chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has a history of skin cancer / did a biopsy showed squamous cancer / left leg in two areas had cancer; was diagnosed with Prurigo or PRN / his left leg in two areas and right leg have Prurigo; experienced atopic dermatitis / did a biopsy showed atopic dermatitis; 5 bumps on both his legs and arms / bump on his belly; itchy welts; itches; he has really rough skin; bumps are crusty; This case was reported by a consumer via call center representative and described the occurrence of skin cancer in a elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 6 months after receiving Shingles vaccine, the patient experienced skin cancer (serious criteria GSK medically significant), prurigo, atopic dermatitis, local swelling, urticaria, pruritus, skin rough and crust. The patient was treated with topical steroid nos (Steroid Cream) and antibiotics nos (Oral Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the skin cancer, prurigo, atopic dermatitis, local swelling, urticaria, pruritus, skin rough and crust were unknown.   It was unknown if the reporter considered the skin cancer, prurigo, atopic dermatitis, local swelling, urticaria, pruritus, skin rough and crust to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported for himself. The age at vaccination was not reported but could be 79 or 80 years. Between July to November 2020, the patient received 1st dose of Shingles vaccine and a week after the vaccination, the patient experienced atopic dermatitis and was diagnosed with Prurigo or PRN. The patient could not 100 percent confirm that he received the Shingrix because he did not have the lot number, but he believed that it was not Zostavax because his vaccine required 2 doses. The patient claimed that he had 5 bumps on both his legs and arms that were itchy welts and bump on his belly. From last year patient had skin cancer, they did a biopsy on his legs and it showed squamous cancer and atopic dermatitis and it keeps getting worse. The patient stated that when they did the biopsy, his left leg in two areas had cancer and Prurigo but his right leg did not show cancer, but it did have Prurigo. The patient claimed that the condition spreads as he itches it and he had really rough skin. The patient was given steroid cream but that did not help him, so he took an oral antibiotic from a previous diagnosis. The patient reported that his bumps are crusty. The patient reported that he was scheduled to get the 2nd dose on 15th January 2021. The reporter consented to follow-up.
A large area around my injection site was red, swollen, warm to touch, firm and itchy covering 3/4 of my upper arm into my underarm and lymph nodes.      I received my first vaccine on 12/23/20 several days after injection the site became very itchy, red and swollen but in a much smaller area and persisted for several days leaving a small area of skin hyper pigmented for ~2 weeks. However  I did not think it was considered an "Adverse" event and would have not reported it if the second dose was to a similar scale.  Also, when I received first vaccine I did not know I was pregnant at the time.   When I went to the doctor on 1/23/21 I was told I was 7.5 weeks pregnant, but there was no heart beat and  I had miscarried.  Being that I am over the age of 40 and a high risk for pregnancy and miscarriage  I am unsure if my miscarriage is directly related to the vaccine but I felt it should add it to the report.   My first vaccine was administered on 12/23/20 @ 5:30pm at Hospital
Wheezing, moderate trouble breathing, tightness in chest- onset approximately 1.5-2 hours after receiving the vaccination
pain in right foot close to knee; not able to walk; ball-kind of inflammation on foot; Pain and burning in right knee (posterior and lateral knee area) with bending impairment; Pain and burning in right knee (posterior and lateral knee area) with bending impairment; This is a spontaneous report from a contactable consumer (patient herself). A 58-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EW0161), via an unspecified route of administration, administered in Arm Right on 14Apr2021 10:00 (at the age of 58 years old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not known for any allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient did not receive any other medication 2 weeks prior to COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EP7534), via an unspecified route of administration, administered in Arm left on 24Mar2021 10:00 AM as dose 1, single for COVID-19 immunization. On 21Apr2021, the patient experienced pain and burning in right knee (posterior and lateral knee area) with bending impairment, next day patient experienced pain in right foot close to knee and not able to walk, with ball-kind of inflammation on foot. The patient did not receive any treatment for adverse events. The outcome of events was not resolved.  No follow-up attempts are needed. No further information required.
Low temperature reached: 26.9F out of range intermittently for 12 days , with no reported adverse event; Excursion product administered to patient; Initial information received on 12-Apr-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an unknown age female patient who reported that low temperature reached: 26.9 F out of range intermittently for 12 days, with no reported adverse event and excursion product administered to patient while receiving vaccines Poliomyelitis Vaccine (Inactivated) (IPOL), Diphtheria, Tetanus, Ac Pertussis, IPV and HIB Vaccine (Pentacel), HIB Vaccine CONJ (Tet Tox) (ACTHIB) And Quadrivalent Influenza Vaccine (Fluzone Quadrivalent).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (Vero) (Poliomyelitis Vaccine (Inactivated) )(lot TIE871M and expiry 10-Oct-2022), Diphtheria, Tetanus, Ac Pertussis, IPV(Pentacel), ActHIB (not produced by Sanofi Pasteur) and Influenza Quadrival A-B Vaccine (Fluzone Quadrivalent) (strength, dosage, route, administration site, expiry date: unknown). Information on Lot number is not reported.  On an unknown date the patient reported low temperature reached: 26.9f out of range intermittently for 12 days, with no reported adverse event" (product temperature excursion issue) excursion product administered to patient (Product use issue) (unknown latency) following the administration of IPV (Vero) (Poliomyelitis Vaccine (Inactivated) )(lot TIE871M and expiry 10-Oct-2022), Diphtheria, Tetanus, Ac Pertussis, IPV (Pentacel), ActHIB (not produced by Sanofi Pasteur) and Influenza Quadrival A-B Vaccine (Fluzone Quadrivalent).  It was reported that Caller reporting she was sure products have been administered but have to look through data to determine affected patients.  Action taken: not applicable.  It was not reported if the patient received a corrective measurement for the event (Low temperature reached: 26.9F out of range intermittently for 12 days, with no reported adverse event).  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
4/2-knee, back and neck pain patient left message last night on adverse reactions, this writer called back patient this morning and recommended for her to take ibuprofen. Follow up call was placed today and she is feeling better than yesterday, will continue to use ibuprofen as needed. If symptoms worsen, advised her to see primary provider.
Patient called the pharmacy to get the name of the vaccine and lot number. He said he was up all night with severe chills, fever, severe headache, and nausea. The site of the immunization was a little sore, but it was more the other side effects that bothered him most. Previously, he had 1 dose of Shingrix by the same manufacturer a few years ago and had a similar reaction to which his providers told him not to get the second vaccine.
Mild headache began around 16 hours after the vaccine. Headache increased to intense levels by around 24 hours after the vaccine. (I would liken the amount of discomfort to at least that of my worst migraines, but the pain was in a different part of my head and was different than my usual migraine pain.) The intense headache persisted for around 12 hours, causing pain that was severe enough to keep me from sleeping, in spite of taking over the counter pain relief medications and drinking plenty of fluids throughout the day. (Note: I also was careful to hydrate more than usual in the 48 hours prior to the vaccine.) Medications attempted included aspirin, naproxen sodium and ibuprofen. (Not all at once.) I am now roughly 60 hours post-vaccine and still have a mild headache, but OTC meds seem to be helping a bit more now.
Syncopal episode lasting less than 60 seconds. Nausea & vomiting. Applied 2L of O2. After 20 min client's BP was 102/62 & was feeling better.
Feeling groggy; Nauseas; High blood pressure (160/80); Arm was swelling; Dizziness; Fatigue/tired; Achiness; Fever of 101.6 F; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (High blood pressure (160/80)), PERIPHERAL SWELLING (Arm was swelling), FEELING ABNORMAL (Feeling groggy), DIZZINESS (Dizziness) and FATIGUE (Fatigue/tired) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to lisinopril, chlorothiazide and cleocin.), Penicillin allergy, Hypertension and Prediabetes. Concomitant products included AMLODIPINE, METOPROLOL and LOSARTAN for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (High blood pressure (160/80)), PERIPHERAL SWELLING (Arm was swelling), DIZZINESS (Dizziness), FATIGUE (Fatigue/tired), MYALGIA (Achiness) and PYREXIA (Fever of 101.6 F). On 19-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling groggy) and NAUSEA (Nauseas). At the time of the report, BLOOD PRESSURE INCREASED (High blood pressure (160/80)), PERIPHERAL SWELLING (Arm was swelling), FEELING ABNORMAL (Feeling groggy), DIZZINESS (Dizziness), FATIGUE (Fatigue/tired), MYALGIA (Achiness), PYREXIA (Fever of 101.6 F) and NAUSEA (Nauseas) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Blood pressure measurement: 160/80 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Tylenol
Patient is a 76 y.o. male patient, DO with history of atrial fibrillation, diabetes, CAD, hyperlipidemia, hypertension, and CKDIII presented with COVID.   Patient reports about 3 days of fatigue, poor appetite, nausea, diarrhea, and SOB.  Patient believes he had a couple of his COVID vaccines but it has been a while.  Patient does not recall a COPD history either and does not normally wear oxygen at home.   In the ED vitals are as follows, temperature 98.1, blood pressure 118/75, heart rate 97, RR 16, and oxygen saturation of 94% on 2L NC. Labs results were significant for creatinine 1.90, BUN 29, glucose 138. The rest of the CBC and CMP were within normal limits. Troponin 26-20. Flu swab negat   Patient is a 76 y.o. male patient, DO with history of atrial fibrillation, diabetes, CAD, hyperlipidemia, hypertension, and CKDIII presented with COVID.   Patient reports about 3 days of fatigue, poor appetite, nausea, diarrhea, and SOB.  Patient believes he had a couple of his COVID vaccines but it has been a while.  Patient does not recall a COPD history either and does not normally wear oxygen at home.   In the ED vitals are as follows, temperature 98.1, blood pressure 118/75, heart rate 97, RR 16, and oxygen saturation of 94% on 2L NC. Labs results were significant for creatinine 1.90, BUN 29, glucose 138. The rest of the CBC and CMP were within normal limits. Troponin 26-20. Flu swab negative. Chest x-ray showed no acute cardiopulmonary process. CT abdomen/pelvis showed diverticulosis, prostatic enlargement, small bilateral fat containing inguinal hernias, chronic bilateral L5 spondylolysis, diffuse demineralization, chronic mild height loss L5 vertebral body, small sliding type hiatal hernia, and mild bilateral renal cortical scarring. Patient was given dexamethasone and 1L NSS bolus. Patient admitted for observation.    Clinical Summary Patient's acute respiratory failure secondary to COVID improved with dexamethasone and remdesivir and was weaned to room air without oxygen requirement at discharge.  Patient's VS and labs were stable otherwise and patient will be discharged home with instructions to follow up with PCP.   Discharge diagnosis Acute respiratory failure secondary to COVID Persistent atrial fibrillation CAD Hyperlipidemia Hypertension Diabetes CKDIII
I got red spots on my back and left arm and they hurt and itched.  Today is 12/1 and I have a few more and they itch and hurt and are red.  Have done nothing so far because I am not sure what to do.  I have to be careful about medications I TAKE.
Information has been received from a consumer concerning her 8 year old daughter with no known medical history or allergies who was vaccinated with a dose of varicella virus vaccine live "over six years ago: .There was no concomitant medication. On 01/28/2005 the mother reported that her daughter developed a significant case of varicella with over 300 lesions.  She was exposed to wildtype recently at her elementary school . Unspecified medical attention was sought. NO lab or diagnostic tests were performed. There was no product quality complaint involved.. The pt  sister (WAES 0503USA00283) also had a similaiar experience following vaccinatinl
Extreme pain in upper arm/shoulder when I move it certain ways.  Very difficult to lift arm, difficult to sleep on my left side (side of injection).  Pain started the day I received flu shot and I am still experiencing the pain now almost 4 weeks later.  Pain lessened some after a couple weeks then slightly alleviated more so for a few days after massage.  But now pain has returned to original pain level.  Ibuprofen at anti-inflammatory dose of 800mg provides some temporary relief.  Shot was given by a nurse leaning to give flu injections.  Injection site felt too high up on arm, about a finger width down from shoulder bone (at junction of shoulder and upper arm).  I tried to keep arm actively moving and continued to massage injection site for first few days.  Planning a visit to my doctor.
Spasms in hands and feet/spasms in his feet was a weird sensation like little explosions going off, like a nerve issue, around feet, toes, and ankles; Both hands went numb; Both hands went numb and were tingling quite a bit and the next day when he woke up it was worse; He is having the tremors around ankles and feet; It is very uncomfortable and has not been able to sleep well because of it.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0183), via intramuscular route administered in left arm (left shoulder as reported) on 17May2021 (age 46-year-old at time of vaccination) (in noon as reported) as single dose for preventative/COVID-19 immunisation. Medical history included had an allergy to penicillin and that was when he was a child, he thinks he had a rash. He does not know if he was still allergic. Prior Vaccinations (within 4 weeks) were none. Concomitant medications were none. It was reported that the evening after getting the first shot on 17May2021, both hands went numb and were tingling quite a bit and the next day when he woke up it was worse. On the third day after getting the shot he started getting and was still have spasms in hands and feet on 20May2021. The spasms in feet was a weird sensation like little explosions going off, like a nerve issue, around feet, toes, and ankles, stated it was also in his hands but not quite as much in hands. He still has numbness and tingling in hands and fingers. It was worrisome since he was an artist and paints. It is hard to paint with numbness and tingling. The numbness and tingling has stayed the same but there are periods of it getting intense from time to time, it has not subsided. He was hoping it would only last 2 or 3 days. As he was talking, he was having the tremors around ankles and feet in 2021. It was very uncomfortable and had not been able to sleep well because of it in 2021. The spasms are still the same, if anything they have worsened. No treatment received for events. The outcome of events tremor and insomnia was unknown and for remaining events was not recovered.  Follow up needed, further information has been requested.
Pt was in  recovery after receiving vaccine. Pt began looking diaphoretic and clammy. Pt became unresponsive for about 5 seconds. Pt was alert and oriented. B/P: 180/102, oxygen at 88% which increased ot 98% within a minute. She was unable to stand to transfer to wheel chair to lay down. B/P retaken 15 minutes later 80/52. B/P 10 minutes later 126/76. Pt transported to Emergency Room for further evaluation.
No adverse effect reported; patient were each administered an improperly stored dose of VARIVAX; This spontaneous report was received from a nurse referring to two unspecified patients of unknown ages and unknown genders. Information of concurrent condition, medical history and concomitant therapy were not provided.    On 24-OCT-2018, patients were vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot#R017635 with expiration date 20-JUN-2020 (strength, dose and route were not reported) for prophylaxis and sterile diluent (STERILE DILUENT). The varicella virus vaccine live (oka/merck)(VARIVAX) vaccines experienced temperature excursion and were stored at 6 to 14 Fahrenheit degrees (9.1 Fahrenheit degrees ) for 50 minutes (Product storage error). There was no previous temperature excursion. No adverse events were reported in any patients. A data logger was involved. The outcome of the event was not reported.  Follow-up information was received from the reporting nurse on 05-JUN-2019.  The nurse reported the patient's demographics and were updated in the case.  It was also reported that on 24-OCT-2018, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) for prophylaxis, lot # R011802, expiration date 21-OCT-2019 (strength, dose, frequency, route of administration and anatomical site of injection were not reported).  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA002234: US-009507513-1810USA011328:
shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77-year-old patient of unknown gender.  On an unknown date in September 2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient was treated by a physician for the following injury, resulting from zoster vaccine live (ZOSTAVAX) vaccination: shingles.  The outcome of the event was unknown. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was related.
Painful lump on her arm; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer reported that a female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  Caller mentioned that she got Prevnar 13 shot on 11Jul and since then she was having a painful lump on her arm the size of a walnut. She also ended up in the emergency room because of it. She would like to know how long it will stay there since her physician does not know what to do with it. Outcome of the events was unknown.   Information on the batch number has been requested.
Immediately following adminstration (within seconds), I felt lightheaded and completely enervated. This lasted a good twenty minutes I believe (you can check with my doctor?s notes).  Because I had had a reaction to Pfizer first dose, my allergist was giving me the booster in her clinic. She split th e dose in half.  At 17 minutes post first half-dose, my doctor had me take a Claritin pill. That did the trick; at 30 min, the lightheaded was gone and only the tiredness remained. So my  doctor?s nurse administered second half-dose?I did not get light-headed.   The extreme tiredness lasted through the following day. Day 2 post-booster I got a rash at the injection site (also sore arm but everyone gets that). Rash lasted a day; I used 2.5% hydrocortisone cream to calm it down.
When needle was removed after injection, blood came out more forceful than usual. Injection site seemed little bruised or have slight hematoma. Dr was notifed. She advised Wellness nurse what to advise patient. Patient was notified and given Dr's advice. Follow up on 12/11/17 - Client reports arm was only slightly sore when pushed on injection site.
Sweats and hot flashes, chills, low grade fever, exhaustion.  They started Thursday early in the AM. They will go away for a certain period of time but then they return.
Patients Dr called pharmacy to report that the pt. has cellulitis at the injection site where the PREVNAR 13 vaccine was administered. Dr. ordered ABx for the patient.
Weakness of legs and arms so she could not get up from chair or walk with walker about 5 hours after the shot. Improved in hospital. Low grade fever, treated with IV fluids. 12/1/08-records received for DOS 10/13-10/15/08-DC DX: fever, likely secondary to vaccination, resolved. Unsteady gait, multifactorial, likely from atherosclerotic cerebrovascular disease and multiple infarcts. Presented with C/O weakness and fever.