chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Pt received second dose of Pfizer vaccine in Jun and did not get her period for the month of Jul. For Aug she had 2 heavy periods.; Pt received second dose of Pfizer vaccine in Jun and did not get her period for the month of Jul. For Aug she had 2 heavy periods.; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient received second bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration on an unknown date in Jun2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration as dose 1, single for COVID-19 immunization. On an unknown date in Jun2021, the patient had received second dose of pfizer vaccine and had not got her period for the month of July2021 and had 2 heavy periods in Aug2021. The patient received no treatment for the events. It was unknow whether the patient had received any other vaccine within 4 weeks. It was unknow whether the patient had not been diagnosed with COVID-19 prior to vaccination or had been tested since the vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Tremor
Clinical narrative: got real bad chills; was shaking so bad I couldn't get warm not matter how many blankets; Headache; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient reported for herself). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FD8448), first dose via intramuscular, administered in upper left arm on 14Aug2021 (at the age of 64-year-old) as dose 2, single for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Verbatim: Asthma, neuropathy peripheral from an unknown date and unknown if ongoing Verbatim: Neuropathy, migraine from an unknown date and unknown if ongoing Verbatim: Migraine, hypersensitivity from an unknown date and unknown if ongoing, neuropathy peripheral from an unknown date and unknown if ongoing. No investigation assessment was reported. Concomitant medications included pregabalin (LYRICA) taken for neuropathy peripheral, start and stop date were not reported; atenolol (ATANOL) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for hypersensitivity, start and stop date were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), first dose via intramuscular, administered in left arm on 24Jul2021 (at the age of 64-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced got real bad chills, was shaking so bad I could not get warm not matter how many blankets, headache. Therapeutic measures were taken as a result of got real bad chills, was shaking so bad I could not get warm not matter how many blankets, headache. Consumer stated, "I got the second dose yesterday and around midnight I got real bad chills, I was shaking so bad I couldn't get warm not matter how many blankets, I am not running a fever and I actually couldn't even read the paper that I was given. I had to get my niece up to see what to do, and she said just try Tylenol (Treatment), that help but the chills are starting back now. And also, I have a headache, so I was wondering how long should this side effects last." Consumer stated, "No it just started last night I took Tylenol, that's it." Consumer stated, "From the Tylenol it improved, and it's started back so I took more Tylenol." The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Two days after vaccine experiencing worsening Tinnitus; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: FC3180, expiration date was not reported), via an unspecified route of administration, administered in left arm on 09Aug2021 11:15 (at the age 56-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, two days after vaccine on 09Aug2021 11:15 AM patient experiencing worsening tinnitus. The adverse events resulted in healthcare professional office/clinic visit. No treatment was received for adverse events. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; muscle aches; This is a spontaneous report from a contactable pharmacist. A 41-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EJ1685, Expiry Date: not reported), intramuscular, administered in left arm on an unspecified date (at the age of 41 years 2 months, as reported) as dose 1, single for covid-19 immunization. Medical history included allergies to medications, food or other products: Fava beans, Sulfa, Bactrim, Iodine contrast, Tegretol, ASA, Clindamycin, Hydroclorothiazide. GERD, Asthma, Bipolar Dusorder, High blood pressure. Type of facility was workplace clinic. Prescription, over the counter medications, dietary supplements of herbal remedies being taken at the time of vaccination included quetiapine fumarate (SEROQUEL), Gabapentin, omeprazole (PROTONIX [OMEPRAZOLE]), Lamotrigine, cariprazine hydrochloride (VRAYLAR), Metoprolol, Hydralazine, escitalopram oxalate (LEXAPRO), fluticasone propionate (FLOVENT). She received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EJ1685, Expiry Date: not reported), intramuscular, administered in left arm on an 09Jan2021 at 15:00 (at the age of 41 years 2 months) as dose 2, single for covid-19 immunisation and experienced fever, chills, muscle aches, tingling numbness in feet which moved up to her abdomen and Guillan-barre. On 09Jan2021, patient developed fever, chills, muscle aches after dose 1 vaccination. The outcome of events fever, chills, muscle ache was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: arthritis in both hands got worse/arthritis to right heel part of foot got worse/worsening arthritis in her hands and right heel/arthritis in her hands also got completely worse; This is a spontaneous report from a contactable consumer, the patient's husband. A 66-years-old female patient second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534, Expiration Date: 30Jun2021) via an unspecified route of administration on 21Mar2021 (at the age of 65 years) as dose 2, single for covid-19 immunization. Medical history included ongoing arthritis. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198, expiration date was not reported), via an unspecified route of administration, administered in left arm on 01Mar2021 (at the age of 65 years) as dose1, single for covid-19 immunization. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced worsening of arthritis in both hands and to the right heel part of foot. It was reported that, arthritis was moderate to severe after getting both doses of vaccine. Therapeutic measures were taken as a result of event and patient took treatment with aspirin (TYLENOL) or arthritis pain relief (lot number 0LR0554, expiration date Aug2022), over the counter medications, which did not help her at all. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Contusion, Dysphonia, Feeling abnormal, Hypoaesthesia
Clinical narrative: hand got numb; her voice is rough; every morning like something is wrong/it felt like someone has punched her in the arm or shoulder.; bruised line going across her arm; pain in arm; Can't hardly lift her left arm, it is weak; Can't hardly lift her left arm, it is weak.; Can't talk, something is wrong with her voice; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received bnt162b2 (BNT162B2) solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration at arm left on 02Aug2021 as a single, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter was a 78-year-old female. She had the first dose of the Pfizer-BioNTech COVID-19 Vaccine on 02Aug2021 and ever since, it felt like someone has punched her in the arm or shoulder. Her hand got numb and mentions she never got arthritis in the shoulder. She also reported that her voice was rough and gets like that every morning like something was wrong. There was also a bruised line going across her arm her son looked at it and it looked like it settled at the top. She also mentioned that a year ago she volunteered to give blood and was drawn on the same arm and her arm went numb. She was asking if she should get the second shot and should she get it in the right arm. She said that she doesn't want to get the second shot and she doesn't want both her arms to hurt. She also has 3 doctor appointments coming up. She had all the papers on it stating inflammation and bleeding and everything. Clarified this was what's listed on the paper. Reporter was not experiencing inflammation and bleeding. Now she can't talk. Something is wrong with her voice. It's rough and she can't hardly change that. Had three doctors, including a kidney and regular general doctor at (#). Her voice is rough this morning, it gets like that every morning. Wondering if she should get the second one because this hasn't gone away since she got the shot the first time. Had been in her house for two and a half years without leaving. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Muscular weakness, Pain in extremity
Clinical narrative: hand got numb; her voice is rough; every morning like something is wrong/it felt like someone has punched her in the arm or shoulder.; bruised line going across her arm; pain in arm; Can't hardly lift her left arm, it is weak; Can't hardly lift her left arm, it is weak.; Can't talk, something is wrong with her voice; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received bnt162b2 (BNT162B2) solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration at arm left on 02Aug2021 as a single, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter was a 78-year-old female. She had the first dose of the Pfizer-BioNTech COVID-19 Vaccine on 02Aug2021 and ever since, it felt like someone has punched her in the arm or shoulder. Her hand got numb and mentions she never got arthritis in the shoulder. She also reported that her voice was rough and gets like that every morning like something was wrong. There was also a bruised line going across her arm her son looked at it and it looked like it settled at the top. She also mentioned that a year ago she volunteered to give blood and was drawn on the same arm and her arm went numb. She was asking if she should get the second shot and should she get it in the right arm. She said that she doesn't want to get the second shot and she doesn't want both her arms to hurt. She also has 3 doctor appointments coming up. She had all the papers on it stating inflammation and bleeding and everything. Clarified this was what's listed on the paper. Reporter was not experiencing inflammation and bleeding. Now she can't talk. Something is wrong with her voice. It's rough and she can't hardly change that. Had three doctors, including a kidney and regular general doctor at (#). Her voice is rough this morning, it gets like that every morning. Wondering if she should get the second one because this hasn't gone away since she got the shot the first time. Had been in her house for two and a half years without leaving. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection; batch/lot# and expiration date not reported), via an unspecified route of administration, on Jul 3, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced body rash and shingles on an unspecified date in 2021. The patient hasn't taken the 2nd dose yet because of the side effects. She would like to know what she needed to do before taking the 2nd dose. The outcome of the events: unknown. The lot number for the vaccine, BNT162B2, not provided and will be requested during follow-up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: swelling/bruising of injection site; swelling/bruising of injection site; bleeding of injection site; fever; headache; muscle pain; joint aches; red itchy bumps on legs; tiredness; nausea; feeling unwell; itchy skin; This is a spontaneous report from a contactable consumer or other non hcp. A 21-years-old female (Non pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Left Arm on 13Aug2021 16:30 for covid-19 immunization. The patient medication history were not reported. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received birth control medication within 2 weeks of vaccination. Prior to vaccination the patient did not diagnosed with COVID-19. Since the vaccination the patient did not tested for COVID-19. On 14Aug2021, patient experienced swelling/bruising of injection site, bleeding of injection site, fever, headache, muscle pain, joint aches, red itchy bumps on legs, tiredness, nausea, feeling unwell, itchy skin. Outcome of event was not recovered.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Pyrexia, Rash pruritic, Vaccination site bruising
Clinical narrative: swelling/bruising of injection site; swelling/bruising of injection site; bleeding of injection site; fever; headache; muscle pain; joint aches; red itchy bumps on legs; tiredness; nausea; feeling unwell; itchy skin; This is a spontaneous report from a contactable consumer or other non hcp. A 21-years-old female (Non pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Left Arm on 13Aug2021 16:30 for covid-19 immunization. The patient medication history were not reported. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received birth control medication within 2 weeks of vaccination. Prior to vaccination the patient did not diagnosed with COVID-19. Since the vaccination the patient did not tested for COVID-19. On 14Aug2021, patient experienced swelling/bruising of injection site, bleeding of injection site, fever, headache, muscle pain, joint aches, red itchy bumps on legs, tiredness, nausea, feeling unwell, itchy skin. Outcome of event was not recovered.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage, Vaccination site swelling
Clinical narrative: swelling/bruising of injection site; swelling/bruising of injection site; bleeding of injection site; fever; headache; muscle pain; joint aches; red itchy bumps on legs; tiredness; nausea; feeling unwell; itchy skin; This is a spontaneous report from a contactable consumer or other non hcp. A 21-years-old female (Non pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Left Arm on 13Aug2021 16:30 for covid-19 immunization. The patient medication history were not reported. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received birth control medication within 2 weeks of vaccination. Prior to vaccination the patient did not diagnosed with COVID-19. Since the vaccination the patient did not tested for COVID-19. On 14Aug2021, patient experienced swelling/bruising of injection site, bleeding of injection site, fever, headache, muscle pain, joint aches, red itchy bumps on legs, tiredness, nausea, feeling unwell, itchy skin. Outcome of event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got both shots and I'm more sick this go around with covid than last time; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A patient of unspecified age and gender received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported), via an unspecified route of administration on an unspecified date as 1st dose single  for covid-19 immunisation.  A patient of unspecified age and gender received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported), via an unspecified route of administration on an unspecified date as 2nd dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced got both shots and i'm more sick this go around with covid than last time on an unspecified date. Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchoscopy, Computerised tomogram, Extra dose administered, Off label use, Therapeutic response unexpected
Clinical narrative: She got vaccinated in Feb. She says her disease has improved and is almost gone.; got the Pfizer booster shot last night, 16Aug2021; got the Pfizer booster shot last night, 16Aug2021; This is a spontaneous report from a contactable consumer (patient herself) from a Pfizer-sponsored program COVAX US Support. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262), via an unspecified route of administration on 04Feb2021 (age at vaccination 65 years) as DOSE 2, SINGLE; dose 3 via an unspecified route of administration on 16Aug2021 (Batch/Lot Number: FC3181) as DOSE 3, SINGLE for covid-19 immunisation. The patient's medical history included mycobacterium avium complex infection and emphysema. Concomitant medication(s) included tiotropium bromide monohydrate (SPIRIVA RESPIMAT) taken for emphysema. On an unknown date, the patient she got vaccinated in February 2021, she says her disease has improved and is almost gone. On 16Aug2021, the patient got the Pfizer booster shot last night. On an unknown date, the patient underwent lab tests and procedures which included bronchoscopy with unknown results, computerised tomogram was normal and MAC had drastically improved, it's hardly there. She is on a thyroid pill and she also takes Spiriva Respimat for her emphysema. She clarifies she had been on these medications for a while (prior to getting the COVID-19 vaccines) and were not new medications. The outcome of the events was unknown. There was no product quality complaint (PQC) present.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I am a Pfizer colleague, yesterday I was speaking with a friend and he told me his arm was sore after receiving the Pfizer Covid 19 vaccine.; This is a spontaneous report from a contactable Pfizer colleague. This Pfizer colleague reported for male consumer (patient/friend). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on unspecified date as a dose number unknown, single for COVID-19 immunization. The patient medical history was unknown and concomitant medication were not reported. Reporter also stated that it was unknown if patient had any allergies. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine and unknown if patient received any list of other medications within 2 weeks of vaccination. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19 and unknown if patient had tested for COVID-19 Since the vaccination. On an unspecified date the reporter stated that reporter was a Pfizer colleague, yesterday he was speaking with a friend and he told reporter that his arm was sore after receiving the Pfizer COVID 19 vaccine. It was unknown if patient receive any treatment for the event reported. Outcome of the reported event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Overdose, Pyrexia, Wrong technique in product usage process
Clinical narrative: three patients who got 6 doses injected at one time and overdose; she had administered the vaccine with the administration error; diarrhea; reported 2 nights of fever; nausea; This is a spontaneous report from a contactable Physician reported for a male patient. A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Lot Number: EWO187; Expiration Date: 31Aug2021) via an unspecified route of administration on 17Aug2021 as dose 1, single (age at vaccination: 16 years) for COVID-19 immunisation. Medical history included COVID-19 from 20May2021 to an unknown date the patient previous had Covid around 20May2021 and recuperated at home and was not hospitalized. Concomitant medications were not reported. No prior vaccinations. On an unspecified date, it was reported that they have three patients (16 years old male, 23 years old female, and 37-year-old female) who got 6 doses injected at one time and overdose. She wanted to know if we have information on this situation and what advice can she give to her patients and had already contacted the CDC and made a VAERS report and followed their internal policy processing and will be notifying the patients and asked if there some adverse reaction they should look for following the event. On 17Aug2021, it was reported 2 nights of fever, nausea, diarrhea and is feeling better today 20Aug2021. No additional medical care or treatment was sought. For the overdose event, HCP reporter suspects full vial of diluted vaccine was administered. Her nurse prepared all the vaccines the same way and realized she had administered the vaccine with the administration error. They had been giving Moderna and JNJ covid vaccines prior to this day, and that was the first time administering Pfizer's. The clinical outcome of the event three patients who got 6 doses injected at one time and overdose, she had administered the vaccine with the administration error was unknown and rest of the events on 20Aug2021 was resolved.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101066605 same reporter/drug/event with different patient
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Dysphagia, Gingival pain, Glossodynia, Oral pain
Clinical narrative: my mouth stays sore; my tongue is very sore; I don't know the name of it (tonsils) it hurts; When I Swallow It Is Uncomfortable, Hurts -Burns; my gums are sensitive; my lips are cracking/splitting; This is a spontaneous report from a contactable other hcp. A 78-years-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included chronic myeloid leukaemia from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included bosutinib (BOSULIF, Formulation: tablet, Expiration date: 31Dec2023) 200 mg, daily via oral taken for chronic myeloid leukaemia from 04Feb2021 to an unspecified stop date, ibandronate sodium (BONIVA) 150 mg tablet, chondroitin sulfate, glucosamine sulfate, turmeric [curcuma longa rhizome] 100 % powder, omeprazole 20 mg capsule DR, acetylsalicylic acid (ASPIRIN EC) LO-DOSE, ONE DAILY FOR WOMEN, fish oil, cyanocobalamin (VITAMIN B-12), potassium, duloxetine hydrochloride (CYMBALTA) and denosumab (PROLIA) 60 mg/ml syringe taken for unspecified indication from an unknown start date. It was reported that, on an unspecified date, my mouth stays sore. My tongue was very sore. I used sensodyne toothpaste and it sets me on fire. I used listerin to rinse my mouth and it hurt so badly. Behind i don't know the name of it (tonsils) it hurt. When I swallow it was uncomfortable, hurts - burns. My gums were sensitive. My lips were cracking/splitting. I don't know if it was from the medication or the covid vaccine. Per patient it started about 3 weeks ago. Patient's MD was not aware, the pharmacist advised the patient to let her prescriber know to see what they suggest going forward. The pharmacist informed the patient that he had never heard of this being a side effect of the covid vaccine. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Tonsillar disorder
Clinical narrative: my mouth stays sore; my tongue is very sore; I don't know the name of it (tonsils) it hurts; When I Swallow It Is Uncomfortable, Hurts -Burns; my gums are sensitive; my lips are cracking/splitting; This is a spontaneous report from a contactable other hcp. A 78-years-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included chronic myeloid leukaemia from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included bosutinib (BOSULIF, Formulation: tablet, Expiration date: 31Dec2023) 200 mg, daily via oral taken for chronic myeloid leukaemia from 04Feb2021 to an unspecified stop date, ibandronate sodium (BONIVA) 150 mg tablet, chondroitin sulfate, glucosamine sulfate, turmeric [curcuma longa rhizome] 100 % powder, omeprazole 20 mg capsule DR, acetylsalicylic acid (ASPIRIN EC) LO-DOSE, ONE DAILY FOR WOMEN, fish oil, cyanocobalamin (VITAMIN B-12), potassium, duloxetine hydrochloride (CYMBALTA) and denosumab (PROLIA) 60 mg/ml syringe taken for unspecified indication from an unknown start date. It was reported that, on an unspecified date, my mouth stays sore. My tongue was very sore. I used sensodyne toothpaste and it sets me on fire. I used listerin to rinse my mouth and it hurt so badly. Behind i don't know the name of it (tonsils) it hurt. When I swallow it was uncomfortable, hurts - burns. My gums were sensitive. My lips were cracking/splitting. I don't know if it was from the medication or the covid vaccine. Per patient it started about 3 weeks ago. Patient's MD was not aware, the pharmacist advised the patient to let her prescriber know to see what they suggest going forward. The pharmacist informed the patient that he had never heard of this being a side effect of the covid vaccine. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Peripheral swelling
Clinical narrative: Localized reaction of pink, warm, swollen arm with tenderness; three patients who got 6 doses injected at one time and overdose; This is a spontaneous report from a contactable physician. This physician reported for a 23-year-old female patient. A 23-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EWO187; Expiration Date: 31Aug2021), dose 1 via an unspecified route of administration on 17Aug2021 as a single dose for covid-19 immunization. Medical history included covid-19 from 20May2021 to 20May2021 Hospitalized due to Covid and experienced psychosis during Covid infection. The psychosis was controlled with medicine and had resolved by the time patient received vaccine. Concomitant medication(s) included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]); aripiprazole (ABILIFY); calcium carbonate (TUMS FRESHERS ANTACID); famotidine; clindamycin hydrochloride; ethinylestradiol, levonorgestrel (ASHLYNA); metformin; sertraline hcl; ipratropium bromide, salbutamol sulfate (DUONEB); amitriptyline. On 17Aug2021, It was reported that they have three patients (16 years old male, 23 years old female, and 37 year old female) who got 6 doses injected at one time and overdose. She wants to know if we have information on this situation and what advice can she give to her patients. The patient experienced localized reaction of pink, warm, swollen arm with tenderness on an unspecified date. Outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101065126 same reporter/drug/event with different patient
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nausea, Overdose, Oxygen saturation, Peripheral swelling
Clinical narrative: three patients who got 6 doses injected at one time and overdose; localized reaction of pink, warm, tender swollen arm; localized reaction of pink, warm, tender swollen arm; Fever; Nausea; This is a spontaneous report from a contactable physician. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWO187; Expiration Date: 31Aug2021) via an unspecified route of administration on 17Aug2021 (at the age of 37 years old) as dose 1, single for COVID-19 immunisation. Medical history included obese (patient was morbidly obese prior to hospitalization at 269lbs in Mar and 266 in May. She lost a lot of weight in the hospital and was 245 lbs at discharge), ongoing alpha-1 antitrypsin deficiency , lung disease, COVID-19 from 20May2021 to an unknown date (had Covid 19 around 20May2021 and was hospitalized for 10 days). Concomitant medication included alpha-1-antitrypsin (PROLASTIN C), albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), ipratropium bromide, salbutamol sulfate (DUONEB), bupropion (BUPROPION), dupilumab (DUPIXENT), fluticasone propionate, salmeterol xinafoate (ADVAIR), furosemide (FUROSEMIDE), glycopyrrolate (GLYCOPYRROLATE), ipratropium bromide (ATROVENT), levothyroxine (LEVOTHYROXINE), metformin (METFORMIN), omeprazole (OMEPRAZOLE), all taken for an unspecified indication, start and stop date were not reported, alprazolam (ALPRAZOLAM) taken for lung disorder, start and stop date were not reported; azithromycin (AZITHROMYCIN) taken for lung disorder, start and stop date were not reported. The patient experienced as, three patients who got 6 doses injected at one time and overdose on 17Aug2021, localized reaction of pink, warm, tender swollen arm, fever, nausea on 2021. Baseline O2 status was 6-8 meters a minute and was on bipap. For the overdose event, HCP reporter suspects full vial of diluted vaccine was administered. The patient underwent lab tests and procedures which included oxygen saturation: 6-8 on May2021 (baseline O2 status was 6-8 meters a minute and was on bipap), weight: 245 lbs on an unspecified date (patient was morbidly obese prior to hospitalization at 269lbs in March and 266 in May. She lost a lot of weight in the hospital and was 245 lbs at discharge), weight: 269 lbs on Mar2021, weight: 266 lbs on May2021. Outcome of the event localized reaction of pink, warm, tender swollen arm was not resolved and unknown for fever, nausea.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Weight
Clinical narrative: three patients who got 6 doses injected at one time and overdose; localized reaction of pink, warm, tender swollen arm; localized reaction of pink, warm, tender swollen arm; Fever; Nausea; This is a spontaneous report from a contactable physician. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWO187; Expiration Date: 31Aug2021) via an unspecified route of administration on 17Aug2021 (at the age of 37 years old) as dose 1, single for COVID-19 immunisation. Medical history included obese (patient was morbidly obese prior to hospitalization at 269lbs in Mar and 266 in May. She lost a lot of weight in the hospital and was 245 lbs at discharge), ongoing alpha-1 antitrypsin deficiency , lung disease, COVID-19 from 20May2021 to an unknown date (had Covid 19 around 20May2021 and was hospitalized for 10 days). Concomitant medication included alpha-1-antitrypsin (PROLASTIN C), albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), ipratropium bromide, salbutamol sulfate (DUONEB), bupropion (BUPROPION), dupilumab (DUPIXENT), fluticasone propionate, salmeterol xinafoate (ADVAIR), furosemide (FUROSEMIDE), glycopyrrolate (GLYCOPYRROLATE), ipratropium bromide (ATROVENT), levothyroxine (LEVOTHYROXINE), metformin (METFORMIN), omeprazole (OMEPRAZOLE), all taken for an unspecified indication, start and stop date were not reported, alprazolam (ALPRAZOLAM) taken for lung disorder, start and stop date were not reported; azithromycin (AZITHROMYCIN) taken for lung disorder, start and stop date were not reported. The patient experienced as, three patients who got 6 doses injected at one time and overdose on 17Aug2021, localized reaction of pink, warm, tender swollen arm, fever, nausea on 2021. Baseline O2 status was 6-8 meters a minute and was on bipap. For the overdose event, HCP reporter suspects full vial of diluted vaccine was administered. The patient underwent lab tests and procedures which included oxygen saturation: 6-8 on May2021 (baseline O2 status was 6-8 meters a minute and was on bipap), weight: 245 lbs on an unspecified date (patient was morbidly obese prior to hospitalization at 269lbs in March and 266 in May. She lost a lot of weight in the hospital and was 245 lbs at discharge), weight: 269 lbs on Mar2021, weight: 266 lbs on May2021. Outcome of the event localized reaction of pink, warm, tender swollen arm was not resolved and unknown for fever, nausea.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: would like to know if high blood pressure is "immunocompromised"/high blood pressure after vaccine; This is a spontaneous report from a contactable consumer or other non hcp via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date in Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. On an unspecified date in 2021, caller stated that she would like to know if high blood pressure was immunocompromised to qualify for booster vaccine. Nurse/faxed to medical for AE - high blood pressure after vaccine. The clinical outcome of the event was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Fever; Hives; rash symptoms that coated his entire body; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection, Batch/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 reporter was not sure if the patient received Pfizer or Moderna COVID-19 vaccine. The patient's medical history and concomitant medications were not reported. On 16Aug2021, the patient experienced fever, hives, and rash symptoms that coated his entire body. Outcome of all events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101068628 same reporter and product; similar events; different patients
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: I had a high heart rate for about a week after the shot/my heart rate was way too high 121 and 124 BPM; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 42 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 27Jul2021 (Batch/Lot Number: EW0180) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included iron (IRON) taken for an unspecified indication, start and stop date were not reported; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported; loratadine (CLARITIN [LORATADINE]) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC  ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) fiber gummies taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation. The patient normally donate plasma twice a week and her normal heart rate is between 80-92. The cut-off to donate is under 100 BPM and was told she can not donate plasma. The patient experienced a high heart rate for about a week after the shot her heart rate was way too high 121 and 124 bpm causing heart rate increased on 29Jul2021 07:00 with outcome of recovered. The patient underwent lab tests and procedures which included heart rate high at 121 and 124 bpm.  Follow-Up (31Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Lymphadenopathy, Rash
Clinical narrative: rash all over her body; right axillary lymph node was swollen; shingles outbreak; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0168), via an unspecified route of administration, administered in Arm Right on 02Aug2021 (at the age of 32-year-old) as dose 1, single for covid-19 immunisation. Medical history included Shingles (Caller said this was diagnosed 5-6 years ago, maybe longer). The concomitant medications of the patient were not reported. Caller stated she broke out into a rash all over her body and her right axillary lymph node got swollen which started on 04Aug2021. She said her rash had gotten a whole lot better, she worked for an Infectious Disease doctor who prescribed her a Medrol pack, dose unknown. Caller stated the Medrol pack was like a Z-pak where one takes it for 6 days and the 6th day you take 6 pills, on the 5th day you take 5 pills, and so on. She said she was not sure about the milligrams. Caller stated she got shingles, so she also had a shingles outbreak, which it was better, and her lymph node swelling got better. The outcome of all events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary mass, Herpes zoster, Nerve injury, Pain
Clinical narrative: 10 days after my 1st dose, I got a lump underMy armpit. It started throbbing and pain growing towards my shoulder blade. Pain worse; It started throbbing and pain growing towards my shoulder blade. I then noticed a big red spot on my back that also started to hurt. Pain worse/he stated I could have long term effects including pain; My armpit. It started throbbing and pain growing towards my shoulder blade. I then noticed a big red spot on my back that also started to hurt. Pain worse; I then noticed a big red spot on my back that also started to hurt. Pain worse; I went to my dr and he said I got shingles; he stated I could have long term effects including pain or nerve damage; This is a spontaneous report from a contactable consumer. A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3180, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 04Aug2021 14:00 (age at vaccination 31 years) as dose 1, single for covid-19 immunisation. Medical history Known allergies to Penicillin. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient visited doctor or other healthcare professional office/clinic visit. On 15Aug2021 14:00 the patient experienced 10 days after her 1st dose, she got a lump under her armpit. it started throbbing and pain growing towards my shoulder blade. she then noticed a big red spot on her back that also started to hurt. pain worse, she went to her dr and he said she got shingles, he stated she could have long term effects including pain or nerve damage, he stated she could have long term effects including pain or nerve damage. Reporter stated, Pain worsened so she went to her doctor said it was probably a reaction to the vaccine given she had no other conditions to cause this and she Otherwise healthy. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 16Aug2021 Nasal Swab. Patient received treatment for reported events. she now have a 7 day medication and pain meds to manage this. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, SARS-CoV-2 test
Clinical narrative: 10 days after my 1st dose, I got a lump underMy armpit. It started throbbing and pain growing towards my shoulder blade. Pain worse; It started throbbing and pain growing towards my shoulder blade. I then noticed a big red spot on my back that also started to hurt. Pain worse/he stated I could have long term effects including pain; My armpit. It started throbbing and pain growing towards my shoulder blade. I then noticed a big red spot on my back that also started to hurt. Pain worse; I then noticed a big red spot on my back that also started to hurt. Pain worse; I went to my dr and he said I got shingles; he stated I could have long term effects including pain or nerve damage; This is a spontaneous report from a contactable consumer. A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3180, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 04Aug2021 14:00 (age at vaccination 31 years) as dose 1, single for covid-19 immunisation. Medical history Known allergies to Penicillin. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient visited doctor or other healthcare professional office/clinic visit. On 15Aug2021 14:00 the patient experienced 10 days after her 1st dose, she got a lump under her armpit. it started throbbing and pain growing towards my shoulder blade. she then noticed a big red spot on her back that also started to hurt. pain worse, she went to her dr and he said she got shingles, he stated she could have long term effects including pain or nerve damage, he stated she could have long term effects including pain or nerve damage. Reporter stated, Pain worsened so she went to her doctor said it was probably a reaction to the vaccine given she had no other conditions to cause this and she Otherwise healthy. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 16Aug2021 Nasal Swab. Patient received treatment for reported events. she now have a 7 day medication and pain meds to manage this. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.