chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In February 2016, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2016, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. In November 2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Patient woke up next AM feeling "sped up" with chest tightness.   Feels her heart is beating faster and anxiety has increased.
currently 34 weeks pregnant, having large swelling at the injection site on my arm, it feels like there is a golf ball under my skin, it itches, burns and is bruised. I?ve had an upset stomach all day with no changes to diet, lack of appetite, extreme fatigue and my body is extremely sore. Every bone and joint in my body hurts as if I?ve got the flu. On top of all the my contractions have intensified since receiving the vaccine.
My arm started to become pruritic at the injection site around 7pm, the injection site felt very warm, swollen and tender. The next day the injection site was worse- more red, swollen and hot to the touch. I asked my friend who is a pharmacist and she said it looks like the injection was given too low on the arm. By 10pm on Wednesday 24th the site was starting to look red and purple as if it is bruising. The site has remained itchy through out this time as well.  I have applied numerous ice packs on the site for swelling but the swelling persists.
Mom states child with hard bump to child's left leg: states better today. Has been giving child Tylenol prn.
At approximately 6.20 pm on 04/24/21 patient during 30 min observation (high risk due to pregnancy) the Pt had hot flashes and asked for assistance. Cold packs were applied for comfort. On assessment at 6.25 pm HR 118, BP 158/90, RR 30, Sa02 99, AA&Ox4.  Patient still had hot flashes and became more nervous. At 6.30  pm HR 160, BP 146/90, RR 30, SaO2 99.  Transportation to ER was advised. The 911 system was initiated by on scene PD. Lung sounds were auscultated, clear and equal bilaterally in all fields. Pt's chest was flushed, however the Pt's chest remained flushed. No hives or weels were noted. The Pt denied itchiness or SOB. Pt did not appear to have increased WOB. **Continued**
p/vax pt exp burning at inj point; hands alternately numb & tingling; felt hot; all joints x/knees & ankles;pt knees & fingers sore; felt spacey; all symptoms went away w/in 36 hr
on 1APR93 severe urticaria which progressed to Stevens Johnson synd; conjunctivitis; 9APR93 rash & mucous membrane;
Erratic, irregular menstrual cycle. Increased cramps, and complete halt of cycle on 3rd day. Cycle continued almost exactly 24 hours after the pause, and was heavier.   Each subsequent period has had a halt on day 3 for almost 24 hours. The most recent cycle in October was even more erratic and would start and stop intermittently throughout the cycle. When cycle would restart, it would be exceptionally heavy. Cramps were worse and started much sooner than typical.   Period has been very regular for over 10 years. No change in medication, diet, habits, exercise, or work apart from 1st vaccine.
This spontaneous report was received from a physician, via a company representative, concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 30-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). On unspecified dates, the PNEUMOVAX 23 had two temperature excursions of 1 Celsius Degree for 168 hours and -1 Celsius Degree for 96 hours, respectively. The vaccine status was reported as "in excursion" and the type of excursion and storage criteria were reported as "refrigerator (R)". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Night sweats, Low grade fever, elevated heart rate, on going soreness at vaccination site, headache.  TYLENOL or NAPROXIN for fever/headache/pain, changed blood pressure med for heart rate (no change).
Patient called 9/15 to cancel second dose at md advice. States md dx pericarditis after first dose
shakes; aches that evening; sore left injection site arm; fever; shivering; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), PAIN (aches that evening), VACCINATION SITE PAIN (sore left injection site arm), PYREXIA (fever) and CHILLS (shivering) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced TREMOR (shakes), PAIN (aches that evening), VACCINATION SITE PAIN (sore left injection site arm), PYREXIA (fever) and CHILLS (shivering). At the time of the report, TREMOR (shakes), PAIN (aches that evening), VACCINATION SITE PAIN (sore left injection site arm), PYREXIA (fever) and CHILLS (shivering) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter   This case was linked to MOD-2021-408634 (Patient Link).   Reporter did not allow further contact
This spontaneous case was initially received on 09-Oct-2015. The case report was received from a Health Professional and concerns a pregnant patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 08-Oct-2015 - 08-Oct-2015, Batch no:T57505, Route of administration: intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 08-Oct-2015, the patient experienced received an IM (intramuscular) dose of AFLURIA that had expired on 30-May-2015. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment/comment: The reporter reported the term 'medication error' and assessed the case as non-serious.
burning from Tetanus Shot; Initial information received on 29-Jun-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 60 years old female patient who experienced burning from tetanus shot after receiving vaccine Tetanus Toxoid.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Tetanus Toxoid produced by unknown manufacturer formulation, strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization).Information on the batch number was requested.  On an unknown date the patient developed a non-serious burning from tetanus shot (vaccination site pain) (unknown latency) following the administration of Tetanus Toxoid.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (burning from Tetanus Shot).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event burning from tetanus shot.; Sender's Comments:  US-SA-2023SA201969:
second time was after having the Shingles Vaccine/Suspected Vaccination Failure; second time was after having the Shingles Vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles before vaccination) and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: second time was after having the Shingles Vaccine/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: second time was after having the Shingles Vaccine). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shingles two times and first time before vaccination. The reporter stated that it took 4 years before symptoms completely subsided. The doctor tried many types of treatments and none worked. That included pain management after medications did not work. The second time shingles was after having the shingles vaccine and was extremely less severe and gone within weeks. Both time it was treated with a viral treatment upon recognition. The reporter highly recommended the shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Patient stated that her lymph nodes in the right arm pit became swollen on Friday Jan 28, 2022. resolved by Monday night Jan 31, 2022
No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 12-month-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 14-APR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009090, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Lot number: FJ6381) at the age of 74 years, in left arm 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative, notes: after testing negative; (06Jun2022) positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical information: The patient did not receive any medications in two weeks. The patient had no known allergies and no other medical history. Recurrence ("rebound")of COVID symptoms and positive test on 06Jun after testing negative and no symptoms on 02Jun, without additional exposure. Also accompanied by acrid odour in nostrils.  No follow-up attempts possible. No further information expected.
Almost immediately I got a sharp pain in my right hip that persisted for a while. Then a generalized ache. A numb, novicaine-like sensation from my eyes, through my face, neck, and arms; down to my hands. my list first became shriveled and then swelled up to triple the size.  I had taken claritin previous to the shot as a prevention, &  benedryl when I went home at the direction of the on-site nurses. Saw my PCP shortly after.
On 3/7/2021 my body was aching and very sore. Later on 3/8/2021 headache, 3/9/2021 vomiting and diarrhea, 3/10/2021 I had aching muscles, 3/11/2021 I broke out in hives. 3/12/2021 I had anxiety very bad, arms gained a rash and hot. Went to the emergency room and was dehydrated was prescribed steroids' and benadryl. Loss hair and loss 10 pounds in two weeks. It also affected period, it started heavy and stopped. On 3/22/2021 I felt dizzy. On 5/21/2021 have muscle twitches and aches.
Patient pale and she said she was going to pass out. Did not pass, but was very pale.
Inadvertently administered the Moderna Covid-19 vaccine which has been exposed to more than 72 hours at room temperature and at the same time expired (06Nov2021) to a patient on 08Nov2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered the Moderna Covid-19 vaccine which has been exposed to more than 72 hours at room temperature and at the same time expired (06Nov2021) to a patient on 08Nov2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered the Moderna Covid-19 vaccine which has been exposed to more than 72 hours at room temperature and at the same time expired (06Nov2021) to a patient on 08Nov2021). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered the Moderna Covid-19 vaccine which has been exposed to more than 72 hours at room temperature and at the same time expired (06Nov2021) to a patient on 08Nov2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
33 Y O female presents with redness and knot and warmth to left upper arm. She received the moderna Covid vaccine about 9 days ago. Felt fine for couple of days without any reaction. However, she noticed the reaction mentioned above yesterday. Has applied cold pack, and rubbed with no improvement.
C/O Swelling of throat along with severe tenderness to site, fever, aches and nausea.
7-year-old patient given an adult dose (0.3mL purple top) of Pfizer vaccine.
This spontaneous report as received from a nurse practitioner via a company representative refers to a female patient of unknown age. Patient's current conditions, pertinent medical history and drug reaction/allergies were not provided. On an unknown date the patient was vaccinated with VARIVAX (Merck) injection (dose, route, frequency, lot# and expiration date not provided). Concomitant medications were not provided. On an unknown date, the patient had titers completed and the results showed a sub-therapeutic level for varicella. The patient had no other adverse effects. The outcome of the event 'sub-therapeutic level of response for varicella' was not known. The reporter did not provide the relatedness of VARIVAX (Merck) to the adverse event. There was no product quality complaint. Additional information has been requested.
Fever of 102 for several hours within 18 hours of injection. Lasted for 6 hours. On day 2 following injection,  fever of over 99 and nausea/heartburn. We will see what tomorrow brings.
Chest pain,dysphagia, dry cough, tachycardia with mild exertion, and profound fatigue 12 days after smallpox vaccination
Patient presented with acute onset neck pain radiating into her arms bilaterally on 4/25.  On 4/27 she acutely became paralyzed in her lower extremities and lose sensation over her abdomen completely and decrease sensation in her legs bilaterally. MRI confirmed large spontaneous epidural hematoma in cervical and thoracic spine.
Diarrhea/stomach cramps (72 hours); Diarrhea/stomach cramps (72 hours); Fatigue and sore arm (24 hours); Fatigue and sore arm (24 hours); HSV2 outbreak (1 week); Menstrual spotting; Hormonal mood swings; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:  EW0150) via an unspecified route of administration in the arm left on 01Apr2021 at 07:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included herpes simplex. The patient had known allergies to amoxicillin and pine nut. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had not received any medication within two weeks of vaccination. On 01Apr2021 at 12:00, the patient experienced diarrhea/stomach cramps (72 hours), fatigue and sore arm (24 hours), HSV2 outbreak (1 week), menstrual spotting and hormonal mood swings (first instance of spotting in history of menstrual cycle). The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, fatigue and sore arm was recovered on 02Apr2021. The clinical outcome of the events stomach cramps/diarrhea was recovered on 04Apr2021. The clinical outcome of the event HSV2 outbreak was recovered on 08Apr2021. The clinical outcome of the events, menstrual spotting and hormonal mood swings was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient with single Moderna vaccination on 12/08/21 who then tested detected for COVID and was admitted to the hospital on 12/25/21 with COVID complications.  Provider discharge note below:  "Brief Summary of Hospital Stay:  75 y/o M w/ PMH of hypothyroidism, LUTS, known COVID positive 12/19  ED with progressive SOB, weakness, cough. He was vaccinated (1st dose moderna) on Dec 8th.  In the ER he was noted to be hypoxic in the 70s on arrival and was placed on Bipap. WCC is 20K. Procal is pending. His lactate was high, wth some transient hypotension, and was given IV fluids. Initial troponin was 85 -> bumped to 145. No CP., EKG does not show anything acute. D-Dimer came back at 35K. CT was neg for PE but shows bilateral infiltrates. BP has improved with IV. He has been started on Rocephin, doxy, steroids, and Remdesevir. He is being transferred to facility, PCU. Pt was on BiPAP and transitioned to the NC oxygen during the stay. Pt failed walk test couple of times due to de-satting on ambulation. Pt received all 4 doses of remdesivier. Decadron continued during the stay. Pt's condition markedly improved, however still requiring the oxygen at discharge. Pt also mentioned about dysuria on 12/29/21 AM, however, UA was unremarkable. Pt and wife refused the home care support, but accepted the equipments such as shower chair and bedside commode, which we provided at the time of discharge. Pt to f/u with his PCP appropriately as he continue to improving with his oxygen requirements once discharged.   Pt's labs for globin was elevated. With the high suspicion of the multiple myeloma, we ordered the SPEP and UPEP prior to discharge and pt is updated. Pt to f/u with his PCP for the results on those labs upon discharge. This was an incidental findings and with the  Pt discharged on 12/30/21 with oxygen."
flu shot caused horrific pain in upper left arm,x-rays & mri done cannot move arm! !!!on meds but do not help. dr says nerve or muscle was hit
Patient complained of redness at the injection site and feeling hot and tender to the touch. Was able to move her arm however. Patient instructed to apply ice pack and take acetaminophen.
This is a prospective pregnancy case. This 35-year-old female subject was enrolled in a study. The subject received the 1st dose of Flu Seasonal QIV (intramuscular) .5 ml on 5th November 2014. The subject's last menstrual period was on 20th October 2014 and estimated date of delivery was 27th July 2015. The subject received Flu Seasonal QIV at week 2 of the pregnancy and during the first trimester of pregnancy. On 5th November 2014, an unknown time after receiving Flu Seasonal QIV the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown of the investigator considered the vaccine exposure during pregnancy to be related to Flu Seasonal QIV. Additional details provided: Called reported that she received FLUARIX QUADRIVALENT. She has received previous flu vaccines without any reactions. She denied other medications, vaccines or relevant medical history. She noted that vaccine it was given by the Nurse but she was not able to provide the HCP that oversees those. The reporter noted that she has not been given an EDD but by LMP date believes her gestation age is 8 weeks.
C/O redness, warmth, pain at injection site right arm. Seen by provider Dec 8, 2019. Antibiotics ordered. Care sought within 48 hrs.
Patient developed a fever of 100 degrees on 7/31 that persisted the whole week. The week prior to that she started feeling extra fatigued and nauseous. She lost 6 lbs. due to loss of appetite from the nausea. She went to urgent care and received a CT which showed no PE and lungs were clear. Fatigue was so severe some days it was difficult to sit and do work in her chair. Patient came into our office on 8/12 and labs showed reactivation of Epstein Barr virus.