chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an administrator referring to a 71 year old female patient. The patient's concurrent conditions included hyperlipidaemia, osteopenia and hypothyroidism. The patient had corticosteroids drug reaction. On 17-APR-2017, the patient was vaccinated with a second dose of PNEUMOVAX23 lot # M043987 and expiration date 30-JUN-2018 intramuscularly, on her left arm for prophylaxis. The date of administration of the first dose of PNEUMOVAX23 (route of administration, lot #, expiration date and anatomical location was unknown.) for prophylaxis. On 17-APR-2017, a few hours after administration of the second dose of PNEUMOVAX23, the patient developed redness, swelling, tightness, and warmth of the left upper arm, extending from the left elbow to the left shoulder. The patient's left hand felt cold, but there was no numbness. On 18-APR-2017, the patient developed a low-grade fever and she self-treated with TYLENOL. The patient sought medical attention (called office by phone). No laboratories were performed. On 24-APR-2017, the patient had recoverd from the events. Additionally, the reporter did not provided causal relationship between the events and vaccination with dose of PNEUMOVAX23. Additional information is not expected as no consent to contact Physician.
Pt recv vax on 9/19/95; on 3/9/99 pt exp 175 papules pustules over body
Next day post vax, the pt broke out in red splotches on sides. On 8/22/98, the pt developed hives, rash, intense itching, shortness of breath, wheezing, and chest pain. Treated with prednisone dose pack and Atarax.
Soon after receiving the vaccine, heart rate increased, and sweating began. Vision then began to fade to white and ears ringing. This persisted for about 15 minutes,  improvement began after 5 minutes. After vaccination, patient was very tired. Sore arm for 5 days. Hot/cold flashes days 3-5. Consitent tiredness 5 days. Muscle aches and cramps days 3-5. After 5 days side effects ceased. Concerns about initial effects
was bed ridden for 2 days afterwards; Initial information received on 14-Feb-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp (non health care professional).  This case involves an unknown age female patient who was bed ridden for 2 days afterwards, after receiving vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection with lot UT7347LA at an unknown dose via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient was bedridden (unknown latency) for 2 day afterwards (bedridden ), so she was concerned, she may had received high dose. This event was leading to disability.  Action taken was not applicable for the event  It was not reported if the patient received a corrective treatment for the event (Bedridden).  At time of reporting, the outcome was Unknown for the event bedridden.; Sender's Comments: Sanofi company comment date 21-Feb-2022:This case concerns a female patient of unknown age who was bedridden for 2 days afterwards, after vaccination with Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent]. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect product cannot be excluded in occurrence of the event.  Further information regarding patient age, concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspected influenza vaccine cannot be excluded in occurrence of the events and role of the individual suspect vaccine cannot be assessed.
This spontaneous report was received from a licensed practical nurse concerning an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of improperly stored VAQTA (lot number, expiry date, dose and route unspecified) which were exposed to 30 degrees Fahrenheit (F) on 19-APR-2013. No concomitant medications were reported. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
NO RASH BUT GENERALIZED INTENSE ITCHING IN MY ARMS,, LEGS, AND MY HEAD
after the vaccine he had a fever of 104 it went away. came back exactly a week later on december 12th 2020,  pediatrician advised us to have him covid tested. I took him to be tested at an urgent care and he tested positive. He was fine with only a runny nose. on December 14th he started doing thing hes never done before. He was walking on his toes, afraid when the dogs bark, but more so concerning was the new mouth movements he had been doing with his mouth almost like a lock jaw that he had no control over. He was showing more signs of reggressive autism,  From December 12th on he had non stop fevers that were daily and would not go away.  A new symptom would appear everyday. He was limping one day, His speech was off, He had nausea, constant head aches and back pain and muscle pain. I continued to call the pediatrician. They continued to say it was covid lingering but i new it was not and something more was going on.  He had been hospitalized numberous of times only to be sent home. We have an infectious disease, cardiologist, rheumatologist, a neurologist and neurodevelopmental involved now as well to be tested for autism. He has always reacted horribly to vaccines and the pediatrician at the time made it seem like these were all normal. not knowing until now that he may have an autoimmune disease.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with the second dose of GARDASIL (Lot # not reported) in 2009 and received her third dose of GARDASIL (Lot # not reported) on 05-DEC-2012. No adverse effect was reported. Additional information has been requested.
Felt dizzy, tingle sensation about an hour pain in left arm for 2 days after receiving the vaccine and had a severe increase in blood pressure around 11:30am about 24 hours after vaccination BP was 196/129 and took about a day to recover at home
Fever 101.6 all day on date after shot, flu like symptoms (achy, tired, headache).  One week later i had a mental breakdown and was taken to the ER for observation. Although I suffer from depression and anxiety, I became out of character and uncontrollable. My family and friends (seeing me in this state of mind) vehemently felt that something chemically was imbalanced.   I was suicidal for 6 days afterwards.  Saw a psychiatrist for the first time in my life.
Moderna COVID-19 Vaccine: Arm started itching with bumps around injection site on 12/30/20 and started feel fatigued, when I woke up at 4:41 am on 12/31/2020 the rash had spread over my upper left arm, left shoulder, front chest area and under both breast. I also feel very tired, scratchy throat, runny nose and headache
Mild pain in shoulder began in the evening of the shot. Next two days were characterized by fever (101), chills, muscle aches, and headaches. Third day, I was just tired, but no fever or chills. Did not take any medicine for the condition.
Red and swollen below administration site(s). Dx cellulitis w/fever >101 degrees. Rx Cephalexin and SMZ/TMP.
Arm Pain, next day-sore neck, arm pain, tired, feverish, second day-same, third day- same with neck shoulder, spine pain, swollen gland in left side of neck, day 6 - burning lungs, day 7 - tired, burning lungs.  Most symptoms disappeared except tightness in lungs in a week.
Experiencing tingling in both arms; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Experiencing tingling in both arms) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PARAESTHESIA (Experiencing tingling in both arms). At the time of the report, PARAESTHESIA (Experiencing tingling in both arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
mom called clinic 8AM 23JUN82 stating pt recvd vax yesterday & exp weakness & nausea & pain @ site of inject since yesterday about 30 mins p/recvd vax; has been so weak hasn't been able to get out of bed;
Approx 4 hours following immunization the pt reported experiencing excruciating pain in the left shoulder area. That was followed by a tingling sensation in 4 of her fingers on left hand. The following day the left arm became red, swollen and warm to the touch.
onset of marked redness rt arm 21hr past vax;itching, pain inj site rt arm;
Rash and hives for almost 2 weeks after,  had to take prescription hydracortisone pills for itching and eventually had a steroid shot
SEVERE HEADACHE; BODY ACHES; ROUGH NIGHT SLEEP; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced severe headache. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced rough night sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, and the outcome of body aches and rough night sleep was not reported. This report was non-serious.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site wheal in a 72-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date November 2020) for prophylaxis. Concurrent medical conditions included asthma, diabetes mellitus (Unknown Type) and obesity. On 1st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd July 2018, 1 days after receiving  SHINGRIX, the patient experienced injection site wheal (serious criteria other: as per reporter), injection site swelling (serious criteria other: as per reporter), injection site erythema (serious criteria other: as per reporter), weight loss (serious criteria other: as per reporter), muscle pain (serious criteria other: as per reporter), decreased appetite (serious criteria other: as per reporter), headache (serious criteria other: as per reporter) and fatigue (serious criteria other: as per reporter). The patient was treated with (NOS) BENADRYL. On 9th July 2018, the outcome of the injection site wheal, injection site swelling, injection site erythema, weight loss, muscle pain, decreased appetite, headache and fatigue were recovered/resolved. The reporter considered the injection site wheal, injection site swelling, injection site erythema, weight loss, muscle pain, decreased appetite, headache and fatigue to be probably related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in the right deltoid. The patient developed a large, swollen red welt at the injection site that spread along her right upper arm and had a decrease in appetite that resulted in 5 pound weight loss. The healthcare professional stated all the adverse event symptoms were worse on 3rd July 2018 and started to improve on 4th July 2018. Only intervention was BENADRYL, and no medical care was sought.
Adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Adverse event) 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 DRUG REACTION (Adverse event). At the time of the report, ADVERSE DRUG REACTION (Adverse event) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Vaccine leaked from the injection site. No adverse event occured. The dose was reattempted intradermally and was successful.
MODERNA COVID  VACCINE #3 GIVEN 12/8/21, LOT #030H21B; pt brought to ED via EMS with unresponsiveness and hypotension; tested positive for COVID on 6/7/22 at SNF; diarrhea; 6/12/22 pt tested positive again for COVID in ED; given ABX; sepsis due to COVID or colitis; renal failure; pt's condition worsened; DNR/DNI; transitioned to comfort care; pt expired in the hospital
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 11:00 (Lot number: FC3183) at the age of 37 years as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number=FA7485, Administration time=03:00 PM, Vaccine location=Left arm), administration date: Aug2021, when the patient was 37 years old, for Covid-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 27Aug2021 01:00, outcome "recovering", described as "whole body chills that resembled spasms"; DREAMY STATE (non-serious), SOMNOLENCE (non-serious) all with onset 27Aug2021 01:00, outcome "recovering" and all described as "I was in a dream state and not able to get up or awake from the episode"; CHILLS (non-serious) with onset 27Aug2021 01:00, outcome "recovering", described as "body flailing in what I would describe as whole body chills"; HEADACHE (non-serious) with onset 27Aug2021 01:00, outcome "recovering", described as "While sleeping I developed an intense headache". Therapeutic measures were taken as a result of headache. Additional information: The patient did not have Covid-19 prior vaccination. The patient did not get Covid-19 tested post vaccination. The patient did not have known allergies. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient mentioned while sleeping he developed an intense headache, followed by his body flailing in what he would describe as whole body chills that resembled spasms. He was in a dream state and not able to get up or awake from the episode. He does not know how long it lasted but he wants to say a few hours. He awoke at 04:00 with a pounding headache for which he took Advil and fell into a deep sleep after that. No follow-up attempts are possible. No further information is expected.
Kidney failure. EGFR prior to vaccines was 60 on 8/13/20.  Since vaccines EGFR has dramatically decreased to 8 with no lifestyle changes.
Patient took injections well; in no apparent distress. Walked to check out, stood there, then passed out, hit the floor. Unconscious. Doctor notified. Carried to exam room. Vitals taken, vomited 2 times. Transferred to hospital. Per follow up report-Pain in right foot braced- going to OT/PT, on Valproic and Depelote for seizure control, home school. Medical record states fever, depressed heart rate, sub dural hematoma, congenital venous malformation, respirtory failure, arrhythmia, sub dural hematoma. msv. Patient fainted at front desk-brain damage. Patient has foot doct as resdual of accident and continues to see patient.
My arm was extremely sore and you could feel the knot in it. I went to work out at the gym a few days after the shot and accidently hit my arm exactly where the shot was given on a door coat hanger. I almost fainted. I was in severe pain for days and the muscle in my arm has still not recovered. Its still sore three months later.
Information has been received from a physician concerning a female patient who on 05-OCT-2007, at two months old, received the first dose of ROTATEQ vaccine (lot#657045/1053U), then at 4 months old on 13-DEC-2007, the patient received the second dose of ROTATEQ vaccine (lot#657668/139U), and finally on 06-MAR-2008 at 6 months old the patient received the third dose of ROTATEQ vaccine (lot#659682/1733U). the physician reported that just recently, no specified date was provided, the patient went to the emergency room and had a stool test done and was diagnosed with rotavirus. At the emergency room the patient was given electrolytes and I.V. fluids, and no admission was necessary. Subsequently, on an unspecified date the patient recovered from diagnosed rotavirus. Additional information has been requested.
This spontaneous case was reported by a patient and describes the occurrence of PAIN (Had a lot of pain/and aching), ASTHENIA (No energy) and MALAISE (She just did not feel well) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The patient's past medical history included COVID-19 virus test positive. Concurrent medical conditions included Diabetes. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (Had a lot of pain/and aching), ASTHENIA (No energy) and MALAISE (She just did not feel well). On 06-Mar-2021, PAIN (Had a lot of pain/and aching), ASTHENIA (No energy) and MALAISE (She just did not feel well) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided.
30 min after vaccination patient felt nausea and started vomiting, chest tightness, trouble breathing, "funky" feeling at chest, sudden movements cause dizziness .  pt notified us on 05/11 and symptoms have resolved, pt instructed to monitor for continue symptoms especially related to chest symptoms tightness, SOB, etc and to go to ER if symptoms arose again
vaccine was given from a vial punctured more than 12 hours ago; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCEPTED PRODUCT ADMINISTRATION ERROR (vaccine was given from a vial punctured more than 12 hours ago) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced INTERCEPTED PRODUCT ADMINISTRATION ERROR (vaccine was given from a vial punctured more than 12 hours ago). On 20-Aug-2021, INTERCEPTED PRODUCT ADMINISTRATION ERROR (vaccine was given from a vial punctured more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial was picked from the hospital which is 5 minutes away from the vaccination site. After this 5 minutes vial was put in the refrigerator on 17Aug2021. It was punctured on 18Aug2021 and dose was given on 20Aug2021. Vial had not suffered any temperature excursion and was had been less than 24 hours exposed to room temperature. No concomitant medications were provided by reporter.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 01-MAR-2016, the patient was vaccinated with dose of MMR II injection, lot # K022284, expiration date 12-NOV-2016 (strength, dose, route and site of administration were not reported), which was exposed to the temperature of 49.1 Fahrenheit degrees for 13.5 hours (cumulative time to the date of reporting). No adverse effect was reported. There were no previous temperature excursions. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax & arm where hep b given reddened & swollen 8cm x 11cm;
Severe rash and hives that led to an abscess, especially in the groin and crotch area. Severe exhaustion.
felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Headache; nausea; could not sleep for 6 days; Heart Racing; Body shaking; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208), via an unspecified route of administration, administered in arm right on 12Mar2021 09:30 (at the age of 61-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma, blood pressure and cholesterol; all from an unknown date. The patient had known allergies. No covid prior vaccination. No other vaccines in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); chlorphenamine maleate, phenylpropanolamine hydrochloride (NASAMEX); simvastatine; ibuprofen; losartan; and furosemide (FUROSE); all were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 10:00, the patient experienced chest pain, rapid heartbeat, high blood pressure, dizziness, felt like she was going to faint and couldn't walk so dizzy. Her heart raced/heart racing for 5 days, headache, nausea and could not sleep for 6 days and body shaking. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events. Double the dose of losartan for blood pressure. Not tested covid post vaccination. The outcome of the events was recovered.
Pt given HPV dose 1.  Approximately 2-3 minutes later she became unresponsive sitting in chair.  Ammonia capsule snapped and patient awoke, c/o nausea.  Applied ice pack to neck and administered juice.  Pt became more responsive, then moved to mat on the floor until she felt that she could sit in chair.
Headache, severe body aches, chills, fever, soreness at injection site, nausea, fatigue
Patient received the Janssen COVID vaccine then shortly after administration patient stated that their vision started to go blurry and the next thing their sight went dark, patient was seen falling out of chair head first after passing out.
difficulty breathing, lt-side flank pain x 5 days, sl jaundiced, inflamed liver;
L leg (+) warmth, erythema slightly raised, 6x5cm area of L thigh.
Patient reported GI distress, overheating, and tremor after approximately 5 minutes post vaccination.
generalized rash & itching p/2nd vax; advised to take DPH;