chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial injection very painful. Persisted ever since. Spread to entire arm and into shoulder and back. Impaired movement of arm to reduced ability to adjust clothing and put on coat.
Angioedema; A spontaneous report was received from a physician assistant concerning a 63 year old female patient who experienced angioedema.  Medical history included dermal filler injections (Botox, Voluma, and Restylane).  Concomitant product use was unknown.   On 03 Feb 2021, the patient received her first of the two planned doses of mRNA-1273 (batch number: 031L20A) for prophylaxis of COVID-19 infection.   On 03 Feb 2021, the patient developed angioedema. She went to emergency room within 24 hours and was given IV treatment with prednisone, Benadryl (diphenhydramine) and Pepcid (famotidine).   The action taken with mRNA-1273 in response to the event angioedema was unknown.   The event of angioedema was considered as resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
A day and a half after getting the vaccine, I experienced heart pounding, body shakes, heart racing, pressure over entire body.  Called 911 and went to the emergency room.
Mother stated client awakened on the morning of the 27th with a rash of small red bumps which itched on the outside of the thighs, itchy hands, puffy face with 3 red areas she stated looked like mosquito bites.  The mother first notified this office on the morning of the 28th and she stated the client's face was no longer puffy, the red areas were much smaller, not open and not fluid filled.  The mother also stated the rash on the thighs had faded and was not itching now.
Initial unsolicited report received from other non- healthcare professional 30 March 2016. This case involves 62-year-old female patient who was vaccinated with first dose of ADACEL (batch number- C4697AA, site of administration not reported) in left gluteal on 04 September 2015. The patient had no known allergy and medical history included obesity, typhoid nodule, spinal stenosis, carpal tunnel and hypertension. Illness at time of vaccination was reported as none. The patient's concomitant medications were not reported. On an unspecified date, about a month following the vaccination, the patient had experienced progressive weakness in legs and felt like there was a bad around one. On 20 November 2015, two months following the vaccination, the patient had experienced ataxia and severe numbness in all extremities and diagnosed with Guillain Barre Syndrome. On 25 October 2015, the patient was hospitalized for 5 days. On 20 November 2015, patient was hospitalized till 01 December 2015. Lab data included electromyography CT scan, MRI Spinal Tap and blood work. The patient's corrective treatment was not reported. The outcome of events was reported as not recovered. List of documents held by sender: none.; Sender's Comments: The reported symptoms are suggestive of the diagnosis of GBS. Time to onset is compatible with the role of the vaccine. Some contributing factors could be the patient's advanced age and the patient's underlying medical conditions including Carpal tunnel, spinal stenosis, hypertension, Typhoid nodule etc. Complementary investigation results (electromyogram, CSF cell counts and units for protein levels, tendon reflex examination), as well as etiological infectious work-up for this pathology which is often preceded by an infection, the most frequent being Campylobacter jejuni, are needed to further asses this case. Based on the available information, no conclusion on a role of the vaccine can be drawn.
Transient weakness, numbness in bilateral lower extremities and cold left arm.  Patient rested and symptoms resolved
About 10 min after vaccine, I started to feel a tickling in my throat and my tongue started to feel numb at the onsite vaccine location.  I went to a RN who told me I was having an adverse reaction. She advised me to take Benadryl which I took immediately.  The Benadryl didn't help, and my jaw started to get numb as well.  That one didn't help either.  The EMT took me to the ER.  By the time I got there I was feeling better.  Sent me home with an EpiPen that I never had to use.
Got the shingle vaccine and got shingles/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.     Additional Information: GSK receipt date: 21-SEP-2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient received shingles vaccine and experienced shingles. The reporter considered the events might had been to be related to shingles vaccine. Additional Supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. .
On sunday night, about 36 hours after vaccination, she started to have numbness of her lower jaw and tongue. She started to have an incredible amount of drooling and could not swallow. She then started to have epigastric cramping and sharp abdominal pain that moved into the right lower quadrant. She had pretty severe headache that started the same time as numbness and drooling with photosensitivity. No fever. No vomiting but she was nauseous.  she went to the ER late on 6/13.  She was then transferred to the hospital for furthur care. She had a neurology consult that thought perhaps her headache, numbness and drooling could have been an atypical migraine-this resolved as of 6/14.  Her abdominal pain resolved after appendectomy and now she just has muscular pain related to surgery.
Patient woke up with headache the next morning that lasted about 8 hours. She was nauseous for 12 hours. She had redness and swelling at injection site and complained of muscle aches, was "wobbly", dizzy and tired for about 36 hours.
Date of Admission: 11/28/2022   Date of Discharge: 12/1/2022   Admission Diagnosis: Atrial fibrillation with RVR (CMS/HCC) [I48.91]   Hospital Principal Problem (Discharge Diagnoses): Atrial fibrillation with RVR (CMS/HCC)   All Hospital Problems (Other Diagnoses): Active Hospital Problems   Diagnosis o Principal Problem: Atrial fibrillation with RVR (CMS/HCC) o Lung mass o Primary hypertension o COVID-19 o Acute on chronic heart failure with preserved ejection fraction (CMS/HCC) o Sinus node dysfunction (CMS/HCC) o Cardiac pacemaker in situ o Mixed hyperlipidemia
Patient described area around vaccine as red, warm, and swollen on 1/21/09.  I instructed her to see the physician as soon as possible.  I followed up with her the morning of 1/22/09.  She had seen a physician at a walk in clinic the evening of 1/21/09.  The doctor outlined the reaction area with a marker.  She prescribed keflex and benadryl.  The doctor expressed concern that it was possibly cellulitis.  Although it cold also be an allergic reaction.  The patient has been instructed to watch closely and see her regular physician again if it does not resolve soon.
Mother reports swelling around the vaccination site (DTAP) as well as patient was running 103.0 Fever.  Mother of patient also reports GI symptoms including upset stomach, nausea and vomiting for two days.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: diffuse area of cellulitis with Urticaria. roughly 1.5 inches in diameter
Erythema, swelling and warmth over the injection site and the surrounding area measuring 7 cm x 6 cm in diameter.   No pain, no itching, no fever.
7:30pm -- patient complained of headache and temperature was 100.0F (tympanic); patient went to sleep; 10:00pm -- patient woke up with temperature of 104F (tympanic), Tylenol given; 10:30pm -- temperature decreased to 102.8F (tympanic); patient awoke the next morning with no complaints and did not develop any other signs of illness; fever went away the following day (9/29).
pain at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided.  Treatment information not provided.
9/6/13. Mother brought pt. back to clinic. R thigh-tender, warm to touch with redness almost up to the kole.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On 18-NOV-2015, the patient was inadvertently vaccinated with the dose of M-M-R II injection, 0.1 ml, lot# reported as L024265 with expiration date 01-JUL-2017, intradermally. On an unspecified date in November 2015, the patient experienced redness around the wheal, which resolved after application of a cold compress (unspecified date in November 2015). The causality between the adverse events and M-M-R II was not reported. Additional information has been requested.
Information has been received from a physician concerning a 4 year old female who in the afternoon of 19-APR-2007 was vaccinated in the left arm with a second dose of VARIVAX (Oka/Merck) (Lot #656572/0115U). There was no illness at time of vaccination. At 11:30 p.m., on 05-JUN-2008, the patient developed one dozen of vesiculopapular scattered on her trunk and extremities. The lesions of varying ages appeared over 48 hours. The patient had no fever. She was diagnosed with chickenpox. Additional information has been requested.
pt recvd vax; became fussy @ approx 7:30pm;fever, sz;shaking, cyanosis; 911 called;adm to hosp; pt sz at hosp x 10";tx w/ valium, kept overnoc for observation;tx w/ amoxicillin for ear infect;
10/28/21: last menstrual period 11/2/21: Moderna booster 11/28/21: positive urine pregnancy test 12/3/21: bleeding started 12/17/21: subchorionic hematoma diagnoses, viable intrauterine pregnancy confirmed  Dec 2021-Feb 2022: on/off light bleeding  Jan 2022: reassuring NIPT + nuchal translucency  2/17/22 gestational age 16 weeks): second opinion sought for ongoing bleeding , ultrasound and fetal ECHO revealed severe oligohydramnios, bilateral renal aplasia, multiple cardiac structural defects (VSD, transposition of great vessels, underdeveloped R atrium, ventral wall thickening) + reduced ejection fraction  2/25/22: D&E for non-viable fetus (GA: 17 weeks)  CVS performed at 16 weeks revealed normal microarray. Whole exome sequencing and pathology results pending.
This spontaneous report has been received from the patient's mother referring to her currently 16 years old daughter. The patient did not have pertinent medical history, drug reactions, allergies, concurrent conditions or concomitant therapies. In approximately 2016, reported as "about a year ago" the patient received the three doses regimen of GARDASIL or GARDASIL 9 intramuscular, (strength, dose, frequency, lot#, expiration date and anatomical location were not provided) for prevention on HPV. The reporter was not sure which vaccine her daughter received. The reporter stated that she received a call from the primary physician stating that the batch of GARDASIL or GARDASIL 9 was involved in a temperature excursion and for that reason her daughter would have to return to the physician's office to receive the regimen again. At the time of reporting the patient did not receive the additional doses of GARDASIL or GARDASIL 9. The patient did not seek medical attention. Neither, no laboratory diagnostics studies were performed or treatment any was given. Additional information has been requested.
Patient has arm pain going down arm. The pain started pretty immediately but it is not getting any better. I recommended patient get follow up with primary care Dr.
He is been sick all night/ Feeling unwell; Injection site pain; Headache; Chills; Fever; Fallen back to just sleep and a fast heartbeat; Fallen back to just sleep and a fast heartbeat; This is a spontaneous report from a contactable consumer (wife).  A 75-year-old male patient (also the age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at the left arm 01Feb2021 11:15 at SINGLE DOSE for Covid-19 immunization. The patient medical history and patient's concomitant medications were not reported. It was reported that "I am calling for about my husband (patient), well he took the Pfizer Vaccine (Covid-19 Vaccine) yesterday at 11:15 on the 01Feb2021 and he's been sick all night, he had the injection site pain, he has headache, chills, fever, he is just feeling unwell, I mean I think he is fallen back to just sleep and a fast heartbeat." For the treatment it was stated "Well, he in just on Tylenol, to keep his temperature down." There was no visit made to Physician Office/ Emergency Room and the reporter stated, "No, we haven't, I just wanted you to know there are some adverse effect that I am afraid people can't get through, I held it for 30 minutes, I don't know if you found out how many people get sick about it?" The reporter asked, "I kind of have a question, should the person if they have that much problem with that should he take the second shot." The outcome of the events was unknown.
PT FELT SLUGGISH /w BODY ACHES.  EVENTS LASTED 5 TO 7 DAYS.  2ND VACCINATION 21Feb90 NO PROBLEMS FOLLOWING VACCINATION.
Breakthrough case admission after 3 vaccines Pfizer 1/20/21 lot# EL3249;  Pfizer 2/9/2 lot# EL9265; Pfizer 12/27/21 lot# FJ1611
Approx 4 days later feel fatigue, malaise, body aches and still feel same as if I have a low grade flu of sorts
HIS LEGS AND ARMS HAD NO STREGTH. HE COULD NOT WALK OR PUSH HIMSELF OUT OF A CHAIR. WE HAD TO CALL MEDICS SINCE WE COULD NOT EVEN GET HIM UP OR TO THE BATHROOM. HE HAD AN ACCIDENT IN HIS CHAIR BUT DOESN'T REMEMBER IT AT ALL.  IN ER AROUND 10PM HE WAS ABLE TO LIFT HIS LEGS ON COMMAND. BEFORE THAT IT WAS LIKE HIS BRAIN WAS NOT ABLE TO COMMUNICATE WITH HIS LEGS OR ARMS.
pt recv vax & devel psoriasis-like sx;MD did not believe the pt sx were r/t to vax;
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 17-year old female patient, who was allergic to nickel and no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 13-JAN-2014 at 3:00 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Parents were informed, patient was revaccinated at no charge on an unspecified date. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
PATIENT WAITED THE 15 MINUTES AS ADVISED BY THE VACCINATOR BECAUSE OF NO PREVIOUS HISTORY OF ADVERSE AFFECTS FROM VACCINES AND NO ALLERGIC REACTIONS TO MEDICATIONS. PATIENT WAS GIVEN FLUIDS AND FOOD. PATIENT STATES THAT HE FEELS BETTER NOW.
Patient presented to the pharmacy with visual pain, inflammation, and redness at the injection site only, with the area of about an 1.5 inch in diameter.  I informed her to take Tylenol, Benadryl to help with the pain and allergy. I also informed her to ice the area several times as needed throughout the day. Patient does not have a primary doctor as she moved from out of state and did not want to go to emergency room. I informed her to contact us if she did not feel better or if the symptoms worsen or spread. She agreed to notify us or come in if the symptoms did not improve.
After receiving vaccine patient stated he felt weak.  He then mentioned that he had a history of getting faint after shots.  Client sat back down.  Giving water to sip and continued to say he felt weaker.  Assisted patient to the ground.  BP 130/80; O2 97%; Pulse 85.  Client  felt clammy. After a few minutes, client stated he was starting to feel better.  Sat up in chair and observed for another 30 minutes.  Client left feeling better on his own.
Total health meltdown, Fever, Vomiting, Swelling, redness, asthma attacks, Pneumonia, Bronchitis, RSV, Bronchiolitis, Etc, Almost Died.
About 5 minutes after receiving 2nd dose of Moderna vaccine client began complaining of chest pain, and feeling of throat closing. RN and EMT present at client's side. Noted that lungs had crackles. EMT gave a total of 324 mg of Baby Aspirin at 1630 (Four 81mg tablets). At this time client's BP was 197/98. At 1633 EMT gave one 0.4mg dose of Nitro sublingual. Client's BP at this time was 176/87. Ambulance arrived and took client to hospital.
VOMITING, CHILLS, BODY ACHES, TACHYCARDIA
Experiencing a reaction, a week after the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experiencing a reaction, a week after the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Experiencing a reaction, a week after the shot). At the time of the report, VACCINATION COMPLICATION (Experiencing a reaction, a week after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment information provided
sore arm; body aches; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 6955) via an unspecified route of administration in the left arm on 08Apr2021 at 11:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient experienced sore arm and body aches. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events sore arm and body aches were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a physician and refers to a 5 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 17-FEB-2017, the patient was inadvertently vaccinated with second doses in immunization series for VARIVAX lot # M038225, expiration date 07-SEP-2018 (dose, route of administration and anatomical location were not reported) and PROQUAD lot # M037010, expiration date 21-FEB-2017, therapy type rHA (dose, route of administration and anatomical location were not reported). The doses were administered concomitantly, and were reconstituted with sterile diluent. No adverse effects were reported. The product quality complaint was not reported. Additional information has been requested.
no additional AE; 7 year old patient was administered a dose of GARDASIL9; This spontaneous report has been received from a pharmacist referring to a 7 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 21-APR-2021, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 milliliter(ml)(a dose), lot # 1637651, expiration date 09-JUN-2022; strength, route and anatomical location were not provided) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE) was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
No additional AE reported; Caller is a medical assistant calling to report an adverse event for PROQUAD. Caller reports that a dose of PROQUAD that experienced a temperautre excursion was administered to the patient after the excursion occured. Additional AE's filed in 021923; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, 0.5 ml, lot number U039262, expiration date reported as 09-JUN-2023, administered for prophylaxis (strength, and route of administration were not provided) after it was exposure to a temperature excursion (product storage error). The temperature excursion was of 7.7 Fahrenheit degrees for 30 minutes. It was reported that there was a previous temperature exclusion. No additional adverse event was reported.; Sender's Comments:  US-009507513-2206USA007839: US-009507513-2206USA007717: US-009507513-2206USA007675: US-009507513-2206USA007710: US-009507513-2206USA007855: US-009507513-2206USA007547: US-009507513-2206USA007894: US-009507513-2206USA007527: US-009507513-2206USA007706: US-009507513-2206USA007910: US-009507513-2206USA007693: