chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; vaccinated with an improperly stored PROQUAD; This spontaneous report was received from a medical assistant, regarding a 4 year old male patient. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included diphtheria toxoid, pertussis acellular 1-component vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid (DTAP-IPV) and "FW".  On 18-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S012472, expiration date 20-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 25.61 degree Celsius from 19-AUG-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA012240: US-009507513-1910USA012356: US-009507513-1910USA012355: US-009507513-1910USA012349: US-009507513-1910USA012351: US-009507513-1910USA012352: US-009507513-1910USA007637: US-009507513-1910USA012350: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012358: US-009507513-1910USA012359: US-009507513-1910USA012360: US-009507513-1910USA012981:
Pt recvd 2nd dose of vax 20AUG92 & 17SEP92 repeat GGTP was 126;
Spasms in left and right leg and right arm every 10-15 minutes on Friday 8/20/21. All Day. Decreased a little on 8/22. And a little more in 8/23.  Right arm very weak and tight- increased spasticity and clonus. On 8/24, left arm began having spasms as well. Spoke with my neurologist. Per Dr. begin muscle relaxer (tzinanadine) bid, if symptoms do not improve in 2 weeks, she will see me for an exam.
Very sore arm even without movement (immediate), injection site warm & swollen (soon after injection), headache, body muscle aches, fatigue - all by following morning.
Started having Hives around belt area and upper legs.  Over the next 24 hours they expanded to upper chest/neck area.  Not breathing issues.  The ER gave me an IV cocktail of Benadryl, Steroid and 2 other medicines I do not remember.  Hives started going away within a few minutes, however, it took 3 or 4 days to completely clear.  Continued taking Diphenhydramine HCL and Prednisone for the next 5 days.
Former 30 week premie twin refused to eat for 18 hours: no fever, inconsolable crying for 18 hours. Sxs started two hours post injection.
4 days following vaccination i developed a severe coough, congestion and body pain. I had a mild fever for a day too.  I am on over the counter medication ( robutussin + advil )Its been 3 days and my congestion and cough have not yet cleared.
Vaccine received by 17 year old; 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received by 17 year old) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received by 17 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received by 17 year old) had resolved. Not Provided      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.   No concomitant and treatment information was provided. No Treatment medication reported by the reporter. Reporter stated in the follow-up that they were not aware of any adverse events but have not had any further contact with this patient since the administration of the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2021-053788 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jul-2021: Follow up received on 04-JUL-2021 and it contains No New Information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-053788:cross linked case
I  believe the very next day or so I developed Blurred Vision and at times Double Vision.  I 'm not saying for sure if this is a side effect or not and wondered if anyone else has had vision problems with the Vaccine.
Narrative: Myalgia, UrticariaPruritus, NauseaVomiting, sweating, chills
Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Soreness of arm). At the time of the report, PAIN IN EXTREMITY (Soreness of arm) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: follow up document received on 14-may-2021 has no new information
Headache immediately after injection  Body aches and joint aches 3 hours after injection, lasting 24 hours 8 days after injection I had a red spot at injection site that was about 2? long by 1.5? wide, it was hot, hard, swollen, itchy. It lasted for 4 days.
Pt received Pediatric Hep A and Gardasil-9 vaccines on 6/19/19 and came back to our office on 6/25/19 and received another Pediatric Hep A and Gardasil-9 vaccines. Our EHR system was down on 6/25/19 and vaccines weren't transferring over since June 13th 2019.
Hep A (Havrix) adult dose vaccine given to 12 month old, instead of pediatric dose.
On day 3 after injection began to have difficulty sleeping.  On day 4, he very suddenly began to have feelings of deep sadness, depression, inability to feel joy, severe headaches, nosebleeds, continued difficulty sleeping.  Frequently described by patient as "mental anguish".  This lasted for 4 days before began to slowly improve.  Three weeks out, the patient has days that are without symptoms and days with symptoms, but nothing like the initial 4 day of max symptoms.  No other precipitating factors.
shingles; This case was reported by a pharmacist and described the occurrence of shingles in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 7Z9H3, expiry date 7th October 2022) for prophylaxis.   On 8th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th December 2020, 1 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The patient received the dose and shingles presented the next day. It was under her right breast and around her back on the right side. It was noted that the patient never had chicken pox. The reporter consented to follow up.
Dizziness.  Started 12 hours after shot.  Still present at 48 hours.
Expired vaccine administrated, 4 days past expiration date. vaccine expired 11/1/2021. dose administered on 11/5/2021. patient reported no side effects after vaccine
Vaccine was received on 12/08/2021, was left out of the fridge and accidently given on 12/13/2021 by night nurse.
PATIENT CAME TO THE PHARMACY WITH HIS DAD. THEY CLAIMED HE IS ALLERGIC TO NUTS. WHEN I APPROACHED TO PROVIDE THE SHOT HE SAYS HE IS VERY SCARED ABOUT NEEDLES. I EXPLAINED THAT IT WON'T HURT AND IT WILL TAKE LESS THAN A SECOND. JUST AFTER I PROVIDED THE SHOT THE PATIENT PASSED OUT, TURNED VERY WHITE. I ASKED MY INTERN TO CALL ED AND WITH THE HELP OF HIS FATHER WE PUT HIM ON THE FLOOR AND IN ABOUT 15 TO 20 SECONDS HE STARTED RECOVERING. HE ASKED WHAT HAPPENED BUT THEN HE STARTED TO ANSWERING QUESTIONS PROPERLY. I TOOK THE BLOOD PRESSURE AND IT WAS VERY LOW ABOUT 85/75. JUST AFTER FINISHING ARRIVED THE RESCUE. AFTER 20 MINUTES WITH HIM THE BP KEPT VERY LOW AND THEY DECIDED TO TAKE IT TO THE HOSPITAL.
Fainted at exit table after receiving vaccination.  Laying down BP = 80/40, HR = 45.  Diaphoretic, passed out, elevated legs, turned on left side, fell on back of head, c/o headache, pallor.  Felt better by 11:50 AM.
Information has been received from a physician concerning a patient who on 12/09/1996 was vaccinated with a dose of varicella virus vaccine live.  The physician reported that on 10/30/1997, the patient presented to the office with chickenpox characterized by less than 50 lesions.  Treatment was not required.  At the time of this report, the outcome was unknown.  The physician also reported that three other patients developed chickenpox after being vaccinated with varicella virus vaccine live.  Additional information is not expected.
herpes zoster; Information has been received from a lawyer and an elderly female patient regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) in a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX): herpes zoster. The outcome of the event was unknown.
Gradual onset of left side Bell's Palsy several hours after receiving MMR/Varicella
2.18  11om. Soreness at injection site.   Sleeplessness.  Nausea.  2.18. 3pm. Headache. Scratchy throat . Slight temp 99.4. My standard temp is 97.7. Continued soreness and bruised feeling at injection site.
Pt has not felt well since receiving the flu vaccine on Thursday. Starting vomiting on Sunday.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 16Sep2023 to 21Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312786 same patient, different drug/AE;
Hospitalized (1.23.22-1.27.22); COVID-19 positive (1.23.22); Fully Vaccinated Patient is a 10 y.o. old male admitted for COVID-19 infection. Admission Date: 1/23/2022  Discharge Date: 1/27/2022 DETAILS OF HOSPITAL STAY: Severe sepsis [A41.9, R65.20] Acute respiratory failure with hypoxia [J96.01] COVID-19 [U07.1] HOSPITAL COURSE: Patient is a 10 y.o. male with congenital glycosylation mutation, global developmental delay with GT dependency, epilepsy on antiepileptics, moderate persistent asthma, CKD, OSA, and neutropenia/lymphopenia with viral infections who is admitted with COVID-19 pneumonia complicated by neutropenia, lymphopenia, and transaminitis. Patient did not require increased oxygen support from his baseline (2L when sleeping), however, given his history of neutropenia and concerning picture for bacterial pneumonia he was started on IV Cefepime.  Given his transaminitis, neutropenia, and risk for thrombosis with his genetic condition and COVID pneumonia and non ambulatory state, Heme/Onc was consulted. They recommended no anticoagulation given his PT/PTT/INR were high normal. Zarxio was started on 1/25 given his neutrophils trending down (calculated on Mandiff 600). His ANC improved >1000 after one day for which his cefepime was discontinued. ID consulted and stated he is not a candidate for IV Remdesivir or decadron given his respiratory stability.
chills; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and MYALGIA (arm soreness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced CHILLS (chills) and MYALGIA (arm soreness). On 07-Feb-2021, CHILLS (chills) and MYALGIA (arm soreness) had resolved.      No treatment information was provided. No relevant concomitant medications reported.  This case was linked to US-MODERNATX, INC.-MOD-2021-008962 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-008962:dose 1
I started feeling sick January 6 or 7. I had a little bit of nausea and extreme fatigue. I had the worst headache and I developed a cough that continued to get worse. I took 2 rapid tests that were negative. I went to an urgent care on January 10 get a PCR. The headaches and coughing got a lot worse. The cough kept me up all night for a solid month. For two and a half months I have had a debilitating headache to which I had to go seek medical care for. I tried migraine medications that did not work. I tried Benadryl at night for sleep along with ibuprofen and Tylenol through out the day. I tried meditating and exercise to help and nothing helped. A month ago I stopped taking the Tylenol and Motrin during the day and the headache started to go away.
nausea, muscle and joint aches, chill, headache, insomnia, dizziness, itchiness, swollen glands, brain fog, rosacea,
Injections site pain, Low grade fever, body aches, headache.  The fever, body aches and headache only lasted 1 day on 5/11/21.  I did take  1 dose of 2 Tylenol to help with the fever and body aches on 5/11.  The injection site is still sore but I had this after my first injection.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "breast cancer in remission" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Mar2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 22Mar2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 in this patient cannot be completely excluded.
Mild dizziness, metallic taste in mouth, flushing and urge to clear throat 13 minutes post 2nd dose vaccine. Symptoms resolved within 30 minutes and client left on own with steady gait.
Patient is a 53 year old male who was given this vaccine off licence (label). He didn't have any adverse reaction to the vaccine.
lung disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A  male (reported as 42, no units)  patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUNG DISORDER (medically significant), outcome "unknown", described as "lung disease". Patient is 42 but he's special needs and has critical lung disease." The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
No adverse reactions to date. Patient arrived at clinic for Td and Flu vaccine.  Technician prepped vaccines so that Td would go into patients left deltoid and the flu vaccine in the right deltoid. Technician gave what was thought to be the flu vaccine in the R deltoid, but realized upon injection, the vaccine was actually Twinrix.   Technician asked the patient to sit down and informed the nurse who took the patient to another room and spoke to him about what occurred and how the clinic would proceed next. The patient returned to the room and asked technician to only give him the flu vaccine, which was put in his L deltoid. Patient stated he would get the Td vaccination at a later time.
Moderna COVID-10 Vaccine EUA. After receiving the vaccine, patient experienced dizziness. Vital signs included BP 139/95, P 77, O2 100%. Cetirizine 10mg PO administered at 16:15. Patient denied SOB, trouble breathing, swallowing or symptoms of anaphylaxis. Upon leaving the clinic, BP was 127/76 and patient felt better. Patient had no additional or worsening symptoms before leaving the clinic.
Initial information received on 01-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 32 years old male patient who received vaccine ADACEL. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. On 21-Feb-2019, the patient received injection of suspect ADACEL lot U5531AA, expiry date 21-Jan-2019 via unknown route in the left deltoid. It was an actual medication error due to expired vaccine used. It was reported that patient received expired ADACEL vaccine on 21-Feb-2019 which was expired on 21-Jan-2019. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
unconsolable, persistent crying x 3 hrs-sound of cry distinctly different than normal;
no range of motion / cannot move shoulder awful pain in shoulder  change in sensation in extremity  temperature changes in extremity Symptoms continue to get worse Doctor tells me to give it time even though it gets worse
UTI symptoms.  COntacted Urgent Care while out of town.  Have had UTIs in past and described same symptoms.  Urgent care prescribed Nitrofurantoin 100mg bid x 5 days starting 10/31/21  with complete resolution of symptoms by 11/2/21  No further symptoms at this time
Sore arm, redness, low grade fever  which resolved after 4-5 days Significant Tinnitus noticed 2 days after vaccinations and is ongoing. No treatment yet
Pt phoned 1/8/09 stating that he had received the Shingles vaccine the day before and was experiencing facial numbness, swollen tongue and droopy (R) ear. Went to ER 1/9/09 was diagnosed with Bell's Palsy.   2/23/09 MR received for ER visit 1/9/09 with dx:  Bells Palsy. Pt presented with 1 day hx of facial droop and weakness. PE (+) for R facial palsy.
When patient presented for second dose of COVID Pfizer vaccine in her RIGHT arm she stated that the night of her first dose her LEFT arm began hurting and had continued to hurt ever since.  She demonstrated limited mobility of LEFT arm.  We gave 2nd dose in RIGHT arm and advised her to see her primary physician if the problem continued.   Patient visited pharmacy on 12/6/21 with update.  Pain & limited mobility remains in LEFT arm.  Patient has seen doctor about this problem.
Syncope episode following injection, approx 30 seconds following vaccination. Member not caught before hitting floor. Patient sat up at 2-3 mins later, placed in chair, then had 2nd syncopal episode at 1 min later. 911 called, pt transported to ER. 24 hr observation. 4/6/09-records received for DOS 2/9-2/10/09-DC DX: Vasovagal syncopal episode. admitted for C/O post vasovagal syncopal episode after receiving anthrax injection with a single episode of confusion, fell and hit back of head. Prior to episode developed tunnel vision. In ED memory waxed and waned. Neurological exam normal.
Pain to left arm at injection site. Fever. Chills. Fatigue. Body aches. Progressive pain down left arm into left wrist. Left axillary pain into left breast. Progressive numbness to left forearm and left wrist.
Case number PHEH2011US02805, is an initial spontaneous report received from a medical assistant on 26 Aug 2011 with follow-up received from a medical assistant on 12 Sep 2011: This report refers to an adult female patient. Medical history included allergy to penicillin and Acetylsalicylic acid. She was concomitantly vaccinated with Human Papiloma virus vaccine and Varicella vaccine. Concomitant medication included Albuterol and Flonase. She was administered only the MenCWY liquid conjugate component of MENVEO batch number 090601A without being reconstituted with MenA conjugate component, intramuscularly, into left deltoid on 23 Aug 2011. No adverse event occurred following this administration. Follow-up received on 12 Sep 2011: Patient demographics, medical history, vaccination site and concomitant medications updated.
In the evening almost at night time I was feeling weak, body pains, and I had a headache. The next morning on 11/27 I got an at home Covid test and then a PCR test and both came back positive. I lost my smell and taste a couple of days later. I was taking some Tylenol. They told me to rest and drink a lot of fluids. I recovered in 5 days.
fever 105 taken to hosp;10JUL97 nurse hosp reported pt is stable;