chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # M024678 for prophylaxis. Concomitant therapies included sterile diluent(MERCK STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Additional information has been requested.
right thigh swelling, redness, tenderness for 2 days, muscle aches at injection site. nearly the size of half the right thigh
Developed tingling in upper lip 20 min after vaccination.  Progressed to itchiness and hives on her back/chest.  Felt that her upper and lower lips were burning.
This spontaneous report as received from a medical assistant refers to unspecified number of patients who on an unknown date received a dose of hepatitis a vaccine, inactivated (manufacturer unknown) (lot # not reported) (dose and route not reported) and a dose of MENACTRA. (On an unknown date the patients experienced fainting. The outcome of fainting was unknown. This case is linked to MARRS 1305USA013836. Additional information has been requested.
Patient came to the emergency department with complaints of feeling unwell increased shortness of breath increased cough due to COVID-19. Patient states he was diagnosed with COVID-19 on August 19, 2021.  The patient was supposed to be having an outpatient infusion starting today but missed the appointment secondary to being here.  States when he takes a deep respiration has significant coughing fit and has had intermittent fevers. The patient was in the hospital for 10 days before being discharged to a skilled nursing facility.
Approximately 2 days after shot, got a rash in upper arm. At 11 days out rash is worsening, itching noted, hard bump and redness. Rash extends 12*13.5cm
Symptoms began approx. 5 hours after the vaccine injection. Sharp 'poking' pain at the back of the neck. Symptom was intermittent over the course of approx. 10-15 minutes. No other obvious cause. Patient did not experience symptom any time prior to vaccine, and once the symptom resolved it did not recur at a later time or day.
1/7/2023 I felt feverish and had around 100 degree fever. I took an at home COVID test and it was positive. I went to urgent care where I had another positive COVID test. I was told to isolate and was prescribed LAGEVRIO. I began taking the medication that day. I remained feverish for about 3-4 days. On the fifth day was the first day I was fever free, but I felt fatigued. I isolated another five days. I took TYLENOL.
Swollen,  knot, warm, w/pinkish circular skin discoloration around the injection site about 3" in diameter.
Chest wall mobile nodular lymph node 2x3 cm ultimately.  Followed closely for 3 weeks and ultimately resolved.  Was about 3-4 cm below R axilla in the same arm MMR and Varicella given.
After receiving the 2nd shot in the SHINGRIX, I developed a full body rash with huge red spots that hurt and and the skin broke open and peeled and drained fluid. I saw my dermatologist 4 times and was treated with creams. She did a skin biopsy and it showed Eczema. It has lasted for more than 2 -3 months. She gave me a Hydrocortisone injection. The spots hurt and are drying up but itch a lot.
Dizziness, breathing difficulty, back pain, increased heart rate. Called 911. Transferred per ambulance to Hospital. In transit received Benadryl.
This spontaneous report as received from a 65 year old female consumer reporting on herself. Medical history and concurrent conditions were not reported. In February 2014 (reported as 16 or 17 of February 2014), the patient was vaccinated with a dose of ZOSTAVAX in the left arm, 1 shot (dose, strength, lot number and expiration date was not reported). Secondary and concomitant therapies were not reported. Consumer report that even though she got ZOSTAVAX vaccine she got a mild case of shingles on 18-FEB-2014 (reported also as a few days later). Consumer started to felt pain on back of head area and also the ear area. Patient pay her physician a visit, who advised she was having a mild case of shingles. The outcome of shingles was not reported.
Left arm was sore on 01/13 Diarrhea started on 01/14, along with nausea
Pt felt weak and lightheaded after vaccination.  She was seated at the time symptoms presented.  After losing consciousness, she was assisted to the floor with lower extremities elevated. Pulse 44. Within a minute she regained conscious; color remained pale with diaphoretic for approximately 5 minutes. Patient refused to eat or drink after event and planned to eat outside of facility.
Vaccinator delivered hypo needle into the patient's muscular site right deltoid, after swabbing with alcohol pad. Upon pushing the vaccine in, almost immediately the vaccine contents squirted out the side of the connection site of the hypo needle and the syringe. Appeared that most of it squirted out.
diarrhea; stomach pain; swelling; Rash aggravated; Vaccination site induration; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pain), SWELLING (swelling), RASH (Rash aggravated) and VACCINATION SITE INDURATION (Vaccination site induration) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004B21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, NORGESTREL (CRYSELLE) for Birth control.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pain), SWELLING (swelling), RASH (Rash aggravated), VACCINATION SITE INDURATION (Vaccination site induration), PYREXIA (fever) and NAUSEA (nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Stomach pain, at a dose of 1 dosage form; PARACETAMOL (TYLENOL) for Stomach pain, at a dose of 1 dosage form and ONDANSETRON for Stomach pain, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pain), SWELLING (swelling), RASH (Rash aggravated), VACCINATION SITE INDURATION (Vaccination site induration) and NAUSEA (nausea) outcome was unknown and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (Inconclusive) 101degree Fahrenheit.         Action taken for Moderna COVID-19 Vaccine was not applicable.   This case was linked to MOD-2021-114684 (Patient Link).
1.  Headache within 1 hour after shot.  Severe after 12 hours.  Still light at 48 hours. 2.  Muscle aches within 8 hours.  Still light at 48 hours.  Peaked at 24 hours after shot. 3.  "Glans/local ache' (lower back/kidneys and testicles) within 8 hours.  Testicle ache stopped with 36 hours after shot.  Kidney/lower back ache still lightly present at 48 hours. 4.  Shaking/Chills.  Started 12 hours after shot.  Went from light to extreme within 30 minutes.  Shaking and shivering uncontrollably.   To the point I would not have been able to dial 911 for help if I had needed.   No matter what I did I could not get warm or stop shaking.  Extreme shaking lasting about 2 hours.  In about 2 more hours shaking subsided and stopped.  So shaking stopped around 16 hours after shot.  Chills continued until around 36 hours after shot. 5.  Cold sweat/Fever.  Sweating starting 11 hours after shot.  Lasting until about 36 hours after shot.  For fever, Unknown how high it was as I was too busy uncontrollably shaking to take my temperature.  Fever remained for about 48 hours in low grade form EXCEPT for hours 11 through 18 after shot - I am sure it was very high due to headache, chills, shaking, etc at that time.  Basically, for most of the 2 days, it felt like the flu.  But for 6 hours, (hours 11 through 17 after receiving the shot), it was the sickest I can recall beings in decades.    Will 'click' I have recovered below in item 20.  But not 100% back to normal yet.  90% back to normal would be a good current 'level'.  Expect to feel 100% again tomorrow or the next day based on recovery rate.
Severe ringing of the ears, it woke me up from a deep sleep. I needed to play music to direct me from the nose. Next day my ear drum was throbbing, very painful. I had arm pain at the site for three days. Ringing reduced by 80% in three days. Day four my ring finger was irritated, in did not think much of it. Week one and two i had fatigue and brain fog. Last week and still this week i have severe urticaria of both hands. My ring finger left hand front and back is red, open, weeping and scaley. Medial pinky same. Back of hand huge weeping welts.  Medial pinky on left same skin problem. All are on the proximal phalanges except for the ring finger, that is on all phalanges. Back of right hand and wrist has welts and weeps. I took pictures. Two days ago it spread to my face.
pain in groin; This spontaneous case was reported by a non-health professional and describes the occurrence of GROIN PAIN (pain in groin) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE for an unknown indication.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GROIN PAIN (pain in groin). At the time of the report, GROIN PAIN (pain in groin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This spontaneous case was reported by a  and describes the occurrence of GROIN PAIN (pain in groin) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced GROIN PAIN (pain in groin). At the time of the report, GROIN PAIN (pain in groin) outcome was unknown.       Patient take Amoxicillin and Prednisone as a Concomitant medication.     Reporter did not allow further contact
The patient received an MMR and had difficulty breathing, skin rash, and itching.  She stated immediately after the shot she had a burning feeling on her nose.  After a few hours the shortness of breath and tight chest started.  She had itching on her chest, legs and a rash on chest only.  She admits to her lips and tongue feeling tight.
none, 9/25/09 Autopsy report received - Cause of Death - Probable Partial Mechanical Obstruction of Airway by Ectopic Thymus. By history baby developed "noisy breathing" by evening. Found prone and unresponsive. Only explanation for abnormal breathing sounds was a benign growth, an extra thymus gland, growing in the wrong place next to his trachea.
She received her first dose of the GARDASIL 9 series on 10-AUG-2019, and shortly after she found out she was pregnant/she thinks he pregnancy gestation is about one week; This spontaneous prospective pregnancy report was received from a a female patient of unknown age, who was reporting on herself. The patient's concomitant therapies included an unspecified hepatitis a virus vaccine.  The patient had no pertinent medical history or drug reactions/allergies.  On 19-AUG-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1.5 milliliter for prophylaxis (route of administration, anatomical location, lot number and expiration date were not provided).   The patient's estimated date of LMP (last menstrual period) was 19-AUG-2019. On approximately 05-SEP-2019 (reported as "about one week"), the patient became pregnant with EDD (estimated date of delivery) of 28-MAY-2020. On 09-SEP-2019, she patient carried out a pregnancy test, which result was positive. No treatment was given and the patient did not seek medical attention.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to 12-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 30-DEC-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009943, expiration date: 26-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry:  devicelotnumber: S009943; expirationdate: 26-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
got her first dose about 4 months ago and did not get the second dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got her first dose about 4 months ago and did not get the second dose) 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 PRODUCT DOSE OMISSION ISSUE (got her first dose about 4 months ago and did not get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got her first dose about 4 months ago and did not get the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRODUCT DOSE OMISSION ISSUE (got her first dose about 4 months ago and did not get the second dose) to be not applicable.    Treatment product information was not provided. Concomitant product use was not provided by the reporter.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: significant follow-up appended, as reporter information added as HCP
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. In July 2014 the patients were vaccinated with PROQUAD (Merck) (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Effects: painful rash along right breast several hours after receiving vaccination later that night, she provided self care and applied Caladryl. The rash did not weep or blister and it dissipated after one week. She notified her PCP who agreed with self care and to avoid getting second dose.
Pt. recv. vax. exp. arm Erythematous, swollen. Suspect thimerosal preservation.
@0906 Pt alerted nurse of SOB with chest discomfort. Nurse approached patient and alerted NP and EMS for further assistance. Pt was seated and assisted to lay down on mat. Pulse ox read saturation of 98% HR 112. Site lead called 911. @0908 NP assessed client. No diaphoresis, mild pallor, denies nausea, no fever, no chills, denies blurry vision, denies dizziness, denies swelling of the throat. No hx of medical issues, no prescribed medications, Hx of surgery for appendix, denies drinking energy drinks only coffee. BP 147/93 HR 93 @0910 NP assessing lung sounds. Lung sounds clear. Oxygen saturation 100% BP 147/93 HR 111. Wife states husband was feeling very anxious prior to vaccine. Patient reports that he has had this happen before and reports that he feels his blood pressure go down. Reports seeing clearly with no dizziness.  @0913 Pt reports same situation happened 3 months ago and happens about 1 time year when he is running. EKG shows normal sinus rhythm. BP 147/93 HR 111  @0914 Pt states feeling better. Pt says has not gone to doctor when this happened in past. Pt reports still feeling anxious. BP 163/93 hr 109. Blood pressure repeated with result of 148/89 Hr 104. Patient does not know what his baseline blood pressure is.  @0917 NP endorsed care to paramedic. PT refused to be taken to hospital. PT left ambulatory with AMA signed with fire department.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020). On 5th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 6th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On 9th April 2018, the patient experienced injection site itching. The patient was treated with BENADRYL. In April 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the injection site itching and injection site erythema were unknown. The reporter considered the injection site pain, injection site itching and injection site erythema to be almost certainly related to SHINGRIX. Additional details were reported as follows: At 15:30 hours, the patient received SHINGRIX in left deltoid. The next day after receiving SHINGRIX, the patient noted some pain and redness at the injection site. The patient was resolved, but the redness persisted and spread. Four days post vaccination it was described as an area approximately 6 inches long and 2 inches wide. The patient began to experience itching around the injection site. At the time of reporting, the patient called the pharmacy where SHINGRIX was administered and reported that he had self medicated with BENADRYL. The reporting healthcare professional (HCP) stated that, the patient was told that, he might continue with BENADRYL and also take TYLENOL if required.
Information has been received from a LPN concerning an 8 year old white female who on 01/30/1997 was vaccinated with a dose of varicella virus vaccine, live. Additional immunization on 08/14/2000 included a 2nd dose of MMR administered SQ in the LL, a 5th dose of DTaP (INFANRIX) administered IM in the RL and a 4th dose of poliovirus vaccine inactivated administered SQ in her LL. On 04/22/2004, the pt was diagnosed with a severe case of chickenpox. The pt had pox in her throat, ears, and nose. She also had a fever, body aches, and photophobia. The pt's tx was rest and antipyretics. It was noted that the pt had greater than 50 lesions. No additional information was available at the time of the report. Unspecified medical attention was sought. There was no product quality complaint . There were no adverse event following prior vaccinations of the pt or siblings. Follow up information from a physician indicated that on 04/22/04, the pt presented with a rash "over entire body". It was noted to be possible chickenpox. The child had a very sore throat and an increased temperature. The mother was also concerned about the pox in the pt's throat and ears. There were numerous red maculopapules everywhere. There was also some clear fluid filled vesicles. There was also a red vesicular lesion on the post palate. No nodes were noted. Her lungs were clear to auscultation. The pt's heart had a regular rhythm and no murmur. The rapid strep test was -. The strep culture was (-). The pt was Dx with chickenpox and a sore throat. Additional information has been requested.
Case number PHEH2016US023765, is an initial spontaneous report received from a pharmacist on 14 Sep 2016. This is also a quality complaint report (QA reference number: 1016892). This report refers to a 26 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUCELVAX Quadrivalent (batch number: 185284) at a dose of 1 ml, intramuscularly on 14 Sep 2016. It was reported that, patient was re vaccinated after partial dose was administered in error with a faulty pre filled syringe on 14 Sep 2016. No adverse event was reported following this medication error. The case was assessed as non serious by the pharmacist. QA investigation is in progress. Follow up information was received from Quality assurance department 11 Oct 2016. QA reference number added.
they have administered FLUZONE QUADRIVALENT to a 65-year-old patient instead of a FLUZONE HIGH DOSE QUADRIVALENT (with no reported adverse event); Initial information received on 02-Oct-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 65 years old female patient who have been administered influenza quadrival A-B vaccine [fluzone quadrivalent] instead of a influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient of 65 year old received a dose of suspect influenza quadrival A-B vaccine Suspension for injection (lot number, strength, dose, expiry date not reported) via unknown route in unknown administration site as immunization instead of influenza quadrival A-B high dose HV vaccine (with no reported adverse event) (wrong product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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 interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
PT NOTICED RED/WARM TO TOUCH ON HER ARM AT INJECTION SITE THIS AM. PER PT LOCAL REACTION STARTED PROBABLY AFTER MIDNIGHT AND SHE NOTICED IT THIS MORNING. PT DID NOT COMPLAIN OF ITCHING. PT WAS ADVISED TO USE HYDROCORTISONE, ICE PACK AND IF NEEDED TO TAKE BENADRYL. PT WAS ADVISED TO FOLLOW UP WITH DR IF SYMPTOMS WORSEN.
Fevers, chills, myalgias, injection site pain, muscle weakness, intermenstrual spotting