chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my injection in my left arm and had pain and swelling at the injection site, but I also experienced pain from my jaw through the left side of my face. The left side of my lip up into my eye was all in pain. When I woke up the next morning, I could feel pain all in that area and it felt like my jaw was set to the right. I heard a cracking sound at some point. When I was eating that morning, I felt a crack and it felt like my jaw shattered. I'm still feeling pain in my face, and it looks asymmetrical. I took a picture. I also developed a red rash on both legs from above my knees and up into my thighs. About 7 inches above my knee, I have been seeing red spots and itchy patches that have been raised. I was taking over the counter non drowsy allergy medication because I was already experiencing some allergy issues, yet I was still seeing the rash on my legs. I went to the doctor who gave me a shot of MEDROL and prescribed prednisone for 10 days and advised that I continue taking BENADRYL and non-drowsy allergy medication and come back in two weeks, unless things get worse, in which case he wants to see me immediately. I have also been experiencing an itching sensation all over in random places.
Initial report received on 07/Aug/2006 from a health care professional.  A 45-year-old male patient had received a left deltoid injection of Adacel, lot number C2556AA, on 1/Jul/2006.  Four days later, the patient was examined in the doctor's office and diagnosed with cellulitis.  He was prescribed cephalexin for a ten day course.  A one inch needle was used to administer the vaccine.  At the time of this report, the patient's recovery status was unknown. The reporter in this case is the same as in case number, case number and case number reported.
Pt presented to EC with SOB, fatigue, diaphoretic. Received Covid booster that morning. Began to feel SOB around 1230-100, started coughing, difficulty breathing. On arrival pt hypertensive, WBC 16,000 creatinine 1.7. Pulmonary edema, pneumonia SaO2 87%, lactic acid 2.9, elevated troponin. Placed on biPap. Elevated D Dimer. Pt wt 103 kg. Pt transferred for heart catherization on 10/04/2021? 10/05/21?
I had started getting a rash behind my knees that looked as if I have been bitten by 1,000 mosquito. I took Benadryl but was awoken by midnight by the itching. The next day the rash spread to my thighs and looked as if I was scalded, I was prescribed a Prednisone taper starting with 20mg. I was also prescribed hydroxyzine to take as needed to help with the itching.
component of PENTACEL given without the Hib component with no reported adverse event; Initial information received on 24-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who was exposed to component of pentacel given without the hib component with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination; and Rotavirus vaccine live reassort oral 5V (Rotateq) for Prophylactic vaccination.  On 23-Jan-2023, the patient received a 0.5 ml dose 2 of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine Suspension for injection with component of pentacel given without the hib component with no reported adverse event (single component of a two-component product administered) (lot: UJ662AAA) via intramuscular route in the right thigh with frequency: once, strength: standard, expiry date: 02-Apr-2023 for immunization.  Action taken: not applicable.  Outcome: unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
The pt developed severe systemic allergic rash (hives) and irritability, approx. 2 or 3 hours following 1 dose of Zithromax. Given Prelone 5mg/5ml, 2 tsp OD X 5 days. She was unable to keep it down, so she was hospitalized. She was given Prevnar at 16 hours prior to reaction. On 3/22/02 while an inpatient, child was diagnosed with Erythema multiforme minor.
Knee pain; This case was reported by a pharmacist via call center representative and described the occurrence of knee pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced knee pain. The patient was treated with cortisone (non-proprietary) (Cortisone Shot). On an unknown date, the outcome of the knee pain was unknown.   The reporter considered the knee pain to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a Cortisone shot after receiving the Shingrix.  The Cortisone was received for Knee Pain. The reporter consented to follow up. The pharmacist did not know the specific condition and did not feel it was related to receiving the Shingrix vaccination.
Headache, Myalgia & Angioedema  Narrative:  Received vaccine on 2/1/21 experiencing swelling on Right side face under jaw and behind right ear, the tightness woke her up during the night. Can  swallow "it feels like a lump in throat, headache and light sensitivity. Using warm  compress to decrease swelling. Advised to follow up with her PCP and monitor the swelling if gets worse seek care immediately. Employee verbalized  understanding
Patient reported no problems on the day of the vaccine administration, but later experienced a fever of 102 degrees Fahrenheit. Her arm was "hot to touch" and "abnormally swollen" in the upper arm where the vaccine was given. The patient was seen by her doctor who determined the reaction was the result of a bacterial infection. He treated the infection with an antibiotic, and the patient recovered. A month later, she reports no other problems.
mom states p/1st & 2nd dose of vax fever up to 104 lasting 1wk;pt was not brought in  to be checked w/either episode;
Patient died we think on March 27th although he wasn't found until March 28th.  We are waiting for the histology report on his cardiac tissue samples. We are suspecting myocarditis.
Localized swelling, redness, knot on L leg. Parent gave Tylenol and applied warm compress.
Patient complained her heart was racing after receiving  2nd dose of vaccine. Onsite EMS was called vitals HR 84 BP 116/72 100% O2. She took her dose of amlodipine just before EMS arrived, she recoverd & went home.
she had a reaction to all 4 Moderna COVID-19 vaccines that she received.; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (she had a reaction to all 4 Moderna COVID-19 vaccines that she received.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 IMMUNISATION REACTION (she had a reaction to all 4 Moderna COVID-19 vaccines that she received.). At the time of the report, IMMUNISATION REACTION (she had a reaction to all 4 Moderna COVID-19 vaccines that she received.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that patient had a reaction to all 4 Moderna COVID-19 vaccines.  It was reported that patient did not receive any other vaccine in the 4 weeks prior to COVID-19 vaccine. No treatment medication was provided.   This case was linked (Patient Link).
Fever, Chills, Body Aches, Head Ache, Upset Stomach.  These symptons lasted for 16 hours once they began.  I received the shot on Tuesday at 11:30am and by 3:30am the next day I was sick.
I don't have the vaccine card on hand, but approximately 2.5 week after the second dose of the moderna covid 19 vaccine, my husband developed an ascending aortic dissection which required emergency open heart surgery.  This is the 3rd person with this, the other 2 reported the same scenario a couple weeks after receiving the 2nd dose of moderna.
Headache, pain 7/10,  started 3 hours after received vaccine, decreased to 2/10 with tylenol.  Lasted for 48 hours and then periodically for an additional 24 hours.  Required ATC tylenol for around 48 hours.  Arm pain at injection site lasted for 48 hours Fatigue lasted 24 hours Myalgias (other than at injection site), lasted 26 hours
Fatigue, ache, Extreme swelling of the lips.   4 occurrences so far covering all 4 quadrants randomly.   Numbness, tingling, itchy sensation.   Last episode involved swelling of the cheek and eye on same side as lip.  Chest and back tightness
On 7th day red bump developed. On 11th day seen at clinic bump was red, slightly warm, elevated & hard. Red area measured apx 20mm x 28mm. Evaluated by employee, determined to be site of PCV13 or influenza. Evaluated by Dr. determined to be vaccine reaction. Area marked, advised to call in if bigger. Ibuprofen & TYLENOL for pain/discomfort.
Severe pain on entire left side of body (same side as injection)-felt like I was in a car accident and badly bruised.  Full body aches and joint pain (remainder of body) Headache and constant pressure Fatigue-could not stay awake Chills-Freezing could not get warm  Called out of work for 2 days (First and second day after the vaccine) Experienced exact same side effects with the first dose of the vaccine and it lasted about 3 full days after the vaccine (not including the day I received the vaccine)
The following month, pt. started to have headaches and nausea and lead to anxiety.  Within 6 months she started to get lightheaded and dizzy when she stood up, passing out several times. She started to become more fatigued and having joint pain.  Then in October 2019, she began having stomach issues and severe stomach pains where she could no longer finish a game of soccer and she had played soccer from 3 years old.  We spent almost a year trying to figure out what was going on with her stomach and then in October 2020, she sprained her ankle and tore tendons and was told 4-6 weeks in a boot.  She had unrelenting pain and by December of 2020 she was diagnosed with CRPS.  By November 2021 she could not keep food down and was throwing up constantly.  She now has POTS, CRPS and gastroparesis.  She developed involuntary movements in September of 2022 and verbal tics in November of  2022.   She had to stop going to school due to all the symptoms and has now been off school her entire Junior high school year and she is still continuing to fight through all of these symptoms each and every day.
Pt received vaccine on 9/6/18, 11:05am. Next morning 9/7/18, woke up with swollen throat, hoarse voice, and difficulty swallowing. He reported that during the day the swelling went down. He said that that night he took two BENADRYL capsules OTC. He said that on 9/8/18, he woke up fine, throat swelling was gone, and no symptoms remained. Pt reported his reaction to the pharmacy 9/11/18, and confirmed that he was not experiencing any problem at the moment. Rph added adverse reaction to pt's file and also contacted pt's new md Dr., to reported reaction to nurse and asked her to follow up with pt.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 21-MAR-2017, the patient was inadvertently vaccinated with ZOSTAVAX lot # L012478 with expiration date on 10-JUL-2016 (anatomical route of vaccination was not provide) for prophylaxis. No adverse events were suffered due to the vaccination and no product quality issue was involved. Additional information has been requested.
rash at the injection site; rash is red, raised, covered from shoulder down to elbow, warm to touch; period stopped; very tired; lightheaded; slight fever 99.2F; nausea; headache; pain and sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired), DIZZINESS (lightheaded), PYREXIA (slight fever 99.2F), NAUSEA (nausea) and HEADACHE (headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FATIGUE (very tired), DIZZINESS (lightheaded), PYREXIA (slight fever 99.2F), NAUSEA (nausea), HEADACHE (headache) and VACCINATION SITE PAIN (pain and sore arm at the injection site). On an unknown date, the patient experienced VACCINATION SITE RASH (rash at the injection site), RASH ERYTHEMATOUS (rash is red, raised, covered from shoulder down to elbow, warm to touch) and MENSTRUAL DISORDER (period stopped). The patient was treated with NAPROXEN at an unspecified dose and frequency and TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, FATIGUE (very tired), DIZZINESS (lightheaded), PYREXIA (slight fever 99.2F), NAUSEA (nausea), HEADACHE (headache), VACCINATION SITE PAIN (pain and sore arm at the injection site), VACCINATION SITE RASH (rash at the injection site), RASH ERYTHEMATOUS (rash is red, raised, covered from shoulder down to elbow, warm to touch) and MENSTRUAL DISORDER (period stopped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient had worsening  SOB after receiving COVID vaccine.  SOB worsened over next 4 days.   Patient referred to Urgent Care for medical evaluation
After couple hours receiving afluria and pneumovax, patient called pharmacy and  reported that his palm of right hand is blackish and left hand fingers were greenish. The patient came to the pharmacy and showed his hands to me. The palm of his right hand became brownish, however, according to the patient, it was dark black earlier. His left fingers had several greenish spots that almost look like print ink stained on them. Patient didn't  not complaint of any irritation or pain and was able to move his hand just fine.  Informed patient to contact his doctor and make sure to consult with him.
3RD DOSE MODERNA COVID VACCINE GIVEN 12/20/21, LOT #030H21B pt resides at Care Center where she had a positive COVID test on 1/18/22, asymptomatic; 1/24/22 pt to hospital for poor oral intake x 2 days, difficulty breathing; hypoxia; given O2 supplementation; positive COVID test; DNR/DNI; IV fluids; Dexamethasone, Remdesivir; Deep venous thrombosis prophylaxis; pt improved and was dc'd on 1/18/22 to Nursing and Rehab where she passed away
very sharp pain in back where lungs might be; She felt it when she breathed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 (Lot number: EP6955) at the age of 22 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BACK PAIN (non-serious) with onset 28Mar2021, outcome "not recovered", described as "very sharp pain in back where lungs might be"; PAINFUL RESPIRATION (non-serious) with onset 28Mar2021, outcome "not recovered", described as "She felt it when she breathed". Therapeutic measures were not taken as a result of back pain, painful respiration. Additional information: Clinical course: The patient got her first shot Saturday at noon. Last night, 28Mar2021, she started getting very sharp pain in her back where lungs might be. She thought it might go away over night, but now it was very sharp pain in her back where her lungs were. She felt it when she breathed. The patient was querying if this was a side effect, and if other people have reported that or was this a muscle issue that has nothing to do with shot. The patient had no additional vaccines administered on same date of the Pfizer suspect, no prior vaccinations (within 4 weeks), no adverse events following prior vaccinations and no family medical history relevant to adverse events.  No follow-up attempts are possible. No further information is expected.
patient was expecting to get pfizer booster and instead moderna booster (0.25ml) was administered to the patient.  no adverse reaction noted after giving moderna
4 days after immunization became lethargic and needed hospitalization. (may have been injection of Tenex). Per annual report- Ingestion of Tenex (Brother's medication).
While at rest pt developed vomiting, and had 3 episodes of vomiting. Pt also had dizziness associated with the vomiting.
Patient presented to the ED complaining of burning and painful vesicular rash on the C5 dermatome. Patient was discharged from the ED with prescription for Zovirax 600 mg po 5 times a day for 7 days and Neurontin 300 mg po HS. Returned to clinic for follow-up, lesions were in the healing process.
pt c/o vertigo; began perspiring on face; skin color pale; had pt lie down on exam table w/cold pack to face, head down; monitored BP, pulse, ranged from 96/60-100/70; pulse 100; pt felt weak for 10 mins; arms were wet & cool for 10 mins;
Thumb on left hand stiff,  sore, red, very hot, pain extends into space between thumb and forefinger. Other 4 fingers not affected.
Moderna  vaccine  ( NDC  80777-0273-98 )  lot #  039D21A  + GTiN  00380777273983 was administered  after the beyond date  of 10/23/2021 . Contacted  Manufacturer  Moderna = no need to repeat dose  .
Rotarix not reconstituted; Diluent given without reconstitution; This non-serious case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a 3-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number KB7FJ) for prophylaxis.   On 13-FEB-2023, the patient received the 1st dose of Rotarix lyophilized formulation (oral). On 13-FEB-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Rotarix not reconstituted) and inappropriate dose of vaccine administered (Verbatim: Diluent given without reconstitution). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-MAR-2023 The reporter stated that, when performing the vaccine count it was noted there was 1 more vial of the live virus vial than the diluent syringe.  The reporter stated three patients had received doses so it was unclear if this patient received the correct dose. The case was linked with case US2023034036 and US2023AMR047920, reported by same reporter for different patients. The patient received diluent portion of Rotarix without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023034036:Same reporter US-GSK-US2023AMR047920:Same reporter
This spontaneous report was received from a pharmacy student refers to a 18 year old female patient. The patient did not have any allergies/drug reactions. On an unknown date, the patient was vaccinated with GARDASIL or GARDASIL 9 (route and site of administration, dose, lot number and expiration date were not reported for both). Concomitant therapy included unspecified birth control pills. On an unknown date, approximately 40 days later, the patient developed shortness of breath, body aches and joint pain. The patient sought medical attention via contacted the pharmacy student. The outcome of the events was unknown. The relatedness between the events and the suspect therapy was not reported. Additional information has been requested.
My arm was instantly hot and felt a strong pinching stinging feeling - within hours a red spot occurred about the size of quarter - by 10pm I had a 4" area that was swollen about 1" high this increased to 1 1/2" high by Thursday and the red hot spot was growing to about 3".  I couldn't lift my arm, my fingers were tingly and the soreness was traveling up to my neck.  I had a fever until late Saturday.  The swelling was iced frequently and still continued to increase just the same - I also took Ibuprofen. Was pretty much better by late Saturday but still exhausted until Monday.
Mother reports fever of 102, muscle aches and sore throat. Muscle aches have relented as of 12/04/2009.
ARM WAS LITTLE HURTING; HEADACHE; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced arm was little hurting. On 25-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from arm was little hurting, and headache. This report was non-serious.