chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow up information has been received from a physician and a healthcare professional, concerning a 26 year old female nurse, with no known allergies, who at 2:00pm, on 25-August-2006, was vaccinated IM with the first dose of GARDASIL (lot #654885/1412F). There was no illness at the time of vaccination. The physician reported that by nighttime, the patient experienced a burning sensation in her cheeks. The next morning, 26-AUG-2007, she developed an itchy rash on her cheeks; the healthcare professional added that on this date, the patient also experienced bruising on her face and pruritus. The healthcare worker confirmed the symptoms lasted for "about 1 week" and then resolved with the exception of the pruritus, which lasted for "more than 3 months." Follow up information stated that on 25-OCT-2006, the patient was vaccinated IM with the second dose of GARDASIL (Lot # 654885/1424F), and she experienced a recurrence of the itching rash on her face, pruritus, and bruising on her face. Again, the symptoms of itching rash and bruising on the face resolved in about 3 week. No further information was expected.
5 minutes after receiving immunization he became confused and foggy, complained of being faint, foggy, and having issues with his cognitive processing, he was also cool and clammy. He stated that he was feeling light headed and dizzy. He was monitored for about 5 more minutes in the pod and his symptoms continued . He brought back to the observation area, vital signs 119/78, oxygen 92% on room air and heart rate 63. He was given apple juice and applesauce and his mask removed, he was also placed on a liter. He was continued to be observed and follow up vital signs were 125/85, heart rate 66 @ 0849. Patient skin was less clammy and patient reporting symptoms improved. patient was able to move to sitting and standing position without any issues he was escorted to the site exit without incident.
red, swollen, itchy rash in spot of injection and all over legs and spots on ar
Extreme weakness Hypotension Transported by ambulance to Medical Center  Hydrated and monitored Home on March 11 still weak and hypotensive
24/7 dizziness, muscle twitching, internal vibrations, migraines, tinnitus, disequilibrium, Icy/hot scalp, chest pain, Pulsating headaches, numbness and tingling, blurred vision
Child started fever, vomiting hours after vaccine were given, child also has pain in (R) leg.
3 Blood clots in left leg (knee and calf) and now on blood thinners (Eliquis) as of 7/14/21. Will need to be on blood thinners for at least 3 months.  No family history of blood clots or previous issues.
fussy p/vax;mom could tell leg where vax given was bothering pt;p/putting pt down in crib overnoc mom heard pt crying;mom went to pt & found pt staring off in space;did not have a natural feeling to body lasted 2-3min
Zostavax accidentally administered instead of varicella.  Patient's mother indicated that patient experienced soreness at administration site that evening.
Headache and neck pain on left side for nearly three weeks; it is debilitating unless I take 3 ibuprofen twice and day, and shows no sign of relenting; exhaustion.
Headache, fatigue, cranky. Sore throat on 10/5/2022 and I tested, and it was positive. I started PAXLOVID last night and I also took ADVIL night. I don't feel too bad considering everything.
Received Pneumovax 23 0.5mL IM left arm. Unable to sleep on left arm 11/04/2003 due to pain.  Evening of 11/05/2003, examined her arm because "it hurt and felt heavy".  I was unable to move it.  Left arm distal to immunization site, red, swollen and warm to touch.  Did not use ice to area as recommended.
On 05/04/2022 I had my second vaccination. On 08/01/2022 I started to experience a visual aura. It was in both eyes. It was like a clear watery single wavy horizontal line and there seemed to be a brightness between the blur. It started being subtle to very strong where it was very blurry. This lasted for about an hour and then went away.
slight soreness at the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "slight soreness at the injection site".  Additional information: Patient age was reported as 60 (unit not available). "I was reminded of the Pfizer vaccine I received last year. I experienced no side effects other than slight soreness at the injection site."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional AEs; expired dose of RECOMBIVAX HB was administered on 11JUN2021; This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-JUN-2021, the patient was vaccinated with an expired dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) 1 time dose, lot # R034547, expiration date 09-JUN-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. No additional adverse event was reported.
Patient came in on 10/14 requesting a High Dose flu shot.  She was given Fluzone HD.  Patient came back in 10/29 and requested another flu shot.  She was given Fluad 65+.  She has not reported any adverse reaction, but wanted to document that patient received 2 flu shots.
Per recipient [at injection site] hard knot that is about the circumference of a golf ball and it is red. It is tender to the touch.
Intense Headache, fever & chills, Blood pressure very high 160/102 - had to go to ER and am now on several medications
sore arm in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of Injection site pain (sore arm in the injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced Injection site pain (sore arm in the injection site). At the time of the report, Injection site pain (sore arm in the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication included Ibuprofen
Fever 103, Myalgia and arthralgia ~18 hours post vaccinations with DTaP, IPV & MMR.  Examined 24 hours after shots, no focal findings.
No adverse event; Vaccine was administered post expiration date 13-JUL-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     Patient did not describe any medical history or conditions.     On 21-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022).    No concomitant medication was reported.   The expiration date was reported as 13-JUL-2022. Caller wanted to know what the stability of the vaccine after 13-Jun-2022.  No treatment information was reported.  This case contains information for patient 4 out of 4.   This case was linked to US-MODERNATX, INC.-MOD-2023-737010 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737010:
0.5 ml VARIVAX given in LUA, SQ, 0.5 ml Hep A given in LVL IM. Parent changed child's position to opposite leg in order to give 3rd vaccine. Child closed eyes slightly, eyes rolled back slightly, child went limp & stopped crying. Episode lasted approx. 10 seconds. Child began crying & responsive. Dr examined before MMR given.
Rash on her hands, knuckles, feet. Diagnosis - Erythema multiforme. Given steroids, for 3 weeks, 9 months ago. Now she has warts on hands and feet.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, frequency, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The pharmacist reported a patient received expired PNEUMOVAX23 on 11-JUL-2014. Pharmacist reported the PNEUMOVAX23 in question did not have any previous temperature excursions and the patient did not report any adverse symptoms. Additional information has been requested.
Pt was seen on 3/28/18 for a well visit and received her 2 month imms that day. She was well appearing with normal growth. Within 24 hours developed, lethargy, diarrhea, poor feeding and presented to the ED the next day with profound metabolic acidosis. She was intubated and admitted to PICU where she was diagnosed with a severe dilated cardiomyopathy. She remained intubated and on high levels of inotropic support for the first 1-2 weeks and then gradually improved. A very extensive workup was done. At time of discharge there was no identifiable etiology for what was a presumed acute and very fulminant myocarditis including extensive metabolic, genetic, and infectious etiologies. She has continued to improve over the last 10 months and is entirely normal developmentally at this time. She is currently being very slowly weaned off all cardiac medications. Her most recent echo is normal. She remains on carnitine supplementation which was started the PICU after she was found to have minimally reduced levels (medical genetics did not feel this was the etiology). Awaiting input to d/c that from genetics. She has not received further vaccinations since her two month shots.
Upper arm swollen; Elbow red and inflamed after receiving Pneumovax, Lot#0813X, Merck & Co.
Dizziness; Light headedness; Nausea; Vomiting; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (Dizziness), DIZZINESS (Light headedness), NAUSEA (Nausea) and VOMITING (Vomiting) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE, LOSARTAN and DOXAZOSIN for Blood pressure high.    On 15-Mar-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021 at 9:00 AM, the patient experienced DIZZINESS (Dizziness), DIZZINESS (Light headedness), NAUSEA (Nausea) and VOMITING (Vomiting). On 22-Mar-2021, NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. At the time of the report, DIZZINESS (Dizziness) and DIZZINESS (Light headedness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took treatment for vomiting and dizziness in emergency room.  Patient went to emergency room on 15-mar-2021 and discharged on the same day.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Reporter address was updated, patient demographics added, patient's medical history added, lab data added, vaccine onset time added, concomitant products were added, event onset time added, emergency room visit date  added, event outcome for all events  were updated from unknown to recovered with stop dates,  unspecified treatment medication was mentioned.
This spontaneous report was received from a Licensed Practical Nurse and refers to a 39 years old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 13-JUN-2016 at 7:00, the patient was vaccinated with a does of improperly stored VARIVAX, subcutaneous (lot number L025210, expiration date 07-JUL-2017, anatomical location and dose were not reported). It was reported that freezer was out of range for 4 hours, lowest temperature was 18 degree on 13-JUN-2015. The reporter stated that patient was called to come back for Varicella titer test. Concomitant therapies were not reported. No adverse effect was reported. This is  one of several reports from the same reporter source. Additional information has been requested.
Moderna has damaged me with a bad product; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (Moderna has damaged me with a bad product) in a  patient of an unknown age and gender 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 VACCINATION COMPLICATION (Moderna has damaged me with a bad product). At the time of the report, VACCINATION COMPLICATION (Moderna has damaged me with a bad product) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications, Lab data details and Treatment information were not provided.
Headache; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Fever) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown and MYALGIA (Body aches) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  The patient's mother reported that he was told not to take Ibuprofen at the time of vaccination.
Heart palpitations and dizziness. Bradycardia. Resting heart rate dropped as low as 40 beats per minute.
Everyday-fatigue 25th Jan 2021-HA @1500, pain at injection site 26th Jan-0930-shaking uncontrollable-she states, COLD, body aches, HA, nauseated, sweating, muscular & joint pain 27th Jan-decreased symptoms some, intermittent SOB, chest pain, rt & left sides 28th Jan-SOB-continues, -she has a history of seasonal allergies, Told to go to the ER if her SOB & chest pain gets worse.  Took Tylenol & Motrin for the body aches, HA, joint pain and discomforts Can't walk-gets fatigued-even short distances
PATIENT'S ARM HAS A RED, SWOLLEN, WELT-LIKE CIRCLE AROUND WHERE THE PATIENT RECEIVED THE VACCINE. THIS REACTION APPEARED A WEEK AFTER THE VACCINE WAS GIVEN.
ActHIB is accidentally given with sterile water; Initial information received on 14-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 15 months old male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] and reported that Act-Hib is accidentally given with sterile water.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  On 09-Aug-2019, the patient received a dose of suspect 0.5 ml HIB (PRP/T) VACCINE lot UJ079AAA and expiry date: 02-Oct-2020 via intramuscular route in the left thigh.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was unknown if the patient had any adverse 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 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.  List of documents held by sender: none.
Erythema - started in first 5 minutes - continued to grow - painful/raised 4 days later now resolving - MD recommended ADVIL/heat.
Heart felt like it was pounding so hard it would come out of my mouth. Call clinic and was told to observe and come in if worsened. It was off and on and eventually went away with a periodic pounding here and there.
16FEB95 devel blotchy lighted non itchy rash neck to abdo; sl raised; not ill;
Vaccination failure; Shingles; Rash on the back of his right shoulder; Some Discomfort; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On 11th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix and 56 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and discomfort. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash and discomfort were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix. It was unknown if the reporter considered the discomfort to be related to Shingrix.  Additional details were provided as follows: The reporter indicated that approximately eight weeks after receiving the second dose of the Shingrix vaccine, the patient developed a rash on the back of his right shoulder with some discomfort. The patient was started on the generic formulation of Valtrex 1 gram every 8 hours, and he took this for four days.   The patient stopped the product on the day of reporting because it upset his stomach, it made him feel fatigued, and caused him to not think clearly.  The event rash has resolved and there was no discomfort at the time of reporting. The reporter did not consent to follow-up. The reporter would not provide any additional information  The reporter wanted to speak with someone in Medical Information.  The manufacturer of the generic formulation of Valtrex and he was counseled to contact the manufacturer to let them know his experience while on the product.
injection site red; injection site itchy; no appetite; body aches; headaches; fatigue; shaking uncontrollably with chills; shaking uncontrollably with chills; nausea; bad heartburn; injection site sore; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking uncontrollably with chills), CHILLS (shaking uncontrollably with chills), NAUSEA (nausea), DYSPEPSIA (bad heartburn) and DECREASED APPETITE (no appetite) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (tested COVID-19 positive on 25 Jul 2020.) on 25-Jul-2020.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced TREMOR (shaking uncontrollably with chills), CHILLS (shaking uncontrollably with chills), NAUSEA (nausea), DYSPEPSIA (bad heartburn) and INJECTION SITE PAIN (injection site sore). On 14-Feb-2021, the patient experienced DECREASED APPETITE (no appetite), PAIN (body aches), HEADACHE (headaches) and FATIGUE (fatigue). On 16-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE PRURITUS (injection site itchy). At the time of the report, TREMOR (shaking uncontrollably with chills), CHILLS (shaking uncontrollably with chills), NAUSEA (nausea), DYSPEPSIA (bad heartburn), DECREASED APPETITE (no appetite), PAIN (body aches), HEADACHE (headaches), FATIGUE (fatigue), INJECTION SITE ERYTHEMA (injection site red), INJECTION SITE PRURITUS (injection site itchy) and INJECTION SITE PAIN (injection site sore) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant products information was not reported.  Treatment information included taking unspecified antacid at 4am.   This case was linked to MOD-2021-029299 (Patient Link).
This spontaneous report as received from a licensed practical nurse refers to a 16 year old male patient. Medical history and drug reactions/allergies were not reported. On 15-NOV-2012, the patient was vaccinated with GARDASIL lot # J007354 expiry date 20-FEB-2016 first dose, 0.5 ml, intramuscular in the left deltoid. On 19-NOV-2013, the patient was vaccinated with GARDASIL second dose, (lot, dose and route not reported). Concomitant medication was not reported. On 19-NOV-2013, the patient was vaccinated with improperly stored GARDASIL, this was the patient second dose in the series. No adverse effects. Additional information is not expected.
Injection site hard and painful. Rash surrounding injection. Red, hot and hard. Noticed the rash, redness, and hardness of tissue surrounding the injection site and the injection site as well at 6:30 am on 2/01/23. Vaccine was given at appointment on 1/31/23 11:00am.
headaches every day. Take ibuprofen, naproxen and Toradol.  Toradol has helped some but the others haven't helped at all.  Not sleeping- I take promethazine, trazodone and they haven't helped at regular doses. I've increased the doses and it has helped increased nausea.