chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose 3 months prior to the 2nd dose. The patient had only 1 to 2 days of pain at the injection site. The patient had not yet seen her healthcare professional. The reporter did not consent to follow-up. The reporter stated it was related to patient. For tolerance to next dose, refer case US2019000455.
Awakened @ 1:00 am with heart palpitations and headache.  Called nurse hotline and described symptoms...nurse asked many questions and advised me to go to emergency room to be evaluated.  Emergency room performed ECG, blood work and results were negative for any other problems...also administered Ibuprofen.  After Visit Summary was printed @ 8:42 am and I was released from Emergency Room.
Mom called and stated that child was diagnosed with orthostatic intolerance on 8-16-16 by cardiologist. Mom also stated that child started falling after receiving vaccines on 8-5-15. Child has been under the care of pediatrician, and has been seen by neurologist and another cardiologist.
Information has been received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported. On 04-DEC-2018, the patient was vaccinated with improperly stored VARIVAX injection, for prophylaxis, lot number R009821 with expiration date in 03-APR-2020 which was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (dose, strength and anatomical location not reported). The VARIVAX was stored at a temperature range of -9 degrees Celsius (°C) to 8 °C (2.8C) for the time frame of 37 hours. There was no previous temperature excursion and the call was because of a data logger. No adverse effects reported. This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1812USA010605: US-009507513-1812USA010604: US-009507513-1812USA010606: US-009507513-1812USA008007:
Pain and slight bruising at the injection site, immediate significant pain when the serum itself was injected, swelling, pain, inflammation, redness of the muscle where the injection was made starting almost immediately, significant itch began two days later.
Severe chills, loss of control of arms/legs, hyperventilation, fever, stutter in speech, sore joints, duration 3 hrs then stopped then reoccurred for 2 hrs.  1/22/08 Reviewed vax record & hospital records which reveal patient experienced severe shaking chills, fever, diaphoresis, uncontrollable shaking in extremities, spasms of hands on day of admit.  Admitted 12/27-12/29/2007.  Temp on admit 38.6 & continued to be febrile until AM of d/c to home.  FINAL DX: Fever w/o obvious infectious source, possible adverse reaction to Tdap vaccine.
I got the normal fever, aches, chills, headache 2 hours after I got the shot and it lasted 2 days. By the third day I began feeling short of breath while talking.  The shortness of breath (SOB) lasted 3 days and was present for about half a day each. Then it all went away. On tuesday, Feb 16th, I began to feel SOB again but this time under my L breast I had pain. I tried to see if it was muscle (I am a PT) but could not tell. The next day the pain moved near where my sternum meets my ribs and then I worked on that and it has been there ever since. It feel heavy and I get chest discomfort on inhalation. I have seen primary care, they said to wait a few weeks and let them know if it is still there. I decided to report my symptoms now because I thought it would go away but it still has not and it does not seem normal to me. I did notice if I take an aleve it feels better but today that has not helped either. I hear that this vaccine can cause inflammation and so I am just wondering is this normal for what I am feeling?
pt recvd vax & exp metallic taste in mouth & numbness of lips & tongue; numbness dec p/waking the following morning 29OCT93;
Came down with shingles months after vaccine. Felt very fatigued and weak starting 7/30/21. Noticed itchy rash starting 8/6/21. More itching than pain. Very swollen lymph node in underarm. Went to clinic a week later
confirmed no reaction or other AE in patient; both were administered to a single patient after they undergone 4 total high temperature excursions; This spontaneous report was received from a Registered Nurse and was referring to a 11 week old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.   On 28-SEP-2020, the patient was vaccinated with a dose of improperly stored hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # R006746, expiration date 09-NOV-2020, (strength, dose, dose number, frequency, route or anatomical location were not reported) as prophylaxis. On the same date, the patient was also vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ), lot number 1676327, expiration date 19-APR-2021, (strength, dose, dose number, or frequency were not reported), orally as prophylaxis. Both, hepatitis b vaccine (recombinant)(RECOMBIVAX HB) and rotavirus vaccine, live, oral, pentavalent(ROTATEQ) experienced the following temperature excursion: on an unknown date in August 2020, first excursion, 49,1 Fahrenheit degrees during 15 minutes; on 09-SEP-2020, second excursion, 46.6 Fahrenheit degrees during 1 minute; on 17-SEP-2020, third excursion, 46.9 Fahrenheit degrees during 8 minutes; on 20-SEP-2020, fourth excursion, 46.8 Fahrenheit degrees during 6 minutes. The digital data logger was involved. The reporter confirmed that the patient did not experience any reaction or adverse event. The reporter also stated that she did not have anything further to report for this case.
Cold Hot Chills Itching Hives Flushing Clamy Change in Vision 4weeks of Migraines Ankle and Feet Sweating
ACUTE NON ST ELEVATION MI ACUTE PULMONARY EMBOLISM 10/15/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pt was complaining pain and loss of sensation traveling down from left arm. He's currently taking Medrol dose pak and hydrocodone. Patient has contacted the MD office as well.
Patient was admitted with community-acquired pneumonia and UTI was treated with a week of antibiotics with good resolution. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
shingles; pain on left chest and under arm; redness on chest; lack of sleep; tingling feeling on left chest; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) (batch number 5JT9C, expiry date 28th August 2021) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix. On 14th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 15th August 2019, the patient experienced tingling sensation. On 17th August 2019, the patient experienced chest pain, localized erythema and sleep loss. On 21st August 2019, the patient experienced shingles. On an unknown date, the outcome of the injection site pain and tingling sensation were recovered/resolved and the outcome of the chest pain, localized erythema, shingles and sleep loss were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, tingling sensation, chest pain, localized erythema, shingles and sleep loss to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had injection site pain, tingling sensation, chest pain, localized erythema and sleep loss and shingles. The wife of the patient reported that her husband planned to continue follow up with his physician on an unknown date. The reporter consented to follow up. This case linked with US2019157548, reported by same reporter.
Patient had an adverse reaction from the second shot on n 5/29/21  He began to shake violently as if having a seizure.   Extremely cold and extremely weak.     We did a tremendous amount of prayer worldwide and also treated appropriately with fluids and blankets.  On 6/14/21, my husband suffered a massive heart attack and coded for 3-4 minutes in the ER.  He was then hospitalized in the ICU/COVID Unit (that's right, they said he was COVID positive).  No way!  He also had COVID in April as well as myself (wife).    He was administered many many tests over and over and they put two stents in his right artery totheheart.
TWO DAYS AFTER VAX, PT EXP ECCHYMOTIC AREAS ON LEFT ARM AND UPPER ABDOMEN.  AREAS ON ARM INTERIOR WRIST AND ON UPPER ARM JUST BELOW ELBOW. ECCHYMOTIC AREAS ON ABDOMEN ARE ABOVE UMBILICUS. PT DESCRIBED AREAS AS "SORE". 5-25-90 NO TREATMENT
BP 215/114, pulse 114, week, dizzy, lethargic, BP continued to be above 100 bottom until 3:00 pm and then was 186/96, pulse 102 4:30 pm BP 178/78, pulse 83.
other zoster-related conditions; shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unspecified age and gender. No information was provided regarding the pt's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On or about 01-FEB-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date after receiving zoster vaccine live (ZOSTAVAX) (reported as "subsequent"), the pt was treated by an unspecified healthcare provider at a emergency room for shingles and other zoster-related conditions (Ill-defined disorder). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of the events was considered not recovered and causality was related to zoster vaccine live (ZOSTAVAX).
injection site started to itch  and has a red area with a slight lump. Took one week to develop.
This case was reported by a pharmacist via call center representative and described the occurrence of burning sensation in eye in a female patient who intended to administer SHINGRIX (batch number 32PE4, expiry date 23rd January 2021) for prophylaxis. On 17th July 2018, the patient received SHINGRIX. On 17th July 2018, immediately after receiving SHINGRIX, the patient experienced burning sensation in eye, inadvertent exposure to vaccine and exposure via eye contact. On an unknown date, the outcome of the burning sensation in eye was not recovered/not resolved and the outcome of the inadvertent exposure to vaccine and exposure via eye contact were unknown. It was unknown if the reporter considered the burning sensation in eye to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that the adjuvant accidently squirted into her eyes when attempting to mix the SHINGRIX vaccine, which led to inadvertent exposure to vaccine, and exposure via eye contact. She felt some burning and rinsed with water. After rinsing she still felt a little burning feeling. The reporting registered pharmacist called immediately following the event requesting information from Medical Information (MI). Her call was transferred to MI.
On the day of the shop my face became numb on the left side.  By the next morning my ankles were swelling and my blood pressure was excessively high.  I had a pain in my lower back by the 4th day.  It has been about 5 months and I am still having spikes in my blood pressure and just had a terrible kidney infection.
Woken up at 0300 by severe headache along with body aches, fatigue, nausea and diarrhea. H/A and body aches lasted for aprox 8-10hrs., continued to have nausea, diarrhea and fatigue for about 24 hrs after initial incident. Symptoms have resolved as of today. Denies any other symptoms.
Patient presented to the ER 12/16/16 seen in outpatient office 12/15/16 given PNEUMOVAX 23 vaccine and was admitted to the hospital-This patient is a 46 y.o M who has a history of DM type 2 who presents complaining of fever, nausea, diarrhea, myalgias, and headache for the past 24 hours. He feels mildly short of breath "like I keep having to take a deep breath every now and then." The patient had his first ever pneumonia shot into the left deltoid muscle yesterday at 1000. He has mild soreness in the left upper arm but no rashes or significant pain. He rates his total level of pain at a 5/10 at this time. No complaints of cough or vomiting. No abdominal pain or chest pain. Treatment:IV fluid, consult Infectious Disease, IV antibiotics Vancomycin, negative blood cultures.
A 17-year-old patient was inadvertently given the Johnson & Johnson COVID-19 vaccine approved for 18-years-old and older.  No adverse reactions were notes at time of vaccination or during observation time.
Rash 1 1/2 - 2 h after flu shot.  Rash on legs, face upper body.  Eyes & neck itchy.  Slight tightness in chest.  Took BENADRYL.  Rash improved but not gone.  Advised to report to PCP.
patch of red warm skin on the arm around the injection site about the size of a postcard. pt complained of itching, as of 1/29/2021 it is clearing up
Per screening questionnaire patient was to be observed x 30 minutes. At 30 min after receiving covid vaccine, c/o feeling hot and dizzy. Skin warm and dry. Dr. notified. Dr. assessed patient.  Vitals  taken 191/99 rr 24 hr 98 100% on room air. Per Dr. continue to observe patient. Patient brought to lie down on gurney. RN at gurney observing patient constantly, with intermittent vital signs.  Stated, "chest pressure." persist.s After observing patient for 60 minutes, BP more stable at 167/82 with 100% Pulse ox on room air. Dr. requested a 911 call for transport to KP Fremont for further assessment of chest discomfort. Transfer by EMS at 1445 to Kaiser Fremont Emergency Department. Last vitals signs prior to transport: BP   167/82 hr 92 rr 20 99% on RA. Continues to  c/o non-radiating chest pressure 8/10.  Points midsternum as source of pressure. Pt. awake alert and orientedx4. Assisted by EMS to gurney for transport.
eating now; got bad flu 25 Christmas still sick couldn't get out of bed for 5 days; Initial information received on 05-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who received Influenza vaccine and had got bad flu 25 Christmas still sick couldn't get out of bed for 5 days but eating now.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Dec-2022, the patient received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site with unknown form, strength, frequency, expiry date for Immunization.  On 25-DEC-2022 the patient got bad flu 25 Christmas still sick couldn't get out of bed for 5 days (influenza) (latency: 8 days) after the administration of Influenza vaccine.  On an unknown date, the patient had eating disorder (unknown latency) after the administration of Influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome : Not Recovered / Not Resolved for influenza and was Recovered / Resolved on an unknown date for eating disorder.
Patinet received improperly stored pedvax; no adverse event; This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-JUN-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S023646; expiry date: 31-MAR-2022) via unspecified route for prophylaxis (product storage error). The vaccine was stored above the temperature of 47°F/9°C 9.15C for 15 minutes. The vaccine had a previous temperature excursion of above 47°F/9°C 8.62C for 11 minutes. The call was because of a digital data logger. No additional adverse effect reported. The outcome of the events was unknown.
Intense soreness in injection site (right arm), headache, weakness, stiffness, pain & numbness & tingling throughout face & body, tiredness, dizziness, unrestful sleep, blurry vision, loss of coordination, chronic fatigue, slower movements, difficulty accomplishing ordinary tasks.
L deltoid injection site swollen, red and warm when touched. Mother did not give any Tylenol or compress to site.
48 hours after receiving booster, woke up with gross hematuria. Was treated for UTI even though gross hematuria was only symptom. 3 weeks later started with gross hematuria and blood clots in urine and experienced bladder retention. Was hospitalized for blood clots in urine  and was catheterized and put on continuous irrigation until clearing. Had blood tests,CT scan and ultrasound with no definitive diagnosis.
Starting on Thursday, Dec. 31, patient began having shoulder and neck tightness.  That night patient began having chills, and noticed redness at the vaccine sight and then the redness started streaking.  Also complaints of itching at the vaccine sight.  Started taking Tylenol for the two days following the vaccine, states feels like it is improving.  Referred to PCP for evaluation. Has appt. Monday, January 4th
FATIGUE, FLU-LIKE SX, ARM SORENESS Narrative:  ALSO STATES "CLOUDY IN MY HEAD"  Other Relevant History:
Scalp started itching Scalp started itching and felt like wanting to pull the head off; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (Scalp started itchingScalp started itching and felt like wanting to pull the head off) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced SKIN IRRITATION (Scalp started itchingScalp started itching and felt like wanting to pull the head off). On 21-Feb-2021, SKIN IRRITATION (Scalp started itchingScalp started itching and felt like wanting to pull the head off) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I encountered a skin reaction.  I had white circular spots around skin and shading areas on limbs (arms and legs).
onset pruritus immed p/inject; onset erythematous macular papular rash on arms/trunk/face & swelling hands approx 16-24 hrs p/inject; no resp distress; no fever; rash
My husband has it and we had the shingle set/ suspected vaccination failure; Shingles; Nerve damage Pain; you can get nerve damage for the shingles, my husband has it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: My husband has it and we had the shingle set/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), post herpetic neuralgia (Verbatim: Nerve damage Pain) and nerve damage (Verbatim: you can get nerve damage for the shingles, my husband has it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the post herpetic neuralgia and nerve damage were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and nerve damage to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, post herpetic neuralgia and nerve damage to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by patient wife via interactive digital media. The reporter reported that patient received both doses of Shingles vaccine set. The reporter stated that you can experience nerve damage for the shingles.  Because her husband had it and had to see a specialist, they said that they are going to work on it so he can stand the pain. The patient will always had the pain. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Flu like symptoms that were extremely intense that knocked me out and down. Severe headache. My blood pressure spiked. I have a job where I need to be on my feet, and getting this vaccine I was almost very to miss work, however I took the vaccine on a Friday and the symptoms lasted to about late Sunday. So 3 days. I did self care at home, I did not see a doctor for this. I had this reaction for the first vaccine as well so I was expecting it, but this 2nd dose it really hit me harder. Not sure if that was normal or just my body just reacted more poorly to the 2nd one because I was expecting it.  I contracted covid sometime after, and I still have a linger cough and still no sense of smell. It was months after taking the vaccine. I took all the precautions and I work at a hospital and I used all the appropriate PPE, but I still came into contact with it because I do covid swabbing.
Rash on arm besides vaccination site but not surrounding it.  Sore and achy and very red 8 days after.  Did not occur until 8 days after.  Now 12 days after and there is still a red ring
May 5th - Red, swollen, hard in local area. May 6th area had gotten larger, hardest went away. Pt also notes sharp pain on her back directly after leaving hospital.