown. Therapeutic measures were taken as a result of leg became numb and one of her toe became numb, numb and tingling, felt like a liquid or something going through her body, arm, leg. she was really freaking out, headache and included treatment with two Benadryl. All the events required physician office visit.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101236214 Same reporter/patient, different drug/events
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Extra dose administered, Lymph node pain, Lymphadenopathy, Neuralgic amyotrophy
Clinical narrative: Return occurrence of Parsonage-Turner Syndrom affecting left arm/back/neck-hand and first two digits.; Return occurrence of Parsonage-Turner Syndrom affecting left arm/back/neck-hand and first two digits.; Swollen and painful left lymph node; Swollen and painful left lymph node; receiving 3rd dose of vaccine; receiving 3rd dose of vaccine; This is a spontaneous report from a contactable other HCP. A 53-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FD8448), via an unspecified route of administration, administered in Arm Right on 25Aug2021 10:45 as DOSE 3, SINGLE (at the age of: 53-year-old) for covid-19 immunization. Medical history included coronary artery disease other medical history: Mild CAD, Migraine, Psoriasis , migraine other medical history: Mild CAD, Migraine, Psoriasis , psoriasis other medical history: Mild CAD, Migraine, Psoriasis , Sulfonamide allergy as known allergies: Sulpha. Facility where the most recent COVID-19 vaccine was administered as Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient received other medications within 2 weeks of vaccination as Finasteride, Atorvastatin, Acitretin. Concomitant medication(s) included finasteride (FINASTERIDE); atorvastatin (ATORVASTATIN); acitretin (ACITRETIN). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19. On 08Sep2021, the patient experienced return occurrence of parsonage-turner syndrom affecting left arm/back/neck-hand and first two digits. On 08Sep2021 the patient experienced swollen and painful left lymph node. On 25Aug2021 10:45 the patient experienced receiving 3rd dose of vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Aug2021. Therapeutic measures were taken as Steroids, gabapentin as a result of return occurrence of parsonage-turner syndrom affecting left arm/back/neck-hand and first two digits, swollen and painful left lymph node. The outcome of event receiving 3rd dose of vaccine was unknown. The outcome of rest all event was not recovered.  Follow-up (22Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, SARS-CoV-2 test
Clinical narrative: Return occurrence of Parsonage-Turner Syndrom affecting left arm/back/neck-hand and first two digits.; Return occurrence of Parsonage-Turner Syndrom affecting left arm/back/neck-hand and first two digits.; Swollen and painful left lymph node; Swollen and painful left lymph node; receiving 3rd dose of vaccine; receiving 3rd dose of vaccine; This is a spontaneous report from a contactable other HCP. A 53-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FD8448), via an unspecified route of administration, administered in Arm Right on 25Aug2021 10:45 as DOSE 3, SINGLE (at the age of: 53-year-old) for covid-19 immunization. Medical history included coronary artery disease other medical history: Mild CAD, Migraine, Psoriasis , migraine other medical history: Mild CAD, Migraine, Psoriasis , psoriasis other medical history: Mild CAD, Migraine, Psoriasis , Sulfonamide allergy as known allergies: Sulpha. Facility where the most recent COVID-19 vaccine was administered as Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient received other medications within 2 weeks of vaccination as Finasteride, Atorvastatin, Acitretin. Concomitant medication(s) included finasteride (FINASTERIDE); atorvastatin (ATORVASTATIN); acitretin (ACITRETIN). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19. On 08Sep2021, the patient experienced return occurrence of parsonage-turner syndrom affecting left arm/back/neck-hand and first two digits. On 08Sep2021 the patient experienced swollen and painful left lymph node. On 25Aug2021 10:45 the patient experienced receiving 3rd dose of vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Aug2021. Therapeutic measures were taken as Steroids, gabapentin as a result of return occurrence of parsonage-turner syndrom affecting left arm/back/neck-hand and first two digits, swollen and painful left lymph node. The outcome of event receiving 3rd dose of vaccine was unknown. The outcome of rest all event was not recovered.  Follow-up (22Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nosebleed; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patient. This is one of 2 reports.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162b2 on an unknown date for Covid-19 immunisation. The patient experienced nosebleed on an unspecified date. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101236195 Same reporter/drug/event for different patients
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Immunisation, Off label use
Clinical narrative: had side effects from third Pfizer COVID Vaccine lasted 3 days; had side effects from third Pfizer COVID Vaccine lasted 3 days; had side effects from third Pfizer COVID Vaccine lasted 3 days; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 and dose 2 via an unspecified route of administration on an unspecified date for covid-19 immunisation. The patient reported had side effects from third Pfizer COVID Vaccine lasted 3 days and this was immune response to vaccine. No additional details provided. No additional information was provided.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Investigation, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: swelling/pain in hands; swelling/pain in hands; also limits her mobility; occasional bruising; had some weight gain; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 03Sep2021 (at the age of 55-years-old) at dose 2, single for COVID-19 immunization. Ongoing medical history included rheumatoid arthritis, fibromyalgia. Concomitant medication included tofacitinib citrate (XELJANZ XR). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunization. Patient hasn't taken her Xeljanz since 03Sep2021 as she got her second COVID vaccine dose. She had some swelling/pain in hands that caused her to not hold things as well and that also limited her mobility in sep2021. She also has occasional bruising, and has had some weight gain in sep2021. She stated that her MD ran tests and determined all of her symptoms are from her rheumatoid arthritis and fibromyalgia. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight increased
Clinical narrative: swelling/pain in hands; swelling/pain in hands; also limits her mobility; occasional bruising; had some weight gain; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 03Sep2021 (at the age of 55-years-old) at dose 2, single for COVID-19 immunization. Ongoing medical history included rheumatoid arthritis, fibromyalgia. Concomitant medication included tofacitinib citrate (XELJANZ XR). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunization. Patient hasn't taken her Xeljanz since 03Sep2021 as she got her second COVID vaccine dose. She had some swelling/pain in hands that caused her to not hold things as well and that also limited her mobility in sep2021. She also has occasional bruising, and has had some weight gain in sep2021. She stated that her MD ran tests and determined all of her symptoms are from her rheumatoid arthritis and fibromyalgia. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: I received the COVID booster yesterday; I received the COVID booster yesterday; Slept a lot; This is a spontaneous report from a contactable other hcp.     A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 3 via an unspecified route of administration on 19Sep2021 (Batch/Lot number was not reported) as dose 3, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Patient previously took first dose and second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection) Covid-19 vaccine via an unspecified route of administration, administered unknown(Batch/Lot Number was unknown) as single dose for covid-19 immunisation.It was Reported that, on 19Sep2021 received the COVID booster yesterday, and have slept a lot, 12 hours last night no other reportable symptoms. This is unusual for me. This is just in case this is a result in which you may be interested, am avoiding driving anywhere today. On an unspecified date the outcome of the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Immunisation, Musculoskeletal discomfort
Clinical narrative: I think the person had covid at the time; 6 months after the 2nd dose he then got a booster/3rd shot; 6 months after the 2nd dose he then got a booster/3rd shot; 102F fever; developed lumps on their neck; very tender and sore; left side back neck. Uncomfortable; hard time moving their head right and left; extremely tired; weak; developed lumps lymph node lumps same side as injection; tender and sore; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccination 42-years-old), as a single dose for COVID-19 immunization. The patient medical history included toxoplasmosis, and mononucleosis. The patient concomitant medications were not reported. Patient previously received first dose of BNT162B2 vaccine, via an unspecified route of administration on an unspecified date (age at the time of vaccination 42-years-old), as a single dose for COVID-19 immunization; and second dose of BNT162B2 vaccine, via an unspecified route of administration on an unspecified date (age at the time of vaccination 42-years-old), as a single dose for COVID-19 immunization and experienced fever, achy, extremely tired. On an unspecified date, the patient experienced I think the person had covid at the time, 6 months after the 2nd dose he then got a booster/3rd shot, 102F fever, developed lumps on their neck; very tender and sore, left side back neck Uncomfortable, hard time moving their head right and left, extremely tired, weak, and developed lumps lymph node lumps same side as injection; tender and sore. On an unspecified date, the patient underwent lab tests and procedures which included Body temperature: 102 Fahrenheit, fever went down to 99.7 in about 3 days. Patient was put on an Amoxil treatment and then fever went down to 99.7 in 3 days. Patient saw a doctor who had no clue and put him on antibiotics. The outcome of the event 102F fever was recovering; and for all the events was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Off label use, Pyrexia, Suspected COVID-19
Clinical narrative: I think the person had covid at the time; 6 months after the 2nd dose he then got a booster/3rd shot; 6 months after the 2nd dose he then got a booster/3rd shot; 102F fever; developed lumps on their neck; very tender and sore; left side back neck. Uncomfortable; hard time moving their head right and left; extremely tired; weak; developed lumps lymph node lumps same side as injection; tender and sore; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccination 42-years-old), as a single dose for COVID-19 immunization. The patient medical history included toxoplasmosis, and mononucleosis. The patient concomitant medications were not reported. Patient previously received first dose of BNT162B2 vaccine, via an unspecified route of administration on an unspecified date (age at the time of vaccination 42-years-old), as a single dose for COVID-19 immunization; and second dose of BNT162B2 vaccine, via an unspecified route of administration on an unspecified date (age at the time of vaccination 42-years-old), as a single dose for COVID-19 immunization and experienced fever, achy, extremely tired. On an unspecified date, the patient experienced I think the person had covid at the time, 6 months after the 2nd dose he then got a booster/3rd shot, 102F fever, developed lumps on their neck; very tender and sore, left side back neck Uncomfortable, hard time moving their head right and left, extremely tired, weak, and developed lumps lymph node lumps same side as injection; tender and sore. On an unspecified date, the patient underwent lab tests and procedures which included Body temperature: 102 Fahrenheit, fever went down to 99.7 in about 3 days. Patient was put on an Amoxil treatment and then fever went down to 99.7 in 3 days. Patient saw a doctor who had no clue and put him on antibiotics. The outcome of the event 102F fever was recovering; and for all the events was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up