chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness to my groin area; Skin rash; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19), ERYTHEMA (Redness to my groin area) and RASH (Skin rash) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01622A, 017FZ1A, 031LZOA and 039K20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Fish allergy, Drug allergy, High cholesterol since 2003, Blood pressure since 2019, COPD since 2017, Allergy since 2015 and Irritable bowel syndrome since 2015. Concomitant products included SIMVASTATIN for High cholesterol, LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETRIZINE HYDROCHLORIDE), ALPRAZOLAM, HYOSCYAMINE, ATENOLOL and COLECALCIFEROL (D3) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced ERYTHEMA (Redness to my groin area) and RASH (Skin rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing from 2021 at a dose of daily. At the time of the report, COVID-19 (COVID-19) outcome was unknown and ERYTHEMA (Redness to my groin area) and RASH (Skin rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ERYTHEMA (Redness to my groin area) and RASH (Skin rash) to be related. No further causality assessment was provided for COVID-19 (COVID-19).    There was no acute illness at the time of vaccination and before one month before reported. It was reported the event caused the patient to seek medical care. No other potential causes for the event, and patient did not experienced similar event in the past. After each vaccine patient developed a severe skin rash and redness to my groin area. Patient went to the Skin doctor and medication did not help. Patient started taking Benadryl daily and did not seem to help some on the rash for awhile but not the groin area. Benadryl did not seem to work as well anymore.   This case was linked to MOD-2021-280030, MOD-2022-662372 (Patient Link).
Numbness in tongue; Back of throat/sinus irritation; Back of throat/sinus irritation; Mild tingling of lips; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0196), dose 2 via an unspecified route of administration, administered in left arm on 11Jun2021 18:15 (at the age of 57-year-old), as single dose for COVID-19 immunisation in pharmacy or drug Store. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0185), administered in left arm on 14May2021 13:00, as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 11Jun2021 at 19:15, the patient experienced mild tingling of lips, numbness in tongue and back of throat/sinus irritation. The patient visit to doctor or other healthcare professional office/clinic. Therapeutic measures were taken as a result of mild tingling of lips, numbness in tongue, back of throat/sinus irritation, back of throat/sinus irritation and treatment with Benedryl. Outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Day 6 post injection, I started feeling a strange nerve sensation/pain from my left deltoid (point of injection) down through my left hand. It feels as though my arm is about to fall asleep all of the time. It feels like there should be weakness in my limb but there isn't. There is no pain when injection site is touched but there is a dull pain that feels deeper in the arm. Tingling down through arm and hand comes and goes but is typically at night. Feels as though there are small muscle twitches or spasms occurring deep in my arm.
Information has been received from a physician concerning an approximately 14 month old female who on 27 DEC 2007 was vaccinated with a first dose of Rotateq, and on 26 FEB 2008 was vaccinated, with a second dose; 2 ml PO, of Rotateq.  The patient developed unspecified symptoms that resulted in the hospitalization of the patient with an unconfirmed diagnosis of intussusception.  Information related to the symptoms, date of onset, treatment and date of hospitalization was not reported.  The status of the patient was unknown at the time of reporting.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.  5/7/2008 MR received for DOS 4/6-10/2008 with DX: Intussusception. Infant presented to ER with 1 day hx of repeated emesis (7-10 times), crying and drawing up of the knees as in pain.  PE (+) for dry mucus membranes and tenderness to palpation of the abdomen. Barium enema attmpted but unsuccessful at fully reducing IS. Taken to OR for R hemicolectomy, Resection of terminal ileum and appendix, Transverse colon and ileum primary anastomosis. Saphenous vein cutdown. Colosigmpid and ileocolic IS found with small serosal tear. Back to normal by POD#4.
large area of redness & warmth in deltoid area @ site swollen, itchy, no pain;pt recovered;
patient received expired dose of DT vaccine/No AE; Initial information was received on 30-Jul-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 84 year old female patient who received an expired dose of DIPHTHERIA AND TETANUS TOXOIDS (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication if any, not reported.  On 29-Jul-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA AND TETANUS TOXOIDS [prefilled syringes, lot number: 46021AA, expiry date: 27-Jul-2020] via an intramuscular route at the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  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 Directive and Module VI of the 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.
I received my Covid- 19 vaccine on 09/27/2021. 12 hours after dose I started getting achy feeling, fever and headache. Symptoms lasted  for 24 hours and went away. Took TYLENOL.
No additional AE; administration of VARIVAX that experienced a temperature excursion; This spontaneous report was received from a office manager referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 21-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # W025274, expiration date 10-AUG-2024 at  0.5 milliliter once for prophylaxis (route was not reported) that experienced a temperature excursion. Confirmed with reporter that no symptomatic adverse effects were reported. The temperature was -13.2 Celsius degrees. The time frame was 0 hours 58 minutes 0 seconds (total)  and there was a previous temperature excursion. The call was not because of a "data logger".
PATIENT PRESENTS WITH RED SPOTS, EDEMA AND ITCH AROUND THE EYE AREA, 15 MINUTES AFTER VACCINATION.
Severe diarrhea; headache; resting heartbeat at 95-105 (unspecified units); feeling of weight on chest like they put on for dental X-ray; swollen lymph glands under right arm; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8727) via an unspecified route of administration in the right arm on 25Mar2021 at 18:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy, micro vessel spasms, COVID-19. Concomitant medications included ranolazine (RANEXA) from an unknown date for micro vessel spasms. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 08:00 the patient experienced Severe diarrhea, headache, then 2 days of resting heartbeat at 95-105. Normal resting heartbeat is 72, also had a feeling of weight on chest like they put for dental X-ray. Blood pressure was normal, oxygen rate was 98. Also had swollen lymph glands under right arm. Patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On an unknown date, the patient measured heartbeat and the result was 95 to 105 (UNSPECIFIED UNIT). On an unknown date, the patient underwent COVID-19 Virus test and the result was Positive. On 27Mar2021, the patient measured blood pressure and the result was normal. On 27Mar2021, the patient measured oxygen rate and the result was 98 (UNSPECIFIED UNITS). The clinical outcome of the events diarrhea, headache, heartbeats increased, chest heaviness, swollen lymph node was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Pt presents with tachycardia after receiving first COVID vaccine at 1710 today. She initially believed she was anxious but when it was time to drive home, she figured it might be more than just a little anxiety. Hypertensive, remained tachycardic into the 130's and RRT EKG revealed PVCs. Received IV Benadryl with resolution of symptoms over 1-2 hours in the ED.
This spontaneous report was received from a registered nurse regarding a 5 year old male patient. The patient's current conditions and medical history were not reported. On 29-JUL-2000 (at the age of "2 years old"), the patient was vaccinated with first dose of M-M-R II (lot # 633097/0255K, expiry: 09-FEB-2002). Concomitant therapies included sertraline hydrochloride and clonazepam. On an unknown date in 2003 (reported as at the age of "5 years old"), the patient was diagnosed with autism. The outcome of the event was unknown. The reporter did not provide causal relationship between the event and suspect therapy. Upon internal review the event autism was considered as medically significant. Additional information has been requested.
Information had been received on 18-JUL-2016 from a nurse practitioner regarding a case for ZOSTAVAX (MARRS# 1607USA007642). Nurse practitioner reported that multiple unknown patients were administered an unspecified dose of ZOSTAVAX (unknown lot#/expiration date) on multiple unknown dates. The nurse practitioner reported that on multiple unknown dates following the administration of ZOSTAVAX the multiple unknown patients then developed a "small injection site reaction or rash". No additional information was provided in regards to this adverse event and no further details were provided regarding these patients. This is one of two reports from the same reporter. Additional information is not expected.
Engerix B pediatric dose to a patient that had expired yesterday; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HBV (Engerix B pediatric) (batch number 3JD32, expiry date 6th April 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric (intramuscular) and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The age at vaccination was not reported. The reporter identified herself as clinical supervisor and reported that Engerix B pediatric dose to the patient that had expired a day before reporting date, which led to expired vaccine used.
I have been a regular blood donor for the last 10 years. I went to donate blood and  they said I had hep C antibody in my blood. I can't donate anymore, and I had no exposure. I went to the doctor, and he did a blood test and he confirm I was Hep C positive. He did a viral load test and I don't have the actual have Hep C virus.
Arm swelled twice the size. Headache. Upset stomach. Arm was red, face was red and puffy, eyes puffy, red on arm was a square. Arm extremely painful.
Had mild pain the day after vaccination, then redness and swelling for a day, which resolved until the redness and swelling returned yesterday.  She denies any pain or difficulty moving her shoulder, states the area is itchy.  No fever/body aches/chills.  No headache.  She has had similar reactions to the Pneumovax vaccine, was treated for cellulitis.  She has not tried any home treatments, not taking anything for pain, since there is no pain.  No chronic medical problems or regular medications. Findings most consistent with localized reaction vs cellulitis, encouraged symptomatic treatment with cool compress, NSAIDs, etc.  Counseled patient that this should not prevent her from receiving a second dose of the vaccine.
Information has been received from a doctor of pharmacy who spoke with a nurse in her facility and stated that on an unspecified date another patient was vaccinated with the GARDASIL series. It was reported that the patient has experienced loss of menses after starting the GARDASIL series. This is one of several cases from the same source. Additional information has been requested.
This spontaneous report was received from a register nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse refers that the patient received the first dose of RECOMBIVAX HB (route, lot number and expiration date not provided) on 21-MAR-2013 and the second dose of RECOMBIVAX HB on 17-MAY-2013 (route and lot number were not provided). Co-suspect therapies and secondary therapies were not reported. On 23-DEC-2013 the patient was vaccinated with RECOMBIVAX HB, lot number reported as H018635 and expiration date 16-DEC-2013 (route was not reported) dose 3 that was expired. No adverse event reported. Additional information is not expected.
2 days p/vax pt had chills, muscle aches, no fever, sl cough & malaise; sx lasted for 1 full day then pt started feeling better the next day;
Was admitted for acute hypoxic respiratory failure due to covid 19 infection, pneumonia, aki/ckdiiib requiring hd, treated with high flow, bipap, respiratory protocol, precedex, bicarb  infusion, decadron, remdesivir and abx. metabolic encephalopathy and acute hypoxic respiratory failure due to covid 19 infection, pneumonia and hyperammonemia resolved. Reactive leukocytosis improving, finished tx for the covid 19 pneumonia.   Acute hypoxic respiratory failure resolved, covid 19 pneumonia, infection improved. Pt was discharged home stable condition, resume home medications, follow up pcp, nephrology;
numbness in lip Narrative:  At 1342, this patient reported that she was experiencing numbness in her lips "like at the dentists". She had not been to the dentist. This writer observed no swelling of her tongue/face/lips. Patient stated that she did not feel any swelling in her tongue/face/lips. Patient was asked if she felt SOB, she stated that she has COPD and was feeling no more SOB that usual. Patient denied dizziness, headache, nausea. Requested another RN assess patient for swelling of lips/face/tongue. RN stated that she also did not observe any swelling. Vital signs were taken at 13:42 and 13:58. At 13:58, patient stated that the numbness in her lips had "mostly resided". Advised the patient and her husband that should she experience swelling of lips/face/tongue or SOB that is worse than the usual SOB she experiences with her COPD to call EMS immediately. VS at 1342: BP 121/84, HR 69, SaO2 93% VS at 1358: BP 128/84, HR 68, SaO2% 94%
shortness of breath, facial flushing, dizziness, sweating, and metallic taste in the mouth. Laid patient down, observed for an extended amount of time, evaluated by PA. Pts symptoms resolved.
Employee states that there was confusion at the time of vaccine injection, and that she was possibly given a second injection right after the first. approximately 45 minutes later she experienced headache and dizziness and had an observed syncopal episode. She was taken to the ER, evaluated for MI. Was found to be stable and was discharged.
Pain and redness in right eye. Diagnosis of Sceritis.  Went to Ophthalmologist (Dr) and was prescribed Naproxen 500mg  twice a day, Prednisone eye drops to use 4 times a day. followed this treatment for one month then went to another Ophthalmologist (Dr) and was prescribed prednisone 50mg taper (currently taking 15mg a day), Methotrexate 20mj , Folic Acid 1mg. The Methotrexate made me sick to my stomach so Dr switched me to Humira and I'm still using the prednisone eye drops.
04/16/2021- I got tired, I was just really tired with it. I just kept on with my life. I found out I had Sleep Apnea, 11/22/2021, just before I got COVID-19 in 11/2020. I got the shot in April and I got more tired. Then I got the 2nd dose in May and I would come home from work and just sleep. I did not have a problem with sleeping and I am still exhausted. I got a cough and sinus problems in July and August 2021 that did not go away. The cough I had was very harsh and makes me feel like I am going to throw up. In September, I saw an ENT. He did a CT scan of my sinuses.  He said it was not my sinuses. The ENT referred me to a Cardiologist. I went to the Cardiologist 11/08/2021 he did an Echocardiogram and a stress test. I do not have my results. I do not know if the exhaustion is related to the vaccine, or that I had COVID-19 in 11/2020. I don't think I have recovered from the COVID-19 virus and I feel the vaccines have made me more tired. I used to be really active and now I am just not.
Patient called Health Dept nurse on 5/6/21 to report symptoms starting several hours after receiving first dose of Pfizer vaccine on 5/1/21. That night she started having severe "heaviness" and aches in her right arm (same side as dose). This made it hard to sleep and took about 24 hours to subside. On 5/2/2021 she began having a severe headache that alternated sides of her head and was not helped by ibuprofen. Same day she also became extremely tired and was sleeping for almost the entire timeframe from about 2200 on 5/2/2021 to 2200 on 5/3/2021. At the time of her call at 1530 on 5/6/21 her symptoms have subsided. She has a history of severe COVID in 2020 including hospitalization.
1307 2nd dose Pfizer COVID-19 vaccine administered.  1327 responded to patient who had been sitting in her car post vaccine.  Patient reported that she had noticed anterior chest pain (4/10) as well as a weighted pressure.  I assessed the patient while she remained in her car.  She has a history of high blood pressure, taking medication and has been under control.  She also reported diagnosis of asthma.  Lisinopril 5mg daily, she had taken this morning.  Albuterol metered dose inhaler (not used today).  She denies heartburn nor taking any medication for it.  She had eaten a hamburger 30 minutes prior to vaccination.  1335 patient reported that her chest pain turned more into a warmth that spread across the chest and a tingling sensation down only the right arm.  1344 she rates the discomfort in chest as a 2/10 the tingling in right arm is gone.  She denies the following symptoms: difficulty breathing, changes to vision/hearing, dizziness/lightheadedness, facial and throat swelling, & nausea.  Patient remained very calm during this observation time and spoke in complete sentences.  She was comfortable with her mask on.  Patient denied these symptoms occurred with her first dose of COVID-19 vaccine nor any other vaccination.   Obtained automatic blood pressure device measured 142/91 (63 beats/min) at 1351.   Patient was able to teach back when she will seek Emergency care: difficulty breathing, face/throat swelling, persistent and or worsening  chest pain/pressure.   Patient and I both agreed she was safe to leave the vaccine clinic.
The patient experienced muscle stiffness in her back and arm and her joints on the left side were burning and stinging. On some days it was difficult for the patient to walk (left foot) and she needed an ankle brace. The patient also experienced difficulty sleeping on her left side and it was hard to lift her left arm.
Tested positive for COVID-19, symptomatic; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04Apr2021 at 08:45 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 08:00, the patient was tested positive for symptomatic, COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of tested positive for symptomatic, COVID-19 and included treatment with over-the-counter cold medicines and isolation from unknown date to unknown date. On 13Apr2021, the patient underwent nasal swab test and the result was positive. The clinical outcome of the event tested positive for symptomatic, COVID-19 was recovered on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received  vaccine this morning and patient leg started to swell in the left leg and red with warm to touch . Patient also was cold and sweaty to touch and normal here in the office. Patient has also been very fussy and very pale in color. Patient has been turning blue in the lips and sucking her lips more than normal since the vaccines