chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Lip disorder, Lip swelling, Musculoskeletal stiffness, Nasal congestion
Clinical narrative: normal stiffness in her arm; legs felt heavy; lips felt greasy with a minor petroleum jelly feeling and taste; nose became stuffy; bottom lip became swollen; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration morning around 11:30 am on 20Mar2021 as dose 1, single for COVID-19 immunisation.  Medical history included anaphylactic reactions to medications, bee stings and shellfish where swelling would start with her lips and then migrate to her tongue and throat. The patient's concomitant medications were not reported. On 20 Mar2021, patient received the first dose of the vaccine in morning around 11:30 am and she stayed at the vaccination site and was monitored for about 30 minutes until 12:05 pm, as she has a history of having anaphylactic reactions. Within 10 minutes her lips felt greasy with a minor petroleum jelly feeling and taste under her mask and also had normal stiffness in her arm and her legs felt heavy. She went home and got lunch and resumed her normal activities. But, around 11 pm, night her nose became stuffy and her bottom lip became swollen. She went into the bathroom and took two 12.5 mg chewable Benadryl tablets and placed them under her tongue for fast absorption. They seemed to work for the right side of her mouth. At the time of report, when she woke up in the morning and looked in the mirror her left side of her lip was still swollen. Patient worried about receiving the second dose of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pyrexia, Vaccination site warmth
Clinical narrative: Fever; tiredness; left armpit nodule swelling; very warm on vaccination area; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6072) via an unspecified route of administration, administered in Left arm on 21Mar2021 (at the age of 43 year old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on 28Feb2021 1:00 (at the age of 43 year old), as single dose for COVID-19 immunization. Prior vaccination, patient did not receive any other vaccines within 4 weeks and was not diagnosed with COVID-19. On an unspecified date, the patient experienced fever, tiredness, left armpit nodule swelling, and very warm on vaccination area. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Feeling cold, Platelet count, Platelet count decreased
Clinical narrative: my platelet level is low; my nose bled a little bit; I felt cold/feel chilly; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 59, no units specified) received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, Batch/Lot number was not reported), via an unspecified route of administration on 21Mar2021, as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 21Mar2021, around 1:15 to 1:30, patient received the vaccine, and the patient experienced nose bled a little bit about 30 minutes. She felt cold/feel chilly, where actually she was hot natured. No fever and don't have any diagnosed blood disorder, but her platelet level was low and was referred to a hematologist. the outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever; Chills; headache; This is a spontaneous report from a contactable consumer (patient's parent). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Left arm on 18Mar2021 09:00 as dose 1, single for COVID-19 immunisation. Medical history included history of 2 times of pneumonia after bronchitis from an unknown date.There were no concomitant medications. Patient had no known allergies. Prior vaccination, patient was diagnosed with COVID and did not receive any other vaccines within four week. On 19Mar2021,after 16 hours of injection, at 01:00, the patient experienced fever, chills and headache. No treatment was received in response to the events. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Limb discomfort, Peripheral swelling, Pyrexia
Clinical narrative: Chills; Fever; Her arm, not the injection site but lower down the arm, towards the elbow, clarified as right above the elbow (in the fleshy area) was totally swollen.; clarifies further that area above her elbow is very swollen and distorted; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date: was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Report was not related to a study or programme. The patient's medical history and concomitant medications were not reported. Other Products was not provided. It was reported that, patient had the COVID vaccine on Tuesday, 2 days ago. The patient experienced chills and fever, but that was all done now, her arm, not the injection site but lower down the arm, towards the elbow, clarified as right above the elbow (in the fleshy area) was totally swollen, clarifies further that area above her elbow is very swollen and distorted on an unspecified date. Patient wanted to know if she should go to the hospital and was that a side effect. No further information was provided or obtained. Investigation Assessment was not provided. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching after first shot; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6203 and Expiration Date: 30Jun2021), via intramuscular, in Left Arm, on 24Feb2021 at 10:00 (at the age of 77-year-old) as DOSE 1, SINGLE for covid-19 immunization in hospital.  Medical history included allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Cyst on kidneys diagnosed in 2010, Hypertension and lipids increased. Concomitant medications included valsartan Started taking many years ago reported as 1998 or something like that, taken for hypertension and spironolactone taken for hypertension from 2010 and  atorvastatin (LIPITOR) taken for lipids increased from 2004. The patient previously took flu vaccine 20 years ago and had a reaction. But the past 2 years, the patient decided to take it to have protection. The patient had a lot of itching and hyperventilating. On 24Feb2021 at 16:00, after first shot, the patient experienced itching. The outcome of the event was recovered in 25Feb2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Lung disorder, Pruritus, Rash, Urticaria
Clinical narrative: hives are on her fingers, forearms, butt, legs, and sometimes on the cheeks of her face as well; itchy; hives started around the injection site; rash now it is scattered; Mother went in for the second Pfizer Covid vaccine, one week later she developed a similar rash that started around the vaccination area; her lungs felt like they were iced & breathing cold fresh air that last bout one hour; During that time she also experienced extreme backache; This is a spontaneous report from a contactable consumer (patients son). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (reported as around 19Feb2021 (not sure)), as dose 2, single, for COVID-19 immunisation. Medical history included cancer, which was controlled and super small, and it was being monitored and was not taking any medication for it. Concomitant medication included unspecified medications. istorical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (reported as around 29Jan2021 (not sure)), as dose 1, single, for COVID-19 immunisation and experienced hives and rash. Reporter was unsure of exact dates for when the patient got the vaccine doses and provided a rough timeline. The patient did not receive any other vaccines prior to COVID vaccine. One week after vaccination, the patient developed a rash that started around the vaccination area and then it was scattered. The patient experienced hives that started around the injection site and then on her fingers, forearms, butt, legs, and sometimes on the cheeks of her face and was itchy. On 18Mar2021, the patient felt her lungs were iced and was breathing cold fresh air that last about one hour. Patient denied difficulty breathing. During that time, she also experienced extreme backache. She took Ibuprofen for the back pain. The doctor prescribed some steroids, and the hives seem to not care about the steroids because the patient was still getting the hives and it was not responding to steroids. The outcome of urticaria was not recovered while the outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site urticaria
Clinical narrative: hives are on her fingers, forearms, butt, legs, and sometimes on the cheeks of her face as well; itchy; hives started around the injection site; rash now it is scattered; Mother went in for the second Pfizer Covid vaccine, one week later she developed a similar rash that started around the vaccination area; her lungs felt like they were iced & breathing cold fresh air that last bout one hour; During that time she also experienced extreme backache; This is a spontaneous report from a contactable consumer (patients son). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (reported as around 19Feb2021 (not sure)), as dose 2, single, for COVID-19 immunisation. Medical history included cancer, which was controlled and super small, and it was being monitored and was not taking any medication for it. Concomitant medication included unspecified medications. istorical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (reported as around 29Jan2021 (not sure)), as dose 1, single, for COVID-19 immunisation and experienced hives and rash. Reporter was unsure of exact dates for when the patient got the vaccine doses and provided a rough timeline. The patient did not receive any other vaccines prior to COVID vaccine. One week after vaccination, the patient developed a rash that started around the vaccination area and then it was scattered. The patient experienced hives that started around the injection site and then on her fingers, forearms, butt, legs, and sometimes on the cheeks of her face and was itchy. On 18Mar2021, the patient felt her lungs were iced and was breathing cold fresh air that last about one hour. Patient denied difficulty breathing. During that time, she also experienced extreme backache. She took Ibuprofen for the back pain. The doctor prescribed some steroids, and the hives seem to not care about the steroids because the patient was still getting the hives and it was not responding to steroids. The outcome of urticaria was not recovered while the outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Pain in extremity
Clinical narrative: pain in knee from an old injury/joint pain in the knees; sore arm; her husband is having issues with his joint as well/reaction in joints; This is a spontaneous report from a contactable other hcp (patient's wife) via a Pfizer-sponsored program reported for patient (husband). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ERV6202; Expiration Date: Jun2021), via intramuscular route of administration in arm (unknown if left or right) on 01Mar2021 at 11:00 (at the age of 67-years-old) as dose 1, 0.3 ml single for COVID-19 immunization. The medical history of the patient included urinary tract infection as he became ill and had to be hospitalized, which he thought was a kidney stone, beginning of sepsis possibly the first stage, both from an unknown date and unknown if ongoing, and COVID-19 from Nov2020 to an unknown date. The concomitant medications of the patient were not reported.  Patient did not receive prior vaccinations within 4 weeks. The family medical history relevant to events was reported as no. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available was reported as none. No additional vaccines administered on same date of the pfizer suspect. On an unknown date in Mar2021, the patient experienced pain in knee from an old injury/joint pain in the knees, sore arm and was having issues with his joint as well/reaction in joints. It was reported that, reaction with his joints started before 4 or 5 days after he got the vaccine, possibly started on 06Mar2021. Reporter thought that joint issues could be arthritis. Patient was about to go for doctor for unspecified reason. Reporter reported the event as not serious, and just painful. The outcome of  the event issues with his joint as well/reaction in joints was not resolved, and outcome of all other events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Myalgia, Pain
Clinical narrative: intense joint/muscle pain in left leg and hips; intense joint/muscle pain in left leg and hips; Unable to use left leg for 3 days. Could walk days # 4-7 with canes,can walk without cane today; Still in pain but can walk without cane today; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6208 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 12Mar2021 at 08:45 (at the age of 64-year-old) as DOSE 2, SINGLE for covid-19 immunization in hospital.  Medical history included mast cell disorder, multiple sclerosis, gluten allergy, underlying autoimmune issues that were totally in remission before shots. Concomitant medications included cromoglicate sodium (CROMOLYN), topiramate (TOPAMAX), alfuzosin, levothyroxine sodium (SYNTHROID), methylphenidate hydrochloride (RITALIN).Historical vaccine included BNT162B2 (Pfizer BioNTech Covid 19 Vaccine; lot number EN6200 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 19Feb2021 (at the age of 64-year-old) as DOSE 1, SINGLE for covid-19 immunization and experienced Horrific joint pain and Couldn't lift arms, use wrists for 1 week. The patient was not pregnant at time of vaccination. The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On an unspecified date, after 2nd shot, patient experienced intense joint/muscle pain in left leg and hips. Unable to use left leg for 3 days. Could walk days 4-7 with canes. Still in pain but can walk without cane now. No treatment was received for the adverse events. The outcome of the event Walking difficulty was recovered while all other events was recovering at time of report.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Lymphadenopathy, Skin burning sensation
Clinical narrative: Numbness in face; Burning in skin in bottom of arm from armpit; Severe lymph node swelling; Severe fatigue; This is a spontaneous report from a contactable consumer reported for patient. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6202, Expiration date was not reported), via intramuscular in arm on 24Feb2021 at 09:00 (at the age of 39-year-old) as a dose 1, single for COVID-19 immunization. The family medical history was reported as none. The patient's medical history included sarcoidosis, on an unspecified date in 2011, sarcoidosis diagnosed 10 years ago and high blood pressure. The patient's concomitant medications included metoprolol, 25 mg, 2x/day, taken for high blood pressure. Stated that, he has been on it for a year and a half. No previous history of all immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior vaccinations (within 4 weeks) were reported as none. AE following prior vaccinations were reported as none. It was reported that, call was received from the consumer regarding the Pfizer COVID 19 vaccine. Stated that, she would like to know about recommendations on getting second dose for her husband. Stated that, he was due for second shot tomorrow. He was scheduled for his second dose tomorrow and wanted to know whether he should get it or not. Was there a recommendation to proceed with second dose given he still has swollen lymph nodes. Stated that, her husband's name was (name withheld). He received first dose on 24Feb2021 at 09:00. Three or four days after receiving, he started to get severe lymph node swelling as well as numbness and burning in skin and pretty severe fatigue. It was reported that, on 24Feb2021 at 11:00, the patient experienced severe fatigue, severe lymph node swelling on 28Feb2021 at 21:00, numbness in face on 15Mar2021 at 05:00 and burning in skin in bottom of arm from armpit on 15Mar2021 at 00:00. The event severe lymph node swelling was reported as worsened. Stated that, there was no prescriber. Stated that, he has a pre-existing condition, so he was up for the phase they were in. She thinks the burning in skin and numbness are related to the swelling in lymph nodes. Stated that, his condition of Sarcoidosis was in 2011. He received the vaccine in the top of arm closer to shoulder. Stated that, no emergency room or physician's office required. Stated that, they called his physician and said to keep an eye on it. If it persisted past next Monday to come in. Also reached out to location they received vaccine and they provided them with Pfizer Drug Safety's number. No relevant tests were reported. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site scab
Clinical narrative: when she took the band aid off, it looked as if she had been burnt and the scab was coming off; Itchy; broke out in a rash; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9266 and expiration date: not reported), via intramuscular, in Left Arm, on 19Feb2021 at 11:00 (at the age of 73-year-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included ongoing asthma and ongoing high Blood pressure. The patient's concomitant medications included asthma medication (unspecified). The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine.  On Feb2021, when the patient took the band aid off, it looked as if she had been burnt and the scab was coming off and patient broke out in a rash. The patient hadn't called when it happened earlier because she was thinking perhaps it was a reaction to the Band Aid. The patient doesn't think it was a reaction. The patient is still very itchy. The patient confirms she is still itchy. She is not as itchy as it was, but she is still itchy. It was not as frequently as it was. The patient confirms the rash was still there. The outcome of the event Vaccination site scab was unknown, Itchy was recovering and Rash was not recovered at time of report.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Hot flush, Pruritus, Rash erythematous
Clinical narrative: redness; warm/hot feel on her face; itching; Swelling of the Face; face is red and blotchy, she is not sure if it is a rash, but the texture is not as smooth as usual, she would say it is rough; face is red and blotchy, she is not sure if it is a rash, but the texture is not as smooth as usual, she would say it is rough; Face is Flushed; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6199; Expiration Date: Jun2021) via an unspecified route of administration, administered in left arm on 13Mar2021 at 13:00 as dose 1, single (at the age of 65-year-old) for covid-19 immunisation. The patient medical history was not reported. The patient previously took Bactrim for UTI from 22Feb2021 to 03Mar2021, stated that she stopped the medication ten days before the vaccine, there were 20 pills, and she took it twice a day for 10 days, and she took all of them as 800/160mg tablet twice a day by mouth. Concomitant medications included ongoing Fiber as 500 mg, 1x/day via orally and Doxylamine succinate taken for sleep aid from an unspecified start date and ongoing as 50 mg, 1x/day (at bedtime) via orally. No additional vaccines was administered prior 4 weeks or on same date of the Pfizer suspect. Prior Vaccinations (within 4 weeks) reported as none, states she has not had a vaccine in a million years, well 20 years. Patient stated when she woke up Wednesday morning (17Mar2021 at 08:00) she had facial swelling and was flushed and so fourth, and it didn't go down during the day, it was not markedly worse but a little worse, certainly no better. Clarifies that her tongue and throat were normal. She states that she was not on any daily prescription medications, just two over the counter ones. On an unspecified date, she experience some swelling in the face, redness and warm/hot feel on her face, also some itching. Since, she was taking her second dose tomorrow, she just wanted to know if she will still experience these side effects that she previously experienced during her first dose. She also mentioned that she had reported this to her physician and physician advised her to take Benadryl for the side effects(unknown if taken). Patient stated that she was not on any daily prescription medications, just two over the counter ones. No visit to emergency room or physician office. No any adverse event prior vaccination. No treatment was received for the events swelling of the face, face is red and blotchy, she is not sure if it is a rash, but the texture is not as smooth as usual, she would say it is rough and face is flushed. Outcome of the events swelling of the face, face is red and blotchy, she is not sure if it is a rash, but the texture is not as smooth as usual, she would say it is rough and face is flushed was not recovered and outcome of rest events was unknown at the time of reporting.  Follow-up attempts completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Swelling face
Clinical narrative: redness; warm/hot feel on her face; itching; Swelling of the Face; face is red and blotchy, she is not sure if it is a rash, but the texture is not as smooth as usual, she would say it is rough; face is red and blotchy, she is not sure if it is a rash, but the texture is not as smooth as usual, she would say it is rough; Face is Flushed; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6199; Expiration Date: Jun2021) via an unspecified route of administration, administered in left arm on 13Mar2021 at 13:00 as dose 1, single (at the age of 65-year-old) for covid-19 immunisation. The patient medical history was not reported. The patient previously took Bactrim for UTI from 22Feb2021 to 03Mar2021, stated that she stopped the medication ten days before the vaccine, there were 20 pills, and she took it twice a day for 10 days, and she took all of them as 800/160mg tablet twice a day by mouth. Concomitant medications included ongoing Fiber as 500 mg, 1x/day via orally and Doxylamine succinate taken for sleep aid from an unspecified start date and ongoing as 50 mg, 1x/day (at bedtime) via orally. No additional vaccines was administered prior 4 weeks or on same date of the Pfizer suspect. Prior Vaccinations (within 4 weeks) reported as none, states she has not had a vaccine in a million years, well 20 years. Patient stated when she woke up Wednesday morning (17Mar2021 at 08:00) she had facial swelling and was flushed and so fourth, and it didn't go down during the day, it was not markedly worse but a little worse, certainly no better. Clarifies that her tongue and throat were normal. She states that she was not on any daily prescription medications, just two over the counter ones. On an unspecified date, she experience some swelling in the face, redness and warm/hot feel on her face, also some itching. Since, she was taking her second dose tomorrow, she just wanted to know if she will still experience these side effects that she previously experienced during her first dose. She also mentioned that she had reported this to her physician and physician advised her to take Benadryl for the side effects(unknown if taken). Patient stated that she was not on any daily prescription medications, just two over the counter ones. No visit to emergency room or physician office. No any adverse event prior vaccination. No treatment was received for the events swelling of the face, face is red and blotchy, she is not sure if it is a rash, but the texture is not as smooth as usual, she would say it is rough and face is flushed. Outcome of the events swelling of the face, face is red and blotchy, she is not sure if it is a rash, but the texture is not as smooth as usual, she would say it is rough and face is flushed was not recovered and outcome of rest events was unknown at the time of reporting.  Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: my arm hurt a little bit, I've had other shots that hurt 10x worse, like pneumonia shot (6years ago).; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration in 2015 (Batch/Lot number was not reported) as single dose for immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included tetanus shot for immunization and experienced arm sore. Suspect product was provided as pneumococcal 13-val conj vac (dipht crm197 protein). When the patient was reporting on events with covid vaccine (received on 16Mar2021), he mentioned that his arm hurt a little bit, he had had other shots that hurt 10x worse, like "pneumonia shot" (6years ago in 2015).  Patient also said that his arm was much more sore after the tetanus shot (10 years ago in 2011) than the Pfizer shot (not specified). The outcome of the event was unknown.  No follow-up attempts are possible; Information about batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This is a spontaneous report received from a contactable health care professional. A 34-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6205), via an unspecified route of administration in an unspecified anatomical site on 17Mar2021 (at the age of 34-year-old), as dose 1, single and via an unspecified route of administration in an unspecified anatomical site on an unknown date, as dose 2, single for COVID-19 immunization. On 17Mar2021, during her 30 minute waiting period after the injection, the patient began to experience itching. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, dizziness, facial swelling, lip swelling and tongue swelling. The patient had experienced same itching with the first dose of vaccine. Patient received treatment after first dose with antihistamines benadryl and pepcid. Follow up response to the treatment was fair. Similar to last time, patient was given benadryl 50 mg and pepcid 20mg for itching, after the second dose of vaccine. Patient was not drowsy at the time of discharge. The clinical outcome of the itching was unknown.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country added. Onset date removed for event as the event occurred with both dose 1 and dose 2.  No follow-up attempts are needed. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Lung disorder, Productive cough
Clinical narrative: cough; mucous in lungs; phlegm and mucous in nose; This is a spontaneous report from a contactable consumer (daughter).   A 88-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 06Mar2021 (at the age of 88-years-old) as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient historical vaccine included BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 13Feb2021 12:40 (at the age of 88-years-old) as dose 1, single for covid-19 immunisation and experienced Leg pain, Numbness in leg and Limbs stiffness. Patient experienced phlegm and mucous in her nose after second dose and had a cough. Reporter adds that the phlegm started that Monday following the vaccination and patient called her to tell her this information. Reporter told her to suck on lemons and she was feeling better, the mucous was still there but phlegm is not in her nostrils. There was mucous in her mother lungs but not a lot of it.  Caller adds that as treatment she told her mother to drink something warm to help. Caller adds that she believes the vaccine was given to her mother around 12-o-clock but maybe not quite 12 pm as that was the scheduled appointment time. Patient had taken lemon as treatment for the events. The outcome of event phlegm and mucous in nose was recovered on an unknown date, the outcome of cough and mucous in lungs was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Swelling face
Clinical narrative: Right side of her face was swollen; This is a spontaneous report from a contactable consumer.  This is report 2 of 2. A 49-year-old female patient received BNT162B2  (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EP7534) dose 1 via an unspecified route of administration, administered in left arm on 18Mar2021 14:00 (at the age of 49-years-old) as dose 1, single for covid-19 immunization.  Medical history included Thyroid problem and cancer and they removed her thyroid about 10 years ago. Concomitant medication included levothyroxine taken for thyroid disorder from 2011 and ongoing.  Prior to vaccination, the patient did not receive any other vaccines within 4 weeks.The patient was driving around after the vaccination; when she came back to her friend's house her friend told her that the right side of her face was swollen, which was maybe about 5 hours after she was administered the PfizerBioNTech COVID-19 Vaccine. The patient underwent lab tests and procedures which included blood test on 11Mar2021, her blood test results had 1 abnormal result that was elevated , computerized tomogram with unknown results   performed because she was having headaches. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Poor quality product administered, Product temperature excursion issue, Pyrexia
Clinical narrative: chills; fever; 7 patients received Pfizer Covid vaccine, out of temperature range; 7 patients received Pfizer Covid vaccine, out of temperature range; This is a spontaneous report from a contactable pharmacist. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207; Expiration Date: Jul2021), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patients received vaccine, that was out of temperature range, where, pharmacist miscalculated the time for temperature storage. It was determined through the control log and the excursion information, where for first time: at 18:27 PM - 46.9 (47 )Degrees Farheneit, at 18:57PM -  47.5 F, at 20:00- 49.4 F, at 20:57-  50.5 (51 F), at 12:42- 51.8 (52 F), at 2:12 - 52.9 (53F), at 3:12 -  49.6 (50 F), at 5:42- 47.3 F, at 8:42- 48.3, at 9:57- 46.7, at 10:12- 46.3 F (16 hours out of range) and at 10:27- 45.8 F. The patient also experienced chills and fever. It was reported that patient believed that the vaccine worked for her. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021305630 Different patient, same drug, same event (split)
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Illness, Pyrexia
Clinical narrative: sick; he had a bad headache; running a fever, 101.5 for a couple of days; very extremely tired from Sunday until today; This is a spontaneous report from a contactable consumer (patient's father in law). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Mar2021 as dose 2, single for COVID-19 immunisation. The patient's  medical history and concomitant medications were not reported. On an unspecified date in Mar2021 (Sunday), patient received the second dose and he was sick for 4 days and had a bad headache, running fever, where temperature of 101.5 for a couple of days, and he was extremely tired from Sunday until at the time of report. The outcome of the event extremely tired was not recovered and of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Palms of hands itched tremendously and turned bright red, 11 days after #2 which was unexpected.; Palms of hands itched tremendously and turned bright red, 11 days after #2 which was unexpected.; Barely sore arm  after dose 2; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6205 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 11Mar2021 at 11:00 (at the age of 71-year-old) as DOSE 2, SINGLE for covid-19 immunization.  Medical history included 17 years post endometrial/ovarian CA, Stage 1 and arthritis. The patient doesn't have any allergy to medications, food, or other products. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6200 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 15Feb2021 at 11:00 (at the age of 71-year-old) as DOSE 1, SINGLE for covid-19 immunization and experienced Extremely sore arm up into neck, chest congestion with coughing lasting 45 minutes, palms of hands itched tremendously and turned bright red, Brain Fog, fatigue, muscle weakness, nausea, slight diarrhea. Concomitant medication included ibuprofen (ADVIL) taken for arthritis. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On Mar2021, 11 days after dose 2, the patient experienced palms of hands itched tremendously and turned bright red, which was unexpected and on an unspecified date in 2021 after dose 2, barely sore arm. The outcome of the events was recovering at time of report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Pain, Pyrexia
Clinical narrative: chills; temperature; ache all over; she has been sicker/really sick; This is a spontaneous report from a Pfizer sponsored Program. A non-contactable consumer reported for female patient. A 75-year-old female patient received bnt162b2 (BNT162B2 Formulation; solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included allergic to everything, bee stings from an unknown date and unknown if ongoing. Concomitant medication included epinephrine (EPIPEN) taken for an unspecified indication, start and stop date were not reported. The patient experienced chills, temperature, ache all over and she has been sicker/ really sick on an unspecified date. It was reported that patient feels a little bit better today and patient always carries any EPIPEN. The outcome of events reported as recovering.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Nasopharyngitis, Nausea
Clinical narrative: cold; fatigue; pain in her shoulders; feeling nauseated; whole body ache/My whole body aches; little bit sick to my stomach; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) dose unknown via an unspecified route of administration on 13Mar2021 (at the age of 64-year-old) as dose number unknown, single for COVID-19 immunisation. Medical history included cancer (She is concerned because her husband has cancer). The patient's concomitant medications was not reported. On 13Mar2021 the patient experienced fatigue, pain in her shoulders, feeling nauseated, whole body ache/my whole body aches, cold on 17Mar2021, little bit sick to my stomach on unknown date in Mar2021. Patient was not received treatment for the events. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: cold; fatigue; pain in her shoulders; feeling nauseated; whole body ache/My whole body aches; little bit sick to my stomach; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) dose unknown via an unspecified route of administration on 13Mar2021 (at the age of 64-year-old) as dose number unknown, single for COVID-19 immunisation. Medical history included cancer (She is concerned because her husband has cancer). The patient's concomitant medications was not reported. On 13Mar2021 the patient experienced fatigue, pain in her shoulders, feeling nauseated, whole body ache/my whole body aches, cold on 17Mar2021, little bit sick to my stomach on unknown date in Mar2021. Patient was not received treatment for the events. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Decreased appetite, Diarrhoea, Headache
Clinical narrative: Headache; abdominal cramping worse than any menstrual cramp; Diarrhea; No Appetite; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727, NDC number: 59267-1000-1), via an unspecified route of administration, administered in Arm Left on 20Mar2021 08:00 (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. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior vaccinations (within 4 weeks) and AE(s) following prior vaccinations were reported as none. Caller stated that on 20Mar2021 around 2:00 p.m. she really had no appetite. Stated by 5:00 p.m. she was experiencing abdominal cramping worse than any menstrual cramp and stated it continued until Monday morning. She stated from Saturday at 10:00 p.m. till 4:00 a.m. Monday it was very uncomfortable. She stated she also has had diarrhea since 5:00 p.m. Saturday (20Mar2021). She stated that it has improved because she has not eaten anything. She also experienced a headache and stated that it woke her up today. The patient was asking if she will experience these side effects again for her 2nd dose and if these side effects will last for 72 hours. She took Naproxen for cramping, stated it was an anti-inflammatory. The outcome of all events cramping, diarrhea, a headache, and no appetite was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives, more on his arms; This is a spontaneous report from a non-contactable consumer (parent) via Medical Information team. A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 15Mar2021, at 15:00 as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reported stated that his son (patient) was 22, a trainer, and his son was sent by football to get the Pfizer COVID vaccine on 15Mar2021, at 15:00. Everything was fine and there were no symptoms on 15Mar2021 (Monday) and 16Mar2021 (Tuesday). The patient put on some new product on his face and followed by body cream on arms. The reporter blamed the body cream. On 17Mar2021, at 07:00, the patient woke up with hives, more on his arms, that's why the reporter suspected the cream. The reporter thought that it has been too long for a reaction to the vaccine. The reporter was asking if this was a reaction to the vaccine and if it was okay to get the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Rash, Skin exfoliation
Clinical narrative: rash on both sides of face, top of ear jaw line; skin peeling/ears are peeling; little itchy; part of his face feels warmer; This is a spontaneous report from a contactable consumer (patient).  A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route of administration at right arm on 11Mar2021 at 10:50 am (lot number: EN6204, expiration date: 30Jun2021) (age at vaccination 57-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included acid reflux and hand tremors from an unknown date and unknown if ongoing. He was fairly healthy and spent 20 years in the military and was a healthy guy he thought. The patient concomitant medications included lansoprazole for acid reflux and propranolol for hand tremors both were ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had any no problems with previous vaccines, that he has had lots of shots in the military. History of all previous immunization with the Pfizer vaccine considered as suspect and additional Vaccines Administered on Same Date of the Pfizer Suspect, relevant tests was none. After 3-4 days of the shot, the patient had rash on both sides of his face starting at the top of his ears about an inch wide down to his jaw he had a line of rash that developed on both sides. States his ears are peeling and he had never had anything like this before and nothing else is going on, States he has not changed his soap or shampoo, little itchy and part of his face feels warmer in Mar2021. The patient had had put some moisturizing lotion on for the peeling and has not done anything else for ears are peeling. The adverse event does not required the visit to emergency room or physician office. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: neck and shoulder soreness; neck and shoulder soreness; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 49-year-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Mar2021, the patient began to experience neck and shoulder soreness that lasted until the time of the reported (specified as today). The outcome of the events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.