chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from nurse refers to a 16 year old male patient. The patient's concurrent condition, medical history and drug reactions/allergies were not reported. The patient's concomitant medication included DILUENT MRK INJ (lot # R002036, expiry date: 25-JAN-2020). On 20-APR-2018 the patient was vaccinated with incomplete dose of Oka-Merck PROQUAD injection (dosing details was not reported) (lot # N028443, expiry date: 09-APR-2019) subcutaneous for prophylaxis, due to needle leakage from patient movement. No adverse effects were reported. No product quality complaint was involved. Lot number [N028443] has been verified to be a valid lot number for (Oka-Merck PROQUAD. Albumin status for PROQUAD is recombinant human albumin (rHA).
Information has been received from a Registered Nurse concerning to multiple unspecified patients (ages and genders not reported) who on unknown dates were vaccinated with improperly stored dosages at -11C for 63 hours, of VARIVAX (Lot numbers M006156, exp. 13-JUL-2018 and M006156, exp. 05-FEB-2018), subcutaneously for prophylaxis. Excursion temperatures were: -12C for 4 hours and 20 minutes; -8.5C for 13 hours; -8C for 3 hours and 40 minutes, and -12.6C for 1 hour and 40 minutes. No adverse effects were reported. The call was made because of a "data logger". Additional information has been requested.
Patient experienced extensive joint pain.  She stated the doctor diagnosed her with inflammation on the left bone marrow.  She now has stress fracture in the right foot.
Around 10:30 AM, started with mild fever (less than 100F), muscle ache, similar to flu-like symptom and pain at/around injection site. In the evening, my temp reached 100.1, and continue to elevate 100.4 (17:55PM). Took Acetaminophen then temp went down to 99.7F (18:28PM), and muscle ache has gone. Also the pain at/around injection site reduced.
3RD DOSE PFIZER COVID VACCINE GIVEN 12/2/21, LOT #1375151; pt admitted to hospital 7/20/22 after being diagnosed with positive COVID test on 7/13/21 at Rehab; on admission to hospital pt required BiPAP; broad spectrum ABX started, steroids, DuoNebs; pt hypotensive, treated with medications; Ventricular Tachycardia requiring defibrillator; CT scan of chest showed multifocal areas infiltrates bilateral lungs; family decided to make pt DNR  and keep defibrillator on; nocturnal NIVVM; pt's condition worsened; family chose to withdraw care and put pt on comfort care; pt passed away iin the hospital
Approx 3 weeks after the vaccine, she developed severe arthralgias and weakness affecting both hips and knees.
MMR vaccine given 8/29/06 about 1400, that evening noted numbness of right mouth and tongue swollen, 8/30 am, right eye unable to close and less movement. Right side of face, also headache back of head, blurred vision, 8/31 ER 1400 CT scan, lab tests, RX prednisone and referred to PCP and neurologist with diagnosis of Bells palsy.
COVID-19 symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 symptoms) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 symptoms). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported.  Company Comment : This case concerns an 82-year old female patient with no medical history, who experienced the unexpected non serious AESI event of Covid 19 Symptoms unspecified days after receiving first dose of mRNA-1273 Vaccine. Elderly age of the patient and current pandemic can be risk factors. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-451540, MOD-2022-451531 (Patient Link).; Sender's Comments: This case concerns an 82-year old female patient with no medical history, who experienced the unexpected non serious AESI event of Covid 19 Symptoms unspecified days after receiving first dose of mRNA-1273 Vaccine. Elderly age of the patient and current pandemic can be a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Systemic: Tachycardia-Severe, Additional Details: HR was about 190. happened on different days up to 5 days after vaccine lasting anywhere from 15min-3 hours. no issues observed during post- vaccination period
Rec'd Shingrix vaccine # 2 at clinic on 4/7/23 in her L deltoid.  Immediately afterward, her L deltoid was painful, but pain was c/w an IM injection, specifically c/w the 1st Shingrix vaccine that she rec'd in February.  The muscle pain was not out of the ordinary.  On 4/8, pt had fever 101.5, but that resolved.  Had nausea as well.  Reports a decreased ROM to L shoulder and L arm, which started on 4/8.  About 10 d ago, pt noticed a dull pain to her LH, L 3rd, 4th, & 5th finger and L wrist (dorsal and volar aspects), but the medial aspect of the LH and L wrist, as well as the L thumb are spared.  Pt has noticed a weakening of LH grip about 4-5 d, which she feels is worsening.  Pain exacerbated by gripping, extending wrist, fastening bra, waving, fastening seatbelt, and typing.  THese actions also cause her to notice the weakened grip more acutely.  She doesn't c/o n/t per se, but states that LH / L wrist feels 'heavy'.  Sometimes the pain radiates up her L lateral arm (w/ certain movements) up to the elbow and a little bit beyond the elbow.  Denies any hx of cardiac dz, HTN, HLD, or DM.  Denies previous issues w/ LH, LUE, L shoulder.  Denies neck problems.  She is RH-dominant.  Pt seen at Clinic for these LH/ LUE complaints on 4/26/23.  Phys exam conducted.  Grip is slightly weaker on L H, but strength is still 5/5.  No other weakness or decreased ROM noted to her LH, L wrist, L elbow, or L shoulder.  Neck is normal.  3+ L radial pulse, w/ + CSM to LH, w/ cap refill < 3 sec.  Referred to PCP for possible PT and possible imaging.
Hurting in the shot area; Hurting in the hip area; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Hurting in the shot area) and ARTHRALGIA (Hurting in the hip area) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Hurting in the shot area) and ARTHRALGIA (Hurting in the hip area). At the time of the report, VACCINATION SITE PAIN (Hurting in the shot area) and ARTHRALGIA (Hurting in the hip area) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported   No treatment information was provided
Information has been received from a consumer concerning her son who was vaccinated with varicella virus vaccine live. Over a year post vaccination, the patient developed "little red bumps" in different parts of his body and that went away after a day. No further information is available.
Pt received vaccine and developed erythema, swelling and tenderness of the upper left arm from shoulder to elbow.
the patient got undiluted pediatric vaccine...called pt an let her know, she called sunday morning and stated the pt had been running a fever all night and was vomiting...tried to call pt back later, they did not answer
SIDE EFFECTS; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (SIDE EFFECTS) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (SIDE EFFECTS). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (SIDE EFFECTS) outcome was unknown.            Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up contains report
This spontaneous report was received from a pharmacist referring to a 35 year old male patient. The patient's medical history, drug reactions/allergies, meanwhile, the patient's concurrent conditions included Human Immunodeficiency Virus (HIV). It was reported that, in April 2016, the patient had a CD4 count which result was 186 (units not provided). Later, on 12-MAY-2016, the patient was vaccinated with a dose of PNEUMOVAX23 lot number reported as: L7332, expiration date: July 2017, (strength, dose, frequency and route of administration were not reported) and PREVNAR 13 (Lot number, expiration date, strength, dose, frequency and route of administration were not reported); both for prophylaxis. No concomitant medications were reported. In June 2016, the patient had another CD4 count and the result was 312 (units not provided). Additionally, in July 2016 (reported as one month later), the patient received another dose of PREVNAR 13. No product quality complaints were involved. At the time of reporting, the outcome of the events was unknown. The Causality between the events with  PNEUMOVAX23) and PREVNAR 13 was not reported. Additional information has been requested.
The two days following the injection, I could not move my left arm. The pain was very intense and any movement or motion would create a sharp pain.  There was a slight swelling at the injection site, but nothing else visible. On the third day after the injection, upon waking up, I regained mobility of the arm.  After I receive flu shots, I will sometimes get a dull ache in my arm for the rest of the day, but this was much more intense and much more painful.   Yesterday, exactly one week after the injection, I began to develop a large rash at the injection site. It is itchy, swollen, and warm to the touch.  I have not experienced this previously with other vaccines so I am going to watch it closely.  I do not know for sure whether the rash is related to the vaccine itself, the injection, or the band-aid used afterwards. I will sometimes have a reaction to the adhesive on some types of band-aids, but that reaction is typically  instantaneous and does not itch.
Large, red and warm area at injection site. Advised patient to apply cool compress until swelling began to subside and report to physician if it continued to get larger.
Tinnitus - non stop buzzing /high pitched frequency in ears that has not gone away after 8 days. Headache/ neck pain that does not respond to Tylenol or Aleve.
Index and middle fingers in both hands broke out in what appears to be very similar rash to my nickel allergy; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK5730) solution for injection in the left arm on 28Dec2020 at 14:15 (at the age of 37-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included allergies to medications, food, or other products: nickel. Concomitant medications included ascorbic acid/biotin/tocopheryl acetate (BIOTIN GUMMY); ergocalciferol (VITAMIN D); and WOMEN'S ONE A DAY MULTIVITAMIN. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 30Dec2020, the patient experienced index and middle fingers in both hands broke out in what appears to be very similar rash to my nickel allergy despite the fact that I have not worn any jewelry or did anything out of the norm. Treatment was provided for the event rash included applying hydrocortisone and diphenhydramine (BENADRYL). The outcome of the event rash was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Patient reports having mouth itchiness about 45 minutes after receiving vaccination. She had already left vaccination site and noticed symptoms once she got home. The symptoms lingered for a few hours which prompted her to  return to site. Her vitals were stable and clinical exam was reassuring, no appreciable oral edema. Airway patent. Patient given 50mg oral Benadryl and monitored for 1 hour. On reassessment patient stated symptoms completely resolved and she was discharged to home.  She was advised to continue to monitor for symptoms, have someone drive her to follow up vaccination.
Site: Pain at Injection Site-Medium, Additional Details: Per pt, he stated that the shot was given too high and his shoulder started to hurt when he moves. However, per security camera, the shot was given within the deltoid area.
Type 1 DM, presented with DKA with pH 6.87 on 12/31/2012.
Immunizations given 05/31/02. Infant seen 06/01/02 with urticarial rash. Infant cheerful, normal exam, no fever. Infant seen again 06/03/02 with continued urticaria.
Small lump at injection site, also a red area around the injection site which got larger several days after the injection.
headaches,nausea,muscle aches and tightness in back and neck, fatigue, cough, weakness in legs, irregular breathing. Notified to take tylenol and drink lots of juices.
On the morning of 9/27/18, the patient noticed redness and bruising at injection site. On the morning of 9/28/18, the patient started experiencing vertigo, nausea, and headaches.
Pain on injection site, other arm; fever; terrific headache; aching ness; This is a spontaneous report from a contactable nurse (patient). A 77-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Feb2021 03:00 am at single dose at left arm for covid-19 immunization. Medical history included asthma, cll (chronic lymphocytic leukaemia), sulfa allergies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took prochlorperazine maleate (PCP) and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The patient experienced pain on injection site, other arm, fever both on 05Feb2021 with outcome of recovered on the same day, terrific headache for three days, aching ness for two days both on 05Feb2021 with outcome of recovered on unspecified date in Feb2021. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care.    Information on the batch/lot number has been requested.
My hands still go numb at night, had started to get better then increased in frequency and duration after the second shot COVID rash from first dose has not gone away  Primary issue with second dose was 4 days of severe hip/back pain in joint- had to stay off of feet, take pain reliever, and use heating pad for relief.
Patient presented to the ED with complaints of nausea and feeling unwell. She was found to be hypertensive with BP in the 220s/120s. Patient was started on a nicardipine drip and transferred to ICU for management. Patient remains in the hospital at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
No known adverse outcome. Administration error only. FK9896 administered after beyond use date of 4/1/22. Error reported to manufacturer to advise on stability of the vaccine and further treatment/revaccination.
Information has been received from a physician concerning a 14 year old female who on 17-NOV-2008 was vaccinated with the second 0.5 ml dose of GARDASIL (lot #660553/0070X). Concomitant vaccine included FLUMIST intranasal (cold adapted Ann Arbor master strain). On 22-NOV-2008 the patient developed sepsis shock, high fever, acute renal failure and coma after getting the second dose of GARDASIL and was hospitalized. It was unknown how many days the patient stayed in hospital. Subsequently, the patient recovered on unspecified dates. It was also reported that the patient did not experience any AE after getting the first dose. No additional information was provided. Additional information has been requested.  3/9/09 Received PCP medical records of 11/17/08-12/19/08 as well as partial hospital records. FINAL DX: encephalitis, septic shock Records reveal patient had sore throat & dx w/URI on 11/17/08 when received HPV #2 & flumist vaccines.  RTC 12/19 for hospital recheck w/residual hemipalsy.  Hospital records of 11/22-12/3/2008: FINAL DX: toxic shock syndrome of unknown etiology, posibly menstrual associated vs post vaccination; acute disseminated encephalomyelitis. Records reveal patient had 2 siblings w/N/V/D 1 week prior to her experienced right frontal HA, chills, fever, bilious emesis, right monocular blurred vision, abdominal pain, diarrhea.  Developed increasing confusion, lethargy, photophobia, emesis & became unconscious w/agonal breathing within 24 hours.  Intubated by EMS for respiratory failure, temp 103.3, posturing, pinpoint unreactive pupils.  Neuro, Neurosurgery, Ophtho, Heme & Renal consults done.  Developed DIC likely related to urosepsis & multiorgan failure, acute renal failure, right hypertropia.  Admitted to ICU & tx w/multiple IV antibiotics, steroids & pressors for low BP. Extubated 11/24.  Remained febrile w/injected eyes, swollen red tongue, rsh & abdominal tenderness.  Improved & transferred to inpatient neurorehab center.  3/12/09 Received additional hospital medical records of 11/22-12/3/2008 admit. Neurorehab consult revealed encephalitis of unknown cause w/cognitive impairment, gait disorder & visual deficits.  Accepted to rehab.
Fatigue; Nausea; Vomiting; Myalgia; Headache; Dose Number: 1 on 12Dec2020, Dose Number: 2 on 09Jan2021; This is a spontaneous report from a non-contactable other HCP. A 35-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose on left arm for covid-19 immunisation. Medical history included none. No COVID prior vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 12Dec2020 02:00 PM on right arm and experienced fatigue and a headache for 2 days. The patient experienced fatigue, nausea, vomiting, myalgia, headache on 09Jan2021. No treatment received for the events. Outcome of events was recovering. No COVID tested post vaccination.  No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
Pain at injection site day 2. Left arm rash and swelling and itching. Slowly dissipating over five days. Pain in arm.
Severe pain in left breast that lasted 4 months, had imaging, nothing was seen treated with ice and over the counter medication. Breast pain stopped after 4 months.  After vaccinated my periods became continuous, not stopping severe discharge, clotting. Saw obgyn who examined me, had internal sonogram amongst other tests. Dr recommended I wait it out, bleeding did not stop, finally saw another obgyn who advised surgery would be the only thing to stop this and then I saw surgeon and had a hysterectomy after 1 year of bleeding cramping and abnormal amount of discharge. Surgery was august 1, 2022
Sudden onset of pronounced and multiple hives in 8 inch (approx) square area of upper right back between base of neck and between spinal column and right shoulder.
NO ADVERSE EVENT, VACCINE GIVEN HAD BEEN MIXED WITH STERILE WATER MINUTES BEFORE INJECTION - NO FURTHER INJECTIONS GIVEN OUT OF THE MIS DILUTED VIAL
Flu like symptoms, fatigue, mild fever, arm soreness, headache. But mostly a large rash all over my torso front and back, arms and legs
Breakthrough case admission after 3 vaccines Moderna 2/25/21 Lot# 037K20A;  Moderna 3/25/21 Lot# 011M20A;  Moderna 7/18/22 Lot# 037A22B
Patient came in for flu and RSV vaccines and was administer flu and Shingrix (in error). No known physical adverse reaction occurred.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102 degrees F), ARTHRALGIA (Pain in joints), HEADACHE (Headache) and CHILLS (chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The patient's past medical history included SARS-CoV-2 test positive (Nasal swab) in October 2020 and COVID-19 (previous diagnosis of Covid-19 with a 100 plus degree F fever). Concurrent medical conditions included Hypertension (25 years). Concomitant products included LOVASTATIN for Cholesterol, TELMISARTAN for Hypertension. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PYREXIA (Fever of 102 degrees F), ARTHRALGIA (Pain in joints), HEADACHE (Headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Jan-2021, PYREXIA (Fever of 102 degrees F), ARTHRALGIA (Pain in joints), HEADACHE (Headache) and CHILLS (chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 102 (High) 102. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 19-Jun-2021 contained significant information: Concomitant products.
pt. vax w/ 1st dose hepatitis B & 5 days later exp distortion in peripheral vision.MRI revealed inflammed optic nerve through 3rd wk AUG.1st wk. SEP peripheral vision returned.
Headache Narrative: Headache, Swelling left shoulder (injection are),pain and discomfort on 1/14
This case was reported by a consumer via call center representative and described the occurrence of fever in a 52-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on 1st December 2018, for tolerance, refer case number US2019043008). On 1st February 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, injection site erythema, injection site pain and injection site swelling. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, injection site erythema, injection site pain and injection site swelling were not reported. It was unknown if the reporter considered the fever, injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received both injections (doses). The adverse events experienced after 1st dose of SHINGRIX were more intense compared to 2nd dose.