chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient recieved diluent portion not the powdered portion with no adverse event; Initial information received on 07-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist and consumer non health care professional via Medical Information number: 00802360.  This case involves an unknown age and unknown gender patient who was recieved diluent portion not the powdered portion DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to inappropriate reconstitution technique (latency: same day).  At the time of reporting, no adverse event was reported.   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.
Redness and swelling at site, approx size little bigger than a quarter, pt reports painful, area was marked and recommended TYLENOL and ice to site. Patient to report back if gets worse.
Right arm was red and swollen; complains of having had pain in chest wall and along arm pit too. Pt is improving.
This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 50-year-old female patient who received Shingles vaccine for prophylaxis. On 3rd December 2018, the patient received Shingles vaccine. In December 2018, less than a week after receiving Shingles vaccine, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown. It was unknown if the reporter considered the dizziness to be related to Shingles vaccine. Additional details were reported as follows: The patient received shingles shot the day before reporting. The patient experienced some mild dizziness. The patient asked how long would this persist.
No adverse event; Moderna Bivalent vaccine was administered Beyond use by date to 6 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients).    No concomitant product was reported. No treatment information was reported.
Moderna COVID- 19 Vaccine EUA: Patient presented to emergency department (ED) one day after receiving  vaccine  reporting dizziness, headache, fever, chills, myalgias, cough, abdominal pain, and congestion since receiving immunization.  Initial vital signs stable except blood pressure 164/83 mmHg. Patient appeared unwell and oxygen saturations dropped to 86% but spntaneously recovered. Transferred to another ED for higher level of care. Adminsitered IV fluids and antiemetics, observed,  symptoms improved, and discharged to home medically stable.
Date of booster 6/20/2022 at 12:30 pm.  Reports woke up on 6/21/2022 at 0500 with left mid back ache "feeling internal."  Report felt tight and firm.  Has been applying OTC icy hot and icing without relief.  Referral to PCP or for further evaluation and work up due to symptoms not improving over the last 7 days.  Continues to complain of "positional internal left back pain" without relief with OTC conservative management.
I had the 1-shot vaccine on Saturday. By Sunday I was experiencing a HSV outbreak. Typically I can feel an outbreak coming. This one came with no warning and is very painful.
02/18/21 0645 - non injury fall 0930 - non injury fall 1635 - Injury fall - fractured pubic bone Sent to ER -> Rehab
This case was reported by a consumer via call center representative and described the occurrence of blood glucose increased in a adult female patient who received SHINGRIX. On 7th May 2018, the patient received SHINGRIX. On 7th May 2018, less than a day after receiving SHINGRIX, the patient experienced blood glucose increased On an unknown date, the outcome of the blood glucose increased was unknown. The reporter considered the blood glucose increased to be unrelated to SHINGRIX. Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. On 7th May 2018 12:00, the patient received SHINGRIX. The patient noted her blood glucose number was high (300 units not reported). The patient insisted that, the SHINGRIX vaccine had nothing to do with high blood glucose, but her eating a candy bar did. The reporter did not wish to continue the report. No additional information was provided.
A spontaneous report was received from a nurse concerning ten patients, who received lower dose for the second dose (0.3 mL dose instead of a 0.5 mL dose) of Moderna's COVID-19 vaccine (mRNA-1273).  The medical history of the patients was not provided. No relevant concomitant medication was reported.  On an unknown date, the patients received their second of the two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On the vaccination day, approximately ten patients received a lower dose for the second dose. The patients were administered with 0.3 mL dose instead of a 0.5 mL dose accidently. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.    The outcome of the event, lower dose for the second dose (0.3 mL dose instead of a 0.5 mL dose), was resolved.; Reporter's Comments: This report refers to a case 10 patients of accidental underdose for mRNA-1273 (lot # 024M20A) with no associated AEs reported.
It was reported post vaccine pt broke out in hives. In follow-up, the physician reported the pt had facial and stomach hives which started on 11/15/2000 at 9:30. The pt recovered from the facial and stomach hives. Unspecified medical attention was sought. Additiona info has been requested.
No immediate symptoms other than a sore arm at injection site that lasted for about 24 hours.  At approximately 36 hours I  noticed a ringing in my ears and blurred vision with pressure behind my left eye.  Went to eye doctor for the second time this year and she could find no abnormalities other than more floaters, which is consistent for my age.  Went to Audiologist to have my hearing tested.   Confirmed it was tinnitus and during hearing test the audiologist had to "pulse" the tones so I could hear them.  Tinnitus is in both ears, sounds like a white noise machine and has not subsided 8 months later.  Went to my MD in October and she suggested I report my symptoms, but I didn't at the time.  She recommended a brain MRI, which did not show anything significant, but since the vision issue has not subsided the radiologist suggested an MRI of the optic nerve, which is scheduled for mid January 2022.  She also referred me to a neurologist and the first available appointment is also mid January 2022.  Saw the NP at the clinic today and she also suggested I submit my symptoms and I will follow up at the clinic after the eye MRI and the neurologist appointment.  Tinnitus is getting louder.
3/3/2021  6pm approximately Angioedema (Face) Hives (between the eyes & forehead) Extreme Fatigue 3/9/2021    Swelling going down   Drinking a lot of water & resting
I had a really bad sore throat and fatigue. I decided to take a rapid test and it came back positive. I decided to contact my doctor and did a PCR test and it came back positive. She advised I should take Paxlovid which did help. After 4-5 days I felt better.
PATIENT GOT MODERNA FOR HIS FIRST VACCINE SERIES ON 9/17/21. WE ACCIDENTALLY GAVE HIM PFIZER FOR HIS SECOND DOSE TODAY 10/18/21.
No known adverse effects; A patient received a dose of M-M-R II via the intramuscular route in error; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concomitant therapy included sterile diluent. No information was provided regarding pertinent medical history and drugs reactions or allergies.   On 28-MAY-2019, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) by intramuscular route (Incorrect route of product administration), lot #R015163, expiration date of 29-MAY-2020 (strength, dose and anatomical site of injection were not reported).   No adverse effects was known.
Extreme fatigue, headache, severe neck pain and stiffness, nausea, joint pain, muscle pain, chest pain, abdominal pain
Extreme pain in arm throughout night/couldn't sleep. Raised red hot where injection was placed. I iced the area several times and took Advil. Reported information to Dr.'s office. Slight red still remains after almost 2 weeks?!?....Itchy at injection site during 2nd week.  Odd!
Exhaustion; This is a spontaneous report from two contactable consumers via the Pfizer representative. An 80-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unknown date via an unknown route for Covid-19 immunization. Medical history and concomitant drug were not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization and experienced similar reaction of exhaustion and stomach upset for about a day after the first dose. He received his second dose on "Saturday" (unknown date) and experienced exhaustion afterwards. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Flushing of face and Severe headache.  Lasted for about 1 hour.   Headache repeated approx 2 hours later with less severity.     No other symptoms other than itching at site of injection later in the evening. Duration approx 1 hour.
Left Chest/sternum pain, heart palpitations, left arm pain and numbness, upper back pain
3 cm diameter swelling and erythema at site of Varivax injection 24 hours afterwards.  No pain, no fever.
Incorrect second dose.  No immediate reaction.  Observed for 30 minutes.  Evaluated by doctor. 1st dos
Patient has experienced extreme fatigue, headache, dizziness, weakness, joint pain, muscle pains, shortness of breath, chest pains, neck pains,  brain fog. Primary care physician referred her to a neurologist, rhuematologist, and a cardiologist and all exams, blood work, and test have come back normal. No one know how to go about treating symptoms.
Pt cam in on Saturday 8/21/21 to receive first COVID shot around 10am. After the shot, she remained in store for 15 to 20 minutes leaving around 10:20am and reports feeling fine until she drove home and when she got out of her car she reports becoming extremely dizzy and that the feeling did not begin to resolve until between 4 to 5pm that evening [Approx. 5 to 6 hours]. She did not faint during this time period . She reports no known allergies and has never had any reaction to any previous vaccine. She has had no further dizzy spells since then as of 8/24/21 @11:15am when she reported the incident via phone.
felt really lethargic and unresponsive; no energy; no emotion; body temperature 1.2° higher than usual/fever; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt really lethargic and unresponsive), ASTHENIA (no energy), EMOTIONAL POVERTY (no emotion) and PYREXIA (body temperature 1.2° higher than usual/fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022BZ1A and 016CZ1A) for COVID-19 vaccination.     The patient's past medical history included Shoulder operation (reconstructive surgery he had on the left shoulder). Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM for Hypothyroidism, FEXOFENADINE, LOSARTAN POTASSIUM, ESCITALOPRAM OXALATE, APIXABAN (ELIQUIS) and FLUVASTATIN SODIUM for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced LETHARGY (felt really lethargic and unresponsive), ASTHENIA (no energy), EMOTIONAL POVERTY (no emotion) and PYREXIA (body temperature 1.2° higher than usual/fever). On 03-Jun-2021, LETHARGY (felt really lethargic and unresponsive), ASTHENIA (no energy), EMOTIONAL POVERTY (no emotion) and PYREXIA (body temperature 1.2° higher than usual/fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Body temperature: 98.2° (High) 98.2° (body temperature was 1.2° higher than usual). On an unknown date, Body temperature: 96.9°f - 97°f (normal) His normal body temperature was 96.9°F - 97°F.         Concomitant medication of the patient also included Sunlife silver which the patient was taking as multivitamin.  The patient received the vaccines on left arm, which was the non-dominant arm.  The patient didn't experience any symptoms after receiving the first dose and stated it was like a walk in the park.  After the second dose, the patient had no problem at all on the day he received the shot, but the next day, he had some mild symptoms. The patient didn't experience pain and didn't consider this situation real negative. The patient went to therapy because of a reconstructive surgery which he had on the left shoulder and this therapy was prescheduled.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-424377 (Patient Link).
Arm tenderness became worse each day. By 48 hours after shot unable to lift arm, feels like shooting nerve pain from upper arm down to wrist.
4 days after administration of Pfizer COVID19 vaccination patient developed shortness of breath and pleuritic chest pain on 6/12/21 evening. Patient came to Emergency Room overnight on 6/13 and was identified to have elevated troponins indicative of myocarditis.
Child presented to office on 8/3/01, 2 days after vaccination with left upper arm swelling and redness from shoulder joint to elbow joint.
Headache; joint pain; nausea; fatigued; fever; felt strange; low blood sugar( weak); This is a spontaneous report from a contactable consumer (patient) reported for herself. A 52-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown), via an unknown route of administration in right arm on 12Mar2021 at 15:15 (at the age of 52-years-old) as dose 2, single for COVID-19 immunization at workplace clinic. The patient's medical history included type 2 diabetes. She had allergy from bee stings and sulfa. Concomitant medication included metformin and Osteo Bioflex taken for an unknown indication from an unknown date (these medications in two weeks). No other vaccine in four weeks. The patient received succinylcholine and sulfamethoxazole as past drug and developed allergy. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown), via an unknown route of administration in left arm on 18Feb2021 at 15:15 (at the age of 52-years-old) as historical vaccine as dose 1, single for COVID-19 immunization. On 12Mar2021 at 15:15, the patient experienced headache, joint pain, nausea, fatigued, fever for 2 days. On third day still had a headache but no fever. About 20 minutes after the injection the patient felt strange, like a feeling like low blood sugar (weak). She was ok enough to drive home. She slept for about 15 hours. No COVID prior vaccination. No COVID tested post vaccination. No treatment for event. The outcome of the event fever was recovered, while the outcome of remaining events was recovering.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Patient had Varivax booster 2 weeks ago 3 days ago got Varicella lesions on lateral thigh - then today got erythema multiforme lesions on arms, legs, hands, feet.
This spontaneous report as received from medical assistant refers to a 19 year old female patient. The patient was vaccinated with the first, the second and the third dose of GARDASIL (dose, route and lot number were not reported) in 2008, in 2009 and 25-JUN-2013, respectively. The patient's outcome was not reported. Additional information has been requested.
Patient received a dose of vaccine from a vial that was mixed on 12/17/21.
Shingles - presented first as nerve pain in right arm and then after 23 days a skin reaction of sores/blisters appeared. Prescribed an anti-viral (acyclovir) and nerve pain reliever gabapentin
Pt vaccinated w/1st & 2nd dose of vax on 8JUN90 & 24JUL90 respectively; vaccine was found to be outdated; In NOV90 pt given 3rd dose of vax; f/u serology results revealed positive titer for Hepatitis B surface antibody;
Sensation you get before breakout; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient had the first shot of Shingles vaccine and had the sensation before breakout. The patient could not get the second shot until it was clear. The follow-up could not be possible as no contact details were available
Pt who was exposed to grandson who was vaccinated with varicella virus vaccine live experienced shingles. The pt was not recently exposed to anyone who had received varicella virus vaccine live, it was greater than six months prior to her herpes zoster outbreak.
This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 21-year-old female patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult and ENGERIX B adult (batch number 92M2J, expiry date 3rd November 2017). On 24th September 2014, the patient received the 1st dose of ENGERIX B adult. On 28th January 2015, the patient received the 2nd dose of ENGERIX B adult. On 31st July 2015, the patient received the 3rd dose of ENGERIX B adult. On 2nd November 2015, 1 year and 39 days after receiving ENGERIX B adult, 278 days after receiving ENGERIX B adult and 94 days after receiving ENGERIX B adult, the patient experienced therapy non-responder. On an unknown date, the patient experienced drug dose administration interval too long, drug dose administration interval too long, and incorrect product storage. On an unknown date, the outcome of therapy non-responder, drug dose administration interval too long, drug dose administration interval too long and incorrect product storage were unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B adult, ENGERIX B adult and ENGERIX B adult. Additional details provided were as follows: The healthcare professional reported a case (US2015GSK160472) for unspecified number of patients about lack of immunity to ENGERIX B therapy. But then the reporter asked if the vaccines were exposed to lower than recommended temperatures could that affect the vaccines. The reporter stated that, the vaccines might have been stored improperly. The reporter does not know if it was due to improper storage or not. The reporter did not have any information on other patients those received the vaccines and showed no immunity. The reporter only had information on the last patient concerned in this case. On 24th September 2014, the patient received the 1st dose of ENGERIX B adult. On 28th January 2015, the patient received the 2nd dose, which led to lengthening of the vaccination schedule. On 31st July 2015, the patient received the 3rd dose, which again led to lengthening of the vaccination schedule. On 2nd November 2015, 404 days after receiving 1st dose of ENGERIX B adult, 278 days after receiving 2nd dose and 94 days after receiving the 3rd dose, the patient underwent blood test for hepatitis B antibody and it showed no immunity (negative). Thus, it caused the patient to be a non-responder to therapy. The reporter only had lot number with an expiry date for 3rd dose.
This spontaneous report as received from a consumer refers to a 50 year old female patient with immunology test normal. On 21-JUN-2017 the patient was vaccinated with ZOSTAVAX, .65 ml, subcutaneous for prophylaxis. On 2017 the patient experienced herpes zoster.  The outcome of herpes zoster was reported as not recovered/not resolved.
Fever, Chills, overall aching, light headedness, dizziness, tiredness. I was sicker than i have ever been in my lifetime. It was over in 2 days
On Sunday an Monday after the shot I had muscle weakness. I felt fine by the end of Monday night, but then on Tuesday morning I started to feel weird brain surges and getting shaky like I was on drugs or something. I went to the ER and they said it's vaccine related and that I just wait it out.
next day with headache, nausea, dizziness, tachycardia up to 170 for about 30 minutes. symptoms started the morning after the vaccine about 24 hours later and then resolved within that next day.
Pt recv vax on 2/18/99; on same day pt exp sore left shoulder x 2 wk; tx=hot compress, Tylenol