chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE information provided; MMR II was administered to three patients after the product's expiration date; This spontaneous report was received from an office manager concerning a patient of unknown age and gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 23-SEP-2022, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant Human albumin (rHA) (M-M-R II) 0.5 mL administered as prophylaxis, lot number T029549 with reported expiration date of 01-SEP-2022, however, upon internal review was determined to be 10-SEP-2022 (route of administration was not provided) (Expired product administered). The product it was stored appropriately prior to administration and had no temperature excursions according to the reporter. No additional adverse event information was provided (No adverse event).   This was one of three cases from the same reporter.; Sender's Comments:  US-009507513-2210USA010243:AE report #: 02276199 US-009507513-2210USA010314:
rash all over body; Itchiness on body; Cold chills; Joint pain; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over body), PRURITUS (Itchiness on body), CHILLS (Cold chills), ARTHRALGIA (Joint pain) and NAUSEA (Nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 03-Dec-2020.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced CHILLS (Cold chills), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and HEADACHE (Headache). On 30-Jan-2021, the patient experienced RASH (rash all over body) and PRURITUS (Itchiness on body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash all over and Generalized itching, at a dose of UNK dosage form and NAPROXEN SODIUM (ALEVE) for Rash all over and Generalized itching, at a dose of UNK dosage form. On 02-Feb-2021, CHILLS (Cold chills), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and HEADACHE (Headache) had resolved. At the time of the report, RASH (rash all over body) and PRURITUS (Itchiness on body) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Dec-2020, SARS-CoV-2 test: positive (Positive) positive COVID test on 03-Dec-2020, and went off of quarantine on 22-Dec-2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants were not reported. The patient mentioned that rash all over body gets inflamed when she is moving around or in the presence of heat. She also mentioned that it would "recced" for few hours after taking Benadryl.
Initially, no side effects Friday night, two and half days after the Wednesday morning vaccination I developed vertigo. The vertigo was severe and kept me in bed for one and half days. For the next seven to eight days (days 3-10 following vaccination), I experienced intermittent dizziness, fatigue, low energy, an "off" feeling that something just wasn't quit right, loss of appetite. After day ten following vaccination, all seemed to return to normal.
A week after vaccine, unexpected chronic GI issues (diarrhea, stomach cramping). No fever or typical symptoms. Spoke with healthcare provider and they suspected it may have been related to the vaccine.
This spontaneous case reported by a consumer, describes the occurrence of insomnia (can't sleep at night) and myalgia (left arm is still extremely sore) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced insomnia (can't sleep at night) and myalgia (left arm is still extremely sore). At the time of the report, insomnia (can't sleep at night) and myalgia (left arm is still extremely sore) outcome: unknown. No concomitant medication or treatment information provided.
23 y/o m referred to clinic by another clinic at 11 AM on 21MAY12. Patient received AVA #1, primary SPV and Typhoid Vi on 15MAY12. Patients presents to clinic with 3-day h/o of isolated sore inside left cheek (buccal mucosa) & under tongue at base of 2nd pre-molar on left. Oral lesions are sensitive ("sting") when in contact with warm liquids, citrus/spicy foods, toothpaste, etc. Patient also has a fine, isolated, pruritic, papulo-pustular lesion behind his right & left knees. which appeared yesterday (day # 5 s/p vaccines), as well as a fine, isolated, pruritic, papulo-pustular lesion on the tibial aspect of his rt lower extremity and one of the medial aspect of his left lower extremity, just above his ankle, which both appeared this morning (day #6 s/p vaccines). Patient states that these four fine, isolated, papulo-pustular lesions behind his knees and on his lower extremities are extremely pruritic. He had difficulty falling asleep last night secondary to the intense itching. These fine, pruritic, papulo-pustular lesions are follicular in appearance and appear to be consistent with Non-Viral Pustulosis (NVP) lesions s/p receipt of SPV. The patient denies any systemic malaise, fever, chills, HA, muscle ache, body ache, chest pain, pressure in center of chest or pleuritic SOB. His Jennerian pustule on his (rt) deltoid is consistent with evolution for Day #6 x/p SPV, w/o any significant erythema, warmth, streaking (lymphangitis) or axillary LAD. The patient is currently afebrile (98.9F), his BP is  113/72, HR is 70 regular and RR is 16. In NAD. Endorses moderate pain of "5"/10 localized in mouth upon ingesting warm liquids, citrus or spicy foods or with use of toothpaste. Patient denies HA, myalgias or arthralgias s/p receipt of vaccines. Endorses allergy to PCN. No food, shellfish or tree nut allergies. No allergies to latex or Neomycin. PMH is significant for h/o boils on lower extremities after bathing with soap. No recent change in soaps, detergents or shampoos. Patient denies a personal h/o eczema, atopic dermatitis, asthma, hay fever or psoriasis. He denies any chronic or autoimmune disease. Hosp/surg hx; Rt knee arthroscopy 2009. MEDS: ALEVER prn knee pain. Social hx: 23 y/o male with 2 (boys) ages 1 and 3 yrs. No smoking; No ETOH; No illicit drugs. IT Tech. Currently on work x 6 months. Start date: 28DEC05 (6 yrs). Family hx: M-55, living-fibromyalgia, cervical dysplagia/malignancy; Father - deceased at 50 yrs of age in log truck accident; Brother deceased at 19 yrs - shot. No first degree relatives to patient's knowledge with h/o eczema, atopic dermatitis, asthma or psoriasis. Knowledge with h/o eczema, atopic dermatitis, asthma or psoriasis.
Information had been received on 14-JUN-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 28-NOV-2012 at a pharmacy (name of pharmacy was specified) as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 22-JUN-2016, the male patient was treated by a physician at a medical clinic for a vesicular outbreak that was diagnosed as severe shingles.  On or about 02-AUG-2016 the patient was treated again for ongoing and worsening symptoms, which was diagnosed as post-herpetic neuralgia.  For management of his painful and chronic condition, the patient was prescribed Gabapentin, acetaminophen and hydrocodone (NORCO), oxycodone and acetaminophen (PERCOCET) and Hydrocodone-Acetaminophen to curb his discomfort. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
pneumonia; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient's husband) reported for a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter was asking for his wife who is scheduled to get a second dose tomorrow 22Apr2021. However, he wants to reschedule the appointment because the doctor informed them not to take the second dose yet because his wife (patient) has pneumonia. They might miss the second dose appointment. Outcome of the event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021454451 same drug and patient, different event and drug dose
Left arm has a hard painful lump at injection site, with different pigmentation at lump site: Mild. Pain with decreased range of motion. Pain shoots like lightening from injection site up into shoulder, neck and scapular area. Since injection time, progressively worsening.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On 12-FEB-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # and expiration date were not provided) 2 ml, oral. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
While playing on her phone in the waiting area, her left arm started to itch and when she looked down she had hives on her arm.  She notified the Paramedic  in the waiting  area and she was given Benadryl to take, pt chose to only take 1 pill at this time due to she drove herself to the vaccine clinic. She was watched for an additional 15 mins (total of 30 min observation); pt stated she felt comfortable to go home, denied SOB and dizziness.
12/04 Vomit p.m. after 11:00 p.m. 12/05 Facial edema A.M. upon wakening. 12/06 Facial edema. 12/07 Facial edema through 12/10.
I got sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I got sick". Additional information: My family took this (the vaccine). My family got sick. My neighbor took this. I got sick. And my sister told me they're getting sick from COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
she began to feel like she was straining to take a deep breath. When she would take a deep breath (like a yawn), she would do her best to stifle it as her chest would experience an immense pain while inhaling deeply/diagnosed with pericarditis; fluid had accumulated around her heart; headache/migraine; patient's lymph nodes on neck were causing her discomfort; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 25Mar2021 10:45 (Batch/Lot Number: ER8730) as SINGLE DOSE for covid-19 immunization. Medical history included "Hypothyroid" (hypothyroidism) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took guaifenesin (MUCINEX) and experienced allergies. On 31Mar2021, the patient's lymph nodes on neck were causing her discomfort which continued throughout. Around 1:00 am on 03Apr2021, she began to have a very intense headache/migraine. She began a regimen of Tylenol (8/day) and Advil (6/day) to mitigate the pain. Although the pain would diminish when she took these over-the-counter medicines, the headache never went away. In the evening of Sunday, 04Apr2021, she began to feel like she was straining to take a deep breath. When she would take a deep breath (like a yawn), she would do her best to stifle it as her chest would experience an immense pain while inhaling deeply. On Monday, 05Apr2021, went to a Clinic as she was straining so hard to breath. After numerous tests, she was diagnosed with pericarditis and, because of this, fluid had accumulated around her heart which was drained in a procedure called pericardiocentesis. They initially drained 230 ml and then 74 additional ml from a drain they had placed. The patient was hospitalized due to the events.  The patient underwent lab tests and procedures on 05Apr2021 which included Nasal Swab (sars-cov-2 test) with negative result. The outcome of events was reported as "recovering". The patient did not receive treatment for "patient's lymph nodes on neck were causing her discomfort" but received treatment for all of the other events.  Follow-up attempts are completed. No further information is expected.
iching; red flat spots in her pubic area, several on her breast, and belly as well as   a couple on her spine; sore left arm; genital rash; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and genital rash. On 24th June 2019, the patient experienced erythromacular rash. On 27th June 2019, the patient experienced pruritus. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the erythromacular rash, pruritus and genital rash were unknown.   It was unknown if the reporter considered the pain in arm, erythromacular rash, pruritus and genital rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on left deltoid. Several hours after the injection in her left arm, the patient developed red flat spots in her pubic area, several on her breast, and belly as well as a couple on her spine. The spots were flat and not itchy, and area a one fourth inch in size. The patient was a quick healer but that these are not healing. The patient stated on night the day before reporting, she noticed she was itching and mentioned that she thought she had lice as her head was itching. The patient took a Benadryl. The patients left arm was also sore for days after having the injection in her left deltoid. The patient reported previously having the older Shingrix vaccine and developing swelling in her arm. The patient stated the older vaccine caused her arm to swell to three times its normal size. The patient asked if she should have second dose. The reporter gave consent to follow up.
Suspected case of shingles; Rash developed on his face; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date unknown) for prophylaxis.   The patient's past medical history included shingles (mild outbreak).   On 29th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles was unknown and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: After receiving the 1st dose of Shingrix, the patient developed Shingles.  The patient reported that, the rash developed on his face on the side opposite of his previous shingles. outbreak. The rash resolved in one week. The reporter was consented to follow up.
6 hours after the patient's second COVID vaccine, she developed nausea, vomiting, and diarrhea. Over the course of 3 days, she had 2 episodes of BRBPR. CT with e/o colitis and diverticulosis. Pt was treated with a course of Augmentin for possible ischemic colitis.
Narrative: Patient is a 72 y/o male with PMH significant for HTN, HLD, CKD, RA, hypothyroidism, and COVID infection in 11/2020 complicated by DVT requiring stenting. He received the third dose of Pfizer COVID-19 vaccine on 9/7/21 with no immediate issues reported. On 9/9, symptoms including SOB and disorientation were reported to his PCP. Additionally, labs showed elevated WBC and LDH, indicating a possible infectious or inflammatory process; the patient was advised to report to the ED for further workup, however he did not report. Heme/Onc was consulted for further evaluation of lab abnormalities. Patient saw non-agency PCP who diagnosed patient with costochondritis. Provider consulted ID pharmacy for review of adverse effect who advised that there has been no association between costochondritis and the COVID vaccine reported in literature, and that event could be reported to VAERS if desired. Due to continued SOB and lower chest wall pain, patient presented to urgent care who ruled out pneumonia. At follow-up visit with agency PCP on 9/28, patient was advised to report to ED due to ongoing SOB, DOE, and lower chest wall pain. Patient was found to have moderate to large pericardial effusion and pleural effusion; dyspnea was suspected to be secondary to fluid overload. He was admitted for further workup and evaluation of possible CHF exacerbation. Diagnosis from cardiology includes pericarditis and myocarditis.
Abrupt onset of ongoing sneezing for 24+ hours. Very itchy throat and stuffy nose. Very similar to a seasonal allergy attack. I did not take any OTC or RX antihistamine medications for this (for fear it would interfere with vaccine effectiveness). I did take 2 ibuprofen approximately 28 hours after the vaccine to decrease pain and swelling of axillary  lymph nodes. It was around this time the sneezing and allergy symptoms resolved. At the time I write this, it appears all symptoms have resolved.
The day of the vaccinations and for several days following, I experienced body aches (muscular not joint pain), which was as expected. The morning following the injections for SHINGRIX and FLUCELVAX (09/10/18), I experienced tingling and numbness at all extremities, followed by vertigo and fainting. Brief loss of consciousness only, and was able to call 911 to request EMT response. I was barely able to remain conscious and experienced profound weakness in my limbs (e.g., difficulty raising arms, could not stand), my head felt numb, and then my throat began to close in the ambulance. The EMTs administered BENADRYL by mouth, which alleviated the swelling. This is what made me think of allergic response rather than a medical issue like stroke, cardiac or panic attack. Vital signs remained within normal levels, EKG test was normal, and I was able to stand on my own after approximately 6 hours. On 09/15/18, the area surrounding the SHINGRIX injection site became very red in color and hot to the touch approximately 2 inches in diameter (I have pictures of this), but this resolved after 36 hours without further spread. All body aches ceased by 09/15/18. I continue to experience some lightheadedness and will have a recommended follow up with a neurologist on 10/9/18. In addition, I noticed that previously existing tinnitus was markedly more pronounced (i.e., louder in volume and higher in pitch) for at least 48 hours after the event. Additional comment: I actually work at Agency and am very supportive of vaccines, and I have participated in vaccine trials without incident. This was an unexpected and severe reaction (possibly to SHINGRIX?), and I hope by filing this report that I can learn more about what may have occurred so that I can recover fully. At this time and out of caution, I do not plan to receive the second dose of SHINGRIX as a result of this experience. I have had both chicken pox and shingles in the past, and made this clear to the Pharmacy clinician to ensure no known issues with this new vaccine.
patient got the flu was the last year; Initial information regarding an unsolicited valid non-serious social media case was received from a non-healthcare professional (consumer) on 09-Dec-2020.  This case involves adult patient who got the flu was the last year (Influenza), while patient received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On unknown date, (unknow latency) patient got the flu was the last year (influenza) (unknown latency) following the administration of INFLUENZA VACCINE..  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.  There will be no information available on the batch number for this case.
Systemic: Patient could not move day following vaccination. PCP suggested hospital admission and patient was admitted-Severe, Systemic: Weakness-Severe