chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse reactions were reported; administered one dose of improperly stored ROTATEQ; administered one dose of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant referring to a 9 weeks old patient of an unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 05-DEC-2018 and 05-FEB-2019, the patient was respectively vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R002059 with expiration date 03-JUN-2019, orally (dose details were not reported) for prophylaxis. The vaccines experienced improperly stored and were stored at below 36 Fahrenheit degrees (F), the detail temperature and time frame information included: 34.2 F for 2hours and 20 minutes, 33.3 F for 30minutes, 34.3 F for 1 hour, 35.4 F for 10 minutes, 34.5 F for 10 minutes, 34.9 F for 30 minutes, 35.6 F for 10 minutes, 32.9 F for 10 minutes and 34 F for 10 minutes. There was no previous temperature excursion and the call was because of a data logger involved. No adverse reactions were reported.
pt recv vax 29OCT96 & pt hosp 30DEC96 w/flu-like illness, transferred to another hosp 2JAN97 w/? GBS;
temperature excursion; Dose administered after a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Dose administered after a temperature excursion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Dose administered after a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (Dose administered after a temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that they had a temperature excursion of about 20 doses of Moderna, it got down to 32 degree F, went up to 34 degree F, then up to 36 degree F, then up to 37 degree F over the course of an hour. The doses were put in a portable transport unit and left at 32-degree F, the transport unit was not prepared for enough time to maintain the temperature.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Initial report received from a consumer who is the patient on 11 June 2013. A 31-year-old female with no concurrent illnesses and allergies to sulfa, bee stings, pollen and ragweed, had received an intramuscular injection of ADACEL (lot number C4344AB) on 07 June 2013 and by that evening developed overall body weakness, slurring of her speech, arms became numb (would come and go). By 08 June 2013, the numbness of arms stopped, but she had pins and needles feeling in her arms and legs that was worse in the arms than the legs. She also complained of sore throat and sinus congestion. She was unable to perform her usual activities due to the weakness and at the time of this report had been resting for 5 days. The patient was seen in urgent care clinic and advised to monitor symptoms and follow-up with a neurologist if symptoms persisted. Patient is afebrile and per the urgent care clinic her vital signs were within normal limits. Recovery status was reported a not recovered. Documents held by sender: None.
This case was reported by a physician via a sales representative and described the occurrence of paralysis in a 16-month-old male subject who was vaccinated with INFANRIX, GlaxoSmithKline.  The subject is currently almost seven years old.  On an unspecified date the subject received unspecified dose of INFANRIX (unknown).  Fifteen minutes after vaccination with INFANRIX, the subject experienced paralysis and within thirty minutes the subject experienced hives.  This case was assessed as medically serious by GSK.  At the time of reporting the paralysis and hives were resolved.  The physician considered the events were possibly related to vaccination with INFANRIX.
COVID infection - with acute on chronic respiratory failure. Doing better, lungs clear and O2 down to 2L - is baseline. Continue steroids, Remdesevir - completing Remdesevir soon. . Home O2 is 2L. Has CPAP on at night for OSA. Rise in D-dimer persists- no CP, will need to r/o PE. CTA chest showed PE, he was started on eliquis at discharge.    OSA - on CPAP at night.    CAD - HX CABG and recent stent placement - stable. No CP. On ASA, Bblocker, Cozaar, statin, Demadex. .    DM - montior BS. BS better now with resuming home glucotrol. Will reduce insulin. Will need insulin on DC home. . On SSI.  Spouse will need teaching on use if DC home from here. Added sliding scale at discharge, resumed his jardiacne and also increased glipizide dose.    HX AS - seeing Dr. for prep for TAVR.    Seizures - not on meds.    HTN - monitor on meds.    Hypothyroid - on supplement.    Hx Bladder cancer   BPH - on flomax.    Recent skin cancer excision - can remove stitches R ear.     PT, OT to eval - recommending home with assist and home PT. Possible DC tomorrow.
This patient was to get his first dose of Pfizer vaccine and it should have been MONOVALENT however he was inadvertently given the BIVALENT vaccine.
Patient is 3YO, should have received Moderna Bivalent Booster for her booster dose.
Fever 38.6'C for first 24 hours, then 37.1 for the following 2 days Severe headache lasting 4 days after vaccination, Shortness of breath on day 5, 7 and 9 lasting the whole day. Arm swelling, pain and redness, fatigue. Overall symptoms lasted a little over a week.
03/16/2021 complained of headache,  and lump with warmth/swelling/tenderness to Left lower leg 04/01/2021 complained of  lump with warmth/swelling/tenderness to Left lower leg, Rash to Right lower leg and heaviness of upper extremities.  04/12/2021  lump with warmth/swelling/tenderness to Left lower leg
Mom called nurse to state pt had severe h/a; 15 mins p/inject pt became nauseated but did not vomit; p78-80; r-16-18; ice pack to head-reste on bed 15-20mins; playful-responses nl-released home w/parent;
Lips tingling and swelling - same day as vaccine. Also developed a sore underneath the lip  Also, slight swelling om side of head (above ear - along hairline) and a small bump, and cheeks slightly swollen. No pain, no nausea.  Felt fine otherwise On Monday, red blotch under 1 eye.  Lip swelling is reduced. On Tuesday. Redness under 2nd eye slight rash Feeling fine otherwise.
The night after taking the vaccine, I woke up shaking relatively violently. I was very warm but shaking quite a bit, and this went on for about an hour. The following morning I woke up with a severe headache.
After injection felt immediately tingling to bilat arms, face, swelling to face and tongue, Itchy feeling to chest, feeling of palpitations and general unease. HR was 120 BPM, scattered hives over chest. No appreciable airway swelling. Treated with Epinephrine 0.3 mg IM, Solumedrol 125 mg IV, Benadryl 25 mg IV, Pepcid 20 mg IV, Ativan  0.5 mg IV. Rx given for Benadryl 25 mg every 6 hr. PRN
inability to think straight; stomach ache; loss of appetite; weakness; achy feet and hands; feeling like she had the flu; nausea; fever; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (inability to think straight) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced MENTAL IMPAIRMENT (inability to think straight) (seriousness criterion intervention required), ABDOMINAL PAIN UPPER (stomach ache), DECREASED APPETITE (loss of appetite), ASTHENIA (weakness), PAIN (achy feet and hands), INFLUENZA LIKE ILLNESS (feeling like she had the flu), NAUSEA (nausea) and PYREXIA (fever). On an unknown date, the patient experienced MYALGIA (muscle ache). On 25-Apr-2021, PYREXIA (fever) had resolved. At the time of the report, MENTAL IMPAIRMENT (inability to think straight), ABDOMINAL PAIN UPPER (stomach ache), DECREASED APPETITE (loss of appetite), ASTHENIA (weakness), PAIN (achy feet and hands), INFLUENZA LIKE ILLNESS (feeling like she had the flu), NAUSEA (nausea) and MYALGIA (muscle ache) outcome was unknown.            Company Comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Nausea, fever and myalgia are consistent with the product safety profile.   This case was linked to MOD-2021-090510 (Patient Link).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Nausea, fever and myalgia are consistent with the product safety profile
This spontaneous report as received from a certificated medical assistant refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with doses of PEDVAXHIB (lot # K025002, expiration date 20-JUL-2017) (Route and dose were not provided), which had temperature excursion. Concomitant medications were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Father received FluBlok quadrivalent flu vaccine made by Protein Sciences Corporation. Died 2 days later. only prescribed medication was Amlodipine Besylate 10mg tab, precribed 11/15/2022. 1 tablet by mouth daily
swollen jaw-woke up w/pain in lt side of face during sleep; reported to clinic next AM;
Pt experienced an episode of Shingles after the administration of the vaccine.  She displayed a rash consistent with Shingles within 20 minutes of the vaccination.
pt recvd vax employing a preparation w/ an expiration date of 16sep90;at time of vax no rxn noted;
BECAME PHYSICALLY RIGHT SIDE PARALYZED (COULD NOT FEEL HALF OF HER BODY); CHEST PAIN; BARELY WALK FLUCTUATES BACK AND FORTH; MIGRAINES; TINGLING; NUMBNESS ALL OVER HER BODY; FEVER; HEADACHE; This spontaneous report received from a parent concerned a 28 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported,1 total, administered on 16-AUG-2021 right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient took vaccine on 16-AUG-2021 since then she experienced chest pain, migraine, headache, tingling, numbness all over her body, fever and can barely walk fluctuates back and forth. On 20-AUG-2021, the patient became physically right side paralyzed (could not feel half of her body). Patient went to emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain, migraines, headache, became physically right side paralyzed (could not feel half of her body), tingling, numbness all over her body, fever and barely walk fluctuates back and forth was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210848879- covid-19 vaccine ad26.cov2.s - Became physically right side paralyzed (could not feel half of her body). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
No adverse event; Received Bivalent Moderna COVID-19 vaccine booster instead of the 2nd Primary monovalent dose; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Bivalent Moderna COVID-19 vaccine booster instead of the 2nd Primary monovalent dose) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax (Dose 1 andFirst Primary monovalent dose (Lot# 083B22A & Exp. Date: unknown)) on 23-Jan-2023. Past adverse reactions to the above products included No adverse event with Spikevax.    On 21-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Received Bivalent Moderna COVID-19 vaccine booster instead of the 2nd Primary monovalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Bivalent Moderna COVID-19 vaccine booster instead of the 2nd Primary monovalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received Bivalent Moderna COVID-19 vaccine booster instead of the 2nd Primary monovalent dose).    Concomitant medication was not provided.   Treatment information was not provided.
Administered the vaccines that were stored outside of normal range; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2EC5G, expiry date 13th January 2023) for prophylaxis.   On 2nd April 2021, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The clinical supervisor called in to check stability of Boostrix vaccine stored at minimum 29 degree F temperatures for 48 hours. The clinical supervisor reported that the patient was inadvertently administered Boostrix vaccine that was stored outside of normal range and needed to be discarded, which led to incorrect storage of drug. The reporter was unable to provide additional details. The reporter did not consent to follow up. This case is one of 5 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021102716:Same reporter US-GLAXOSMITHKLINE-US2021102720:Same reporter US-GLAXOSMITHKLINE-US2021102721:Same reporter
Pt reports red, raised, itchy rash began on arm of injection site, then later on right arm, then trunk and finally both legs. Did also have mild cold sx 1-2 days following injection Denies any breathing trouble. Did seek medical treatment with PCP for itching, and this has improved greatly. Some rash remains about the legs (predominant) & arms. No fever or GI sx reported.
This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 26-JUN-2014 the patient was vaccinated with second dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) for prophylaxis which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA12910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955,  1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962,  1407USA012963,  1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986,  1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013, and 1407USA013014 (same reporter link). Additional information has been requested.
I started experiencing soreness in my legs, regardless of the amount of exercise or activity. I have also had joint pain in my right hip and at the base of my thumb. Not sure what was causing it, I assumed it might be inflammation in my body. I started increasing the degree of healthy-food choices, the amount of physical activity, and taking occasional over-the-counter anti-inflammatory medications. Nothing helped. It has increased in frequency and has, over the course of a year, affected my quality of life. I have also had an increase in the frequency of headaches. Just recently, I have experienced light-headedness and vertigo.
3 inch red, swollen area on left deltoid. Child denies pain- good range of motion- advised warm compress to area- Tylenol four times a day. Return to clinic 1-2 days if worse.
Tiredness; Muscle pain; Chills; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07May2021 at 13:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Apr2021 at 13:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 09May2021, the patient experienced tiredness, muscle pain and chills which had long lasting side effects; lasting up to 5 to 6 days after injection. Tiredness increased in intensity two days after injection, lasting to 5 days after injection. The events had resulted in doctors or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness, muscle pain and chills was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Double vision with 6th nerve palsy that improved with IV steroids. She was subsequently diagnosed with multiple sclerosis, however this was the first event.
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was not reported. No treatment medication was not reported
severe soreness in arm 13OCt & 14OCT;fever in arm 14OCT;cont pain, throbbing, unable to lift arm out or over head 16-17OCT;APAP for pain, cool compacts during onset of fever (3X day)work arm throughout day, if pain consist through weekend;
Initial report was received from a consumer on 27 September 2011. A female patient had received the first dose of an injection of IMOVAX, sanofi pasteur SA (lot number, site and route of administration unknown) on 20 September 2011 and three days later on 22 September 2011 experienced a rapid heart rate tat lasted for two hours. The patient had received the second dose of an injection of IMOVAX, sanofi pasteur SA (lot number, site and route of administration unknown) on 23 September 2011 and later that day experienced rapid heart rate. The patient took BENADRYL and the rapid heart rate lasted one and a half hours. The patient also experienced muscle twitching after the second dose. The patient had received the third dose of an injection of IMOVAX, sanofi pasteur SA (lot number, site and route of administration unknown) on 27 September 2011 and later that day experienced rapid heart rate that lasted one and a half hours. No other vaccinations were given within four weeks and the patient had no illness at the time of vaccination. It was unknown if the patient had any past medical history or took any concomitant medications. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a consumer on 05 March 2012. On 27 September 2011, the patient was seen in follow-up with concern that she may be having an allergic reaction to the vaccination. The physician stated that the symptoms were relatively mild and recommended continuing the vaccination. On 10 October 2011, the patient as seen again for heart palpitations, loss of appetite and legs tingling. She thought she had Lyme disease due to a tick bite " weeks ago". The physician noted a lot of anxiety and suggested talking to a counselor about the stress. The patient outcome was reported as recovered/resolved. Documents held by sender: none.