chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per client's mother Hep A and Meningitis given on 08/07/2018 three hours after receiving shot client became ill. Feeling "fatigue, not able to hold plate dropped it on the table due to arm weakness. Also per patient she is not able to keep any food down" "glands swollen under both jaws". Client states she can only drink water but still unable to eat anything at this time. Client presented today at 2:45 pm. Referred for follow-up of care. Per mother we will go to an Urgent care because patient has to be at University on Saturday at 9:00 am.
A nurse practitioner reported that a 5 year old male received FluMist on Oct 24 2005, and that the next day, the patients mother called the office to report that the patient experienced facial swelling on the areas of the forehead, nose and cheeks. On Oct 26 2005, the patient was seen at the clinic. The reporter examined the patient and noted tenderness on the swollen areas. She was informed by the mother that the patient was given oral Benadryl starting on Oct 25 2005. The reporter ordered an x ray of the fact to rule facial trauma. However, as of Nov 1 05, the x ray has not been performed yet per the patients mother. The patients clinical outcome is unknown at this time. The reporter assessed the event as possibly related to FluMist.
I began experiencing severe tinnitus about 9 days after my first Moderna vaccine dose. Very loud electronic hissing tone throughout my head. This has not subsided since March 22. It is ongoing, 24 hours a day. This produced distress, discomfort, and anxiety. I went to the ER at Hospital on March 22 due to the sudden tinnitus onset and the accompanying anxiety. They gave me referrals for an audiologist, PCP, and psychiatrist. At the hospital, they gave me Ativan.  The tinnitus is very uncomfortable, scary, loud, and disruptive. I've had two separate audiologists test my hearing and examine my ears and both are fine. Nothing remarkable. I've also had an MRI done with normal results. I've been to my PCP, another doctor at the same clinic, and an ENT doctor. I also went to a psychiatric physician's assistant. No one seems to know the cause or what to do. I've been prescribed 20 mg of fluoxetine daily, o.5 mg alprazolam as needed for distress. Also prescribed, 25 mg amitriptyline, and 50mg trazodone to help sleep. The trazodone had no effect so I stopped it. Also prescribed a 6-day course of methylprednisolone, but I had to stop on the third day because it kept me up for almost three days, so I stopped. I'm also taking daily Zyrtec, Benadryl, generic multi-symptom allergy medication, 2000mg Vitamin C, B12, and two Chinese herbs. I've also been seeing a chiropractor 3 x a week. I've seen a craniosacral therapist once and will start acupuncture this Sat.
Pfizer vaccine vial was not diluted prior to administration.  Patient received 0.3 mL of undiluted vaccine.  Patient and physician were notified of error and monitored for adverse events/flu-like symptoms per CDC recommendations.    Patient remained hospitalized for reasons unrelated to COVID-19 vaccine administration (M1 hold).  No adverse events documented by nursing or providers, no fevers or other adverse reactions noted.
Information has been received from a Physician's Assistant (P.A.) who overheard a conversation, which stated a female patient, who on unknown date was vaccinated with a dose of GARDASIL (lot#, dose and route not reported). It was reported that the patient following vaccination of GARDASIL, "was in a wheelchair for 3-4 months". The patient sought unspecified medical attention. At the time of reporting, the patient's status was unknown. "Was in a wheelchair for 3-4 months" was considered to be disabling. Additional information is not expected.
Severe body aches, fever, and tachycardia along with blood pressure spikes even with Lisinopril.
Nausea, diarrhea, chills since night of vaccine administration, symptoms still ongoing but improving
Client states she had elliptical nickel sized area (Right arm) when vaccine given that itched and developed blisters the day vaccine was given. Client left town - call to  report on 12/30/05. Stated blisters were resolving but still there. Not in area where band aid was placed.
24hr of vax had pain, redness & swelling of rt arm w/redness extending nearly to elbow per mom;also mom described a blister @ site of Td inj;T102;APAP relieves fever;pain was persistent on 18JAN98;saw MD for poss infect & inflam;
No energy  Armpit is sore  Foggy brain  Dull discomfort in stomach  Achy neck
This case was reported by a pharmacist and described the occurrence of dizziness in an adult female subject who was vaccinated with Engerix-B for prophylaxis. The subject's medical history included needle stick injury which occurred on an unspecified date in April 2006 prior to the administration of Engerix-B. On 26 April 2006 the subject received a dose of Engerix-B (dose number and lot number not provided). On 26 April 2006, less than one day after vaccination with Engerix-B, the subject experienced dizziness. The outcome of the event was not reported. The pharmacist considered the event was probably related to vaccination with Engerix-B.
Lightheaded; passed out; Lymph knot under armpit; A spontaneous report was received from a consumer for a 67-year-old female patient who experienced light headedness and passed out. She also had lymph knots under her armpit.  The patient's medical history was not reported. No concomitant product use was reported.  On 26 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 27 Feb 2021, next day after receiving the vaccine, the patient felt lightheaded and passed out and was hospitalized. She also experienced lymph knots under her armpit.  Action taken with mRNA-1273 with respect to the events was not reported.  The outcome of the events was not reported.  The reporter did not provide the causality assessment for the events.; Reporter's Comments: Based on the current available information which shows a strong temporal association between the use of the product and the start date of the reported event, a causal relationship with the event cannot be excluded. Axillary lymphadenopathy is consistent with the known safety profile of the mRNA-1273
pt called stated arm warm, painful @ 130PM;430PM pt called told to come to office noted 3" x 5" swelling;lt arm 10x18 cm indurated warm area;no erythema;
Myalgia, Fever, Rash, inj site pain/discomfort; chills Narative:
developed myalgias, bodyaches two days after vaccine. seen in clinic on 6/18/21 due to worsening b/l thigh pain. Found to have elevated CK levels concerning for mild rhabdomyolysis (CK level on 6/18/21 was 1600). Treated at home with oral fluids, rest and ice compressions. Symptoms resolved by follow up in clinic today on 6/21/21.
1/22/21 at 1:30p I received my 2 shot.  2 hrs later I began to experience chest pain while sitting w/o accompanying SX. During the night I continued to have increased frequency and intensity of chest that waxed and waned. At 10:30 a I was awoken with intense CP and subsequently went downstairs to eat yogurt. While standing at the counter I felt myself passing out and called for assistance. I woke up 20 feet away with my husband trying to arouse me. He stated I was unconscious for 2 mins. I was to weakened to get up. He called squad and taken to ED.  CXR, labs, EKG done. 2 liters NS infusion done. Discharged to home 6p with continued CP and lightheadness. F/u with PCP today as near syncopal  episodes continue  day 5 post-injection with CP and moderate H/A.
Rash on left cheek. Appeared to be like a herpes zoster  patch., but atypical.  Vesicles on a red base.
6 hour post injection:  stabbing headache with pains every min or so.  Temp 100 . 12 hours post:  headaches continued with temp 100.5 - acetaminophen tried several times with no relief 18 hours post:  temp rise to 101.5;  headaches still stabbing - took oxycondon 6 hours a part 3 times - was able to sleep 24 hours:  temp 101 headaches still present, not as constant  36 hours:  temp  99 and feeling better with only occ headache Resolved within 6 more hours
Patient arrived at the pharmacy to get IMZ with her husband. Pt received Fluzone HD, Prevnar, and Shingrix as requested. Pt was instructed to wait 10-15mins after IMZ administration in order to assess the occurrence of any ADRs. The pt did not comply. The pt collapsed in the Pharmacy Store Parking lot. EMS was contacted and she was taken to the ER for evaluation.
Swelling has moved doesn't toward my elbow; Swelling belowinjection site; This spontaneous report was received from a consumer referring to himself, a 78-year-old male patient. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided.  On 25-OCT-2021 at 2 pm (reported as monday), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided).  On 26-OCT-2021 (reported as tuesday), the patient experienced swelling below injection site (vaccination site swelling) and, on 27-OCT-2021 (reported as today), the patient's swelling had moved but did not towards his elbow (extensive swelling of vaccinated limb).  The patient reported that he still had the events at the reporting time (not recovered).  The reporter considered vaccination site swelling and extensive swelling of vaccinated limb to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) administration.
Information has been received from a 65 year old female who on approximately 24-JUN-2007 was vaccinated with Zostavax (Oka/Merck).  There was no concomitant medication.  On approximately 24-JUN-2007, the patient experienced a non-stop cough and tickling feeling in chest while coughing.  The patient's non-stop cough and tickling feeling in chest while coughing persisted.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. In follow-up, it was reported that the patient's last office visit was 21-JUN-2007. The patient did not mention any adverse experiences pertaining to ZOSTAVAX. At the time of reporting, the patient was seeing another physician. Additional information is not expected.
This is a spontaneous case initially received from other health professional on 16-Nov-2018, concerning a female patient of an unspecified age. On an unspecified date, the patient was administered partial dose of FLUAD (TIV) [route of administration: intramuscular, anatomical location: deltoid, dose, batch number and expiry date: not reported]. It was reported that when the needle was pulled out after vaccination, a little drop came back out, which they wonder to be a drop of the vaccine. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious.
arm is painful; cannot move arm; difficult to do her job; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm is painful), MOBILITY DECREASED (cannot move arm) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficult to do her job) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is painful), MOBILITY DECREASED (cannot move arm) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficult to do her job). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN (MOTRIN IB) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm is painful), MOBILITY DECREASED (cannot move arm) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficult to do her job) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included acetaminophen, ibuprofen.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events  is not applicable
fever; Swollen lymph nodes; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 50-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186) via an unspecified route of administration, administered in arm left on 13Jun2021 07:30 PM as DOSE 1, SINGLE for covid-19 immunisation (Pharmacy or Drug Store). Medical history included thrombocytopenia, allergies to penicillin, eggs, kiwi and covid-19 all from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at time of vaccination and has not taken any other vaccines in four weeks. Patient has covid before vaccination and not been tested post vaccination. The patient experienced fever, swollen lymph nodes, chills, nausea and vomiting on 14Jun2021. Patient has not taken any treatments for the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Arthralgia, Fever, NauseaVomiting, chills and fatigue Narrative:  Other Relevant History:
Myocarditis; Fever; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDITIS (Myocarditis) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant) and PYREXIA (Fever). At the time of the report, MYOCARDITIS (Myocarditis) had resolved and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.  It was reported that the patient had 2 shots of the Moderna vaccine and experienced some fever. Then, the patient had a first booster with Moderna and ended up with myocarditis. The patient reported it was extremely painful, but only lasted 8-10 hours.  No treatment medications were reported.    Company Comment: This is a spontaneous case concerning a female patient of unknown age with no reported medical history, who experienced the serious (due to medically significant) expected event of Myocarditis and the non-serious expected event of Pyrexia. The event Myocarditis occurred after the third (booster) dose of mRNA-1273 vaccine administration and the event Pyrexia occurred after the first and second dose of mRNA-1273 vaccine administration. Clinical course, supportive diagnostic procedures and treatment were not provided. The outcome of the event Myocarditis was reported as resolved.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact
16NOV90 pt had urticaria x/soles of feet, breasts & face; By 19NOV90 pt report entire body covered w/eczema, pruritus, burning & sensation of needles pricking the skin was described by pt; Admitted to Hosp 19NOV90 w/chest pains;
Child was given 2nd dose too early therefore repeat given 8/2/21. See attached. 5 minutes after administration child had 2 small hives @ left wrist. Then some hives on back No SOB, no stridor, no retracting. Baby taking  breastmilk. Benadryl 25mg/10ml 3.75ml given
Patient received flu vaccine in the morning and had a 103.8 temp by the evening, temp lasted for three days; patient also had a decreased appetite and increased fussiness.
Lt. arm sore, red & swollen. Fever to 101 degrees F, hives on lower back, (+) pruritus. Rest, fluids, OTC pain relief & BENADRYL, seek MD treatment.
Initial report was received from a consumer, who was also the patient, on 14 September 2012. An 84-year-old female patient received a dose one intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE, lot number U4494AA, on 10 September 2012. On 11 September 2012, the patient developed redness and severe itching over her neck, face, eyes, right arm, chest and pelvic area. The patient also had welts develop on the neck and across the side of the face. She saw her healthcare provider (HCP) and was given MEDROL pack. The patient had no illness at the time of vaccination and an allergy to penicillin and sulfa drugs. The patient had influenza vaccines in the past and never had any type of reaction. The patient received no other vaccinations within four weeks of FLUZONE. The patient's outcome was not recovered. Documents held by sender: None.
Pt received her first dose of the Pedi Pfizer covid19 vaccine however the vaccinator did not catch that the pt was 12yo and therefore should have received the regular dosed Pfizer vaccine instead.   Parent was informed by health director and the pt's mother was advised to get the regular dose for dose #2.
Felt faint and diaphoretic.  12:28pm bp=100/74.  12:34pm bp=122/80.  12:41pm bp=118/78.  Patient reports feeling much better, no longer diaphoretic.  Patient feels safe to drive self home @ 12:42pm
Syncopal episode 2 plus hrs post FLUMIST. Jan 23 2013 12:34PM Spoke with mom, patient was in for FLUMIST this am. She states he is at school now and they have called to say he isn't feeling well. He c/o nausea and is weak, no fever. Encouraged her to have him eat and drink something. Mom is on her way to pick him up and will call back with an update. Jan 23 2013 1:27 PM Mom called back to give update. Regarding Hx of today's episode, mom states that this am, he ate cereal went to a dental appt, came here for FLUMIST, ate a donut, & proceeded to class. She states that he passed out in the classroom about 15 minutes after arriving this morning and 2 hours after receiving the FLUMIST. He was seated at his desk, appeared pale/white then slumped causing his desk to tip over and pt was briefly unresponsive to teacher/classmates. He was eventually given some apple juice. Thereafter, mom was able to check his pulse and  BP (at home) and his HR was 68 and seated BPs were: 113/51. 101/48/ 106/44. Currently acting ok, alert, still pale w/ cold extremities. No emesis, though recalls nausea prior to syncope. Currently resting at home. Disc Sx c/w a vagal episode. Reassured mom this is uncommon with FLUMIST, but we would submit a VAERS report. Mom is confident that his episode was due to the vaccine. Rec update call in am. Mom agreeable.
Pt recv vax on 9/14/98; on 9/15/98 pt exp left shoulder pain & 10 large water blisters on upper back shoulder area lasting 3-5dy.
Arm soreness; Fatigue; Throbbing headache; Rib and upper back pain; Rib and upper back pain; Axilla pain; Rapid pulse; Temp; This is a spontaneous report from a contactable other health Care Professional. A 51-years-old female patient received first dose of BNT162B2 (PFIZER COVID-19 VACCINE ;solution for injection; Lot Number: EN53185/21) via intramuscular to right arm on 29Jan2021 at 11:00 as single dose for COVID-19 immunisation. Medical history included hypertension, gastrooesophageal reflux disease, anxiety, thrombosis, COVID-19. The patient had Covid prior vaccination. Concomitant medications included labetalol, NORVASC, ELIQUIS, OMEPRAZOLE, ZOLOFT, VIT D and VIT C. The patient experienced Arm soreness, temp, fatigue, throbbing headache, rib and upper back pain, axilla pain, rapid pulse on 29Jan2021 at 20:00. The patient underwent lab tests and procedures which included body temperature with unknown result heart rate with rapid result, viral test with negative on 01Feb2021. Therapeutic measures were taken for the events with Tylenol. The outcome of the events was recovering.  Follow-up activities have been completed and no further information is expected.
Hives on trunk and thighs Children's Benadryl administered the evening of shot, following morning and evening Hives did not reoccur after the second day
Misery. Fever, chills, nausea, vomiting, diaphoresis. A feeling similar to heat exhaustion.  I did not start feeling better until receiving oral Zofran in triage at emergency room at approximately  7:00 pm on 04/16/21.
Patient came back to the pharmacy 2 days after stating that she felt itchy at the site of injection.
Patient received Pfizer COVID19 booster. Later that day, back at the developmental disabilities group home where he lives, he reportedly developed seizures and then cardiopulmonary arrest. CPR was initiated by household staff; they administered on shock with AED. Upon EMS arrival, patient was apneic and pulseless, with initial rhythm of asystole. Patient was intubated and vascular access was established via IO route. He received several rounds of epinephrine, one dose of atropine, two doses of amiodarone, one dose of sodium bicarbonate, and a normal saline bolus. Rhythm progressed to a PEA agonal rhythm and then Idioventricular rhythm with faint carotid pulse, then to course VF. He was defibrillated once at 200 J. H
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 30-DEC-2010, the patient was inoculated with ZOSTAVAX by a physician, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-MAR-2016, she was treated (by an unspecified healthcare professional) at a family care office, for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as chronic herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Patient began having complaints of itching at injection site(Left shoulder and arm)at the end of 15 minute observation period. No shortness of breath or rash or hives noted. BP135/80, pulse 69 and SAO2 96%.
Arm began to swell immediately after vaccine.  Very sore and swelling lasted about 3 days.  Upper arm is still bruised at this time.
patient had hives all over body (neck, arms, legs) several hours after receiving vaccine, not at pharmacy when happened. Reported at second shot appointment.