chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 14-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis. On the same date, the patient was vaccinated with an improperly stored dose of MMRII (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for the same indication. Both vaccines were stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved.  This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: Original Case : 1701USA004150: US-009507513-1701USA007922: Original Case : 1701USA007906: US-009507513-1701USA007881: Original Case : 1701USA007910: US-009507513-1701USA007913: Original Case : 1701USA007910: US-009507513-1701USA007882: Original Case : 1701USA007910: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
urticaria 8hr p/vax;2hr p/vax had abd cramping & diarrhea which persisted for 5hr;
I felt very tired. Then my arm felt heavier and sensitive to touch. Three days after taking the 1st dose, I developed a strange rash. It wasn't itchy or painful, but it was a very odd & unusual rash. It appeared as speckles & they were spaced out. These speckles or pimple like rash would pop up and then go back down. It showed up on my chest as well. This rash appeared for months on both my arms too. I went to the doctor regarding this rash. I was prescribed with a Benadryl cream, Benadryl pills (which I eventually stopped using and went back on my regular allergy medication). I was also prescribed with loratadine and Claritin. This rash lasted for about 5 months.
Information has been received from a physician concerning an approximately 70 year old male who on approximately 26-SEP-2007 was vaccinated SC with a single dose of Zostavax (Oka/Merck).  On approximately 29-SEP-2007 the patient's wife called the office and stated that the patient's arm was red and swollen several inches around the injection site.  The physician reported that the patient's wife was a nurse and stated that the patient may also have had a slight temperature.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Patient reported redness, soreness/ aches and warmth at injection site. Patient states that side effects have been improving/ lessening when reporting to pharmacy on 10/15/2018. Patient states that they have been taking Tylenol/ ibuprofen to relieve pain. Patient was instructed to watch reaction area and report to Dr if symptoms do not continue to get better or they worsen.
feels like she has the flu; Chills; Diarrhea; slightly Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (feels like she has the flu), HEADACHE (slightly Headache) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced DIARRHOEA (Diarrhea) and HEADACHE (slightly Headache). On 28-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (feels like she has the flu) and CHILLS (Chills). At the time of the report, DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (feels like she has the flu), HEADACHE (slightly Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment information was provided.
Chest tightness, wheezing, voice hoarseness 2 hrs after administration. Given 25 mg BENADRYL, Albuterol, & 40 mg Prednisone.
Patient received the vaccine and was walked to the observation area. She was on the phone with her mother when she said she was feeling faint and proceeded to faint.  Woke almost immediately, no injuries. Said had a history of fainting once awake. EMS onsite took glucose which as 110.
(L) arm 2x2 cm red, cellulitic area were INFANRIX given - x2 days - warm compresses-PO AUGMENTIN, 400 POBID
Hospitalization: 2/17/2023 - 2/23/2023 (6 days) Presentation to the ED: hypoxia COVID + date: 2/17/2023 Treatment: decadron  Discharge to: home. EN5318  2/3/2021 EN6201 2/25/2021 FA7485 8/17/2021 FP4554 6/30/2022 Moderna BiValent 051D22A 12/4/2022
Pt presented to the ED with cough and SOB.  + for COVID.  No distress.  Discharged to home.
Injection to L/arm and was very sore an hour later. Now 4 days later the pain is worse, the area is red, and I now have limited mobility in this arm. Significant muscle pain in this arm and can not lift it over my head.
Approximately 5 min. after vaccine administration child developed "red spots"/hives on legs and trunk. Was examined by physician, and given a single dose of oral Benadryl (6.25 mg).
2-3 weeks post vax the pt experienced a rash consisting of 5 non-vesicular lesions. The pt also experienced slight itching. At the time of this report the lesions were resolving.
Pt experienced ringing in the ears and felt hot after 1 hour of administration. Then her blood pressure was over 200 (systolic) and 180 average after multiple readings per caregiver. These episodes have occurred before without vaccination due to low metoprolol daily dose.
pt recv vax 3NOV95 & 6DEC96 pt exp a gen rash w/greater than 50 lesions;pt sibling also devel a rash p/vax;
41yo gentleman w/ acute gallstone pancreatitis admitted to ICU due to septic shock and AKI. Went into a-fib w/ RVR overnight, but now back to sinus with no tachycardia. Hemodynamics normal.   Patient was admitted to inpatient level of care on 12-18  with abdominal pain and distension. Patient being treated for cholangitis/pancreatitis . Patient has a medical history that is significant for cerebral palsy and scoliosis.
after an accident, which she broke multiple bones; after an accident, which she broke multiple bones; she fell; has some soreness at the site of injection; This is a spontaneous report from a contactable consumer (reporting about sister, patient). A 57-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 21Apr2021 (Batch/Lot Number: Pfizer 9810) as single dose for covid-19 immunisation at the age of 57-year-old. Medical history included ongoing diabetes. There were no concomitant medications. The patient experienced soreness at the site of the injection on unspecified date in 2021. In May2021, the patient had an accident, broke multiple bones, she fell, was in hospital. The outcome of events was unknown. The consumer reported the patient just has some soreness at the site of injection, but after she fell, she has described many indications, indications that are going to affect her, those indications are not related to COVID at all, they are related to her injury and diabetes.  Information about batch/ lot number has been requested.  Follow-up (27May2021): New information received from the same contactable consumer included: Lot number, medical history, new events (accident, broke multiple bones, fell, soreness at the site of the injection). The case was upgraded from non-serious to serious.  Follow-up attempts are needed. further information is expected.
Pt had swelling, redness, and streaking down entire arm to fingers tips, fever, aches, pain. She iced her arm and took Motrin and Benadryl.  She continues to have redness, warmth, swelling, itching and pain a week after vaccination.  She will have a follow up visit with the physician next week.
This spontaneous report as received from medical assistant refers to her daughter, a 13 year old female patient. Patient's concurrent conditions and relevant medical history was none. Patient had drug reactions/allergies to penicillin and amoxicillin. When the patient was ready for the kindergarten, she received M-M-R II (lot number, dose and route unspecified) on an unknown date. Concomitant medications was reported as none. The patient has been seen in an unspecified emergency room on an unspecified date. The patient sought medical attention but was not admitted to the unspecified hospital. After receiving M-M-R II the patient's arm swelled. The outcome of the event was reported as not recovered/not resolved. The causality of the event with M-M-R II was not reported. Product quality issue was not involved. This is one of the two reports regarding the same patient. Additional information has been requested.
Their entire left arm up to the elbow became red; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (Their entire left arm up to the elbow became red) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced ERYTHEMA (Their entire left arm up to the elbow became red). At the time of the report, ERYTHEMA (Their entire left arm up to the elbow became red) 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. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of erythema, a causal relationship cannot be excluded.
sore shoulder; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder soreness 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 shoulder soreness. On an unknown date, the outcome of the shoulder soreness was recovered/resolved.   It was unknown if the reporter considered the shoulder soreness to be related to Shingles vaccine.     Linked case(s) involving the same patient: US2022AMR089796   Additional Information: GSK Receipt Date: 05-JUN-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient received the dose of Shingles vaccine and only reaction the patient experienced was a sore shoulder for a couple of days. The patient reported that they said if you drink plenty of water throughout the day when you get it you did not have as many reactions really recommend getting it. Additional supportive information: For the tolerance of 2nd dose, refer linked case US2022AMR089796. The follow-up would not possible as no contact details were available.
Pt reported receiving flu shot in the afternoon an developed lower back and hip pain that evening. Denies any symptoms- no fever, local redness, cold symptoms. HA. Did fall in December. Was referred to private MD. Has had flu shots in the past with no problems.
Headache, Myalgia, Fever, FATIGUE, CHILLS Narrative:
3 hr post immunization pt had fever of 102 and 24 hr after accompanied by headache
Death Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 90 and suffered cardiac arrest at home on 2/25/21. Patient had afib w/ a pacemaker, cardiomyopathy, CKD4, and PVD.
Shots given 11AM 1/9/08.  Began inconsolable crying spell then developed fever to 103.  To ER-sepsis workup including LP negative so far.  Still fussy but consolable on 1/10/08.
HBP called to report a T/E on PROQUAD that was improperly stored and administered. Confirmed no symptoms or side effects reported. See related AE cases 02441564 and 02441564. No additional AE/no PQC.         ?    Names of vaccines involved (includi; HBP called to report a T/E on PROQUAD that was improperly stored and administered. Confirmed no symptoms or side effects reported. See related AE cases 02441564 and 02441564. No additional AE/no PQC.         ?    Names of vaccines involved (includi; This spontaneous report was received from an administrator and referred to a 4-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent.   On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, once (lot #X007085 has been verified to be a valid lot number, expiration date: 04-SEP-2024), administered for prophylaxis (strength, and route of administration were not provided).  01-AUG-2023, the reporter reported a temperature excursion (temperature: 17.8F for 1 hour 30minutes) for the vaccine that was improperly stored and administered (product storage error). Confirmed no symptoms or side effects reported. No additional adverse event or product quality complaint reported (no adverse event).
a slight vibration feeling in my legs.; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non pregnent female patient received bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 16Feb2021 09:15 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history was not reported. Concomitant medication(s) included ascorbic acid, betacarotene, biotin, calcium lactate, choline bitartrate, chromium nicotinate, colecalciferol, cyanocobalamin, dexpanthenol, dl-selenomethionine, folic acid, inositol, magnesium lactate, manganese gluconate, nicotinamide, potassium citrate, potassium iodide, pyridoxine hydrochloride, retinol palmitate, riboflavin phosphate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTI VITAMIN & MINERAL) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient do not have allergies to medications, food, or other products. Previously patient received BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, solution for injection) dose 1 via an unspecified route of administration, administered in arm left on 26Jan2021 14:15 (Batch/Lot Number: EL9263) for covid-19 immunization. The patient experienced a slight vibration feeling in her legs on 16Feb2021 10:00. After getting home from vaccine, she noticed a slight vibration feeling in her legs. She had noticed this feeling since having the vaccine through her body. It was almost 1 week since having the vaccine. She noticed it when standing still, laying down, etc. it felt like they were standing on a floor that was vibrating slightly. It does not caused pain but was worrisome and not sure why it was happening. It very annoying feeling to have all the time. It comes and goes. The sensation was not painful but was worrisome. She actually filed out the thing while she was waiting, but she thought she would talk to someone. She wanted to know if they give feedback. The symptom she thinks she had had ever since she got the second shot was a mild vibration in her body. Obviously, she doesn't hear that as a normal symptom of the COVID vaccine. Caller clarified that she was looking for information about mild vibration in her body after the second dose of the COVID vaccine. Caller confirmed that there had not been a new event since she reported her experience. She enquired that is this something that has  been reported before. The patient referred to HCP for treatment if symptom persists. No treatment was received for the event.The outcome of event was not recovered.   No follow-up attempts are needed. No further information is expected.
During a 2nd dose mobile clinic for the Moderna vaccine, it was determined that this patient had been vaccinated with his 1st dose of Moderna under the approved age as outlined by the EUA. Patient was 16 at time of first dose administration, turning 17 three days later. Patient had no known adverse reactions to receiving a dose of Moderna, but was not administered a 2nd dose when it was determined that he did not meet the approved age. Patient's pediatrician was notified at time of finding, and had no further guidance.
Muscle pain, Shortness of Breath, sore throat, loss of smell, low fever starting the day following vaccination leading to ER visit on 08/25/2021
Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with the first dose of GARDASIL (lot not reported).  After receiving the first dose the patient experienced a rash on her abdomen and her arm.  The patient took some BENADRYL and got prednisone (manufacturer unknown).  The patient came back to the physician's office because she wanted to get the second shot of GARDASIL (lot not reported).  About a week after the shot the patient broke out in to even more extensive rash and had to get prednisone again.  The nurse reported she will not administer the third dose of GARDASIL.  The patient's status was not reported.  Additional information has been requested.  02/18/2010 Follow up informatino was received. The patient was vaccinated with the first dose of GARDASIL (lot 659699/1086U) via IM in the left deltoid on 21-FEB-2008. The patient was vaccinated with the second dose of GARDASIL (lot 655604/0052X) via IM in the left deltoid on 28-APR-2008. On 23-FEB-2008 after the frist injections the patient developed a rash across abdomen and her legs. On 5-MAY-2008 the patient developed a rash on her right arm and shoulder and a burning feeling-cold type symptoms. The patient recovered on a unspecified date. The patient has penicillin allergy. No further information is expected. Follow-up information was received which reported that the 19 year patient experienced an adverse event after the first dose of GARDASIL. The patient then received a second dose of GARDASIL and had the same adverse event but to a great extend. The patient experienced a rash starting on her arms, then processing down her abdomen and legs. She also had flu like symptoms and joint and arm pain. The patient was prescribed a course of steroids, BENDADRYL and ATIVAN. The registered nurse considered the rash across abdomen and on her legs, a rash on her right arm and shoulder and a burning feeling - cold typ/flu-like symptoms to be an other important medical event. This is an amended report. The nurse considered the rash across the abdomen, on her legs, a rash on her right arm and shoulder, burning feeling, cold type/flue-like symptoms to be other important medical events. Follow-up information was received from a registered nurse (R.N.) who reported that she did not known if the patient recovered from arm pain and joint pain. The nurse did not indicate if the patient would receive the third dose of GARDASIL. Additional information has been requested.
that noc had acute onset of coughing for hr;couldn't sleep;devel heavy mucous in head & chest;cont 2wk;legs & abd became swollen;hosp;fluid around heart;tx several wk;tire very easily;CAT scan shows sinus mucous;nasal polyps;
Mild discomfort at site ((L) deltoid) 1st 36 hours, then increasing pain shoulder to elbow and red, raised, non-itchy area over deltoid - one inch streak circumscribing arm. Unable to touch or sleep on (L) side for 1 week, even with use of warm pack (to underarm) and Hydrocod. Pink area +1-2 inch diameter mod. firm and sl. tender to pressure to this date.
Multidose vial prepared, only one dose given however the volume of the vial was only half full. Staff reported no wastage of vaccine. Employee who prepared the vial is also the one who administered the single dose used. He reports preparation happened without issue and patient displayed no adverse reaction during or after receiving vaccine. Report being file due to  doses left to give not matching the quantity that should be available in the vial. Provider informed and states no further action needed. Patient guardian informed of event.
Initial misuse report received from a healthcare professional on 04 June 2013. Administered DAPTACEL instead of ADACEL to a 12-year-old patient. No adverse event was reported. List of documents held by sender: none.
In discussing the zoster vaccine with my doctor, I asked about side effects. She indicated that she had given many of these vaccines and had not had any patients who experienced side effects. I had the vaccine on 12/2/13. Within a day or so, I developed extreme sensitivity on the right side of my body both in my hip/top of right thigh area and also near my back left shoulder area including very sharp, intense shooting pains. I then developed an outbreak/rash on the back of my upper right thigh. I went back to Dr. on 12/18. While she was surprised at my symptoms and the rash, she was in agreement that the rash did appear to be a shingles rash. So, it appears I developed a mild case of shingles directly after receiving the vaccine. Please note: I do not remember having chicken pox as a child and my mother said I never did even though my siblings did have chicken pox. However, a titer test done by Dr. indicated I had antibodies to chicken pox.
The patient experienced severe pain, edema and erythema to region of left deltoid extending the entire circumference of her arm down to her distal humerous.
Dizziness, Feels faint, lightheaded/Anxiety; VS WNL; Patient was stable and released from vaccination site
extreme redness from shoulder to elbow, underarm & upper rt chest; contacted ER on 28OCT95 9AM explained rxn was told to come in put on ATB; poss arthus type rxn