chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The next day, I just barely bumped my left hand and I got a hematoma about the size of a large grape. My hand swelled up and turned black and blue for about 3 weeks.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 44-month-old female. Neither the patient's medical history nor the concomitant medications have been reported for this patient. The product expired on 25-Dec-2011. On 05-Jan-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was obtained on 26-Mar-2012: reporter's information and no late occurring adverse events were reported for this patient.
flu sx, nausea, diarrhea, abdo pain, dizziness, malaise;
Patients upper arm became swollen, red and warm to touch with pain.  Patients mother reached out for assistance the next day 7 May and referred to ER where child was treated for Cellulitis with antibiotics, and followed up with clinic 8 May.
Approximately two minutes after receiving the HPV vaccine, my son's eyes rolled backward, his arms began to posture and stiffen and he started moaning.  That continued for roughly three minutes.  He suddenly came to his regular state but has felt slightly dizzy for the remainder of the day.
Bruising & petechial on 9/3/2000. The pt was transferred to a medical center in pediatric hematology.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 12/14/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Fainted; Dizzyand lightheadedness; Arm was huge; Swollen at the injection site; Arm was red at the injection site; A spontaneous report  was received from a 33-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fainted, dizzy, huge arm, red and swollen arm at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Jan 2021, at 05:00 pm, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient experienced delayed reactions where the patient fainted which is a medically significant event, while walking up the stairs and felt dizzy. The injection site was about 3 inches tall and 2 inches wide and raised which remained the same for about 4 days. The patient fainted again on Monday and felt dizzy and light-headness at the time of report.  Treatment medication included diphenhydramine cream for arm.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events fainted, dizzy, huge arm, red and swollen arm at the injection site was considered as unknown.; Reporter's Comments: This case concerns a 32-year-old female who had serious unexpected events of syncope and NS unexpected dizziness, peripheral swelling and expected vaccination site swelling, vaccination site erythema.  Event onset occurred 12 days after the first dose of mRNA-1273. Treated with Benadryl cream. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Low grade fever - 99-100; body aches and headaches - general malaise and not feeling well. It's usually at night that I feel this. It's associated with nighttime. Urgent Care.  Drinking fluids and take Tylenol and Ibuprofen as needed. I'm still having these symptoms at night - the last few nights for sure. I have had to take Tylenol for it the last few nights. I am feeling tired, too.  Note: I had my second shingles shot  after the second Pfizer vaccine - not that  long after it- it took me down. I was so very sick after it.
Symptoms include headaches, localized swelling at vaccine site, lymphangitis, lymphadenitis, edema, redness, fever at vaccine and lymphangitis sites. Lymph node involvement includes the axillary, subclavian and submandibular nodes. Time course of symptoms is currently at 5 days. Treatment includes 400-600 mg Naproxen sodium with 50mg Benadryl every 6 hours as needed. Additional events included the appearance of a reddish color maculopapular rash over both arms, neck, face and chest that only lasted a few hours.
Paralysis - right leg - ascending; 1/15/13 awoke with partial blindness (right eye); 1/19/13 awoke with total blindness (left eye); Hospitalized for extreme illness from 1/23/13-1/26/13.
Information has been received from a physician and a 72 year old male dentist with hypertension, cholesterol high and arthritis who on 09-FEB-2007 was vaccinated SC with a 0.65 ml dose of Zostavax. Concomitant therapy included DIOVA, atorvastatin calcium (LIPITOR) and VOLTAREN. On 18-FEB-2007 the patient developed a mild case of zoster which involved the left side of his face. It was reported that there was no injection site reaction, however on the evening of 18-FEB-2007 he developed soreness on the top of his head (also reported as soreness on the scalp to the touch and blisters on the scalp). The soreness progressed to the left side of his scalp, cheek and ear. The patient stated that he did not experience any real pain, only soreness. He saw his primary care physician on 21-FEB-2007 where he had unspecified blood work and x-rays performed, both tests were "negative for inflammation." Around 24-FEB-2007 or 25-FEB-2007 the patient noticed swelling over his left eyebrow area with 2 pronounced edematous areas. The 2 areas were red, raised and painful to the touch. There was an occasional ache in his left eyeball area. He saw a dermatologist on 28-FEB-2007 who said that it appeared to be zoster. Prior to the dermatologist appointment the patient had taken left over VALTREX; he had on hand (which he occasionally used for a herpes simplex infection), 2000 mg initially and 2000 mg 12 hours later for one day. The dermatologist then prescribed VALTREX 1000 mg 3 times a day. The patient saw an ophthalmologist the day after he saw the dermatologist. The ophthalmologist noted that there was no photophobia. He prescribed PRED FORTE, ALPHAGAN-P and MSD. In the following days of starting the eye drops, the patient experienced clouding of his cornea in the morning when he would initially wake up but then his vision would improve within an hour. The ophthalmologist told him to continue the drops and within a few days his eye was completely clear. As of 15-MAR-2007 the lesions remained present and crusted but no longer painful to the touch. Combing his hair and taking a shower were "annoyingly sore" for him. The VZVIP program was discussed with the patient (the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the manufacturer vaccine VZV strain). The patient thought that a specimen would not yield good results. He stated that if he developed any other rash, he will discuss it with his health care provider as to whether a specimen should be sent at that time.  Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA5788, expiry date 30th September 2021) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. On 14th January 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 14th January 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter reported that a patient was inadvertently administered an expired dose of Bexsero on the date of reporting, which led to expired vaccine used. No further events were reported. The reporter agreed to be contacted for follow-up.
body aches; chills; fever; sore throat; A spontaneous report was received from a consumer concerning a 68-year-old, female patient who experienced  body aches/ pain, chills, fever/ pyrexia, sore throat/ Oropharyngeal pain.  The patient's medical history was not provided.   Concomitant product use was not provided  by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A] on 10-FEB-2021.  intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 10-FEB-2021, 68-year-old female patient received her first of two planned mRNA-1273 for prophylaxis of COVID-19. and approximately after 6 days on 16-FEB-2021 she experienced body ache, chills, fever, sore throat. Treatment information was  provided by reporter is she used Tylenol.    Action taken with mRNA-1273 in response to the event(s) was unknown.  The event(s), body aches/ pain, chills, fever/ pyrexia, sore throat/ Oropharyngeal pain. were considered unknown.  Based on MSA comment, Pain is Unlisted in all RSI.
"COVID" Arm/"Moderna" Arm.  Large round, bumpy, itchy rash formed right below injection site.  Benadryl tablets taken daily till rash went away.  Took roughly 5 days to disappear.
Beginning on approximately 05/20/2021 I began having, what were later diagnosed as cluster headaches. I sought treatment for the cluster headaches with the neurologist who also diagnosed peripheral neuropathy.  These cluster headaches were incredibly intense and came on every evening for approximately a month and then subsided. The connection to the vaccine was not made until I received the bivalent booster 05/28/2022 and on 06/04/2022 for approximately 2 weeks the cluster headaches returned which were milder this time.
Feb. 12 (day after shot) red sore arm lasting 4 days. Feb. 18  headache, nausea  lasting 1 day.  Feb.19 woke up with redness near injection sight. ..very sore and itchy.  Still have redness at injection sight today (Feb. 22) Treatments : ice,  1% Hydrocortisone,  Benadryl
I couldn't sleep the first night, after I got 2 to 3 hours sleep a night , 6 days after doctor gave Ambien. Still can't sleep.
5 minutes after Menactra 0.5ml IM given, client lost consciousness. Epinephrine 0.5mg SQ given. Client regained consciousness and was transported to ER for medical evaluation.
headaches since the first vaccine; warmth/redness, warmth, itching and soreness on the injection site; rash that has been increasing in size/the rash is now the sized of her open hand; rash that has been increasing in size; itching/redness, warmth, itching and soreness on the injection site; redness, warmth, itching and soreness on the injection site; redness, warmth, itching and soreness on the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmth/redness, warmth, itching and soreness on the injection site), CONDITION AGGRAVATED (rash that has been increasing in size/the rash is now the sized of her open hand), RASH (rash that has been increasing in size), VACCINATION SITE PRURITUS (itching/redness, warmth, itching and soreness on the injection site) and VACCINATION SITE ERYTHEMA (redness, warmth, itching and soreness on the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included METFORMIN, LISINOPRIL and ATENOLOL for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warmth/redness, warmth, itching and soreness on the injection site), CONDITION AGGRAVATED (rash that has been increasing in size/the rash is now the sized of her open hand), RASH (rash that has been increasing in size), VACCINATION SITE PRURITUS (itching/redness, warmth, itching and soreness on the injection site), VACCINATION SITE ERYTHEMA (redness, warmth, itching and soreness on the injection site) and VACCINATION SITE PAIN (redness, warmth, itching and soreness on the injection site). On an unknown date, the patient experienced HEADACHE (headaches since the first vaccine). At the time of the report, VACCINATION SITE WARMTH (warmth/redness, warmth, itching and soreness on the injection site), CONDITION AGGRAVATED (rash that has been increasing in size/the rash is now the sized of her open hand), RASH (rash that has been increasing in size), VACCINATION SITE PRURITUS (itching/redness, warmth, itching and soreness on the injection site), VACCINATION SITE ERYTHEMA (redness, warmth, itching and soreness on the injection site), VACCINATION SITE PAIN (redness, warmth, itching and soreness on the injection site) and HEADACHE (headaches since the first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided.   This case was linked to MOD-2021-122049 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: Follow-up information On 08-May-2021: Follow up information
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Moderna vaccine on 2/24/2021 and 3/24/2021. Presented to hospital on 10/10 with altered mental status and decreased level of consciousness. Admitted and underwent MRI and MRA head/neck which was unremarkable for acute abnormality. His conditioned worsened and he was transferred on 10/14 for further evaluation. CT brain revealed extensive acute intracranial hemorrhage including a large intraparenchymal hematoma in the right frontal lobe with severe leftward shift and bilateral descending transtentorial herniation. Pt was transitioned to comfort care and expired on 10/14/22.
Hospitalization: 12/1/2022 - 12/4/2022 (3 days) Presentation to the ED: suicidal ideation COVID + date: 12/1/2022  Treatment: NONE -Asymptomatic.  Discharge to: HOME.  MODERNA LOT # 031H21A 11/16/2021 MODERNA LOT # 056M21A 4/30/2022 MODERNA BIVALENT LOT # 042H22A 12/17/2022
fibromyalgia flair. Pain level 8 or 9 for weeks. I still have pain. I was in remission before 2nd shot. I was not taking any pain medication on a regular basis before 2nd shot. Now I have to take pain medication every day.  Debilitating muscle pain and stiffness. Mostly in upper arms and legs. Treatment includes massage therapy, Norco (opiate pain medication daily) and exercise to tolerance.  Later, in June, I was hospitalized for pancreatitis. I have no risk factors. I don't know if it's related. Note: I had no reaction to the first vaccine.
Wheezing began 15 mins after vaccination; triggered asthma. Was put on steroids by healthcare professional.
obesity; Poor quality Sleep; Injection site worsening with swelling and induration; Injection site worsening with swelling and induration; Injection site pain; Headache; Fatigue; Myalgias; Left knee pain/pain on any movement mostly joint lines; This spontaneous case was reported by a health care professional and describes the occurrence of OBESITY (obesity), POOR QUALITY SLEEP (Poor quality Sleep), VACCINATION SITE INDURATION (Injection site worsening with swelling and induration), VACCINATION SITE SWELLING (Injection site worsening with swelling and induration) and VACCINATION SITE PAIN (Injection site pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 300042721) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTRADIOL VALERATE for Menopause.   On 22-Feb-2021 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ARTHRALGIA (Left knee pain/pain on any movement mostly joint lines). On an unknown date, the patient experienced OBESITY (obesity), POOR QUALITY SLEEP (Poor quality Sleep), VACCINATION SITE INDURATION (Injection site worsening with swelling and induration), VACCINATION SITE SWELLING (Injection site worsening with swelling and induration), VACCINATION SITE PAIN (Injection site pain), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Myalgias). On 31-Mar-2021, ARTHRALGIA (Left knee pain/pain on any movement mostly joint lines) had resolved. At the time of the report, OBESITY (obesity), POOR QUALITY SLEEP (Poor quality Sleep), VACCINATION SITE INDURATION (Injection site worsening with swelling and induration), VACCINATION SITE SWELLING (Injection site worsening with swelling and induration), VACCINATION SITE PAIN (Injection site pain), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Myalgias) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information included ice and topical pain relief.   This case was linked to US-MODERNATX, INC.-MOD-2021-058239 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: ADR added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058239:First dose case
03/01/2021 you noticed a rash on my chest and stomach area, then as time went on when going out in the heat/sun it is all over my face and body. It still ongoing as of today. I was prescribed Zyrtec and Triamcinolone.
Patient had no difficulty breathing. Arm swelled. Was initially the size of a golf ball. Really hard to the touch. After 20 minutes it got smaller. Then 20 minutes later got little smaller and less hard. Gave patient 1 BENADRYL tablet.
Case number PHEH2014US003799 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 14-years-old male patient. His medical history and concomitant medications were not reported. It was reported that his patient under 18-years of age was vaccinated with a dose of FLUCELVAX 2013/2014 (batch number: 006031A, expiry date: JUN 2014) intramuscularly at a dose of 0.5 ml on 08 NOV 2013. No adverse events were reported following the maladministration.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Has area on L arm located about 2-3 in away from affected area where shot was administered. There were a 2 rounded red areas and then several  other reddened areas- flat not raised. States ache from shoulder to elbow.
Itchy papular rash at injection site, developed 2 days after injection. Given triamcinolone cream for treatment.
3/31/21 was second day of period, late in light it is not heavy... soon after period was EXTREMELY HEAVY for a few days. It stopped - as one would expect - yet only for three days. A second period started. Also heavy. Today is day 9 of bleeding. Seeing doctor tomorrow. In addition to period impact, I had sore throat for few days (hard to swallow) which turned into a scratchy throat and then a wee cough at night. I was tired; though could be loss of blood yet I believe it was independent.  So three main side effects: bleeding, throat and tired.
Went to ER with chest pain and cough, diagnosed with mediastinal mass and lymphadenopathy. I am now being evaluated for malignancy. These symptoms began only in the last few months, since receiving my vaccinations.
Case number PHEH2016US021716 is an initial spontaneous report received from nurse on 25 Aug 2016. This report refers to female patient of an unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.1 ml intramuscularly on 25 Aug 2016, prescribed dose was 0.5 ml and patient administered less than 0.1 ml. No adverse event was reported following this medication error (Vaccine underdose).
TOOK TWO UNREFRIGERATED DOSE; This spontaneous case report was received from a consumer (PVX2019-480) on 21-Feb-2019. The report describes a 21-year-old male consumer who "took two unrefrigerated dose". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took two unrefrigerated doses of Vivotif.  The action taken with Vivotif with respect to the event "took two unrefrigerated dose" was not applicable.  The clinical outcome of the event took "took two unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.
the patient may be pregnant; patient may be breast feeding; Patient administered second dose from an expired vial of the Moderna COVID-19 vaccine; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (the patient may be pregnant), MATERNAL EXPOSURE DURING BREAST FEEDING (patient may be breast feeding) and EXPIRED PRODUCT ADMINISTERED (Patient administered second dose from an expired vial of the Moderna COVID-19 vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 14-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 14-Jun-2021, the patient experienced EXPOSURE DURING PREGNANCY (the patient may be pregnant), MATERNAL EXPOSURE DURING BREAST FEEDING (patient may be breast feeding) and EXPIRED PRODUCT ADMINISTERED (Patient administered second dose from an expired vial of the Moderna COVID-19 vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (the patient may be pregnant), MATERNAL EXPOSURE DURING BREAST FEEDING (patient may be breast feeding) and EXPIRED PRODUCT ADMINISTERED (Patient administered second dose from an expired vial of the Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. treatment information not provided The patient received the second of the Moderna COVID-19 vaccine from a vial that was in its 31st day of storage. The vial in question was received on 14MAY2021 and kept in constant refrigeration until 14JUN2021, when it was finally punctured at 10:00AM. At 10:15AM two doses were drawn and administered. The reporter stated this patient may be pregnant or breastfeeding. Other relevant medication history included Prenatal Vitamins.   This case was linked to MOD-2021-222161 (Patient Link).