chrisvoncsefalvay/vaers-outcomes huggingface dataset:
increase in blood pressure; nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (increase in blood pressure) and EPISTAXIS (nose bleed) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ATENOLOL and SPIRONOLACTONE for Hypertension.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced EPISTAXIS (nose bleed). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (increase in blood pressure). At the time of the report, BLOOD PRESSURE INCREASED (increase in blood pressure) and EPISTAXIS (nose bleed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment:Took her blood pressure medicine, put ice on her neck and applied pressure on the nose
S/P SMALLPOX VACC, POSS LUE CELLULITIS
Shot Tuesday. Wed.: fever, headache. Thurs.: fever, nausea, small rash on right arm.
Given H1N1 vaccine in left deltoid while sitting on exam table at 10:05 AM.  Pt then complained (after approx 1 min) of feeling funny under her rib cage so I asked her to lay back on the table.  She then almost immediately felt "lump" in her throat.  Given Epi, Called 911 for EMS to come.  She also felt some "lightheadedness" at the time of throat symptoms.  Never felt labored breathing or shortness of breath. Vitals:   10:10am  Hr 90  resp 18, BP 128/80 10:13 am  Epi 0.3 IM lateral right thigh given and vitals after this 140/80  HR 112 Resp 18.  Approx 2 min after Epi given lump feeling in throat resolved.  Vitals at 10:15am resp 18, HR 110  BP  140/78.  EMS here at 10:19am and took patient to hosptial.   Patient returned with Rx from ER a few hours later and was to take Prednisone and Benadryl for the next few days. She was feeling better.
Td vaccine given to right arm on 3/21/07 at 9:30 am.  On 3/22/07 approximately 5:00 pm patient felt soreness to arm and soreness spread to entire right side of body. That same night around 9 pm he experienced fever of 102.0 and chills.  Today, 3/23/07 temp is 98.8, but has generalized body aches.  No pain medication taken.  Will see doctor today.  Sent home to rest.  Report back if symptoms persist or worsen.
This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 21-JAN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L031066, expiration date 20-JAN-2016, exact dose and route of administration were not reported). The dose of vaccine was expired. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Donor c/o red rash on left upper arm that began in the evening after receiving a second rabies Imovax vaccine. Donor presented to ZLB Plasma center 4/11/07 with a red pinpoint rash on left upper arm. Consulted Dr with regards to this. Donor denied any other symptoms. Donor deferred from rabies program for her safety.
Difficulty breathing- 2 weeks, rash on left arm - 2 weeks, still can't bend arm back after 1 month
Patient had a local reaction, with swelling and redness around the injection site that was raised and about 5 inches long and 2 inches wide. Started as a small reaction the morning of 9/30/14 and increased to be much larger as of 3:15pm 9/30/14.
Vomit, diarrhea, chills, tightness in chest, sore muscles.
COVID breakthrough case. I received my 2nd booster shot on 05/10/2022 and My COVID symptoms started on 05/22/2022 with a headache and congestions. on 05/23/2022 in the evening around 6-7PM with headache, sore throat, chills, nasal congestions, muscle aches, fatigue, this continued till few days. I did 2 tele health with my doctor and he gave me PAXLOVID for five days. After 10 days I tested positive. My symptoms have improved but they are still trying to figure out what is happening with me.
After receiving the vaccine at 1:15PM, I woke up that night around 1AM with moderate to severe pelvic pain. I assumed it was cramping because I was expecting my period. I took ibuprofen so that resolved the pain. Since then I intermittently had very mild pain in my pelvic area and lower back. I still haven't had my menstrual cycle yet. The day after receiving the vaccine, 2 or 3 days later, I had some pain radiating from both my armpits to the side of my breast. It was worse in the left. I am breastfeeding. I feel like I have had some engorged spots in my breast but I didn't feel anything. I feel like I did have some swollen lymph nodes in my armpits as well. I have taken multiple pregnancy test since then and they are all negative.
pt recv vax 19AUG98 & later in the evening pt exp somnolence, itching, severe gen urticaria, vomiting;pt did not have a fever;sx were treated w/DPH;
Vertigo, malaise, tachycardia, faint feeling, flushing, acute joint pain, light-headedness, neuropathy. Acute joint pain, vertigo, neuropathy & light-headedness still continuing.
This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 11May2021(at the age of 30-year-old) and second dose of of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 01Jun2021(at the age of 30-year-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient previously received amoxicillin on an unknown date and for unknown indication and experienced drug allergy. 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 11May2021 the patient experienced  severe muscle weakness, joint pain ever since receiving the first vaccine and also had sweat heavily when sleeping. No therapeutic measures were taken as a result of adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe muscle weakness, joint pain and also sweat heavily when sleeping were not resolved.
Reddened, tender to touch area 80 x 80 cm - raised area in center 30 cm at longest.
I began to experience extreme vertigo approximately 48 hours after I received this year's flu shot. The acute phase of the vertigo lasted approximately 48 hours. I am still experiencing vertigo approximately one week after the flu shot. The doctor prescribed anti-nausea medication which has helped some. I had no other symptoms.
On 5/17/01, aunt called to report swelling, tenderness and redness in left arm to elbow. Aunt states it "looks almost like a burn area". Instructed aunt to use cold compress/ice to affected area and fever medicines for fever. Referred child to child's doctor or ER for evaluation per the RN. Child evaluated by FMC ER doctor on 5/17/01 and doctor told parent that it was a local reaction per RN.
Pt called about an hour after receiving vaccine c/o flushing and diaphoresis.
Symptoms got much worse after the 2nd shot; Bone pain; Difficulty breathing / Shortness of breath; Difficulty focusing; Fogginess; Absolute exhaustion; Horrible chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Horrible chills), BONE PAIN (Bone pain), DYSPNOEA (Difficulty breathing / Shortness of breath) and FEELING ABNORMAL (Fogginess) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MIRTAZAPINE, ATENOLOL, AMLODIPINE and LEVOTHYROXINE for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Horrible chills), BONE PAIN (Bone pain), DYSPNOEA (Difficulty breathing / Shortness of breath), FEELING ABNORMAL (Fogginess), DISTURBANCE IN ATTENTION (Difficulty focusing), FATIGUE (Absolute exhaustion) and CONDITION AGGRAVATED (Symptoms got much worse after the 2nd shot). At the time of the report, PYREXIA (Fever), CHILLS (Horrible chills), BONE PAIN (Bone pain), DYSPNOEA (Difficulty breathing / Shortness of breath), FEELING ABNORMAL (Fogginess), DISTURBANCE IN ATTENTION (Difficulty focusing), FATIGUE (Absolute exhaustion) and CONDITION AGGRAVATED (Symptoms got much worse after the 2nd shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-239302 (Patient Link).
Information has been received from a registered nurse concerning a 8 year old male patient with no known medical history who on 10/21/96 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 617692/0770D). Concomitant vaccination the same day included a first dose of MMR (lot # 616442/1181B) given in the right arm and a fourth dose of HIB conjugate vaccine given in the right leg. There was no illness at the time of vaccination. On 5/9/04 the patient experienced an outbreak of chicken pox. He presented with many lesions and some accompanying infection, which superimposed on 5/12/04. The physician prescribed cephalexin 400mg for the infection. It was reported that the patient was recovering. There was no product quality complaint involved. It was noted that the patient had no adverse events following prior vaccination. The nurse also reported that the patient's younger brother (WAES0407USA00451) also experienced chicken pox following exposure to varicella virus vaccine live. No further information is available.
This case meets vaccine breakthrough review.   SxS include cough, fevers, nausea, myalgias, SOB.
About 12 hours after receiving the second dose of the COVID 19 Vaccine (1/9/21), I had sudden onset of fever, chills, nausea, headache, and fatigue. The fever, chills, nausea lasted for about 36 hours from onset, and notable headache and fatigue lasted for about 2.5- 3 days after onset of symptoms. They resolved by the evening of 1/12/2021.
Pt recvd pneumococcal vaccine 23 polyvalent (lot # 1531J or 0677K) and subsequently tested negative for antibodies. The reporter was wondering if there had been "any reports of subpotency with these lots." The records of testing prior to release of lots 0677K and 1531J have been checked by Biological Quality Assurance and found to be satisfactory. Lot #s 0677K and 1531J comply with the standards of the Center for Biologics Evaluation and Research and were released. Unspecified medical attention was sought. Addtl info has been requested.
Fatigue, fever 102, aching joints, chills, rapid heart rate - 135 bpm per Polar heart rate monitor while at rest.  Began around 6:00pm day of injection. Worsened until 10:00pm when I contacted the 24 hour nurse about my hear rate.  Was advised to monitor it and rest.  Slept until 8:00am next day and woke in pool of sweat with slight headache.  Fever was gone and heart was back to normal.  Drank lots of water and rested.  By noon I felt 100% fine again.
Information has been received from a physician via company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. ON 27-MAR-2-15, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv") Lot No. K001631 ,exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 48. The lowest recorded temperatures was 32. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT RECEIVED VACCINE AT HIGH SCHOOL ON 3/31/2021.  UNKNOWN VACCINE LOT NUMBER.  PATIENT HAS HAD FATIGUE AND ARM PAIN SINCE TWO DAYS LATER.  VACCINE WAS INJECTED INTO LEFT ARM. PATIENT WITH RIGHT SIDED PAIN.  PATIENT SEEN IN OFFICE 4/20/2021. NO NEURO DEFICITS NOTED, ABDOMINAL PAIN, SOB, LEG SWELLING, PETECHIAE NOTED.    CBC DONE 4/20/2021, NO ELEVATED PLT COUNT.  ON F/U CALL 4/23/2021 PATIENT REPORTS INCREASING PAIN IN RIGHT ARM AND NEW CHEST PAIN.  PATIENT INSTRUCTED TO REPORT TO EMERGENCY DEPARTMENT FOR EVALUATION.
Seven days after receiving the Moderna Covid 19 vaccination, I woke up this morning (January 29)  at 8 a.m. with swelling and hardness at the injection site.  My arm also aches at the injection site.  It is now 4:00 p.m. and the reactions remain the same.
Patient presented to the hospital for dyspnea and hypoxemia and found to have COVID. Patient was started on supplemental oxygen and decadron,
The same night into early morning I started to experience body aches, fever/chills, extreme headache, nausea, and some vomiting.
Inflammed gallbladder; Large mass in left breast; Inflammed gallbladder - severe pain; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received her first single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine) via an unspecified route of administration in left arm on 11Apr2021 09:00 (lot number ER8737) at the age of 35-year-old for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. On 14Apr2021 12:00 AM, the patient experienced large mass in left breast, Inflammed gallbladder - severe pain. The patient did not receive any treatment for the events. The patient had not recovered from the events at the time of reporting. The patient considered the events were non-serious. Follow-up attempts are needed. Further information is expected.
Patient received covid-19 vaccine dose a few days early, No reported adverse effects at this time.  Doctor and supervisors were notified. No further tests nor orders were requested.
After 1st dose, had some hearing loss due to fullness in ears, took 2 weeks for symptoms to subside. Since 1st dose, have had 4 HSV1 cold sores come about.  After 2nd dose experiencing severe heartburn. Also continue to have HSV1 cold sore outbreaks.
Within 10 min. client became faint and became limp.  Client exhibited extreme pallor.  Client jerked 3 times, was unresponsive to voice.  Client became alert but became pale again and vomited X 1.  911 called.
Egg sized blotch; Red; Itching; Rash on arm at injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Egg sized blotch), INJECTION SITE PRURITUS (Itching), FATIGUE (Fatigue), VACCINATION SITE RASH (Rash on arm at injection site) and INJECTION SITE ERYTHEMA (Red) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced FATIGUE (Fatigue). On 06-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash on arm at injection site). On 07-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itching). On 09-Feb-2021, the patient experienced RASH MACULAR (Egg sized blotch) and INJECTION SITE ERYTHEMA (Red). At the time of the report, RASH MACULAR (Egg sized blotch), INJECTION SITE PRURITUS (Itching), FATIGUE (Fatigue), VACCINATION SITE RASH (Rash on arm at injection site) and INJECTION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Patient called PCP office on 5/28/19 - c/o bruising to her arms, legs + hips 1-2 days after vaccines. Stated 3 days later noted "burst capillaries" all over her body. Menstruating-heavy period. Also stated pulled out tick over the weekend. Pt seen by PCP on 5/28 ED on 5/28 5/28-Patient seen in Emergency-Diagnosed with ITP prescribed Prednisone. Patient declined admission received IV SOLO MEDROL in ED. Followed up with Infectious Disease 5/31/19
Intially employee complained at itching on arm given at 10 am. By 11 am she had small pin point bumps/hives both arms and was scratching her all upper body as she complained of increase in itching.
Fever and vomiting.  Fever lasted one day.  Vomiting lasted 3 days, non-bilious.  (This also occurred with her 2mo immunizations but it was not reported since at that time I didn't think it was a cause of the vaccine.)
Intense and fast heartbeat that woke me up from sleeping. It settled down and I went back to bed.  Chest has an overall weird feeling like a slight burning.
Patient received a vaccine with a beyond use date of 09/14/2022 based on the expiration date of manufacturer (10 weeks expiration date when vaccine is thawed from ulta-cold). Patient received vaccine on 10/12/2022. On 10/13/2022, patient's caregiver reported that patient is experiencing the usual soreness in the site of administration.
I was visiting my family out of state when I started having periods of dizziness caused by increased heart rates. This happened over a period of a week --I watched my heart rate go up to 127 while I was standing still looking at my watch (non Fitbit). I ended up calling my cardiologist and scheduled a video-visit with the NP. I came in the following week for a follow-up which included wearing a monitor for a week. No abnormalities were found during that period. I haven't had any such episode since. However, it had been a stressful time with family after the death of my brother which had previously occurred before I arrived.  I have experienced stressful situations before and never had any episode like that one.
On approximately 6/3/99, the pt received her first dose of Lymerix.  On 7/1/99, the pt received her second dose of Lymerix. The following day, on 7/2/99, she felt as if she had a 24-hour flu. She experienced achiness and soreness in hips/legs that felt like arthritis. An MD visit was required. The pt was treated with Medrol.  FU states she experienced extremem joint and muscle pain all over her body. She stated she felt like she had "went from 58 to 85". In Sept 1999 she was hospitalized as she could not move her legs.
Information has been received from a physician concerning a patient who on 9/1/95 was vaccinated with a dose of VARIVAX. It was reported that on 4/9/97 the patient experienced a case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought, but there was no treatment and no hospitalization. The patient recovered. No product quality complaint was involved. This is one patient out of 40 reported. Thirty nine other cases (WAES0407USA01446, 0409USA01855 to 0409USA01866, 0409USA01868 through 0409USA01893) experienced breakthrough varicella after vaccination with VARIVAX. Additional information is not expected.
Patient seen in PC due to tetanus shot - 10 years since last vaccination given. Patient given injection in right deltoid. Pt seen in hospital complaining of redness, tightness and swelling of arm at injection site. Patient treated with APAP and ice pack.
pt presented on 9/20/21 to clinic. covid + 2 June. some chest discomfort manifested after the vaccine mainly with deep inspiration feels like knives poking his chest thinks it is probably suprasternal but unsure. Worse with exertion relieved eventually with rest. Shortness of breath also worsened with the vaccine but back to baseline level it was at during his last appointment. When he gets into his car in the morning feels like it is hard to get a full breath. Had fevers for couple days but that was after a shot a week ago. None since. No loss of taste or smell. Dry cough persists since last appointment.. No relief with Flovent or albuterol.
Pt called c/o top lip swollen 3 hrs post injection. Pharmacist advised 50 mg Benadryl if no improvement go to ER.
The mother reported the shaking of extremities that stopped if she held his hand. The pt was admitted to the hospital to rule out seizure. Neurologist did not think this was a seizure.
Pericarditis, chest pain, dyspnea, difficulty breathing, shortness of breath, dizziness, light- headed
PATIENT REPORTS HAVING A GOLF BALL SIZED RASH AT THE INJECTION SITE 10 DAYS POST VACCINATION. ALSO EXPERIENCED REDNESS AT THE INJECTION SITE.
Patient's age was misrepresented and he received first dose of vaccine. Was attempting to get 2nd dose but was not permitted.
full body hives and swelling, low grade fever and chills started morning after the 2nd shot was administered, today 5/28/2021 is much worse than yesterday
A Patient who was over 65 years of age inadvertently received Fluzone Quadrivalent rather than Fluzone High-Dose Quadrivalent /No AE; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a over 65 years of age female patient who received a 0.5 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number and expiry date not reported) via un unknown route and administration site on an unknown date for prophylactic vaccination, inadvertently rather than  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Wrong product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to the wrong vaccine administered (latency: at the time of vaccination).  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 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.  There will be no information available on the batch number for this case.
Vaccinated with Pediarix in left vastus lateralis, PCV-7, PedvaxHIB both in right vastus lateralis. Immediately following, developed generalized fine rash from head to toe. Also had 4-5 small 1-2mm reddened areas on left leg, site where Pediarix given; reddened for approximately 15 minutes. Rash fades quickly - still present on stomach for 45 minutes.