chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Piloerection, Vaccination site pain
Clinical narrative: Goosebumps, tingling and numbness on the left side of her face and left side of her arm; Goosebumps, tingling and numbness on the left side of her face and left side of her arm; Goosebumps, tingling and numbness on the left side of her face and left side of her arm; Goosebumps, tingling and numbness on the left side of her face and left side of her arm; Pain at the injection site; This is a spontaneous report from a contactable Nurse or Other Health Care Professional. This nurse reported for a 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/Lot Number: EW0185; Expiration Date: Aug2021) via an unspecified route of administration on 15May2021 (at the age of 16 years) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No illness at time of vaccination. No family medical history relevant to ae. It was unknown if any AEs following prior vaccinations. Patient was not taken any medications within 4 weeks, prior vaccination. No additional vaccines administered on same date of the Pfizer suspect. No history of all previous immunization with the Pfizer vaccine considered as suspect. The caller stated that on 15may2021, the same day of vaccine in the afternoon after the first dose, patient experienced goosebumps, tingling, numbness to the left side of her face and left arm, and pain at the injection site in her arm. All the adverse events resulted in physician office. Relevant tests were none. The outcome of events was not recovered.  Further follow up excepted. Batch/lot number can be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report from a Pfizer sponsored. A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 12:00 (Age at vaccination 37 years old) (Batch/Lot Number: ER8729) as DOSE1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No Prior Vaccinations (within 4 weeks). On 09Apr2021 she stated she felt tired 24 hours after the first dose. Vaccination Facility. No Emergency Room and Physician Office visit. None relevant test. Outcome of event was recovered on 10Apr2021.  follow-up attempts are needed. further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives all over my body, like a rash and they kind of turned into hives; Hives all over my body, like a rash and they kind of turned into hives; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), second dose via an unspecified route of administration on an unspecified date 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 and expiration date was not reported), first dose via an unspecified route of administration on an unspecified date single for covid-19 immunisation. On an unspecified date the patient experienced hives all over body, like a rash and they kind of turned into hives. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cyst, Breast mass, Mammogram abnormal
Clinical narrative: had a mammogram on 21Apr2021 and had a bad reading. She has a 3mm mass or cyst; had a mammogram on 21Apr2021 and had a bad reading. She has a 3mm mass or cyst; This is a spontaneous report from a contactable consumer or other non hcp.    A 74-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: ENE202), dose 2 via an unspecified route of administration, administered in Arm Left on 27Feb2021 10:00 as 2nd dose, single for covid-19 immunisation. Medical history included pain in extremity. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that, A female consumer had both doses of Pfizer COVID vaccine on 06Feb2021 and 27Feb2021. She had a mammogram on 21Apr2021 and had a bad reading. She has a 3mm mass or cyst and they are not sure what it is. She was talking to her physical therapist who told her that you have to wait 3 months after your last vaccine for a mammogram because there have been having false readings. She has been wondering if that was true. The outcome of the events was unknown on 21Apr2021.The patient underwent lab tests and procedures which included mammogram abnormal: 3-millimetre mass or cyst on 21Apr2021 Bad reading on mammogram; 3-millimetre mass or cyst.    Follow-up (21May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported information included.  Information on Lot/Batch number is available; Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Contusion, Diarrhoea, Dizziness
Clinical narrative: Sore arm/soreness in her right arm; Headache; Diarrhea; Nausea; Really bad anxiety; Sore throat; Body hurts; Tingling all over; Has a bruise on her arm; Dizzy; This is a spontaneous report from a contactable consumer (patient's daughter). A 65-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unknown route of administration, administered in right arm on 20May2021 at 09:45 (at the age of 65-years-old) as dose 1, single for covid-19 immunisation. Medical history included brain aneurysm diagnosed with it 10-15 years ago/13 years ago from an unknown date and COPD (chronic obstructive pulmonary disease) diagnosed about 8 years ago from an unknown date. There were no concomitant medications. On an unknown date in May2021, patient's daughter reported that her mother had no side effects until 7 hours later; then she had soreness, sore throat, headache, diarrhea, her body hurts and she had really bad anxiety. The patient's daughter reported that her mother had soreness of her right arm yesterday 20May2021 that got worse. She wanted to raise her arm last night and it took her to the moon. Patient's daughter does not clarified this statement, but stated that her mother had a bruise on her arm on an unknown date in May2021. She stated her mother also had tingling all over, nausea, headache, sore throat, was dizzy, diarrhea, body soreness and really bad anxiety on an unknown date in May2021. A plethora of symptoms that patient's daughter reported was unable to capture as she rattled them off. Patient did not receive any other vaccinations yesterday or in the four weeks prior to covid-19 vaccine. Patient's daughter reported that, two weeks ago on an unknown date in May2021 they drew a blood panel on her mom and results were unknown. Outcome of events was unknown.   Information on the lot/batch number has been requested, further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Sore arm/soreness in her right arm; Headache; Diarrhea; Nausea; Really bad anxiety; Sore throat; Body hurts; Tingling all over; Has a bruise on her arm; Dizzy; This is a spontaneous report from a contactable consumer (patient's daughter). A 65-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unknown route of administration, administered in right arm on 20May2021 at 09:45 (at the age of 65-years-old) as dose 1, single for covid-19 immunisation. Medical history included brain aneurysm diagnosed with it 10-15 years ago/13 years ago from an unknown date and COPD (chronic obstructive pulmonary disease) diagnosed about 8 years ago from an unknown date. There were no concomitant medications. On an unknown date in May2021, patient's daughter reported that her mother had no side effects until 7 hours later; then she had soreness, sore throat, headache, diarrhea, her body hurts and she had really bad anxiety. The patient's daughter reported that her mother had soreness of her right arm yesterday 20May2021 that got worse. She wanted to raise her arm last night and it took her to the moon. Patient's daughter does not clarified this statement, but stated that her mother had a bruise on her arm on an unknown date in May2021. She stated her mother also had tingling all over, nausea, headache, sore throat, was dizzy, diarrhea, body soreness and really bad anxiety on an unknown date in May2021. A plethora of symptoms that patient's daughter reported was unable to capture as she rattled them off. Patient did not receive any other vaccinations yesterday or in the four weeks prior to covid-19 vaccine. Patient's daughter reported that, two weeks ago on an unknown date in May2021 they drew a blood panel on her mom and results were unknown. Outcome of events was unknown.   Information on the lot/batch number has been requested, further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Sore arm/soreness in her right arm; Headache; Diarrhea; Nausea; Really bad anxiety; Sore throat; Body hurts; Tingling all over; Has a bruise on her arm; Dizzy; This is a spontaneous report from a contactable consumer (patient's daughter). A 65-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unknown route of administration, administered in right arm on 20May2021 at 09:45 (at the age of 65-years-old) as dose 1, single for covid-19 immunisation. Medical history included brain aneurysm diagnosed with it 10-15 years ago/13 years ago from an unknown date and COPD (chronic obstructive pulmonary disease) diagnosed about 8 years ago from an unknown date. There were no concomitant medications. On an unknown date in May2021, patient's daughter reported that her mother had no side effects until 7 hours later; then she had soreness, sore throat, headache, diarrhea, her body hurts and she had really bad anxiety. The patient's daughter reported that her mother had soreness of her right arm yesterday 20May2021 that got worse. She wanted to raise her arm last night and it took her to the moon. Patient's daughter does not clarified this statement, but stated that her mother had a bruise on her arm on an unknown date in May2021. She stated her mother also had tingling all over, nausea, headache, sore throat, was dizzy, diarrhea, body soreness and really bad anxiety on an unknown date in May2021. A plethora of symptoms that patient's daughter reported was unable to capture as she rattled them off. Patient did not receive any other vaccinations yesterday or in the four weeks prior to covid-19 vaccine. Patient's daughter reported that, two weeks ago on an unknown date in May2021 they drew a blood panel on her mom and results were unknown. Outcome of events was unknown.   Information on the lot/batch number has been requested, further information has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Troponin, Vaccination site pain
Clinical narrative: tenderness at the shot site; very tired; This is a spontaneous report from contactable consumer(parent) reported for a 20-year-old male patient (reporter's son). A 20-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on (age at the time of vaccination 20-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not report any adverse events prior to vaccination. The caller was calling about the Pfizer COVID vaccine on behalf of her son. The patient was 20 years old and was extremely healthy. The patient was very strict on his health. The patient was a vegetarian, he was very health conscious. It was reported that after the first dose the patient had some tenderness at the shot site and felt very tired on an unspecified date. The patient underwent lab tests and procedures which included EKG: heart attack on 20May2021, troponin: elevated on 20May2021, troponin: elevated on 20May2021. Outcome of the event tenderness at the shot site was reported as recovering and other event outcome was unknown at this time of the report.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: I have alopecia/ all but disappeared; This is a spontaneous report from a contactable consumer (reported for himself) via a Pfizer sponsored program. A 75-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: E69267), via intramuscular, administered in Arm Left on 06Feb2021 13:30 as DOSE 1, SINGLE and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206), intramuscular, administered in Arm Left on 09Mar2021 07:00 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced he have alopecia, all but disappeared. Patient reported that in Feb and Mar he had the Pfizer COVID-19 vaccine. Did very well with both. Patient have little hair anywhere. After the COVID shots his eyebrows and eyelashes began to fill in very nicely. After a few weeks after the shots, it went the other way gain and have all but disappeared. Do you think this can possibly be related. Nothing else has been done different during this time, meds. etc. Patient would like to hear from us. This was not a complaint. Just wanted to know, if something in the vaccine affected his immune system that caused his hair to start regrowth his eye brows, eye lashes and a little chest hair were affected. Though may be something extraordinary was happened. It has since gone the other way. The clinical outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Vomiting
Clinical narrative: Threw up; Pain on my side like between my ribs; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date: Unknown), via an unspecified route of administration in an unspecified anatomical location on 21May2021 (at the age of 60-year-old), as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date: Unknown) via an unspecified route of administration in an unspecified anatomical location on an unspecified date (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The caller got the second dose on Friday afternoon, 21May2021, and she was perfectly fine at first. Later Friday, 21May2021, the caller was throwing up like crazy and that just stopped as of yesterday, 23May2021. The caller was throwing up all Friday afternoon and she could not stop. Now, the caller's muscles, like the ones that are in-between her ribs, are hurting. It especially hurts when the caller sits down and when she lays down. The patient wanted to know whether the muscle pain will go away. The outcome of the event vomiting was reported as resolved on 23May2021 and for pain was unknown.  Follow up needed, further information has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: a little tired; This is a spontaneous report from a contactable consumer (reported for herself). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267), via intramuscular route of administration on 13Feb2021 (at the age of 80-year-old), as dose 2, single in upper left arm for COVID-19 immunization at Pharmacy/drug store. The patient's medical history was reported as none and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), via intramuscular route of administration on 21Jan2021 at 12:30 (at the age of 80-year-old), as single dose in upper left arm for COVID-19 immunization. On 14Feb2021, the next day after receiving the second dose, the patient felt a little tired, but not fatigues at all. The clinical outcome of the event was unknown.  Follow-up attempts are needed. Further information has been expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck mass, Pain, Ultrasound scan
Clinical narrative: a lot of pain; a lot of little balls around her neck; her lymph nodes to be swollen.; This is spontaneous report from contactable consumer (Patient herself). A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 09Mar2021 (at the age of 51-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had her first dose of the PFIZER-BIONTECH COVID-19 VACCINE on 09March2021. A week later after her first dose, on 16March2021, she reported that she woke up with a lot of pain and a lot of little balls around her neck. Her doctor ordered for her ultrasound and assessed her lymph nodes to be swollen. Further evaluation was conducted, and her oncologist assessed that she looks okay and should get the second dose. Her main question was that, given that it has been 77 days or 11 weeks past her 1st dose. Does she still need to get a second dose, or does she need to start over again with her vaccination. Spoke mainly on the Second Dose Later than 3 Weeks as advised by Agency. Advised of Pfizer-BioNTech COVID-19 Vaccine vaccination series to be given 2 doses given 3 weeks apart.1. The patient underwent lab tests and procedures which included ultrasound on unspecified date in Mar2021. Outcome of the events was unknown.  Information on the Lot/Batch number has been requested.  Follow up #1 (26Jul2021): Follow-up activities closed: Batch/lot number not available.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Epistaxis, Fatigue, Feeling abnormal
Clinical narrative: Feeling  tired with flu like symptoms; Chills; Experienced clots when blowing his nose; Feel bad; sore; Very tired; Sore; Leg pains; neck pain; shoulder pain; This is a spontaneous report from a contactable consumer (patient) or other non HCP via Medical Information Team.   A 82-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8737, Expiration date: unknown) via an unspecified route of administration on 20May2021 (at the age of 82-years-old) as dose 1 single for covid-19 immunization. The patient Medical history included Heart attack from an unknown date and unknown if ongoing Verbatim: Heart attack, diabetes mellitus from an unknown date and unknown if ongoing Verbatim: Diabetes. Concomitant medication(s) included carvedilol (CARVEDILOL AL) taken for an unspecified indication, Metformin taken for an unspecified indication, furosemide sodium (FUROSEMIDE AL) taken for an unspecified indication, tamsulosin taken for an unspecified indication, glipizide (GLIPIZIDE) taken for diabetes mellitus and finasteride (FINASTERIDE) taken for an unspecified indication start and stop date were not reported. On an unspecified date patient experienced Feeling tired with flu like symptoms, Chills, clots when blowing his nose, feel bad, Leg pains, the neck, shoulder, Sore. it was reported that after administration of vaccine patient started to feel bad, this was a first shot, leg pains, the neck, shoulder and chills on an unspecified date yesterday he started to feel a little better, today even had some breakfast and a little lunch and hour and half ago he stared to get chill again real cold and real achy again in his legs and So he kind of bunded up and he took two Tylenol, Confirmed Tylenol as treatment for the side effects He had the blow his nose constantly and he has been  getting the 3 good size clots coming out of his wrong side of his nose on an unspecified date kind of blackish and blood and blood on the other side of his nose also. His only problem is his legs, he thinks he got neuropathy (Further clarification unknown), people make this know that some old guy hardly walk believe he just concerned that it might be a side effect and real sick and dying. The outcome of events was Unknown.   Follow-up attempts have been completed and no further information is expected
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Neck pain, Pain, Pain in extremity
Clinical narrative: Feeling  tired with flu like symptoms; Chills; Experienced clots when blowing his nose; Feel bad; sore; Very tired; Sore; Leg pains; neck pain; shoulder pain; This is a spontaneous report from a contactable consumer (patient) or other non HCP via Medical Information Team.   A 82-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8737, Expiration date: unknown) via an unspecified route of administration on 20May2021 (at the age of 82-years-old) as dose 1 single for covid-19 immunization. The patient Medical history included Heart attack from an unknown date and unknown if ongoing Verbatim: Heart attack, diabetes mellitus from an unknown date and unknown if ongoing Verbatim: Diabetes. Concomitant medication(s) included carvedilol (CARVEDILOL AL) taken for an unspecified indication, Metformin taken for an unspecified indication, furosemide sodium (FUROSEMIDE AL) taken for an unspecified indication, tamsulosin taken for an unspecified indication, glipizide (GLIPIZIDE) taken for diabetes mellitus and finasteride (FINASTERIDE) taken for an unspecified indication start and stop date were not reported. On an unspecified date patient experienced Feeling tired with flu like symptoms, Chills, clots when blowing his nose, feel bad, Leg pains, the neck, shoulder, Sore. it was reported that after administration of vaccine patient started to feel bad, this was a first shot, leg pains, the neck, shoulder and chills on an unspecified date yesterday he started to feel a little better, today even had some breakfast and a little lunch and hour and half ago he stared to get chill again real cold and real achy again in his legs and So he kind of bunded up and he took two Tylenol, Confirmed Tylenol as treatment for the side effects He had the blow his nose constantly and he has been  getting the 3 good size clots coming out of his wrong side of his nose on an unspecified date kind of blackish and blood and blood on the other side of his nose also. His only problem is his legs, he thinks he got neuropathy (Further clarification unknown), people make this know that some old guy hardly walk believe he just concerned that it might be a side effect and real sick and dying. The outcome of events was Unknown.   Follow-up attempts have been completed and no further information is expected
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Developed a rash on the face; Rash has now spread on the face, behind the ears, neck and on the stomach, rash did not itch; He has no itching its just bumps; This is a spontaneous report from a contactable consumer (patient's mother).A 14-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization.The patient's medical history and concomitant medications were not reported.On an unknown date, after 10-15 minutes of vaccine administration, the patient began having a rash on his face. It was reported that the rash had now spread to most of his face, behind his ears, down his neck, on his stomach and sides. The rash was not itchy, it was just bumps and was not bothering him, he felt fine. He was doing everything like normal and eating junk food, everything that a age boy would normally do. She asked if it was safe for him to receive the second dose of the vaccine since he had this side effect. The outcome of event was unknown.   information about lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Nausea
Clinical narrative: Still having nausea and chills; Still having nausea and chills; This is a spontaneous report from a contactable consumer. This 73-year-old male consumer (patient) reported for himself that:  If known, what role does the reporter have? Patient/Consumer Patient Details: Gender: Male  Pfizer Product Name or Description: 2nd shot Covid-19 vaccine 01Mar2021 Also takes testosterone shots  Was the product used by the patient? Yes  Description of the event, comment, or concern as provided by the reporter: Still having nausea and chills  Follow-up attempts are needed. Information about batch/lot has been requested. .
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Muscle spasms, Muscle twitching, Nausea
Clinical narrative: Gout; on and off nauseated; twitching and cramps in hamstrings, feet and hands; twitching and cramps in hamstrings, feet and hands; This is a spontaneous report from a contactable consumer. This 53-year-old male consumer (patient) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 11:00 (at the age of 53-years-old) (Batch/Lot Number: ER8737) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously took bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (Batch/Lot Number: EN6200) as DOSE 1, SINGLE for covid-19 immunisation and experienced Hand swelling, Numbness and tingling in fingers/numbness and tingling in toes, Feet swelling, Ankle swelling, Cold chills without a fever, Fatigue and Gout. The patient was on and off nauseated and twitching and cramps in hamstrings, feet and hands on 02Apr2021, the patient states after the second shot that he got on 01Apr2021 this went on for a three-week period where he could not eat hardly, and he never threw up but always felt like it. He started getting better around 23Apr2021 or 24Apr2021. He still had it a little, but it was not as severe. Patient also had gout on 25May2021 and patient states last night at three in the morning he woke up with unbelievable pain and swelling in his left foot where he could not walk on it so he went to the emergency room and the doctor listened to all his symptoms and said they would treat his foot. Patient states they did not aspirate the joint in his foot he was just given a steroid injection and some pain meds and now the doctor wants him to see a podiatrist for the aspiration. Patient stated he was on pain meds and cannot walk because of it. He stated he did want to mention he had also been having twitching and cramps in hamstrings, feet and hands as well but not all the time as it comes randomly. Patient had not administered additional vaccines. Patient had no vaccination within 4 weeks and not prior also. Informed patient for medical advice to contact a doctor but if the patient was wondering if the symptoms, he had been experiencing had been reported side effects of the vaccine this DSU agent can transfer him to USMI. The outcome of event nauseated was recovering and all other events outcome was unknown.  Information on Lot/Batch number was available. Additional information has been requested
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Pregnancy test
Clinical narrative: I have not received my period since getting the vaccine/ Period has been regular for 15+ years.; This is a spontaneous report from a contactable consumer or Other-HCP (patient). A 37-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0153), via an unspecified route of administration in Arm Left on an unspecified date Apr2021 10:00 AM (age at the time of vaccination 37-years-old), as a single dose for COVID-9 immunization. The patient's medical history included Migraine. Patient had no known allergies. The patient's concomitant medication includes Topamax, Maxalt, Amitriptyline, and Multivitamin. No prior Vaccinations within 4 weeks. No covid prior vaccination. No covid tested post vaccination. On 09Apr2021, the patient experienced I have not received my period since getting the vaccine/ Period has been regular for 15+ years. On an unspecified date, the patient underwent lab tests and procedures which included pregnancy test: negative, I have confirmed negative blood pregnancy test from physician. Patient received Medroxyprogesterone 10mg as a treatment for adverse event. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered.  No Follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Computerised tomogram, Decreased appetite, Fatigue, Full blood count
Clinical narrative: I had a pounding headache; exhausted and my appetite was heavily suppressed; exhausted and my appetite was heavily suppressed; I typically run 40-50 miles a week and I was barely able to get down my stairs.; I lost 7 pounds in 2 weeks from these symptoms; Nausea; bedridden for 16-18 hours everyday; This is a spontaneous report from a contactable consumer, the patient herself and contactable physician. A 26-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: ER8730 EUA 4/21 SWY/ALB), via intramuscular route, administered in Left deltoid, on 05May2021 at 09:00 as dose 2, single (age at vaccination: 26 years), for covid-19 immunization. Medical history included ongoing HPV Positive from Jan2021 and Mild intermittent asthma from Dec2017; also had a history of Mild cervical dysplasia from Feb2019, unknown if ongoing. The patient had no known allergies. Concomitant medications included oral sumatriptan taken for headache, start and stop date were not reported. The patient previously received dose 1 of bnt162b2 (Lot: ER8730 EUA 4/21 SWY/ALB) as a single dose in Left arm, on 14Apr2021 at 10:00 AM (age at vaccination: 26 years), for covid-19 immunization. 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 and since the vaccination, the patient had not been tested for COVID-19. The patient stated that, on 05May2021 at 18:00, she started experiencing a pounding headache which was still somewhat prevalent that was so severe that she was bedridden for 16-18 hours every day, also started feeling exhausted, her appetite was heavily suppressed and she typically ran 40-50 miles a week and was barely able to get down her stairs. She told that, she had prolonged side effects from the vaccine going on 4 weeks. She stated that, she lost 7 pounds in 2 weeks from these symptoms (onset date: May2021). It was also reported that, the patient started experiencing nausea since an unknown date in 2021. The seriousness for the events were reported as non-serious. The adverse event resulted in Emergency room/department or urgent care. For headache and nausea, both Emergency room and physician office visits were required. The patient underwent lab tests and procedures which included CT head (Computerized tomogram), CBC (Full blood count), U HCG (Human chorionic gonadotropin), CMP (Metabolic function test) and UA (urine analysis), all with negative results on 23May2021. The patient did not receive treatment for headache and nausea and for other events received a shot of Toradol, and an IV of Promethazine. The outcome for all the events was reported as recovering.   No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Human chorionic gonadotropin, Metabolic function test, Nausea
Clinical narrative: I had a pounding headache; exhausted and my appetite was heavily suppressed; exhausted and my appetite was heavily suppressed; I typically run 40-50 miles a week and I was barely able to get down my stairs.; I lost 7 pounds in 2 weeks from these symptoms; Nausea; bedridden for 16-18 hours everyday; This is a spontaneous report from a contactable consumer, the patient herself and contactable physician. A 26-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: ER8730 EUA 4/21 SWY/ALB), via intramuscular route, administered in Left deltoid, on 05May2021 at 09:00 as dose 2, single (age at vaccination: 26 years), for covid-19 immunization. Medical history included ongoing HPV Positive from Jan2021 and Mild intermittent asthma from Dec2017; also had a history of Mild cervical dysplasia from Feb2019, unknown if ongoing. The patient had no known allergies. Concomitant medications included oral sumatriptan taken for headache, start and stop date were not reported. The patient previously received dose 1 of bnt162b2 (Lot: ER8730 EUA 4/21 SWY/ALB) as a single dose in Left arm, on 14Apr2021 at 10:00 AM (age at vaccination: 26 years), for covid-19 immunization. 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 and since the vaccination, the patient had not been tested for COVID-19. The patient stated that, on 05May2021 at 18:00, she started experiencing a pounding headache which was still somewhat prevalent that was so severe that she was bedridden for 16-18 hours every day, also started feeling exhausted, her appetite was heavily suppressed and she typically ran 40-50 miles a week and was barely able to get down her stairs. She told that, she had prolonged side effects from the vaccine going on 4 weeks. She stated that, she lost 7 pounds in 2 weeks from these symptoms (onset date: May2021). It was also reported that, the patient started experiencing nausea since an unknown date in 2021. The seriousness for the events were reported as non-serious. The adverse event resulted in Emergency room/department or urgent care. For headache and nausea, both Emergency room and physician office visits were required. The patient underwent lab tests and procedures which included CT head (Computerized tomogram), CBC (Full blood count), U HCG (Human chorionic gonadotropin), CMP (Metabolic function test) and UA (urine analysis), all with negative results on 23May2021. The patient did not receive treatment for headache and nausea and for other events received a shot of Toradol, and an IV of Promethazine. The outcome for all the events was reported as recovering.   No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Weight decreased
Clinical narrative: I had a pounding headache; exhausted and my appetite was heavily suppressed; exhausted and my appetite was heavily suppressed; I typically run 40-50 miles a week and I was barely able to get down my stairs.; I lost 7 pounds in 2 weeks from these symptoms; Nausea; bedridden for 16-18 hours everyday; This is a spontaneous report from a contactable consumer, the patient herself and contactable physician. A 26-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: ER8730 EUA 4/21 SWY/ALB), via intramuscular route, administered in Left deltoid, on 05May2021 at 09:00 as dose 2, single (age at vaccination: 26 years), for covid-19 immunization. Medical history included ongoing HPV Positive from Jan2021 and Mild intermittent asthma from Dec2017; also had a history of Mild cervical dysplasia from Feb2019, unknown if ongoing. The patient had no known allergies. Concomitant medications included oral sumatriptan taken for headache, start and stop date were not reported. The patient previously received dose 1 of bnt162b2 (Lot: ER8730 EUA 4/21 SWY/ALB) as a single dose in Left arm, on 14Apr2021 at 10:00 AM (age at vaccination: 26 years), for covid-19 immunization. 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 and since the vaccination, the patient had not been tested for COVID-19. The patient stated that, on 05May2021 at 18:00, she started experiencing a pounding headache which was still somewhat prevalent that was so severe that she was bedridden for 16-18 hours every day, also started feeling exhausted, her appetite was heavily suppressed and she typically ran 40-50 miles a week and was barely able to get down her stairs. She told that, she had prolonged side effects from the vaccine going on 4 weeks. She stated that, she lost 7 pounds in 2 weeks from these symptoms (onset date: May2021). It was also reported that, the patient started experiencing nausea since an unknown date in 2021. The seriousness for the events were reported as non-serious. The adverse event resulted in Emergency room/department or urgent care. For headache and nausea, both Emergency room and physician office visits were required. The patient underwent lab tests and procedures which included CT head (Computerized tomogram), CBC (Full blood count), U HCG (Human chorionic gonadotropin), CMP (Metabolic function test) and UA (urine analysis), all with negative results on 23May2021. The patient did not receive treatment for headache and nausea and for other events received a shot of Toradol, and an IV of Promethazine. The outcome for all the events was reported as recovering.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Ear congestion, Lymphadenopathy, Pain of skin
Clinical narrative: I got little dizzy; I had swollen glands like my throat was really swollen then, I got extremely dizzy and had my ears were completely clogged; I got little dizzy; I had swollen glands like my throat was really swollen then, I got extremely dizzy and had my ears were completely clogged; I got little dizzy; I had swollen glands like my throat was really swollen then, I got extremely dizzy and had my ears were completely clogged; I had diarrhea and my skin was hurt; I had diarrhea and my skin was hurt; I got little dizzy; I had swollen glands like my throat was really swollen then, I got extremely dizzy and had my ears were completely clogged; This is a spontaneous report from a contactable consumer or other non-HCP. A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8737), via an unspecified route of administration, administered in Arm Left on 05Apr2021 as DOSE 1, SINGLE (at the age of: 52-year-old) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 05Apr2021 the patient experienced she got little dizzy; on 06Apr2021 she had swollen glands like her throat was really swollen then, she got extremely dizzy and had her ears were completely clogged. On 06Apr2021 the patient experienced she had diarrhea and her skin was hurt. The outcome of all events was recovered on Apr2021. Treatment was given for the reported events as steroid shot.  Follow-up (05Jul2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021611449 similar report from same reporter
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: I got little dizzy; I had swollen glands like my throat was really swollen then, I got extremely dizzy and had my ears were completely clogged; I got little dizzy; I had swollen glands like my throat was really swollen then, I got extremely dizzy and had my ears were completely clogged; I got little dizzy; I had swollen glands like my throat was really swollen then, I got extremely dizzy and had my ears were completely clogged; I had diarrhea and my skin was hurt; I had diarrhea and my skin was hurt; I got little dizzy; I had swollen glands like my throat was really swollen then, I got extremely dizzy and had my ears were completely clogged; This is a spontaneous report from a contactable consumer or other non-HCP. A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8737), via an unspecified route of administration, administered in Arm Left on 05Apr2021 as DOSE 1, SINGLE (at the age of: 52-year-old) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 05Apr2021 the patient experienced she got little dizzy; on 06Apr2021 she had swollen glands like her throat was really swollen then, she got extremely dizzy and had her ears were completely clogged. On 06Apr2021 the patient experienced she had diarrhea and her skin was hurt. The outcome of all events was recovered on Apr2021. Treatment was given for the reported events as steroid shot.  Follow-up (05Jul2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021611449 similar report from same reporter
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: I took the first shot, the side of my foot swelled up/ When I got the first shot of Pfizer side of my foot swelled up; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: EW0167, Expiry date: not reported) via an unspecified route of administration on 30Apr2021 (age at vaccination 50-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension and kidney transplant from an unknown date and unknown if ongoing. Concomitant medications included tacrolimus (PROGRAF) taken for renal transplant and amlodipine taken for hypertension, start and stop date were not reported. On an unspecified date, patient stated that he was having real bad side effects, so he took the first shot, the side of his foot swelled up. Patient stated that taking Tylenol but its not working. The outcome of the event was unknown.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Heart rate, Heart rate increased, Supraventricular tachycardia
Clinical narrative: asymptomatic supraventricular tachycardia (SVT); abnormal ECG, heart rate around 150; This is a spontaneous report from a contactable consumer or other non hcp. A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EW0177; Expiration Date: 31Aug2021)) dose 1 via an unspecified route of administration, administered in the left arm on 14May2021 18:30 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. 0n 17May2021, the patient experienced asymptomatic supraventricular tachycardia (svt) (supraventricular tachycardia), abnormal ECG, heart rate around 150 (heart rate increased. During a routine doctor's visit on 17May2021, pediatrician noticed an elevated heart rate. The patient visited emergency room and physician office. The patient underwent lab tests and procedures which included electrocardiogram was abnormal and heart rate around150 on 20May2021. Device timestamp was on 28May2021. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles diagnosed on 23May2021; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 42-year-old female patient received bnt162b2 (Pfizer covid 19, formulation: solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration, administered in Arm Left on 13May2021 18:30 (at the age of 42-years-old) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included rubber sensitivity for allergies= Latex, HPV (Human papilloma virus infection). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22May2021, the patient experienced shingles and was diagnosed on 23May2021. Therapeutic measures were taken as a result of shingles was antiviral for 7 days. The outcome of the event was recovering.  Follow-up attempts completed. No further information expected.