chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large red area on rt arm is inflamed and hot.  Pt reports feeling feverish and generally ill two days later.   Today is improving but area is still getting larger but less gone using TYLENOLO and BENADRYL.  F/U 9/21/09 pt doing well still little redness but resolving.
Administer vaccines below, client became groggy, not responding and fainted. Client placed supine with feet elevated, compressed to face, stimuli, monitored VS. Called for assistance from MD & nurses when client fainted. Alert, oriented & talkative. Left with mom in good condition. Provided with cola.
Information has been received from a physician concerning an 18 or 19 year old female with a history of seizure "in the past during an IV administration on an unknown date" who was vaccinated IM with a 0.5 ml third dose of GARDASIL (date of administration and lot # were not known). Subsequently the patient experienced a seizure following the third vaccination. Unspecified medical attention was sought. Lab tests were performed, all of following were normal: MRI, CT scan and EEG. The patient did not experience postictal symptoms. The patient recovered from seizure on an unknown date. The seizure was considered to be an other important medical event. Additional information is not expected.
This spontaneous report as received from a physician via field representative refers to a 51 years old male patient. Pertinent medical history included chronic obstructive pulmonary disease (COPD), smoker and asthma. On 15-NOV-2011, the patient was vaccinated with PNEUMOVAX23 (strength, dose, frequency and route of administration were not provided) for high risk patient. No concomitant medications were reported. On 17-NOV-2011, the patient developed an area around the injection site where PNEUMOVAX23 was administered that was red, tender and hot to touch. Physician mentioned the patient had streaking down the arm. Patient sought medical attention due to office visit. Unspecified antihistamine, KEFLEX was given for adverse events. No product quality complaint (PQC) was involved. On 21-NOV-2011, the outcome of events was resolved. Causality was not reported. NO further information provided. Additional information has been requested.
Patient had 6-7 cm red area at injection site. The next day area was raised, is now flat but continues to have redness. Patient is pregnant. Having warm feeling and loose stools.
Mom called to report that patient received flu vaccine at our community flu program, on 9/25/22, her husband took pt. to the Dr on 10/11 who then gave a second flu vaccine since the vaccine given on 9/25/22 was not showing up in system.  No reactions occurred per mom, however she stated that it was two weeks early to be given and that she contacted the CDC and recommended a VAERS be submitted.
mom discovered 4" induration rt arm muscle (deltoid) 6 days p/inj-states it was very red-no pain or fever; applied heat to area completely gone by 2nd day;
Elevated temperature of 99.3°F; Oxygen saturation level 91%; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Elevated temperature of 99.3°F), OXYGEN SATURATION (Oxygen saturation level 91%) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 043L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CALCIUM CARBONATE, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL SLOW RELEASE 1200) for Bone pain, SIMVASTATIN for High cholesterol, LEVOTHYROXINE for Hypothyroidism, VITAMIN D3 and WOMEN'S DAILY for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced BODY TEMPERATURE INCREASED (Elevated temperature of 99.3°F), OXYGEN SATURATION (Oxygen saturation level 91%) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Feb-2021, BODY TEMPERATURE INCREASED (Elevated temperature of 99.3°F), OXYGEN SATURATION (Oxygen saturation level 91%) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 99.3 Farad High. On 26-Feb-2021, Oxygen saturation: 91 % abnormal.         On Friday 26Feb2021 on the afternoon and evening patient had elevated temperature of 99.3°F at 4pm.  Took one Tylenol at 3pm and another that night  Recently added concomitant medications.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Patient information added.concomitants added (Levothyroxin , Simvastatin ,Citracal slow release, Vitamin D3 ,One a Day women's 50 plus)
Patient passed out while driving home from vaccination appt.  event occurred approximately 45 minutes after vaccine given.
low fever, up to 100.0, aches, nausea, fatigue, arm continues to be sore. Symptoms on and off since vaccination; worse today
Fever ARM PAIN, CHILLS, FATIGUE, MUSCLE ACHES, NAUSEA Narrative:
This spontaneous report as received from a nurse, concerning to a 15 year male patient. His medical history and concurrent conditions were not reported. On 26-APR-2016 at 11:00, the patient was vaccinated for the first time with an improperly stored dose of VARIVAX subcutaneously, lot number L013826 and expiration date of 21-APR-2017 (dose was not provided). No concomitant therapies was reported. It was reported that the vaccines were stored at 26.5F for 3 hours and previously stored at 46F for 50 hours and at 46F for 20 minutes (dates unspecified). The temperature excursion was captured via a Data Logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up was received.
I started having symptoms on 01/28/2022 of fatigue, headache, and body aches. The symptoms stayed the same but I tested on 01/31/2022 with a PCR test so I could return to work and that came back Positive. My symptoms stayed the same the whole time. I did not take another test and by day 6 or 7 I felt better and was back at work by day 10. I just took OTL Ibuprofen for headaches. I did travel and was back on the 01/17/2022.
suspected vaccination failure/had all inoculations still have contracted shingles; shingles 4 times; pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure/had all inoculations still have contracted shingles) (serious criteria GSK medically significant), shingles (Verbatim: shingles 4 times) and pain (Verbatim: pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-Mar-2023 The case was received from the patient via interactive digital media. The patient have had all of the inoculations and had still contracted shingles 4 times. The patient believed the shots minimized the severity of pain and duration. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
suspected vaccination failure; 6 weeks later shingles on torso & back, under arms, neck; this time more painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 weeks after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  The patient had shingles around torso, awful experience.  The physician prompted the patient for 2nd year to get the vaccine. The patient could not afford it. Third year, the patient got vaccinated. Six weeks later, the patient had shingles again on torso, back, up under arms, neck and this time more painful than the 1st go around. The reporter stated that sometimes it would reoccur with or without the shot. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection were unknown. The reporter did not consent to follow up. This case has been linked to US2021AMR015360, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR015360:Same Reporter
Had the vaccine after working out.  He came home and showered and then went to get vaccine at 6:30.  He came home ate dinner and went to bed much earlier than usual around 9:30.  Woke up with chills and fever around 8:30.   Came downstairs and fainted.  Said he felt dizzy.  Stood back up and while I was taking his temperature he fainted again (fell backwards from standing position).  Got him up he went to bathroom and collapsed on floor.  Got him up and were headed to car to take him to the hospital and he collapsed again.  Got him up again and the paramedics were called.  They arrived and he had a blood sugar of 60 and they thought he may be dehydrated.  He did not have fever when they arrived.   They left.  He ate some breakfast and was tired the remainder of that day and the next.
shaking; freezing; My skin was very hot; body ached/ Head, arm, body aches; Head, arm, body aches; Head, arm, body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 09:45 (Lot number: 331308A) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Tree nuts" (unspecified if ongoing), notes: Known allergy: Tree nuts. Concomitant medication(s) included: ZOLOFT; VITAMIN D3; VITAMIN B6; ASPIRIN (E.C.). The following information was reported: TREMOR (non-serious) with onset 16Dec2021 02:30, outcome "recovering", described as "shaking"; FEELING COLD (non-serious) with onset 16Dec2021 02:30, outcome "recovering", described as "freezing"; SKIN WARM (non-serious) with onset 16Dec2021 02:30, outcome "recovering", described as "My skin was very hot"; PAIN (non-serious) with onset 16Dec2021 02:30, outcome "recovering", described as "body ached/ Head, arm, body aches"; HEADACHE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 16Dec2021 02:30, outcome "recovering" and all described as "Head, arm, body aches". Therapeutic measures were not taken as a result of tremor, feeling cold, skin warm, pain, headache, pain in extremity.  Additional information: No other vaccine in four weeks.  No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a physician refers to a 1 year old patient. On 02-SEP-2014 the patient was vaccinated with VARIVAX (Merck) (1 shot, lot # K002048, exp 10-FEB-2016, Injection in the left thigh). Concomitant therapies included VAQTA. On an unknown date (in September 2014) the patient experienced varicella-like blister at injection site. No treatment was given. The outcome of varicella-like blister at injection site was reported as recovered/resolved. Additional information has been requested.
42 yo F p/f side effects from COVID vaccine - received Pfizer on 4/8/2021. 30 mins after vaccine noted bilateral tingling on cheeks and cheeks "felt tight". This persisted for 24 hrs. She felt fine 4/10-4/11 but then on 4/12 tingling resumed and spread to posterior left scalp so she was advised to come in for visit for evaluation. Received Pfizer vaccine on R arm.   Today she continues to have tingling sensation, "pins and needles, feels like right before your foot falls asleep", still bilateral. No vision changes, focal motor weakness, dysarthria or difficulty speaking, balance issues, dizziness, headache. No rash noted. No chest pain, dyspnea, palpitations.
Beginning 26 hours after his vaccine,  on 2/15/2021 around 3:30 pm he was at work and had to leave because he felt bad.  Somehow he drove home .  I am his wife and when I saw him try to exit his car in our driveway,  I thought it looked like a stroke.  I called the ER and drove  to the ER.   He could no longer speak any recognizable words.  We arrived just after 4:00 pm approx.   The Care crew of  professionals in the ER were there immediatley .  They worked with him for maybe an hour or so, while I was in the waiting room.   They brought me into see him who had almost totally recovered his speech. They were all so happy that we had arrived in time for there to be this meaningful recovery.
No adverse event. Will inform parents inadvertently administered MMR/Varicella and Varicella instead of separate MMR only noted at 2yr check-up when saw extra vaccine on vaccine list.
RED PAINFUL KNOT TO RIGHT TRICEP AREA AFTER VARICELLA IMMUNIZATION 2 DAYS AGO. TREATED WITH IBUPROFEN 800MG TID, DIPHENHYDRAMINE 25MG PO Q 6 HRS PRN ITHCHING, HEAT/COLD BAGS.
Redness around injection site-then on 5/17 redness increased and diameter of redness increased-per MD Tylenol and ice.
The vaccinee had seasonal allgeries and took no concomitant medications. There was no illness at the time of the vaccination. No adverse events were reported following dose 1 of Engerix-B. On 6 February 2001, the vaccinee received her second IM-left deltoid dose of Engerix-B. 30 minutes later, she developed a hard lump (at the injection site). The lump was warm at bedtime and felt al ittle itchy. The vaccinee had "blood in arm the size of a fifty cent piece and the site was kind of blue." On 7 February 2001, the vaccinee still had a blue bruise. At noon, severe itching began and the area got redder and the "hard spot" grew to 1 to 1.5 inches in diameter.  In the evening, the area was 6 to 8 inches long and three inches wide. The area was red, hard and hot. She experienced "swelling/pain in deltoid" (injection site). She treated herself with cool compresses and ibuprofen. On 8 February 2001, she was seen by a physician, who treated her with amoxicillin trihydrate/clavulanic acid (Augmentin). As of 27 March 2001, the outcome of the events was unknown.
pt recvd vax & exp myalgia, left upper quadrant pain & submandibular lymphadenopathy; pt devel also calf cramping & loose tools; pt had mild elevation of sgot to 47;
no symptoms as of now, error found on 2/1/23, patient was given the booster Moderna dose and the first dose in the primary series.  I am currently trying to reach patient, to bring her back into the office, to administer the first dose of the Primary Moderna series, per the recommendations set by Moderna.
a patient received the 2nd dose of the Moderna Covid-19 Vaccine after the 42 day mark from the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient received the 2nd dose of the Moderna Covid-19 Vaccine after the 42 day mark from the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient received the 2nd dose of the Moderna Covid-19 Vaccine after the 42 day mark from the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient received the 2nd dose of the Moderna Covid-19 Vaccine after the 42 day mark from the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was not provided.  No treatment medication was not provided.   Reporter did not allow further contact
I know I got the second dose a little bit later.; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (I know I got the second dose a little bit later.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (I know I got the second dose a little bit later.). On 28-May-2021, INTENTIONAL PRODUCT USE ISSUE (I know I got the second dose a little bit later.) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
felt bad; Achy; Headache; Delta Covid virus variant. C; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad), PAIN (Achy), HEADACHE (Headache) and COVID-19 (Delta Covid virus variant. C) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt bad), PAIN (Achy), HEADACHE (Headache) and COVID-19 (Delta Covid virus variant. C). At the time of the report, FEELING ABNORMAL (felt bad), PAIN (Achy), HEADACHE (Headache) and COVID-19 (Delta Covid virus variant. C) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive, Delta Covid virus variant.         Concomitant product use was not provided by the reporter.  It was reported that the entire facility at patient part time job was positive for Covid and they were all vaccinated. no specific identifiers were not provided.  Treatment information was not provided.   Reporter did not allow further contact
ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 5/24/2022 METABOLIC ENCEPHALOPATHY ACUTE DVT OF RIGHT PERONEAL VEIN 6/22/2022 METABOLIC ENCEPHALOPATHY ACUTE HYPERCAPNIC RESPIRATORY FAILURE DUE TO OBSTRUCTIVE SLEEP APNEA 6/22/2022 METABOLIC ENCEPHALOPATHY ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 5/24/2022 WEAKNESS ACUTE DVT OF RIGHT PERONEAL VEIN 6/22/2022 WEAKNESS ACUTE HYPERCAPNIC RESPIRATORY FAILURE DUE TO OBSTRUCTIVE SLEEP APNEA 6/22/2022 WEAKNESS
This spontaneous report was received from a 48 year old female patient regarding herself. The patient had a prior history of shingles. The patient's concurrent conditions included allergy to DARVOCET and penicillin and migraine headaches. One and a half years ago, in approximately December 2014, the patient was vaccinated with ZOSTAVAX 'one time vaccine' to lessen the spreading of future outbreaks of shingles, on the right arm, via the subcutaneous route. Concomitant therapy included VALTREX. About 4 days after vaccination, in approximately December 2014, the patient had shingles outbreaks on both hips, which currently (in approximately 2016) progressed to 2 circles on the right hip, and 3 on her left hip, about the size of "fifty cent pieces". She also stated after getting the vaccine, her migraines, had gotten worse. Patient sought medical attention and received treatment for the events. Outcome of the shingles that occurred in December 2014 was not known, while outcome of shingles that occurred 'currently' (2016) was considered 'not recovered'. The outcome of migraine was not known. Causality assessment was not provided. Additional information has been requested.
pt recv vax;lt upper arm itchy on 21apr95;noticed hives lt upper arm 22apr; PC to MD; took dph; seen in ofc, red & raised noted lt upper arm w/ tenderness;
Parent noticed increased redness + swelling of L arm @ injection site on 5/21 (PM), worsened on 5/22 with increase swelling ("fist sized" are of swelling) @ injection site;  painful to touch red, swollen + had no impaired ROM;  received Tylenol x2 for discomfort.
Information has been received from a physician concerning a 17 year old female patient with no pertinent medical history who on 02-SEP-2010 was vaccinated with the first dose of GARDASIL (lot number not provided). There was no concomitant medication. The physician reported that the patient presented to the hospital on 21-SEP-2010 feeling "ill". The patient was diagnosed with aplastic anaemia. The physician reported that the patient was hospitalized and treated with a course of anti-thymocyte globulin and immunosuppressive therapy, including cyclosporine and prednisone to depress her immune system. At the time of the report the patient had been released and was recovering while still being treated with immunosuppressant. Laboratory tests performed included bone marrow biopsy and blood work with no results provided. The aplastic anaemia was considered to be disabling and immediately life-threatening by the physician. Additional information has been requested.
WIDELY SPREAD/DIVERSE SEVERE ECZEMA....UPPER&LOWER LEFT LEG, TOP&MIDDLE OF CHEST, LEFT FLANK,SHOULDERS FRONT&BACK, BACK--TOP, MIDDLE, LOWER, LEFT SIDE FACE...NUMEROUS SKIN LESIONS WITH EXTREME ITCHING.  TREATMENT....  TOPICAL STEROIDS WITHOUT RELIEF, ORAL STEROIDS WITHOUT SIGNIFICANT RELIEF....POSSIBLE DUXINENT AND OTHER TREATMENTS BEING NEEDED.  RESULTS YET UNKNOWN.  LIKELY PERMENANT DAMAGE AND LIFE LONG ISSUE.