chrisvoncsefalvay/vaers-outcomes huggingface dataset:
45 minutes after receiving seasonal flu vaccine, patient started shaking uncontrollably, lost of breath and chest pains. The patient also had body aches but no fever. The patient was given oxygen and admitted to the hospital. Patient is still in hospital under observation. Low blood pressure. 11/13/2009 MR and DC summary  for 11/2-11/5/2009. Patient with c/o's hypotension, bradycardia, headaches, difficulty breathing, chills, shakiness, chest pain. Hx of recent multiple falls with no LOC, orthostatic in nature. Cardio consult, hold patint's Aricept, dx orthostatic syndrome, asymptomatic bradycardia
Patient received the first dose of the SHINGRIX vaccine on 04/19/2018, administered by the pharmacist on duty. The patient experienced pain in the muscle of the upper left arm (deltoid) after receiving the vaccine. The pain continued for several weeks and the patient went in for testing (MRI) to determine if there was any damage. Patient can move her arm but complains of pain in the area surrounding the injection site. The results of the MRI were not available at the time of this report. The patient received the second dose of SHINGRIX on 08/20/2018 and did not have any issues after the second dose.
Developed fever, nausea and vomiting about 24 hours later. Symptoms lasted two days and began to subside, at which time shortness of breath began. Patient drove himself to the hospital for evaluation and treatment on Saturday, March 27th where he collapsed in cardiac arrest. he was resuscitated and stabilized on life support. He died of multiple organ failure on Monday March 29th. The official diagnosis was Severe Septic Shock. It is unclear if any infective agent was identified. It should be noted that sepsis is a condition in which immune dysregulation is inherent and includes cytokine storm activity. The possible correlation between vaccination and the subsequent development of sepsis should be investigated.
Day 1- Site was swollen, sensitive to touch, I started feeling light headed.,  Next day  I was very light headed, dizzy, couldn't focus at work. Day 3, I woke up feeling awful. I was vomiting and had diarrhea at the same time. Had small bumps appear on my back. I went to the ER, they ran tests and said I had a severe allergic  to the vaccine. Still itching all over
Patient reported sweating and blurred vision shortly after vaccine admin. Gave patient water . Observed patient. Called 911-  They observed patient-patient was fine-no sweating. vision  ok- EMT said patient had a Vagal response- nervous reaction to getting a vaccine. Patient reported having a similar reaction when younger and getting a vaccine.
A nurse reported the occurrence of an injection site reaction in a 4-year-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  There was no relevant medical history.  Concurrent medications were not specified.  On 05/31/2002, the child received an injection of Infanrix; the number of previous injections of Infanrix was not specified.  On that date, he also received injections of inactivated poliomyelitis virus vaccine (IPOL) and measles, mumps and rubella virus vaccine (MMR II).  Later that day, the thigh into which Infanrix had been injected swelled to twice the size of his other thigh.  On 06/01/2002, the child was seen in the emergency room.  Initially, a diagnosis of cellulitis was made, but the diagnosis was later changed to injection site reaction.  Treatment included tapering doses of precnisone.  These events resolved on 06/03/2002.
Patient reported itchiness on her back, arms and neck. No redness observed. Patient given 25mg of Benadryl. Patient reported relief of itchiness.
Had a little soreness in the arm; Rash developed on the opposite side that ran down the back / like spider bites; Injection site felt like a bee sting; Injection site / it turned red / "looked ugly"; Injection site / swelled up / "looked ugly"; Injection site / was warm to the touch / "looked ugly"; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number B9YS2, expiry date 10th October 2022) for prophylaxis.   Previously administered products included shingrix (received 1st dose on unknown date).   On 18th February 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd March 2021, 12 days after receiving Shingrix, the patient experienced injection site stinging, injection site erythema, injection site swelling and injection site warmth. On an unknown date, the patient experienced pain in arm and rash. On an unknown date, the outcome of the pain in arm and rash were recovered/resolved and the outcome of the injection site stinging, injection site erythema, injection site swelling and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, rash, injection site stinging, injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.  Additional information was provided as follows: The reporter stated that, after vaccination, the patient initially had a little soreness in the arm, but then a rash developed on the opposite side that ran down the back. The patient stated that it looked like spider bites, this reaction was resolved. On day 12 after receiving 2nd dose, the injection site felt like a bee sting and it was then turned to red, swelled up, was warmth to touch and looked ugly.  This reaction was not resolved and was ongoing. The reporter consented to follow up.
Flu; Arms swelled up; Hairs started to shed off; Rashes; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu), PERIPHERAL SWELLING (Arms swelled up), ALOPECIA (Hairs started to shed off) and RASH (Rashes) in a male 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) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced INFLUENZA (Flu), PERIPHERAL SWELLING (Arms swelled up), ALOPECIA (Hairs started to shed off) and RASH (Rashes). At the time of the report, INFLUENZA (Flu), PERIPHERAL SWELLING (Arms swelled up) and RASH (Rashes) had resolved and ALOPECIA (Hairs started to shed off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Caller states that she only experienced a little soreness with the first dose; This is a spontaneous report from a contactable consumer or other non health care professional. A 67-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (Age at vaccination: 67 years) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a little soreness with the first dose. she was supposed to receive the second dose in the same or different arm. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Patient felt dizzy, headache, dizzy, chest pain after 2nd Pfizer COVID vaccination. Referred to Urgent Care for further evaluation.
Approx. 18-19hrs after receiving the vaccine I suddenly became nauseous and had an upset stomach, lack of appetite. Then shortly followed a headache, muscle aches, bone/joint pain, weakness, fatigue, dizziness, chills, fever of 102.4f, general feeling of illness or unwell, anxiety, tachycardia, painful breathing and slight SOB with exertion. O2 saturation?s 94%  per my Apple Watch. Fever controlled with Tylenol, I have not sought out further medical treatment at this point. Full recovery of this adverse event is pending.
VARIVAX #1 - 6 weeks post vaccination L arm numbness & neck pain - sudden onset - resolved.  VARIVAX #2 - 3 days post vaccination - similar symptoms - still resolving.
Achy, Dizzy , light headed , vomiting , diarrhea , No energy  1 week later was diagnosed with COVID
Pt recvd vax & immediately p/vax exp low-grade fever, weakness & tiredness which have lessened but are not completely resolved;
Information has been received from a medical assistant on 02-JUL-2015, concerning a patient of an unknown age and gender. On 13-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO (batch number 157101, expiry date unknown). In August 2016, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional information was reported as follows: The age at vaccination was not reported. The reporter's clinic had a patient who was vaccinated around 11th August 2016 that had severe pain at the injection site. The patient ended up going to the Emergency Room. The reporter agreed to follow up. This case is 1 of the 8 cases reported by the same reporter.
Received Hep A and Varicella, within 1 hr reported low grade fever then upper lip swelling and didn't feel well.
I can't be standing for more than a few minutes; My legs begin to cramp up; Muscle aches; Sore throat; Couldn't get out of bed all weekend; White blood and platelets count abnormally low; White blood and platelets count abnormally low; Mononucleosis; Cough; Dizziness; Muscle weakness; Fever; Headache; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in left arm on 15Apr2021 10:00 as single dose for Covid-19 immunization. Medical history included gastritis and sensitive stomach from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination. Concomitant medications included drospirenone, ethinylestradiol (NIKKI); pantoprazole sodium sesquihydrate (PROTONIX); and an unspecified vitamin, all taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for Covid-19 immunization. The patient received her second dose on 15Apr2021, Thursday, and on 16Apr2021, Friday night, she got a mild headache. Beginning 17Apr2021 09:00, Saturday, she got severe headache, dizziness, muscle weakness, and a fever. Symptoms worsened throughout the days. On 19Apr2021, Monday, she also got a sore throat. She couldn't get out of bed all weekend. She went to the hospital and they found that her white blood and platelets count were abnormally low, among other low things (white blood at 1.8). She was hospitalized until 20Apr2021, Tuesday, and was found to have mononucleosis. Cough developed and ended Tuesday, 20Apr2021. Beginning 20Apr2021 onward, the muscle aches were the biggest complaint, she can't be standing for more than a few minutes or her legs begin to cramp up. Headaches and dizziness continued. Sore throat stopped, and fever began to subside. On 19Apr2021, the patient underwent lab tests and procedures which included platelet count: abnormally low, Nasal Swab/PCR: negative, and white blood cell count: 1.8. The events resulted in Doctor or healthcare professional office/clinic visit, Emergency room/department or urgent care, and events from 19Apr2021 caused hospitalization until 20Apr2021. Treatment for the events included Tylenol and IV fluids. The outcome of sore throat recovered in Apr2021, cough resolved on 20Apr2021, fever was recovering and for other events was not recovered.
fully vaccinated on 3/15/2021. admitted to hospital with kidney infection. Tested (+) COVID 12/16/2021. Only symptom was a fever > 100.4. Wife reported hospitalized due to kidney issues. Remains in ICU as of 12/23/2021.
Numbness on left side of body. From foot up to face. Dizziness, fell to floor. Had symptoms for 3 days while hospitalized. Was treated as if I was having mini strokes. MRI on head, Doppler on carotid arteries, wore heart monitor, echocardiogram.
8-8-08 AM woke up in AM with hives/rash on face which progressed to neck and arms. Pt went to an urgent care and got Rx for zyrtec which is not helping. F/U at medical center 8/12/08 now has "bumps on legs".
Woke approximately 36 hours following injection with warm, red area on Left deltoid. Afebrile. No systemic symptoms. No pruritis. Tender to palpation. Area 10x8 cm on exam.
Pt had dizziness and some hives on her right lower arm 10 minutes after she had the flu vaccine.
Broke out in hives, progressivly got worse all over body. 8-16-10 Went to Dr office.. prescribed Prednisone for 7 days.
This vaccine was administered by her GI clinic today due to her having Ulcerative colitis and being immunocompromised. Came to Urgent Care for evaluation due to swelling, redness, pain of her left upper arm where site of injection. Symptoms progressing. No airway compromised. She applied BENADRYL cream prior to her visit at the Urgent Care and TYLENOL. She has had PPV13 3/2018 with no problem.
Day 3 woke up with dizziness; Vertigo; Feel soreness in arm almost right after shot. Moved arm and massaged.; Developed a red rash at site for next 12 hours.; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 25Mar2021, (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient was allergic to amoxicillin and erythromycin. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021, at 07:00, the patient felt soreness in arm almost right after shot, moved arm and massaged and also developed a red rash at site for next 12 hours. Developed a red rash at site for next 12 hours. On 27Mar2021, the patient woke up with dizziness and vertigo. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events soreness in arm, vertigo and dizziness was not resolved, while the clinical outcome of red rash was resolved. No follow-up attempts possible. No further information expected.
Hurting in arm with movement/in his right arm where he got his shot; his arm would bother him when he would lift it up or move it.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 06:12 (Lot number: ER8727) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 25Mar2021, outcome "unknown", described as "his arm would bother him when he would lift it up or move it."; VACCINATION SITE PAIN (non-serious) with onset 27Mar2021, outcome "unknown", described as "Hurting in arm with movement/in his right arm where he got his shot". Additional information: Caller is a 46 year old male patient who received his 1st dose of the Pfizer COVID Vaccine on 25/Mar/2021 and after a couple of days after, who noticed that his arm would bother him when he would lift it up or move it. He could not describe how it bothers him but he denied pain or weakness. He is schedule for his 2nd dose today and is asking if this would affect his 2nd dose. Caller stated he felt a pinch when getting the shot. After a few days, when he was sleeping and woke up, he was feeling a little pain in his arm but only with movement. He was wondering if there had been reports of pain in the arm. It was verified with caller pain location, in his right arm where he got his shot and only with movement. Why was the patient taking Covid shot, Pfizer (Verbatim): Everybody wanted to be safe. Other Products: No. Patient History: No. Investigation Assessment: Not Provided. History of all previous immunization with the Pfizer vaccine considered as suspect: No. Additional Vaccines Administered on Same Date of the Pfizer Suspect: No. Emergency Room: No. Physician Office: No. If the patient was hospitalized, how many days was the hospital stay: N/A. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): No.  No follow-up attempts are possible. No further information is expected.
pt recv vaxx 2DEC96;pt exp gross hematuria, fever, nausea, vomit, abd pain & confusion;pt hosp & was found p/work-up to have thrombocytopenic purpura;
Patient woke up in the middle of the night and said her arm was painful and the pain moved up to her neck and she felt like her whole body ached, like the flu. She took ibuprofen 200mg and went to sleep. Felt better in the morning, but then felt the same later in the day and took another ibuprofen 200mg. She felt better and is feeling okay now, more than 24 hours later.
L arm redness, itchy rash, started on 1/13/21 in the late afternoon, still red and itchy today 1/14/21
Pt received vaccine and about to sit in observation area, felt lightheaded/dizzy and fell. Had little bruise on head. Paramedics were called in, was talking with patient thru out, he was able to communicate everything. He denied any medical attention further. Pt was feeling fine and was going to call friend to pick him up. He left the store and going to call from outside.
Information has been received from a physician concerning a female patient who was vaccinated with on unspecified date with a dose of GARDASIL. Within 1 week of vaccination the patient developed Bell's palsy. The patient sought medical attention by contacted office. Upon internal review Bell's palsy was considered to be as an other important medical event. Additional information has  been requested.
9/19/21: Patient arrived at the ER due to complaints of cough, chest pain, shortness of breath, onset a week ago, was seen on 09/16/2021, was tested for COVID and was COVID positive.
lethargy; a very severe reaction; sore arm; not feeling well; trouble with balance; Systolic blood pressure <90 mmHg; Diarrhoea; really bad fatigue; bouts of nausea; vomited; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a very severe reaction), MALAISE (not feeling well), BALANCE DISORDER (trouble with balance), LETHARGY (lethargy) and BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced BALANCE DISORDER (trouble with balance), FATIGUE (really bad fatigue), NAUSEA (bouts of nausea) and VOMITING (vomited). 01-Sep-2021, the patient experienced BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg) and DIARRHOEA (Diarrhoea). On 07-Sep-2021, the patient experienced MALAISE (not feeling well). On an unknown date, the patient experienced VACCINATION COMPLICATION (a very severe reaction), LETHARGY (lethargy) and MYALGIA (sore arm). At the time of the report, VACCINATION COMPLICATION (a very severe reaction), MALAISE (not feeling well), BALANCE DISORDER (trouble with balance), LETHARGY (lethargy), BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg), DIARRHOEA (Diarrhoea), FATIGUE (really bad fatigue), NAUSEA (bouts of nausea), VOMITING (vomited) and MYALGIA (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, Blood pressure measurement: 110/75 (normal) 110/75. On an unknown date, Blood pressure measurement: 88/70 (Low) 88/70 and 115/75 (normal) 115/75.         Concomitant medications were not provided.  No Treatment information was provided   This case was linked to MOD-2021-311336, MOD-2021-311337 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Significant follow-up adr form received,events added
severe pain; frozen shoulders; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe pain) and PERIARTHRITIS (frozen shoulders) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 013L20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN for an unknown indication.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PERIARTHRITIS (frozen shoulders). On an unknown date, the patient experienced PAIN (severe pain). At the time of the report, PAIN (severe pain) and PERIARTHRITIS (frozen shoulders) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is taking diabetic medication and high blood pressure medication No Treatment received by the patient; Sender's Comments: This is a regulatory authority case concerning a  40-year-old female patient  medical history of diabetes, who experienced unexpected events of pain and Periarthritis. The events occurred on an unknown date after the second dose of mRNA-1273 vaccine. Patient developed severe pain that required therapy. She doesn't know if its the way she got the vaccine. She has had frozen shoulders since February. She closed her eyes so she is unsure of where they administered the vaccine in her arm. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
I received the flu vaccine (FLUZONE. Sanofi Pasteur Inc. lot UH890AA ndc 49281-013-88) at 12:30 on 09/12/2013. At 16:30 I began to experience tightness in the chest, increased respiratory effort, swelling of the neck, tachycardia, and urticaria of skin and eyes. No new food, or other agent exposure took place during the space of time from injection to reaction. Diphenhydramine 50mg PO taken and SpO2 , and respiratory monitoring initiated and continued 12 hours. Post monitoring symptoms included urticaria of eyes and tearing only.