chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a adult female patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received the 1st dose of SHINGRIX. On 2nd May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site wheal, injection site erythema, injection site bruising, injection site induration and injection site swelling. On 3rd May 2018, the patient experienced lethargy, injection site joint pain, myalgia, injection site pain and fatigue. On 3rd May 2018, the outcome of the injection site pain was recovered/resolved. In May 2018, the outcome of the injection site wheal, injection site erythema, lethargy, injection site joint pain, myalgia, injection site bruising, injection site induration and injection site swelling were recovered/resolved. On an unknown date, the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the injection site wheal, injection site erythema, lethargy, injection site joint pain, myalgia, injection site pain, injection site bruising, injection site induration, injection site swelling and fatigue to be related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX on left arm. The patient stated all of the listed events were located around the injection site. She mentioned that she received the injection in morning. The myalgia, fatigue, headache and joint pain were resolved after a few days later. She said that the swelling at the injection site lasted for about 2 weeks and the bruising went away after about 3 weeks.
Rash all over her eye lids; Rash above her mouth; Burn kind of almost like sun burn/burns; Rash down the left side of her nose; Face was little itchy/itch; Tiny little tons of bumps all over/all along her lower chin area", "top of her forehead and along hairline; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Face was little itchy/itch), NODULE (Tiny little tons of bumps all over/all along her lower chin area", "top of her forehead and along hairline), EYELID RASH (Rash all over her eye lids), ORAL MUCOSAL ERUPTION (Rash above her mouth) and BURNING SENSATION (Burn kind of almost like sun burn/burns) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression (since as a teenager), Bipolar disorder since 2013 and Shellfish allergy. Concomitant products included QUETIAPINE FUMARATE (SEROQUEL) and ALPRAZOLAM (XANAX) for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PRURITUS (Face was little itchy/itch) and NODULE (Tiny little tons of bumps all over/all along her lower chin area", "top of her forehead and along hairline). On 30-Apr-2021, the patient experienced EYELID RASH (Rash all over her eye lids), ORAL MUCOSAL ERUPTION (Rash above her mouth), BURNING SENSATION (Burn kind of almost like sun burn/burns) and RASH (Rash down the left side of her nose). At the time of the report, PRURITUS (Face was little itchy/itch), NODULE (Tiny little tons of bumps all over/all along her lower chin area", "top of her forehead and along hairline), EYELID RASH (Rash all over her eye lids), ORAL MUCOSAL ERUPTION (Rash above her mouth), BURNING SENSATION (Burn kind of almost like sun burn/burns) and RASH (Rash down the left side of her nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medication included unspecified birth control pill.  Treatment information was not reported.
mom notified on 2FEB93 of pt react p/shot on 11JAN94; pt had swelling, lump-took pt to MD mom stated dx lump as sterile abcess; pt also had fever, mom stated on 11JAN-12JAN94; MD had mom take pt to ER;
10/31/17 0750 shot administered; headache started within 30 minutes; within 6 hours-left facial numbness/tingling, left 4th and 5th digit parasthesias, severe left arm/shoulder/neck pain; later that evening had severe generalized pain, aches, malaise and 2 loose stools 11/1/17 am-facial parasthesia resolved; severe generealized pain. malaize, continued left hand parasthesias: saw urgent care MD and diagnosed with low grade fever, lymphadenopathy impacting left brachial plexus: by 8pm that evening severe uncontrolled diarrhea started which lasted 72 hours, lost 9 lbs in first 48 hours of onset of diarrhea, diarrhea did not completely stop until 11/9/17 am. Continued LUE pain and intermittent parasthesias. 11/9/17 LUE pain increased with loss of ROM, marked weakness and decreased function 11/12/17 saw urgent care MD diagnosed as left cervical radiculopathy due to adverse reaction of influenza vaccine, started Prednisone 20mg po daily x 5 days and Gabapentin 200mg po titrate to tid.  11/21/17 saw primary MD for continued parasthesia, severe pain and decreased function of LUE-diagnosis serum sickness syndrome with brachial plexopathy and left subdeltoid bursitis as evidenced on ultrasound.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 9/27/2022 Discharge Date: 10/7/2022  PRESENTING PROBLEM: Altered mental status [R41.82] Altered mental status, unspecified altered mental status type [R41.82]   HOSPITAL COURSE: Pt is a 79 year old male with PMH of DDM, diabetic neuropathy, CAD, HLD, HTN, prior CVA, vascular dementia. Pt. presented to the ED after an unwitnessed fall and AMS. He was admitted with concerns for stroke. CT head and neck studies showed only chronic changes, no acute findings. MRI brain was done and found to have an acute to subacute left pon infarct. Neuro has been consulted. ECHO with EF 61%. EEG with no evidence of epilepsy. Neuro recommended medical manage with home ASA and adding plavix for 90 days along with discharge with zio patch. Therapy evaluated the patient and recommended acute rehab at DC.    The patient was awaiting placement when he became febrile. He did not endorse infectious symptoms. As part of the work up a COVID test was checked and was positive. He completed 5 days of remdesivir inpatient and continued on dexamethasone at discharge to complete 10 days. Was consulted and assisted with management of steroid induced hyperglycemia. CTA thorax negative for PE but showed some mild fluid overload, so he was gently diuresed. Pt weaned from 6L NC to 2L on day of discharge. Zio patch was placed and pt discharged in stable condition.   While hospitalized, pt was noted to have mild asymptomatic bradycardia. His home metoprolol XL was decreased and pt encouraged to follow up with PCP as outpatient.
pt mom called WIC office on 1JUL98 stating believes had a rxn to immun recv 23JUN98;stated a reddened, raised, rash appeared on chest, back, neck & head on 24JUN98 & is still present;warm to touch;
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (HAD 2 SPOTS THAT WOULD NOT GO AWAY/WERE SORE IF RUBBED UP) and VACCINATION SITE PAIN (ARM WAS SORE FROM THE COVID VACCINE AT INJECITON SITE) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (HAD 2 SPOTS THAT WOULD NOT GO AWAY/WERE SORE IF RUBBED UP) and VACCINATION SITE PAIN (ARM WAS SORE FROM THE COVID VACCINE AT INJECITON SITE). At the time of the report, PAIN (HAD 2 SPOTS THAT WOULD NOT GO AWAY/WERE SORE IF RUBBED UP) and VACCINATION SITE PAIN (ARM WAS SORE FROM THE COVID VACCINE AT INJECITON SITE) outcome was unknown. No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality with Humira for the events of ARM WAS SORE FROM THE COVID VACCINE AT INJECITON SITE was not provided. The reporter's causality for the event(s) of HAD 2 SPOTS THAT WOULD NOT GO AWAY/WERE SORE IF RUBBED UP with HUMIRA(ADALIMUMAB) was no reasonable possibility. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient came to the pharmacy on 9/13/17 and proceeded to show myself and intern his left arm. It appeared to be swollen and was red and warm to the touch. It states it was painful when touched. I advised to go to urgent care or ER. I also called the doctor who also stated patient to do the same and go to the ER. I called the patient household and spoke with patient's wife who was also present when patient came to the pharmacy. She verbalized understanding. (I spoke to the answering service with whom Dr left message to go to ER.) At this point, I do not know if patient went to the ER. The swelling was to his elbow.
Felt lump in throat 2 minutes after receiving vaccine. 3 minutes later she felt chest pressure and had a metallic taste in mouth and with smell. She was brought to TEC for futher evaluation.
Generalized red, raised rash consistent with hives; 2+ tonsils, increased fatigue, mild diarrhea, mild conjunctiva injection, & bilateral anterior cervical lymphadenopathy.
Oct 6, 11 -> numbness feet -> sacral area -> upper extremities. Gait progressively worse. Admitted to hospital 10/12-18/11. DX: Guillain Barre Syndrome. Received IVIG daily x 5 days.
Information has been received from a registered nurse referring to an adult patient of unknown age and gender. The patient was supposed to received a dose of M-M-R II and VARIVAX (Merck) on 31-MAR-2015 for the second dose in the series. However, the patient received a dose of VARIVAX (Merck)  and a dose of PROQUAD (Merck) injection, subcutaneously. No adverse effects were reported. Additional information is not expected because the reporter did not want to be contacted.
51 female with h/o HTN (improved, off meds) presented to ED from her PMD office for further work up due to right leg weakness since yesterday and was dx with a stroke. Patient has received JJ vaccine 4/10/21. Patient denies f/c, n/v/d, CP, SOB, abdominal pain. Patient reports mild posterior right hip tenderness. She denies numbness.
had fluttering of heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 58-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: CARDIAC FLUTTER (medically significant), outcome "unknown", described as "had fluttering of heart".  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.
Vaccine stored at potentially longer than recommended period of time (potentially up to 28 days post puncture), no adverse reactions no illness
nausea and vomiting starting 2 days later with abdominal pain.   Presented 4 days later to the ER, for nausea, vomiting, dehydration.  He was found to be hypotensive, tachycardic.
Information has been received from an unidentified friend of a physician concerning a 16 year old female who on unspecified date was vaccinated with the third dose of GARDASIL (lot # not reported). It was reported that 10 days after receiving the third dose, the patient experienced parkinsonian-like symptoms and was being admitted to the hospital (unspecified hospital). At the time of reporting, the patient's parkinsonian-like symptoms persisted. Additional information has been requested.
I had a rash on the right side of my abdomen that traveled over to the left just past my belly button. It wasn't bad initially. There were small  bumps but got worse. After my surgery,  on 12/23/020 there was no rash at the incision points. The rash was more angry after the vaccine in January 2021. I went to see my dermatologist and prescribed a  topical ointment.
Left lymph mode swollen and painful - swelling began w/in 8 hrs after rec'ing injection - ED -treated with MOTRIN - @ work x 3 days. C/o numbness/tingling in RT arm immediately after shot (elbow to hand)
back hurting; small rash on back; fatigue; knees aching; right shoulder hurting; felt like vomiting; headache; achy; shoulder/arm aching, leg pain; eyes glossy; pupils delated; blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), PAIN IN EXTREMITY (shoulder/arm aching, leg pain), GLASSY EYES (eyes glossy), MYDRIASIS (pupils delated) and VISION BLURRED (blurred vision) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (achy), PAIN IN EXTREMITY (shoulder/arm aching, leg pain), GLASSY EYES (eyes glossy), MYDRIASIS (pupils delated), VISION BLURRED (blurred vision), NAUSEA (felt like vomiting) and HEADACHE (headache). On 27-Feb-2021, the patient experienced BACK PAIN (back hurting), RASH (small rash on back), FATIGUE (fatigue), ARTHRALGIA (knees aching) and ARTHRALGIA (right shoulder hurting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (achy), GLASSY EYES (eyes glossy), MYDRIASIS (pupils delated), VISION BLURRED (blurred vision), BACK PAIN (back hurting), RASH (small rash on back), NAUSEA (felt like vomiting), FATIGUE (fatigue) and ARTHRALGIA (right shoulder hurting) outcome was unknown and PAIN IN EXTREMITY (shoulder/arm aching, leg pain), HEADACHE (headache) and ARTHRALGIA (knees aching) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 29 JUL 2021. Event outcomes were updated.
Within hours I quickly became extremely sore, fatigued, and had difficulty breathing. I was unable to eat  until the breathing issues subsided late afternoon Sunday since I felt as though I was choking when I  attempted to eat. The fatigue and body pain was pronounced enough for me to have to call off work  Monday, but they gradually diminished. I am submitting this on 3/11, and I am still experiencing some  body aches though the constant feeling of exhaustion is no longer present.
Unresponsiveness, respiratory distress, tonic seizure activity, unsure if patient lost consciousness.
I had the vaccination (my second) and waited the required 15 minutes after the injection.  I felt fine and got on my bike and road home.  I took a longer route (10 miles), and I remember things up to almost the end.  The bike ride ended with a bad fall, I presumably had a syncopal event and crashed my bicycle.  Bad hit on helmet, and I was unconscious for probably five minutes.  I was found and woken up by a passerby (I have no memory of this) and then the EMTs arrived.  Checked into Emergency Room.  They suspected a cardiac event, but I have so far passed all the tests (exercise stress test, echocardiogram, normal QT).  I have *never* had an event like this, the bike ride, while a little long, was quite normal for me.  I also note that I had possibly not had enough to eat or drink that morning.  So, based on the curious timing of this event, I personally believe it's related to the shot.  I also don't really believe this is an anxiety related syncopal event (it was more than an hour after the shot), but rather I suspect an immune response, perhaps aggravated by dehydration/lack of enough food.  But who knows?  I was out cold, and don't remember the minute or so up to the crash.  I did go back to inspect the bikeway that I was on to see if there was anything there that could have caused a crash (tree branches, rough surface) and I found nothing.  It was a pretty flat easy bike path at that point.
Patient was administered Moderna's bivalent booster on 9/14/2023. The FDA pulled the authorization for this vaccine on 9/11/23
Subsequently post vax, the pt experienced a fever of 103 degrees and a generalized rash. The pt received unspecified medical attention. Follow up data states patient recovered.
That night she felt really dizzy, like she wanted to pass out after showering. Then she started to be nauseous and throwing up. The next day she felt some better but still nauseous.
10MAR98 pt had a vesicle type lesion devel on rt labia majora;fever devel 13MAR98;14MAR98 two more additional vesicles devel;15MAR98 inc redness;T103,cough clear sputum production;runny nose;not tolerating solids;
persistent low grade fever ranging from 99.7 to 100.2 Has been taking Tylenol with no relief. Recommended staying hydrated, applying cold compress to forehead, continue to take Tylenol as directed. If worsening fever, contact MD. 4/20-temperature peaked at 101.1 F around noon. Advised to continue with APAP, if symptoms worsen seek medical attention. 4/23-feeling better; reports temp of 99.1F today. controlled with antipyretics.
Had sinus pressure, headache and congestion. Took a Home COVID-19 test and was positive. Prescribed Paxlovid and started feeling better, but sinus pressure has never abated.
Starting 20 hours post 2nd vaccine, I started experiencing severe pain on my right side and flank. Aniston impossible to rise from a chair and painful to walk. Has continued for 5 days, sometimes better, sometimes worse. Extra strength Tylenol and Advil didn?t work. I took Tramadol on two nights and it helped me sleep. Also have alternated between heating pad and cold pack, but relief doesn?t last long.  Note because I didn?t see where to enter date for 1st dose: March 17th. Lot # corresponds to first dose. Provider didn?t write down lot # on 2nd dose.
Immediately could taste the shot within 15 min  felt light headed had severe headache . blood pressure taken @ site 170/ 104 rash on face . 45 min later was at home slept had chills body aches  headaches still persist some shortness of breath paramedics came to site they checked bp bs asked if I would like to go to hospital I refused . I followed up with my pcp 4/13 d/t ongoing headache increased bp labs were drawn ct of head completed recommended I see a hematologist d/t  finding out I have factor 5 Leiden
Client was diagnosed with lichen planus at the dermatologist. She had purple, itchy bumps in various areas on her skin that started 4-5 days after 2nd dose of Moderna vaccine. She has received light radiation treatment at the dermatologist (on the inside of her wrists and a couple of other places only).  She has been prescribed steroid cream from the dermatologist. She has f/u with her PCP as well. Both told  her this is likely an allergic reaction to a component of the vaccine and to not receive further COVID vaccines. Dermatologist told her she has only seen this once previously in an allergic rxn to a BP medication. The bumps continue to appear in new places.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Treatment of COVID-19; (unspecified date) negative, notes: Tested positive again for covid after 2 negative tests; (unspecified date) negative, notes: Tested positive again for covid after 2 negative tests; (27Jan2023) positive, notes: Tested positive again for covid after 2 negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 23Jan2023 to 27Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Shingles outbreak left side of face. Treating with antiviral, pain med and steroid.
After IM given, child stood up and went to mothers side. Nurse discussing immunization with mom for another child, and the child passed out and slide down the wall to the floor. Had been about 2-3 minutes after shot given. She bumped her head on the wall. child recovered rapidly. was assisted to a chair, she complained of nausea, so mask removed and trash can placed beside her.  Had her sit for awhile and then moved to the waiting room. No injuries noted Childs gait was steady and moved all extremities well and equal.
mom describes devere unusual high pithched inconsolably cry; fever 100.3; lasted several hrs;
Patient passed out after administration - said it was due to fear of needles, has happened before but he did not tell the pharmacist. Patient regained quickly, got some ice for his head and gave him water, ambulance was called.
4x6 cm area of redness and swelling left deltoid. Pink fine macular rash-back of neck and upper 1/3 of neck.
pt admitted to hosp w/ twitching of eyes deviation to Lt; smacking of lips; drooling & stiffening of body;
As the Moderna vaccine was being administered to the patient, the vaccine (solution) started to spill from the sides of where the syringe and needle attach. The vaccine solution was noticeable dripping down the side of the patient's arm. We can confirm that the patient did not receive at least half or more of the dose. The pharmacist and intern verified that the needle was securely attached to the syringe and that the syringe/needle could have been faulty. The second dose was re-administered to the patient on 03/17/21.
Approx. 35 minutes after the injection Heavy feeling s in his body and light headed.  New funny   taste.  PMH hypertension. No itching no rash no SOB normal VitalS igns . Sent to ED observed and released
Chills, pain at injection site (R) deltoid radiating to (R) shoulder down to (L) elbow. Afebrile.
CHILLS ON AND OFF FOR 6 HOURS; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced tiredness, and chills on and off for 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness and chills on and off for 6 hours was not reported. This report was non-serious.