chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Feeling abnormal, Headache
Clinical narrative: I had chills, headaches, body aches, arm soreness and fevers up until almost the full 48 hours. My arm is still red, swollen, and warm to touch at injection site. However my main concern is my chest. It began at about 12 hours post vaccine. I felt pressure in my chest and a weird feeling in my throat that brought on a cough. At about 18 hours when I laid down I had this tingling feeling on my tongue that was almost like I had ate something hot and burnt my tongue, but I hadn't.  After 48 hours I thought the feeling was gone. However at night I found myself unable to sleep again because the pressure in my chest when laying down was back. When I attempt to take a deep breath while laying down I have to cough. It is a dry cough. Also, the feeling in my tongue came back again...tingly amost like all my taste buds were tasting something metallic.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pain in extremity
Clinical narrative: I had chills, headaches, body aches, arm soreness and fevers up until almost the full 48 hours. My arm is still red, swollen, and warm to touch at injection site. However my main concern is my chest. It began at about 12 hours post vaccine. I felt pressure in my chest and a weird feeling in my throat that brought on a cough. At about 18 hours when I laid down I had this tingling feeling on my tongue that was almost like I had ate something hot and burnt my tongue, but I hadn't.  After 48 hours I thought the feeling was gone. However at night I found myself unable to sleep again because the pressure in my chest when laying down was back. When I attempt to take a deep breath while laying down I have to cough. It is a dry cough. Also, the feeling in my tongue came back again...tingly amost like all my taste buds were tasting something metallic.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pyrexia, Sleep disorder, Throat irritation, Tongue discomfort
Clinical narrative: I had chills, headaches, body aches, arm soreness and fevers up until almost the full 48 hours. My arm is still red, swollen, and warm to touch at injection site. However my main concern is my chest. It began at about 12 hours post vaccine. I felt pressure in my chest and a weird feeling in my throat that brought on a cough. At about 18 hours when I laid down I had this tingling feeling on my tongue that was almost like I had ate something hot and burnt my tongue, but I hadn't.  After 48 hours I thought the feeling was gone. However at night I found myself unable to sleep again because the pressure in my chest when laying down was back. When I attempt to take a deep breath while laying down I have to cough. It is a dry cough. Also, the feeling in my tongue came back again...tingly amost like all my taste buds were tasting something metallic.
Sex: F
Vaccine: COVID19
Symptoms: Blood count, Blood count abnormal
Clinical narrative: blood count was low; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 77-year-old female patient received COVID-19 vaccine (UNSPECIFIED TRADE NAME) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she received a covid 19 vaccine shot, and her blood count was low. The outcome of the event was unknown.    Information about lot/batch number was requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This is a spontaneous report based on the information received by Pfizer. (Case Number: 01845505). A  non-contactable consumer (Wife) reported 50-year-old male patient that:  Description: Voicemail left on PIR line on 14Jan2021 at 10:29 PM. She learned of from her husband, on the Pfizer COVID-19 vaccine. He had his first vaccine on 13Jan2021 and on 14Jan2021 reported that his arm was sore, "really really sore like he had been punched in the arm". There is not permission to contact the patient about this report. No PQC reported.   Physical information: Product: Pfizer Covid-19 vaccine Product circular#: N/A Lot number: EL3249 Expiration date: Unknown by reporter Dose/ frequency: single dose   No follow-up attempts are possible. No further information expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Feeling hot, Pain in extremity, Peripheral swelling, Vaccination site pain
Clinical narrative: patient arm hurt/very sore; swollen very hard; arm hurt and it was warm; very painful for him to touch where the injection went in; not comfortable; This is a spontaneous report from a contactable consumer (patient wife). An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Jan2021, patient arm hurt, started to feel pain on 22Jan2021 and in the morning his arm was very swollen and very sore. He got up in the middle of the night and he said that his arm was swollen, and it was warm and swollen very hard, and 5 days later, the arm was still hard and warm and it was still very painful for him to touch where the injection went in. Caller was very concerned that this point that 5 days later could the shot gone in and then not gone anywhere just be sitting in that muscle. Patient can't touch it because it hurt too much. It was reported patient was not comfortable. Outcome of events was unknown.
Age: 78.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Pruritus
Clinical narrative: Itchy and red
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for husband.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 10Jan2021 for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced COVID-19 virus test positive on 19Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test positive on 19Jan2021. He was scheduled for the second dose on 31Jan2021.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Arthritis, Diarrhoea, Erythema
Clinical narrative: Stomach pain; Nausea; headache; Joint pain; did not feel good; more tired than usual; redness/arm was red; arm was hurting; arm red with a red bump; diarrhea; she has arthritis and her pain has gotten worse; This is a spontaneous report from a Pfizer-sponsored program.  A nurse aide (consumer or other non hcp) reported for herself that the 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E13302), intramuscular injection in the left arm on 20Jan2021 at single dose for COVID-19 prophylaxis. Medical history included ongoing arthritis from an unknown date. Concomitant medication included duloxetine hydrochloride (CYMBALTA) and ibuprofen for arthritis. The patient got the vaccination on 20Jan2021 and experienced redness, pain and nausea on an unspecified date in Jan2021. She said that that night (on 20Jan2021) and the next morning her arm was hurting and it was red with a red bump. On Thursday (21Jan2021) and Friday (22Jan2021), she felt joint pain, no fever, and did not feel good. The patient experienced more tired and did not feel good on 21Jan2021. The patient experienced headache on 23Jan2021. Saturday (23Jan2021) she was more tired than usual and on Sunday (24Jan2021) she was home and felt completely tired and had stomach pain, joint pain, nausea, headache, but did not have a fever. She was feeling the same today (on 25Jan2021) and worse. The patient said that her arm was not red anymore, but it still had a small bump. Stomach pain comes and goes. She stated that she had some diarrhea, but not much in Jan2021. Her nausea comes and goes as well. She said that it was like you want to throw up, but she had not thrown up. She said that you just know that something was not right. She said that her headache was like a heaviness on top of her head and forehead. She said that it was bothering her but it was not terrible. Next dose is due on 10Feb2021. The patient said that she worked in a facility with elderly people. She said that she has arthritis and her pain has gotten worse in Jan2021. She said that even with the medication. She did not take her medication until Thursday evening to see if she had any effects from the vaccine. She took Ibuprofen 800mg and CYMBALTA for her arthritis. She said that her tiredness had nothing to do with her medications. She said that it was very rare that she even had a headache. The reason that she called was to see if she should she do anything, is it safe for her to go back to work. Event Joint pain, more tired and did not feel good were reported as worsened. The outcome of event arm was red was recovered on an unspecified date in Jan2021. The outcome of events arm was hurting, arm with a red bump, diarrhea was recovering. The outcome of events Joint pain, did not feel good, more tired than usual, Stomach pain, Nausea, headache was not recovered. The outcome of the other events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea, Pain in extremity
Clinical narrative: Stomach pain; Nausea; headache; Joint pain; did not feel good; more tired than usual; redness/arm was red; arm was hurting; arm red with a red bump; diarrhea; she has arthritis and her pain has gotten worse; This is a spontaneous report from a Pfizer-sponsored program.  A nurse aide (consumer or other non hcp) reported for herself that the 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E13302), intramuscular injection in the left arm on 20Jan2021 at single dose for COVID-19 prophylaxis. Medical history included ongoing arthritis from an unknown date. Concomitant medication included duloxetine hydrochloride (CYMBALTA) and ibuprofen for arthritis. The patient got the vaccination on 20Jan2021 and experienced redness, pain and nausea on an unspecified date in Jan2021. She said that that night (on 20Jan2021) and the next morning her arm was hurting and it was red with a red bump. On Thursday (21Jan2021) and Friday (22Jan2021), she felt joint pain, no fever, and did not feel good. The patient experienced more tired and did not feel good on 21Jan2021. The patient experienced headache on 23Jan2021. Saturday (23Jan2021) she was more tired than usual and on Sunday (24Jan2021) she was home and felt completely tired and had stomach pain, joint pain, nausea, headache, but did not have a fever. She was feeling the same today (on 25Jan2021) and worse. The patient said that her arm was not red anymore, but it still had a small bump. Stomach pain comes and goes. She stated that she had some diarrhea, but not much in Jan2021. Her nausea comes and goes as well. She said that it was like you want to throw up, but she had not thrown up. She said that you just know that something was not right. She said that her headache was like a heaviness on top of her head and forehead. She said that it was bothering her but it was not terrible. Next dose is due on 10Feb2021. The patient said that she worked in a facility with elderly people. She said that she has arthritis and her pain has gotten worse in Jan2021. She said that even with the medication. She did not take her medication until Thursday evening to see if she had any effects from the vaccine. She took Ibuprofen 800mg and CYMBALTA for her arthritis. She said that her tiredness had nothing to do with her medications. She said that it was very rare that she even had a headache. The reason that she called was to see if she should she do anything, is it safe for her to go back to work. Event Joint pain, more tired and did not feel good were reported as worsened. The outcome of event arm was red was recovered on an unspecified date in Jan2021. The outcome of events arm was hurting, arm with a red bump, diarrhea was recovering. The outcome of events Joint pain, did not feel good, more tired than usual, Stomach pain, Nausea, headache was not recovered. The outcome of the other events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Stomach pain; Nausea; headache; Joint pain; did not feel good; more tired than usual; redness/arm was red; arm was hurting; arm red with a red bump; diarrhea; she has arthritis and her pain has gotten worse; This is a spontaneous report from a Pfizer-sponsored program.  A nurse aide (consumer or other non hcp) reported for herself that the 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E13302), intramuscular injection in the left arm on 20Jan2021 at single dose for COVID-19 prophylaxis. Medical history included ongoing arthritis from an unknown date. Concomitant medication included duloxetine hydrochloride (CYMBALTA) and ibuprofen for arthritis. The patient got the vaccination on 20Jan2021 and experienced redness, pain and nausea on an unspecified date in Jan2021. She said that that night (on 20Jan2021) and the next morning her arm was hurting and it was red with a red bump. On Thursday (21Jan2021) and Friday (22Jan2021), she felt joint pain, no fever, and did not feel good. The patient experienced more tired and did not feel good on 21Jan2021. The patient experienced headache on 23Jan2021. Saturday (23Jan2021) she was more tired than usual and on Sunday (24Jan2021) she was home and felt completely tired and had stomach pain, joint pain, nausea, headache, but did not have a fever. She was feeling the same today (on 25Jan2021) and worse. The patient said that her arm was not red anymore, but it still had a small bump. Stomach pain comes and goes. She stated that she had some diarrhea, but not much in Jan2021. Her nausea comes and goes as well. She said that it was like you want to throw up, but she had not thrown up. She said that you just know that something was not right. She said that her headache was like a heaviness on top of her head and forehead. She said that it was bothering her but it was not terrible. Next dose is due on 10Feb2021. The patient said that she worked in a facility with elderly people. She said that she has arthritis and her pain has gotten worse in Jan2021. She said that even with the medication. She did not take her medication until Thursday evening to see if she had any effects from the vaccine. She took Ibuprofen 800mg and CYMBALTA for her arthritis. She said that her tiredness had nothing to do with her medications. She said that it was very rare that she even had a headache. The reason that she called was to see if she should she do anything, is it safe for her to go back to work. Event Joint pain, more tired and did not feel good were reported as worsened. The outcome of event arm was red was recovered on an unspecified date in Jan2021. The outcome of events arm was hurting, arm with a red bump, diarrhea was recovering. The outcome of events Joint pain, did not feel good, more tired than usual, Stomach pain, Nausea, headache was not recovered. The outcome of the other events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Generalized body aches began mild and progressively worsened  Generalized joint pain began mild and progressively worsened-most severe in lower back, arms/fingers
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Influenza virus test negative, Malaise, Pain
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program.   A 65-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation. Medical was none. There were no concomitant medications. The patient got covid positive/the covid-19 virus molecular test was positive on an unspecified date with outcome of unknown. On 20Jan2021 the patient started with the first symptoms of got very sick, had terrible body pain, sharp pain and aches, terrible cough, fever and felt completely like physically collapsed. The patient got positive covid-19 virus molecular test on 23Jan2021 with outcome of recovering. On 22Jan2021 the antigen test was negative. On 23Jan2021 the patient had also a negative flu rapid test.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program.   A 65-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation. Medical was none. There were no concomitant medications. The patient got covid positive/the covid-19 virus molecular test was positive on an unspecified date with outcome of unknown. On 20Jan2021 the patient started with the first symptoms of got very sick, had terrible body pain, sharp pain and aches, terrible cough, fever and felt completely like physically collapsed. The patient got positive covid-19 virus molecular test on 23Jan2021 with outcome of recovering. On 22Jan2021 the antigen test was negative. On 23Jan2021 the patient had also a negative flu rapid test.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, COVID-19, Diarrhoea, Malaise, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer Sponsored Program. A contactable male consumer (patient) reported for himself.   A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL3248, exp date 30Apr2021, NDC number of COVID Vaccine: 59267-1000-2, on 07Jan2021 16:56 at 0,3ml single dose for COVID-19 immunization via unspecified route of administration at the left arm. The second dose of vaccine was scheduled on 28Jan2021. The patient medical history included Acid reflux. Concomitant medication included omeprazole for acid reflux, 20mg capsule once a day. Since Jan2021, the patient was violently sick one day, experienced diarrhea, puking and like a rock in his gut he could not get rid of. On 20Jan2021 he found out he had contracted COVID and tested positive for COVID. The outcome of the event was unknown. He has not had any additional COVID testing done since the one done on 20Jan2021.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer Sponsored Program. A contactable male consumer (patient) reported for himself.   A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL3248, exp date 30Apr2021, NDC number of COVID Vaccine: 59267-1000-2, on 07Jan2021 16:56 at 0,3ml single dose for COVID-19 immunization via unspecified route of administration at the left arm. The second dose of vaccine was scheduled on 28Jan2021. The patient medical history included Acid reflux. Concomitant medication included omeprazole for acid reflux, 20mg capsule once a day. Since Jan2021, the patient was violently sick one day, experienced diarrhea, puking and like a rock in his gut he could not get rid of. On 20Jan2021 he found out he had contracted COVID and tested positive for COVID. The outcome of the event was unknown. He has not had any additional COVID testing done since the one done on 20Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Oropharyngeal pain, Vaccination site pain
Clinical narrative: little sore throat; muscle pain at the site of the injection; if it's fine to take a shot of steroid for her back; This is a spontaneous report from a Pfizer-sponsored program from a contactable female consumer. A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced little sore throat and muscle pain at the site of the injection on an unspecified date. The reporter was asking if it was fine to take a shot of steroid for her back this Wednesday morning 27Jan2021. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot and batch number could not be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Headache, Injection site erythema, Injection site pain
Clinical narrative: Vaccine 2/2 @09:20am Pain at injection, unusual   2/2@ about hour after Arm sore all day, felt bruised at site, slight headache  2/3- am -Felt like body wasn?t straight, angling to the right side -stiff neck, feel wiggling down mid spine  -headaches  -neck pain -arm pain Noon-rest of the night  -nausea  -arm pain -stiff neck -light headed  2/8-mid day- all day -Neck stiffness -Pain to rotate left to right, up and down ?mostly looking down -Pain in mid upper back, feels almost on spine a little to the left  -headaches    2/9- am -Injection site red and puffed up  and increased in size -Headaches -site is a little itchy PM- all night -nausea -light head -feeling like I need to vomit  -site is warm to touch -burning sensation, Still itchy. -redness spreading larger
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Musculoskeletal stiffness, Nausea
Clinical narrative: Vaccine 2/2 @09:20am Pain at injection, unusual   2/2@ about hour after Arm sore all day, felt bruised at site, slight headache  2/3- am -Felt like body wasn?t straight, angling to the right side -stiff neck, feel wiggling down mid spine  -headaches  -neck pain -arm pain Noon-rest of the night  -nausea  -arm pain -stiff neck -light headed  2/8-mid day- all day -Neck stiffness -Pain to rotate left to right, up and down ?mostly looking down -Pain in mid upper back, feels almost on spine a little to the left  -headaches    2/9- am -Injection site red and puffed up  and increased in size -Headaches -site is a little itchy PM- all night -nausea -light head -feeling like I need to vomit  -site is warm to touch -burning sensation, Still itchy. -redness spreading larger
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Vaccine 2/2 @09:20am Pain at injection, unusual   2/2@ about hour after Arm sore all day, felt bruised at site, slight headache  2/3- am -Felt like body wasn?t straight, angling to the right side -stiff neck, feel wiggling down mid spine  -headaches  -neck pain -arm pain Noon-rest of the night  -nausea  -arm pain -stiff neck -light headed  2/8-mid day- all day -Neck stiffness -Pain to rotate left to right, up and down ?mostly looking down -Pain in mid upper back, feels almost on spine a little to the left  -headaches    2/9- am -Injection site red and puffed up  and increased in size -Headaches -site is a little itchy PM- all night -nausea -light head -feeling like I need to vomit  -site is warm to touch -burning sensation, Still itchy. -redness spreading larger
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Nasopharyngitis, Pain in extremity
Clinical narrative: Pain in arm; back pain; runny nose; fatigue; chills; cold; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced pain in arm, chills, back pain, runny nose, fatigue, cold in Jan2021, the patient wondered how long the side effects will last. AE for symptoms after covid vaccine, hold time too long, cold transferred to PMI. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Pain in arm; back pain; runny nose; fatigue; chills; cold; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced pain in arm, chills, back pain, runny nose, fatigue, cold in Jan2021, the patient wondered how long the side effects will last. AE for symptoms after covid vaccine, hold time too long, cold transferred to PMI. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itchy all over her body/Itching in face, arms, neck, chest, and armpits.; Hives on face, neck, armpits, chest; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Parent) reported for a 20-year-old female patient received the first dose of BNT162B2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 07Jan2021 at single dose for covid-19 immunization. Medical history included High cholesterol, Apricots allergies. The patient's concomitant medications included Birth control, cholesterol meds. She works in a nursing home, she got the Covid-19 vaccine on 07Jan2021, she started getting high and really got itchy all over her body, especially in her face, in her neck, her armpits. Hives on face, neck, armpits, chest. Itching in face, arms, neck, chest, and armpits. The events occurred on 21Jan2021. No treatment received. The patient was no pregnant. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Swelling, Swelling face
Clinical narrative: Swollen chin, severe itching and bumps on head, neck, buttocks, the palm of hand, forehead
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Back pain, Fatigue
Clinical narrative: shoulder pain that day and for the next 6 days; axilla pain starting the next day and lasting about 4-5 days; fatigue and achy back all the next day and evening; fatigue and achy back all the next day and evening; This is a spontaneous report from a non-contactable physician (patient). A female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unknown date. After received the second COVID-19 vaccine dose the patient felt shoulder pain that day and for the next 6 days. She had axilla pain starting the next day and lasting about 4-5 days. She had fatigue and achy back all the next day and evening. The outcome of all events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in her arm; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for herself that an 82-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain in her arm on 23Jan2021 and was wondering if she could take Tylenol for this since she heard that you're not supposed to take it as it may interfere with the vaccine. Patient stated that she couldn't find any information on the sheet given to her whether she could take Tylenol or not after getting the vaccine. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: felt awful like they had the flu for 48 hours post vaccination; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported similar events for 3 patients. This is 1 of 3 reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced felt awful like had the flu for 48 hours post vaccination on an unspecified date with outcome of unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082187 same reporter,event/ different patient
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: felt awful like they had the flu for 48 hours post vaccination; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar event for 3 patients. This is 2nd of three report.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced felt awful like had the flu for 48 hours post vaccination on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082161 same reporter/drug/event, different patient;US-PFIZER INC-2021082186 same reporter/drug/event, different patient
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: Bright yellow urine; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient reported received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on 25Jan2021 at 46-year-old. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient had bright yellow urine after second dose of COVID-19 vaccination taken on 25Jan2021. Action taken for BNT162B2 was not applicable. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Respiratory rate increased, Tremor
Clinical narrative: Shaking violently due to chills, body aches, breathing is rapid
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Malaise, Pyrexia
Clinical narrative: Fever; chills; sweats; Site injection pain; general malaise; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative. A 73-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 22Jan2021 08:00 at single dose for COVID-19 immunisation. Medical history included blood pressure abnormal. Concomitant medication included benazepril as blood pressure medication. Patient experienced site injection pain and general malaise on Saturday 23Jan2021. Fever of 101.2 F and chills and sweats on Sunday 24Jan2021. Fever managed with ibuprofen. Fever resolved on 25Jan2021 - temp back to 98.8 F. Outcome of fever was resolved. Outcome of other events was unknown.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever; chills; sweats; Site injection pain; general malaise; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative. A 73-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 22Jan2021 08:00 at single dose for COVID-19 immunisation. Medical history included blood pressure abnormal. Concomitant medication included benazepril as blood pressure medication. Patient experienced site injection pain and general malaise on Saturday 23Jan2021. Fever of 101.2 F and chills and sweats on Sunday 24Jan2021. Fever managed with ibuprofen. Fever resolved on 25Jan2021 - temp back to 98.8 F. Outcome of fever was resolved. Outcome of other events was unknown.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Asthenia, Dysgeusia, Headache, Nausea
Clinical narrative: Nasty taste in mouth , Headache, started 25 min. after shot. Nausea and stomach pain started at 10 PMon the 6 Feb. 2021. body aches. On 7th the same. Nausea went away on 8th. arm sore. went away on 9th. the nasty taste still have it on 10th. No headche stopped on 9th. Just feel week. going away on 9th of Feb.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Nasty taste in mouth , Headache, started 25 min. after shot. Nausea and stomach pain started at 10 PMon the 6 Feb. 2021. body aches. On 7th the same. Nausea went away on 8th. arm sore. went away on 9th. the nasty taste still have it on 10th. No headche stopped on 9th. Just feel week. going away on 9th of Feb.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Ageusia, Anosmia, Headache, Nausea
Clinical narrative: Nasty taste in mouth , Headache, started 25 min. after shot. Nausea and stomach pain started at 10 PMon the 6 Feb. 2021. body aches. On 7th the same. Nausea went away on 8th. arm sore. went away on 9th. the nasty taste still have it on 10th. No headche stopped on 9th. Just feel week. going away on 9th of Feb.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Nasty taste in mouth , Headache, started 25 min. after shot. Nausea and stomach pain started at 10 PMon the 6 Feb. 2021. body aches. On 7th the same. Nausea went away on 8th. arm sore. went away on 9th. the nasty taste still have it on 10th. No headche stopped on 9th. Just feel week. going away on 9th of Feb.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer Sponsored Program. A contactable nurse reported that a male patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, 2 days after taking his first vaccine, the patient tested positive. Event outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive based on the known safety profile.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable healthcare professional. This other HCP reported similar event for two patients. This is 2nd of 2 reports. A patient received 2nd dose of bnt162b2 (BNT162B2) on unknown date for COVID-19 immunization. Medical history and concomitant drugs were not provided. Historical vaccine included bnt162b2 for COVID-19 immunization. The patient had fever and chill with second dose on unknown date. X-ray was needed. The outcome of the events was unknown.   No follow-up attempts are possible. Information about Lot/Batch cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021084250 same drug and event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: bad headache; body aches; chills; she experience arm sore after the vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. She receive 1st dose of covid19 vaccine last Saturday and she experience arm sore after the vaccine and today 25Jan2021 she also had symptoms bad headache, body aches and chills. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: More localized pain at the injection site than was usual for a vaccine; This is a spontaneous report from a contactable physician. This physician reported same event for herself and one patient (her nurse). This is a second of two reports reported for her nurse. A female patient (her nurse) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunisation. Medical history included O+. She tolerated both doses well. More localized pain at the injection site than was usual for a vaccine. Outcome of the event was recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021085283 same reporter, same drug, same event, different patients
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lip swelling, Myalgia, Pain in extremity, Painful erection
Clinical narrative: S/S  after recieving second dose ; severe HA,  fever,  painful Erection for 3.5 hrs, swollen lips, muscular pain . Bilateral L/E pain.   Treatment tylenol 500 prn.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: S/S  after recieving second dose ; severe HA,  fever,  painful Erection for 3.5 hrs, swollen lips, muscular pain . Bilateral L/E pain.   Treatment tylenol 500 prn.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Pain
Clinical narrative: chills; fatigue; She is feeling miserable; body aches all over her body; This is a spontaneous report from a Pfizer-sponsored program, by a contactable consumer (patient).   This female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 19Jan2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On an unspecified date, the patient experienced chills, fatigue, she is feeling miserable, body aches all over her body. The patient was treated with Tylenol but did not feel any improvement. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer of unspecified age reported that she received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient tested positive after the 1st dose of Covid vaccine and was wondering what to do about the 2nd dose. Event outcome was unknown. Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Fall, Gait disturbance
Clinical narrative: Approximately 3-5 minutes after vaccination, patient reports walked towards post-vaccination area and vision began closing in to where she could not see.  Accoriding to post vaccination staff witness, patient appeard to walk into traffic cone and then stumbled and fell to knees on asphalt. Staff assisted patient to lying position. Patient did not hit head. Patient alert and oriented x3, and remained so for the duration. BP taken at scene at 1326  (124/80 HR 90 R 18); 1329 (120/78 HR 78 R 18); 1335-standing (120/82 HR 80 R 18); 1346 sitting(122/72 HR 80 R 18). Allowed patient to lie down until she reported feeling better. Vital signs also taken in sitting and standing position--all stable, reports no dizziness.
Sex: M
Vaccine: COVID19
Symptoms: Ear congestion, Nasal congestion, Upper respiratory tract congestion
Clinical narrative: congestion in his ears, nose and throat. He went to the ER; congestion in his ears, nose and throat. He went to the ER; congestion in his ears, nose and throat. He went to the ER; This is a Spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (reported as 'Saturday') at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Covid vaccine on Saturday and last night (25Jan2021) he started to get congestion in his ears, nose and throat. He went to the ER this morning and they told him it could be side effects from getting the Covid vaccine. He needed to know for work how long the side effects could last. The outcome of the events was unknown  Information on the Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This is a spontaneous report from two contactable consumers.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced chills on 23Dec2020. The patient outcome of the events was recovered.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Ocular discomfort
Clinical narrative: Patient complained of pressure behind left eye, small headache. Rates pain 3/10  on 0-10 pain scale.  Gradual onset. Patient reports she is not in much discomfort. Intends to continue with her errands after she is released.  Monitored, discussed seeking additional medical assistance if headache did not subside or got worse. Patient expressed understanding.  Released from post-vaccination area at 12:45pm
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 78-year-old female patient started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot/batch number not reported), via an unspecified route of administration on an unspecified date in Nov2020 at single dose for immunisation. The patient medical history and concomitant medications were not reported. Patient had an allergic reaction to pneumococcal 13-val conj vac (dipht crm197 protein) vaccine last 17Nov2020. The outcome of event was unknown.    No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyschromatopsia, Hyperhidrosis, Presyncope
Clinical narrative: Almost going to pass out; she sees the room as color yellow and red; sweat breakouts; This is a spontaneous report from a Pfizer-sponsored program reported from a contactable consumer (patient's mother). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation. Patient age at vaccination was 40 years. The patient's medical history and patient's concomitant medications were not reported. The reporter stated the patient had COVID-19 vaccine 3 weeks ago and she will have the 2nd dose of vaccine 'tomorrow'. The reporter was kind of nervous about her getting the 2nd dose as the patient is experiencing a sweat breakouts and almost going to pass out, she sees the room as color yellow and red. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Heart rate increased, Malaise, Neoplasm skin
Clinical narrative: heart started beating fast; lumps grow up on my arm; short of breath; kind of weak; uncomfortable feeling; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse (patient) reported a 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via unspecified route on right deltoid single dose for COVID-19 immunization on 03Jan2021, at 41-year-old. No medical history. Concomitant medication was reported but unspecified. After the patient had received the shot (Jan2021), her heart started beating fast, felt lumps grow up on her arm and became little short of breath. That went away rather quickly, about within 3 hours and the patient was still kind of weak and just uncomfortable feeling. Action taken for BNT162B2 was not applicable. Outcome of the events heart started beating fast, lumps grow up on her arm, short of breath was resolved in Jan2021; outcome of the other events was unknown. Causality assessment per the reporter was checked as yes.
Age: 52.0
Sex: M
Vaccine: RAB
Symptoms: Angina pectoris, Myocarditis
Clinical narrative: Myocarditis and Angina pectoris
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart condition; This is a spontaneous report from a contactable consumer (patient). A female patient with age of 75 (unknown unit) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL), apixaban (ELIQUIS), lisinopril, metoprolol, ascorbic acid; betacarotene; chromium picolinate; lycopene; mecobalamin; pyridoxine; retinol acetate; riboflavin; thiamine; tocopheryl acetate; vitamin b12 nos; xantofyl; zinc sulfate (OPTIVITE), clopidogrel bisulfate (PLAVIX), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]).  Patient stated she had a heart condition and had caner. Caller asked if she can use antipyretics before or after vaccination? Caller stated her daughter told her that paracetamol makes the vaccine less effective.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Impaired work ability, Malaise
Clinical narrative: Fever 101 F; rigors; chills; malaise; nausea; anorexia; arthralgias; myalgia;  36 hours duration Ibuprofen; hydration; bed rest;  Work absenteeism x 3 days
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Fever 101 F; rigors; chills; malaise; nausea; anorexia; arthralgias; myalgia;  36 hours duration Ibuprofen; hydration; bed rest;  Work absenteeism x 3 days