chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: first dose Pfizer covid vaccine on 22Mar2021, tested positive for COVID on 02Apr2021; This is a spontaneous report from a contactable consumer (patient's daughter).  This consumer reported same event for 2 patients (her father and mother). This is the second of two reports.   A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 22Mar2021 (batch/lot number and expiration date were not reported) at the age of 61 years old, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient received first dose Pfizer COVID vaccine on 22Mar2021, and tested positive for COVID on 02Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test (COVID-19): positive on 02Apr2021. Outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021445679 same reporter, same event, same product, different patients
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site erythema, Vaccination site mass, Vaccination site swelling, Vaccination site vesicles
Clinical narrative: Swelling, reddness, hard lump and a small blister at point of injection in the right arm.; Swelling, reddness, hard lump and a small blister at point of injection in the right arm.; Swelling, reddness, hard lump and a small blister at point of injection in the right arm.; Swelling, reddness, hard lump and a small blister at point of injection in the right arm.; Severe right shoulder joint pain.; This is a spontaneous report from a contactable consumer, the patient. A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), dose 1 via an unspecified route of administration, administered in right arm on Feb2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. Patient was not allergies to medications, food, or other products. Concomitant medication included amlodipine, valsartan, and finasteride. In Feb2021, the patient experienced swelling, redness, hard lump, and a small blister at point of injection in the right arm, severe right shoulder joint pain. Treatment was not received for the adverse event. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Body temperature, Body temperature fluctuation, Chills
Clinical narrative: she wasn't sleeping well/awake multiple times.; her hands were especially horrible; her temperature was fluctuating; sweated; fever; fatigue; muscle pain; joint pain; mild case of COVID.; headache; chills; This is a spontaneous report from a contactable consumer (patient).   A 73-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in the left arm on 04Mar2021 09:30 (Batch/Lot Number: EN6202) as single dose for covid-19 immunisation.  The patient had received the first dose of vaccine on 11Feb2021 at the upper left arm. Medical history included ongoing arthritis (She says she has had this condition for probably 15 years maybe, it's not rheumatoid, it's the other kind, she forgets what to call it), ongoing urinary tract infection (She says she had some bleeding with one of them, they thought it was a tumor but it was just a good old urinary tract infection. She says she used to get it when she worked, for about 20 years even, she hasn't had many, she rarely gets them), ongoing glucose tolerance impaired , ongoing atrial fibrillation , ongoing weight abnormal , ongoing thyroid hormones decreased , cold-stimulus headache from an unknown date and unknown if ongoing , sleep apnoea syndrome from 2006 and ongoing , blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medications included metformin hcl taken for glucose tolerance impaired, start and stop date were not reported; apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; olmesartan taken for hypertension, start and stop date were not reported; levothyroxine taken for thyroid hormones decreased, start and stop date were not reported. The patient experienced headache on 11Apr2021 with outcome of recovered, chills on 11Apr2021 with outcome of recovered, fever on 12Apr2021 with outcome of recovered, fatigue on 11Apr2021 with outcome of recovered, muscle pain on 11Apr2021 with outcome of recovered, joint pain on 11Apr2021 with outcome of recovered, sweated on 14Apr2021 with outcome of recovered, she wasn't sleeping well/awake multiple times on an unspecified date with outcome of unknown, her hands were especially horrible on an unspecified date with outcome of unknown, her temperature was fluctuating on an unspecified date with outcome of unknown. The patient suspected covid-19, but there is no positive antigen test to confirm COVID-19. The patient underwent lab tests and procedures which included blood test: negative on 15Apr2021, body temperature: 99 on 11Apr2021, body temperature: 101 on 14Apr2021, urine analysis: negative on 15Apr2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Insomnia, Limb injury
Clinical narrative: she wasn't sleeping well/awake multiple times.; her hands were especially horrible; her temperature was fluctuating; sweated; fever; fatigue; muscle pain; joint pain; mild case of COVID.; headache; chills; This is a spontaneous report from a contactable consumer (patient).   A 73-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in the left arm on 04Mar2021 09:30 (Batch/Lot Number: EN6202) as single dose for covid-19 immunisation.  The patient had received the first dose of vaccine on 11Feb2021 at the upper left arm. Medical history included ongoing arthritis (She says she has had this condition for probably 15 years maybe, it's not rheumatoid, it's the other kind, she forgets what to call it), ongoing urinary tract infection (She says she had some bleeding with one of them, they thought it was a tumor but it was just a good old urinary tract infection. She says she used to get it when she worked, for about 20 years even, she hasn't had many, she rarely gets them), ongoing glucose tolerance impaired , ongoing atrial fibrillation , ongoing weight abnormal , ongoing thyroid hormones decreased , cold-stimulus headache from an unknown date and unknown if ongoing , sleep apnoea syndrome from 2006 and ongoing , blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medications included metformin hcl taken for glucose tolerance impaired, start and stop date were not reported; apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; olmesartan taken for hypertension, start and stop date were not reported; levothyroxine taken for thyroid hormones decreased, start and stop date were not reported. The patient experienced headache on 11Apr2021 with outcome of recovered, chills on 11Apr2021 with outcome of recovered, fever on 12Apr2021 with outcome of recovered, fatigue on 11Apr2021 with outcome of recovered, muscle pain on 11Apr2021 with outcome of recovered, joint pain on 11Apr2021 with outcome of recovered, sweated on 14Apr2021 with outcome of recovered, she wasn't sleeping well/awake multiple times on an unspecified date with outcome of unknown, her hands were especially horrible on an unspecified date with outcome of unknown, her temperature was fluctuating on an unspecified date with outcome of unknown. The patient suspected covid-19, but there is no positive antigen test to confirm COVID-19. The patient underwent lab tests and procedures which included blood test: negative on 15Apr2021, body temperature: 99 on 11Apr2021, body temperature: 101 on 14Apr2021, urine analysis: negative on 15Apr2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Suspected COVID-19, Urine analysis
Clinical narrative: she wasn't sleeping well/awake multiple times.; her hands were especially horrible; her temperature was fluctuating; sweated; fever; fatigue; muscle pain; joint pain; mild case of COVID.; headache; chills; This is a spontaneous report from a contactable consumer (patient).   A 73-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in the left arm on 04Mar2021 09:30 (Batch/Lot Number: EN6202) as single dose for covid-19 immunisation.  The patient had received the first dose of vaccine on 11Feb2021 at the upper left arm. Medical history included ongoing arthritis (She says she has had this condition for probably 15 years maybe, it's not rheumatoid, it's the other kind, she forgets what to call it), ongoing urinary tract infection (She says she had some bleeding with one of them, they thought it was a tumor but it was just a good old urinary tract infection. She says she used to get it when she worked, for about 20 years even, she hasn't had many, she rarely gets them), ongoing glucose tolerance impaired , ongoing atrial fibrillation , ongoing weight abnormal , ongoing thyroid hormones decreased , cold-stimulus headache from an unknown date and unknown if ongoing , sleep apnoea syndrome from 2006 and ongoing , blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medications included metformin hcl taken for glucose tolerance impaired, start and stop date were not reported; apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; olmesartan taken for hypertension, start and stop date were not reported; levothyroxine taken for thyroid hormones decreased, start and stop date were not reported. The patient experienced headache on 11Apr2021 with outcome of recovered, chills on 11Apr2021 with outcome of recovered, fever on 12Apr2021 with outcome of recovered, fatigue on 11Apr2021 with outcome of recovered, muscle pain on 11Apr2021 with outcome of recovered, joint pain on 11Apr2021 with outcome of recovered, sweated on 14Apr2021 with outcome of recovered, she wasn't sleeping well/awake multiple times on an unspecified date with outcome of unknown, her hands were especially horrible on an unspecified date with outcome of unknown, her temperature was fluctuating on an unspecified date with outcome of unknown. The patient suspected covid-19, but there is no positive antigen test to confirm COVID-19. The patient underwent lab tests and procedures which included blood test: negative on 15Apr2021, body temperature: 99 on 11Apr2021, body temperature: 101 on 14Apr2021, urine analysis: negative on 15Apr2021.
Sex: M
Vaccine: COVID19
Symptoms: Aphthous ulcer, Lip blister, Oral mucosal blistering
Clinical narrative: After my 1st dose, my mouth and lips developed cold blisters outside and inside my mouth. I had "bumps on the inside of my mouth "and "it took 7-10 days for the cold blisters to go away.; bumps "inside my mouth are still there and the size of kidney beans; After my 1st dose, my mouth and lips developed cold blisters outside and inside my mouth. I had "bumps on the inside of my mouth "and "it took 7-10 days for the cold blisters to go away.; This is a spontaneous report from a contactable consumer (the patient). This is one of the 2 report of same patient. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number, Expiration date: Unknown), via an unspecified route of administration on 10Mar2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient reported "After my 1st dose, my mouth and lips developed cold blisters outside and inside my mouth (oral mucosal blistering and lip blister). I had "bumps on the inside of my mouth" (Aphthous ulcer) and "it took 7-10 days for the cold blisters to go away". He used Abbreva which was expensive." The caller stated the bumps "inside my mouth are still there and the size of kidney beans. The patient received treatment. Outcome of the events oral mucosal blistering and lip blister was recovered on unknown date in 2021 and the event aphthous ulcer was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Dry throat, Feeling hot, Rash macular, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Lot number: ER0113) via an unspecified route at arm right on 17Apr2021 in the afternoon (around 15:30) (reported as this past Saturday) as a single dose for covid-19 immunisation and diphenhydramine (Lot Number: P122793 and Expiry Date: NOV2023) for two black spots under the site and that part was swollen too, it itches. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Lot number: ER8730) via an unspecified route at arm right on 27Mar2021 in the afternoon (around 14:00) as a single dose for covid-19 immunisation with no adverse effects. On Apr2021, patient had experienced the site under where she got it was swollen and hard and it hurt. she put ice on it for the swelling. Patient reported that it started as just one spot which turned black and then she had little black spots everywhere under the spot where the vaccine went in. She had two spots and then those spots turned black and then she has tiny spots like polka dots over her arms and when she woke up next day, she had two black spots under the site and that part was swollen too. She took 2 allergy Diphenhydramine HCl 25 mg antihistamine that morning. They are oozing and she has the little black spots on her left and her right arm, but she had the vaccine in her right arm (further stated that the black spots that are oozing and it was kind of hard under it and under the site. The spots were blacker and more discolored). Patient stated that it itches and that's why she took allergy Diphenhydramine HCl 25 mg antihistamine but that made her drowsy. Patient felt like throat was kind of dry and was feeling hot and had COVID-19 test resulted in everything okay, she didn't have COVID. Patient right deltoid and right below it, maybe 3 fingerbreadths below on the left and right side bilaterally she had blotches that appeared, and they looked red. Next day they looked more like a burn kind, when a darker person gets burned by an iron then the spot gets darker in nature. One of the spots has like a vesicle that was fluid filled kind of like a blister and it was weeping. Overnight this went from blotched to burn-like marks with one vesicles that was oozing and then there are spots dispersed through her body. On her right arm, left arm, and on her right leg as well it was like black spots. Patient does not require to visit emergency room or physician office for the events. Outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Somnolence, Vaccination site discharge, Vaccination site discolouration, Vaccination site erythema
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Lot number: ER0113) via an unspecified route at arm right on 17Apr2021 in the afternoon (around 15:30) (reported as this past Saturday) as a single dose for covid-19 immunisation and diphenhydramine (Lot Number: P122793 and Expiry Date: NOV2023) for two black spots under the site and that part was swollen too, it itches. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Lot number: ER8730) via an unspecified route at arm right on 27Mar2021 in the afternoon (around 14:00) as a single dose for covid-19 immunisation with no adverse effects. On Apr2021, patient had experienced the site under where she got it was swollen and hard and it hurt. she put ice on it for the swelling. Patient reported that it started as just one spot which turned black and then she had little black spots everywhere under the spot where the vaccine went in. She had two spots and then those spots turned black and then she has tiny spots like polka dots over her arms and when she woke up next day, she had two black spots under the site and that part was swollen too. She took 2 allergy Diphenhydramine HCl 25 mg antihistamine that morning. They are oozing and she has the little black spots on her left and her right arm, but she had the vaccine in her right arm (further stated that the black spots that are oozing and it was kind of hard under it and under the site. The spots were blacker and more discolored). Patient stated that it itches and that's why she took allergy Diphenhydramine HCl 25 mg antihistamine but that made her drowsy. Patient felt like throat was kind of dry and was feeling hot and had COVID-19 test resulted in everything okay, she didn't have COVID. Patient right deltoid and right below it, maybe 3 fingerbreadths below on the left and right side bilaterally she had blotches that appeared, and they looked red. Next day they looked more like a burn kind, when a darker person gets burned by an iron then the spot gets darker in nature. One of the spots has like a vesicle that was fluid filled kind of like a blister and it was weeping. Overnight this went from blotched to burn-like marks with one vesicles that was oozing and then there are spots dispersed through her body. On her right arm, left arm, and on her right leg as well it was like black spots. Patient does not require to visit emergency room or physician office for the events. Outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Lot number: ER0113) via an unspecified route at arm right on 17Apr2021 in the afternoon (around 15:30) (reported as this past Saturday) as a single dose for covid-19 immunisation and diphenhydramine (Lot Number: P122793 and Expiry Date: NOV2023) for two black spots under the site and that part was swollen too, it itches. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Lot number: ER8730) via an unspecified route at arm right on 27Mar2021 in the afternoon (around 14:00) as a single dose for covid-19 immunisation with no adverse effects. On Apr2021, patient had experienced the site under where she got it was swollen and hard and it hurt. she put ice on it for the swelling. Patient reported that it started as just one spot which turned black and then she had little black spots everywhere under the spot where the vaccine went in. She had two spots and then those spots turned black and then she has tiny spots like polka dots over her arms and when she woke up next day, she had two black spots under the site and that part was swollen too. She took 2 allergy Diphenhydramine HCl 25 mg antihistamine that morning. They are oozing and she has the little black spots on her left and her right arm, but she had the vaccine in her right arm (further stated that the black spots that are oozing and it was kind of hard under it and under the site. The spots were blacker and more discolored). Patient stated that it itches and that's why she took allergy Diphenhydramine HCl 25 mg antihistamine but that made her drowsy. Patient felt like throat was kind of dry and was feeling hot and had COVID-19 test resulted in everything okay, she didn't have COVID. Patient right deltoid and right below it, maybe 3 fingerbreadths below on the left and right side bilaterally she had blotches that appeared, and they looked red. Next day they looked more like a burn kind, when a darker person gets burned by an iron then the spot gets darker in nature. One of the spots has like a vesicle that was fluid filled kind of like a blister and it was weeping. Overnight this went from blotched to burn-like marks with one vesicles that was oozing and then there are spots dispersed through her body. On her right arm, left arm, and on her right leg as well it was like black spots. Patient does not require to visit emergency room or physician office for the events. Outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a sore arm; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program . A 64-year-old patient of unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration from an unknown date (Lot#: not provided) at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient got a sore arm after received the Pfizer vaccine on an unspecified date, there is no any other issue with it. Event outcome was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Depressed mood
Clinical narrative: I was just kind of mopey; This is a spontaneous report from a Pfizer Sponsored Program via a contactable consumer (patient). A 76-years-old patient of an unspecified gender received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient just wanna thank you for the vaccine, got em both and feeling very safe. Just on the second shot patient was just kind of mopey but other than that was wonderful. Event outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain in extremity
Clinical narrative: Developed a sore arm; chills; overall not feeling well.; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included amlodipine taken for hypertension. On an unspecified date, the patient experienced a sore arm, chills, soreness and just overall not feeling well. Patient wants to know if she can take tylenol for the side effects. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Discomfort, Influenza like illness, Pain in extremity
Clinical narrative: Sore arm; it was just some discomfort; Feeling like he is getting the flu; This is a spontaneous report from a contactable consumer.   A 75-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, by injection, administered in left arm on 20Apr2021 14:15 (Batch/Lot Number: EW0171) as single dose for covid-19 immunisation. Medical history were none. Concomitant medication(s) included atorvastatin (ATORVASTATIN) taking for several years at 20mg, once daily by mouth for blood cholesterol; lisinopril (LISINOPRIL), taking for a year; prior to that he took Atenolol, 50/25mg once daily; [withheld] vial at 5mg, one twice daily by mouth for blood pressure, all ongoing. Historical vaccine included first dose, BNT162B2 on 30Mar2021 between 14:15PM and 14:30PM in the left arm,Lot number EW0150 and experienced sore arm on 30Mar2021. The patient received the 2nd dose of the Pfizer covid vaccine yesterday, waken about 2am, feeling as if he has the flu, no fever, just blah feeling. Can he take Tylenol or Advil, just to feel a little better. He has some discomfort in the arm and is feeling like he has the flu but with no fever. The second shot he had a little soreness in the arm again but less than the first time. Adds that soreness is still there when he raises his arm and he can tell he had a needle in his arm. This morning when he awakened, about 16 hours after the shot, he felt like he was getting the flu, but it was just some discomfort. Adds he checked his temperature and he had no fever. No emergency room or physician office visit. Not vaccinated at   Facility. Feeling like he is getting the flu was on 21Mar2021. Outcome was not recovered for all events.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This is a spontaneous report from a contactable Other HCP. A 59-year-old female patient (Other HCP) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: unknown, Expiry date: unknown) via an unspecified route of administration on 20Apr2021 for COVID-19 immunization. The medical history included focal migraines. Concomitant medications were not reported. In Apr2021, she was experiencing a migraine at the moment, but she's had migraines in the past, specifically focal migraines, for which light was the factor. When she gets them, she "can't see very well", everything was "just too bright. The second dose schedule is on 05May2021. The events were reported as non-serious. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye pain, Eye pruritus, Lacrimation increased
Clinical narrative: Eyes are dry and itchy, and also eyes are watering; Eyes are dry and itchy, and also eyes are watering; eyes are dry and itchy, and also eyes are watering; Eye pain; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced eyes were dry and itchy, and also eyes were watering. Patient stated that she researched it and read there was no treatment for eye pain, and also people got shingles after the COVID shot. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Joint stiffness, Musculoskeletal stiffness, Myalgia
Clinical narrative: a lot of muscle and joint pain; a lot of muscle and joint pain/sore in her hip joint; stiff neck and shoulders and shortly after it went to her lower back and legs and she couldn't bend over; stiff and sore in her hip joint and lower back; stiff and sore in her hip joint and lower back; This is a spontaneous report received from a non-contactable consumer(patient). This 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient got the first shot on 30Mar2021 and had been having a lot of muscle and joint pain. It started a couple of days after, she got a stiff neck and shoulders and shortly after it went to her lower back and legs and she couldn't bend over. It was still stiff and sore in her hip joint and lower back but she said it was somewhat maybe a little better. She is scheduled for the second shot tomorrow and is very hesitant. She asked how long this will last and if the second shot will make things worse. The outcome of events was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hypersensitivity, Nasopharyngitis, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever of 104; Sore throat; Chills; Symptoms like alergies; Cold like symptoms; This is a spontaneous report from a contactable consumer via Pfizer Sponsored Program. A 16-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 15Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient was fine until Sunday (Apr2021) then the patient had a fever of 104, sore throat, chills, and symptoms like allergies. The patient was treated with Tylenol and the fever broke but still having cold like symptoms. The reporter wants to know what should do now.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Blood pressure is now reading 170/80 and dropped a little to 140/90; This is a spontaneous report received from a contactable consumer (patient). A 61-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ew0162), via an unspecified route of administration on 10Apr2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant mediation was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ep7534), via an unspecified route of administration on 20Mar2021 as a single dose for COVID-19 immunization and had no problems. The patient reported that for 10 years she gets up, she works out and checks her B/P which was usually 110/70, 110/60. Since the vaccination, the patient blood pressure was now reading 170/80 and dropped a little to 140/90 and it had never been that high and stated that sorry the patient got the vaccine. The patient was beside physician because the patient's blood pressure had never been so high. The clinical outcome of the event was unknown.  No follow-up attempts are needed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Rash
Clinical narrative: a rash, it is like blisters; a rash, it is like blisters; This is a spontaneous report received from a contactable consumer reported for self. This female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 as single dose for covid-19 immunisation. Medical history was none. This week the patient noticed a rash, it is like blisters in Apr2021. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain in extremity, Vertigo
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the morning of 17Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. The patient got the first dose on 17Apr2021 morning, she was fine that day, although at night she had arm pain. The next day (18Apr2021), her arm pain continued and she felt very tired. In morning of 19Apr2021, she began having vertigo, she had it since 19Apr2021 until the reporting time, patient asked is it normal after the vaccine? Previously she had no vertigo. She got dizzy, she felt dizzy when she turned around on an unspecified date in Apr2021. Outcome of the event vertigo was not recovered, while other events was unknown. This report was assessed as non-serious.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported similar events for two patients. This is the 2nd of two reports. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration, administered on the arm on 04Mar2021 at a single dose for COVID-19 immunisation. The patient had no relevant medical history and patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on 09Feb2021 at a single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Hospital. On 14Mar2021, patient experienced shingles (reported as approximately 7-10 days after vaccination). Patient resumed use of valacyclovir (VALTREX) as a result of the event. The outcome of shingles was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021443578 Same reporter, drug, and event; different patient
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: developed an itchy trunk; rash radiated to arms; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a 74-year-old male patient that received first dose of BNT162B2 (BNT162B2, Pfizer-BioNTech Covid-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced/developed an itchy trunk and then rash radiated to arms on an unspecified date with outcome of unknown. She wants to know if he can receive the second dose of the vaccine in a retail setting. The pharmacist reported that "is itchiness of the trunk and arms a contraindication to the vaccine?"  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: contracted shingles; This is a spontaneous report from a contactable consumer report for self. This 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient said she was due tomorrow for her second dose but she has contracted shingles this week (in Apr2021) and started on Valtrex medication for it 2 days ago. Event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: arm hurt; headache; This is a spontaneous report from a non-contactable consumer. A male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm hurt and headache on an unspecified date. Reported as: Upon callback, caller's mother stated, "Your shot is wonderful. My whole generation got it; my brother in law, sister in law, everybody took it. They got a light headache and their arm hurt, but it was not bad. We loved it. My husband is fine. My husband feels stronger now than anything." The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Chills, Dyspnoea
Clinical narrative: lost the sense of smell and taste; Lost the sense of smell and taste; I have trouble breathing; Chills; Fever; body aches/pain; Sore throat; very weak; felt really bad/not feeling well; This is a spontaneous report from a contactable consumer (patient). This male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. On Saturday 17Apr2021, patient received the first dose of the COVID-19 vaccine from Pfizer. On Sunday (18Apr2021), he was not feeling well and felt really bad. On Monday (19Apr2021), he had chills, fever, body aches/pain, sore throat, he felt very bad, very weak. Today (21Apr2021), patient woke up feeling better, but about an hour ago he felt like he had lost the sense of smell and taste, and he had trouble breathing. On 21Apr2021, patient felt great, but now he had lunch and lost his sense of smell and taste. On Friday 16Apr2021 (1 day before receiving the vaccine), he got tested to see if he was infected with COVID-19 and it came back negative, 10 days ago he also had a test and it was negative, so he claimed that he did not have COVID and these symptoms should be because of the vaccine. Lab data included COVID-19 with result of negative on unspecified date and on 16Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: lost the sense of smell and taste; Lost the sense of smell and taste; I have trouble breathing; Chills; Fever; body aches/pain; Sore throat; very weak; felt really bad/not feeling well; This is a spontaneous report from a contactable consumer (patient). This male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. On Saturday 17Apr2021, patient received the first dose of the COVID-19 vaccine from Pfizer. On Sunday (18Apr2021), he was not feeling well and felt really bad. On Monday (19Apr2021), he had chills, fever, body aches/pain, sore throat, he felt very bad, very weak. Today (21Apr2021), patient woke up feeling better, but about an hour ago he felt like he had lost the sense of smell and taste, and he had trouble breathing. On 21Apr2021, patient felt great, but now he had lunch and lost his sense of smell and taste. On Friday 16Apr2021 (1 day before receiving the vaccine), he got tested to see if he was infected with COVID-19 and it came back negative, 10 days ago he also had a test and it was negative, so he claimed that he did not have COVID and these symptoms should be because of the vaccine. Lab data included COVID-19 with result of negative on unspecified date and on 16Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Feeling abnormal, Headache, Insomnia, Nausea
Clinical narrative: he is feeling nauseous. everything wants to come out; thirsty; she cannot eat; she has a headache from hell; she didn't get a wink of sleep; does not feel good; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiry date unknown), via an unspecified route of administration on 20Apr2021 as a SINGLE DOSE for COVID-19 immunisation. Medical history and concomitant medications were not reported. About 1 hour after the vaccine, the patient developed side effects. Caller stated she has a headache from hell, she can not eat and everything wants to come out. Caller stated this does not feel good stating she feels bad. Caller wanted to know what she can do. Caller stated got the 1st dose of the vaccine yesterday, April 20 and she is calling to report that she is feeling nauseous, thirsty and cannot eat. Caller wants to know if when she can feel like a normal person again. Patient reported that she will be 63 in about a week. The caller stated that she got the first shot yesterday and all was fine on the way home but when she was home her head was pounding. She has a headache the size of the Mississippi river and she didn't get a wink of sleep. She said the headache is so horrible. She asked when this will go away. Outcome of the events were not reported.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: he is feeling nauseous. everything wants to come out; thirsty; she cannot eat; she has a headache from hell; she didn't get a wink of sleep; does not feel good; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiry date unknown), via an unspecified route of administration on 20Apr2021 as a SINGLE DOSE for COVID-19 immunisation. Medical history and concomitant medications were not reported. About 1 hour after the vaccine, the patient developed side effects. Caller stated she has a headache from hell, she can not eat and everything wants to come out. Caller stated this does not feel good stating she feels bad. Caller wanted to know what she can do. Caller stated got the 1st dose of the vaccine yesterday, April 20 and she is calling to report that she is feeling nauseous, thirsty and cannot eat. Caller wants to know if when she can feel like a normal person again. Patient reported that she will be 63 in about a week. The caller stated that she got the first shot yesterday and all was fine on the way home but when she was home her head was pounding. She has a headache the size of the Mississippi river and she didn't get a wink of sleep. She said the headache is so horrible. She asked when this will go away. Outcome of the events were not reported.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hyperhidrosis, Miosis
Clinical narrative: her baby's pediatrician told her the patient could pass antibodies to the baby through breastfeeding; her baby's pediatrician told her the patient could pass antibodies to the baby through breastfeeding; headache; light sensitivity; vision changed; extreme fatigue /Exhaustion; overall body aches; sweaty /Sweating Profusely; her pupils were dilating and constricting; her pupils were dilating and constricting; Brain Fog; This is a spontaneous report received from a contactable consumer (patient). The consumer reported information for both mother and baby. This is the maternal report.  A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Apr2021 at age of 36 years at single dose for COVID-19 immunisation. Medical history included ongoing asthma, had basically had all of her life; since she was about 8 years old. Her grandfather had strokes. Her father died of a heart attack. Patient had no concomitant medications. Patient received her first Pfizer Covid vaccine dose on 20Apr2021. She stated that after the vaccine was administered (on 20Apr2021), she started to experience extreme fatigue and needed to sleep. After waking up from a nap, she noticed vision changed, headache with light sensitivity, overall body aches, and sweaty. Her husband told her that her pupils were dilating and constricting. Her MD advised her to go to the ED. Patient stated why the patient taking covid vaccination was asthma, medical worker and having a 9-month-old baby. Patient stated that she had been experiencing vision problems and a severe headache. Said her pupils had been dilating and contracting. Patient had severe headache, vision problems; pupils keep dilating and contracting, exhaustion, brain fog, sweating profusely on 20Apr2021. Said her symptoms started yesterday 20Apr2021, stopped, and then started again today. Stated she had questions about her side effects and asked should she go the Emergency Room; especially for the headache. Said today they were just as bad as yesterday; except she was not as exhausted today as she was yesterday. Patient stated that her main reason was because her baby's pediatrician told her the patient could pass antibodies to the baby through breastfeeding. Patient denied any medications, labs, testing, or treatments relevant to report. AE(s) did not require a visit to Emergency Room and Physician Office. Patient stated no adverse events after prior vaccinations; only an antibiotic. Outcome of exhaustion was recovering and the other events was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446591 Same reporter/drug, different patient/event (baby case)