chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a literature report for the following literature source(s): "Subungual hematomas after mRNA Covid-19 vaccine administration", Journal of Travel Medicine, 2022. A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migrant" (unspecified if ongoing); "numbness" (unspecified if ongoing), notes: on palms and fingers, bilaterally; "tingling" (unspecified if ongoing), notes: on palms and fingers, bilaterally; "excruciating pain" (unspecified if ongoing); "prickling" (unspecified if ongoing), notes: 3 hours afterwards; "generalized distal finger phalanx pain" (unspecified if ongoing), notes: 3 hours afterwards. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: TRAUMATIC HAEMATOMA (medically significant), 1 week after the suspect product(s) administration, outcome "recovering", described as "She developed multiple large, polymorphic subungual hemorrhages in several fingers". The patient underwent the following laboratory tests and procedures: Antibody test: Normal; Antineutrophil cytoplasmic antibody: Normal; Antinuclear antibody: Normal; Blood glucose: Normal, notes: fasting glycemia; 125 mg/dl; Blood test: Normal; Coagulation time: Normal; Full blood count: Normal; Immune complex assay: Normal; A1c: Normal; 10%; clinical evaluation: ruled out any significant, notes: active cardiovascular and pulmonary abnormalities; normal; Red blood cell sedimentation rate: Normal; SARS-CoV-2 antibody test: negative, notes: against SARS-Cov-2 by an immunoassay; negative, notes: against SARS-Cov-2 by an immunoassay; Total complement activity test: Normal; Ultrasound Doppler: failed to reveal deep, notes: or superficial vein thrombosis. Therapeutic measures were taken as a result of traumatic haematoma. Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), on Mar 16, 2021, at 15:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had a hot flush/short hot flash, onset Mar 16, 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Interface dermatitis style reaction at prior smallpox vaccination marks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 (Lot number: ER8735) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Shingles", start date: 27Aug2014, stop date: Sep2014, notes: Illness/AE: Shingles, Onset Date: 27Aug2014, Stop Date: Sep2014, Pertinent Details: Postherpetic Neuralgia in the affected area (Right side of the head) Ongoing; "Impetigo", start date: 06Apr2019, stop date: 20Apr2019, notes: Illness/AE: Impetigo, Onset Date: 06Apr2019, Stop Date: 20Apr2019, Illness/AE: Impetigo, Onset Date: 01Sep2019, Stop Date: 16Sep2019; "Dermatitis/ Cheilitis", start date: Aug2019 (ongoing), notes: Illness/AE: Contact Dermatitis/ Cheilitis, Onset Date: Aug2019, Ongoing. Concomitant medication(s) included: FLUOCINOLONE ACETONIDE taken for dermatitis contact, start date: May2020. The following information was reported: VACCINATION SITE DERMATITIS (non-serious), outcome "not recovered", described as "Interface dermatitis style reaction at prior smallpox vaccination marks".  No follow-up attempts are possible. No further information is expected.
Pt received Dtap and HIB vaccines on Right thigh. Two days later 2 lumps were noticed at the vaccination site. Pt iced affected area swelling went down then took pt to ER and has been seen by primary.
(1) Severe pain in left shoulder and arm, radiating to wrist; (2) fever (99.8F-101.9F); (3) fatigue, malaise. Symptoms have continued with increasing severity for 2+ weeks since vaccination. Possible bursitis in L shoulder resultant from injection site injury to sub-deltoid bursa.
Pt. said her arm has been paralyzed since she received the flu shot on 11/23/11.
15 minutes after vaccination, patient's hand on injection site started itching and tingling around the knuckles. Patient not in acute physical or respiratory distress. Pulse oximetry taken and within normal limits. Patient stayed in the observation area for a longer duration.
Pt began experiencing intermittent palpitations and chest pain four days after event, which are still ongoing 4 months later without a clear etiology. EKG with sinus tachycardia, ECHO was normal. Troponins normal. She did have elevated CRP at time of initial symptoms which is now improving. She has been seen by cardiology without any clear dx thus far. Several ED trips for chest pain, palpitations as well as a few primary care visits.
"flu" like symptoms; tired; "not sleeping"; "feels like an increased heart rate"; feeling "hit by a truck."; fever; left arm injection site "extremely sore"; swollen injection site; injection site red and hot; injection site red and hot; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number FE272, expiry date 18th February 2022) for prophylaxis.   On 10th June 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 11th June 2020, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, tiredness, insomnia, heart rate increased, feeling unwell, fever, injection site pain, injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the influenza-like symptoms, tiredness, insomnia, heart rate increased, feeling unwell, fever, injection site pain, injection site swelling, injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, tiredness, insomnia, heart rate increased, feeling unwell, fever, injection site pain, injection site swelling, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and he woke up with flu like symptoms, fever, feeling tired, not sleeping, feeling an increased heart rate, feeling hit by a truck. The patient had extremely sore injection site and the injection site was swollen, red, and hot to the touch.  The reporter stated that these symptoms are extending below the injection site. The reporter consented to follow up.
Patient represented appointment and up through getting the booster as the 4th dose (2nd booster) with pharmacy staff.  After shot was given, patient presented a 2nd vaccination card wanting cards combined. RPh then realized patient actually just got a 5th shot/dose which hasn't been approved yet.  Pt had not reported any issues after 5th shot/dose as of time of VAERS submitted.
pt recvd vax;that noc devel swelling w/in area of inject site as well as soreness;following day red area encompassing inject site;
Mom presented child to physicians office 5 weeks after date of immunization with lump on the child's right thigh. In progress notes mom stated child also had fever for 2 days post immunization. Child was treated with tylenol.
Chills; sore arm; bruise; redness on arm below vaccination site; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0187), via an unspecified route of administration in left arm on 17May2021 at 14:30 (at the age of 41 years old, not pregnant at the time of vaccination) as dose 2, single for covid-19 immunisation. There was no medical history. The patient had no known allergies. Concomitant medications the patient received within 2 weeks of vaccinations included ethinylestradiol, norethisterone acetate (AUROVELA 1/20) for contraception; omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for contraception; ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS [ASCORBIC ACID; ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for contraception. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0176), via an unspecified route of administration in left arm on 26Apr2021 at 16:30 (at the age of 41 years old) for covid-19 immunisation and experienced - just headache/foggy, sore arm and some swelling for 3-4 days.Tinnitus was the reason she was reporting, however, this started after the first vaccine; she would say about 1 week or so prior to the second shot. she have never had it before, and it has not resolved. She will be contacting her doctor about it, to notify her. She wasn't sure what the cause was, until recently learning it was something happening to others who have been vaccinated, as well. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 18May2021, 2day after application patient experienced chills, sore arm, bruise, redness on arm below vaccination site. The patient did not received treatment due to the events. The outcome of events was not recovered.  Follow-up (19Aug2021): Follow-up attempts are completed. No further information is expected.
Information has been received from a registered pharmacist concerning a female patient who 3 weeks ago on approximately 31-MAY-2010, was vaccinated with a first dose of GARDASIL. The pharmacist reported that the patient developed itching the follow day on approximately 01-JUN-2010 and later the patient developed a rash. At the time of the report the rash still persisted and the patient was recovering from itching. The patient sought medical attention by an office visit. Follow-up information was received from the registered pharmacist who stated that the physician was taking care of reporting the adverse event and that he was not familiar with the case and did not even know the patient's name. No further information is available.
Patient with history of hypertension and interstitial lung disease on oxygen. No change from baseline after vaccine. Patient declined recommendation from paramedic and primary care physician to go to emergency room.
that night, work from sleep with rapid heart beat, headache, sweating, nausea, took aspirin, drank more water, work just feeling off, slight headache and nausea, and left arm pain, concern of blood clots.
02/01/21- pain, tenderness and swelling under right arm 02/02/21- small (dime size) itchy red spot near injection  02/03/21-  red spot increased (quarter size) itches more 02/04/21- red spot increased (2 inches wide) itchy, swollen, hot to touch, benedryl cream, ibuprofen  02/05/21- red spot same, underarm pain , and pain in right breast benedryl cream, ibuprofen  02/06/21- swelling, redness decreased, underarm pain decreased  02/21/21- pain, tenderness in right breast returned; has not gone away  02/24/21 second injection  02/25/21 - fatigue and body aches; Tylenol and rest 2/26/21- red itchy arm 2/27/21 red itchy arm
As per grandmother, pt developed redness and swelling to left thigh area of 2 1/2" X 3 1/2" in diameter, the next day, post vax, on 11/28/00 AM. Pt taking OTC and Advil and to apply warm compresses.
Patient received Moderna vaccine and was waiting in our waiting area as per protocol.  He approached our counter about 10 minutes later saying he felt sweaty, dizzy, and said  "I can feel the blood thru my veins".  Patient was asked if he would like us to call 911 and he answered yes.  911 was called and EMS arrived approximately 4 minutes later. Patient was given water and pharmacist stayed with him until EMS arrived.  He left the building with EMS about 10:22am under his own power.  Patient did not lose consciousness at any time.
Information has been received from a physician concerning a male who on 12-JAN-2007 and 13-MAR-2007 was vaccinated PO with the first and second doses, respectively, of Rotateq (lot number not reported). The physician reported that on 02-MAY-2007, the patient developed a fever. On 09-MAY-2007, the patient was admitted to the hospital where a diagnosis of Kawasaki's disease was made. At the time of this report, the outcome was unknown. The physician noted that the patient would not receive the third dose of Rotateq. Additional information has been requested.  07/16/2007 MR received for admission 5/10-13/2007 of a child who presented with a 9 day hx of fever, rash, and swelling of hands and feet. Rash was on head, chest, and abdomen.  Child's lips were dry, red and cracked, and conjuctival injection was present. Several episodes of vomiting the week before.  (+) peeling skin. Txd with Ig infusion and ASA. Discharge DX: Kawasaki Disease.
FEVER; ACHY; RUNNY NOSE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 04:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced achy. On MAR-2021, the subject experienced runny nose. On 08-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.1. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and the outcome of achy and runny nose was not reported. This report was non-serious.
pt recv vax & 14 days post vax pt devel a rash;MD inquired if the pt was contagious;
Hot to touch, itching, headache, swollen, 4 inch by 3 inch red spot on right arm at injection site. It was brought to my attention on 5/25/2017 about 6pm.
Cough - which is productive, sinus congestion, sneezing; Oxycycline (VIBRAMYCIN) 100 mg capsule; Take 1 capsule (100 mg total) by mouth 2 (two) times a day  for 10 days; Will begin antibiotic as pt current everyday tobacco user
The patient experienced localized itching starting about 10 minutes after the injection in the arm with the injection site and up the side of the neck and face. Patient was given 50mg of liquid benadryl and observed for an additional 15 minutes. The patient was checked on throughout the additional 15 minutes. After the additional 15 minutes, the patient stated that she no longer experienced itching and felt ok.
Large lump on the left side of breast; This is a spontaneous report from a contactable Consumer(patient). A 14-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration, administered in Left arm on 20Aug2021 at 12:00 PM (Batch/Lot Number: FO3182) as dose 1, single for COVID-19 immunization. The patients medical history included COVID-19. The patient had no known allergies. The patients concomitant medications were not reported. On 22Aug2021 at 06:00 AM the patient experienced large lump on the left side of breast. Prior to the vaccination, the patient was diagnosed with COVID-19. 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. The outcome of event was not recovered.  Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected.  Follow-up (24Sep2021): The following information was received from a contactable Other health professional, Health Care Professional Questionnaire received: patient not provide information to you regarding the reported adverse events with the use of the product  No follow-up attempts are needed. No further information is expected
Pt devel generalized urticaria over entire body the morning p/receiving the immun;
PFIZER MONOVALENT WAS ADMINSTERED INSTEAD OF THE BIOVALENT FOR THE 4TH DOSE
Itchy rash, widespread papules/macules, vesicles. Dx: varicella Tx: symptomatic.
Fever: 100.9, fatigue, nausea, muscle pain, chills and headache
My arm was sore to the touch and it was very big and the size of an Avocado. It was very hot to the touch. I had put some lotion on it and it did not itch. I was given antibiotics. The doctor thought it was moving down my arm. They drew a circle around it, and it did not grow. It slowly went down over the course of a week. I got the second dose, and I was poorly for two and a half days. My arm was not affected by the second dose. I did have a low appetite for a month after the second shot. LOT # 024M20A
pt told me one month after the vaccine that for the 5 days following vaccination the bottom of her feet were numb.  she did not describe any weakness.  on the 4th day of these symptoms, she fell getting up from the couch and thought that the lack of feeling in her feet contributed to her fall.  xray obtained more than 4 weeks after the injury did show a tibial and 5th metatarsal fracture.
Right ear pain, shooting/stabbing, around 8:40 pm May 31. Woke from sleep around 4 am June 1, severe pain right ear. Walked around 5:20 am, pain outside and top of left foot. Right side ear pain continued through morning, as did foot pain. Foot pain eased around 10 am. Scalp on right side hurt too much to brush hair. Eye pain/discomfort started before noon. Felt like bruise and burning, especially bottom lid and inside half of eye. Went to ER around 2. Ear pain had lessened, only jolts of pain, certain facial expressions exacerbated pain. Eye discomfort more prominent. Scalp most painful right side, rear half.
Fever; Headache; Nausea; Lethargy; Sleeping difficulty; pain with movement of the head; debilitating; Chills; Hot flashes; This case was reported by a consumer via call center representative and described the occurrence of chills in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 1st July 2022, the patient received the 2nd dose of Shingrix. On 1st July 2022, 10 hrs after receiving Shingrix, the patient experienced chills. On 2nd July 2022, the patient experienced fever, headache, nausea, lethargy, difficulty sleeping, pain upon movement and weakness. In July 2022, the patient experienced hot flashes. On an unknown date, the outcome of the chills, headache, nausea, lethargy, difficulty sleeping, pain upon movement, hot flashes and weakness were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the chills, fever, headache, nausea, lethargy, difficulty sleeping, pain upon movement, hot flashes and weakness to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-Jul-2022 Reporter's Comments: The patient self-reported this case. The patient received second dose of Shingrix around noon on 01st July 2022 and experienced chills around 10pm that night, that lasted throughout the night. The patient woke up on 02nd July 2022 with a 102 fever, severe headache, nausea, and lethargy. The patient further stated that the severe headache caused sleeping difficulty and pain with movement of the head. The patient also experienced hot flashes in the past couple of days, which alternate with experiencing chills. The patient reported that the fever had resolved and all other symptoms were ongoing, but to a lesser degree. The patient stated that the headache still felt debilitating, but was no longer lasting 24 hours a day, but then comes and goes. The reporter consented to follow up.
Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 28-FEB-2014, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-JUL-2016, the patient was treated by a physician at a hospital emergency room for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient presents 1.5 hours after receiving vaccine earlier from clinic. C/o pain in (L) arm extending up into neck "arm getting stiff" excruciating pain with movement. Crying fatigue "feels cold, nausea, abd pain."
Patient received moderna vaccine on 2/12/21, 3/12/21 and 12/29/21. Presented to ER on 7/19/22. COVID positive on 7/14/22. presents emergency department for further treatment and evaluation feeling dizzy while he was at home.  Patient also states that he got clammy as well as slightly short of breath while this was occurring.  Patient states upon arrival to the ED he does feel better.  The patient also does reports a general feeling unwellness.  Patient states that he has been experiencing some epigastric pain.  With no radiation.  Patient is COVID-19 positive.  Confirm 07/14/2022.  Patient did receive oral therapy.  Patient is also complaining of right-sided thigh pain.  Patient denies any vision changes, sore throat, difficulty swallowing, patient states maybe had some chills.  Denies any fever, increased cough, chest pain, heart palpitations, nausea vomiting diarrhea, abdominal pain, constipation, difficulty urinating, painful urination, increased urinary frequency, blood in urine, patient denies any new numbness or tingling in his extremities.  Patient denies any new edema in his extremities.  Patient has a significant medical history of hypertension.  Recent COVID-19.  TIA.  Currently on Plavix.   ED course-patient was found to have extensive DVTs in the right lower extremity.  Heparin drip was initiated.  High sensitive troponin was found to be elevated 7613.3.  Repeat is pending.  CMP significant for BUN elevated 26. BUN creatinine ratio elevated 22.  AST elevated 66. PT INR within normal limits.  CBC essentially unremarkable. Patient treated for DVT. Discharged on 7/22/22