chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On unknown dates, the patients were vaccinated with PEDVAXHIB (dose, route and site not reported) lot # J010382 with expiration date on 28-MAY-2016, that on an unspecified date was improperly stored at -1.7 C during 24 hours. It was reported that the vaccine did not experienced previous temperature excursion. It was unknown if the patients sought medical attention. No product quality complain was involved. This is one of several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
Fell; Severe Stiffening and Cramping up of all muscles for hours; Worse Severe Unbearable pain in body ever felt; Stiffening of muscles; Worse pain in neck and head ever. Went to the ER twice and finally got an appt at primary care, now seeking another primary care Dr.
Nine days after receiving number 1 COVID vaccine, a red rash developed at the site of the injection and spread around the arm and to the elbow.  It is hot, hard, itchy and has remained through the time of this reporting, February 10, 2021.  It is now beginning to fade but continues to itch and radiate heat.
Expired dose of Adacel was inadvertently administered / No AE; Initial information was received on 11-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 47 years old female patient who on 11-Feb-2020 was vaccinated with 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U5872AA and expiry 06-Feb-2020) via intramuscular route in the left deltoid for prophylactic vaccination (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included RABIES VACCINE (RABIES VACCINE) for an unknown indication.  It was an actual medication error case due to expired vaccine used.  At a time of reporting no adverse event 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.
Patient recieved vaccine.  Approximately 45min later patient complained of generalized itching.  At this time 50mg of oral diphenhydramine was given.  10 mins later patient begin to break out in hives. 50mg of IM diphenhydramine was given and paramedics called.  Upon arrival of paramedics patient had normal vital signs and symptoms hives and itching were disappering. Patient refused any additional medical care.
Within five minutes of injection, patient became diaphoretic and pale and felt tingling all over. HR 60. 911 called. Patient released and went home.
Patient remained in store for the 15 minutes required. After the immunizations he said for a second it felt a little hard to breathe. However, he took a deep breath and then felt fine. He walked around the store a few more minutes then felt a pain in his lower back that radiated down the leg and caused a severe muscle cramp in bag of leg. Patient was stabilized, checked breathing, EMS came and checked vital signs, etc. After approximately 20 minutes patient said he felt ok to go home. After talking to patient on the phone several hours after the incident he said he felt fine except it was like the leg was sore from muscle cramp soreness.
Headaches; Lightheadedness; lump under left armpit; This is a spontaneous report from a contactable nurse. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0164) via an intramuscular route of administration in the left arm on 27Jul2021 at 16:45 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The medical history included polycystic ovarian syndrome (PCOS), hypertension (HTN), obesity and COVID-19. The patient had no known allergies. 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 vaccination. The concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) and lisdexamfetamine mesilate (VYVANSE), all from unknown dates and for unspecified indications. On 27Jul2021, the patient experienced headaches, light-headedness and lump under left armpit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headaches, light-headedness and lump under left armpit were unknown at the time of this report.
2/13/21 -- c/o fatigue; slept most of the day, cold; warmed with blankets 2/14/21 -- chilled, can't warm with blankets; no thermometer available  2/15/21 -- somewhat tired, better 2/16/21 -- visited ED for lymphedema treatment (chronic idiopathic condition) of ankles and mid-calf; treated with prednisone
Information has been received from a physician concerning a 15 month old female who on 12-APR-2007 was vaccinated subcutaneously in her thigh with a dose of Proquad. On 16-APR-2007 the patient experienced a 2 cm area of inguinal lymphadenopathy. The child did not experience fever. Medical attention was sought. As of 19-Apr-2007 the patient was recovering. No product quality complaint was involved. Additional information has been requested.
On April 3 symptoms of miscarriage (pain, bleeding began).  Was approximately 8 weeks pregnant. Symptoms worsened across next week.  Miscarriage was confirmed by sonogram + quantitative HCG levels, resulting in a D&C on 4/14 to evacuate remaining uterine contents.
Complaining of headache, nausea. BPs 124/76 (pulse 109), 153/97 (pulse 101). O2 sat 99%. Taken to the ED.
moderate/severe enlargement of left axillary node. Moderna injection was given in the left arm.
Adverse event NOS/ Possible AE; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse event NOS/ Possible AE   ) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event NOS/ Possible AE   ). At the time of the report, ADVERSE EVENT (Adverse event NOS/ Possible AE   ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.
The only symptom I had was the evening after my first dose of the Pfizer vaccine (which I had received that morning).  After sex, I started pouring blood from my vagina. There was a lot, and it was fresh blood, not period blood. It stopped fairly soon (within a few minutes), and did not happen again.  This has never happened to me before or since then.
ADMINISTERED 0.5 ML OF MODERNA BOOSTER INTRAMUSCULARLY INSTEAD OF 0.25 ML RECOMMENDED DOSE.
little cold which was not too bad; Initial information was received on 27-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case is linked to cases 2020SA305222, 2020SA305230, 2020SA305270, 2020SA305371, 2020SA305401, 2020SA305420, 2020SA305444, 2020SA305474, 2020SA305488, 2020SA305527, 2020SA305545, 2020SA305591, 2020SA305629 and 2020SA305651 (same reporter).  This case involves a male patient (age unspecified) who had little cold which was not too bad (nasopharyngitis), when received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a little cold which was not too bad (nasopharyngitis) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  The patient got the cold before flu shot settled in the 2 weeks duration. The patient was feeling much better now though  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was recovering.  There will be no information available on the batch number for this case.
Information has been received from a registered nurse concerning a female who was vaccinated with GARDASIL.  Awhile back the patient fainted after vaccination.  The patient was seen at the office.  On unspecified date, the patient recovered.  This is one of several reports from the same source.  Additional information has been requested.
Fever up to 99.9, chills, nausea, lethargy, difficulty sleeping, swollen lymph node in left armpit
Just under a week after getting the J&J vaccine, I started to develop a rash, along my waist and under my breast. Then is appeared on the back of my legs from pantie line down to the back of my knee, also along the inner thigh, and after a few more days in the anal area, and vaginal area. The rash is both very painful, and itchy, I saw my primary doctor who then referred me to a Dermatologist, who said it was Lichen Sclerosus, and there is no cure for it. He prescribed 2 medications that both have steroids in them, but I am still having pain and itch. Pain feels like my skin is being ripped off me or will tear. Life is not real enjoyable dealing with this
Dull headache within an hour of 2nd vaccine. Uncontrollable chills, teeth chattering approximately 12 hours later (10:15pm)Chills and fever all night with sore joints and muscles. Awakened to severe headache, muscle and joint pain. Chills and fever for next 12 hours. Took Advil which helped, but could not even work my remote job primarily due to severe headache and fatigue.  Low energy through next two days.
Left Upper erythema/induration/tenderness 10cm. Keflex 500 mg BID X 5 days, Heat.
Information has been received from a physician concerning a 37 year old female pt with a codeine allergy and a history of allergic asthma. It was noted that the pt visited another country in March 2001 and experienced a sore throat in May 2001. On 07/30/2001, the pt was vaccinated in the left arm with a second dose of hep A vaccine. There was no illnesses at the time of vaccination. Concomitant therapy included Allegra D, Maxair, Serevent, and Celebrex. On approximately 08/15/2001, the pt had two episodes of severe nausea and vomiting, chills, fevers and joint and muscle pain. The pt's physician is considering possible malaria as a causative agent. Unspecified medical attention was sought. Follow-up info indicated that all labs (unspecified were normal). The pt recovered on approximtely 09/05/2001. No further info is available.
5/23 difficulty breathing episodes, red face, swollen face, could not move, then cries loud x 2. Took ER call 2200. 5/24 about 1900 episodes x 2, 5/25 about 1900 episodes x 5.
Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an eight-year old child patient who received 0.5 ml fifth dose of DAPTACEL (batch number, expiry date was not reported) intramuscularly in left deltoid instead of 0.5 ml ADACEL on 25 Sep 2018. Concomitant medication involved IPOL (lot details C5171AA, expiry date 23 Mar 2019) in right deltoid. It was a case of actual medication error as wrong vaccine administered and inappropriate age at vaccine administration. 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 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. Documents held by sender: none.
Approximately 2 weeks post vax the pt began to walk with a limp on his right leg and developed alternating pain in his right shoulder, knee, hip and ankle with progressive worsening. Upon internal review the pt's experience was determined to be an
following vaccination, pt had a  BMBx on 5/3/21 with FISH and cyto showing clear progression and then 6/7/21 BMBx back to normal. Also chimerism dropped and then back to 100% marrow. Continues on Aza/APR maintenance
Erythema and urticaria to bilateral hands and face 15 minutes post influenza vaccine.  No reactions in past, no sob, no difficulty swallowing.
Fatigue (slept 22 out of 24 hr period); Mild temperature (99-101); This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm right on 31Mar2021 at 11:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, asthma, and allergy to nuts. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) on unknown date and lisinopril, hydrochlorothiazide (MANUFACTURER UNKNOWN) on unknown date both for unknown indications. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the arm right on 10Mar2021 at 11:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 22:45 the patient experienced mild temperature (99-101) and severe fatigue at 23:15 and slept 22 out of 24 hr period. On 31Mar2021, the patient checked the body temperature test and it was 99-101 (units unspecified). The 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. The clinical outcome of the event mild temperature (99-101) and fatigue (slept 22 out of 24 hr period) was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Non-pulsatile, constant headache in bilateral temporal areas of head that radiate into neck and trapezius muscles bilaterally - also feel pressure being the eyes when the headache is bad.  Bending over to pick things up definitely makes all this worse.
Admitted to the hospital with symptoms consistent with an acute ischemic stroke on 1/28/23. On 1/25 or 1/26 he noticed intermittent blurry vision, primarily with near vision (did not have difficulty driving to the HCF on 1/28). On 1/27 at 8pm, he developed acute onset tongue numbness, a feeling that his L face was rubbery, and L UE/LE weakness and  numbness, primarily in his hand and leg. Noticed it was harder to lift his L leg  to walk but was still able to. Looked on the internet 1/28 and was concerned about a stroke, so he drove to the ED and walked unassisted inside. On admission on 1/28, reported that his weakness/numbness is improving but not resolved. Exam notable for tongue protrusion w/ R deviation, SILT in all extremities but decreased on L UE/LE, strength 5/5 R UE/LE and 4/5 L UE/LE, no pronator drift, FNF wnl. ASA and plavix loaded in the ED, seen by neuro and discussed with cardiology. Remains admitted undergoing stroke work-up, including ICD interrogation, TTE, and repeat CT. Unfortunately, this HCF does not do MRIs in patients with ICDs. Currently on a heparin drip and home medications except aspirin, with final plan to be decided 1/30.
About 3 days after receiving my second dose, my heart started beating irregular and I would get super dizzy. I was experiencing chest pains too. I wanted to go see my cardiologist, but I learned that they had passed away. I was sending messages through my portal, but never received a response. I was also experiencing heavy periods for two months, that came earlier than usual. I spoke with doctor about my uterine cramping and abdominal pain that started the day after receiving my vaccine. I did have to contact him after my first dose as well for the same problems with bleeding. I talked to him about going through three post-partum pads. I spoke with doctor on 10/20 about my heart condition and he told me that he recommended that I still get the booster. My heart symptoms resolved about 5-7 days after.
Pain at the injection site; red bumps on his nose; Redness at injection site/redness went down all the way to his elbow.; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 31st January 2020, 17 days after receiving Shingrix, the patient experienced red rash. On an unknown date, the patient experienced injection site pain and localized erythema. The patient was treated with prednisone. On an unknown date, the outcome of the injection site pain and localized erythema were recovered/resolved and the outcome of the red rash was unknown.   It was unknown if the reporter considered the injection site pain, localized erythema and red rash to be related to Shingrix.  Additional details were provided as follows:  The patient received the Shingrix in right arm. The patient experienced pain and redness at the injection site after receiving Shingrix, within 2 to 3 days the redness went down all the way to his elbow. The patient went to his physician and he was given prednisone for 10 days. The event was recovered in total of 10 days. The patient experienced red bumps on his nose. No further details were provided. Consent to follow up was denied. This is 1 of the 5 cases, reported by same reporter.
tingling and numbness down left arm to fingers; tingling and numbness down left arm to fingers; severe pain with some pain on the right arm but unbearable on left; severe pain with some pain on the right arm but unbearable on left; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (tingling and numbness down left arm to fingers), VACCINATION SITE ANAESTHESIA (tingling and numbness down left arm to fingers), PAIN IN EXTREMITY (severe pain with some pain on the right arm but unbearable on left), VACCINATION SITE PAIN (severe pain with some pain on the right arm but unbearable on left) and HEADACHE (headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OXYCODONE, IBUPROFEN and ACETAMINOPHEN for Arthritis.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PARAESTHESIA (tingling and numbness down left arm to fingers), VACCINATION SITE ANAESTHESIA (tingling and numbness down left arm to fingers), PAIN IN EXTREMITY (severe pain with some pain on the right arm but unbearable on left), VACCINATION SITE PAIN (severe pain with some pain on the right arm but unbearable on left) and HEADACHE (headache). At the time of the report, VACCINATION SITE PARAESTHESIA (tingling and numbness down left arm to fingers), VACCINATION SITE ANAESTHESIA (tingling and numbness down left arm to fingers) and VACCINATION SITE PAIN (severe pain with some pain on the right arm but unbearable on left) outcome was unknown, PAIN IN EXTREMITY (severe pain with some pain on the right arm but unbearable on left) had not resolved and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included diphenhydramine and acetaminophen
Report 2000032248-1 describes injection site soreness in a 14 year old male  who received a hepatitis-b vaccine for prophylaxis of hepatitis-B.  The reporter denied allergies, medical history and concomitant medications.  On 27-SEP-00, the vaccinee received his first dose of a hepatitis-b vaccine.  On 28-SEP-00, he experienced injection site soreness.   No treatment was given. As of 30-Oct-oo, the outcome of the event is ongoing.
I woke up on the 14 and my arm was itching. I thought nothing of it. Waking up on the 15th though, not only was it itching it was burning a little too. I looked at my arm and I saw a raised red circle all around the shot area. I called the doctors office immediately. they suggested that I pick up some Benadryl for the discomfort that I'm having. Everything is still the same this morning. No change as of yet.
Cold chill; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Cold chill) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 6039K209) for COVID-19 vaccination.     The patient's past medical history included Bronchitis. Concurrent medical conditions included Allergy (Allergic to grass and mold.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced CHILLS (Cold chill). At the time of the report, CHILLS (Cold chill) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.