chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he noticed a rash that looked like poison ivy on his left chest; Sharp pain on left chest/ pain was on the left side of his chest got sharper and more constant; Shingles/ pain from the shingles; Felt like something was on his back; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles/ pain from the shingles), SENSORY DISTURBANCE (Felt like something was on his back), CHEST PAIN (Sharp pain on left chest/ pain was on the left side of his chest got sharper and more constant) and DERMATITIS CONTACT (he noticed a rash that looked like poison ivy on his left chest) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 038C21A.) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced HERPES ZOSTER (Shingles/ pain from the shingles) and SENSORY DISTURBANCE (Felt like something was on his back). On 22-Aug-2021, the patient experienced CHEST PAIN (Sharp pain on left chest/ pain was on the left side of his chest got sharper and more constant). On 27-Aug-2021, the patient experienced DERMATITIS CONTACT (he noticed a rash that looked like poison ivy on his left chest). At the time of the report, HERPES ZOSTER (Shingles/ pain from the shingles), SENSORY DISTURBANCE (Felt like something was on his back), CHEST PAIN (Sharp pain on left chest/ pain was on the left side of his chest got sharper and more constant) and DERMATITIS CONTACT (he noticed a rash that looked like poison ivy on his left chest) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment Drug was reported
Patient was given the wrong vaccine for his COVID Booster.  He was given the Monovalent instead of the Bivalent dose.
Patient called our pharmacy and explained to us that the day following his vaccine and reported that he had blood in his stool that gradually got better over a few days but was concerned since it was the day after his vaccine.
This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seizure(has being treated with pharmacological agents), non-alcohol user, non-smoker, and arthritis, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient experienced hives when treated with benzylpenicillin. 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 patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever. This report was non-serious.
Severe fever. Chills. Nausea. Dizzy. Confusion. Weak fever high of 105.3, stiff neck and super high liver blood count.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037D21A and 038821A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (diarrhea). On 20-Apr-2021, DIARRHOEA (diarrhea) had resolved.      No concomitant medication was provided. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-114380 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114380:Dose 1 case
nausea w/o vomiting;h/a unrelieved by usual pain meds; pain @ inj site worse than 1st;felt poorly x 2 days;lessening on 3rd day post inj;off work x 2 days as a result
Severe urticaria and hives with burning & itching on both legs & some on arms started first in mMay 2021 & stayed around for 6-8 weeks with little relief with Zyrtec, Prednisone and Benadryl plus local cortisone 10% cream.  Then again starting March 5/6 ,2022 more severe rash with hives, burning & itching  all over on my thighs and both arms . This time no relief with prednisone, Zyrtec& cortisone cream to the hives/ burning/ itching. Had to cance scheduled knee surgery on 3/15/22  because of spreading hives & rashes
After first dose felt extremely fatigued with slight headache; After first dose felt extremely fatigued with slight headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (After first dose felt extremely fatigued with slight headache) and HEADACHE (After first dose felt extremely fatigued with slight headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (After first dose felt extremely fatigued with slight headache) and HEADACHE (After first dose felt extremely fatigued with slight headache). At the time of the report, FATIGUE (After first dose felt extremely fatigued with slight headache) and HEADACHE (After first dose felt extremely fatigued with slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment medication was not reported.   This case was linked to MOD-2021-311070 (Patient Link).
Rash 3 days now. Painful, stiff knees; difficult to walk.
Post vaccine pt felt slight dizziness and warmth in face and neck followed by shallow breathing.  Reports feeling better when moved to medical observation area. Vitals obtained and monitored: 1614 LYING BP 123/77 HR 85 RR 16 SpO2 100% 1621 LYING BP 114/75 HR 84 RR 14 Sp02 99% 1632 Standing BP 117/72 HR 77 RR 14 SpO2 95%
Redness to injection arm, severe headache, cough, fever, pain, fogginess.   Treated with Benadryl and ASA and overhang cough syrup
Inconsolable, high pitched, odd screaming unrecognizable to me, (his mother.) Signs of brain inflammation, encephalitis, potential brain damage.. extreme sleepiness and lethargy followed. No treatment.
Extreme perspiring, reddening of face, turning blue almost looking bruising around eyes, mouth, sides of face.
5- 27 - 28 - Hot flush - 5-28 - red raised welt egg shape/size - hot -  5-29 - still warm -ache shoulder - elbow - swelling gone - no energy - 6-8 - arm shoulder to elbow aches yet
Arm swelling, double in size from shoulder/injection site to fingers. Red, warm, hives in palm, occurred a few hours after vaccine administered, lasted 7 days.
Information has been received from a health professional concerning a 57 year old male employee with hypertension, gout, and no allergies, who on 16-SEP-2005 was vaccinated with a dose of MMR II. On 30-SEP-2005 the pt was admitted to the hospital with a fever, chills, a sore throat and a non-pruritic whole body rash. He was treated with BENADRYL. Subsequently, the pt recovered. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Brief dizzy spell, extreme tiredness.  I went home and slept from 6pm to the next day. Next day I had a sore throat and runny nose and still felt very tired. Day 3 I began to feel better.  Day 4 (today) December 25, remission back to feeling worse. Sore throat, stuffy head, tired etc....
Red, warm, raised, no tenderness, swollen, red area right distal and lateral to injection site which lies at margin. 5x8 cm wide, 1 day post, no treatment.
Chills, Temp of 101°, sleeping for 20 our of 24 hours. Lasted 1 1/2 days Three days after shot, developing Covid Arm. Also had Covid Arm in my left arm for 0 days after the first shot.
I tested positive for COVID-19 on 16FEB2023, I had a sore throat and headaches. these lasting about 4-5 days. I had a tele health visit on the 17th, I was prescribed PAXLOVID. After couple of days I started feeling a lot better. I still feel fatigued even after I felt better.
pt recv vax 17JUL97 & 28SEP97 pt was dx w/rubella;
Patient received her 1st dose of Moderna on 3/22/2021, patient was observed for the appropriate amount of time and left without any reaction/concerns or questions. Patient's daughter called our facility on 03/23/2021 @ 10:00 am, she states that her mother called her and had fallen and was not able to speak appropriately. Nursing advised the patient to present to the ER, an ambulance was called and the patient went to the  ER. Patient was subsequently transferred to  due to space in . Patient was found to have a right internal carotid artery occlusion that required stenting and an angioplasty, she also required a right middle cerebral artery clot aspiration for a semi-occlusive clot. Patient was then transferred to  for rehab for 3 days, and she was discharged home.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported for two patients. This is the first of the two patients. An elderly patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration in the arm (not further specified) on an unknown date at 0.5ml single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced significant swelling in the arm from injection site in the upper deltoid down toward the elbow. Laboratory data was not reported. The clinical outcome of the event, significant swelling in the arm from injection site in the upper deltoid down toward the elbow, was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016526435 same reporter/ drug/ AE, different patient.
Person who administered shot gave the shot in a place very high up on my left arm. I asked why so high. I had never gotten a flu shot that high up. It also hurt a lot. Never had that happen before. That night I could not move my arm.
Patient is here today for a covid vaccination. It was noted by RN that he was complaining of a headache.   At 14:23, call placed to outside EMS.    History of: Asthma   Nursing Assessment:  Airway: Open Breathing: Spontaneous Circulation: Pulse present Mentation: Alert Skin: Normal    Patient monitored., Vital signs obtained and recorded. and Oxygen saturation level obtained.  BP 118/70, pulse 88, O2 100.   He was transported to the emergency department at Clinic via ambulance at 1423.   Call type: Minor   Time event completed: 1450
Information has been received from a health professional concerning a 13 year old white female with allergies to sulfa, cephalosporins, sulfamethoxazole (+) trimethoprim, cefaclor, and sufrax, who on 1/4/96 was vaccinated with a SC first dose of varicella virus vaccine live (lot # 610257/0750B). There was no known illness at the time of vaccination. It was reported that a first lesion was noted on 9/17/05. On 9/23/05the patient broke out in shingles on her left abdomen, under her breast, and with one on her right thigh. She had about 14 total lesions on her abdomen and one on her thigh. It was noted that the patient would be put on antivirals if it recurred in the future. Subsequently, the patient recovered. There were no laboratory or diagnostic tests performed. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar event for 3 patients. This is the 2nd of 3 reports. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced arm swelling on an unspecified date with outcome of unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017169045 Same product/event/reporter, different patient;US-PFIZER INC-2017169080 Same product/event/reporter, different patient.
Nausea, Vomiting, initially   Frontal headache Loss of balance, Feeling off balance  this has continued for more than 8 days
Next day, found a very unique square form around my shot/injection site. A perfect square about 1 inch x 1 inch formed. 4 red dots (my blood) followed with a perfect straight dotted lines down, sideways to each dot forming a perfect square - never seen anything like that. Went to pharmacy after day 3 but it had slightly faded but staff said they have never seen anything like that and finally Pharmacist came - said it was just a bruise - how I reacted to it.... hesitant to take 2nd Covid vaccine.... was planning for tomorrow but very concerned.  Did not have any other side effects but cramps on calves but that could have been anything.
dizzy; disoriented; sore muscles; chills; shaking all over; This case was reported by a consumer and described the occurrence of dizziness in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 24th September 2020, 1 hr after receiving Shingrix, the patient experienced dizziness, disorientation, muscle soreness, chills and tremor. On an unknown date, the outcome of the dizziness, disorientation, muscle soreness, chills and tremor were recovered/resolved.   It was unknown if the reporter considered the dizziness, disorientation, muscle soreness, chills and tremor to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. One hour after receiving 1st dose of Shingrix, patient experienced chills, shaking all over, sore muscle, disoriented and dizziness. The reporter stated that the events were resolved. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR254620:same reporter
Information has been received from a health professional concerning a 24 year old female with no medical history who in July 2007, was vaccinated with a second dose of GARDASIL.  After the vaccination the patient found to be pregnant.  Medical attention was sought.  No product quality complaint was involved.  On 06-MAR-2008, the patient delivered a normal, healthy male baby weighing 8 lb and 4.75 onz, length not reported, apgar score 8/9, head circumference not reported.  No congenital anomalies.  Complications during pregnancy included gestational diabetes.  Complications during labor/delivery included labor stalled at 9cm and the patient subsequently underwent a Caesarian section.  Upon internal review stalled at 9 cm was considered to be an other important medical event.  No further information is available.
Rash appeared on stomach and complaining of nausea and vomiting. Told patient to go to ER.
Lack of Response - Information has been received from a physician concerning several patients who were vaccinated with two dose of varicella virus vaccine live.  Subsequent laboratory evaluation revealed a lack of response.
SLEEPY; ARM HURT; TIRED; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced sleepy, arm hurt, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepy, arm hurt, and tired. This report was non-serious. This case, from the same reporter is linked to 20210727807.
Had a local reaction at the injection site on her left thigh to include a large red spot that has grown over time since injection, fever, and achiness. Please note that this is the first injection she has received from this clinic of the Dtap, Hib and Prevnar.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 04-SEP-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # K026247, expiration date 29-JAN-2017. On 25-SEP-2015, the patient received the second dose of GARDASIL 9 loot # K026247, expiration date 29-JAN-2017 and on 16-OCT-2015 the third dose of GARDASIL 9 lot # L007560, expiration date 15-JUN-2017 (exact dose and route was not reported for all doses). The patient inadvertently received doses of GARDASIL 9 outside of the recommended series intervals. No adverse events were reported. Additional information has been requested.
Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 07May2021 (Batch/Lot number: unknown) as dose 2, single and administration date 16Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "Muscle pain".  Additional information: Reporter received Pfizer Covid-19 vaccine 1st dose on 16Apr2021 and received the 2nd dose today 07May2021 and experienced muscle pain. He asked if he could take pain medications.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Inappropriate schedule of vaccine administered (Inappropriate schedule of drug administration). A non-serious spontaneous report of administration of FLUMIST 12 days apart was received from a patient parent concerning a 36-month-old male subsequent to the administration of FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history or concomitant medications were reported. The patient received FLUMIST 12 days apart, first on 27-Aug-2009 and then inadvertently on 08-Sept-2009. There was no adverse event associated with this medication error, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved.   All follow-up attempts have been made per company SOPs.  No further information is available. 08 Mar 2010.
transient ischemic attacks; hives; loss of balance; hearing problems; blurred vision; eye pain; herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information regarding current condition, historical condition or concomitant medication was not provided. On or around 24-OCT-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered constant and severe burning and blistering of her skin, resulting in scarring. The pt was diagnosed with herpes zoster. Subsequently, the pt experienced loss of balance, hearing problems, blurred vision and eye pain, as well as transient ischemic attacks. The pt also suffered a second outbreak of her skin and was diagnosed with hives. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presented prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all the events was considered as not recovered. The lawyer considered all the events to be related to zoster vaccine live (ZOSTAVAX).     Transient ischemic attack, herpes zoster, urticaria, loss of balance, hearing problems, blurred vision and eye pain were considered to be disability. Upon internal review, transient ischemic attack was considerd to be medically significant.
rash w/itching on upper chest & upper back, thighs between legs;fine, prickly rash noted;
This case was reported by a physician via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 10 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. The reporter considered the shingles to be unrelated to SHINGRIX. Additional details were provided as follows: This case was reported via click to chat. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional (HCP) reported that he had a patient who developed shingles after receiving SHINGRIX vaccine. The HCP stated it was most likely unrelated but wanted to see if increased episodes of shingles were observed during first two weeks post-intervention. Additional information was not obtained as the HCP ended the chat abruptly.
Patient presented to ED on 8/20/21 with dyspnea at rest and recurrent fever after casirivimab and imdevimab infusion.  Patient is fully vaccinated and was tested positive for Covid on 8/17. Patient was treated appropriately for Covid and was discharged on 8/25 with dexamethasone PO to complete a ten day course on 8/30.
Patient intake did not properly identify that the patient was under 18 years of age and the parent/guardian did not surface the age during check-in.  Because of this the 1st dose was administered on March 11, 2021.    During check-in for the 2nd dose the age was properly identified.  The patient, and parent/guardian, were notified that the 1st dose was invalid and that a 2nd dose would not be provided.  The patient did not have any adverse effects or side effects from the 1st dose.