chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gastrointestinal disorder, Headache, Influenza like illness, Muscle fatigue
Clinical narrative: Flu-like symptoms; Headache; Weakness; Fever; Muscle fatigue; leg shakiness; GI symptoms; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EK5730 and expiry date unknown), intramuscularly in left upper arm on 28Dec2020 at 09:20 as a single dose for COVID-19 immunisation. Medical history included a recurring history of croup since she was very young, with her last croup diagnosis during christmas of 2018. Concomitant medications included Vitamin D (Nature Made Vitamin D 2000iu, Formulation: soft gel, Lot Number: 2404901, and Expiration Date: Oct2023) 2 doses daily. The patient did not receive any other vaccines within four weeks prior to the vaccination and no vaccines were administered on the same day of vaccination. The patient received flu vaccine in mid-Nov2020. On 28Dec2020, the patient experienced Injection site pain and on 30Dec2020, flu-like symptoms felt like the flu minus vomiting, headache, GI symptoms, weakness, fever, muscle fatigue, leg shakiness. Reported she had an issue after she received her first dose of the COVID-19 Vaccine. She said she had immediate injection site pain. She said the injection site pain was not bad, but the pain was constant, and by the second day the injection site pain had faded. Reported 2 days after receiving her first COVID-19 Vaccine dose she developed flu-like symptoms. She said she had weakness that lasted 3 days. She said she also had a headache, GI symptoms. She clarified her flu-like symptoms felt like the flu minus vomiting. She said she had a fever, muscle fatigue, and leg shakiness, as well, before she moved into the recovery period on 01Jan2021. She said by 02Jan2021 or 03Jan2021, she had recovered completely, and she had no more symptoms, or fatigue, or weakness. The events did not result in emergency room or physician office. No investigations were done. Therapeutic measures were taken with 2 Ibuprofen 200mg tablets, twice a day, for 2 days and had continued as normal taking Vitamin D (Nature Made Vitamin D 2000iu, Lot Number: 2404901, Expiration Date: Oct2023). Outcome of Injection site pain was reported as resolved on 30Dec2020, and all other events were reported as resolved on an unspecified date in Jan2021.      Follow-up attempts are completed. No further information is expected. .
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor, Vaccination site pain
Clinical narrative: Flu-like symptoms; Headache; Weakness; Fever; Muscle fatigue; leg shakiness; GI symptoms; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EK5730 and expiry date unknown), intramuscularly in left upper arm on 28Dec2020 at 09:20 as a single dose for COVID-19 immunisation. Medical history included a recurring history of croup since she was very young, with her last croup diagnosis during christmas of 2018. Concomitant medications included Vitamin D (Nature Made Vitamin D 2000iu, Formulation: soft gel, Lot Number: 2404901, and Expiration Date: Oct2023) 2 doses daily. The patient did not receive any other vaccines within four weeks prior to the vaccination and no vaccines were administered on the same day of vaccination. The patient received flu vaccine in mid-Nov2020. On 28Dec2020, the patient experienced Injection site pain and on 30Dec2020, flu-like symptoms felt like the flu minus vomiting, headache, GI symptoms, weakness, fever, muscle fatigue, leg shakiness. Reported she had an issue after she received her first dose of the COVID-19 Vaccine. She said she had immediate injection site pain. She said the injection site pain was not bad, but the pain was constant, and by the second day the injection site pain had faded. Reported 2 days after receiving her first COVID-19 Vaccine dose she developed flu-like symptoms. She said she had weakness that lasted 3 days. She said she also had a headache, GI symptoms. She clarified her flu-like symptoms felt like the flu minus vomiting. She said she had a fever, muscle fatigue, and leg shakiness, as well, before she moved into the recovery period on 01Jan2021. She said by 02Jan2021 or 03Jan2021, she had recovered completely, and she had no more symptoms, or fatigue, or weakness. The events did not result in emergency room or physician office. No investigations were done. Therapeutic measures were taken with 2 Ibuprofen 200mg tablets, twice a day, for 2 days and had continued as normal taking Vitamin D (Nature Made Vitamin D 2000iu, Lot Number: 2404901, Expiration Date: Oct2023). Outcome of Injection site pain was reported as resolved on 30Dec2020, and all other events were reported as resolved on an unspecified date in Jan2021.      Follow-up attempts are completed. No further information is expected. .
Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body height, Body height decreased, Dizziness, Feeling abnormal, Headache
Clinical narrative: Headache; Shrunk; Weight gain; Not feeling that great; Dizziness; Felt weird when went for walk; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3249, expiration date: 31May2021) via unknown route of administration in right upper arm on 21Jan2021 at 11:00, at a dose of 0.3mL as a single dose for Covid-19 immunization in Hospital and received new refill of Mycophenolate mofetil, which is an immunosuppressant at a dose of 250mg, 2 capsules by mouth two times daily for focal segmental glomerulosclerosis on the same day (21Jan2021). Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes and obesity), kidney problem and focal segmental glomerulosclerosis. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jan2021, the patient experienced the dizziness, that started 10 days after the first dose of the vaccine and on the new refill of Mycophenolate mofetil and patient felt weird when she went for walk. On 01Feb2021, the patient was not feeling that great. Last Saturday (30Jan2021) and again today she felt some dizziness, felt weird, but did not think it can be blamed on the vaccine, or did that happen. She enquired whether that could also interact with the vaccine and had zero reactions until last Saturday. So, she wanted to check with Pfizer first and then with her kidney doctor. At that time, she was dizzy and could not shake it all that morning lone. Patient was on Mycophenolate mofetil for 2-3 years and it was a refill she just started on. With the timing right then with the dizziness wonders if related to the new batch she started that day. Unable to provide the NDC, Lot, or expiry for the Mycophenolate mofetil, but provided a discard date of 19Jan2022 from the white manufacture bottle and mentions (name) label over bottle. Mentioned that she does not take product as read on bottle it has been changed after discussion with the provider. Was using this prescription 2 in the morning and 1 at night and since she has been having the dizziness, she has switched to taking it 1 in the morning and 2 at night. Did read on the instructions that this can cause dizziness, but she had taken this stuff for over 3 years and was trying to figure out if it's a bad batch or not. On an unspecified date, the patient experienced headache and thinks she was shrunk and may have gained some weight. The outcome for the events dizziness, felt weird when went for walk, not feeling that great was not recovered and for headache, was shrunk and may have gained some weight was unknown.  Information about lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise, Weight, Weight increased
Clinical narrative: Headache; Shrunk; Weight gain; Not feeling that great; Dizziness; Felt weird when went for walk; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3249, expiration date: 31May2021) via unknown route of administration in right upper arm on 21Jan2021 at 11:00, at a dose of 0.3mL as a single dose for Covid-19 immunization in Hospital and received new refill of Mycophenolate mofetil, which is an immunosuppressant at a dose of 250mg, 2 capsules by mouth two times daily for focal segmental glomerulosclerosis on the same day (21Jan2021). Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes and obesity), kidney problem and focal segmental glomerulosclerosis. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jan2021, the patient experienced the dizziness, that started 10 days after the first dose of the vaccine and on the new refill of Mycophenolate mofetil and patient felt weird when she went for walk. On 01Feb2021, the patient was not feeling that great. Last Saturday (30Jan2021) and again today she felt some dizziness, felt weird, but did not think it can be blamed on the vaccine, or did that happen. She enquired whether that could also interact with the vaccine and had zero reactions until last Saturday. So, she wanted to check with Pfizer first and then with her kidney doctor. At that time, she was dizzy and could not shake it all that morning lone. Patient was on Mycophenolate mofetil for 2-3 years and it was a refill she just started on. With the timing right then with the dizziness wonders if related to the new batch she started that day. Unable to provide the NDC, Lot, or expiry for the Mycophenolate mofetil, but provided a discard date of 19Jan2022 from the white manufacture bottle and mentions (name) label over bottle. Mentioned that she does not take product as read on bottle it has been changed after discussion with the provider. Was using this prescription 2 in the morning and 1 at night and since she has been having the dizziness, she has switched to taking it 1 in the morning and 2 at night. Did read on the instructions that this can cause dizziness, but she had taken this stuff for over 3 years and was trying to figure out if it's a bad batch or not. On an unspecified date, the patient experienced headache and thinks she was shrunk and may have gained some weight. The outcome for the events dizziness, felt weird when went for walk, not feeling that great was not recovered and for headache, was shrunk and may have gained some weight was unknown.  Information about lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm was sore; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9810 and expiration date was not reported), intramuscular on arm left on 06Feb2021 at 11:00 as single dose for Preventative (COVID-19 immunization) in hospital. The patient medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not administer additional vaccines on same date of suspect vaccine. No relevant tests were reported. It was reported that she got first shot of COVID vaccine on 06Feb2021 (Saturday). She was fine, she just had a sore in left arm Saturday night (06Feb2021). She was due to get the first shot on Tuesday 02Feb2021 but due to the snowstorm she had to get the shot on Saturday instead. The appointment for her second shot was scheduled for 23Feb2021, stated this was four days before the 21-day guidance and she inquired if this was ok. She stated that it was just like getting a flu shot, she occasionally got a sore arm for a couple of hours. She had been getting one for 24 years. She did not have the name or lot number for the flu shot she had received. She declined for any treatment of the event. She did not visit emergency room or physician office. The outcome of the event left arm was sore was resolved on 06Feb2021.
Sex: M
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: he has had a "toe problem for a while now"; This is a spontaneous report from a Pfizer-sponsored program from contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via unspecified route of administration, on 05Feb2021 (reported as last Friday) as a single dose for COVID-19 Immunisation. Patient's medical history and concomitant medications were not reported. Patient reported that he had a "toe problem for a while now'' in Feb2021 and planned to see his doctor about it who may or may not prescribe antibiotics. He inquired if it is ok if he takes an antibiotic if one is prescribed. The patient stated about toe problem that ''this is not due to the vaccine''. Outcome of the event was reported as unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on information given in the narrative, the reporter has denied the causality by stating that toe problem is not due to the vaccine. Hence the event is considered not related to the suspect vaccine.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: daily recurring headache; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Lot number: ENS318, Expiration date was not reported) via unspecified route of administration 28Jan2021 10:45 right arm as single dose for covid-19 immunisation. The patient medical history included CAD, asthma, high blood pressure and high cholesterol. The patient concomitant medication included valsartan (VALSAR) at 160 mg, atorvastatin at 40 mg and metoprolol at 75 mg. Patient did not have Covid prior vaccination. Patient did not test Covid post vaccination. The patient experienced daily recurring headache on 28Jan2021. Patient did not receive any treatment for adverse event. The outcome of the event was not recovered.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Arthralgia, Body temperature, Chills, Headache
Clinical narrative: had a bad headache; stomach was queezy; chills; temp was 100.5F then up to 101.8F; joints ached knees and toes ached; had headache and some aches; I've never been so sick in my life/I was dry heaving all night; This is a spontaneous report from a contactable consumer. Follow up (15Apr2021) received in response to an outbound call requesting a mailing address was processed together along with initial information.   A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 06Feb2021 at 11am at single dose for COVID-19 immunization. The patient medical history included COVID-19 twice an unspecified date (70days before), pneumonia and lung problems from an unspecified date. The patient Concomitant medications were not reported. On 06Feb2021 at 8pm, the patient's stomach was queezy, body ache all over, chills, temp was 100.5F further raised to 101.8F and joints ache knees and toes ache also had bad headache, and he was dry heaving all night. He was never been so sick in his life. On Sunday temp 100.6F-101.8F, felt miserable Monday morning had headache and some aches, temp. was 100F and he took a nap after when woke up at 4pm felt fine, so for 44hours". He added "he know 50 teachers who had the vaccine, and they say they had high temp. 100F and they felt tired, some had body ached and headache, but no one had anything like he had. The lab test included body temperature, results: 100F. He was told and wanted to know, that if had covid before patient react more severely to the 1st dose of the vaccine and will be milder for 2nd dose. He also further wanted to know if he could take second dose. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Illness, Pain, Pyrexia
Clinical narrative: had a bad headache; stomach was queezy; chills; temp was 100.5F then up to 101.8F; joints ached knees and toes ached; had headache and some aches; I've never been so sick in my life/I was dry heaving all night; This is a spontaneous report from a contactable consumer. Follow up (15Apr2021) received in response to an outbound call requesting a mailing address was processed together along with initial information.   A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 06Feb2021 at 11am at single dose for COVID-19 immunization. The patient medical history included COVID-19 twice an unspecified date (70days before), pneumonia and lung problems from an unspecified date. The patient Concomitant medications were not reported. On 06Feb2021 at 8pm, the patient's stomach was queezy, body ache all over, chills, temp was 100.5F further raised to 101.8F and joints ache knees and toes ache also had bad headache, and he was dry heaving all night. He was never been so sick in his life. On Sunday temp 100.6F-101.8F, felt miserable Monday morning had headache and some aches, temp. was 100F and he took a nap after when woke up at 4pm felt fine, so for 44hours". He added "he know 50 teachers who had the vaccine, and they say they had high temp. 100F and they felt tired, some had body ached and headache, but no one had anything like he had. The lab test included body temperature, results: 100F. He was told and wanted to know, that if had covid before patient react more severely to the 1st dose of the vaccine and will be milder for 2nd dose. He also further wanted to know if he could take second dose. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Condition aggravated, Feeling abnormal
Clinical narrative: had a bad headache; stomach was queezy; chills; temp was 100.5F then up to 101.8F; joints ached knees and toes ached; had headache and some aches; I've never been so sick in my life/I was dry heaving all night; This is a spontaneous report from a contactable consumer. Follow up (15Apr2021) received in response to an outbound call requesting a mailing address was processed together along with initial information.   A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 06Feb2021 at 11am at single dose for COVID-19 immunization. The patient medical history included COVID-19 twice an unspecified date (70days before), pneumonia and lung problems from an unspecified date. The patient Concomitant medications were not reported. On 06Feb2021 at 8pm, the patient's stomach was queezy, body ache all over, chills, temp was 100.5F further raised to 101.8F and joints ache knees and toes ache also had bad headache, and he was dry heaving all night. He was never been so sick in his life. On Sunday temp 100.6F-101.8F, felt miserable Monday morning had headache and some aches, temp. was 100F and he took a nap after when woke up at 4pm felt fine, so for 44hours". He added "he know 50 teachers who had the vaccine, and they say they had high temp. 100F and they felt tired, some had body ached and headache, but no one had anything like he had. The lab test included body temperature, results: 100F. He was told and wanted to know, that if had covid before patient react more severely to the 1st dose of the vaccine and will be milder for 2nd dose. He also further wanted to know if he could take second dose. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Illness, Influenza like illness, Nausea, Pain
Clinical narrative: had a bad headache; stomach was queezy; chills; temp was 100.5F then up to 101.8F; joints ached knees and toes ached; had headache and some aches; I've never been so sick in my life/I was dry heaving all night; This is a spontaneous report from a contactable consumer. Follow up (15Apr2021) received in response to an outbound call requesting a mailing address was processed together along with initial information.   A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 06Feb2021 at 11am at single dose for COVID-19 immunization. The patient medical history included COVID-19 twice an unspecified date (70days before), pneumonia and lung problems from an unspecified date. The patient Concomitant medications were not reported. On 06Feb2021 at 8pm, the patient's stomach was queezy, body ache all over, chills, temp was 100.5F further raised to 101.8F and joints ache knees and toes ache also had bad headache, and he was dry heaving all night. He was never been so sick in his life. On Sunday temp 100.6F-101.8F, felt miserable Monday morning had headache and some aches, temp. was 100F and he took a nap after when woke up at 4pm felt fine, so for 44hours". He added "he know 50 teachers who had the vaccine, and they say they had high temp. 100F and they felt tired, some had body ached and headache, but no one had anything like he had. The lab test included body temperature, results: 100F. He was told and wanted to know, that if had covid before patient react more severely to the 1st dose of the vaccine and will be milder for 2nd dose. He also further wanted to know if he could take second dose. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Retching
Clinical narrative: had a bad headache; stomach was queezy; chills; temp was 100.5F then up to 101.8F; joints ached knees and toes ached; had headache and some aches; I've never been so sick in my life/I was dry heaving all night; This is a spontaneous report from a contactable consumer. Follow up (15Apr2021) received in response to an outbound call requesting a mailing address was processed together along with initial information.   A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 06Feb2021 at 11am at single dose for COVID-19 immunization. The patient medical history included COVID-19 twice an unspecified date (70days before), pneumonia and lung problems from an unspecified date. The patient Concomitant medications were not reported. On 06Feb2021 at 8pm, the patient's stomach was queezy, body ache all over, chills, temp was 100.5F further raised to 101.8F and joints ache knees and toes ache also had bad headache, and he was dry heaving all night. He was never been so sick in his life. On Sunday temp 100.6F-101.8F, felt miserable Monday morning had headache and some aches, temp. was 100F and he took a nap after when woke up at 4pm felt fine, so for 44hours". He added "he know 50 teachers who had the vaccine, and they say they had high temp. 100F and they felt tired, some had body ached and headache, but no one had anything like he had. The lab test included body temperature, results: 100F. He was told and wanted to know, that if had covid before patient react more severely to the 1st dose of the vaccine and will be milder for 2nd dose. He also further wanted to know if he could take second dose. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Computerised tomogram, Headache, Influenza, Nausea
Clinical narrative: had a bad headache; stomach was queezy; chills; temp was 100.5F then up to 101.8F; joints ached knees and toes ached; had headache and some aches; I've never been so sick in my life/I was dry heaving all night; This is a spontaneous report from a contactable consumer. Follow up (15Apr2021) received in response to an outbound call requesting a mailing address was processed together along with initial information.   A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 06Feb2021 at 11am at single dose for COVID-19 immunization. The patient medical history included COVID-19 twice an unspecified date (70days before), pneumonia and lung problems from an unspecified date. The patient Concomitant medications were not reported. On 06Feb2021 at 8pm, the patient's stomach was queezy, body ache all over, chills, temp was 100.5F further raised to 101.8F and joints ache knees and toes ache also had bad headache, and he was dry heaving all night. He was never been so sick in his life. On Sunday temp 100.6F-101.8F, felt miserable Monday morning had headache and some aches, temp. was 100F and he took a nap after when woke up at 4pm felt fine, so for 44hours". He added "he know 50 teachers who had the vaccine, and they say they had high temp. 100F and they felt tired, some had body ached and headache, but no one had anything like he had. The lab test included body temperature, results: 100F. He was told and wanted to know, that if had covid before patient react more severely to the 1st dose of the vaccine and will be milder for 2nd dose. He also further wanted to know if he could take second dose. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: had a bad headache; stomach was queezy; chills; temp was 100.5F then up to 101.8F; joints ached knees and toes ached; had headache and some aches; I've never been so sick in my life/I was dry heaving all night; This is a spontaneous report from a contactable consumer. Follow up (15Apr2021) received in response to an outbound call requesting a mailing address was processed together along with initial information.   A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 06Feb2021 at 11am at single dose for COVID-19 immunization. The patient medical history included COVID-19 twice an unspecified date (70days before), pneumonia and lung problems from an unspecified date. The patient Concomitant medications were not reported. On 06Feb2021 at 8pm, the patient's stomach was queezy, body ache all over, chills, temp was 100.5F further raised to 101.8F and joints ache knees and toes ache also had bad headache, and he was dry heaving all night. He was never been so sick in his life. On Sunday temp 100.6F-101.8F, felt miserable Monday morning had headache and some aches, temp. was 100F and he took a nap after when woke up at 4pm felt fine, so for 44hours". He added "he know 50 teachers who had the vaccine, and they say they had high temp. 100F and they felt tired, some had body ached and headache, but no one had anything like he had. The lab test included body temperature, results: 100F. He was told and wanted to know, that if had covid before patient react more severely to the 1st dose of the vaccine and will be milder for 2nd dose. He also further wanted to know if he could take second dose. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Muscle disorder, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: feeling like she had no strength in her upper body as if she were about to collapse; muscle weakness; have felt a little weak; muscles were being lost in the top of her, it stopped before got to legs; left side of neck sore; arm sore; arm soreness and  neck stiffness; This is a spontaneous report from a contactable consumer (Patient). A 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 as single dose for covid-19 immunisation. Medical history included Left Hip Replacement from 17Dec2019 to an unknown date (she did experience a loss of feeling in her legs, and one time she even had a fall from it, like her legs did not hold her up). The patient's concomitant medications were not reported. The patient previously took enoxaparin sodium started the product on 20Dec2019 and stopped it on 27Dec2019, even though she was supposed to take it for 14 days. Patient got the first shot of vaccine on 06Feb2021 and her only side effects were that her arm was sore which present till 09Feb 2021, and her left side of her neck was sore from 07Feb2021 to 09Feb 2021. On 09Feb2021, she was at her kitchen sink and it was like her muscles were being lost, in the top of her, but it stopped before it got to her legs, and then she felt okay. she had not experienced that again, but on 10Feb2021, she has felt a little week. Caller is wondering if that could have been a side effect of the vaccine. Patient stated that, she was taller but she thinks she is now between 4' 11 and 5 foot. She got the vaccine in her left arm, and it was her left arm that was sore. she had no other vaccines on the same day as the COVID vaccine. Patient stated that after her hip replacement, she did experience a loss of feeling in her legs, and one time she even had a fall from it, like her legs did not hold her up. Patient stated that the fall occurred four days after starting a blood thinning medicine called Enoxaparin and once she stopped that medicine, she got to feeling better. she read somewhere that the COVID shot was given in the muscle, and that was why she thought the COVID shot might be related to her feeling like she was losing her muscles in her top half last night. The outcome of the event arm soreness, neck stiffness, left side of neck sore and muscles were being lost in the top of her, it stopped before got to legs was recovered and for other it was unknown.      Information on the lot/batch number has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: feeling like she had no strength in her upper body as if she were about to collapse; muscle weakness; have felt a little weak; muscles were being lost in the top of her, it stopped before got to legs; left side of neck sore; arm sore; arm soreness and  neck stiffness; This is a spontaneous report from a contactable consumer (Patient). A 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 as single dose for covid-19 immunisation. Medical history included Left Hip Replacement from 17Dec2019 to an unknown date (she did experience a loss of feeling in her legs, and one time she even had a fall from it, like her legs did not hold her up). The patient's concomitant medications were not reported. The patient previously took enoxaparin sodium started the product on 20Dec2019 and stopped it on 27Dec2019, even though she was supposed to take it for 14 days. Patient got the first shot of vaccine on 06Feb2021 and her only side effects were that her arm was sore which present till 09Feb 2021, and her left side of her neck was sore from 07Feb2021 to 09Feb 2021. On 09Feb2021, she was at her kitchen sink and it was like her muscles were being lost, in the top of her, but it stopped before it got to her legs, and then she felt okay. she had not experienced that again, but on 10Feb2021, she has felt a little week. Caller is wondering if that could have been a side effect of the vaccine. Patient stated that, she was taller but she thinks she is now between 4' 11 and 5 foot. She got the vaccine in her left arm, and it was her left arm that was sore. she had no other vaccines on the same day as the COVID vaccine. Patient stated that after her hip replacement, she did experience a loss of feeling in her legs, and one time she even had a fall from it, like her legs did not hold her up. Patient stated that the fall occurred four days after starting a blood thinning medicine called Enoxaparin and once she stopped that medicine, she got to feeling better. she read somewhere that the COVID shot was given in the muscle, and that was why she thought the COVID shot might be related to her feeling like she was losing her muscles in her top half last night. The outcome of the event arm soreness, neck stiffness, left side of neck sore and muscles were being lost in the top of her, it stopped before got to legs was recovered and for other it was unknown.      Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Myalgia, Tremor
Clinical narrative: sore muscles, especially lower back; some shakes and/or chills; some shakes and/or chills; sore muscles, especially lower back; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in in Arm left on 09Feb2021 14:30 (Batch was not reported /Lot number 2192050) (at the age of 76-years-old) as single dose for covid-19 immunisation. Medical history included breast cancer from an unspecified date in 2016, penicillin allergy and sulphate allergy. Concomitant medications included multi vitamin (unspecified), acetylsalicylic acid (ASPIRINE) and anastrozole. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date, administered in arm left (Batch/Lot number was not reported) for covid-19 immunisation. On 10Feb2021 14:00, the patient experienced some shakes and/or chills, sore muscles, especially lower back. No treatment was given for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: flu like symptoms (chills, headache and tiredness); flu like symptoms (chills, headache and tiredness); flu like symptoms (chills, headache and tiredness); flu like symptoms (chills, headache and tiredness); Dose number: 1; Administration date: 26Jan2021/ Dose number: 2; Administration date: 09Feb2021; Dose number: 1; Administration date: 26Jan2021/ Dose number: 2; Administration date: 09Feb2021; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via unknown route of administration on 09Feb2021 at 09:30 AM as a single dose in the left arm for covid-19 immunisation at Workplace clinic. The patient medical history was not reported. No covid prior vaccination. The patient was not pregnant at the time of vaccination. There were no known allergies. No other vaccine in four weeks. Concomitant medications were reported as none. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 26Jan2021 at 09:30 AM in left arm for covid-19 immunisation. On 09Feb2021 at approximately 09:00 PM, the patient experienced flu like symptoms which included chills, headache and tiredness. The patient did not receive any treatment for the events. No covid tested post vaccination. The outcome of events inappropriate schedule of vaccine administered and off label use was unknown, while for other events was recovered on 10Feb2021 (reported as the next day) at around 5pm.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: flu like symptoms (chills, headache and tiredness); flu like symptoms (chills, headache and tiredness); flu like symptoms (chills, headache and tiredness); flu like symptoms (chills, headache and tiredness); Dose number: 1; Administration date: 26Jan2021/ Dose number: 2; Administration date: 09Feb2021; Dose number: 1; Administration date: 26Jan2021/ Dose number: 2; Administration date: 09Feb2021; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via unknown route of administration on 09Feb2021 at 09:30 AM as a single dose in the left arm for covid-19 immunisation at Workplace clinic. The patient medical history was not reported. No covid prior vaccination. The patient was not pregnant at the time of vaccination. There were no known allergies. No other vaccine in four weeks. Concomitant medications were reported as none. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 26Jan2021 at 09:30 AM in left arm for covid-19 immunisation. On 09Feb2021 at approximately 09:00 PM, the patient experienced flu like symptoms which included chills, headache and tiredness. The patient did not receive any treatment for the events. No covid tested post vaccination. The outcome of events inappropriate schedule of vaccine administered and off label use was unknown, while for other events was recovered on 10Feb2021 (reported as the next day) at around 5pm.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Little pain in her arm.; This is a spontaneous report received from a Pfizer sponsored program. A contactable female consumer (patient) of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 09Feb2021 as single dose for COVID-19 immunization. Patient previously took Celebrex (discontinued taking her daily Celebrex for two days before her vaccine). The concomitant medications were not reported. Patient stated that she received her 1st COVID vaccine last 09Feb2021 and she said she was advised not to take celebrex. She asked if this would affect the efficacy of our vaccine. She also felt a little pain in her arm. Patient asked can she take her celebrex around her vaccination or is this recommendation the same for the second dose.The outcome of the event pain in her arm was unknown.  Information about batch/lot number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Back pain, Chills, Flank pain
Clinical narrative: limited ROM to my left side of the neck; chills; fevers; severe headaches; muscle and joint pain; muscle and joint pain; numbness in my left arm; back pain; nausea; flank pain; abdominal pain; This is a spontaneous report from a contactable nurse, the patient. A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 16:45 (Batch/Lot Number: EL3249) (at the age of 38-years old) as single dose for covid-19 immunisation. Medical history included allergies to latex. No concomitant medications were reported (within 2 weeks of vaccination). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 (Batch/Lot Number: EL1283) within 4 weeks prior to the second dose, for covid-19 immunisation (at age 38-years old). Prior to vaccination the patient was not diagnosed with COVID-19. The patient reported that with her second dose on 11Feb2021 at 03:00 she started experiencing chills, fevers, severe headaches, muscle and joint pain, numbness in my left arm, back pain, limited ROM (range of motion) to my left side of the neck, nausea, flank pain and abdominal pain. The patient underwent lab test and procedure which included nasal swab test on an unknow date in 2021 and the result was negative. Therapeutic measures taken as a result of events and included treatment with ibuprofen. The outcome of all the events were reported as not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Joint range of motion decreased, Myalgia, Nausea
Clinical narrative: limited ROM to my left side of the neck; chills; fevers; severe headaches; muscle and joint pain; muscle and joint pain; numbness in my left arm; back pain; nausea; flank pain; abdominal pain; This is a spontaneous report from a contactable nurse, the patient. A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 16:45 (Batch/Lot Number: EL3249) (at the age of 38-years old) as single dose for covid-19 immunisation. Medical history included allergies to latex. No concomitant medications were reported (within 2 weeks of vaccination). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 (Batch/Lot Number: EL1283) within 4 weeks prior to the second dose, for covid-19 immunisation (at age 38-years old). Prior to vaccination the patient was not diagnosed with COVID-19. The patient reported that with her second dose on 11Feb2021 at 03:00 she started experiencing chills, fevers, severe headaches, muscle and joint pain, numbness in my left arm, back pain, limited ROM (range of motion) to my left side of the neck, nausea, flank pain and abdominal pain. The patient underwent lab test and procedure which included nasal swab test on an unknow date in 2021 and the result was negative. Therapeutic measures taken as a result of events and included treatment with ibuprofen. The outcome of all the events were reported as not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: limited ROM to my left side of the neck; chills; fevers; severe headaches; muscle and joint pain; muscle and joint pain; numbness in my left arm; back pain; nausea; flank pain; abdominal pain; This is a spontaneous report from a contactable nurse, the patient. A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 16:45 (Batch/Lot Number: EL3249) (at the age of 38-years old) as single dose for covid-19 immunisation. Medical history included allergies to latex. No concomitant medications were reported (within 2 weeks of vaccination). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 (Batch/Lot Number: EL1283) within 4 weeks prior to the second dose, for covid-19 immunisation (at age 38-years old). Prior to vaccination the patient was not diagnosed with COVID-19. The patient reported that with her second dose on 11Feb2021 at 03:00 she started experiencing chills, fevers, severe headaches, muscle and joint pain, numbness in my left arm, back pain, limited ROM (range of motion) to my left side of the neck, nausea, flank pain and abdominal pain. The patient underwent lab test and procedure which included nasal swab test on an unknow date in 2021 and the result was negative. Therapeutic measures taken as a result of events and included treatment with ibuprofen. The outcome of all the events were reported as not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling, Vaccination site pain
Clinical narrative: swelling starting 8 days later and continuing two weeks; Lymph nodes under arm and near breast, swelling starting; burning in arm immediately after injection; This is a spontaneous report from a contactable consumer (patient). A 66-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9263), via unspecified route of administration on 28Jan2021 at 1:00 PM (at the age of 66-years-old) in left arm at a single dose for covid-19 immunisation. No Other Vaccination within 4 weeks. The patient medical history included hashimoto's disease. The patient had known allergies with morphin based drugs. Concomitant medication patient had in two weeks included thyroid medication. The patient experienced burning in arm immediately after injection. Lymph nodes under arm and near breast, swelling starting 8 days later and continuing two weeks on 04Feb2021 at 08:00 AM. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the events was not recovered. .
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Nasal congestion, Respiratory symptom
Clinical narrative: Patient received her first Covid vaccination not knowing that she was about one month pregnant.; congestion; upper respiratory symptoms; This is a spontaneous report from two contactable Other-HCP (patient). This is a maternal report.  A pregnant female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient received her first Covid vaccination not knowing that she was about one month pregnant. Experienced congestion and upper respiratory symptoms which she is not sure had anything to do with her exposure to the vaccine. She and her provider opted for her not to receive the second dose once she learned she was pregnant. She is doing well with her pregnancy and it is about 12 to 15 weeks along.  The mother reported she became pregnant while taking bnt162b2.  The outcome of the events was unknown.  Information on the lot/batch number has been requested.