chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call representative and described the occurrence of fever in a 11-year-old female patient who received PEDIARIX. On 16th March 2016, the patient received PEDIARIX. On 16th March 2016, less than a day after receiving PEDIARIX, the patient experienced fever, screaming and rash. The patient was treated with MOTRIN and TYLENOL. On an unknown date, the outcome of the fever and rash were recovering/resolving and the outcome of the screaming was recovered/resolved. The reporter considered the fever, screaming and rash to be almost certainly related to PEDIARIX. Additional details were received as follows: This case was previously reported to a doctor. The patient experienced rash bilaterally on back of legs, fever, and screaming with random movements. The patient had fever of 104 degree F and abated to 101 degree F after receiving doctor ordered TYLENOL and MOTRIN. The reporter was unable to provide complete details on vaccination.
Mom called 8/29/03, reported that pt had red areas on her thighs. R leg approx 2 1/2", L leg approx 1". Pt had temp 99 deg.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Medical history and drug allergies were not reported. Since 31-OCT-2013, the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular (lot number and concentration were not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Patient received first dose of Pfizer COVID-19 vaccine on 8/18/21. On the morning of 8/20/21 patient complained of nausea but still went to school. When arrived at school, went straight to restroom and vomited. Remained near toilet, vomited again and passed out for unknown amount of time. Patient returned home, and parent contacted pediatrician's office who then instructed her to contact the vaccinating pharmacy. She detailed the vomiting/syncope symptoms, also noted that when she is lying down she feels better but when she attempts to stand or remain upright the feelings of nausea return. Patient also noted pain in her legs when she was vomiting at school. Instructed parent to continue monitoring the patient and to notify healthcare provider and vaccinating pharmacy of any further developments.
Pt developed a urticarial rash with itching of lips and perioral area. She had joint swelling and pain. She was treated with Benadryl. Urticarial rash resolved over 24 hours. Joint pain and swelling resolved over 4 days.
Redness, hot, swollen area right deltoid 3.5x4.25 inches.
Pt 6 months old administered varicella IM instead of SC instead of HIB. Clinic RN drew up immunization. No reaction.
Information has been received from a 74 year old female with a previous reaction to Tetanus shot and allergy to egg whites, yeast who recently was vaccinated with PNEUMOVAX (route and site not reported) and tetanus shots (manufacturers and names unspecified). Subsequently, after receiving the vaccines the patient broke out hives.  The patient thought it was the tetanus shot because she previously had a reaction to one.  The patient also mentioned developing hives after taking progesterone (manufacturer unspecified).  No further information is available.
Third dose of RabAvert was not administered because the patient was throwing up; Third dose of RabAvert was not administered; Case reference number US-BN-2022-002333 is a spontaneous case report initially received on 09-Sep-2022 from a health care professional via Communication (reference number: USBAV22-1332) and concerns a 15-year-old patient.  The patient's relevant medical history and concomitant medications were not reported.  On 02-Sep-2022, the patient was vaccinated with first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP) (PCEC); batch number: unknown) administered at an unreported dose, unknown route, or anatomical site for post exposure for rabies.   On 05-Sep-2022, three days after the first dose, the patient was vaccinated with second dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP) (PCEC); batch number: unknown) administered at an unreported dose, unknown route, or anatomical site.  On unspecified date, the patient experienced vomiting, which is why the third dose was delayed (explicitly coded as 'Missed dose').  Additional information received on 09-Sep-2022 included local case ID.; Reporter's Comments: A 15-year-old patient experienced vomiting, which is why the third dose of RabAvert was delayed and that is considered as missed dose, unknown time after the patient was vaccinated with the first dose (administered at an unreported dose, unknown route, or anatomical site for post exposure for rabies) and second dose of RabAvert (administered at an unreported dose, unknown route, or anatomical site). Vomiting is listed according to guidelines for RabAvert and product dose omission issue is considered listed per company convention. The outcome was unknown. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Product dose omission is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 15-year-old patient experienced vomiting, which is why the third dose of RabAvert was delayed and that is considered as missed dose, unknown time after the patient was vaccinated with the first dose (administered at an unreported dose, unknown route, or anatomical site for post exposure for rabies) and second dose of RabAvert (administered at an unreported dose, unknown route, or anatomical site). Vomiting is listed according to guidelines for RabAvert and product dose omission issue is considered listed per company convention. The outcome was unknown. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Product dose omission is assessed as not related to suspect product but to human factor. The case is non-serious.
Patient reported hives on lower right arm followed by "throat tightening" and difficulty breathing approximately 2 hours post Flublok administration. She received IV Benadryl from paramedics and observed in Emergency Room and discharged the same day.
At 2:30PM, pt notified me that she had started to have metallic taste in mouth at 9:30 AM, pt was immediately given 0.3ml Epinepherine in left deltoid.  Pt/vitals were monitored and pt was released at 3:15 PM with no restrictions.
Started with mild nausea at about 20 after, facial flushing at about 25 minutes after injection, right arm numbness and tingling that spread to my chest at about 30 minutes out, chest pressure, anxiety, slight SOB at about 25 minutes out, Tongue tingling at about 30 minutes out, thigh tingling about 45 minutes out, some itchiness on underside of right arm. Most symptoms were not persistent other than the facial flushing. All resolved about 5:15.  No interventions were given.
Toe infection - Osteomyelitis of third toe of right foot. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Pentacel was administered post expiration date with no reported adverse event; Initial information received on 23-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient (unknown age and unknown gender) to whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)]  was administered post expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered unknown dose of suspect  diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection, (lot UJ666AA; Expiration Date: 04-May-2023, Strength: not reported)  via unknown route in unknown administration site for prophylactic vaccination post expiration date with no reported adverse event (expired product administered) (latency; same day). It was asked what is the grace period for inadvertently administering an expired vaccine; As well as, what would be the following steps regarding this unforeseen issue.  Action taken : not applicable.  Outcome :  Unknown for the event pentacel was administered post expiration date with no reported adverse event.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Painful to touch; Shoulder inflamed; Nerve pain; Vertigo; Dizziness; Joint pain; Fatigue; Arm redness; Muscle pain; Fare up in her immune systems; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Painful to touch), INFLAMMATION (Shoulder inflamed), NEURALGIA (Nerve pain), VERTIGO (Vertigo) and DIZZINESS (Dizziness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-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 PAIN (Painful to touch), INFLAMMATION (Shoulder inflamed), NEURALGIA (Nerve pain), VERTIGO (Vertigo), DIZZINESS (Dizziness), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), ERYTHEMA (Arm redness), MYALGIA (Muscle pain) and IMMUNE SYSTEM DISORDER (Fare up in her immune systems). At the time of the report, PAIN (Painful to touch), INFLAMMATION (Shoulder inflamed), NEURALGIA (Nerve pain), ARTHRALGIA (Joint pain), ERYTHEMA (Arm redness), MYALGIA (Muscle pain) and IMMUNE SYSTEM DISORDER (Fare up in her immune systems) had resolved and VERTIGO (Vertigo), DIZZINESS (Dizziness) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant and treatment information were not provided.
2 days p/vax & w/in 4 wks of OPV vax pt devel 8 1/2 cm erythema, induration & inguinal adenopathy-lt thigh; fever 102-103, vomiting & myalgia; neurological exam nl; 23AUG leg was better; tx included antihistamines & Duricef;
Large red rash around 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 RASH (Large red rash around 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 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Large red rash around injection site). At the time of the report, VACCINATION SITE RASH (Large red rash around injection site) outcome was unknown.            Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided.  Action taken with the drug in response to events was not applicable.
This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PEAU D'ORANGE (Cellulite on the injection site) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for an unknown indication.     The patient's past medical history included No adverse event (No medical history reported).    On 15-Jan-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 PEAU D'ORANGE (Cellulite on the injection site). At the time of the report, PEAU D'ORANGE (Cellulite on the injection site) 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.   Treatment included antibiotics as prescribed by HCP
HEADACHE; UPSET STOMACH; FATIGUE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced headache, upset stomach, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, upset stomach and fatigue was not reported. This report was non-serious.
After 30 min post vaccination my hands started itching like crazy - skin was red and blotchy appearance but no rashy appearance.  Lasted about 2 hours still after medicating myself with antihistamines.  About 3 days after the vaccine I noticed a different vaginal discharge that has a different odor, almost like a  metallic one.  I am not sexually active at the moment  but this happened after the vaccine. I have never smelled something like this. It does not smell like an STD odor. I got body aches and severe headaches, congestion and runny nose, I felt terrible, I had a low grade fever (99.1F) I am usually on the 97F range) , general malaise and fatigue, I could not get out of the bed, just to go out to the bathroom. Went to the PCP who tested me for flu and covid and both were negative.  The symptoms lasted about 48 to 72 hours.  Except the discharge/vaginal odor all symptoms subsided.
onset of severe lt arm pain @ inject site on 15MAR94; pain-intermittent daily; denies redness/swelling @ site; also described difficulty lifting objects or squeezing items w/lt arm; limitation primarily due to pain;
9:15 am 3/3/09 Pt. received HEP A #1 and VARIVAX #2 wt. 280.6#, temp. 99 T. No reaction noted at time.  3/4/09 pt. returned with c/c: Rt lower arm swollen, redness, warm to touch and itching pt. was tx with ATARAX 25 mg.  3/5/09 site approx 4 mm in size 3/6/09 @ 11:45 a.m. Mom pt well.
Patient was brought to the ER with shortness of breath and cough from last 24 hours and wheezing. Also he reported diarrhea last 2 days. Former smoker.  In emergency room, he was tachycardic with 103 and his O2 saturation was 95% on room air.    COVID-19 was positive.  Chest x-ray was unremarkablev.The patient was started on IV hydration.  Creatinine was 1.7.  He has chronic shortness of breath, COPD is not worsening The patient was admitted for further evaluation.
Pain at injection site, headache, chills, fever, fatigue, myalgia. Symptoms severe at 10-12 hours post-injection, fever resolved approximately 24 hours later, headache resolved after 36 hours. Pain at injection site resolved after 3 days.
Patient reported "feeling sick", and reported feeling dizzy, nauseous, chest tightness, and chills. Patient temperature was 100.1. Patient accepted PRN medications and inhaler.
Enlarged supraclavicular and axillary on R side - Huge elevated Red, Hot, painful, itchy welt/hive R arm 8-10 in. generalized Rash - peeling, flaking, skine Redness and itching - very easy bruising for months
Sore throat. Malaise, myalgia, anorexia. Left work sick at noon on 2 Oct 2012.  Stayed home sick 3 Oct 2012.  Today is improved, but still residual malaise.
pt recv vax 2JAN98 & 2hr post vax pt devel a rough, non-pruritic rash w/heat all over body x/hands, fever of 103.5,malaise & arthralgias which required an ER or MD visit;dx vasculitis; This is a follow-up to report (s) previously submitted on 03/01/1999. Information has been received from a health care professional concerning a 36 year ol female with no known allergies and a history of hepatitis b exposure and gfestational diabetes mallitus, who in 1992 was vaccinated with the entire series of RECOMBIVAX vaccine. In October 1997, the patient "had an sxposure". Antibody evaluation "at the time" was negative. On 02-JAN-1998 the patient was vaccinated with a fourth dose of RECOMBIVAX IM in the left deltoid. Approximately two hours post-vaccination, the patient developed a rough, non-pruritus rash "with heat" all over her body except her hands, afever of 103.5 malaise, myalgias and arthralgias which required an emergency room or physician's visit. On 06-JAN-1998, the following laboratory values wre noted: serum glucose 107, A/G ratio 1.1, AST 49 and ALT 66.That same day, the patient was diagnosed with vasculitis. She was treated with PREDNISONE (Sterapred DS) at that time. On 09-JAN-1998, her arthralgia symptoms worsened. PREDNISONE was stopped and TAGAMET and ALLEGRA were ordered. The patient improved at that time. At some time during this condition , serum glucose was 144. On 16-JAN-1998, all laboratory values were  within normal limits. The reporter also noted that the patient did not recover. Follow-up information received from ahealth care professinal indicated that on 19-JAN-1999 the patient recovered from her experiences and subsequently returned to work. No further information is available.
On 05/31/02 received 1st MMR, 1st Hep B and 1st Td. About 30 min later complained of blurred vision bilaterally. No other symptoms. Referred to MD. Per tp had an appts. 06/04 at center as well as an appt. at eye MD 6/5 at center clinic.
Parent incorrectly reported the date of birth of the patient (son), to be 4/17/2009 on the informed consent form. The patient's legal date of birth was confirmed as 4/17/2010. This makes the patient 11 years old rather than 12, making him ineligible for the adult dose Pfizer COVID-19 vaccine. the patient had received two full doses of the vaccine on 5/15/21 and 6/5/21 at local Hosp- Outpatient pharmacy as documented on the Immunization System. The patient received a 0.3 dose booster on 1/25/22 at a clinic organized by school in collaboration with local Pharmacy. On the registration form the patient has two profiles created with the same name and address, but the incorrect date of birth only lists his Pfizer vaccinations. After contacting his pediatrician's office, they were able to confirm his legal date of birth to be 4/17/2010. The mother was then contacted, and confirmed the error was done purposefully.
muscle cramps in front of the chest; cant use his arm because of pain; muscle pain; fever; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (fever), MYALGIA (muscle pain), MUSCLE SPASMS (muscle cramps in front of the chest) and PAIN IN EXTREMITY (cant use his arm because of pain) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (fever), MYALGIA (muscle pain), MUSCLE SPASMS (muscle cramps in front of the chest) and PAIN IN EXTREMITY (cant use his arm because of pain). At the time of the report, PYREXIA (fever), MYALGIA (muscle pain), MUSCLE SPASMS (muscle cramps in front of the chest) and PAIN IN EXTREMITY (cant use his arm because of pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
On May 13th participant went to the hospital because her muscles from the hip down was hurting extremely. Participant stated she could barely move, the next day it felt even worse than the day before. Body was in pain for days could barely walk. Went to medical center and they diagnosed her with polymyalgia rheumatica (PMR). They put her on steroid everyday until she got better.
During the week of 3/29/21 (the week following my vaccine), I began to experience periodic lower abdominal pain (lower right and lower center) during movement (walking or going from sitting to standing.   On Monday, 4/5/21 (13 days after my vaccine), I began experiencing severe abdominal pain upon getting out of bed at 7am.  The pain was worse with movement of any kind (walking, turning, going from sitting to standing).  I was convinced something was seriously wrong, and called my Dr's office .  While waiting for the NP to call me, I decided that I should go to the hospital.  My husband drove me, and even the car ride there was painful (bumps and turns).  The pain upon standing was as if my bladder was going to fall out.  The pain when walking was a stabbing type of pain in my lower right abdomen and a stretching sensation in my center/lower abdomen. The E.R. Dr  diagnosed me with epiplogic appendagitis, and instructed me to rest, hydrate, and take tylenol. I followed the Drs advice.  I took 4/5&6 off from work, spending most of that time in a reclining position in my livingroom and I drank plenty of water. I felt noticeable improvements daily.  I saw my PCP  for a follow-up visit on 4/8 for an abdominal exam, at which time I was experiencing pain primarily in bed (in a stretched out position) and periodically with movement (walking and going from sitting to standing or turning).  I had my second follow-up today with my PCP (4/15).  I continue to improve daily.
In January 2021, I had a colonoscopy, and everything was fine. After taking the vaccine, I was having increased GI distress with quite a bit of pain. I had an MRI with contrast done to take pictures of my midsection, bowels, liver, and pancreas. The report showed that there was an area of concern and there appears to be some ulcerations after taking the vaccine. I am still experiencing some abdominal pain.
From mailed correspondence received at manufacturer on 8/21/02 from a manufacturer, it was reported that an 18 month old male received a dose of Polio vaccine. No date of vaccination provided. Patient developed a damaged nerve in his leg. The doctor's first thought it was drop foot but later determined that it was related to the polio shot. The patient was hospitalized. Physician contact permission was denied by the reporter. No further details were provided.
Blood rushed to head, both hands tingling, racing heart and face turned bright red. Fast pulse and shaking. Racing heart lasted the rest of the day and through the night.