chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2016US001420, is an initial spontaneous report received from a physician on 07 Jan 2016. This report refers to an elderly female patient. Historical condition was not reported. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly 2 years ago (year and date unspecified). The patient experienced redness and pain in upper arm of injection (in unspecified year and date). The outcome of the event, seriousness and causality was not reported.
8 days post vax the pt developed macular rash all over the anterior chest and abdomen with fever of 102F.
10/12/2015 - Symptoms - currently in treatment severe head pain in the back of my head and neck, fatigue, body ache, joint pain and nauseous, diarrhea, neck stiffness, muscle spasms both legs, cold chills, dizziness.
MMR injected, pt's arm reddened, wheal appeared & chest area began to redden; DPH given;
I woke up the day after my booster shot with a huge red, swollen, and hot rash that made a circle around the shot area. This gradually grew over the next couple of days. As I am filling this form out, the redness, and swelling has gone down tremendously, but there is still a little redness from the growth of the past few days.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Seizure-Mild, Additional Details: pt was sitting after adminstering the shot, 5 minutes later he fell off the chair and when i reached out to him he was shaking for 5 seconds i am not sure if it was a seizure or not. he responded back immediately. i watched him for about 20 minutes after that. he mentioned that he always faint after blood drawing.
No adverse effects reported/No additional AE/No PQC.; Improperly stored; This spontaneous report was received from a medical assistance and refers to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reaction and allergies were not reported.  On 13-JUL-2023, the patient was vaccinated with a improperly stored a varicella virus vaccine live (oka/merck) (VARIVAX), injection, 0.5 milliliter, lot #W018825, expiration date: 14-JUN-2024, (strength, dose#, route of administration, and anatomical site of vaccination were not provided) for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).
Severe muscle cramps in thighs, adductors muscles (both legs), left calf muscle, brachioradialis, and extensor muscles of arms. Cramping persisted severly for two days, which made walking difficult, climbing and descending stairs impossible, and sitting and standing extremely difficult and painful. Symptoms persisted severely for two days, and gradually improved on day three and full 100 per cent recovery took seven days.
Patient called the pharmacy on 10/12/2019 stating that her previous vaccinations may hurt somewhat but this time her arm felt paralyzed. Patient stated she was unable to raise her arm.
Baseline health till 2 days after immunization. He got flu shot 10/2013 by outside provider. Shortly got sick developed rash and persistent leg swelling. Hosp 11/15 - 11/23/2013 outside hosp for "delay sensitivity reaction to flu shot with transient angiitis" and acute renal failure. Cr 2.5. Limited response to prednisone trial - readmit 1/3 - 1/10/2014 and has pulmonary/renal symptom and positive RF.
Information has been received from a 33 year old female consumer reporting on herself with no pertinent medical history and no drug reactions or allergies, for VARIVAX (Merck), a Pregnancy Registry product, who on 01-SEP-2010 was vaccinated subcutaneously, 0.5 ml dose of VARIVAX (Merck) (lot # unknown). There was no concomitant medication. The consumer stated that "a couple of weeks after" receiving a booster of VARIVAX, she found out she was pregnant. She had 7 weeks of gestation. Her last menstrual period was in approximately 15-AUG-2010 and estimate delivery date is on 24-MAY-2011. Patient did not report an adverse effect. The consumer also stated that on an unspecified date "a number of lab tests" were performed (results not provided. Follow up information has been received from a physician concerning a 32 years old (also reported as 33 years old) female patient who on 01-SEP-2010 was vaccinated with the first dose of VARIVAX (Merck) intramuscularly in right arm at 7:30 AM. Other medication used during pregnancy included metamucil for constipation and OTC prenatal vitamins. It was reported that the patient had no complication with the vaccination. No adverse events was reported. The patient had 4 previous pregnancy (2 full-term deliveries, 1 pre-term births, 1 still birth or miscarriage). No birth defect occurred in previous pregnancies. The patient was not tested for varicella antibodies before vaccination, on 03-DEC-2010, a MSAFP (serum alpha-fetoprotein test) revealed negative for ONTD (open neural tube defects). On 06-JAN-2011, an ultrasound revealed a normal result. On 16-MAY-2011 (40.2 weeks from LMP) the patient delivered a normal female baby weighing 7 pound and 5 ounce. There was no complication during pregnancy or delivery. Follow up information has been received from the physician's office who reported that this was not their patient. This was a pediatric practice. Additional information is not expected.
On 7/13/21 7:00 PM I felt a stabbing pain in my chest that I have never experienced before.  I did deep breathing while thinking that at some point I will need to call emergency number.  Then after 30 minutes I felt better.   On 7/16/21 1:00 PM I felt a stabbing pain in my chest  for 10 minutes and it passed.  On 7/25/21 5:30 PM I felt a twinge in my chest and it passed.  On 8/9/21 12:00 PM I felt discomfort in my chest while walking for 40 minutes.
No additional AE details; Nurse called to report temperature excursion and states that the vaccine was administered to patient during the excursion; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions/allergies was not provided.  On 28-DEC-2020, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter orally (lot # 1660998, expiration date 03-MAY-2021) for prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion of below 2 degree Celsius (1.3 degree Celsius) for 24 minutes recorded by a data logger. The previous temperature excursion was reported as below 2 degree Celsius (1.6 degree Celsius) for 24 minutes. No additional adverse event (AE) details.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA001046: US-009507513-2101USA001003: US-009507513-2101USA001285: US-009507513-2101USA000963: US-009507513-2101USA000908:
Not sleeping well; Range of motion is completely messed up/ Can not find a position to sleep in; Hard to pick up my son with both hands/ Can only lift him to a certain height before I can not lift him anymore; Extreme pain inshoulders on the side where we got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Not sleeping well), JOINT RANGE OF MOTION DECREASED (Range of motion is completely messed up/ Can not find a position to sleep in), HYPOKINESIA (Hard to pick up my son with both hands/ Can only lift him to a certain height before I can not lift him anymore) and VACCINATION SITE PAIN (Extreme pain inshoulders on the side where we got the vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 041B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced INSOMNIA (Not sleeping well), JOINT RANGE OF MOTION DECREASED (Range of motion is completely messed up/ Can not find a position to sleep in) and HYPOKINESIA (Hard to pick up my son with both hands/ Can only lift him to a certain height before I can not lift him anymore). 17-May-2021, the patient experienced VACCINATION SITE PAIN (Extreme pain inshoulders on the side where we got the vaccine). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form and CYCLOBENZAPRINE for Adverse event, at a dose of 1 dosage form. At the time of the report, INSOMNIA (Not sleeping well), JOINT RANGE OF MOTION DECREASED (Range of motion is completely messed up/ Can not find a position to sleep in), HYPOKINESIA (Hard to pick up my son with both hands/ Can only lift him to a certain height before I can not lift him anymore) and VACCINATION SITE PAIN (Extreme pain inshoulders on the side where we got the vaccine) outcome was unknown.            No concomitant medication was provided.  On 29-Jul-2021, the patient consulted with the physician was who thought that the shoulder pain may be due to an injury during the administration of the vaccine. The patient was recommended physical therapy, use of pain killers, and taking sleeping pills as treatment medication.   This case was linked to MOD-2021-288148 (Patient Link).
Redness in arm about 6" by 8" patch. Not raised but hard & hot. Began 11/18/11. Area was over PNEUMOVAX but hot over FLUZONE inj. site. Pt. took Ibuprofen and BENADRYL and symptoms gone by 11/22/11.
Initial report was received 01 November 2010 from a consumer, who is the patient's sister. A female patient (age and date of birth not reported) had received a first dose injection of FLUZONE HIGH-DOSE (lot number, route, site and date of administration not reported) and one week later, she experienced coughing, sneezing and congestion. it was unknown if the event required a doctor's visit. Laboratory and diagnostic test results were not reported. At the time of the report, the patient's recovery status was unknown and the reporter had no additional information to provide. Follow-up information was received from the consumer's sister on 22 November 2010. The 83-year-old female patient received FLUZONE HIGH-DOSE on 08 October 2010. On the 10 October 2010, two days later, the patient also developed fever and chills. The outcome was reported as recovered. The reporter for this case is the same as for case number 2010-06289. Documents held by sender: None.
Tinnitus in right ear.    Also sensorineural hearing loss in right ear.  Took steroids for a couple of weeks.  No improvement.
tired of getting the flu; tired of getting the flu; Initial information was received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case from a consumer/non-healthcare professional.  This case involves an unknown age/gender patient who experienced tired of getting the flu after being vaccinated with INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, route, formulation, lot number, expiry date, administration site: for prophylactic vaccination (Immunisation).  On an unknown date the patient developed non-serious events tired of getting the flu (fatigue) (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both the events.  Outcome: Unknown for both the events.
This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a 65-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included carcinoma brain (was diagnosed 12 years ago and he continues to suffer from it, completed 4 doses of chemotherapy). On 25th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced hearing loss (serious criteria GSK medically significant), allergic reaction, shingles, fever and general body pain. SHINGRIX was discontinued. On an unknown date, the outcome of the hearing loss, allergic reaction, fever and general body pain were unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the hearing loss, allergic reaction, shingles, fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by wife of the patient. At 17:30 hours, the patient received SHINGRIX on right arm. The patient had an allergic reaction. Within a few days the patient experienced low grade fever and all over aches. The reporter stated that the patient experienced shingles and also experienced hearing loss. The patient was on medical leave for brain cancer that was diagnosed 12 years ago and he continued to suffer from it. The reporter disconnected from call when more specific questions about events was asked. The reporter was threatening law suit against GlaxoSmithKline. This case has been linked with US2018151991, reported by the same reporter.
Information received from a RN, post vaccine pt developed generalized fever,flu symptoms, a red polka dot rash and swelling on her L arm and both legs. It was noted that the pt was also being treated for a pulled muscle in the leg.
Administer Expired Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment medications are provided. The vaccines were stored in freezer, they take out one to two vials and placed in fridge each day as needed.
The patient and mother came in for a Pfizer vaccine. Mother did not have the child's vaccine record card on hand and when asked if the child needed Pfizer the mother confirmed. Once in the room with the pharmacist the pharmacist verified that both mother and child were getting Pfizer vaccine and she confirmed then as well. The following day the mother called and stated that her child was given the wrong vaccine and was supposed to receive Moderna 2nd dose. The mother informed the pediatrician about the situation and will wait 3 months for the next dose with either Moderna or Pfizer to complete the series.
My son had his vaccines at 10:00am on May 15, 2004.  He immediatly went to sleep. When we got home, he woke up for a few minutes, crying.  He ate a few ounces of his bottle and went back to sleep.  At approximatly 5:00, I got concerned and went to check on him.  I was unable to wake him.  I called the doctor's office and was told to call 911, which I did.  When the firemen got there, they could not wake him at first.  He finally woke up after about 5 minutes.  His heart rate was elevated in the ambulance.  When we got to the hospital, they checked everything and said it was a reaction to the shots.  He was admitted and did not go home until the 17. There were 3 or 4 times after that date that I had trouble waking him and was told to return to the hospital or doctor's office.  They could not find anything wrong.  He has been seen by a neurologist who also could not find anything wrong. Follow up on 06/24/04 states: "Mom also described child as "limp" (hypotonia). He received Hep B at birth as well. Child did not receive MMR."  Nurse follow up on 08/19/04 states: "Per discharge summary, final diagnosis is "altered mental status secondary to vaccines". Admission diagnosis was lethargy. Slight irritability upon discharge."
This spontaneous report as received from a Nurse Practitioner via the Company Representative refers to a 17 year old patient. On 12-MAR-2013 "6 days ago", the patient was vaccinated with the second dose of GARDASIL (lot# not reported). The Nurse Practitioner stated that approximately on 18-MAR-2013, 6 days after vaccination, a patient had shooting arm pain and loss of range of motion. The patient's arm did not hurt if it was not moving but it hurt when the arm was raised to side or above her head. The N.P. recommended her to take 800 mg of ibuprofen. The patient had experienced "shooting pain" from upper arm down to knuckles since receiving a dose of GARDASIL on 12-MAR-2013. The patient got pain when the arm was raised. The N.P. did not see any visual reactions on the injection site. The patient sought unspecified medical attention. At the time of reporting, the patient was not recovered. The relatedness for the events was unknown for GARDASIL. Additional information has been requested.
wrong vaccine (Quadracel) for the patients age last month, no AE; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves patient (with unknown demographics) who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number and Exp. Date not reported) via unknown route in unknown administration site that was wrong vaccine for the patient's age last month.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  It was reported that RMA's gave a patient the wrong vaccine (Quadracel) for the patients age last month. She called Sanofi to make sure there was no harm to the patient and was told there should be no harm.  The patient did not experience any 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 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.  Information on the batch number was requested.  List of documents held by sender: none.
Information has been received from a nurse practitioner concerning a 23 year old male patient with no medical history, who on 25-FEB-2011 , was vaccinated with a dose of GARDASIL (lot # 666163/0664Z) 0.5 mL, intramuscularly. No concomitant therapy reported. The nurse indicated that on 23-MAR-2011, the patient developed a lump at the injection site. No laboratories studies performed. The patient sought unspecified medical attention. At the time of this report the patient had not recovered from the lump at the injection site. Follow up information has been received from the nurse practitioner who reported that the 23 year old male student patient with no pre-existing allergies, birth defects or medical conditions who on 25-FEB-2011, was vaccinated IM with the first dose of GARDASIL in the left arm. There was no illness at the time of vaccination. Event reported as none (conflicted information previously reported as a lump at the injection site by the nurse practitioner). The patient did not seek medical attention. At the time of the report the outcome of the patient was unknown. Follow up information has been received from the nurse practitioner who clarified that the male patient did indeed had a lump at injection site. No further information is available.
This case was reported by a physician and described the occurrence of an unspecified illness in a child of unspecified gender who was vaccinated with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. On an unspecified date on or before May 12 2005, the subject received a dose of Engerix B (dose number nor provided, lot ENG5224B9). The physician reported that, at an unspecified period of time following the administration of Engerix B, on an unspecified date on or before May 12 2005, the subject became very sick. At the time of reporting, May 12 2005, the outcome of the event was not reported.
Approximately 1 week following vaccination a large rectangular red area developed at the injection site.  Reddened area was approximately 4 inches by 4 inches.
Atrial Fibrillation; Seizure; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial Fibrillation) and SEIZURE (Seizure) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A,NDC80777-273-10) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation (Patient gets Atrial fibrillation periodically.).    On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Atrial Fibrillation) (seriousness criterion medically significant), SEIZURE (Seizure) (seriousness criterion medically significant) and NAUSEA (Nauseous). In February 2021, SEIZURE (Seizure) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial Fibrillation) and NAUSEA (Nauseous) outcome was unknown.            No concomitant product was provided. No treatment information was provided.  Patient does not have a seizure before. They called 911 but seizure was over-with shortly before they arrived. Company comment: This Spontaneous case concerns a 78-year-old, male patient, with medical history of atrial fibrillation, who experienced the unexpected, serious (Medically significant) and AESI of atrial fibrillation and seizure, among others. The patient developed atrial fibrillation and seizure after 1 day of receiving the second dose of mRNA-1273 vaccine. It was reported that the patient had episodes of atrial fibrillation before, however, it was the first time he experienced a seizure. Patient's age and the with medical history of atrial fibrillation remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events atrial fibrillation and seizure were automatically upgraded as a Serious event as per IME list and kept as serious as per medical judgement, despite they were reported as non-serious.; Sender's Comments: This Spontaneous case concerns a 78-year-old, male patient, with medical history of atrial fibrillation, who experienced the unexpected, serious (Medically significant) and AESI of atrial fibrillation and seizure, among others. The patient developed atrial fibrillation and seizure after 1 day of receiving the second dose of mRNA-1273 vaccine. It was reported that the patient had episodes of atrial fibrillation before, however, it was the first time he experienced a seizure. Patient's age and the with medical history of atrial fibrillation remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events atrial fibrillation and seizure were automatically upgraded as a Serious event as per IME list and kept as serious as per medical judgement, despite they were reported as non-serious.