chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 09-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old patient (gender unknown) who received (3rd) dose of ACT-HIB instead receiving PCV-13 two weeks after second dose. The patient's past medical history included Seizure with from 2-month vaccine, thinking it was from pertussis in the DTap. The patient's family history was not provided. Concomitant medications included IPOL on an unknown date. On 08-Aug-2018, the patient received a third 0.5ml dose of suspect HIB (PRP/T) VACCINE lot UI910AA, expiry date 18 Nov 2019 via intramuscular route in the right thigh instead of PCV-13 vaccine not produced by Sanofi Pasteur lot number not reported. It was an actual medication error due to wrong vaccine administered and extra dose administered. 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Within four (4) hours of injection I experience  sensations of  mild ?electrical? vibrations, throughout my chest area; plus a head ache.  By 11 p.m. I felt unstable on my feel but d/n fall.  Throughout the night, in bed, those sensations/discomfort continued. I was told symptoms were within norm.  Finally, at 5 p.m. 10/8/21 ? I took two (2) Tylenol Tablets. The symptoms were greatly reduced.  Today, 10-9/21 ? I am NOT back to normal but the electrical sensation in heart area is gone. Still, mild head ache and not ?bouncing? down the stairs.  I have had almost every vaccination on the market Polio, Measles,  Shingles, Flu, Etc. ?- I have NEVER experienced the discomfort of any Vaccination product like with Modern #3!  Thankfully ? day three (3) is better! I will see my doctor 10/12 for regularly scheduled appointment.
Redness and swelling of most of the left arm- She just started prednisone- pt put on Prednisone 9/9/19
Expired vaccine was given. Vaccine had been expired for four days.  Moderna has been notified and we are waiting for a response from them as to what the next steps are.  Update: Moderna informed clinic today; "The vaccine administered on May 24, 2022 from lot number 033K21-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."
Bilateral Sensorinerural Hearing Loss; Ramsey Hunt Syndrome; Paralytic Lagophthalmos; Exposure Keratopathy; Severe Ocular synkinesis; tinnitus; herpes zoster; This spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation on 10-AUG-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around 23-AUG-2010, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient suffered left sided facial paralysis, blisters, ringing in her ears, and vision problems and was diagnosed with herpes zoster, bilateral sensorineural hearing loss, tinnitus, ramsey hunt syndrome, paralytic lagophthalmos, severe ocular synkinesis, and exposure keratopathy. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient symptoms had resulted in physical limitations not presented prior to using Zoster Vaccine Live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of the events was considered as not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events deafness neurosensory, herpes zoster oticus, and paralytic lagophthalmos were considered to be medically significant.
Productive cough (phlegm); Pain in left leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCTIVE COUGH (Productive cough (phlegm)) and PAIN IN EXTREMITY (Pain in left leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced PAIN IN EXTREMITY (Pain in left leg). On 26-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCTIVE COUGH (Productive cough (phlegm)). On 01-Jun-2021, PAIN IN EXTREMITY (Pain in left leg) had resolved. At the time of the report, PRODUCTIVE COUGH (Productive cough (phlegm)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  The pharmacist recommended ibuprofen for pain in leg but the patient denied using it. The HCP did blood work 2 days before the shot and 2 days after the vaccination for comparison but no discrepancies were reported.
no other AEs reported; improperly stored dose of VARlVAX was administered; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.   On 19-JUN-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 injection, lot # T032322, expiration date 22-SEP-2022 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced temperature excursion of 28 degrees Fahrenheit for 4 hours. There was no previous excursion reported. Digital data logger was involved. There was no additional adverse event reported.
Felt cold; headache; mild body aches; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Felt cold), HEADACHE (headache), PAIN (mild body aches) and PYREXIA (slight fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced NASOPHARYNGITIS (Felt cold), HEADACHE (headache), PAIN (mild body aches) and PYREXIA (slight fever). At the time of the report, NASOPHARYNGITIS (Felt cold), HEADACHE (headache), PAIN (mild body aches) and PYREXIA (slight fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 101 degrees Farenheight.         No relevant concomitant medication was reported.  Treatment information was not provided.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 58-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). The patient's past medical history included cancer (at unknown site). On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a month after receiving SHINGRIX, the patient experienced headache. On an unknown, the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The case was reported by registered pharmacist (Rph). The patient received a dose of SHINGRIX in left deltoid. Only partial information was provided by the pharmacist.
immunocompromised patient received booster dose instead of third dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient received booster dose instead of third dose) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (before second dose. She may had it later on, but not positive. Not sure of exact date.) in May 2021. Concurrent medical conditions included Immunocompromised, Reaction to preservatives (food preservative) and Seasonal allergy (regular seasonal allergies). Concomitant products included DICLOFENAC for Antiinflammatory therapy.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 14-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient received booster dose instead of third dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient received booster dose instead of third dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported she may have had COVID19+ later on, but not positive. Not sure of exact date.No treatment information was reported.   This case was linked to MOD-2022-508410 (Patient Link).
chest pains for a week, uncontrollable gushing nosebleeds, severe headaches,
Allergic reaction from shingles shot Friday. Received Shingle vaccination Friday on left deltoid muscle. Saturday, developed painful red lump on left upper arm with redness and itchiness, fever/chills. Per patient, also with painful lymph nodes left under arm. Left upper arm (deltoid) with redness, indurated. Vitals: most recent BMI: 31.4 Temp: 98.8 F [37.1 C] (08/05/2013 10:21) Pulse: 97 (08/05/2013 10:21) Resp: 18 (08/05/2013 10:21) BP: 135/75 (08/05/2013 10:21) Pain: 8 (08/05/2013 10:21) Pulse oximetry: Measurement DT POx.
Syncopal episode  17 minutes after shot (not immediate) Evening of shot- very sleepy , some blurred vision, low grade fever Next day- axillary lymphadenopathy  large on same side, fever. 2days- headache, drowsy, low grade fever,  eye pain
PM following IZ, pt developed sore throat, HA, fever and chills. Seen back in Health Center next day . Pt had fever of 102 degrees F, b/p-140/80,P-112. Nasal congestion, throat injected zero exudates, lungs clear, heart SI SIIreg rr. Rapid strep(-),Tx with ibuprofen, rest, fluids and to follow up in 24hours.
Crying and agitated for hours. Myoclonic jerking of head while awake and asleep-will be going to neurology for eval.
Vaso Vagal episode, diaphoretic with chest tightness (nausea, almost fainted)
Pt recv vax on 1/19/99; on 1/23/99 pt exp fever (104) x 36 hr, eyes rolled back-very fast eye movement
Fever, muscle aches, cough, shortness of breath, nausea, vomiting, headache, loss of taste and smell, congestion
pt recv vax; elev T in pm;to er @ 9pm; high pitched screaming;Motrin given;
exhaustion, headache, hypertension, intermittent tachcardia, premature contractions, bounding pulse,
Fever shortly after vaccination, patient with osteosarcoma s/p BKA, sent to EC for evaluation of fever - patient has central
Received vaccination around 10:15 AM and began experiencing soreness in left arm around 1 PM. Consumed regular diet and drank about 2 L of fluids until 6 PM. Laid in bed around 5 PM and got up at 6 PM to urinate. Felt fine, just a bit tired and sore arm.   While urinating, experienced slight nausea. When washing hands, experienced dizziness and lightheadedness. Attempted to stabilize self on doorway of bathroom and quickly after exiting bathroom, lost consciousness and fainted. Remained unconscious for a couple of minutes and returned with full clarity and processing, but weakness. Checked bp about 3 hrs later and was very low, with orthostatic numbers even lower. Fever measured at 100.5 F. Took 250 mg Tylenol and hydrated.   Days later, bp remains low -- Friday, one day after: standing - 81/57 with temperature of 101.4 F, remaining entire day, with fatigue, joint pain, muscle cramps.  on Monday: 86/64, with fatigue, no fever   Bp is usually on lower side of healthy range, but no history of clinically low blood pressure, nor orthostatic bp.
The first shot, everything was fine. I had the normal side effects. The second shot I received on 05/08/2021, I felt fine afterwards, there were normal side effects. That following Monday 05/10/2021 I started to have pain in the labia minora, swelling in the vaginal canal, and general vaginal discomfort. I went to the doctor the following Monday (05/17/2021), my doctor told me I was having a HSV-2 (Herpes simplex) breakout. I had been diagnosed with HSV-2 four years before in November of 2017. This shocked me because I have not had a breakout since my initial breakout in November of 2017. I have taken 1 gram of  Valacyclovir every few days (2-3 times a week) for the last four years as recommend by my primary care doctor. I firmly believe that the second dose of the vaccine triggered something in my body that caused the herpes breakout. As of today (05/24/2021) it has not gone away. I look forward to more developing research and hopefully my testimonial will help collect data and information as the possible side effects of this vaccine. Thanks.  * I want to note I have NOT had ANY other side effects at all. *
Approximately 30-60 min after vaccines given pt became unresponsive x 10 min. No cyanosis, was breathing, but did not move or resp. to stimuli. For next 20 min, pt sleepy. After 30 min, pt was back to baseline. Pt referred to ER. NL exam. No testing done.
fatigue 3 days, swollen painful lump lymph node under right arm 3 days, headache 1 day, painful at injection site 4 days
2/14/2018 Developed pain/redness inflammation following a dose of immz. given 2/12/18.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 25th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, cold, lethargy, shivering, myalgia and headache. On an unknown date, the outcome of the injection site pain, cold, lethargy, shivering, myalgia and headache were recovered/resolved. It was unknown if the reporter considered the injection site pain, cold, lethargy, shivering, myalgia and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. After receiving SHINGRIX, the patient experienced reported side effects.
Tested positive pre-op for COVID. Vaccinated x3. Worsened and presented ED, was admitted for COVID pna. Treated with O2, steroids, rocephin, azithro, eliquis, singulair, remdesivir. Improved and was dc home.
Patient had Covid-19 infection Dec 27 2021.  Had dose 1 of Covid-19 vaccine 1/19/2022 and then 5 hours later started with itching on back of neck but no rash. In the morning after waking on 1/20/2022 was noted to have erythema on forehead and slight erythema on cheeks. Not urticarial, and not itchy. Came into office for evaluation in the afternoon and noted to have rash as described. No urticaria. Got oral Benadryl without resolution of rash and approximately 4-5 hrs. later received Zyrtec and erythema started to decrease. In the am of 1/21/2022, erythema had resolved.
This spontaneous report as received from a pharmacy technician refers to a 41 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 13-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Pt presented to COVID Clinic at 1220  after receiving the vaccine at 1030 complaining of headache and body aches , but denied wanting to go to the ER.
07/04/02- broke out in a rash on face and some on chest. 07/07/02 Rash on arms and legs and itching. Saw Dr, Dr stated not vaccine related-due to weeds child played in.
Shoulder pain and reduced range of motion in arm where shot was given immediately after given. Had chills 4 hrs. later. Pain still cont and can't lay on shoulder in bed. Also, vomited w/chills.
Initial misuse report received from a healthcare professional on 26 September 2013. A child of (age reported 3) unknown gender received FLUZONE 0.25 ml on an unknown date. The patient received incorrect dose of vaccine. No adverse event was reported. The list of documents held by sender: none.
Rec'd. vx for foreign travel on a Friday.  Over the weekend, developed fever followed by rash all over body (sm. red bumps, no vesicles or blisters).  Pediatrician ruled out chickenpox; prescribed Benadryl.
Pain and ache  in area of injection.  In evening also felt ache around my neck and shoulders. Slightly swollen and red dot around injection area.
"Covid Arm" the area around the site of injection is red and itchy. Approximately 2" diameter.
p/vax pt devel a rash w/more than 50 disseminated lesions & a fever of 102 to 103;it was not known if the child had had exposure to chickenpox @ the time of vax;pt sought unspecified medical attention;
Fever 101.3F, fatigue, body aches 12/20 2245 Chills overnight & cough, fatigue remain  12/21(time of this report).
Felt shock and pain when nurse injected high on the Deltoid of left shoulder, ping pong size knot developed. 10-16-15 significant pain in arm, muscle atrophy in deltoid, 11-11-15 noticed atrophy in shoulder blade. Constant burning in entire are, side of neck and shoulder blade. Pain medication for pain, physical therapy started 11-11-15.
SM developed HA approx 4 hrs after receiving a booster dose of anthrax on 7/13/09.  Went to bed with the HA and woke up with the HA.  No N&V or photophobia with HA.  Denied any previous h/o HA.
Pt felt dizzy after shot given but then felt better.  Went to pharmacy where her vision clouded, has brief clonic jerk of her arms, then started to crumple (was seated in chair).  On my arrive pt extremely pale, and pulse quite low.  Before could count HR, it accelerated to high 90's, BP systolic in mid-90's, and color came back.  Came back to pediatrics via wheelchair until felt back to baseline.  Orthostatic VS normal at discharge.
Symptoms lasted a year. Pain from shoulder to wrist on both arms numbness and tingling, high blood pressure, lost of since of balance.
Information has been received from a registered nurse concerning an 6 year old patient who was vaccinated with a dose of Zostavax instead of Varivax. It was reported that it was due to nursing error. No symptoms were noted. A product quality complaint was not involved. Additional information has been received from the registered nurse who stated that the event occurred because both vaccines were stored in the freezer and an employee grabbed the wrong box. It was noted that the employee was new and was just confused. It was reported that they have now put a tape on Zostavax that says it is for adults only. Additional information has been requested. This is one of several reports received from the same source.
Hives lasting 3 days, sweating, nauseous, light headed, ill feeling, pain in injection arm. Pain in joints after a couple days.
After the shot I started to have shoulder and arm pain. The next day I continued to have worsened pain and started to feel tingling and numbness down the whole arm and into the  hand and fingers.  The pain has now continued for over 2 weeks. During a visit with my Cardiologist 2 weeks after the shot I mentioned the pain. He prescribed me Ibuprofen for the pain and inflammation. That night after seeing the Cardiologist I started looking online and saw that my symptoms could be a serious problem and possible condition called Brachial Neuritis that can occur following a flu vaccination, so I made an appointment with a Neurologist who examined and referred me for physical therapy and has mentioned that we could do a EMG test  following the physical therapy.
Got first dose of the vaccine 2 months ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got first dose of the vaccine 2 months ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    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 DOSE OMISSION ISSUE (Got first dose of the vaccine 2 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Got first dose of the vaccine 2 months ago) had resolved.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
it was rpt by MD concerning pt 5-10 min p/ vax pt devel giant hive at inject site on leg. 2-3 wks later little vesicles & a 2x4 cm area of induration @ inject site.