chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Dysgeusia, Flushing, Headache
Clinical narrative: joint pains; metallic flavor in mouth; his joints, knees, and elbows were hurting; headache; discomfort; injection site soreness; slight flushness; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL1283, Expiration Date: 30Apr2021) via an unspecified route of administration, administered in Arm Left on 13Jan2021 13:30 (at the age of 47-years-old) as dose 1, single for COVID-19 immunization. Medical history included shin splints (1991-1995 is when this started, that was more because of shoe cushioning wearing out ) and migraine (started 1992 or 1993 while in the military) from an unknown date and unknown if ongoing. Concomitant medication included unspecified vitamins and bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10) taken for an unspecified indication, has been taking for about 7 or 8 months. No investigation assessment was performed. No prior vaccinations within 4 weeks. On an unspecified date in Jan2021, the patient experienced injection site soreness, this happened and hour or two after receiving the vaccines. This didn't go away until the following day. Most of the other symptoms besides the injection site soreness happened when he woke up the following day after receiving the first vaccine. He had slight flushness, discomfort, his joints, knees, and elbows were hurting and headache. He mentioned that he had migraines and sinus infections before, but this was just a strong headache. The headache lasted about a day and a half. He had no fever but felt flushed- he felt warm. On 14Jan2021, the patient had joint pain and metallic flavor in mouth. He compared it to when a person was receiving a CAT scan or something and they give an injection, and the person gets a flavor in their mouth. He was drinking water and juice and the metallic flavor was still there.  He thought this was just normal since COVID makes people lose their sense of taste, so maybe the metallic flavor was a reaction. With the first vaccine, symptoms were pretty mild. He stated that  most events happened on the 14Jan2021, he was back to normal on 15Jan2021. No visit to ER or Physician. Therapeutic measures were taken as a result of joint pain. The outcome of the events was recovered on 15Jan2021.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: joint pains; metallic flavor in mouth; his joints, knees, and elbows were hurting; headache; discomfort; injection site soreness; slight flushness; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL1283, Expiration Date: 30Apr2021) via an unspecified route of administration, administered in Arm Left on 13Jan2021 13:30 (at the age of 47-years-old) as dose 1, single for COVID-19 immunization. Medical history included shin splints (1991-1995 is when this started, that was more because of shoe cushioning wearing out ) and migraine (started 1992 or 1993 while in the military) from an unknown date and unknown if ongoing. Concomitant medication included unspecified vitamins and bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10) taken for an unspecified indication, has been taking for about 7 or 8 months. No investigation assessment was performed. No prior vaccinations within 4 weeks. On an unspecified date in Jan2021, the patient experienced injection site soreness, this happened and hour or two after receiving the vaccines. This didn't go away until the following day. Most of the other symptoms besides the injection site soreness happened when he woke up the following day after receiving the first vaccine. He had slight flushness, discomfort, his joints, knees, and elbows were hurting and headache. He mentioned that he had migraines and sinus infections before, but this was just a strong headache. The headache lasted about a day and a half. He had no fever but felt flushed- he felt warm. On 14Jan2021, the patient had joint pain and metallic flavor in mouth. He compared it to when a person was receiving a CAT scan or something and they give an injection, and the person gets a flavor in their mouth. He was drinking water and juice and the metallic flavor was still there.  He thought this was just normal since COVID makes people lose their sense of taste, so maybe the metallic flavor was a reaction. With the first vaccine, symptoms were pretty mild. He stated that  most events happened on the 14Jan2021, he was back to normal on 15Jan2021. No visit to ER or Physician. Therapeutic measures were taken as a result of joint pain. The outcome of the events was recovered on 15Jan2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Limb discomfort
Clinical narrative: problem with her leg after receiving the covid vaccine; inflammation; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program [ Support].  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 17Mar2021 as dose 1, single for covid-19 immunization. Medical history included neuralgia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On Mar2021, patient experienced problem with her leg after receiving the covid vaccine, inflammation. second dose will be (07Apr2021) she's not experiencing any symptoms and hasn't taken any medicines yet, just wanted to know. She will take Advil for nerve pain, or should she wait after having the 2nd dose before taking. At the time of reporting, the outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pruritus
Clinical narrative: body soreness; swelling; Fatigue; headache; fever; chills; itchy; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6203 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 01Mar2021 at 10:00 AM (age at vaccination: 53 years), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included diabetes type 2 and thyroid. Concomitant medications were not reported. It was unknown if the patient had known allergies. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks. On 01Mar2021 at 11:30 AM, the patient experienced fatigue, headache, body soreness, fever, chills and a week later COVID arm at injection site, soreness and itchy with swelling. The patient did not receive any treatment for the events. Outcome of the events was resolved on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: body soreness; swelling; Fatigue; headache; fever; chills; itchy; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6203 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 01Mar2021 at 10:00 AM (age at vaccination: 53 years), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included diabetes type 2 and thyroid. Concomitant medications were not reported. It was unknown if the patient had known allergies. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks. On 01Mar2021 at 11:30 AM, the patient experienced fatigue, headache, body soreness, fever, chills and a week later COVID arm at injection site, soreness and itchy with swelling. The patient did not receive any treatment for the events. Outcome of the events was resolved on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: hives on the back of his neck that swelled up; He said he had a rash on his scalp; hives inside of his hands, wrists and around his body/he had hives on the rest of his body (arms, chest, and stuff); This is a spontaneous report from a contactable consumer. A 61-years-old male patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: EN6199), dose 1 in the left arm on 15Mar2021 as Dose 1 SINGLE for covid-19 immunization (Age at vaccination was 61years). The patient medical included difficulty sleeping, and Itch and concomitant medication included MELATONIN 5mg. He said his kids had some Melatonin and thought he should try the Melatonin to help him sleep. He said the Melatonin didn't help too much with sleep, so he stopped taking the Melatonin after that. Stated he started the Melatonin 5mg tablet either on 10Mar2021 or 11Mar2021, providing: Natrol Brand Melatonin 5mg tablet. The patient had not received any prior vaccination within 4 weeks. On 16Mar2021 the patient had hives inside of his hands, wrists and around his body. On an unspecified date the patient had rash and his neck swelled up. The patient reported that he had a rash on his scalp, clarified as hives. He said the hives went through to the rest of his body, his chest, where his skin hits against his clothes, almost anywhere on his body. Reported his scalp hives had lasted a couple days, and then he went camping, and then his scalp hives got worse, and the hives started to progress. He clarified he had hives on the back of his neck that swelled up, and he had hives on the rest of his body (arms, chest, and stuff).  He said his scalp was better. He said he was hoping the hives were going to get getting better on the rest of his body once he started the spray on lotion (that he had to pick up at the pharmacy). He said the hives were persisting and moving around on his body. He said the hives had gone down a little to his chest, and behind his knees, too.  He said he wanted to report his side effect to Pfizer and ask if he should get the second COVID-19 Vaccine shot. He said his doctor said he probably should not get the second COVID-19 Vaccine. Reporter was advised he would be transferred to Pfizer Medical Information for further assistance with his ketoconazole Shampoo 2% every 3 days, and he was hoping his hives would go quickly. He said the doctor prescribed 2 2 bottles of Ketoconazole Shampoo 2% with the same NDC Number: 45802-465-64, Lot Number: 146931 and expiration date was Apr2022. Reported he did not know the name of the spray-on medication that he had to pick up at the pharmacy. He said the pharmacist told him the doctor had ordered quite a bit of the spray-on medication because the doctor had never seen hives as bad as what he had before. He said his spray-on medication was supposed to be in at the pharmacy today. The outcome of the event Hives was not recovered. The outcome of the event  swelling and rash were unknown.  No follow up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hypersensitivity, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp.   A 59-years-old male patient received bnt162b2 (bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: 6207; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 12:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus for about 10 years ago, Back surgery in 2021. Past drug included Lidocaine. Concomitant medication(s) included cefalexin (CEPHALEXINE) taken for an unspecified indication from 11Mar2021 and ongoing. On 17Mar2021, it was reported he had received his first COVID-19 Vaccine, and had an allergic reaction. He said he had a rash all over his body. He clarified his rash had started about 7-8 hours after he had received his COVID-19 Vaccine on 17Mar2021. He said the rash started on the inside of his arms and around his upper thighs and waist last night (17Mar2021). He said today (18Mar2021) in the morning and throughout the day, his rash got worse. He said his rash went down both of his arms and legs, and on his chest and back. Reported approximately 2 weeks ago he had minor back surgery with a local anesthesia. He said he believed the anesthesia was something like Lidocaine for pain. He said he had just started an antibiotic (Cephalexin 500mg capsule) about a week ago (Thursday, 11Mar2021). He stated he had a 14-day prescription for the Cephalexin 500mg capsule with instructions to take 1 500mg capsule by mouth, twice a day. He said he was about halfway through his prescription with 6 more days to go. He said the Cephalexin 500mg was dispensed in a pharmacy bottle with no NDC, Lot, and Expiration Date. It was reported that his saw his doctor today, and his doctor prescribed over-the-counter medications for his rash. He said he was told to take one tablet a day of the Zyrtec and Pepcid AC. He said he was already feeling better since he had taken a dose of the Zyrtec and Pepcid AC. He said he needed to use an eye loop and put the Zyrtec bottle under light, so he could see the product label information better. He said it wasn't that the Zyrtec product label information was really, really, tiny, but that he wanted to make sure he provided the information correctly to the Pfizer agent. His doctor recommended he not get the second Pfizer COVID-19 Vaccine. He said his doctor told him to wait three months and then get the Johnson & Johnson COVID-19 Vaccine shot. Therapeutic measures were taken as a result of rash all over (rash), his rash got worse (condition aggravated). The outcome of the event allergic reaction was unknown, rash all over was recovering , his rash got worse was unknown.    No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: It wasn't like everywhere just one spot; it is only in middle of my torso; It's not like it's red or anything, it just itches; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6200 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 01Mar2021 (age at vaccination: 76 years), as a single dose for COVID-19 immunization. The patient's medical history included blood pressure measurement and slight depression. Concomitant medications included colecalciferol (VITAMIN D), lisinopril, pravastatin and chlorothiazide. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9264 and expiry date was not reported), via an unspecified route of administration, on 01Feb2021 (age at vaccination: 76 years), as a single dose for COVID-19 immunization. On an unspecified date in Mar2021, the patient had it wasn't like everywhere just one spot; it was only in middle of her torso; It's not like it's red or anything, it just itches. The patient reported that she really did not have right immediately follow but couple days ago she started itching and she did not know if it's from that or what, but it's been 15 days since she had the shot. But she did not know if, because she could not think of anything else different that she has done to make her body itchy. The patient stated that she did not know if it's from that, she just wondered of it that was one of the side effects. She thought it was one of the side effects, because she did not do anything different. So, she was just calling to ask if that was possible. She used some anti-itch creams that she had and it's for anything that itches. It helped because she could sleep last night but then she got to put some more on. She was going to call her doctor to find out what to do for it but then she figured out to call you guys first. The patient used anti-itch creams some a couple of days ago and then she used it last night. It's not like it's read or anything, it just itches. It's little bit red when she itch it. Outcome of the event was not recovered.  No follow-up attempts are possible; No further information is expected
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain, Butterfly rash, Full blood count, Pain in extremity, Platelet count
Clinical narrative: I felt an abdominal pain, Strong abdominal pain; My face had a little rash, a butterfly rash; not really bad and it didn't feel hot; I didn't have any other itches; I started feeling, my body itching on the inside; It spreading through the day; oozing blood from the injection site; The bandage was soaked in blood; there was oozing blood from the injection site; the bruise was forming; My arm started hurting like a regular after flu-shot; maybe a little more than a regular flu-shot; The bruise was getting bigger; the swelling was about the same and the pain, the discomfort was there but nothing out; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6200 and expiration date: not reported), via an unspecified route of administration, in Right Arm on 27Feb2021, as DOSE 1, SINGLE for covid-19 immunization and prednisone via an unspecified route of administration, on an unspecified date, 5mg, for immune thrombocytopenic purpura. Medical history included thrombocytopenic purpura, the patient had ITP, low platelets and the day before shot, platelets were 43,000.  The patient had thrombocytopenia prophylaxis, for 30 years, In Oct2020, patient got very bad case of shingles and platelets dropped after few weeks of being on prednisone and was being taken off the prednisone they dropped to the 20,000 and then they increased the prednisone. The patient had blood pressure. Concomitant medications included cholecalciferol (VITAMIN D3) and metoprolol taken for hypertension.  On 27Feb2021,20 minutes after patient got the shot, patient looked in the mirror and her face had a little rash, a butterfly rash. Not really bad and it didn't feel hot, patient didn't have any other itches. The patient came home and within about 2 hours, the patient started feeling, body itching on the inside. It is spreading through the day. On 27feb2021, 6 hours after the shot, patient's husband took the bandage off and the bandage was soaked in blood and there was oozing blood from the injection site and the bruise was forming and that night patient arm started hurting like a regular after flu-shot, maybe a little more than a regular flu-shot and then by the next day, the bruise was getting bigger, and the swelling was about the same and the pain. The patient felt an abdominal pain, Strong abdominal pain on an unspecified date.  The patient underwent lab tests and procedures which included full blood count: normal on an unknown date, platelet count: 43,000  on day before shot. Therapeutic measures were taken as a result of butterfly rash included Benadryl and hydrocortisone cream. The outcome of the event Butterfly rash was not recovered, while that of all other events was unknown at time of report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pruritus, Vaccination site bruising, Vaccination site haemorrhage, Vaccination site swelling
Clinical narrative: I felt an abdominal pain, Strong abdominal pain; My face had a little rash, a butterfly rash; not really bad and it didn't feel hot; I didn't have any other itches; I started feeling, my body itching on the inside; It spreading through the day; oozing blood from the injection site; The bandage was soaked in blood; there was oozing blood from the injection site; the bruise was forming; My arm started hurting like a regular after flu-shot; maybe a little more than a regular flu-shot; The bruise was getting bigger; the swelling was about the same and the pain, the discomfort was there but nothing out; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6200 and expiration date: not reported), via an unspecified route of administration, in Right Arm on 27Feb2021, as DOSE 1, SINGLE for covid-19 immunization and prednisone via an unspecified route of administration, on an unspecified date, 5mg, for immune thrombocytopenic purpura. Medical history included thrombocytopenic purpura, the patient had ITP, low platelets and the day before shot, platelets were 43,000.  The patient had thrombocytopenia prophylaxis, for 30 years, In Oct2020, patient got very bad case of shingles and platelets dropped after few weeks of being on prednisone and was being taken off the prednisone they dropped to the 20,000 and then they increased the prednisone. The patient had blood pressure. Concomitant medications included cholecalciferol (VITAMIN D3) and metoprolol taken for hypertension.  On 27Feb2021,20 minutes after patient got the shot, patient looked in the mirror and her face had a little rash, a butterfly rash. Not really bad and it didn't feel hot, patient didn't have any other itches. The patient came home and within about 2 hours, the patient started feeling, body itching on the inside. It is spreading through the day. On 27feb2021, 6 hours after the shot, patient's husband took the bandage off and the bandage was soaked in blood and there was oozing blood from the injection site and the bruise was forming and that night patient arm started hurting like a regular after flu-shot, maybe a little more than a regular flu-shot and then by the next day, the bruise was getting bigger, and the swelling was about the same and the pain. The patient felt an abdominal pain, Strong abdominal pain on an unspecified date.  The patient underwent lab tests and procedures which included full blood count: normal on an unknown date, platelet count: 43,000  on day before shot. Therapeutic measures were taken as a result of butterfly rash included Benadryl and hydrocortisone cream. The outcome of the event Butterfly rash was not recovered, while that of all other events was unknown at time of report.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pruritus
Clinical narrative: Pins and Needles Feeling in Both Lips; Upper Body Itching All Over; This is a spontaneous report from a contactable Consumer or other non-health care professional (Patient).  An 85-years-old male patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; (Batch no: not reported/Lot Number: EN6198) via an unspecified route of administration, administered in Arm Right on 03Mar2021 08:30 (at the age of 85 years) dose 1, single for covid-19 immunization at Hospital Main Building. Medical history and concomitant medications were not reported. Known allergies reported as he was severely allergic to all crustaceans, shrimp, crab, lobster and first time he had an anaphylactic reaction was when he was 16-years-old, also highly allergic to penicillin (was 20 years ago), cipro (was given once as prophylactic during a medical procedure of Colonoscopy and he reacted within 10 sec), sulfa drugs (he experienced that reaction while getting x rays) and allergic to grass, dust, pollen, perfume, and flowers. No Family Medical History Relevant to AE. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior vaccinations taken within 4 weeks. On 03Mar2021, Patient had the injection at 8:30 AM and the reaction started at 10:30 AM within two hours after the first injection, he experienced with reactions of pins and needles in both lips and his upper body was itching all over. He immediately took 50mg of Benadryl and a half an hour later his symptoms went away and he stated that he was not sure if the Benadryl stopped the reaction because it stopped quickly. AEs did not require to visit Emergency Room or Physician's office. No Investigation Assessment was provided. No relevant tests reported. Therapeutic measures included 50mg of Benadryl. Patient reported that he was scheduled for his second shot tomorrow and was very concerned about getting the next injection. The outcome of the events was recovered on 03Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Oropharyngeal pain, Pain, Swelling
Clinical narrative: swelling on the side of her neck; pain on the left side of her neck that went to her shoulder; Sore throat; Hoarseness; This is a spontaneous report from a contactable consumer(Patient). A 66-year-old female patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number EN6207) via an unspecified route of administration into arm left on 16Mar2021 as DOSE 1, SINGLE for covid-19 immunization (at the age of 66 year). The patient medical history had included Diabetes mellitus( from unknown to Ongoing and spasmatic fibrosis(from unknown To Ongoing). The patient concomitant medication included Rosuvastatin (20 mg) for the indication of High cholesterol and it has been used since 15 years.It was reported that the patient did not take any vaccination within four weeks of the vaccination and also reported that She saw her doctor 3-4 days before she received the vaccine. The patient did not received any prior vaccination within 4 weeks. No additional vaccine was administered on Same Date of the Pfizer Suspect. The doctor said since she was getting the vaccine he was going to hold off giving her a pneumonia shot. She switched doctors. The last time she had her cholesterol checked her doctor said it was fine. Since she has had two T strokes the doctor wanted her to stay on her cholesterol medication. The last stroke was 12 years ago. The first one was 25 years ago. She didn't know that she had a stroke until she fell and had an X-ray of her head. The X-ray indicated that she had the two strokes She was in her twenties when she had the first stroke. She remembers that her arm was numb and she had pain. She dropped the cup that she was holding. The numbness and pain went away after 1-2 minutes.On 17 Mar2021, the patient had experienced sore throat and Hoarseness. On 18Mar2021 the patient had experienced pain on the left side of her neck that went to her shoulder and swelling on the side of her neck. Patient applied alcohol twice for the event pain on the left side of her neck that went to her shoulder and swelling on the side of her neck and it went down. The outcome of the events were recovering .  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Peripheral swelling, Tenderness
Clinical narrative: Swollen big toe and joint; Big toe, right foot, that joint has just got so swollen and tender and there has been real bad pain; Swollen big toe and joint; Big toe, right foot, that joint has just got so swollen and tender and there has been real bad pain; Swollen big toe and joint; Big toe, right foot, that joint has just got so swollen and tender and there has been real bad pain; Swollen big toe and joint; Big toe, right foot, that joint has just got so swollen and tender and there has been real bad pain; This is a spontaneous report from a contactable consumer (patient).  A 58-year-old male female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 11Mar2021 (at the age of 58-years-old) as dose 1, single for covid 19 immunization. The patients medical history and concomitant medications were not reported. Reporter stated that he received a Pfizer vaccine shot on 11Mar2021. The only thing he had with the actual shot was stuck with the needle in it and he didn't feel any fever, no chills, no headache, nothing in the whole week. But exactly one weeks later, patient guessed and stated that on 18Mar2021, he did get a swollen big toe and joint and he looked it up, it looks like a gout. Patient had big toe, right foot, that joint had just got so swollen and tender and there had been real bad pain. Patient received aleve which was Naproxen and also, he had been taking Ibuprofen, over the counter for the treatment of events reported. Reporter further stated that he never had this before and queried for what should he be doing to alleviate his pain. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Back pain, Intervertebral disc protrusion, Magnetic resonance imaging, Pruritus
Clinical narrative: This is a spontaneous report from a contactable other health care professional (patient himself). A 37-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246) via an unspecified route of administration on left arm on 20Jan2021 06:30 (at the age of vaccination of 37-year-old) as dose 2, single for COVID-19 immunization. Historical vaccine included, bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL0140) via an unspecified route of administration on left arm on 30Dec2020 06:30 as dose 1, single for COVID-19 immunization. On an unspecified date, after dose 1 patient experienced his arm completely cramped up. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, patient had not been tested for COVID-19. Patient's relevant medical history included, arthritis in hips and allergy to sulfur drugs from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 20Jan2021, patient experienced entire body became full blown itchy an hour after. Day after patient's arthritis flared up and had lower back pain since. MRI (magnetic resonance imaging) showed bulging disc and was given steroid shot. Patient still had pain. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment as steroid shot. The patient underwent lab tests and procedures which included magnetic resonance imaging: showed bulging disc on an unspecified date in Jan2021. Outcome of the all events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: doesn't know if she has a fever as one minute it is saying one thing, she has a fever, and one saying another, she is low; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6207, expiration date was not reported), via an unspecified route of administration on 16Mar2021 (at the age of 58-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that on 19Mar2021 the patient doesn't know if she has a fever as one minute it is saying one thing, she has a fever, and one saying another, she is low. Patient, reporting on the Pfizer COVID vaccine, who explains she has a monitor to check her temperature and this morning when she woke up and checked it, it says she has a fever but she doesn't feel like she has a fever. Patient has a physical therapy appointment today and wants to know if she should go to the appointment. Patient got her first shot on 16Mar2021. This morning when she checked, the device she uses said she had temperature. She doesn't feel like she does though. It is noted that the information she was given says that a person could get a fever after the first shot. She is not going to go to the appointment, she doesn't want to take any chances. When asked the reading the device provided for her temperature she says it said 90-91 but then says she isn't sure, it said she had a fever. When asked to clarify the patient offers to recheck her temperature and then explains that it says low now, she remarks she doesn't know as the device is acting a fool. Consumer clarifies this statement saying she doesn't know if she has a fever as one minute it is saying one thing, she has a fever, and one saying another, she is reading a low temperature. Treatment: she just woke up to this, she hasn't done anything. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Feeling hot, Pruritus, Rash erythematous, Rash papular
Clinical narrative: itching starting at the injection site going up the left shoulder; itching starting at the injection site going up the left shoulder; feel a slight rough texture to the skin on her arm at the area of the itching; this has spread across the back of her neck to her other shoulder; itchy, red, bumpy, hot rash; itchy, red, bumpy, hot rash; itchy, red, bumpy, hot rash; itchy, red, bumpy, hot rash; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 54-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP7534, expiration date: not reported) via an unspecified route of administration, administered in left arm on 19Mar2021 at 17:00 (at the age of 54-years-old) as dose 1, single for covid-19 immunization. Medical history included Gastric Sleeve Surgery from an unknown date and unknown if ongoing Verbatim: Gastric Sleeve Surgery, sinus, allergies, AV Node reentry and tachycardia, nerve pain fibromyalgia, COPD and Depression, start and stop date unknown. Patient had no family history. Concomitant medication(s) included gabapentin (GABAPENTIN) taken ongoing, 400mg; take one four times a day by mouth taking 8 years for nerve pain fibromyalgia; montelukast (MONTELUKAST) taken ongoing 10mg; take once daily by mouth, taking 4 years for allergies; diltiazem hydrochloride (CARTIA XT) taken ongoing, 120mg; take once daily by mouth, taking 4 years for AV Node reentry and tachycardia; fluticasone propionate (FLUTICASONE PROPIONATE) taken ongoing, two sprays each nostril once daily, using four years for allergies; bupropion hydrochloride (BUPROPION HCL XL) taken ongoing, 150mg; take one twice daily by mouth, taking for 2 years for Depression; cetirizine hydrochloride (CETIRIZINE HYDROCHLORIDE) taken ongoing, 10mg; take once daily by mouth, taking for 6 months for sinus; tiotropium bromide (SPIRIVA) taken ongoing, 18mcg; take once daily by mouth, taking for 8 years for COPD; salbutamol sulfate (PROAIR HFA) taken ongoing, inhaler use as needed, taking for 8 years for COPD and Multivitamin taken ongoing taking for three years. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No Prior Vaccinations (within 4 weeks). On 20Mar2021, patient experienced itching starting at the injection site going up the left shoulder, feel a slight rough texture to the skin on her arm at the area of the itching; this has spread across the back of her neck to her other shoulder, itchy, red, bumpy, hot rash. The outcome of all events were not recovered.   No follow up attempts are possible. Information about lot/batch number cannot been obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site pruritus
Clinical narrative: itching starting at the injection site going up the left shoulder; itching starting at the injection site going up the left shoulder; feel a slight rough texture to the skin on her arm at the area of the itching; this has spread across the back of her neck to her other shoulder; itchy, red, bumpy, hot rash; itchy, red, bumpy, hot rash; itchy, red, bumpy, hot rash; itchy, red, bumpy, hot rash; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 54-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP7534, expiration date: not reported) via an unspecified route of administration, administered in left arm on 19Mar2021 at 17:00 (at the age of 54-years-old) as dose 1, single for covid-19 immunization. Medical history included Gastric Sleeve Surgery from an unknown date and unknown if ongoing Verbatim: Gastric Sleeve Surgery, sinus, allergies, AV Node reentry and tachycardia, nerve pain fibromyalgia, COPD and Depression, start and stop date unknown. Patient had no family history. Concomitant medication(s) included gabapentin (GABAPENTIN) taken ongoing, 400mg; take one four times a day by mouth taking 8 years for nerve pain fibromyalgia; montelukast (MONTELUKAST) taken ongoing 10mg; take once daily by mouth, taking 4 years for allergies; diltiazem hydrochloride (CARTIA XT) taken ongoing, 120mg; take once daily by mouth, taking 4 years for AV Node reentry and tachycardia; fluticasone propionate (FLUTICASONE PROPIONATE) taken ongoing, two sprays each nostril once daily, using four years for allergies; bupropion hydrochloride (BUPROPION HCL XL) taken ongoing, 150mg; take one twice daily by mouth, taking for 2 years for Depression; cetirizine hydrochloride (CETIRIZINE HYDROCHLORIDE) taken ongoing, 10mg; take once daily by mouth, taking for 6 months for sinus; tiotropium bromide (SPIRIVA) taken ongoing, 18mcg; take once daily by mouth, taking for 8 years for COPD; salbutamol sulfate (PROAIR HFA) taken ongoing, inhaler use as needed, taking for 8 years for COPD and Multivitamin taken ongoing taking for three years. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No Prior Vaccinations (within 4 weeks). On 20Mar2021, patient experienced itching starting at the injection site going up the left shoulder, feel a slight rough texture to the skin on her arm at the area of the itching; this has spread across the back of her neck to her other shoulder, itchy, red, bumpy, hot rash. The outcome of all events were not recovered.   No follow up attempts are possible. Information about lot/batch number cannot been obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Back pain, Dyspnoea, Feeling abnormal, Nasopharyngitis
Clinical narrative: A little more than 24 hours after the shot, I experienced severe back pain and severe pain in what I called my adenoids; A little more than 24 hours after the shot, I experienced severe back pain and severe pain in what I called my adenoids; Get a bad cold; Stuffed head for two days; Last night I experienced trouble Breathing.; Asthma; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number: EN6208, Expiry date: unknown) via an unspecified route of administration, administered in arm right on 18Mar2021 12:00 (age at vaccination: 59-years-old) as dose 1, single for COVID-19 immunization (facility). Medical history included asthma and hypertension from an unknown date and unknown if ongoing. Concomitant medication included hydrocodone taken for limb injury. On 19Mar2021 13:00, patient experienced severe back pain and severe pain in what she called her adenoids which was the first sign that she was going to get a bad cold. Stuffed head for two days then last night she experienced trouble breathing. She had diagnosed with asthma and she had asthma medicines there which she took. Patient had no Covid prior and after the vaccine and no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 and not tested for covid post vaccination. Patient received prednisone, symbicort and albuterol prevented a trip to the hospital for the treatment of the event asthma. Patient did not take any treatment for the events severe back pain, severe pain, bad cold, stuffed head and trouble breathing. The outcome of the events was reported as resolving.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: A little more than 24 hours after the shot, I experienced severe back pain and severe pain in what I called my adenoids; A little more than 24 hours after the shot, I experienced severe back pain and severe pain in what I called my adenoids; Get a bad cold; Stuffed head for two days; Last night I experienced trouble Breathing.; Asthma; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number: EN6208, Expiry date: unknown) via an unspecified route of administration, administered in arm right on 18Mar2021 12:00 (age at vaccination: 59-years-old) as dose 1, single for COVID-19 immunization (facility). Medical history included asthma and hypertension from an unknown date and unknown if ongoing. Concomitant medication included hydrocodone taken for limb injury. On 19Mar2021 13:00, patient experienced severe back pain and severe pain in what she called her adenoids which was the first sign that she was going to get a bad cold. Stuffed head for two days then last night she experienced trouble breathing. She had diagnosed with asthma and she had asthma medicines there which she took. Patient had no Covid prior and after the vaccine and no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 and not tested for covid post vaccination. Patient received prednisone, symbicort and albuterol prevented a trip to the hospital for the treatment of the event asthma. Patient did not take any treatment for the events severe back pain, severe pain, bad cold, stuffed head and trouble breathing. The outcome of the events was reported as resolving.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Illness
Clinical narrative: Chills; Joint pain; Muscle pain; Nausea; Headache; Tired all the time; got really sick the day after she got the shot; whole body was hurting; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206; Expiration Date: Jun2021) via an unspecified route of administration, administered in Arm on 07Mar2021 10:00 (at the age of 70 years old) as dose 1, single for COVID-19 immunisation at school. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced nausea, headache on 08Mar2021, joint pain, muscle pain on 09Mar2021, chills on 11Mar2021, tired all the time, got really sick the day after she got the shot, whole body was hurting on Mar2021. Reported as, the patient got really sick the day after she got the shot and it was being a week and a half now. Patient started with nausea, then it went to joint pain, then muscle pain, then chills, then a really bad headache, then really tired all the time. Patient whole body was hurting. Patient has recovered from the joint pain and muscle pain. The chills, headache, and nausea all come and go. Patient was given nausea medicine. Adverse event resulted in Physician office: Primary Care Provider. Therapeutic measures were taken as a result of nausea (nausea). Outcome of the event joint pain, muscle pain was recovered on Mar2021, recovering for nausea, headache, chills, not recovered for got really sick the day after she got the shot, and unknown for tired all the time, whole body was hurting.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain
Clinical narrative: Chills; Joint pain; Muscle pain; Nausea; Headache; Tired all the time; got really sick the day after she got the shot; whole body was hurting; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206; Expiration Date: Jun2021) via an unspecified route of administration, administered in Arm on 07Mar2021 10:00 (at the age of 70 years old) as dose 1, single for COVID-19 immunisation at school. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced nausea, headache on 08Mar2021, joint pain, muscle pain on 09Mar2021, chills on 11Mar2021, tired all the time, got really sick the day after she got the shot, whole body was hurting on Mar2021. Reported as, the patient got really sick the day after she got the shot and it was being a week and a half now. Patient started with nausea, then it went to joint pain, then muscle pain, then chills, then a really bad headache, then really tired all the time. Patient whole body was hurting. Patient has recovered from the joint pain and muscle pain. The chills, headache, and nausea all come and go. Patient was given nausea medicine. Adverse event resulted in Physician office: Primary Care Provider. Therapeutic measures were taken as a result of nausea (nausea). Outcome of the event joint pain, muscle pain was recovered on Mar2021, recovering for nausea, headache, chills, not recovered for got really sick the day after she got the shot, and unknown for tired all the time, whole body was hurting.  No follow-up attempts are possible. No further information is expected.