chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got the first Shingrix shot on Wednesday, August 28th. The first couple of days my arm was very sore but I was prepared for that. It was not until late Saturday and Sunday that the blotches appeared and then swelled up with extreme itching. One of the swollen blotches ended being about 5 inches long and 3 inches wide. I was so uncomfortable that I called a friend who is in the medical profession (it was the holiday) and she recommended to take an antihistamine to help with the itching and internal swelling. I started taking Allegra on Monday noontime, by Tuesday it was better and have been taking it ever since.  I did not have any flu-like symptoms such as fever, headache, nausea or other listed side effects.
At 11:35 AM, patient stated that she was having difficulty breathing. Patient was sitting upright. Encouraged patient to take deep breaths as vital signs were measured. Patient was awake, alert, and oriented x3. Patient displayed signs of hyperventilation and anxiety. Verbalized that left arm was becoming numb as well her legs. Patient's right and left hands became contracted and unable to move. Vital signs were BP: 110/72mmHg, HR: 106b/m, and O2: 99% at RA.   At 11:40 AM, patient verbalized chest was tightening. Administered Epinephrine Injection Auto-Injector 0.15mg at left upper thigh.   At 11:45 AM, EMS arrived and transferred patient to hospital.
Right arm- red circular area 3.5cm in diameter tender to touch. Mother reports area has not spread.
Felt cold; No appetite through the weekend/Didn't eat for 3 days.; stayed in bed on Saturday and Sunday; Muscles ached; chills; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (Felt cold), DECREASED APPETITE (No appetite through the weekend/Didn't eat for 3 days.), BEDRIDDEN (stayed in bed on Saturday and Sunday), MYALGIA (Muscles ached) and CHILLS (chills) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Nov-2022, the patient experienced NASOPHARYNGITIS (Felt cold), DECREASED APPETITE (No appetite through the weekend/Didn't eat for 3 days.), BEDRIDDEN (stayed in bed on Saturday and Sunday), MYALGIA (Muscles ached) and CHILLS (chills). At the time of the report, NASOPHARYNGITIS (Felt cold), DECREASED APPETITE (No appetite through the weekend/Didn't eat for 3 days.), BEDRIDDEN (stayed in bed on Saturday and Sunday), MYALGIA (Muscles ached) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported. On 10-MAR-2021, the patient received first dose of Moderna vaccine (Lot number 001B21A). Patient reported no Adverse Reactions. On 7-APR-2021, the patient received second dose of Moderna vaccine (Lot number 026B21A). Patient reported no Adverse Reactions. On 21-DEC-2021, the patient received first Moderna COVID 19 vaccine booster dose(Lot number 069H21A). Patient reported no Adverse Reactions. On 02-JUN-2022, the patient received second Moderna COVID 19 vaccine booster dose(Lot number 056M21A). Patient reported no Adverse Reactions. No treatment medications were reported.
18 y/o F that presented for COVID-19 Vaccination. She provided a history or allergic reaction to vaccines after receiving a plethora of vaccinations on 30Jul21. At that time she was given benadryl but no epinephrine. She had been evaluated by an ER provider who did not feel that the patient had anaphylaxis. I reviewed the patient's medical record and determined that the patient was a candidate for vaccination. The medical box with epinephrine and benadryl was opened and set in the observation area in preparation for possible reaction. The patient was vaccinated with Pfizer 0.3mL. She was brought over to the 30-minute observation area in good condition. Approx. 5 minutes after vaccination she began complaining of difficulty swallowing and complained of a bad headache but endorsed breathing well and not having any abdominal pain or itching. There were no rashes. Her HR was in the 60's and her RR was 14. She did not feel cold or clammy. No diaphoresis and was answering questions appropriately. At this time IM Benadryl was prepared but NOT given because at approximately 10 minutes after vaccination, she developed more severe symptoms and began coughing and throat clearing with gagging. She was immediately placed in the supine position. EMS was called while simultaneously giving IM epinephrine (@1717, left lateral thigh). The patient had immediate improvement in symptoms. Patient began speaking again clearly and answered questions appropriately and no longer complained of such severe difficulty swallowing. No additional epinephrine was administered. EMS arrived at approx 1722 and care of the patient was handed off at that time.   At no time did patient have AMS or hives. No pruritus.   I was present for the entire event and presided over the care of the patient and administration of epinephrine.   - Dr.    In the ER the patient was reportedly well appearing and doing quite well without additional symptoms.
Patient received the vaccine at about 5:30PM. Within 10 minutes he changed his behavior and became fussy ( which is uncommon for him). By 6:15 his checks began to become beat read followed by his ears, watery eyes, red chest, stomach, arms, legs, followed by hives covering his body. He began to kick and scream w/ irritaton. He also had a fever of 102. He could not walk due to dizziness and agitaton. At this point I knew he was having a reaction and gave him his medication of Hydarax ( dose 1.875). It took apx 40 after giving the Hydarax that he became calm, redness, hives and fever went away. The symptoms did not continue through tha night. I do believe had I not had the medication needed on hand i would of had to take patient to the local emergancy room or if the medication given did not work.
had an allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 20Sep2023 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: HYPERSENSITIVITY (non-serious) with onset Sep2023, outcome "unknown", described as "had an allergic reaction".  Additional information: The reporter mentioned she go the new Pfizer COVID-19 vaccine yesterday (20Sep2023) and had an allergic reaction. She was wondering if it contains any seafood, shellfish, or anything like that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, cough, nausea, headache, muscle aches, chills, fatigue, arm soreness. Started during the night 11/14- headache, arm soreness. Started mid-morning- nausea. Started later afternoon- fever, cough, muscle aches, chills, fatigue.
Severe heart palpitations.  Infrequent at first then gradually increasing frequency up every 30-60 seconds over the course of first 3 weeks post shot. Afterwards averaging 6 palpitations a day
Two weeks after having second dose of vaccine in April 2021 and then booster in December 2021, patient began experiencing hives and rash that have persisted. She continues to have itching and rash when she scratches. Patient has gone to urgent care and was placed on steroids.
Person possibly received an injection with an empty syringe. Administering staff could not confirm whether or not medication was in syringe after administration, but RN administering stated that syringe (obtained from a vacant station) was from a bin that contained empty syringes. There were no adverse effects from the administration, but vaccine administration errors are encouraged to be reported. Person reported that they had a sore arm at the injection site post administration, but there were no side effects experienced. There was no confirmation with reasonable certainty that the syringe was full or empty as she did not experience any side effects other than localized soreness. Interventions afterwards included; reporting to VAERS, calling epidemiology for guidance of when to administer the initial/subsequent dose, and encouraging the person to report to their provider to obtain guidance about when it would be the safest and most appropriate to administer the vaccine. The syringes at the station that were full, were verified to be correct doses.
Red rash about the size of a quarter at injection site.  Soreness and heaviness between elbow and shoulder as well as heat and sore to touch  about 8 days after vaccination.
This spontaneous report as received from a certified medical assistant refers to a 24 patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (route was not reported; lot # K005881, expiry date 14-JAN-2017). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Case completed her primary Covid vaccine series in March 2021, then was admitted to hospital in October of 2021 for treatment of Covid.
a portion of the doses were frozen/ no AE; Initial information was received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a Consumer via Regulatory authority (Reference number- 00814920) and transmitted to Sanofi on 15-Oct-2021.  This case involves a 50-year-old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] and a portion of the doses were frozen with no adverse event (Product storage error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 20-Sep-2021, the patient received a 0.5 ml (once) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7330LA and expiry date not provided] via intramuscular route in left deltoid for prophylactic vaccination, a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not reported] via unknown route in unknown administration site.  It was reported "Doses of possibly frozen FLUZONE HIGH-DOSE and FLUZONE QUADRIVALENT were administered on accident after a shipment of FLUZONE HIGH-DOSE and FLUZONE QUADRIVALENT arrived frozen. The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment".  It was a case of actual medication error due to Product storage error temperature too low (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number of FLUZONE HIGH-DOSE QUADRIVALENT and FLUZONE QUADRIVALENT for this case.
On 10/20/2000 the patient experienced chicken pox. Unspecified medical attention was sought. Additional information has been requested.
Patient developed tongue tingling and a sensation of "possible" difficulty swallowing 1 minute after receiving the vaccine. This then progressed to lip tingling, and "possible" tongue swelling. BP 130/84 100% O2 R 36 P 100 Patient clinically appeared anxious. No obvious angioedema, abnormal heart or lung sounds, or other distress. Patient was given 50mg Oral of benadryl with improvement of symptoms. Patient for about 5 minutes developed subjective upper extremity and RLE tingling that completely resolved. She has expressive aphasia that makes history very difficult. The writer advised going to the ER for further evaluation of the allergic reaction, but she refused. They stated they will go home and consider going if symptoms worsen or they decide to. Risks of not going include worsening condition or death and this was explained. They were advised to f/u with PCP tomorrow and to see allergist before getting next shot. Advised ER sooner if symptoms worsen, although the recommendation is going to the ER right now. Stable on discharge.
Information has been received from a physician concerning a 14 year old female patient who on 13-MAR-2008 was vaccinated with her first dose of GARDASIL.  Concomitant therapy included MENACTRA.  On 09-APR-2008, the patient experienced back pain, fever and headache.  The patient was given Z-PAK.  On 14-APR-2008, the patient presented at the office with complete facial paralysis and was admitted to the hospital.  On 18-APR-2008, the patient was discharged.  A neurologist in the hospital diagnosed her with possible Guillain-Barre and bilateral 7th cranial nerve palsy.  On 24-APR-2008, the patient was seen by a physician and her adverse events were resolving but not complete.  On 15-MAY-2008, the neurologist felt her symptoms were resolving and possibly not related to Guillain-Barre or GARDASIL.  The neurologist diagnosed her as having Epstein-Barr meningitis.  Back pain, fever, headache, facial paralysis and Epstein-Barr meningitis were considered to be disabling, immediately life-threatening and an other important medical event.  Additional information has been requested.  10/3/08 Reviewed neuro medical records of 5/15/2008. FINAL DX: Epstein Barr viral meningitis with montherapy multiplex Records reveal patient experienced HA x 2 weeks in 4/2008.  Developed shoulder pain, LBP, sleep disturbance & fever.  Seen in ER, dx w/throat lesion & tx w/antibiotics.  No response to antibiotic therapy although throat lesion did improve.  Developed severe pain, facial weakness, tingling in fingertips.  Hospitalized & brain MRI revealed inflammation of VII crainal nerve bilaterally.  LP showed WBC (H), protein (H) & marginal glucose indicating viral meningitis.  EBV IgM (H).  Neuro exam on 5/15/08 revealed right facial weakness w/depressed UE reflexes.  10/31/08 Reviewed hospital medical records of 4/14-4/18/2008. FINAL DX: bilateral 7th cranial nerve palsy, possible variant of GBS triggered by acute Epstein-Barr infection. Records reveal patient experienced HA, muscle aches, fevers, strep throat, mono x approx 2 wks.  Developed facial paralysis 3 days prior to admit.  Exam revealed cervical & submandibular lymphadenopathy w/peritonsillar erythema.  Unable to close eyes completely, could not wrinkle forehead, smile or frown.  Right patella areflexia.  Neuro consult done.  Tx w/IVIG.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.No Medical History information was reported. On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were reported. Treatment information was not provided.It was reported that vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
I gave a TRUMENBA Meningococcal Grouop B vaccine to patient per IM route in her left arm at 4:49:19pm on Fri 07/06/2018. I used proper technique. I also vigorously shook, per vaccine instructions, then ensured no air bubbles were in the vaccine, before administering it. There was no blood after removing needle. I also asked patient if she ever had fainted post vaccine in the past and she said no, so I felt comfortable walking away from patient, when she asked me to fill out her shot record. I reentered the pharmacy to grab her consent form to make sure I spelled vaccine correctly. As I was filling in the shot record info, I heard a sound that sounded like a snore and looked up to see the seated patient with her head back and eyes closed. I immediately ran around the counter to stabilize patient. Her mother helped move the chair as I lowered patient to the ground. I re-gloved after making sure she was breathing and not shaking, then grabbed her shoulders, said her name, and asked if she were ok. She woke up and looked wide-eyed around. I told her she fainted and that she was ok. I asked if she knew her name, where she was, and why she was here. She answered all q's right but said she was confused and felt like she just woke up from sleeping. I told her she kinda did, as I heard a snoring noise that made me respond to her for help. She felt a little warm and I asked if she were hot or had been before entering store; she said no. After talking a little bit, she said she felt fine, but I asked her to stay here for 15 minutes. She agreed and sat back in chair. I went to finish shot record and she fainted forward at 4:53:47pm. Her mother and I immediately went to her. I told my intern to call 911. She looked as if she fainted again, but I wanted to have her looked at to rule out seizure. A nurse offered to help before the paramedics arrived.
Bruise-type pain at injection site starting +5 hours lasting for about a day. Mild Diarrhea starting +8 hours roughly every 1-2 hours for a day or so. Persistent headache starting +12 hours for a few days (somewhat hard to judge causation given being a long time regular migraine sufferer but seemed more than usual / different). Mild vertigo / balance issues starting +2 days lasting for 3-4 days. Can't confirm causation but definitely atypical / no other known cause. Difficulty maintaining balance (like walking while drunk only I don't drink anymore) NO nausea/spinning just balance.
Headache h on injection site, generalized itchiness, and headache. Symptoms resolving per employee on 1/19/21. Narrative:
Swelling under both of his armpits; "Strange twinges" in his left armpit area, arm, and across his chest; "Strange twinges" in his left armpit area, arm, and across his chest; "Strange twinges" in his left armpit area, arm, and across his chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 (Lot number: FF2593, Expiration Date: 31Dec2021) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Keep hair from falling out" (unspecified if ongoing), notes: Keep hair from falling out; "He is 5 feet 10 inches to 5 feet 11 inches, and that he probably shrunk" (unspecified if ongoing), notes: he is 5 feet 10 inches to 5 feet 11 inches, and that he probably shrunk. Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased, start date: Dec2010; ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiac disorder, start date: 2000; FINASTERIDE taken for alopecia. Vaccination history included: Covid-19 vaccine (Dose: 1, Lot: EN6202), administration date: 08Mar2021, when the patient was 61 years old, for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, Lot: ER2613, Received his 2nd dose of the vaccine on his left arm), administration date: 29Mar2021, when the patient was 61 years old, for COVID-19 Immunization, reaction(s): "Swelling under his left armpit". The following information was reported: SWELLING (non-serious) with onset Nov2021, outcome "not recovered", described as "Swelling under both of his armpits"; PAIN IN EXTREMITY (non-serious), CHEST PAIN (non-serious), AXILLARY PAIN (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as ""Strange twinges" in his left armpit area, arm, and across his chest". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that his doctor mentioned that the swelling would go down but it persisted for a couple of weeks. Bloodwork, urine test, and other test have been done to him as per his report. It is stated by the patient that this began after the second shot, left him wondering if others report that their glands were swelling for months on end, like if this is something a certain percentage of people who get the vaccines experience.   No follow-up attempts are possible. No further information is expected.
Following day reported to pharmacy with reddened area at injection site. Followed up 2 days later & patient assured me that it was resolving.
Tingly lips, felt like throat was swelling.  I was able to breath fine.  Given Prednisone and Prevacid and symptoms went away.
Severe diarrhea; Both legs were weak that he find it hard to urinate standing; Pain in the entire body; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe diarrhea), MUSCULAR WEAKNESS (Both legs were weak that he find it hard to urinate standing), PAIN (Pain in the entire body) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (Aloe vera rash).   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced DIARRHOEA (Severe diarrhea), MUSCULAR WEAKNESS (Both legs were weak that he find it hard to urinate standing), PAIN (Pain in the entire body) and FATIGUE (Fatigue). At the time of the report, DIARRHOEA (Severe diarrhea), MUSCULAR WEAKNESS (Both legs were weak that he find it hard to urinate standing), PAIN (Pain in the entire body) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Followup information received include second dose information added.