chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Physician referring to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # reported as: L002042 expiration date: 28-JUL-2016 (administration route was not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of several reports from the same reporter. Additional information has been requested.
Admitted to hospital with COVID-19 pneumonia.  At time of admission, reports 2 weeks of dry cough with 4 days of progressive dyspnea on exertion.  Required supplemental oxygen at presentation to ER.
Lymph gland swollen (size and shape of chicken egg) under left arm. Same arm as received flu shot. Extremely sore. Took Tylenol for pain. As of this filing, still swollen, not as sore.
She got her vaccine, there was no immediate reaction.  The next morning her hands itched really bad.  That evening her feet and toes itched, and has been continuous every evening and every morning since.  They itch in between the digits and on the palms of her hands and soles of her feet.  She has not taken anything for the reaction.  She has not talked to anybody regarding the reaction, and is going to call her PCP for this.
receiving Monovalent COVID-19 vaccine as booster dose after August 31, 2022
headache; shaky; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergic rhinitis due to pollen" (unspecified if ongoing); "Disorder of bone, unspecified" (unspecified if ongoing); "Iron deficiency anemia secondary to blood loss (chronic)" (unspecified if ongoing); "antineoplastic chemotherapy" (unspecified if ongoing); "Neoplasm related pain" (unspecified if ongoing), notes: acute and chronic; "Type 2 diabetes mellitus without complications" (unspecified if ongoing); "Neoplasm of uncertain behavior of left breast" (unspecified if ongoing). Concomitant medication(s) included: ANASTRAZOLE DENK; ASPIRIN EC; ATENOLOL; ATORVASTATIN CALCIUM; CALCIUM 600 WITH VITAMIN D3; CALCIUM CARBONATE; CETIRIZINE; FEROSUL; GLIPIZIDE;METFORMIN; LOSARTAN POTASSIUM; MELOXICAM; MONTELUKAST SODIUM; COQ-10. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; TREMOR (non-serious), outcome "unknown", described as "shaky". The events "headache" and "shaky" were evaluated at the physician office visit.  Additional information: Patient concomitant medication included multivitamin (as reported). It was reported that the doctor was aware of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt received her first covid vaccine on Thursday.  Friday had some soreness of the right arm, fatigue.  sunday march 14th evening she noted some axillary pain, by Monday had more severe pain and noted swelling and discoloration of her right arm and hand.  she went to the ER and had labs and ultrasound confirming dvt of right upper extremity.
C/O "throat closing and itching" after flu vaccine (12:15 p.m.). BENADRYL 50mg. IM administered at 1230 p.m. (approx.). To hospital via 911 (1245 arrival of ambulance).
Rash (per mother - parent made phone call) over trunk and arms. Fine rash.
Swollen left arm that worsened almost a week after the event. Was treated for cellulitis of his left upper arm.
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. The patient's historical drugs, medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (MERCK). On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). On an unknown date, the patient had angioedema reaction. It was unknown if the patient received any treatment or if diagnostic laboratories were performed. At the time of reporting, the outcome of angioedema was unknown. Additionally, the causality assessment between angioedema and ZOSTAVAX was not provided. Upon internal review, angioedema was determined to be a medically significant event.
2 days p/vax pt devel cellulitis @ pnu imune23 site;pt was hosp treated w/IV ATB & d/c from the hosp on 28OCT;
I'm not sure this was from the vaccine, but it seems like the only likely cause: I had Pfizer Shot#2 on 2/23/21. I was feeling great for an entire week. Then, a week after the second shot, I got the worst fatigue I can ever remember, except maybe when I was pregnant, starting the evening of March 1. When I awoke on March 2, my body aches were so intense, I felt like I couldn't move out of bed. Then during the day, I tried to take my usual outdoor walk - usually ~ 5 miles/day. I had to turn around part-way because I was so exhausted and my legs felt both like concrete and like they were quaking from tiredness. Later that afternoon, I  fell asleep sitting up in my chair SIX times, even though I almost NEVER take a nap! I kept doubting myself because I haven't read about delayed onset of symptoms, but we don't go anywhere indoors at all except for getting the shot at the pharmacy and an MD clinic appointment now and then. (I did have an annual MD appointment on March 2, so was in the clinic that very day, using all precautions. I don't imagine I could have gotten ill instantly from something at the clinic though?) In ensuing days, I continued to feel super-fatigued, but have had more energy each day, to the point where, now, 6 days later, I feel "almost" like myself. I'm still unsure of walking the full 5 miles without getting too tired, and certain body aches are still hanging on (knee, wrists, fingers), but I'm otherwise feeling good. If I had the symptoms right after the shot, I would have been sure it was from the shot, but since it was delayed a week, I was uneasy and it felt a bit scary because I felt so unlike my healthy, spry, active, motivated self.   One other odd thing, that may be totally unrelated, but just in case - on the very day of the second shot, I got a huge stye on my left eye - something I haven't had in decades. It has still not gone away after 2 weeks. Just in case you get other reports, I am letting you know about this as well. The fatigue and body aches sound a lot like what is to be expected after the shot, but I do know there have been some eye-related issues as well.
Patient started hallucinating at 3:00am. He had a low grade fever which we thought might be the cause. Slept and appeared dizzy upon waking but alert. At 3:30 pm, he again started hallucinating.
dose which expired was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received HAV (Havrix) (batch number 3hr79, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 12th October 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was medical assistant and stated that, a dose of Havrix which expired on 16th September 2021 was administered the day before reporting day, which led to expired vaccine used. The reporter did not consent to follow-up.
This is a spontaneous report from a non-contactable pharmacist via Pfizer sales representative. An elderly female (over 65) patient of an unspecified ethnicity received PREVNAR 13 intramuscular at single dose at deltoid muscle sometime in 2016 (in the past month before this report, not specified if Sep or Oct2016) for pneumonia pneumococcal immunization. The patient medical history was not reported. Concomitant medication included influenza vaccine (INFLUENZA, Flu shot) on the same day in 2016. The patient experienced cellulitis on the arm where the PREVNAR 13 was administered in 2016 with outcome unknown. She was treated with Clinamycin. The patient stated she would not get the product again. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: date of vaccination and onset date of the event. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a health care professional concerning a current 20 year old female patient  who in 1991 and 1994 was vaccinated with a first and second dose of MMR II (Lot # not provided). It was reported that he patient failed to seroconvert to measles. No adverse effects reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Did not have AE to first Shingrix shot.  Patient administered 2nd Shingrix to L arm on 12/01/2020. By 16:30, patient heartrate increased. Went for a run and never got the taccycardia down; above 140BPM. Have never had experienced event like this. Patient went to ER. They administered medication to lower heart rate. BP 155/100. Sinus Taccycardia, vertigo. Heartrate was in and out of taccycardia on 12/2/2020. By 12/4/2020 it was much better;Resting HR has been in the 80's (normal is the 50's). Patient 'slowly feeling like going back to normal'.   Had flu shot well before 30 days shingrix, 2nd dose.
My first Pfizer Vaccine was on April 19, 2021 and my second vaccination was taken on May 10, 2021.  Four days after the second vaccination, I started having ear problems, dizziness and vertigo whilst working in front of my computer in the office and outside of work related duties.
I had chills, fever, and body aches after every dose I received. However, after my first booster, I had fatigue and body chills that lasted for a couple of days. I had redness and soreness at the injection site on my arm. I have random brain fog and ear congestion since receiving my first booster. I've suffered from loss of balance and insomnia as well. I also suffer from random swelling below my kneecaps and above my shin area. I informed my rheumatologist about it; they've been drawing blood work for testing for any autoimmune diseases like lupus and suspected dependent rubor, a type of peripheral artery disease. My testing came back with red flags that required additional blood work and testing to be done. I wake up with random headaches that last for 5-6 days in the back of my head constantly on and off since receiving the vaccine. I've been having random flare ups and weird, bizarre things happening to me since receiving the vaccine. I'll have random hair loss, loss of body weight/loss of appetite, blue toenails and swelling and have to go the emergency room who directs me back to my rheumatologist for further testing. They haven't had any conclusive test to determine what I've been suffering from.
Patient called Medical Group at 0800 on 5 Nov 2017 with c/o possible reaction from vaccination that was administered on 3 Nov 2017. Patient reports having pain and swelling to left arm at injection site which is where the Yellow Fever vaccination was administered. Patient was asked to report to the clinic to have further assessment. Patient was seen in the clinic by MD. Vitals  - BP 130/79, Temp 97.3. Per MD site of injection was noted to be red, swollen, and hot to the touch. Patient was noted to be stable and referred to Express Care for further evaluation.
Lips feel big; Back of head burning; Tingling torso/ Tingling face; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lips feel big), BURNING SENSATION (Back of head burning), PARAESTHESIA (Tingling torso/ Tingling face) and PYREXIA (Fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIP SWELLING (Lips feel big) and BURNING SENSATION (Back of head burning). 01-May-2021, the patient experienced PARAESTHESIA (Tingling torso/ Tingling face) and PYREXIA (Fever). At the time of the report, LIP SWELLING (Lips feel big), BURNING SENSATION (Back of head burning), PARAESTHESIA (Tingling torso/ Tingling face) and PYREXIA (Fever) outcome was unknown.            No treatment information provided.   No concomitant medication provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow-up information received on 31 May 2021 contains no new information.
Varicella given, but patient has already recieved 2 MMRV vaccines previously. No symptoms reported. Provider who saw patient for his exam was notified of the extra varicella vaccine and given the documentation supporting the patient already reieved 2 doses of MMRV. Provider was to call parent(s)/guardian(s) to inform them of this error and advise further instructions on their behalf for the patient.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
Tactile fever; fatigue; Arm pain moderate; Arm swelling mild; This case was reported by a physician via sales rep and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2020, the patient received the 1st dose of Shingrix. On 14th August 2020, less than a day after receiving Shingrix, the patient experienced fever, fatigue, pain in arm and swelling arm. On 15th August 2020, the outcome of the fever was recovered/resolved. On 16th August 2020, the outcome of the fatigue, pain in arm and swelling arm were recovered/resolved.   The reporter considered the fever, fatigue, pain in arm and swelling arm to be probably related to Shingrix.  Additional details were provided as follows: The patient received the vaccine in left deltoid. Patient was not admitted to the hospital overnight or prolong an existing hospitalization. Health care professional did not consider the event(s) to be life threatening. Health care professional did not consider the event(s) to result in persistent or significant disability/incapacity. No surgical or medical intervention to prevent one of the outcomes described in preceding questions. The patient did not result in a congenital anomaly or birth defect. This case has been linked with case US2020AMR174130reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR174130:Same reporter (husband)
Symptoms began at 0900 on 8/13/21. Patient was at home and became dizzy and weak with complaints of blurred vision. Then developed occipital headache and pain behind his right eye. Was having difficulty ambulating during this event. Patient presented to the emergency department at 0930, no neurological symptoms were noted, patient only complaining of the headache at this time. Head CT was performed to rule out hemorrhage, then head CT/neck with contrast was performed. Acute vascular findings were ruled out, but incidental findings of  mediastinal lymphadenopathy as well as nodular and interstitial change at the lung apices were found. Chest CTA was then performed which found mediastinal and bilateral hilar lymphadenopathy and  pulmonary findings that were strongly suggestive of sarcoidosis, or possibly lymphoma but less likely.   Patient was able to discharge home with diagnosis of sarcoidosis and leukopenia.
Day 1 (1/19/2021) First symptom was vomiting at 12:30 p.m. then more symptoms developed after vomiting including  chills, headache, achy from head to toes, pain radiated from injection site to fingers after vomiting episode.  At 2:30 p.m., event of diarrhea.  At 3:30 p.m. 100.2F temperature recorded Severe tiredness and increased thirst which led to increased urination Fever broke at 8:00 p.m. and temperature recording was 98.5F Next morning: symptoms of swollen face, difficulty breathing (band around chest feeling), post nasal drip, body aches After 3 days, symptoms gradually went away.
Case number PHEH2012US023699 is an initial spontaneous report from consumer (patient's husband) received on 30 Nov 2012. This case refers to 60-year-old female patient. The patient's medical history included use of medicines (unspecified) for controlling blood pressure. The patient was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on an unspecified date. On an unspecified date, one day after the flu shot, the patient had severe blood pressure issues with blood pressure reading of 200/100 mmHg. The patient went to emergency department for her episodes. The patient's tests in emergency room included electrocardiogram (EKGs) and CT scans. The patient also experienced migraines caused by her high blood pressure. The patient started on medications for her episodes which included morphine, BENADRYL and ibuprofen on IV push (for migraines). On an unspecified date, the patient was diagnosed with tachycardia and very high blood pressure. The reporter was not sure if she had arrhythmias. The patient's episodes were described as warm feeling in her body right before her blood pressure doubled the normal rate. She would take her medicine and 3 minutes later it would go away. This occurred in waves over the past 3 months. The episodes would be lasted for one hour and then would taper down. The last episode lasted for 3 minutes. The seriousness, outcome and causality of the events was not reported.
Narrative: Covid+, Moderna x 3, cough, tachy, decrease oxygen sats, lactic acidosis, d/c home
This spontaneous report as received from a consumer via Clinic refers to a currently 54 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUL-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
muscle weakness in both legs 4 days p/vax;pt seen by neurologist who does not feel these sx are an adverse rxn;pt having MRI,EMG & CAT scan to r/o poss CVA;
pretty serious side effects; Lethargy; severe pain in arm which was swollen up; severe pain in arm which was swollen up / arm was painfull; fever; fatigue; nausea; Arm sore at injection site; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE DRUG REACTION (pretty serious side effects), LETHARGY (Lethargy), PERIPHERAL SWELLING (severe pain in arm which was swollen up), MYALGIA (severe pain in arm which was swollen up / arm was painfull) and PYREXIA (fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia in 2009, Hypoglycemia in 1980, Hypothyroidism in 2015, Irritable bowel syndrome in 1980 and Hysterectomy in 1994. Concurrent medical conditions included Allergic reaction to drug, Peanut allergy, Allergy to edible fungus and Allergy to vaccine. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ESTRADIOL for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (pretty serious side effects), LETHARGY (Lethargy), PERIPHERAL SWELLING (severe pain in arm which was swollen up), MYALGIA (severe pain in arm which was swollen up / arm was painfull), PYREXIA (fever), FATIGUE (fatigue), NAUSEA (nausea) and VACCINATION SITE PAIN (Arm sore at injection site). At the time of the report, ADVERSE DRUG REACTION (pretty serious side effects), PERIPHERAL SWELLING (severe pain in arm which was swollen up), MYALGIA (severe pain in arm which was swollen up / arm was painfull), PYREXIA (fever), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient experienced similar kind of adverse events on March 29 2021 and 23 APR 2021 to Tetanus vaccine. Treatment medication include Tylenol which did not help.    Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Significant follow-up appended
Patient left the exam room and after leaving the lobby, felt very dizzy while she was standing by the elevator. Told mother her vision was going "white". Mother supported her upright and called for assistance. RN's from the unit brought her into an exam room and helped her lie down on the exam table. She was reportedly pale and sweaty.RN's checked vital signs; teen was stable. They had MD come to check her. Over course of 10-15' she felt well enough to leave. I called mother later in evening. She said that patient was still a little pale but was much better. mostly embarassed about almsot fainting.She was saying that her arm felt heavy all the way down. She had full motion and pink fingers. Reviewed on-call availability with mother.