chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. No information about medical history, concurrent conditions was reported for the patient. On an unknown date the patient was vaccinated with ZOSTAVAX (strength unspecified) dose/frequency 1 single shot. No concomitant therapy was reported. The physician stated that after ZOSTAVAX on an unknown date the patient developed shingles. The outcome of shingles is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Student nurse gave the injection into the shoulder joint instead of muscle.  Within 30 min began having severe shoulder pain and decreased motion.
From initial information received on 05/23/03 from a physician, regarding an adverse event occurring in the US, it was reported that a 16 year old female pt received a dose of TD ADS ADULT, in the left arm on 05/13/03.  The lot # and route were not reported. The same day, the pt experienced pain at the injection site as well as the entire arm, muscle aches and mild swelling of her fingers. Reportedly, the pt is improving.
Vaccinated at 12:45. No reaction until  7:45 pm. Racing heart, labored breathing, pressure and slight pain in chest.  Called 911 and to Hospital ER.  Aspirin given in ambulance. All back to normal by 10 pm and went home.
Arm is tender when moving sometimes; Cellulitis in left arm; Red bump on the injection site; Red bump on the injection site that started to grow; A spontaneous report was received from a consumer, who was also a 62-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced cellulitis in left arm / cellulitis, swollen left arm / peripheral swelling, arm is tender when moving sometimes / tenderness, red bump on the injection site / injection site erythema, and red bump on the injection site that started to grow / injection site swelling.    The patient's medical history was not provided. Concomitant medications reported included cholesterol medication (not specified) and blood pressure medication (not specified).  On 23 Dec 2020, approximately one day prior to the onset of events, the patient received their first of two planned dose of mRNA-1273 (Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 24 Dec 2020, a red bump appeared at the injection site that started to grow and grow. Her left arm became swollen.  On 28 Dec 2020, the patient's left arm didn't look fine and she went to the emergency room. She was treated with two different oral antibiotics (not specified) to be taken for one week.  On 29 Jan 2021, the patient's left arm was still swollen, above and below the elbow, and considerably larger than her right arm. Her left arm was tender with movement but she was still able to move her arm.   On unknown date, the patient underwent a vascular ultrasound that showed her vascularity was fine. The left arm was noted to be 5 cm bigger (larger) and 3 cm bigger above the elbow.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events, cellulitis in left arm, swollen left arm, arm is tender when moving sometimes, red bump on the injection site, and red bump on the injection site that started to grow, were not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded
HIGH FEVER (101.1), GENERAL BODY ACHE AND PAIN AT INJECTION SITE
Covid19 breakthrough.  Vaccinated on 12/26/2021.  58 y/o PMH HTN presents to ED with Covid19 symptoms that started 6 days ago when tested + for Covid.  Pt c/o worsening cough, SOB and low O2 sats recorded at home.  Denies fever, chills, N/V, HA or dizziness.  CXR- multifocal PNA.  T-102.5 , requires O2 at 2L NC-94%.  Started on IV ABX/IV steroids and Remdesivir.
This spontaneous report as received from a physician via a field employee refers to 2 girl young patients of unknown age. On an unspecified date at an unspecified time, the patient was vaccinated with a dose of GARDASIL injection, 0.5 ml, once, intramuscular (lot # and expired date were not reported). Concomitant therapy was not reported. The 2 girl patients waited 30 minutes in office post vaccination then went to a local restaurant nearby (unspecified) where each girl fainted. An ambulance was called by restaurant personnel, the girl patients were determined to be "fine" and did not go to emergency department. A report of incident was made to an unspecified source. The patient present status was reported as "doing fine". The relationship  between adverse event and GARDASIL was not reported. Additional information has been requested.
I had this reaction 15 hours after I received my vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had this reaction 15 hours after I received my vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (I had this reaction 15 hours after I received my vaccine). At the time of the report, VACCINATION COMPLICATION (I had this reaction 15 hours after I received my vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  The patient believed the reason the patient had the reaction 15 hours after receiving the vaccine. The patient did not believed it was a reaction from the vaccine. The patient though it was because the patient already had COVID 19 and didn't know it. No treatment information was provided.
Temp between 99.8-100.6; Body aches significant; Joint pain; Restlessness in bed due to pain; Loss of appetite; Nausea; Diarrhea; Weakness; Tiredness; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 22Apr2021 at 13:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic pain, back instrumentation, hypothyroidism, depression, bone on bone knees needing surgery, partially recovered foot fracture and lactose intolerance. The patient has known allergy to adhesive on butrans patch. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), celecoxib (CELEBREX), duloxetine (MANUFACTURER UNKNOWN) and methadone (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 01Apr2021 at 13:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 08:00, the patient experienced temp between 99.8-100.6, body aches significant, joint pain, restlessness in bed due to pain, loss of appetite, nausea, diarrhea, weakness, tiredness and arm pain. On the same day, the patient underwent body temperature test and the result was 99.8-100.6 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with unspecified pain meds. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body aches significant, joint pain, restlessness in bed due to pain, loss of appetite, nausea, diarrhea, weakness, tiredness and arm pain was resolved on 27Apr2021; while that of the event temp between 99.8-100.6 was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Lg red area, warm to touch, raised (bump) approx 5 cm, at injection site. Pt c/o achy pain in joints one day, Tylenol relieved symptoms.
At approx 2:30AM patient c/o "itching & hives head to toe", redness & splotchy areas to arms, legs, torso, no difficulty breathing, no pain, no acute distress.  Most symptoms subsided by approx 8:00AM with minor itching remaining.  Patient felt no need for further followup but was informed if symptom reoccur/persist/become worse report by center for followup/seek med ATTN immediately.
Information has been received from a consumer concerning her 7 year old son who on 03/04/97 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included montelukast sodium and Zyrtec. On 10/04/03 the pt broke out with one small spot on his arm and has since spread over his body.  The pt's mother reported that this was an outbreak of chickenpox. Unspecified medical attention was sought. As of 10/08/03, the pt had not recovered and was still resting at home. There was no product quality complaint involved. Follow up information from the health care professional indicated that the pt got active chickenpox in the fall of 2003. He had been vaccinated at 12-13 months of age. No unusual reaction to the vaccine and no serious chickenpox was reported.  The reporter also indicated that the pt's brother (WAES # 0310USA01194) had similar experience following exposure to varicella vaccine live. No further information is expected.
pt recvd vax; generalized sz w/ fever < 24 hrs p/ vax; nl lytes-septic w/u neg including LP
fever; rash at the injection site; red at the injection site; scratchy at the injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 21st March 2019, refer case US2019149405).   On 7th August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced fever, injection site rash, injection site erythema and injection site abrasion. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever was unknown and the outcome of the injection site rash, injection site erythema and injection site abrasion were recovered/resolved.   It was unknown if the reporter considered the fever, injection site rash, injection site erythema and injection site abrasion to be related to Shingrix.  Additional details were provided as follows: The husband reported that his wife had Shingrix and experienced a fever of 101 to 101.5, but the symptoms were worse. The reporter Consented to follow up. No additional details were available as the reporter's cell phone died in a remote location. The reporter also added that his wife had a decent rash at the injection site. It was red at the injection site and scratchy at the injection site. The events were gone by time of reporting. This case has been linked with US2019149405, reported by same reporter.      Lab Comments: Lab test performed on an unknown date
Rash started on arm at injection site. Rash also on neck and stomach, fever and vomiting. ER visit, given Benadryl and anti-nausea meds. Still have rash and vomiting.
Muscle aches in upper arm and neck for months. Sharp stabbing pains yet in upper arm, and weakness.
Fever, Dilated eyes, rash, rapid heart, eye infection, sick to stomach. Patient has suffered with severe stomach issues since,MMR 3rd shot given Januany 6th 2003,when 2 doses had been admistered years before and not properly documented in the Drs office.
Fever, body chills, joint and muscle pain, mild nausea - 4 days. Headache - 5 days and counting.
Pt was given a moderna vaccine at the age of 17yo when recommendations for this vaccine were 18yo and up. However, there was a release from the CDC 03/17/21 that stated if a Pt younger than 18yo received moderna vaccine that it was okay to give 2nd dose as scheduled. Pt did not have any adverse side effects or reactions from the vaccine and did receive both doses of Moderna Covid vaccine.
2 1/2 mos old male infant in office for 1st vaccination: Pediarix, Hib, Prevnar, Rotateq. Temp max 99. Within 12 hours developed mushy stools with incredibly foul odor, then severe bowel cramping, followed by massive stooling. (he is exclusively breast fed). On day 3 he passed mucous and blood with his stool. The stomach cramping has resolved and the mucous and blood have decreased by today. The foetor has diminished. I suspect he was developing intussusception and is resolving it. His parents are informed to take him immediately to the hospital upon any recurrence of pain or any worsening of any symptoms. Will observe for next 3 weeks. He is not fully recovered yet.
Patient stated she felt light headed, warm and nauseated. She requested that writer inject her with an EPI pen and that an ambulance be called. Patient was injected with EPI pen x 1.
Patient came in stating that received the SHINGRIX on Wednesday and on Friday was driving to a place he has gone to before and knew where it was but couldn't remember how to get there and this happened again the next day. He stated that this has never happened before he received the immunization.
Patient was supposed to have received a regular tetanus vaccine, we use Tenivac, but the MA gave the patient the Kinrix vaccine instead. No adverse reaction just wrong vaccine received.
Information has been received from a health care worker concerning a 73 year old female with no pertinent medical history or concomitant medication use and an allergy to penicillin who on 09-OCT-2007 was vaccinated (site and route not reported) with pneumococcal 23v polysaccharide vaccine (lot# 658074/0961U). On 10-OCT-2007, the patient developed severe arm pain, numbness and developed weakness in the injection site arm. There was no redness or swelling at the injection site. The patient had an ultrasound done (outcome not reported) and received unspecified medical attention. The severe arm pain, numbness and weakness in the injection site arm lasted for 10 days and then resolved. This is one of several reports with the same source. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (very itchy where I got the shot) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (very itchy where I got the shot). At the time of the report, VACCINATION SITE PRURITUS (very itchy where I got the shot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication were included. Reporter denied further follow up.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20/05/2021 included TCR added/ Outcome of event updated.
Hives began at injection sites on right arm. Patient received Varicella and Hep A vaccines in right arm. Hives spread to legs, groin and upper arms. No shortness of breath or difficulty breathing. Mother administered BENADRYL to patient.
Vomiting; dizziness; extreme fatigue; disoriented; migraine; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Feb2021 at 11:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety and hypothyroidism. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levonorgestrel (MIRENA), sertraline hydrochloride (ZOLOFT) and levothyroxine (MANUFACTURER UNKNOWN); all from an unknown date and unknown if ongoing for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient previously received codeine on an unknown date and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and did not experience any side effects. On 16Feb2021 at 06:00, the patient experienced vomiting, dizziness, migraine, extreme fatigue. It was reported that on the same day about 20 hours after the vaccination, the patient couldn't move her body out of her bed and her husband helped the patient to the bathroom where the patient threw up multiple times and slept for about 4 hours. On the same day, following the sleep when she opened her eyes, the patient felt very dizzy and disoriented and even had migraines for 2-3 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting, dizziness, migraine, extreme fatigue and disoriented was resolved on an unknown date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1/30 @ 4am passed out 8n bathroom from lain and nausea. Could leave bed til 4pm that day. Due to body pain, chills and headache.  72 hours later left ear full, very dizzy and slight nausea still.
Information has been received from a physician concerning a female patient who on unspecified dates was vaccinated with the first, second and third doses of GARDASIL. The patient developed pharyngitis about ten days after she received the first, second and third doses of GARDASIL. The patient was seen by the physician. It was reported that on an unspecified date the patient recovered from pharyngitis. Follow up information has been received form a physician's assistant. She reported that the patient developed pharyngitis following each of the three doses of GARDASIL. This is one of two reports from the same source. Additional information has been requested.
pt recv vax & 2hr later devel pain & redness @ the inj site;2 days post vax pt was seen in ER dx of cellulitis made;
cellulitis; postherpetic neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In or around 04-FEB-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered a painful burning rash on her foot and she was diagnosed with herpes zoster, cellulitis and postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient 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 patient sustained severe and permanent personal injuries. Further, the patient 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 patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the all events was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered all events to be disability. Upon internal review, the event of cellulitis was determined to be medically significant.
Seemingly shot was injected too high at the shoulder joint. Immediate sharp pain upon needle entering left deltoid. Three hours later was unable to lift left arm at all. The use of the left arm was improved two days later, however nerve pain at the injection site persists over one month later. Still hard to push and pull without pain.
My baby died and was stillborn 3 days after vaccination on June 2, 2014.
On 04/17/01, MMR given, HIB and PNE-CON. On 04/25/01, approximately 4 PM, the grandmother brought the infant into the clinic with what she called a rash. He had a fever of 101 (A) for the past 2 days and the infant was very whiney. The grandmother stated his skin looked funny for the past couple of days. The nurse stated to the doctor the skin appeared mottled, no rash felt or seen. The doctor who saw the infant 2 hours after LCHD stated he saw subtle erythematous papules on his back. the grandmother also stated the baby had loose stools on 04/24/01. The physician was not sure of reaction being viral or immunization related.
experienced sore and itch in the injection site; experienced sore and itch in the injection site; This is a spontaneous report received from Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 07Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunization.The patient experienced sore and itch in the injection site in Apr2021. She had not removed the bandage in the injection site when she got it until this day. She can't remember when she received the 1st dose but she has no reaction during the first dose. Outcome of events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
On 12MAR2023 I had  a tickle in my throat and was coughing I woke up 13MAR2023 with a fever and two swabs both negative. When I woke upon 14MAR2023 I woke up with a fever of 102.5 and tested positive for COVID-19 with a home test. I had a PCR test which confirmed my COVID-19 positive result, I got on my telehealth and was prescribed Paxlovid for five days.