chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Dizziness, Pain in extremity, Pyrexia
Clinical narrative: arm soreness; chills; fever 101.9 Fahrenheit; backache; lightheadedness; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 68-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, batch number: not reported/ Lot Number: EM9809), via an unspecified route of administration, administered in Arm Left on 12Mar2021 08:15 (age at the time of vaccination was 68 years) as dose 2, single for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, batch/lot number: not reported), via an unspecified route of administration on unspecified date (age at the time of vaccination was 68 years) as dose 1, single for covid-19 immunization. Concomitant medication included atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported. On 12Mar2021 the patient experienced arm soreness, chills, fever, backache and lightheadedness. The patient underwent lab tests and procedures in which fever was 101.9 fahrenheit on unspecified date. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Heart rate increased, Hypoaesthesia, Pain in extremity
Clinical narrative: Tinnitus; fatigued; fast heartbeat; slowed breathing on the 2nd and 3rd day; developed a bumpy rash on the elbow of my other arm the next day; instantly had a sore arm; numb fingers/My arm felt dead; felt a heaviness in my chest since the day after and still have that; This is a spontaneous report from a contactable consumer (patient). A 47-years-old non-pregnant female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration administered in left arm on 06Mar2021 at 14:00 hours as dose 1, single (at the age of 22-years-old) for COVID-19 immunisation. Medical history included Gastrooesophageal reflux disease (GERD) and anaemia (both from an unknown date and unknown if ongoing). The patient previously took amoxicillin and experienced allergy to amoxicillin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received no other medications/concomitant medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 06Mar2021 at 15:00 hours, patient instantly had a sore arm and had numb fingers, her arm felt dead. On 07Mar2021 (next day), patient developed a bumpy rash on the elbow of her other arm. On 07Mar2021 (on the 2nd and 3rd day (08Mar2021)), patient was fatigued, had fast heartbeat and slowed breathing. On Mar2021, patient felt a heaviness in her chest since the day after and still had that. On 25Mar2021, the patient experienced tinnitus. Patient received no treatment for the events. The outcome of all the events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Respiratory rate decreased, Tinnitus
Clinical narrative: Tinnitus; fatigued; fast heartbeat; slowed breathing on the 2nd and 3rd day; developed a bumpy rash on the elbow of my other arm the next day; instantly had a sore arm; numb fingers/My arm felt dead; felt a heaviness in my chest since the day after and still have that; This is a spontaneous report from a contactable consumer (patient). A 47-years-old non-pregnant female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration administered in left arm on 06Mar2021 at 14:00 hours as dose 1, single (at the age of 22-years-old) for COVID-19 immunisation. Medical history included Gastrooesophageal reflux disease (GERD) and anaemia (both from an unknown date and unknown if ongoing). The patient previously took amoxicillin and experienced allergy to amoxicillin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received no other medications/concomitant medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 06Mar2021 at 15:00 hours, patient instantly had a sore arm and had numb fingers, her arm felt dead. On 07Mar2021 (next day), patient developed a bumpy rash on the elbow of her other arm. On 07Mar2021 (on the 2nd and 3rd day (08Mar2021)), patient was fatigued, had fast heartbeat and slowed breathing. On Mar2021, patient felt a heaviness in her chest since the day after and still had that. On 25Mar2021, the patient experienced tinnitus. Patient received no treatment for the events. The outcome of all the events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bone pain, Chills, Fatigue
Clinical narrative: extreme low back, pelvis pain; extreme low back, pelvis pain; bone pain; torso body rash, hot to touch non itchy; tired; night sweats; general malaise; Body aches; Joint pain; stiffness; chills; swollen left axillary soar lymph nodes; This is a spontaneous report from a contactable other health care professional (patient). A 56-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EP6955, expiration date was not reported), via an unspecified route of administration, administered in left arm on 11Mar2021 13:00 (at the age of 56-years-old) as dose 2, single for covid-19 immunization at facility. The patient medical history included cancer, low thyroid, depression, Hx breast cancer , neuropathy, fatigue, brain fog, brain fog weight gain uncontrolled, Known allergies: Sulfa, Known allergies: bee stings, FLOXED. Patient has known allergies. Concomitant medications included levothyroxine, glutathione, levothyroxine sodium (SYNTHROID), omeprazole sodium (OMEGA [OMEPRAZOLE SODIUM]) all taken for unknown indications from an unknown date. Other medications patient received within two weeks included Synthroid, mitocore, fishoil, glutathione, Omegas VD NAD, levothyroxine. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL9267, expiration date was not reported), via an unspecified route of administration, administered on left arm on 11Feb2021 01:00 PM (at the age of 56-years-old) as dose 1, single for covid-19 immunization at facility. The patient previously took levaquin and experienced Known allergies: levaquin, morphine and experienced Known allergies: morphine, neulasta and experienced Known allergies: Neulasta, Hydrochlorothiazide and experienced Known allergies: Hydrochlorothiazide. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, on 12Mar2021 04:00 PM the patient experienced body aches, join pain, stiffness, chills, swollen left axillary soar lymph nodes. It was also reported that on 12Mar2021 06:00 PM 30hrs post 2nd vac the patient experienced, extreme low back, pelvis pain, bone pain, day 2 post, swollen lymph nodes, torso body rash, hot to touch non itchy, tired, chills, night sweats, general malaise, body ache, for a week. No treatment was received for the adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Musculoskeletal stiffness, Night sweats, Pain
Clinical narrative: extreme low back, pelvis pain; extreme low back, pelvis pain; bone pain; torso body rash, hot to touch non itchy; tired; night sweats; general malaise; Body aches; Joint pain; stiffness; chills; swollen left axillary soar lymph nodes; This is a spontaneous report from a contactable other health care professional (patient). A 56-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EP6955, expiration date was not reported), via an unspecified route of administration, administered in left arm on 11Mar2021 13:00 (at the age of 56-years-old) as dose 2, single for covid-19 immunization at facility. The patient medical history included cancer, low thyroid, depression, Hx breast cancer , neuropathy, fatigue, brain fog, brain fog weight gain uncontrolled, Known allergies: Sulfa, Known allergies: bee stings, FLOXED. Patient has known allergies. Concomitant medications included levothyroxine, glutathione, levothyroxine sodium (SYNTHROID), omeprazole sodium (OMEGA [OMEPRAZOLE SODIUM]) all taken for unknown indications from an unknown date. Other medications patient received within two weeks included Synthroid, mitocore, fishoil, glutathione, Omegas VD NAD, levothyroxine. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL9267, expiration date was not reported), via an unspecified route of administration, administered on left arm on 11Feb2021 01:00 PM (at the age of 56-years-old) as dose 1, single for covid-19 immunization at facility. The patient previously took levaquin and experienced Known allergies: levaquin, morphine and experienced Known allergies: morphine, neulasta and experienced Known allergies: Neulasta, Hydrochlorothiazide and experienced Known allergies: Hydrochlorothiazide. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, on 12Mar2021 04:00 PM the patient experienced body aches, join pain, stiffness, chills, swollen left axillary soar lymph nodes. It was also reported that on 12Mar2021 06:00 PM 30hrs post 2nd vac the patient experienced, extreme low back, pelvis pain, bone pain, day 2 post, swollen lymph nodes, torso body rash, hot to touch non itchy, tired, chills, night sweats, general malaise, body ache, for a week. No treatment was received for the adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pelvic pain, Rash
Clinical narrative: extreme low back, pelvis pain; extreme low back, pelvis pain; bone pain; torso body rash, hot to touch non itchy; tired; night sweats; general malaise; Body aches; Joint pain; stiffness; chills; swollen left axillary soar lymph nodes; This is a spontaneous report from a contactable other health care professional (patient). A 56-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EP6955, expiration date was not reported), via an unspecified route of administration, administered in left arm on 11Mar2021 13:00 (at the age of 56-years-old) as dose 2, single for covid-19 immunization at facility. The patient medical history included cancer, low thyroid, depression, Hx breast cancer , neuropathy, fatigue, brain fog, brain fog weight gain uncontrolled, Known allergies: Sulfa, Known allergies: bee stings, FLOXED. Patient has known allergies. Concomitant medications included levothyroxine, glutathione, levothyroxine sodium (SYNTHROID), omeprazole sodium (OMEGA [OMEPRAZOLE SODIUM]) all taken for unknown indications from an unknown date. Other medications patient received within two weeks included Synthroid, mitocore, fishoil, glutathione, Omegas VD NAD, levothyroxine. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL9267, expiration date was not reported), via an unspecified route of administration, administered on left arm on 11Feb2021 01:00 PM (at the age of 56-years-old) as dose 1, single for covid-19 immunization at facility. The patient previously took levaquin and experienced Known allergies: levaquin, morphine and experienced Known allergies: morphine, neulasta and experienced Known allergies: Neulasta, Hydrochlorothiazide and experienced Known allergies: Hydrochlorothiazide. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, on 12Mar2021 04:00 PM the patient experienced body aches, join pain, stiffness, chills, swollen left axillary soar lymph nodes. It was also reported that on 12Mar2021 06:00 PM 30hrs post 2nd vac the patient experienced, extreme low back, pelvis pain, bone pain, day 2 post, swollen lymph nodes, torso body rash, hot to touch non itchy, tired, chills, night sweats, general malaise, body ache, for a week. No treatment was received for the adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Hypersomnia, Lethargy
Clinical narrative: nausea; dizziness; joint pain; headache; lethargy; went to bed for 2 -3 days; went to bed for about 3 days; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection), dose 1 via an unspecified route of administration on 08Mar2021 (Batch/Lot Number: EN6206) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Mar2021, the patient experienced nausea, dizziness, joint pain, headache, lethargy and went to bed for 2 -3 days. Patient's second vaccine was scheduled on 29Mar2021. At the time of this report, the outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: nausea; dizziness; joint pain; headache; lethargy; went to bed for 2 -3 days; went to bed for about 3 days; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection), dose 1 via an unspecified route of administration on 08Mar2021 (Batch/Lot Number: EN6206) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Mar2021, the patient experienced nausea, dizziness, joint pain, headache, lethargy and went to bed for 2 -3 days. Patient's second vaccine was scheduled on 29Mar2021. At the time of this report, the outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Malaise, Pain in extremity
Clinical narrative: feeling sick/feeling overall un well all day/She got up didn't feel good at all; headache; fever; fatigue/she is little tired; weak; arm soreness/Little soreness in her arm; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Mar2021, the patient experienced arm soreness/little soreness in her arm. On 13Mar2021, patient experienced feeling sick/feeling overall unwell all day/she got up didn't feel good at all, headache, fever, fatigue/she is little tired, weak. The outcome of the event fever was recovered on 14Mar2021. The outcome of the event arm soreness/little soreness in her arm and feeling sick/feeling overall unwell all day/she got up didn't feel good at all was unknown. The outcome of the events headache, fatigue/she is little tired, weak was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feeling sick/feeling overall un well all day/She got up didn't feel good at all; headache; fever; fatigue/she is little tired; weak; arm soreness/Little soreness in her arm; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Mar2021, the patient experienced arm soreness/little soreness in her arm. On 13Mar2021, patient experienced feeling sick/feeling overall unwell all day/she got up didn't feel good at all, headache, fever, fatigue/she is little tired, weak. The outcome of the event fever was recovered on 14Mar2021. The outcome of the event arm soreness/little soreness in her arm and feeling sick/feeling overall unwell all day/she got up didn't feel good at all was unknown. The outcome of the events headache, fatigue/she is little tired, weak was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal discomfort, Nervousness
Clinical narrative: I went to a specialist yesterday for my shoulder; I lifted up because I was nervous; shoulder pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6200, expiration date was not reported), via an unspecified route of administration on 22Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient got her first shot on 22Feb2021 and she scheduled on this coming monday 15Mar2021 for her second Covid shot, she went to a specialist yesterday for her shoulder and she thought it was just a consult and if she needed to do it she can schedule it later after he talked with her he said Ok he is going to give her a Cortisone he left the room and she was on a therapy with her second shot and so when he came back in she told him and he said oh it won't interfere with it. So, he gave her the shot at last she got home and she lifted up because she was nervous, she was ok to get her second shot monday. He said it would not interfere the Pfizer Covid shot, so she was just nervous that she let him giving the shot and is it okay if she get the second shot of Covid. she was having shoulder pain, and call a specialist and said it will be a consult, so she went yesterday and She was given a steroid shot, and she asked the nurse if steroid will not affect with the vaccine and said that it won't affect it. So she looked it up online, and she know it is nothing sure, so she would want to know if it won't interfere with her vaccine for the 2nd shot on 15Mar2021. Therapeutic measures were taken as a result of shoulder pain. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: severely fatigued; chills; aches; fever; arm was also sore; This is a spontaneous report from a contactable consumer (patient) via  Pfizer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6203, Expiration Date: Jun2021), via an unspecified route of administration on 10Mar2021, at 13:20 as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 11Mar2021, the patient woke up severely fatigued. The patient took a sick day and stayed in bed all day, but she was starting to feel better. The patient had chills, aches, and a fever - all mild. The patient's arm was also sore. The fatigue was the most prominent adverse effect.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: severe left arm and shoulder pain; severe left arm and shoulder pain; This is a spontaneous report from a contactable Nurse, a Pharmacist and a Physician. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on an unspecified date as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced severe left arm and shoulder pain. The outcome of the events was not recovered.  This follow up report contains no new medically significant safety information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (reporter's wife). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265), via an unspecified route of administration on 26Feb2021 (Friday) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On 28Feb2021 (on the following Sunday), the patient had a reaction to the shot and started hurting and she was still hurting 2 weeks later, she hurts in her shoulders, arms, and she just hurts all over. The patient can't touch her wrist, all pain down her shoulder and her arms. On 11Mar2021 (yesterday), the patient had a burning in her chest and said it was hard to get air. The patient had to fight to get a good deep breath. She was having trouble breathing and got the deep breath. It was reported that the patient needed to go someplace to get something done. Outcome of the events were unknown. No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Influenza like illness, Malaise
Clinical narrative: quick onset flu like symptoms; high fever with chills; sensitive skin; body aches; still foggy; headache; Colleague reported not feeling well; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration, administered in left arm on 09Mar2021 at 07:00 (at the age of 43-year-old) as single dose for COVID-19 immunisation. The patient's medical history included pregnancy and C-section on 01Apr202, the patient did have a baby within the past year via C-section. No longer breastfeeding though. She was born on 01Apr2021. The patient's concomitant medications were not reported. It was not reported whether prior to vaccination, the patient was diagnosed with COVID-19 or since the vaccination, the patient has been tested for COVID-19. On 10Mar2021, the patient experienced quick onset flu like symptoms, high fever with chills, sensitive skin, body aches, still foggy, headache and colleague reported not feeling well. After first dose of COVID vaccine the patient experienced quick onset flu like symptoms on 10Mar2021. The symptoms started approximately 24 hours after receiving the vaccine. The patient on 10Mar2021, felt like had a very high fever with chills, sensitive skin, and body aches. The patient took the temperature, and it was normal. The more severe symptoms lasted about 12 hours. When the patient woke up the next morning, felt much better but still foggy with headache. The patient had no underlying conditions besides weight. The patient also reported of not feeling well, was not being able to work in the morning on the day after the shot. By early afternoon the patient was feeling ok. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature: normal on 10Mar2021. The patient was not recovered from the events still foggy and headache, colleague reported not feeling well was recovered on an unspecified date in Mar2021 and the patient was recovered from all the other events on 11Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sensitive skin
Clinical narrative: quick onset flu like symptoms; high fever with chills; sensitive skin; body aches; still foggy; headache; Colleague reported not feeling well; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration, administered in left arm on 09Mar2021 at 07:00 (at the age of 43-year-old) as single dose for COVID-19 immunisation. The patient's medical history included pregnancy and C-section on 01Apr202, the patient did have a baby within the past year via C-section. No longer breastfeeding though. She was born on 01Apr2021. The patient's concomitant medications were not reported. It was not reported whether prior to vaccination, the patient was diagnosed with COVID-19 or since the vaccination, the patient has been tested for COVID-19. On 10Mar2021, the patient experienced quick onset flu like symptoms, high fever with chills, sensitive skin, body aches, still foggy, headache and colleague reported not feeling well. After first dose of COVID vaccine the patient experienced quick onset flu like symptoms on 10Mar2021. The symptoms started approximately 24 hours after receiving the vaccine. The patient on 10Mar2021, felt like had a very high fever with chills, sensitive skin, and body aches. The patient took the temperature, and it was normal. The more severe symptoms lasted about 12 hours. When the patient woke up the next morning, felt much better but still foggy with headache. The patient had no underlying conditions besides weight. The patient also reported of not feeling well, was not being able to work in the morning on the day after the shot. By early afternoon the patient was feeling ok. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature: normal on 10Mar2021. The patient was not recovered from the events still foggy and headache, colleague reported not feeling well was recovered on an unspecified date in Mar2021 and the patient was recovered from all the other events on 11Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever; Chills; Headache; This is a spontaneous report received from a contactable consumer (patient) via a Regulatory Authority. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 09Mar2021 (Batch/lot number not reported), as dose number unknown, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. In Mar2021, after the vaccination, the patient experienced fever, chills and headache. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Myalgia, Pyrexia
Clinical narrative: Muscle pain; Headache; An overall feeling of lethargy; Slightly elevated fever; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced muscle pain causing myalgia on 14Mar2021 with outcome of unknown, headache on 14Mar2021 with outcome of unknown, an overall feeling of lethargy on 14Mar2021 with outcome of unknown, slightly elevated fever causing pyrexia on 14Mar2021 with outcome of unknown. Therapeutic measures were taken as a result of this with Advil   Follow-up (15Mar2021) this is a follow-up spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported that: She had both covid vaccines with 14Mar2021 being day 11 after her 2nd Pfizer shot. On 14Mar2021 she woke up with Muscle pain, headache, slightly elevated fever and overall feeling of lethargy. Took Advil and also reached Out to her physician. She is wondering if side effects this far out after receiving the shot is normal or if Something else could be going on.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Bone pain, Dyspnoea, Fatigue
Clinical narrative: felt tired and weak/was very weak, can't pick up heavy things/Weakness; excessive sweating in her feet/Feet were sweating; muscle pain/muscular pain; had pain in the bones; fatigue; short of breath; nausea; stomach is different/ stomach feels different/she felt stomach congestion, she felt a "bad stomach; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199, Expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (at the age of 62-year-old) as dose 1, single for covid-19 immunisation. Medical history included asthenia (felt weak back in Aug but they said it wasn't anaemia), blood cholesterol increased (high cholesterol but that is under control now) and overweight. The concomitant medications were not reported. The patient received first dose of Pfizer-BioNtech Covid-19 vaccine on 05Mar2021, she has second dose scheduled on 26Mar2021. On 05Mar201 the patient experienced stomach congestion, she felt a "bad stomach,"  she felt her stomach was sick, she had nausea for 3 days, at night she felt tired and weak, she also had muscle aches and excessive sweating in her feet, she still has this last symptom. She would like to know if these symptoms were normal. She felt her stomach was different. From that morning, she felt nausea for 3-4 days (on 06Mar2021). Now sometimes the caller had fatigue, feels down, she had some questions. The nausea was for 3-5 days. She felt totally different, no power, short of breath, she was typically very healthy. Was this normal, was these allergies, and should she get the second dose of the vaccine? The nausea lasted about 3 days then it stopped so she doesn't have stomach issues, then she had more symptoms. Feet were sweating which also happened sometimes. She had shortness of breath, but it was more controlled. She also has muscular pain and felt weak and had to gasp for air when she had the loss of air. She also had pain in the bones, was very weak, can't pick up heavy things. After the nausea she felt weak, it had been at least 3 days. The outcome of the event nausea was recovered on 08Mar2021 while for rest of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Nausea
Clinical narrative: felt tired and weak/was very weak, can't pick up heavy things/Weakness; excessive sweating in her feet/Feet were sweating; muscle pain/muscular pain; had pain in the bones; fatigue; short of breath; nausea; stomach is different/ stomach feels different/she felt stomach congestion, she felt a "bad stomach; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199, Expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (at the age of 62-year-old) as dose 1, single for covid-19 immunisation. Medical history included asthenia (felt weak back in Aug but they said it wasn't anaemia), blood cholesterol increased (high cholesterol but that is under control now) and overweight. The concomitant medications were not reported. The patient received first dose of Pfizer-BioNtech Covid-19 vaccine on 05Mar2021, she has second dose scheduled on 26Mar2021. On 05Mar201 the patient experienced stomach congestion, she felt a "bad stomach,"  she felt her stomach was sick, she had nausea for 3 days, at night she felt tired and weak, she also had muscle aches and excessive sweating in her feet, she still has this last symptom. She would like to know if these symptoms were normal. She felt her stomach was different. From that morning, she felt nausea for 3-4 days (on 06Mar2021). Now sometimes the caller had fatigue, feels down, she had some questions. The nausea was for 3-5 days. She felt totally different, no power, short of breath, she was typically very healthy. Was this normal, was these allergies, and should she get the second dose of the vaccine? The nausea lasted about 3 days then it stopped so she doesn't have stomach issues, then she had more symptoms. Feet were sweating which also happened sometimes. She had shortness of breath, but it was more controlled. She also has muscular pain and felt weak and had to gasp for air when she had the loss of air. She also had pain in the bones, was very weak, can't pick up heavy things. After the nausea she felt weak, it had been at least 3 days. The outcome of the event nausea was recovered on 08Mar2021 while for rest of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Minor rash at the area where he got the shot; Minor rash at the area where he got the shot- can barely see it, but there are little itchy red spots, area is about the size of a baseball; Minor rash at the area where he got the shot- can barely see it, but there are little itchy red spots, area is about the size of a baseball; This is a spontaneous report from a contactable consumer (patient) received from Medical Information Team. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Not reported), via an unspecified route of administration on an unspecified date in Feb2021 as a single dose for COVID-19 immunization. Patient medical history and Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Batch/lot number: Not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. On an unspecified date in 2021, after second vaccination, patient developed a minor rash at the area where he got the shot- can barely see it, but there are little itchy red spots, area is about the size of a baseball. It was reported that, patient had his 2 shots, going on a month now and was doing fine (at the time of report), he had second dose of the Pfizer COVID-19 vaccine near the end of the February (probably the week of 21Feb2021, Exact date unknown), and he developed a rash at the injection site that has lasted a little over 3 weeks. He describes the rash as, diameter is about the size of about a tennis ball. It's a light rash with pin point red marks or little red spots, it itches pretty bad, the area about the size of a baseball that is involved and it itches around the area of where the shot was administered. Patient have been putting lotion on it - clarified as 2% topical lotion, lotion seems to be helping a little but it doesn't seem to be going away, and he is not concerned about the rash itself but he wants to know if the rash is indicative of a more serious side effect or problem. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Neck mass, Pain in extremity, Pruritus, Rash
Clinical narrative: red; itchy; bumps started appearing on her neck; some kind of a rash on her neck/looked like Blisters and welts appeared on her neck; some kind of a rash on her neck/looked like Blisters and welts appeared on her neck; rash only hurts to touch it; The caller also reported that her arm did get sore for 1.5-2 days; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205), via intramuscularly in left arm on 11Mar2021 11:00 AM (age at vaccination was 66 years) as dose 1, single for COVID-19 Vaccination. Medical history included allergic to poison ivy and it looked like red and itchy from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 11Mar2021, 5 hours after vaccination developed some kind of a rash on her neck. The patient reported it looked like blisters and welts appeared on her neck, but the patient was not bothersome at all; it was just there. The patient wanted to know whether she should be concerned and should she get the second dose. She said that she knew that people have reported something like this happening on their arm and they call it Covid arm. It was also reported that bumps started appearing on her neck around 17: 00 that afternoon on 11Mar2021 and that was still red, still hurts, and was itchy. On 13Mar2021 it turned red on Saturday 13Mar2021 and still looked about the same as it did then. On an unknown date in Mar2021 the patient arm did get sore for 1.5-2 days and it was better then. Her rash only hurts to touch it. She wanted to follow up on it and see if she should go see her physician. Her husband did not even feel it. Patient had not received any other vaccine within 4 weeks. No investigation assessment reported. Outcome of the event some kind of a rash on her neck/looked like Blisters and welts appeared on her neck unknown. Bumps started appearing on her neck, red, itchy and rash only hurts to touch it was not resolved. Outcome of arm did get sore for 1.5-2 days was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash vesicular, Urticaria
Clinical narrative: red; itchy; bumps started appearing on her neck; some kind of a rash on her neck/looked like Blisters and welts appeared on her neck; some kind of a rash on her neck/looked like Blisters and welts appeared on her neck; rash only hurts to touch it; The caller also reported that her arm did get sore for 1.5-2 days; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205), via intramuscularly in left arm on 11Mar2021 11:00 AM (age at vaccination was 66 years) as dose 1, single for COVID-19 Vaccination. Medical history included allergic to poison ivy and it looked like red and itchy from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 11Mar2021, 5 hours after vaccination developed some kind of a rash on her neck. The patient reported it looked like blisters and welts appeared on her neck, but the patient was not bothersome at all; it was just there. The patient wanted to know whether she should be concerned and should she get the second dose. She said that she knew that people have reported something like this happening on their arm and they call it Covid arm. It was also reported that bumps started appearing on her neck around 17: 00 that afternoon on 11Mar2021 and that was still red, still hurts, and was itchy. On 13Mar2021 it turned red on Saturday 13Mar2021 and still looked about the same as it did then. On an unknown date in Mar2021 the patient arm did get sore for 1.5-2 days and it was better then. Her rash only hurts to touch it. She wanted to follow up on it and see if she should go see her physician. Her husband did not even feel it. Patient had not received any other vaccine within 4 weeks. No investigation assessment reported. Outcome of the event some kind of a rash on her neck/looked like Blisters and welts appeared on her neck unknown. Bumps started appearing on her neck, red, itchy and rash only hurts to touch it was not resolved. Outcome of arm did get sore for 1.5-2 days was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: started having a lot of muscle soreness in her neck and shoulders and it has not subsided; started having a lot of muscle soreness in her neck and shoulders and it has not subsided; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208; Expiration Date: Jul2021),  via an unspecified route of administration, administered in Arm Left on 09Mar2021 14:45 (at the age of 66-year-old) as dose 1, single for covid-19 immunisation.  Medical history included corrective lens user from an unknown date and unknown if ongoing she needs a magnifying glass to read the lot number maybe and placed her husband on the line to read the lot number. There were no concomitant medications. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021, the patient experienced started having a lot of muscle soreness in her neck and shoulders and it has not subsided. Patient received the second dose after reaction with first dose. The events did not result in emergency room or physician office visit. No treatment was received as a result of events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disorientation, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Head spinning; severe nausea/intense nausea; heart beat started racing; fast heart rate/increased heart rate; felt disoriented; difficulty breathing; panicking/panicked for 60 seconds; chills; my hearing went muffled for ten seconds, then I was fine/muffled hearing; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, lot number and expiration date: unknown) via an unspecified route of administration on 12Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 12Mar2021, the patient experienced head spinning, severe/intense nausea, felt like she was going to throw up, heart beat started racing, fast heart rate/increased heart rate, felt disoriented, difficulty breathing for only a short time, panicking because she thought she was going to throw up/panicked for 60 seconds, chills, her hearing went muffled for ten seconds, then she was fine/muffled hearing (this lasted only a minute or 2) and dizziness. She thought a minute to a minute and a half, she had nothing since then. She stated 13 minutes into the 15 waiting, and she was fine. On an unspecified date in Mar2021, all the events resolved.  No follow-up attempts were possible, information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Nausea, Palpitations, Panic reaction, Vertigo
Clinical narrative: Head spinning; severe nausea/intense nausea; heart beat started racing; fast heart rate/increased heart rate; felt disoriented; difficulty breathing; panicking/panicked for 60 seconds; chills; my hearing went muffled for ten seconds, then I was fine/muffled hearing; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, lot number and expiration date: unknown) via an unspecified route of administration on 12Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 12Mar2021, the patient experienced head spinning, severe/intense nausea, felt like she was going to throw up, heart beat started racing, fast heart rate/increased heart rate, felt disoriented, difficulty breathing for only a short time, panicking because she thought she was going to throw up/panicked for 60 seconds, chills, her hearing went muffled for ten seconds, then she was fine/muffled hearing (this lasted only a minute or 2) and dizziness. She thought a minute to a minute and a half, she had nothing since then. She stated 13 minutes into the 15 waiting, and she was fine. On an unspecified date in Mar2021, all the events resolved.  No follow-up attempts were possible, information about lot/batch number could not be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Rash pruritic
Clinical narrative: rash is red; itchy; rash is red, itchy that comes and goes and is on the side of his stomach and looks like it wants to go up under my breast; This is a spontaneous report from a contactable consumer (patient himself). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 11Mar2021 11:30 as dose 1, single for COVID-19 immunisation (Age at Vaccination was 73 years). The patient medical history included Blood pressure high (controlled by medication) and Blood thinner. Concomitant medications included ongoing Clopidogrel, 75mg daily taken for blood thinner from 2005 and ongoing Atenolol, 25mg twice daily taken for Blood pressure high from 2005. On 13Mar2021, the patient experienced rash is red, itchy that comes and goes, and is on the side of his stomach and looks like it wants to go up under my breast. Therapeutic measures were taken as a result of events include topical Triamcinolone Acetate 1% cream. The seriousness of the events was non-serious. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.