chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: He had a sore arm/my arm was sore; This is a spontaneous report from a contactable consumer or other non hcp.   A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 17Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced he had a sore arm/my arm was sore on an unspecified date. The event outcome was reported as unknown.  No follow up attempts are possible; Information about Lot and batch number could not be obtained.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Sensitive skin, Vaccination site pain
Clinical narrative: slight skin sensitivity; Injection arm became very sore; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EL3247) via unspecified route of administration, in left arm on 19Feb2021 14:45 as dose 2, single (at the age of 23-years-old) for COVID-19 immunization in other facility. The patient medical history and concomitant medication were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3247), via unspecified route of administration, in left arm on 29Jan2021 02:45 PM (at the age of 23-years-old) as a dose 1, single for covid-19 immunization in other facility. Patient did not have any known allergies. Patient did not have any other vaccine in four weeks and no other medications in two weeks. Patient not had COVID prior to vaccination and was not tested for COVID post vaccination. On 19Feb2021 22:00 the patient experienced injection arm became very sore. On 20Feb2021 the patient experienced slight skin sensitivity. The patient did not receive any treatment for the reported events. Outcome of all the reported events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Headache/teeny-tiny headache /last night and have a terrible headache; Arm soreness; Nauseated; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.   A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, on 15Feb2021 (Lot Number: EN6201, at the age of 47-year-old), as single dose for COVID-19 immunization. Medical history included psoriasis from an unknown date and unknown if ongoing. Concomitant medications included clarithromycin (CLARITIN [CLARITHROMYCIN]) and vitamins taken for an unspecified indication, start and stop date were not reported. 19Feb2021, she had headache/teeny-tiny headache /last night and have a terrible headache. Unknown date in Feb2021, she had arm soreness, nauseated. Monday at 11 in the morning, the patient had just really mild symptoms nothing unmanageable at all, just arm soreness and maybe just a teeny-tiny headache and a little bit nauseated, but not bad at all. The patient could go to work and do everything, but the patient went to bed last night and had a terrible headache this morning think so, and the patient did not usually get headaches. The patient reported that it was been five days. The patient was asking if it was possible to be side effect, five days later. It feels migraineish. The patient reported that it was a little better now and that the patient took some Advil (treatment) to help. So, the patient just wondered how long after the vaccine could expect to possibly have symptoms. Therapeutic measures were taken as a result of headache/teeny-tiny headache /last night and have a terrible headache. The clinical outcome of headache/teeny-tiny headache /last night and have a terrible headache was not recovered while not arm soreness, nauseated was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain
Clinical narrative: back pain; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Mother) that: A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Feb2021 as dose 1, single for covid-19 immunisation and acetylsalicylic acid (BABY ASPIRIN), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) daily (Everyday) for blood pressure abnormal. Medical history included drug hypersensitivity (allergic to penicillin) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced back pain. The patient has back pain which she said was unrelated to the vaccine. The reporter wanted to know if it was safe for the patient to take painkillers like Aspirin. The patient also takes a baby aspirin everyday for her BP. Someone told the patient not to take this medicine. The reporter wanted to know if it is okay to take it. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: The causal association between the event  back pain and the suspect vaccine is assessed as related . The case will be reassessed once new information is available.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: when I move it hurts. I was tired and ache when I move, but I have no temperature; when I move it hurts. I was tired and ache when I move, but I have no temperature; This is a spontaneous report from a Pfizer-sponsored program . This is a spontaneous report from a contactable consumer reported for herself. A 68 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date were unknown), via an unspecified route of administration, administered at an unspecified anatomical location on 20Feb2021 10:00 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were unknown. On 20Feb2021, the patient experienced when I move it hurts. I was tired and ache when I move, but I have no temperature. The events accessed as a non serious. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Neck pain
Clinical narrative: back pain; neck pain; This is a spontaneous report from a contactable consumer (Patient) from a medical information Team. A consumer (caregiver) mother received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation : Solution for injection , Batch /Lot number : Not reported) dose 2, Via an unspecified route of administration on Feb2021 as a single dose for COVID-19 immunisation. Patient medical history and concomitant medication were not reported. She was taking Oxycodone before for her chronic back pain. Historical vaccine include bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation : Solution for injection , Batch /Lot number : Not reported) dose 1, Via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Patient experienced back pain for back and neck pain on an unspecified date in 2021. Outcome of the events was Unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness mostly head swimming; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in the right arm on 19Feb2021 at 15:45 (at the age of 70-year-old) as dose 1, single for COVID-19 immunization at Hospital. Medical history included stoke 10 years before (unspecified date) and COVID-19, Prior to the vaccination, the patient was diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medications were not reported, patient received other medications within 2 weeks of vaccination (unspecified). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Feb2021, at 15:00, the patient experienced dizziness mostly head swimming. The outcome of the event was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: 33 hours after second shot: tired, dizzy. Continuing through today (10.5 days later); 33 hours after second shot: tired, dizzy. Continuing through today (10.5 days later); This is a spontaneous report from a contactable consumer (Patient). A 82-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 07:00 as dose 2, single (At the age of 82-years) for covid-19 immunisation. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included leukaemia and allergic to penicillium, anti-inflamatories. from an unknown date and unknown if ongoing. No other vaccine given in four weeks. Prior to vaccination, patient was not diagnosed with covid-19. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM), amlodipine (AMLODIPINE), lisinopril (LISINOPRIL), sulfamethoxazole, trimethoprim (BACTRIM) and glucose (GLUCOS) all taken for an unspecified indication, start and stop date were not reported. On 12Feb2021 at 14:00 the patient experienced 33 hours after second shot: tired, dizzy. continuing through today (10.5 days later). Since the vaccination, patient has not been tested for covid-19. Patient did not receive any treatment for the events. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: his wife is experiencing "a bump underneath her skin, red, and its painful."/redness and a little bump and lot of pain; his wife is experiencing "a bump underneath her skin, red, and its painful."/redness and a little bump and lot of pain; his wife is experiencing "a bump underneath her skin, red, and its painful."/redness and a little bump and lot of pain; This is a spontaneous report from a contactable consumer (Patient's husband) via Medical Information Team.   A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6200; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in right arm on 17Feb2021 (at the age of 78-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history included a broken arm couple of years ago and lost the use of that arm and the hand anyways, that's why we have to put the shot in her right arm and reporter does not know about treatment. The patient takes a lot of unspecified concomitant medications. On an unspecified date in Feb2021, the patient experienced a bump underneath her skin, red, and its painful, redness and a little bump and lot of pain. The reporter clarified that his wife was experiencing this at the injection site and has been going on for the last two days and has been taking Advil PM for this reaction. The patient was scheduled to have second dose on 10Mar2021. The reporter asked if patient would react differently with the second dose. The patient received treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Facial eczema in remission for many years, resurfaced after the second dose of vaccine; This is a spontaneous report from a contactable Physician (patient). A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN9581) via unknown route administered in Arm Left on 04Feb2021 (at the age of 49 years old) as dose 2, single for COVID-19 immunisation. The patient medical history included Facial eczema. The patient did not have allergies. The concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: El3246) via unknown route administered in Arm Left on 13Jan2021 at 01:00 PM (at the age of 49 years old) as dose 1, single for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. On 18Feb2021 at 01:00 PM, the patient experienced Facial eczema in remission for many years, resurfaced after the second dose of vaccine. Patient did not receive treatment for the event.  The patient did not have covid prior vaccination and not tested for covid post vaccination. The outcome was not recovered.  Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient, reported for self). A 54-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and expiry date: unknown), dose 2 via an unspecified route of administration, administered in left arm on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. The patient had earlier received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Not reported) via via an unspecified route of administration, administered in left arm (reported as) on 31Jan2021 at 12:00 (at the age of 54-years-old) for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. On 20Feb2021 13:30, the patient experienced sore arm. Felt as if punched in the arm. Even hurt when not using arm. By 22Feb, arm only hurt when using it. Much less sore. Patient received no treatment for the event. Post vaccination, the patient was not tested for COVID-19. The outcome of event was recovering.   Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Headache, Hypersomnia
Clinical narrative: fatigue; general malise; Chills; body ache; headache; slept appx. 19 out of 24 hours per day; This is a spontaneous report from a contactable consumer(patient). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Not Reported, Expiry Date: Not Reported), via an unspecified route of administration, administered in Arm Left on 17Feb2021 (at the age of 49-year-old) at 17:15 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included clonazepam (CLONAZEPAM) taken for an unspecified indication, start and stop date were not reported; allopurinol (ALLOPURINOL) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. It was unknown if the patient was diagnosed with covid prior vaccination. The patient was not tested for covid post vaccination. On 17Feb2021 at 18:30, the patient experienced fatigue, general malaise. On an unspecified date in feb2021 that is on days two and three, the patient experienced chills, body aches, headache, slept appx. 19 out of 24 hours per day. On day four, there was a slight improvement, slept 16 out of 24 hours. On day five, the adverse event improved, but still feeling about 70% well. The patient did not receive any treatment for the reported event. Outcome of the events was recovered with sequelae.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: fatigue; general malise; Chills; body ache; headache; slept appx. 19 out of 24 hours per day; This is a spontaneous report from a contactable consumer(patient). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Not Reported, Expiry Date: Not Reported), via an unspecified route of administration, administered in Arm Left on 17Feb2021 (at the age of 49-year-old) at 17:15 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included clonazepam (CLONAZEPAM) taken for an unspecified indication, start and stop date were not reported; allopurinol (ALLOPURINOL) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. It was unknown if the patient was diagnosed with covid prior vaccination. The patient was not tested for covid post vaccination. On 17Feb2021 at 18:30, the patient experienced fatigue, general malaise. On an unspecified date in feb2021 that is on days two and three, the patient experienced chills, body aches, headache, slept appx. 19 out of 24 hours per day. On day four, there was a slight improvement, slept 16 out of 24 hours. On day five, the adverse event improved, but still feeling about 70% well. The patient did not receive any treatment for the reported event. Outcome of the events was recovered with sequelae.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: First vaccine - tenderness in injection site; A 67-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3246) via an unspecified route of administration, administered in right arm on 20Jan2021 10:15 (at the age of 67-year-old) as dose 1, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included Irritable bowel syndrome and osteoporosis from an unknown date and unknown if ongoing. Concomitant medication included tetanus vaccine taken for an unspecified indication on 22Jan2021. Patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other unspecified medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. No Covid prior vaccination. Since the vaccination, the patient had been tested for COVID-19. On an unspecified date, patient experienced tenderness at the injection site. No treatment received for the adverse event. Outcome of the event was resolved with sequelae.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: bad jaw pain; This is a spontaneous report from a contactable consumer who reported for a female (patient). A adult female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if patient was pregnant at the time of vaccination. Allergies to medications, food, or other products was unknown. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient diagnosed with COVID-19 was unknown. It was unknown if the patient been tested for COVID-19 since the vaccination.The patient experienced really bad jaw pain on an unknown date in Feb2021. It was unknown if patient received treatment for the adverse event. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Reported her daughter had a tender shoulder after her first COVID-19 Vaccine dose; This is a spontaneous report from a contactable consumer or other non-healthcare professional (parent). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Jan2021 (age at the time of vaccination was 35 years) as DOSE 1, SINGLE for covid-19 immunization at Clinic. The patient medical history, concomitant medications and other products were not reported. On an unspecified date in 2021, the reporter(s) her daughter had a tender shoulder after her first covid-19 vaccine dose. The reporter clarified her daughter's shoulder was tender enough to wake her up at night was she laid on her shoulder. It was reported her daughter got her COVID-19 Vaccine from the Health Department and stated that her daughter was a clinical psychologist. She said her daughter received her first COVID-19 Vaccine dose within the first 3 weeks of giving the COVID-19 Vaccine out. It was reported her daughter's shoulder tenderness lessened over the following days, and in 2-3 days her daughter's tender shoulder was gone. It was reported that as maybe her daughter took the same brand Ibuprofen she used (Equiline Brand) because she had seen a bottle of Equiline Brand Ibuprofen at her daughter's house. The reporter said she did not have the Ibuprofen NDC, Lot, and Expiration Date. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A first dose of female patient of an unspecified age received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number: not reported), 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. she had the Pfizer vaccine and it has not quite been 21 days since that dose. She stated her next dose if scheduled at 19 days after the first dose. She stated she takes a blood thinner for a-fib and stated this was Amlodipine. She stated she did not have any symptoms after her first dose other than a sore arm, which lasted 5 to 6 days, which was longer than her daughter. The caller stated she heard the second dose is more.She stated she heard people were dying from the second dose. She heard that what they put in the second dose is bad, like stuff from babies and that the dose is more than the first and that they aren't telling people what they put in it but it is bad. She wanted to know if the second dose was worse and if people died from it. The patient experienced her next dose if scheduled at 19 days after the first dose and sore arm. The outcome of the events was unknown.   Information about batch/lot number has been requested  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity, Somnolence
Clinical narrative: diarrhea- not a formed stool or a mousse stool; she slept like 4 days after, she slept and slept; Pain in arm; This is a spontaneous report from a contactable consumer (patient's husband). A 79-years-old female patient received bnt162b2 (BNT162B2, formulation; solution for injection, lot number: EL9262), via an unspecified route of administration, administered in Arm Left on 04Feb2021 (at the age of 79 years) as dose 1, single for covid-19 immunization. Medical history included arthritis from an unknown date and unknown if ongoing (it is hard for his wife to walk due to this, she has a lot of it, and it was diagnosed a long time ago), diabetes from an unknown date and unknown if ongoing (this was diagnosed a long time ago), neuropathy from an unknown date and unknown if ongoing (this was diagnosed a long time ago). There were no concomitant medications. On an unspecified date, the patient experienced diarrhea- not a formed stool or a mousse stool, she slept like 4 days after, she slept and slept, pain in arm. Reporter said she had a form of diarrhea, she says not, reporter said there was no form to it, it just came out, it was not formed stool, and she has always had formed stool, now she had whatever you call it, reporter called it diarrhea. She was scheduled to take her second shot on Thursday, and they were concerned about the diarrhea since it was still going on, and she was always exhausted after the bowel movement. One other thing was his wife had pain in her arm after getting the shot that lasted about 4 days. They did no treatment for diarrhea, they were not sure if it was gonna be short time or what, also because it wasn't affecting anything. When patient first got the shot, she slept like 4 days after, she slept and slept, he had to get her up to make her eat, she slept an awful lot. There has been no treatments. Clinical outcome of the event was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Interchange of vaccine products, Off label use, Pain
Clinical narrative: little chills, and minor soreness; little chills, and minor soreness; got both the Pfizer and Moderna Covid-19 Vaccines; got both the Pfizer and Moderna Covid-19 Vaccines; This is a spontaneous report from a Contactable Consumer. A 77-Year-old male consumer reported that: Patient received (Pfizer-Biontech Covid-19 Vaccine, Formulation, solution for injection, Batch/lot number: Unknown, Expiry Date of Covid-19 Vaccine: Unknown) via unspecified route of administration in left arm on 20Feb2021 as dose 2, single (age at vaccination 77 years )for COVID-19 vaccination. The patient medical history and concomitant medication were not reported. Historical vaccine included Moderna Covid-19 Vaccine Batch/lot number: Unknown, Expiry Date of Covid-19 Vaccine: Unknown) on 30Jan2021 for COVID-19 vaccination. Patient received the 1st dose of the Moderna vaccine on 30Jan2021 and received the 2nd dose is from Pfizer on 20Feb2021. It was reported that patient was not experiencing side effects other than little chills, and minor soreness. Patient was asking if there had been reports about my situation and any potential side effects. The outcome of events were unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Myalgia, Pain, Pain in extremity
Clinical narrative: arm soreness; muscle soreness; general body aches; Headache/migraine; Headache/migraine; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-year-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration, administered in arm on 21Feb2021 as dose 2, single for COVID-19 immunization. Action taken with drug was reported as unknown. The patient's medical history and concomitant medications were not reported. It was reported that she received her second Pfizer COVID vaccine dose 21Feb2021. She experienced arm soreness, muscle soreness, general body aches, and a headache after receiving the second dose. She took Excedrin migraine and tramadol to treat the symptoms. She wants to know if this was ok to do. Caller on the line calling about the vaccine, for the virus, clarified to be the COVID Vaccine. She stated she just had the second one yesterday on 21Feb2021. After the second one her arm was really sore. It continued to get worse as the evening went on. Then her muscles started to get sore and she got achy. She was calling to confirm if whatever she took after getting the second dose was okay. She stated she took a Excedrin Migraine because she also had a headache/migraine. Then after the middle of the night around 3-4 she could not sleep. She was sore so she took Tramadol. On an unspecified date in 2021 patient experienced arm soreness, muscle soreness, general body aches, headache/migraine. Seriousness of the events was reported as non serious. Therapeutic measures were taken as a result of the adverse events which included Excedrin migraine and tramadol. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Head ache; Fatigue; Some nausea; This is a spontaneous report from a contactable consumer (patient).   A 34-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3247, Expiry date: not reported), via an unspecified route of administration in left arm on 19Feb2021 13:15 (at age of 34-years-old) as dose 2, single for covid-19 immunisation in workplace clinic. The patient medical history was not reported. The patient had no known allergies and had no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: EL3247, Expiration Date: Not reported), via an unspecified route of administration in left arm on 29Jan2021 13:15 as dose 1, single for covid-19 immunisation. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported and multi vitamin. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 20Feb2021 at 06:00, the patient experienced headache, fatigue, some nausea. No therapeutic measures were taken in response to the events. The events recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: pain in rotator cuff and back; sore throat; This is a spontaneous report from a contactable consumer (patient).  A 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in arm left on 22Jan2021 (at the age of 81-years) as dose 1, single for covid-19 immunization. Patient medical history and concomitant medications were not reported. The patient had her first dose of the Pfizer Covid vaccine on 22Jan2021, states ten days later on 02Feb2021, had a sore throat, lasted about 8 days, had to take a Z-pack, not normal for her and states it went away around the 09Feb2021. States the patient got the second dose of the Pfizer Covid vaccine on 12Feb2021 and the patient got up Sunday morning, 21Feb2021, with a sore throat again, states it was worse today that it was when the patient woke up yesterday. The patient had a tear in her rotator cuff, started hurting her last week, got a corticosteroid injection in that area about 6 weeks ago prior to vaccine, states now arm was hurting and back was hurting and was unsure if it was related to the vaccine. The patient did had little spot about the size of a nickel after the vaccine where they gave the shot that was a little sore, whole arm was fine. when the patient gets a flu shot, she did not even move her arm for days. The patient did not go to the emergency room and physician office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not had relevant tests. The patient received treatment for adverse event. The outcome of the event oropharyngeal pain was resolved on 09Feb2021 and outcome of the event pain extremity was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Exposure via skin contact, Underdose, Vaccination site pain
Clinical narrative: felt a sting when the needle went in to her arm; The liquid in the vial squirted out as the nurse was giving it to her and it ran down her arm; The liquid in the vial squirted out as the nurse was giving it to her and it ran down her arm; The liquid in the vial squirted out as the nurse was giving it to her and it ran down her arm; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), intramuscular in the right arm, on 19Feb2021 10:00 (Lot number: EL9267; Expiration date: 31May2021), at age 76 years old, as dose 1, single, for COVID-19 immunisation, at a public health department. The patient has no medical history and concomitant medications. The patient received her first dose of the Pfizer COVID-19 vaccine on Friday, 19Feb2021 10:00. She stated that the liquid in the vial squirted out as the nurse was giving it to her, and it ran down her arm. She stated that the nurse asked someone to report it, but the nurse told the patient just to come back for her second dose stating it should cover you. She reported that the nurse said, well that doesn't seem right, and then the nurse said, well that was fast. When the caller looked at her arm, the liquid was running down her arm. The nurse said it squirted out at her, so the patient has no idea how much she vaccine got. The patient wanted to know if it was safe to get the second dose if you did not receive the first dose and if it is important to get two full doses. Also, the patient felt a sting when the needle went in her arm. She felt the needle go in but felt nothing after that. The events did not require emergency room and physician's office visits. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Dry mouth, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EL9265) via an unspecified route of administration in arm right on 16Feb2021 (age at Vaccination 66 years) as dose 2, single for COVID-19 immunization. Medical history included palpitations (she had them for about 8 years now), hypothyroid and a nodule on her thyroid. She did not suffer from anxiety. With the palpitations, she get shaky, teeth chatters, she do cold packs, and breathing exercises. There concomitant medications were none. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EL8982) via an unspecified route of administration on 25Jan2021 (age at Vaccination 66 years) as dose 1, single for COVID-19 immunization. On 19Feb2021, the patient experienced nausea, pain at the injection site and increased palpitations. On an unspecified date, the patient experienced dizziness, weakness, headache, tiredness, lethargy, diarrhoea and dry mouth like she was dehydrated. She said that last night she was up until 5am with severe palpitations. She said that she has a nodule on her thyroid and is trying to rule everything out. She has a biopsy scheduled for next month. They gave her alprazolam 3 mg and she took it early and it did the trick. She was prescribed metoprolol. Therapeutic measures were taken as a result of nausea and increased palpitations. She took some Pepto Bismol. She said that 3 days after the injection she had increased palpitations, nausea, and pain at the injection site. The nausea subsided, but she reported that she also had dizziness, weakness, diarrhea, slight headache. She said that always has headaches though. She said that she also had tiredness and was lethargic. She said that her main concern was the palpitations. She also had dry mouth like she was dehydrated. She was wondering if it trigger something with her thyroid. On an unspecified date in 2021, the event nausea was recovered. The outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Nausea, Palpitations, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EL9265) via an unspecified route of administration in arm right on 16Feb2021 (age at Vaccination 66 years) as dose 2, single for COVID-19 immunization. Medical history included palpitations (she had them for about 8 years now), hypothyroid and a nodule on her thyroid. She did not suffer from anxiety. With the palpitations, she get shaky, teeth chatters, she do cold packs, and breathing exercises. There concomitant medications were none. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EL8982) via an unspecified route of administration on 25Jan2021 (age at Vaccination 66 years) as dose 1, single for COVID-19 immunization. On 19Feb2021, the patient experienced nausea, pain at the injection site and increased palpitations. On an unspecified date, the patient experienced dizziness, weakness, headache, tiredness, lethargy, diarrhoea and dry mouth like she was dehydrated. She said that last night she was up until 5am with severe palpitations. She said that she has a nodule on her thyroid and is trying to rule everything out. She has a biopsy scheduled for next month. They gave her alprazolam 3 mg and she took it early and it did the trick. She was prescribed metoprolol. Therapeutic measures were taken as a result of nausea and increased palpitations. She took some Pepto Bismol. She said that 3 days after the injection she had increased palpitations, nausea, and pain at the injection site. The nausea subsided, but she reported that she also had dizziness, weakness, diarrhea, slight headache. She said that always has headaches though. She said that she also had tiredness and was lethargic. She said that her main concern was the palpitations. She also had dry mouth like she was dehydrated. She was wondering if it trigger something with her thyroid. On an unspecified date in 2021, the event nausea was recovered. The outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Oxygen saturation, Pain in extremity, SARS-CoV-2 test, Vaccination site erythema
Clinical narrative: sore arm; she has redness and a hard raised lump around the injection site; she has redness and a hard raised lump around the injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was reported as EL9266, Expiry date was not reported) on an unspecified route of administration, administered in arm right on 19Feb2021 (at the age of 61 years old) dose 1, single for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing Hereditary Diabetic. Reporter reported that she had Covid around Dec2020 and she was in the hospital for 5 days, was on Remdesivir, steroids, insulin, and blood thinners. Concomitant medications included metformin taken for diabetes mellitus, start and stop date were not reported, Cinnamomum verum (CINNAMON) Capsule taken for diabetes mellitus, start and stop date were not reported, acetylsalicylic acid (BABY ASPIRIN) 81 mg taken for an unspecified indication, start and stop date were not reported; Multivitamin. Patient got her First Dose 19Feb2021 between 4-5 PM. On an unspecified date in Feb2021 the patient states she has redness and a hard raised lump around the injection site. Her arm was sore but that was okay, however it had got like a hard lump around it, she asks if it will go down, it about the size of a silver dollar, it is red and raised. On 20Feb2021 the patient experienced sore arm. The reporter stated her husband put a circle around her, and that is when she saw the size. It being a hard lump was noticed Sunday. The lump has gone down, but it is a weird hard. The patient underwent lab tests and procedures which included heart rate which was high on unspecified date; Oxygen (Oxygen saturation) Result as 83 on unspecified date, Covid Rapid Test (SARS-CoV-2 test) result as positive nasal swab on Dec2020. Patient has had no covid tests since then. The outcome for the event sore arm, she has redness was unknown and for the event she has redness and a hard raised lump around the injection site was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: sore arm; she has redness and a hard raised lump around the injection site; she has redness and a hard raised lump around the injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was reported as EL9266, Expiry date was not reported) on an unspecified route of administration, administered in arm right on 19Feb2021 (at the age of 61 years old) dose 1, single for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing Hereditary Diabetic. Reporter reported that she had Covid around Dec2020 and she was in the hospital for 5 days, was on Remdesivir, steroids, insulin, and blood thinners. Concomitant medications included metformin taken for diabetes mellitus, start and stop date were not reported, Cinnamomum verum (CINNAMON) Capsule taken for diabetes mellitus, start and stop date were not reported, acetylsalicylic acid (BABY ASPIRIN) 81 mg taken for an unspecified indication, start and stop date were not reported; Multivitamin. Patient got her First Dose 19Feb2021 between 4-5 PM. On an unspecified date in Feb2021 the patient states she has redness and a hard raised lump around the injection site. Her arm was sore but that was okay, however it had got like a hard lump around it, she asks if it will go down, it about the size of a silver dollar, it is red and raised. On 20Feb2021 the patient experienced sore arm. The reporter stated her husband put a circle around her, and that is when she saw the size. It being a hard lump was noticed Sunday. The lump has gone down, but it is a weird hard. The patient underwent lab tests and procedures which included heart rate which was high on unspecified date; Oxygen (Oxygen saturation) Result as 83 on unspecified date, Covid Rapid Test (SARS-CoV-2 test) result as positive nasal swab on Dec2020. Patient has had no covid tests since then. The outcome for the event sore arm, she has redness was unknown and for the event she has redness and a hard raised lump around the injection site was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: Lightheadedness; Shaking really bad and was frozen; Shaking really bad and was frozen; Headache; Sore arm; Wasn't feeling good; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in left arm on 21Feb2021 (age at vaccination 81 years) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included ongoing essential tremors (started in her twenties), shoulder replacement; left shoulder two years ago and right shoulder ten years ago and mild Covid in Dec2020. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported, Expiration Date: 30May2021) via an unspecified route of administration, administered in right arm, on 31Jan2021 as DOSE 1, SINGLE, for COVID-19 immunisation The patient's concomitant medications were not reported. The patient reported that after receiving the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine yesterday, she experienced some side effects. On 21Feb2021 22:30 she was shaking really bad, and was frozen She also had headache, sore arms. She also mentioned that on her card, she saw a sticker with the expiration date, 30Jun2021. The patient wanted to know if this was the expiration date for the vaccine, and if she needs to take another dose of the vaccine after the vaccine expires. She read all the information. She was fine until bedtime. She went to bed early because she was not feeling good. She woke at 10:30pm and was shaking so bad and was frozen. She keeps the heat at 70. She turned it up to 72 degrees and had two sweaters on and she was still cold. She guesses that was to be expected. She also had a headache and a sore arm. She was lightheaded this morning on 22Feb2021. She guesses that goes with it. Therapeutic measures were taken as a result of shaking really bad and was frozen. Outcome of the events Light-headedness recovered on 22Feb2021, event of not feeling good was unknown and other events was not recovered.  No follow-up attempts are possible. No further information is expected.