chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacy technician (the patient's mother) refers to a 7 year old male patient. In 2010 (exact date unspecified) the patient was vaccinated with GARDASIL (0.5 ml, intramuscular, anatomical location, lot number were not reported) when he was 7 years of age. No adverse effects reported. Additional information has been requested.
Pain from elbow up to shoulder and under armpit. Large area of swelling about 3 inches in diameter and hives around the injection site.  Stomach ache, soft bowel movements.
Sx onset 7/16/2021 with cough, headache, runny nose and nasal congestion. Tested positive for COVID-19 on 7/18/2021
3" oval area where DT was injected reddened & inflamed;tx warm compresses;
Patient came to pharmacy for Moderna booster Covid-19 vaccine. She had previously had vaccines at health department and reacted to the second vaccine resulting in throat rash and difficulty swallowing, successfully treated with two doses of Benadryl. I discussed the option to continue and the possibility of continues response to the booster, patient elected to continue and get the booster. Approximately 5-7 minutes post vaccine, patient showed signs of aggitation and small rash appeared on cheeks. we administered a dose of 10ml Benadryl and fluids. Patient stayed in the pharmacy area for 15-20 and rash went away and patient felt comfortable enough to leave for work. we followed up with patient an hour later and approximately 6 hours later at home, she said she felt much better and had taken another dose of benadryl.
There were no adverse side effects, and patients mother was spoken to over the phone and has agreed to the vaccine that was given, and mother is not upset.
Patient reported chest pressure and discomfort as well as shortness of breath. Pt. had elevated troponin and CXRP. Mild fever, migraine . Hx of connective tissue disorder. Sever swelling in lymph nodes. EKG showed diffuse ST-depression. Held for observation, and prescribed prednisone 40 mg and colchicine. On day of discharge was asymptomatic and able to ambulate.
PT PRESENTED TO CLINIC WITH A SWOLLEN LEFT THIGH DUE TO PENTACEL VACCINATION AND IT WAS WARM TO THE TOUCH HAD LOCAL REDNESS. PT WAS CRYING AND VERY FUSSY.
a second dose of MMR II was inadvertently administered instead of VARIVAX; fatigue; Information has been received from a medical assistant referring to a 13 months old female patient. The patient's concomitant medication was not provided, and the patient had no pertinent medical history or drug/allergies reactions.   On 01-MAY-2019, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number and expiration date, frequency and route were not provided) for prophylaxis. On 11-JUN-2019 (also reported as 05-JUN-2019), a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot R020923, expiration date 22-JUL-2020, route was subcutaneous) was inadvertently administered instead of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number and expiration date, frequency, indication and route were not provided) (wrong product administered). The patient was now experiencing fatigue. It was confirmed that this was human error and not product confusion.   No product quality complaint (PQC) was involved. There was no treatment given for the adverse events, lab diagnostics/studies performed, or medical attention. The outcome of fatigue was reported as not recovered. The causality assessment was not provided.   Lot Number R020923 with therapy type of rHA is valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live.
Got ADACEL vaccine on 2-20-12. The following day had size of apple red area on upper arm. Slightly raised non tender. Mom gave BENADRYL.
Pt vaccinated with DTP 4 hrs later developed temp of 104 x 24hrs, lethargic, decreased apetite for 36hrs; no crying no voiding diarrhea
This spontaneous report as received from a pharmacist refers to a 58 year old male patient. The patient had no drug reactions or allergies. On 04-NOV-2013 the patient was vaccinated with ZOSTAVAX lot # J006828, expiry date 14-SEP-2014, dose 0.65 ml, subcutaneous to prevent shingles. No concomitant medications were reported. On 05-NOV-2013, the patient experienced open redness at the injection site after receiving ZOSTAVAX. The patient reported that the injection site was warm and sensitive and sore to touch. The outcome of the events was reported as not recovered/not resolved. The patient sought medical attention and visited a pharmacist in the pharmacy on 06-NOV-2013. Additional information has been requested.
2 blood clots in my lungs; 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 PULMONARY EMBOLISM (2 blood clots in my lungs) 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 PULMONARY EMBOLISM (2 blood clots in my lungs) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (2 blood clots in my lungs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
In 30 minutes my ear plugged completely and my nose started running. I had fatigue, and the next day on the 2nd of October i had the worse Diarrhea  and nausea symptoms of my life. I had a heart rate bellow 50 and its very abnormal. My heart rate is usually fast. I got tighten of chest and chest pressure. On day 4 my ear that had gotten plugged caught an infection and I lost hearing and i got a loud ringing that hasn't been resolved . This was on my left ear,  I'm currently on Dexamethasone to try to resolve it.  My chest pressure feels like a swollen feeling but it comes and goes.  I felt vascular headache pain as if it was my veins hurting and they would come as go. My menstrual cycle has not started on time.  I have been instructed by the doctor to not take the second dose.
Sudden onset of menstrual cramps and menstrual period that lasted five days, outside of typical cycle. Rash at injection site.
sore right injection site arm; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE PAIN (sore right injection site arm) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore right injection site arm). At the time of the report, VACCINATION SITE PAIN (sore right injection site arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Intramuscular) and mRNA-1273 (Unknown) was unknown.       No concomitant medications were  provided. Treatment Information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-076360 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076360:First dose
The following symptoms occurred between week 2 and week 3 of my second shot: Itchy rash on small of back where tattooed  Left leg muscle pain ( tibialis anterior) Bilateral hand pain - unable to make a fist worse in left hand...this happened during sleep and got better as the day wore on. (these reactions are in addition to the "normal" reactions that I had within 48 hours of shot #1 and #2)
Her shoulder blade muscle, the back of her arm, and the side of her arm has been hurting; Her shoulder blade muscle, the back of her arm, and the side of her arm has been hurting; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 30Jun2021 as dose 2, single for COVID-19 immunization. The historical vaccine include BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 09Jun2021 as dose 1, single for COVID-19 immunization. The report  was not related to a study or programme. The patient's medical history and concomitant medications were not reported. The patient experienced her shoulder blade muscle, the back of her arm, and the side of her arm has been hurting on 02Jul2021. Caller wanted to enquire if there were any reports of any muscle problems and she was wondering if she had not taken the vaccine just like everyone else and said that she might just go to the hospital. Patient got the 2nd dose of the Pfizer vaccine last 30Jun2021 and mentioned that it's been 10 days now and she was still experiencing muscle pain in her back and a pain in her shoulder blade and arms. She wanted to know if she needs to go to the hospital and needs some assistance. She got her first dose on 09Jun2021. The outcome of the event was non recovered.  Information on the lot/batch has been requested.
Diffuse rash on face and body.  Began on face. Scalp, neck, chest, abdomen, back, extremities, and palms involved. Clinic visit 08/12/2013
This case was reported by a consumer and described the occurrence of injection site swelling in a 54-year-old female patient who received DTaP vaccine. Concurrent medical conditions included penicillin allergy, iodine allergy. Concomitant products included Tuberculosis vaccine. On 16th October 2014 11:00, the patient received DTaP vaccine (subcutaneous). On 16th October 2014, 30 min after receiving DTaP vaccine, the patient experienced injection site swelling, feeling hot, tingling of extremity and headache. The patient was treated with hydrocodone, PARACETAMOL. On an unknown date, the outcome of the injection site swelling, feeling hot, tingling of extremity and headache were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, feeling hot, tingling of extremity and headache to be related to DTaP vaccine. Additional information received: The patient received Tdap vaccine subcutaneously in the left arm below the deltoid muscle. She experienced symptoms within 30 minutes of the administration. She reported it to doctor's office but she was not given any guidance. She called the hospital this morning and was told to ice it and to keep it elevated.
swelling, hardness, tenderness @ site & related pain;sl fever-no tx;advised by administering RN to apply ice to area;use analgesic as directed;massage area;seek reg med MD;
"Moderna COVID-19 EUA" Event: Rash,hardness, heat and swelling around injection site, headache, chills, fever, fatigue  Treatment: Tylenol, ice and rest Outcome: 48hrs plus all clear
Influenza-like illness Narrative:  Improved within 6 hrs-no medications taken
I felt funny within an hour of the vaccination. By 1 p.m my lower lip felt tight, when I looked in the mirror around 3 p.m. I noticed my lower lip was  swollen.  My husband says it was swollen and purple. By bedtime, the swelling in the lip had gone down. About 3 am, I was awoken by shivers going through my whole body. My feet and hands were like ice cubes. I curled up and stuck my head under the covers, but keep shaking. Got up about 5 am, and stood by the fireplace. Heavy shaking stopped by 7am. I continued with lighter shivers through the morning. Temperature taken at noon showed low grade fever of 99.4 ..  Took Tylenol and felt better. Not much of an appetite had toast and chicken noodle soup to eat, lots of water. Following day I felt back to normal.
Sore arm and some fatigue were my only side effects. My due date is July and have had a normal pregnancy thus far.
Information has been received through the Pregnancy registry from a registered nurse concerning a 16 year old female with no medical history or allergies who on 03-OCT-2007 was vaccinated SQ on right arm with a second dose of VARIVAX (Lot # 658422/1030U). Secondary suspect therapy on the same day included a dose on left arm DTaP (unspecified) (+) Tetanus toxoid. Other concomitant medications included iron (unspecified), calcium (unspecified) and prenatal vitamins (unspecified). A blood test done on 03-OCT-2007 was positive for pregnancy. Ultrasound performed on patient on 12-OCT-2007 showed normal fetal development with a due date of 30-MAR-2008. The patient's LMP was in June 2007. The patient has no previous history of pregnancy of miscarriage. There were no adverse events reported. A product quality complaint was not involved. Follow-up information indicated that on 25-OCT-2007 prenatal testing for MSAFP showed negative screen for the patient (LMP 01-JUN-2007, EDD 30-MAR-2008). It was unknown whether any maternal adverse events occurred. It was also unknown whether the patient was tested for varicella antibodies before vaccination with VZV containing vaccine. Follow-up information was received, which reported that on 03-MAR-2008, the patient had a normal female infant who weighted 5 pounds 8 ounces. No congenital anomalies, complications or abnormalities were reported. There were no features of congenital varicella zoster syndrome on the infant. It was reported that during pregnancy, the patient experienced a strep throat infection. There were no complications during pregnancy or delivery. No further information is available.
12/30/03 mom brought child to physiican-chief c/o rash. Dx-shingles-had varicella vaccine 6/18/03 rash appeared 12/27/03.
Caused extreme dehydration. 3 days after shot her Kinsey?s went into failure and she never recovered despite all the efforts of the doctors / staff. She was never advised not to get shot if she had kidney issues. She diesels eight days after getting shot
Patient C/o facial numbness, rash and hives on face and neck 25 minutes after vaccine given. lips swelling and numbness. Epi pen given. Patient rash and hives continued. patient shaky and nervous. patient denied difficulty breathing. BP elevated. O2 sats stable. IV placed in right AC , IV Benadryl 50mg given IV push. Paramedics on site. Patient transported to ED.
31JAN94 PC from client; states had hep vax 28JAN94; 29JAN94 lt arm started swelling & became sore from elbow up to neck; 30JAN94 broke out w/hives on lt arm which spread to chest & abdo; face was blotchy & had a few hives on back & leg;
Booster Vaccine administered 4 weeks early. Pt experienced no sympotms or reactions.
pt described intense itching on 6NOV96 approx 24hr p/vax devel red welt like eruption on feet, hands & under buttocks;tx w/DPH & steroid cream, OTC;seen by MD for pharyngitis & given DPH for hives;
Bad allergies; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Bad allergies) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 216B21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Mar-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 HYPERSENSITIVITY (Bad allergies). At the time of the report, HYPERSENSITIVITY (Bad allergies) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient's medical history included unspecified medical conditions. No relevant concomitant medications were reported. No treatment information was provided.
I got COVID after Dose 3 started with difficulty breathing and a sharp pain by my right shoulder blade. I experienced a low grade fever, very tired, no appetite, little nausea and bad headache symptoms lasted about 5 days.
Client developed an edematous, red-purple area distal to the injection site on her left arm and extending to her elbow.  Based on a picture provided to this RN, it appeared to be roughly 8-12 cm in width (around the arm) and roughly 15-18 cm long (longitudinal toward her hand).  Swelling was greater dependent to the injection site.   Client was advised to seek medical attention of a physician or go to the ED of the local hospital urgently.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 15-MAY-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-SEP-2015, it was reported that the patient was treated for a painful and blistering vesicular outbreak, which was diagnosed by a physician as herpes zoster, or shingles. The patient was prescribed Valacyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expense, pain and suffering, and other damages. Additional information has been requested.
Redness, swelling, itching at injection site.   Back of throat "scratchy", moderate facial sweilling
HPI  70 y.o. female with pmh of HTN presenting w/aphasia and R sided facial and extremity weakness onset 15m prior to EMS activation. Per EMS, pt may be on anticoagulation, unk meds. LKW 15 minutes prior to activation pt began slurring her speech and spoused noted R facial droop and R sided weakness. Patient unable to provide history based aphasia however cannot yes or no to questions. Pt is no longer taking medications for BP.   Patient positive of intracranial hemorrhage.
Had Herpes Zoster/Shingles. Rashes appeared on lest side of belly and back. Felt painful on different spots of the body.  On the fourth day when this happened,  Took one VALACYCLOVIR HCL 1GM TAB three times a day/ Took three GABAPENTIN 100MG CAPS per day/  Took  one ACETAMINOPHEN ER 650MG TBCR as pain reliever four times a day / Took one B-COMPLEX per day/
Severe pain in injection site getting progressively worse, fatigue, chills/hot flashes, stomach pain, diarrhea, falling (on 1/12/21 at 8:00 am I collapsed and fell but did not go unconscious).
Cerebellitis, Acute Cerebellar Ataxia; Sudden onset weakness and Ataxia  10/07/08 Reviewed hospital medical records of 8/8-8/11/2008, FINAL DX: acute cerebellar ataxia Records reveal patient experienced sudden onset of ataxia on 8/8 consisting of HA, trembling & difficulty walking which progressively worsened until unable to walk.  Had been transferred from outlying ER.  Neuro consult abnormal & revealed ataxic gait,  decreased reflexes, Romberg (+).  Improved & d/c to home w/continued mild ataxia in AM that improved during the day. 1/26/2010 Majority of symptoms are resolved but has persisting fine motor problems.
On the date of vaccination, I experienced no symptoms but my symptoms started on January 10th I went to Urgent Care for a urinary track infection and got treated, January 11th I started experiencing abdominal pain and thought it was a side affect of the urinary track infection medicine, in addition I have been spotting for years and it usually can be controlled with a vaginal moisturizer and this time it could not. I went to see my PCP and did a CT scan and nothing showed up, things continued to get worse so I went to see my gynecologist because I had a  suspicion this may be uterine cancer and they did a ultrasound and saw that the uterine lining was thickened so they did a Biopsy on Feb 9th, I had a hysterectomy on March 13th and after that it showed cancer had gotten into other parts of the body so now I am undergoing chemotherapy.
Pain in all joints in my left arm started about 1-2 hours after receiving injection. Joints: Shoulder, elbow, wrist and hands. Obviously pain in the muscle where I received the injection but thats exp; pain in the muscle where I received the injection; This is a spontaneous report from a contactable nurse, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via intramuscular route of administration in the left arm on 05Apr2021 (At the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not receive any medication within two weeks of vaccination. 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 05Apr2021 at 11:00 the patient experienced pain in all joints in left arm started about 1-2 hours after receiving injection. Joints: Shoulder, elbow, wrist and hands. Obviously pain in the muscle where she received the injection but that was expected with any intramuscular injection. Patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events joint pain, muscle pain was not recovered.  No follow-up attempts are needed. No further information is expected.
Strong strong fatigue, I was scared to go to sleep. But I only slept for 3 hours and was kept up til 4 am Around 5am same night technically next day I couldn?t sleep because I had crazy shakes, and I never get cold and it was cold in my room I was shaking uncontrollably. I drink water and ate a banana, that didn?t do anything really but eventually I got to sleep. I woke up at 8 this morning and I have a major headache and I forgot all night I had a sharp pain in my neck. It did go away when I woke up this morning. And now I have back pain.
Patient developed COVID 19 infection, diagnosed March 3/28, greater and developed symptoms Approximately March 20th, approximately 4 weeks after being fully vaccinated. Patient also received chemotherapy treatment of Benamustine and Rituximab March 22 and 23rd, receiving monthly injections.
Pt. presented with generalized papular lesions on back and chest.  Lesions appeared Approximately 4 days post vaccination. Pt. denied complaints of fever/chills.  C/O generalized tiredness associated with development of lesions.