chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain, Tooth disorder
Clinical narrative: body aches; bad tooth; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A male patient with age 57 received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on 25Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced body aches and bad tooth. The patient wants to know when can take ibuprofen for his tooth. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoglycaemia
Clinical narrative: I experienced a hypoglycemic event of 58 at 10:40 PM; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EN5318), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 09:15 AM as dose 2, single for covid-19 immunisation (at the age of 46-year-old). Medical history included type 2 diabetes mellitus, dairy allergy, obesity from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included insulin degludec, liraglutide (XULTOPHY), lisinopril (LISINOPRIL), metformin (METFORMIN), rosuvastatin (ROSUVAS-TATIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (Lot number EN5318) in arm right on 27Jan2021 10:30 AM as dose 1, single for covid-19 immunisation. Reporter stated that I experienced a hypoglycemic event of 58 at 10:40 PM on 25Feb2020 as recorded. Previous value was 214 post meal at 7:13 PM. Following glucose support value resolved to 84 at 2300. No medical intervention was given other than self-administered glucose tabs. The treatment was not received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovered.  No follow up attempts are possible; No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: sore arm/Soreness in my arm; tiredness/May be little bit tired; She feels like she hasn't had anything; This is a spontaneous report from a contactable consumer.    A 66-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6203; Expiration Date: Unknown) via an unspecified route of administration on 24Feb2021 (age at vaccination 66 years old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN9581; Expiration Date: Unknown) via an unspecified route of administration on 03Feb2021 as dose 1, single for covid-19 immunization. Patient stated that she had the vaccine, the second dose of the Pfizer vaccine on Wednesday afternoon and she really have not had any reactions. know just have soreness in her arm and may be little bit tired on 24Feb2021, she was yesterday that would have been the first day after but that's all.  Also added that (25Feb2021)   Right, today she was not tired but she was little bit yesterday, just a little bit not bad and she have a walk 3 and half so it would might be that. On an unknown date in Feb2021, she felt like she hasn't had anything. The outcome event feeling abnormal was unknown and patient recovered from other events in Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymphadenopathy in the ipsilateral axillary region; This is a spontaneous report from a contactable consumer (patient). A 57-years-old male patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EL3247 and Expiration date was not reported) via an unspecified route of administration, administered in right arm on 23Feb2021 at 12:30 hours as dose 2, single (at the age of 57-years-old) for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) within 2 weeks of vaccination included acetylsalicylic acid (Aspirin) taken for an unspecified indication, start and stop date were not reported. Patient had no allergies to medications, food, or other products. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EL3247 and Expiration date was not reported) via an unspecified route of administration, administered in right arm on 02Feb2021 at 14:00 hours as dose 1, single (at the age of 57-years-old) for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 24Feb2021, the day after receiving the second dose, patient developed lymphadenopathy in the ipsilateral axillary region.  The size of the enlarged lymph node was approximately the size of a tennis ball. Also had lymphadenopathy in the right side of the neck region and currently, the axillary lymphadenopathy has decreased slightly in size and neck lymphadenopathy also slightly decreased. Patient had doctor or other healthcare professional office/clinic visit for the event. Patient received no treatment for the event. The outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Intermittent chills; headache; mild muscle aches; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 3247 and expiration date was not reported), via an unspecified route of administration, administered in arm left on 25Feb2021 10:00 am (at the age of 47-year) as dose 2, single for covid-19 immunization. Patient had no known allergies and relevant medical history includes Crohn's disease. The patient concomitant medications includes vitamin B12, vitamin D and probiotics received 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: 3247 and expiration date was not reported), as first dose, on 04Feb2021 10.00 am for covid-19 immunization. Reported on behalf of herself- received the dose on 25Feb2021 and started experiencing symptoms that same evening on 25Feb2021. The patient experience intermittent chills, headache and mild muscle aches on 25Feb2021, 11:00 PM. The events were considered as non-Serious. The patient received acetaminophen treatment for adverse event. The outcome of the events was recovered on an unspecified date in 2021.    No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Tremor, Vertigo, Vomiting
Clinical narrative: Vertigo; It was like she was being shaken; She got sick; Threw up; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL1283, Expiry Date: Unknown) via an unspecified route of administration in left arm on 02Feb2021 at 09:45 (at the age of 63 years-old) as dose 1, single for COVID-19 immunization. Patient medical history included ongoing Cancer (neoplasm malignant, patient medical comments reported as multiple sclerosis), sick, helps not to throw up (vomiting), Heartburn (dyspepsia) from an unknown start and stop date. The concomitant medications included dexamethasone acetate (DEXAMETHASONE ACETATE) taken as a real small dose 0.25mg once a day for sick and helps not to throw up from an unspecified start date and still ongoing, omeprazole sodium (OMEPRAZOLE [OMEPRAZOLE SODIUM]) taken as a dose of 20mg twice a day for heartburn from an unspecified start date and still ongoing, talazoparib tosylate (TALZENNA) taken 1mg a day for indication Cancer from an unspecified start date and still ongoing. The vaccination facility type reported as hospital and vaccine were administered at military facility. Additional vaccines administered on same date of the pfizer suspect was reported as none. No Prior Vaccinations within 4 weeks and adverse events following prior vaccinations. About 2 weeks after the first dose patient experienced an episode of vertigo, it was coming out of the blue. She was sitting down and then all of a sudden it was like her head and world was tilted. It was like she was being shaken. This only lasted for like a minute. She got sick and threw up from this on 17Feb2021 at 7:30. She spent the rest of the day trying to take it easy. By the end of the day, she was fine. she has never had vertigo before and wanted to know if caused by the shot. Stated due to this event she was scared to get the second shot. Patient is asking these symptoms to be a result of vaccination, should she have waited longer before calling to see if symptoms would have resolved on their own. No investigation assessment was done. The patient taken second dose of vaccine in left arm on 23Feb2021 at 9:30. The patient was not visited to physician office visit and emergency room for the events. Stated she has cancer, and she has not been seen by her regular doctor She sees her oncologist. She was also being treated for cancer (not chemotherapy), but she had stated that usually the pill does not bother me at all. The clinical outcome of all events was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug specific antibody, Drug specific antibody absent, Vaccination site pain
Clinical narrative: Arm is a little sore, left arm/her arm hurts after she took the 1st dose; my body hasn't built antibodies, yet from the vaccine; This is a spontaneous report from a Pfizer-sponsored program (NCSP: 159558) from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration, administered in left arm on 25Feb2021 as a single dose for COVID-19 immunization. Patient medical history included patient went to the doctors 2 days before the vaccination because of kidney stone, woke up with feeling sick yesterday (24Feb2021) before the vaccination like having cold, sore throat, runny nose, sinus and went to get the vaccine. The patient believed that was a cold, not virus. No fever, she really did not believe it was covid. She had colds twice and been tested twice. She said it was not Covid since he had not gone out for a month. Concomitant medication included homeopathy medication Oscillococcinum; they were all antiviral or immune boosters. The patient previously took elderberry gummies before the patient went to get the vaccine. On 25Feb2021, patient was feeling better today, and her arm was a little sore, left arm, with no pain, no redness after she took the 1st dose, but it's not swollen or no redness at all and it's not her main concern. The patient had no antibodies when she came back. Her body had not built antibodies yet from the vaccine. The patient wanted to know whether it was okay to take herbal antiviral, ginger tea, tumeric, zinc, elderberry gummies and licorice; whether it was interfered with vaccine. The patient knew she could take antipyretics drugs. The patient underwent lab test which included drug specific antibody: absent on an unspecified date and covid test twice: unknown as she really did not believe it was covid. She had cold twice and been tested twice. The clinical outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Feeling hot, Headache, Influenza like illness
Clinical narrative: Nausea/nauseous; tired; flu like symptoms; severe headaches/bad headache; Migraine; achy/aches and pains; freezing; hot; This is a spontaneous report from a contactable nurse (patient) reporting for herself. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, NDC number and Expiry Date are not Provided), via an unspecified route of administration on 15Feb2021 at 09:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Investigation assessment was not provided. The Reporter got the COVID shot and had a reaction from it. On 16Feb2021, the patient experienced flu like symptoms, severe headaches/bad headache, migraine, achy/aches and pains, freezing, hot, tired and on 16Feb2021 at 11:00, the patient experienced nausea/nauseous. The clinical course was reported as follows: the reporter stated that she had the first dose of the pfizer covid 19 vaccine twelve days ago on Monday, 15Feb2021 at 9 AM. She reported that 24-25 hours later she had flu like symptoms, severe headaches, migraines and aches and pains. She stated that she has had these symptoms for twelve days and wants to know if that is normal. Twenty-four hours after, she developed flu like symptoms. She still has them. They are the same exact flu like symptoms too. She was achy, freezing, hot, and very nauseous. She had a migraine and bad headache as well. She can't seem to get over it. Then on Tuesday at 11 am, her side effects began with nausea, and increased to aches, pains, etc. The nausea was pretty intense. She still has it. The aches and pain are still there. The nausea was a little milder. She was tired. She is afraid to take the second vaccine. She said she has a question. She had the first COVID vaccine. This Monday will be 2 weeks since her 1st Pfizer vaccine. The reporter wanted to know if there is an issue with her getting the second shot because of her side effects to the first dose. The case was reported as non-serious. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain
Clinical narrative: Nausea/nauseous; tired; flu like symptoms; severe headaches/bad headache; Migraine; achy/aches and pains; freezing; hot; This is a spontaneous report from a contactable nurse (patient) reporting for herself. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, NDC number and Expiry Date are not Provided), via an unspecified route of administration on 15Feb2021 at 09:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Investigation assessment was not provided. The Reporter got the COVID shot and had a reaction from it. On 16Feb2021, the patient experienced flu like symptoms, severe headaches/bad headache, migraine, achy/aches and pains, freezing, hot, tired and on 16Feb2021 at 11:00, the patient experienced nausea/nauseous. The clinical course was reported as follows: the reporter stated that she had the first dose of the pfizer covid 19 vaccine twelve days ago on Monday, 15Feb2021 at 9 AM. She reported that 24-25 hours later she had flu like symptoms, severe headaches, migraines and aches and pains. She stated that she has had these symptoms for twelve days and wants to know if that is normal. Twenty-four hours after, she developed flu like symptoms. She still has them. They are the same exact flu like symptoms too. She was achy, freezing, hot, and very nauseous. She had a migraine and bad headache as well. She can't seem to get over it. Then on Tuesday at 11 am, her side effects began with nausea, and increased to aches, pains, etc. The nausea was pretty intense. She still has it. The aches and pain are still there. The nausea was a little milder. She was tired. She is afraid to take the second vaccine. She said she has a question. She had the first COVID vaccine. This Monday will be 2 weeks since her 1st Pfizer vaccine. The reporter wanted to know if there is an issue with her getting the second shot because of her side effects to the first dose. The case was reported as non-serious. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Influenza like illness, Malaise, Musculoskeletal stiffness
Clinical narrative: Vaccine administered in Gluteus; flu like symptoms; body/skin tender to touch; felt terrible; heart raced like no one business. My heart rate was 100; neck felt like she slept on it wrong. Caller stated, "like it was stiff."; This is a spontaneous report from a contactable Nurse (patient) reported for herself via Medical Information Team. A 67-year-old female patient received second 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 Gluteus (as reported) on 22Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Jan2021 (at the age of 67-years-old) as DOSE 1, SINGLE for COVID-19 immunisation and experienced normal reactions. Patient stated when receiving her second vaccination on 22Feb2021, it has put her on her butt, she experienced (on an unspecified date in 2021) flu like symptoms and body/skin tender to touch, she felt terrible. At night she had on a long sleeve night gown and robe and was wrapped up with blankets. Her heart raced like no one business and heart rate was 100 not long but for a few hours (on an unspecified date in 2021). And she stated that her neck felt like she slept on it wrong, like it was stiff (on an unspecified date in 2021). She further questioned could she use antipyretics before or after vaccination with the Pfizer-BIONTECH COVID-19 vaccine and had anyone reported anything happening with their 4th cranial nerve. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Product administered at inappropriate site
Clinical narrative: Vaccine administered in Gluteus; flu like symptoms; body/skin tender to touch; felt terrible; heart raced like no one business. My heart rate was 100; neck felt like she slept on it wrong. Caller stated, "like it was stiff."; This is a spontaneous report from a contactable Nurse (patient) reported for herself via Medical Information Team. A 67-year-old female patient received second 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 Gluteus (as reported) on 22Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Jan2021 (at the age of 67-years-old) as DOSE 1, SINGLE for COVID-19 immunisation and experienced normal reactions. Patient stated when receiving her second vaccination on 22Feb2021, it has put her on her butt, she experienced (on an unspecified date in 2021) flu like symptoms and body/skin tender to touch, she felt terrible. At night she had on a long sleeve night gown and robe and was wrapped up with blankets. Her heart raced like no one business and heart rate was 100 not long but for a few hours (on an unspecified date in 2021). And she stated that her neck felt like she slept on it wrong, like it was stiff (on an unspecified date in 2021). She further questioned could she use antipyretics before or after vaccination with the Pfizer-BIONTECH COVID-19 vaccine and had anyone reported anything happening with their 4th cranial nerve. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Influenza like illness, Musculoskeletal stiffness, Pain
Clinical narrative: Vaccine administered in Gluteus; flu like symptoms; body/skin tender to touch; felt terrible; heart raced like no one business. My heart rate was 100; neck felt like she slept on it wrong. Caller stated, "like it was stiff."; This is a spontaneous report from a contactable Nurse (patient) reported for herself via Medical Information Team. A 67-year-old female patient received second 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 Gluteus (as reported) on 22Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Jan2021 (at the age of 67-years-old) as DOSE 1, SINGLE for COVID-19 immunisation and experienced normal reactions. Patient stated when receiving her second vaccination on 22Feb2021, it has put her on her butt, she experienced (on an unspecified date in 2021) flu like symptoms and body/skin tender to touch, she felt terrible. At night she had on a long sleeve night gown and robe and was wrapped up with blankets. Her heart raced like no one business and heart rate was 100 not long but for a few hours (on an unspecified date in 2021). And she stated that her neck felt like she slept on it wrong, like it was stiff (on an unspecified date in 2021). She further questioned could she use antipyretics before or after vaccination with the Pfizer-BIONTECH COVID-19 vaccine and had anyone reported anything happening with their 4th cranial nerve. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain of skin
Clinical narrative: Vaccine administered in Gluteus; flu like symptoms; body/skin tender to touch; felt terrible; heart raced like no one business. My heart rate was 100; neck felt like she slept on it wrong. Caller stated, "like it was stiff."; This is a spontaneous report from a contactable Nurse (patient) reported for herself via Medical Information Team. A 67-year-old female patient received second 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 Gluteus (as reported) on 22Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Jan2021 (at the age of 67-years-old) as DOSE 1, SINGLE for COVID-19 immunisation and experienced normal reactions. Patient stated when receiving her second vaccination on 22Feb2021, it has put her on her butt, she experienced (on an unspecified date in 2021) flu like symptoms and body/skin tender to touch, she felt terrible. At night she had on a long sleeve night gown and robe and was wrapped up with blankets. Her heart raced like no one business and heart rate was 100 not long but for a few hours (on an unspecified date in 2021). And she stated that her neck felt like she slept on it wrong, like it was stiff (on an unspecified date in 2021). She further questioned could she use antipyretics before or after vaccination with the Pfizer-BIONTECH COVID-19 vaccine and had anyone reported anything happening with their 4th cranial nerve. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Nausea, Vomiting
Clinical narrative: weakness; dizziness; nausea; throwing up; everything was spinning; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25Feb2021 (at the age of 54-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Feb2021 at 04:00 the patient experienced dizziness, nausea, throwing up, everything was spinning, weakness. It was reported that and patient took the first one and then at 4 AM she woke up, she was dizzy, everything was spinning and she started feeling nausea and throwing up. She wants to know if that is an allergy reaction, does she need to go to the hospital. She wants to know if she should go to the hospital and if what she is experiencing is an allergic reaction.  Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: pain at the injection site; muscle pain; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 12:00 as dose 1, single for covid-19 immunisation (at the age of 77-year-old). Medical history included ongoing hypertension, ongoing blood cholesterol increased, prostate cancer from 2011 to an unknown date, throat cancer from 2006 to an unknown date. Concomitant medications included finasteride (FINASTERIDE) 5mg daily, lisinopril (LIS-INOPRIL) 20 mg daily, simvastatin (SIMVASTATIN) 40 mg daily, tamsulosin (TAMSULOSIN) 4mg daily taken for an unspecified indication from unspecified date of 2012 and ongoing; alendronate sodium (ALENDRONATE) 70 mg weekly taken for an unspecified indication from Dec2020 and ongoing; paracetamol (TYLENOL) 650mg three times daily taken for an unspecified indication from Aug2020 and ongoing. On an unspecified date of Feb2021 patient experienced muscle pain at night and wants to know how long the muscle pain will last. The muscle pain started 4-5 days later after receiving the vaccine. The consumer said that he is experiencing pain at the injection site after the 1st dose of the vaccine. The 1st dose was on 30Jan2021, and the 2nd dose is scheduled for 05Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased
Clinical narrative: his temperature goes up and down from his normal temp of 97.6 up to 99.5; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 23Feb2021 as dose 1, single for COVID-19 immunization. Medical history of the patient included Guillain-Barre syndrome in 1975 and was completely paralyzed, hospitalized, flu. Concomitant medications were not reported. Patient read an article which suggested the vaccine can trigger an auto-immune response if you have a history of Guillain-Barre syndrome. Reportedly, patient had history of Guillain-Barre syndrome. He didn't get it from the vaccine. He just got it from the flu. Patient was hospitalized for 6 months and put on a ventilator for 2 months. It was shown one dose is 70% effective. Patient would just get one dose. Patient have asked doctor's and pharmacist if eligible to receive the second. They referred patient to call Pfizer." Patient asked if he was eligible to receive the vaccine. On an unspecified date after first dose of vaccination, patient had noticed that his temperature goes up and down from his normal temp of 97.6 up to 99.5 but stated that his immune response could be triggering temperature. Patient asked if there was any contraindication to using Norco, Lortab or Mobic when getting the covid vaccine. Patient had his first Pfizer shot 3 days ago [date unspecified] and he has done a lot of research but can't find anything other than don't take Tylenol or medicine like that because it can affect the efficacy. He asked if there was any more information and how much does it affect the immune response? Patient only takes those medicines as needed and will likely not take it to prevent any kind of decreased effectiveness. Patient asked "when does the vaccine start protecting me? How does the vaccine work? Is antibody testing helpful to determine immunity?" Outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Limb discomfort, Pain in extremity, Somnolence
Clinical narrative: feel sleepy; headache; Three hours after administrating the 1st dose on my left arm, the whole arm suffered a big pain; some numbness on the left hand; could not move the arm at all because of the pain; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, solution for injection, Batch/Lot number: EL3247), via an unspecified route of administration, administered in left arm on 24Feb2021 at 10:00 as a single dose for covid-19 immunization. The patient's medical history included DCIS on left breast. The patient's concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other medications in four weeks. The patient had no COVID prior to vaccination and was not COVID tested post vaccination. On 24Feb2021 at 13:00, three hours after administrating the 1st dose on left arm, the whole arm suffered a big pain and there was even some numbness on the left hand. The patient could not move the arm at all because of the pain. Six hours after administrating, on 24Feb2021 at 16:00 hours, the patient started to feel sleepy and have headache. The patient did not receive any treatment for the adverse events. The outcome for the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Also experienced a headache; Soreness in left arm; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), via an unspecified route of administration, administered in Arm Left on 25Feb2021 11:15 (at the age of 55-year-old) as single dose for COVID-19 immunization. Medical history included COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient did not have allergies to medications, food or other products. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. On 25Feb2021, the patient experienced soreness in left arm following injection that increased throughout the day but was much improved by morning of 26Feb2021.  Also experienced a headache the morning after, on 26Feb2021 which resolved after taking Advil. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event soreness in left arm was recovered on 26Feb2021; headache was recovered in Feb2021.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anal incontinence, Dizziness
Clinical narrative: felt a little dizzy about 1 hour 1/2 after dosage; I had an upset stomach with multiple bowel movements; I had an upset stomach with multiple bowel movements; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration in right arm on 23Feb2021 at 15:30 (at the age of 52 years old) as dose 1, single for covid-19 immunisation. Medical history included self-known allergic to dust/animal hair allergy. Concomitant medications in two weeks included acetylsalicylic acid (ASPIRIN (E.C.)); pseudoephedrine hydrochloride (NASAL DECONGESTANT [PSEUDOEPHEDRINE HYDROCHLORIDE]); alprazolam (XANAX), vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 23Feb2021 at 17:00 patient experienced felt a little dizzy about 1-hour 1/2 after dosage. She had an upset stomach with multiple bowel movements afterwards. Next day she felt fine. The patient did not receive any treatments for the events. Reporter considered events as non-serious. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Musculoskeletal chest pain, Myalgia, Oropharyngeal pain
Clinical narrative: scratchy and sore throat; scratchy and sore throat; her ribs are sore; her muscles are aching (muscle near the injection site).; chills; her head feels like she is in the clouds; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202) via an unspecified route of administration on 26Feb2021 (at the age of 70 years old) as dose 1, single for COVID-19 immunisation. Medical history included allergic to whole strawberries. No concomitant medications were reported. Patient got the first dose of the Pfizer BioNTech COVID-19 vaccine today (26Feb2021) and she developed adverse events. Her adverse events are scratchy and sore throat, and she feels like she has the flu, her ribs are sore, her muscles are aching (muscle near the injection site), her head feels like she was in the clouds and also chills, she began feeling all of this about 45 minutes after the shot. She wanted to know if it was a typical reaction with the Pfizer COVID-19 vaccine. Patient also stated instead of the standard 15 minutes they had her wait 30 minutes. She didn't feel sick or anything at all, her throat didn't start bothering her. She was telling her daughter about how she got the vaccine and everything was flawless, she had no aches and pains then she had to tell her she was going to have to go because her throat, she thought she was talking too much she told her daughter maybe her throat was dry. She told her daughter she was going to have to stop talking and it has gone since then. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: scratchy and sore throat; scratchy and sore throat; her ribs are sore; her muscles are aching (muscle near the injection site).; chills; her head feels like she is in the clouds; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202) via an unspecified route of administration on 26Feb2021 (at the age of 70 years old) as dose 1, single for COVID-19 immunisation. Medical history included allergic to whole strawberries. No concomitant medications were reported. Patient got the first dose of the Pfizer BioNTech COVID-19 vaccine today (26Feb2021) and she developed adverse events. Her adverse events are scratchy and sore throat, and she feels like she has the flu, her ribs are sore, her muscles are aching (muscle near the injection site), her head feels like she was in the clouds and also chills, she began feeling all of this about 45 minutes after the shot. She wanted to know if it was a typical reaction with the Pfizer COVID-19 vaccine. Patient also stated instead of the standard 15 minutes they had her wait 30 minutes. She didn't feel sick or anything at all, her throat didn't start bothering her. She was telling her daughter about how she got the vaccine and everything was flawless, she had no aches and pains then she had to tell her she was going to have to go because her throat, she thought she was talking too much she told her daughter maybe her throat was dry. She told her daughter she was going to have to stop talking and it has gone since then. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site on the day of injection; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain at injection site on the day of injection on unspecified date. Both he and his wife experienced pain at injection site on the day of injection. On the second day after the vaccine, she started suffering from joint pain, muscle pain and inflammation (swelling in hands and wrist) and has been ongoing since and had not noticeably resolved. States her pain seems to subside during day but comes back at night. Also reports that the pain seems to travel throughout her body from one shoulder to the next shoulder. She had consulted her hcp who has prescribed anti inflammatory which helps the pain. The outcome of the event was unknown.  Information about lot/batch number has been requested  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Gastrointestinal sounds abnormal
Clinical narrative: stomach cramps; stomach "noises"/noises in her stomach; diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient) and physician. A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6198; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in arm right on 22Feb2021 (at the age of 67-year-old) at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient is 67 y/o. Received her first dose of the Pfizer Covid vaccine on Monday 22Feb2021. On 23Feb2021 around 8 pm she experienced stomach "noises" and diarrhea. On 24Feb2021 she said she was ok with no diarrhea. On 25Feb2021 around 11:30 pm she had stomach cramps and diarrhea, and on 26Feb2021 she has experienced just stomach cramping. She wants to know how long will the diarrhea last. Additional Context: Reporter stated that she has questions about reactions to the vaccine, states she had the vaccine on Monday 22Feb2021, and initially had no reaction, states Tuesday she thought she felt ok, states she took her dog to the park, Tuesday night around 8PM she started having diarrhea and noises in her stomach, on Wednesday she was fine, mostly solid stools, states yesterday 25Feb2021 she had one small bowel movement and last night around 11:30PM she had diarrhea again. Should the side effects be lasting this long. Reporter encouraged to reach out to health care provider for any medical advice. Outcome of the event diarrhea was not resolved and remaining other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Really dizzy; Really nauseous; Felt like weakness in her arms and legs; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EN6202 and expiry date was not reported), via an unspecified route of administration in arm left, on 26Feb2021 at 08:00 (at the age of 27-year-old), as a dose 1, single for COVID-19 immunization. The patient's medical history includes allergy to morphine probably around 2018, when she had her son. The patient stated that she had no reactions to vaccinations. It was reported that on an unspecified date in Jul2020 the patient had COVID and due to having COVID the patient developed really bad allergies that sometimes make it hard for her to breathe, but nothing else that she was aware of. The patient concomitant medication includes mepyramine maleate, pamabrom, paracetamol (Pamprin) (Start: Unknown Stop: Unknown) for cramps. Reportedly within four weeks prior to the first administration date of the suspect vaccine the patient did not receive any other vaccine. On 26Feb2021, probably around 5 hours after being administered the vaccine, around 13:00, the patient felt fine almost all morning but then she felt really dizzy, really nauseous and felt like weakness in her arms and legs and she could still hold things and stuff. She wanted to make sure that these are normal reactions to the vaccine, or if they are serious events, and if she should follow-up with doctor or medical attention. The clinical outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: slight sore throat; This is a spontaneous report from a contactable consumer (patient). A female patient of an un-specified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported a slight sore throat as she was speaking. Patient was scheduled to receive the second dose of the vaccine but doesn't know the time and date. The outcome of the event unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after both injections.; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer-sponsored program.  A male patient of an unspecified age (Age: 60; Unit: Unknown) received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on 25Jan2021 as single dose and first dose via an unspecified route of administration on 04Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included paracetamol (TYLENOL). It was reported that caller was calling on behalf of her husband who works in healthcare and has received both doses of the Covid vaccine. Caller had question on behalf of her husband. Caller stated that her husband took Tylenol prior to receiving both doses of the vaccine with the intention of pre-medicating and wanted to know if that was okay. Caller then clarified husband only took Tylenol before first dose. Caller stated that he was unaware of the guideline to not take Tylenol prior to receiving the vaccine and did not take Tylenol after receiving the vaccine. Caller stated that her husband experienced a sore arm after both injections on Jan2021. Caller was asking if her husband needs to take a booster due to him medicating with Tylenol prior to receiving either dose. Caller stated, it was her fault on telling him to do that. They used to tell her to do that with their kids. Caller asked if Tylenol would lessen the effectivity of the vaccine and if need to take any other shot of the vaccine again. Precautionary AE. Seriousness of the event was non serious. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained.