chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Did not take the fourth dose of Vivotif; Took third dose of Vivotif on day 4; Spontaneous report received on 06JAN2020.  A pharmacist reported that a consumer "took third dose of Vivotif on day 4" (PT: Inappropriate schedule of product administration) and "did not take the fourth dose of Vivotif" (PT: Incomplete course of vaccination) while being on Vivotif for immunisation. The consumer took first, second and third dose of Vivotif on 23DEC2019, 25DEC2019 and 26DEC2019 respectively. It was reported that the consumer did not take the fourth dose. Action taken with Vivotif with respect to the reported events was not applicable. The outcome of the reported events was unknown.  Company Comment: A consumer took third dose of Vivotif on day 4" (Inappropriate schedule of product administration) and also did not take the fourth dose of Vivotif (Incomplete course of vaccination). Considering the nature of the events, the causality of both the events is not applicable to Vivotif.; Sender's Comments: A consumer took third dose of Vivotif on day 4" (Inappropriate schedule of product administration) and also did not take the fourth dose of Vivotif (Incomplete course of vaccination). Considering the nature of the events, the causality of both the events is not applicable to Vivotif.
3 inch in diameter reaction at the site within 10 hours. Swollen, hard, red and hot to the touch. Severe body aches beginning 11 hours after injection & continuing. I?m one day out.
9/20/2016 Patient visit for reaction to MENB shot Right arm with redness, swelling and pain. Accompanied by mom. 13 YO received the following vaccinations three days ago: In Right arm: TRUMENBA In Left arm: GARDASIL and FLUZONE. Since then the vaccinations sites on both arms have been tender, swollen and red, Right>Left side. No fever, nausea, dizziness. Mother gave her BENADRYL before bed last night. Using TYLENOL for pain. Using cool compresses to sites. Redness is less today but pain persists R>L side with use of the arm.
feel like I was hit by a bus; Back pain; hip pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (feel like I was hit by a bus), BACK PAIN (Back pain) and PAIN (hip pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for an unknown indication.     Concurrent medical conditions included Arthritis (hip arthritis). Concomitant products included IBUPROFEN for Arthritis.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN (feel like I was hit by a bus), BACK PAIN (Back pain) and PAIN (hip pain). At the time of the report, PAIN (feel like I was hit by a bus) and BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information is not provided.
Left upper arm red, swollen ant warm to touch from deltoid to elbow. Temperature 97.5 then elevated to 100.5 for night shift, down with Tylenol 650mg PO. On 11/16/2001 still red with decrease of swelling, afebrile.
No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant therapies were not reported.  On 08-OCT-2021, it was administered therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number T033814 had been verified to be a valid number; expiration date: 05-OCT-2022; strength, dose, route of administration, and anatomical location were not provided) that underwent temperature excursion (product storage error). It was reported the temperature excursion was above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that no had previous temperature excursion. No addittional adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA007428: US-009507513-2112USA007429: US-009507513-2112USA007430: US-009507513-2112USA007431: US-009507513-2112USA007432: US-009507513-2112USA007433: US-009507513-2112USA007434: US-009507513-2112USA007435: US-009507513-2112USA007451: US-009507513-2112USA007437: US-009507513-2112USA007438: US-009507513-2112USA007439: US-009507513-2112USA007440: US-009507513-2112USA007441: US-009507513-2112USA007442: US-009507513-2112USA007443: US-009507513-2112USA007444: US-009507513-2112USA007445: US-009507513-2112USA007446: US-009507513-2112USA007447: US-009507513-2112USA007449: US-009507513-2112USA007450: US-009507513-2112USA007427: US-009507513-2112USA007426: US-009507513-2112USA007425: US-009507513-2112USA007436:
Freezing, couldn't get warm. Went to the ER and my white blood cell was elevated and I had a 101.3 temperature. Had a little trouble breathing. Was given intravenous antibiotics and a couple of Advil. Was released at 3:30 AM.
patient received flu vaccine and the next day his full body was itchy with swelling. after 4 weeks patients itching or swelling has not gotten better
SUFFERING WITH M G (MYASTHENIA GRAVIS); This spontaneous report received from a patient via a social media  through a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported and expiry: Unknown) dose was not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The patient described that the vaccine doctor gave was nearly killed the patient. On an unspecified date, the patient had been suffering with M G (myasthenia gravis), and immune system even a wreck ever since. The patient had been treated by a neurologist and also had thymus removed and was performed with a series of plasmapheresis.  It was reported that "Your Johnson and Johnson COVID vaccine that my doctor gave me dam near killed me. I have been suffering with M.G. ever since. My immune system even a wreck ever since. I can not do anything about it. Yes I being treated by a neurologist. I also had my thymus removed, and a series of plasmapheresis performed". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suffering with M G (myasthenia gravis). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221244196-M G (myasthenia gravis). Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
This spontaneous report as received from a male nurse refers to himself. The patient had no pertinent Medical History and Drug Reactions/Allergies. On 20-JUN-2001, when the patient was 14 year old, the patient was vaccinated with his first dose of VARIVAX (Merck) (lot #, dose and therapy route was unspecified). On 26-OCT-2007, the patient was vaccinated with his second dose of VARIVAX (Merck) (lot # 658407/1176U, Exp date: 24-JUL-2009) 0.5 ml, intramuscularly. Concomitant Medication was not reported. On 19-NOV-2013, the patient had a negative vzv antibody titer with a result of 0.6 (units unspecified). No treatment was given for the events. The outcome of the event was unknown. Additional information has been requested.
BODY ACHES; DIARRHEA; CHILLS; TEMP 99.2; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to codeine ivp dye.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, expiry: UNKNOWN) .5 ml, administered on 12-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the subject experienced diarrhea. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced temp 99.2. On 12-MAR-2021, the subject experienced body aches. Laboratory data included: Body temperature (NR: not provided) 99.2 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea, chills, temp 99.2 and body aches was not reported. This report was non-serious.
Around 8Pm I started getting chills. My left arm was sore and warm to the touch. I also developed a hard knot at injection sight.  I felt weak, dizzy, tired, sore and achy all over.  I felt like I had the flu. It has been on and off all weekend.  I hope to feel better today.
Immediately afterward I started having horrible pains and called in. The doctor said it was normal.  It?s been a year since and I?ve had cases of pericarditis and costochronitis, chest pains, muscle aches, swelling in left breast plate, restless legs and Cronus fatigue. The symptoms started on the first day of the first dose and continue after one year and almost 2 months.
pt c/o weakness, shakiness & not feeling right;BG 153 p/gatoraide & crackers;rest, fluids secondary observation;
the child had a reaction to the product after the first dose; fever; rash; This spontaneous report as received from a nurse refers to a 5 years old male patient. The patient's concomitant medication, pertinent medical history, drug reactions/allergies were unknown.   On an unknown date in 2016, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, site of administration, lot number and expiration date were not provided) subcutaneously (SQ) for prevention of measles, mumps, and rubella.       On an unknown day in 2016 (reported as 5 years ago), the patient had a reaction to the product (adverse reaction) at one year of age after first dose and also experienced fever and rash. It was unknown if treatment was given, lab diagnostics/studies was performed, medical attention was sought or not. The outcome of adverse reaction, fever and rash was unknown. The action taken was not applicable.  The causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
Began with severe arm pain, redness, swelling, warmth around injection site about 2 hours after receiving vaccine. Symptoms diminished slightly over the next few days but redness and warmth spread around arm and down to elbow. Over a week after receiving the vaccine arm is still quite painful and shoulder is hurting quite a bit. Painkillers do not seem to help. Been getting vaccines my whole life and never had a reaction like this. If I react at all, symptoms have always been gone within two days.
Localized but spreading redness at injection site. Patient stated she could barely grasp a fist and could not lift her arm above waist level. Profuse sweating.
This spontaneous report was received from a pharmacist, who is also a male patient of unknown age who reports on himself. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 12-OCT-2018, the pharmacist had accidental exposure of PNEUMOVAX 23 lot# R007721 with expiration date on 01-MAR-2020, to his face and his mouth, while he was drawing up PNEUMOVAX 23 from vial. No adverse effect was reported.
Enlarged lymph node under left armpit (site of injection); This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 30Dec2020 at a single dose on the left arm (reported as left armpit) for COVID-19 immunization in a hospital. Medical history was reported as none. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received an unspecified birth control within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Jan2021, the patient experienced enlarged lymph node under left armpit (site of injection). The patient was not given any treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Initial information received on 14-Feb-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 55 years old male patient who was vaccinated with a dose of  FLUZONE HIGH DOSE instead of FLUZONE QUADRIVALENT Vaccine (lot number and Expiry date unknown) via unknown route in unknown administration site, on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered, Inappropriate age at vaccine administration and Overdose. It was unknown whether patient experienced any adverse reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Mother states that when her son woke up this am that he had vesicles throughout his body.  Mother states that he is afebrile.  Mother brought her son to see his PCP.  PCP gave mother Benadryl to give to her son.
Rash on my arm where I received the shot.  I have photos.  Rash arrived weeks after the shot.
Blood clots in Lungs; Peripheral Neuropathy; High Blood Pressure; horrific back & amp; leg pain; horrific back & amp; leg pain; Neck, Shoulder's, arms, and hands Pain.; Neck, Shoulder's, arms, and hands Pain.; Neck, Shoulder's, arms, and hands Pain.; Neck, Shoulder's, arms, and hands Pain.; have been sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 04Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset 04Dec2021, outcome "unknown", described as "have been sick"; PULMONARY EMBOLISM (hospitalization, medically significant), outcome "unknown", described as "Blood clots in Lungs"; NEUROPATHY PERIPHERAL (hospitalization, medically significant), outcome "unknown", described as "Peripheral Neuropathy"; HYPERTENSION (hospitalization), outcome "unknown", described as "High Blood Pressure"; PAIN IN EXTREMITY (hospitalization), BACK PAIN (hospitalization), outcome "unknown" and all described as "horrific back & amp; leg pain"; NECK PAIN (hospitalization), ARTHRALGIA (hospitalization), PAIN IN EXTREMITY (hospitalization), PAIN IN EXTREMITY (hospitalization), outcome "unknown" and all described as "Neck, Shoulder's, arms, and hands Pain.". The events "blood clots in lungs", "peripheral neuropathy", "high blood pressure", "horrific back & amp; leg pain" and "neck, shoulder's, arms, and hands pain." required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 202. Additional information: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine, mRNA [Monovalent and/or Bivalent]. Patient inquired asking for Company Doctor's advice on what kind of medicine shot she can get to combat the Pfizer Booster Shot she got on 04Dec2021 and have been sick since then. She has been to about 7 Doctors and hospital with High Blood Pressure (202), Blood clots in Lungs, Peripheral Neuropathy, horrific back & amp; leg pain. And constant Neck, Shoulder's, arms, and hands Pain. She was slowly dieing and no one can seem to help her.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Approximate 6 cm blistered, hard to touch area, red. Approximately 15-17 cm area around, red, puffy and hot to touch. Itching. Skin appears slightly scaly in this area. Treated with Benadryl PO - Cefazolin (IV) x doses the PO Keflex x 7 days.
Flushing, tachycardia, dizziness, diaphoresis, nausea, weakness, starting about 2 minutes after receiving the immunization, patient sat upright in a chair for a 10-15 minutes and symptoms resolved.  Later that evening around 5pm started experiencing rigors, body aches, possible fever, headache and dry cough, these symptoms worsened around 7pm.  She almost went to the ER but ultimately did not.  Her symptoms resolved about 3am.
Patient is a 76 y.o. is a 76 y.o. gentleman with profound thrombocytopenia of unclear etiology but presumed to be ITP perhaps due to recent RSV vaccination. He has been refractory to corticosteroids as well as IVIG 1g/kg daily x2 given in conjunction with corticosteroids. He has been having ongoing ecchymoses and bleeding (epistaxis). He has now received romiplostim 1mcg/kg on 11/14.  Lack of response so far on platelets. Ongoing mild bleeds on and off  Would have next dose be increased to 3 mcg/kg instead of 2.
Significant swelling and redness around vaccination site, > 5 cm in diamter, painful to touch.
pt went home & slept; awakened 230PM w/high pitched screaming & was not consolable; during the episode had 3-4 episodes of generalized twitching of entire body lasting 1 min; pt seen by pediatrician;
Client received Janssen brand COVID-19 vaccine during an outdoor drive-up mass clinic. Client was vaccinated by a volunteer, healthcare professional, before the client's age was verified. Client was not eligible to receive the vaccination at 16 years old. The Janssen brand of COVID-19 vaccine is indicated for individuals 18 years of age and older. Therefore, this vaccination was administered in error. Client waited for 15 minutes post-vaccination, per standard protocol, and no signs/sympotms of adverse reaction were observed immediately after vaccination.
Fever of unknown origin (FUO); This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (Fever of unknown origin (FUO)) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of unknown origin (FUO)). At the time of the report, PYREXIA (Fever of unknown origin (FUO)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
Started with a "sunburn" feeling on my lower right back, lasted about 5 days. Then developed small rash, itchy, on right side of back, waist, and stomach. That went about 5 days, very itchy, no pain, nothing pustular, just tiny itchy, red bumps. Then it spread to my left side, all of the same symptoms as on the right side. Finally went to PA and was told it absolutely was not shingles, but likely an allergic reaction. Was given prednisone and zyrtec to combat the rash.
Itchy throat, left arm tingling and sporadic numbness, tingling in both legs, injection sight pain, swelling, and redness, fatigue. All except the fatigue started a few minutes after the vaccine while I was still at the clinic (~1:05pm) fatigue started roughly 1.5 hours after vaccine (~2:30pm)
Information has been received from a registered nurse concerning a 6 year old female with no allergies or medical history who on 02/05/1999 was vaccinated with a dose of varicella virus vaccine live (oka/merck).  There was no concomitant medication.  On 04/09/2004, the patient experienced a case of varicella with a vesicular pruritic rash on her face, scalp, arms, legs, and trunk.  She was noted to be afebrile.  The patient had been exposed to a case of varicella at school prior to the start of symptoms.  She was treated with acyclovir, diphenhydramine hydrochloride, calamine, camphor, pramoxine hydrochloride, oatmeal baths, and ibuprofen or acetaminophen.  A product quality complaint was not involved. Additional information has been requested.
10 days after vaccination: redness, wamth, induration, itching at vaccination site for about 36 hours
Injection site swelling within 45 mins of injection. Swelling is red, painful, and warm to touch.  43 hours hours later swelling is about 2 inches wide and 1.5 inches in height, still red, warm, hard, and painful.
Approximately 20 minutes after the patients first COVID vaccine, patient began to get full body itching so was taken over to the emergency room where patient was given Benadryl and observed for an hour and then sent home.
He tested positive for COVID-19 on April 7 2021.  He qualified for monoclonal antibody therapy and presented for that therapy 4/9/2021.  After starting the infusion he developed sudden onset shortness of breath.  He is noted to be wheezing.  He was given Solu-Medrol and benadryl prior to transfer to ED.   Acute hypoxic respiratory failure in patient with recent Covid diagnosis with sudden worsening during monoclonal antibody infusion.  Differential includes allergic reaction/anaphylaxis, flash pulmonary edema, worsening Covid. Given the wheezing he was given a DuoNeb with no significant improvement but may be slightly decreased wheezing.  Patient was placed on BiPAP given concern for pulmonary edema and increased work of breathing.  We were able to titrate down the FiO2 to 40%.  He was transitioned to high flow nasal cannula.  Will admit to the hospital for further supportive cares given Covid and hypoxic respiratory failure.