chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of enlargement of lymph nodes in a 59-year-old male patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. On 20th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 21st August 2018, 1 days after receiving SHINGRIX, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was not recovered/not resolved. It was unknown if the reporter considered the enlargement of lymph nodes to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in right deltoid. The patient reported to the pharmacist that his left arm lymph node which was opposite side of the injection site was swollen.
being diagnosed with autism; This spontaneous report was received from a consumer via vendor, referring to her nephew, a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On unknown date in 1998 (reported as 24 years ago), the patient vas vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, strength, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient was diagnosed with autism. The outcome of the event was not provided.   The causal relationship between event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown. The reporter acknowledged the events may not have been related.  Upon internal review, being diagnosed with autism was determined to be medically significant.
pt recv vax & devel a delayed hypersensitivity rxn including severe abd pain; migraine h/a, dizziness; double vision; a flushing sensation; burning sensation on the top of the legs, face, & arms; & a tingling sensation on the back of legs;
Initial local erythema developing into 2cm deep erythema with induration and pruritus by day 3. No treatment. Expect it will resolve. Notified MD.
no adverse effects reported; improperly stored dose of vaccine was administered to the patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 01-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R024144, expiration date: 23-AUG-2020 for prophylaxis (dose and route of administration were not reported) reconstituted in sterile diluent (STERILE DILUENT) (lot # and expiration date were not reported). It was unspecified of sterile diluent underwent any temperature excursions. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 16.6 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA004595: US-009507513-1905USA011854: US-009507513-1905USA011855: US-009507513-1905USA011856: US-009507513-1905USA011857: US-009507513-1905USA011858: US-009507513-1905USA011860: US-009507513-1905USA011861:
She got her vaccine, she did not have any symptoms.  Since March or April of this year she started having pain in her knees real bad, and also her legs.  Her left arm also hurts, her shoulder, sometimes she has it in her fingers and her thumb, arms, round in the middle of her back.  She saw her PCP 2 weeks ago who asked her if she fell and she felt that it was from her shot, as she heard other people state that they had problems from it.  She states she is not taking the boosters and not taking the chance of having reactions.  Her doctor felt that he did not know what her symptoms were from.  She was given some prescriptions for the symptoms but she continues to have symptoms.  Her whole body hurts.
Information has been received from a registered nurse concerning an 85 year old Caucasian female who on 10/10/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (lot # 643503/0541M), IM in the left deltoid. There was no illness at the time of vaccination. The patient reported redness and swelling the next day after shot. The area was also reported to be warm to touch. The patient was treated with Keflex for 7 days. There were no relevant diagnostic tests or laboratory data. It was reported that the patient recovered. The reporter considered the patient's experience to be an other important medical event (OMIC). It was also reported that another patient (WAES0210USA01552) developed cellulitis and was vaccinated from the same lot. The reporter requested that the lot be checked. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. No further information is expected.
A report was received from a health professional on 10/09/2001 concerning a patient who was inadvertently given last season's Fluvirin vaccine. There was no adverse event reported. There was insufficient information to determine the reporter's causality assessment.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning an approximately 62-year-old female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-MAY-2015, the pt was vaccinated in a physician office with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose #, anatomical location and route not specified) for the long-term prevention of shingles and zoster-related conditions. As a direct and proximate result of her zoster vaccine live (ZOSTAVAX) vaccination, she suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences. On June 2015, the pt was caused to suffer shingles as a result from pt's zoster vaccine live (ZOSTAVAX) use and was treated by a health provider for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Initial unsolicited report received from a healthcare professional on 05 February 2015. A 3-month old female patient, with no reported medical history, received an injection of DAPTACEL (lot number not reported) on 06 March 2008. The patient's mother reported symptoms began on the day of vaccination; within 3 days of vaccination, the patient's mother reported irritability, poor feeding, decreased babbling, and that the infant was not responsive. The patient's mother reported to the healthcare professional that the patient had been evaluated by a neurologist and diagnosed with encephalopathy, however the patient was not hospitalized for treatment. Per the reporter, the patient seemed developmentally appropriate for her age at the time of the report, but the patient's mother had some behavioral concerns. Outcome was not reported. The reporter noted that the event had been reported to VAERS, however this information was unavailable to the reporter. Documents held by sender: None.
Syncope ~2 min after injection, fell, struck head (laceration), brief tonic/clonic movement.
no additional AEs reported; Varivax and GFK Shringix received at the same time (a minimum of 8 weeks interval should be provided); Varivax and GFK Shringix received at the same time; This spontaneous report was received from a medical assistant and refers to a 50-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 26-OCT-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml subcutaneously, lot # T025944, expiration date 30-JUL-2021 and at the same time (also reported as at the same visit) with varicella zoster vaccine rge (cho)(SHINGRIX) 0.5 ml intramuscularly, lot # NX7NA (expiration date was not provided), both for prophylaxis (inappropriate schedule of drug administration, overdose). No adverse events were reported.
Lymph node severely swollen under arm and breast. Hot to the touch. Can not move arm with out being in pain. Can not straighten arm out.
Cellulitis for 3-5 days per patients mom. Whom is a LNP, cellutis only presented on left deltoid
A week and a half after taking the Janssen COVID shot I had a knot and pain come up in my lower back. After going to the chiropractor two times the knot and pain ended up in my right leg. I then went to Urgent Care where they diagnosed me with a large blood clot. They sent me to imaging and after scanning the area confirmed that there was a blood clot in my right leg. Urgent Care then set me up with a specialist.
fever, generalized body aches, fatigue and headache  o Rest  o Plenty of fluids to avoid dehydration. If you are not urinating at least several times per day you may be dehydrated  o Tylenol (acetaminophen) is first choice for fever and aches  o Ibuprofen or naproxen can be used if you can't take or don't get benefit from Tylenol (acetaminophen) o Any other cough and cold medications you usually take are fine
not able to move legs for 6 hours after couple of hours of receiving the vaccine/ legs were not working 100 percent; felt sick; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (not able to move legs for 6 hours after couple of hours of receiving the vaccine/ legs were not working 100 percent) and ILLNESS (felt sick) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced LIMB DISCOMFORT (not able to move legs for 6 hours after couple of hours of receiving the vaccine/ legs were not working 100 percent) and ILLNESS (felt sick). At the time of the report, LIMB DISCOMFORT (not able to move legs for 6 hours after couple of hours of receiving the vaccine/ legs were not working 100 percent) had not resolved and ILLNESS (felt sick) outcome was unknown.            No concomitant medications were reported by the reporter.  The patient reported that her legs were working, but not well and still had issues at the time of this report.  Treatment medication was not provided by the reporter.
Swelling at injection site with redness (expanding an inch out from injection site) present two days post injection. Lymph node swelling under affected arm.  Fatigue. Fever, chills.
No additional AE reported; Varivax intramuscular instead of subcutaneous route today; This spontaneous report was received from a pharmacist referring to a 24 years old female patient. The patient's pertinent medical history, concomitant drugs and drug allergies were reported unknown.  On 18-JUN-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, strength, lot number and expiration date were not reported) intramuscularly instead of subcutaneously for prophylaxis (subcutaneous injection formulation administered by other route). No additional adverse event was reported. Medical attention was not sought, and there was no intervention performed at this time. Permission was given to follow-up with the reporter if necessary.
Patient brought to the hospital for evaluation due to being found on the floor, unknown amount of time.  Patient has no memory of event.
Headache chills, joint pain, muscle pain, fatigue Narrative:  Other Relevant History:
Complains of  left arm swelling and pain.  She had the COVID-19 vaccine on December 23.  The next day she had some mild pain at the injection site.  She massaged it and use Tylenol.  On December 24 he developed pain down all of her left arm.   On the 25th she had complete loss of sensation and feeling in her left hand for about 3 hours.  Then the arm seemed to tingle and feeling came back.  That night she developed pain down in her wrist.  Complains of some swelling in the left forearm.  That area is burning and throbbing.  Pain is affecting her sleep.  She has tenderness to palpation on her wrist area.  She also has pain with with wrist movements.  .  .
Patient ended up getting shingles that went up her back entirely with blisters creating immense pain and itching for the patient following the immunization.
Vaccine expiration date was misread. Read as 05/30/15. Actual expiration date was 05/03/15.
48 hours p admin. of DTaP to R Deltoid, client experienced reddness and inflammation at IM site.  Sx doubled in size over 8 hours.  Taken to ED, treated by Dr., given 2 days of Cephalexin P.O.  Client was instructed to follow up at HD and was seen today (5 days p injection).  No reddness noted; denied pain or tenderness; slight swelling @ inj. site noted.  Client's father stated reddness and swelling was severely diminished p 48 hours of Cephalexin tx.  Client and father were advised to return to the Health Dept. if condition does not continue to improve.
Pt had severe pain, vomiting, headache and was short of breath. Left arm still can't stretch it out, lift it up and no strength. Had Motrin and Toradol injection and physical therapy. Some better but not 100%.
1/4/2021:  swollen/hard inguinal lymph nodes (right and left side - harder on left side). Pain scale: 2 out of 10. Remained tender and swollen for 2 days.  1/6/2021:  Significantly swollen  axillary lymph node in left armpit. Discomfort. Pain scale: 2.5 out of 10. Tender and uncomfortable with arm up and down.
Low grade fever (99.6 F) Chills Fatigue Myalgia Headache
Vaccination Group: Hepatitis B Series: 3 Vaccination: Engerix-B Injection Suspension 20 MCG/ML - NDC 58160-0821-52 Mfr / Lot# / Exp.Date: GlaxoSmithKline / HN5BE / 9/16/2021 Amt. Given / Route / Site: 1 mL / IM / Right Thigh NDC / CVX: 58160082152 / 43 Administered Date: 6/21/2021 10:34 VIS Date: 7/20/2016 VIS Given / VIS Given On: Yes / 6/21/2021 Comments: THE PATIENT DID NOT HAVE A REACTION TO THIS INJECTION. Administered by: Staff
Information has been received from a physician concerning her 19 year old daughter with no drug reactions/allergies who on 23-OCT-2007 was vaccinated with a third dose of Gardasil (lot# 658563/1063U).  Concomitant therapy on the same day included a tetanus vaccination in the same arm.  On 23-OCT-2007, the patient was standing when given the Gardasil.  The patient became faint after receiving the Gardasil but may not have lost consciousness.  The patient's arm was sore after the Gardasil injection and the patient complained of pain for 3 days post vaccination.  Unspecified medical attention was sought.  No further information was available.  At the time of reporting on an unspecified date the patient recovered.  Additional information has been requested.
One and a half hours after receiving injection redness, rash and itching to right arm from palm up to forearm.  Given 25 mg PO Benadryl with resolution of symptoms in 30-45 minutes.
No rxn to 1st vax. 2nd dose exp urticaria. 1/29/99 3rd dose - fever, gen erythemia, prolonged urticaria. 8/18/99 pt seen at hosp urticaria spreads all over body. Fever and gen erythemia. Prescribed Hydroxyzine 10mg PO tabs PRN.
Light and late menstrual period which is normally very regular. This also happened after the second vaccine and no other times.; Light and late menstrual period which is normally very regular. This also happened after the second vaccine and no other times.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single and administered in arm left, administration date 22Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "allergies: Sulfa drugs" (unspecified if ongoing); "allergies: grapefruit" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: TOPIRAMATE; BUPROPION. Vaccination history included: Bnt162b2 (Dose 1, Location of injection: Arm Right), for Covid-19 Immunization. The following information was reported: MENSTRUATION DELAYED (non-serious), OLIGOMENORRHOEA (non-serious), outcome "unknown" and all described as "Light and late menstrual period which is normally very regular. This also happened after the second vaccine and no other times.". The event "light and late menstrual period which is normally very regular. this also happened after the second vaccine and no other times." and "light and late menstrual period which is normally very regular. this also happened after the second vaccine and no other times." was evaluated at the physician office visit.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced light and late menstrual period which is normally very regular. This also happened after the second vaccine and no other times. Adverse events start date after 3rd dose was 28Jan2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.
no additional AE; temperature excursion/ vaccines have been administered to patients; This spontaneous report was received from a licensed vocational nurse and refers to 8-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-MAR-2021, the patient was vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate (LIQUID PEDVAXHIB) lot # 1742460, expiration date 16-NOV-2021 (exact dose, route of administration and anatomical location were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # T006849, expiration date 16-JUN-2022 (exact dose,was not reported). Both vaccines were administered for prophylaxis. On 09-MAR-2021, administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 30 minutes. There was no previous excursion reported. Digital data logger was involved. There was no adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA006817: US-009507513-2105USA007003: US-009507513-2105USA006749: US-009507513-2105USA007032:
Extreme Swelling, large knot, welt, tingling in fingers and lips, dry throat. Pain in arm down to fingers. Pain in back of neck pounding headache, dizziness, chills, flushed face., nausea, jittery ER treatment sought evening of 5/28.   5/31 sought treatment @ doctor's office one bruising at site, dizziness, muscle & severe joint pain left arm and neck, throbbing headache back of head & neck, nausea, dizziness & high blood pressure   Still being treated
Severe allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), 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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Severe allergies".  Additional information: Description of Event Outcome: My son was strongly advised not to get a 2nd vaccination after receiving a letter of opinion from two doctors due to side effects (severe allergies) after the first vaccination of Pfizer. But he was currently in the process of receiving permanent residency and the Immigration Dep was demanding the results of his 2nd vaccination as a required document. Therefore, wanted the official letter of Pfizer so that he can continue the permanent residency process without getting the 2nd vac.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt recvd 1 dose of Engerix-B & 3 days following dose exp dizziness resulting in fall, nausea, stomach upset, diarrhea & was tired; has 2 MD visit;
Serious reaction / Itching all over my arm; Serious reaction / Scarred all over my arm; Serious reaction / Affected the Nerve in my arm; Serious reaction / Rash; This case was reported by a other health professional via interactive digital media and described the occurrence of pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pruritus (serious criteria other: Serious per reporter), scar (serious criteria other: Serious per reporter), nerve injury (serious criteria other: Serious per reporter) and rash (serious criteria other: Serious per reporter). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the pruritus and scar were not recovered/not resolved and the outcome of the nerve injury and rash were unknown.   It was unknown if the reporter considered the pruritus, scar, nerve injury and rash to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient experienced serious reaction with this injection which was still with the pateint over a year later. The patient still had itching all over arm that was injected and the patient now scarred all over arm. The patient gotten several doses of steroids trying to remedy and also tried and antibiotic neck injections to see of it would remedy my symptoms no avail. The patient was healthcare worker and felt like look like a Junkie with all these open itched out scars all over arm. The pateint stated it had affected his/her profession. It affected the nerve in the arm and was creating this rash.
c/o left arm red & warm since pneumonia vaccine on 5/9/11  redness 22cm x 17cm noted to left upper arm  red area warm to touch no edema noted denies any pain - states had slight pain at site of injection same night the  injection was given denies any soa or itching  reviewed with pcp advised PO benadryl & ice pack
Flu-like symptoms, full body aches, short episodes of afib.  I had a cardiac ablation over 10 years ago for afib and take flecainide as a prophylactic.  Normally I don't not have any afib and haven't had an episode in several years.
8 hours post vaccination Friday 4/9/21 : chills, headache, muscle aches, very tired  Saturday 4/10/21:not hungry, headache, nausea, chills, fever, rash on chest, hands feel like they are on fire, body feels heavy and weak, very tired  Sunday 4/11/21: dizzy, nausea, not hungry, achey, tired, heart racing  Monday 4/12/21: dizzy, tired, not hungry, body feels heavy, heart racing if too much movement   Tuesday 4/13/21:DIZZY, tired, heavy feeling body (like moving through mud), heart races if I move too much
no adverse reaction . patient was under 50 . had a Janssenn as primary , pfizer as ist booster . missed that he did not qualift for 2nd booster at this time
The next day after receiving the first dose of Moderna, I began experiencing a sore right arm and soreness in my shoulder blade on the same side.  I also felt very tired and heavy overall.  Then, a week after I received the shot, I started experiencing swollen lymph nodes in my armpits.  First, the left side (opposite arm of the site), and now both sides. The swollen lymph nodes are very painful when I move my arms.  I still feel tired.