chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Arm  pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm  pain) and PYREXIA (Fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm  pain). On 16-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Arm  pain) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a 59 year old female patient (registered nurse), regarding herself. The patient's medical history included broken hip. The patient's concurrent conditions included allergy to a lot of unspecified medications and antibiotics including penicillin. On 28-DEC-2016, the patient was vaccinated with ZOSTAVAX 19,400 plaque forming units (PFU) (lot#, expiry date and dosing details not reported), subcutaneously in the right upper posterior arm for routine vaccination. Patient reported that almost immediately after vaccination, she began to develop hives and mucous in throat. Soon after, on an unknown date, she began to develop itching. She reported that her physician prescribed diphenhydramine (BENADRYL) for the treatment of hives and itching, which helped her. She also mentioned that over the next few days, her right arm began to swell from elbow to shoulder and her whole body ached. She stated that, the swelling moved up her neck and her right arm bone (humerus) also ached during the following three weeks. It was reported that, she was already taking acetaminophen (TYLENOL), tramadol hydrochloride (manufacturer unknown) and ibuprofen (manufacturer unknown) for her broken hip, which occurred before vaccination and she felt that, those medications helped with her discomfort from the adverse experience to ZOSTAVAX. The patient also had cellulitis at the ZOSTAVAX injection site and her physician prescribed levofloxacin (manufacturer unknown) for the adverse event. At the time of this report, the patient was recovering. The reporter had not assessed the causality of the events with ZOSTAVAX. Additional information has been requested.
pt devel swelling & erythema distal to inject site; associated  inc nasal secretions; no resp; resolved w/use of DPH;
Pt called the pharmacy on 4/26/2021 stating that since approximately 4/16/2021 (roughly 10 days after receiving the Janssen Vaccine) she began noticing that she felt tired and fatigued and that she didn't have the normal 'energy'  that she was used to.  After that time she has noticed a worsening of the fatigue and 'tiredness' to the point that she can no longer perform normal activities.  She states that she is normally very active and enjoys activities like cutting the grass and other outdoor chores.  But for the last 10 days or so she has been unable to do those things and finds herself falling back asleep during the day.  She says this overwhelming feeling of tiredness seems to be getting worse.  I suggested she visit her doctor for bloodwork and she said she would do so.
tender lymph node; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (tender lymph node) and FATIGUE (fatigue) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced FATIGUE (fatigue). On 28-Jan-2021, the patient experienced LYMPHADENOPATHY (tender lymph node). At the time of the report, LYMPHADENOPATHY (tender lymph node) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
This spontaneous report was received from a nurse (also reported as healthcare worker) refers to unspecified number of patients of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date an unspecified number of patients were vaccinated with improperly stored PEDVAXHIB (lot # L004740, expiration date 16-NOV-2017). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sinus congestion; Feels terrible; Sore arm; Headache; Fever; Chills; Nausea; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID in may and was hospitalized for 19 days for the disease.) in May 2020. Concomitant products included ATORVASTATIN for Cholesterol.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced NAUSEA (Nausea). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) with FEELING ABNORMAL (Feels terrible) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Mar-2021, NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No new information appended
Patient came in for a Moderna additional dose but received Pfizer instead. He received his first dose of Moderna on 2/9/21 and second dose on 3/9/21. The patient was seated at a Moderna table and stated that he was there for an additional dose. However, the syringe on the table was Pfizer and the nurse did not cross check before administering the vaccine. The nurse thought that she had a Moderna syringe with the lot number 037C21A. Patient was informed of error and differences between Moderna and Pfizer were communicated. Patient was also informed that for additional doses, either mRNA vaccine may be administered and CDC link for that information was forwarded to the patient. CDC and NJDOH both say that an additional may be either mRNA vaccine, if other unavailable.
chills; She said her fever was as high as 104 degrees on Saturday; Nausea; Headache; said she got very ill; Dry heaves; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9263, NDC number, expiry date was reported as unknown) via an unspecified route of administration on 22Jan2021 at approximately 14:00 (at the age of 69-years-old) in left arm as a single dose for covid-19 immunization. Medical history (including any illness at time of vaccination) included thyroid disorder and gastroesophageal reflux disease for years from an unknown date and unknown if ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect, prior vaccinations (within 4 weeks), adverse events following prior vaccinations were reported as none. Family medical history relevant to adverse events was not reported. Concomitant medications included thyroid and acid reflux medication for years, start date and stop date were not reported. The patient received her first Pfizer covid-19 vaccine on 22Jan2021 at approximately 14:00, she got very ill that night. She said she woke up at 4:00 on 23Jan2021, with chills, fever as high as 104 degrees, nausea, and headache. She had read to take a Tylenol and drink a lot of water if side effects are experienced after the covid-19 vaccine. She got dry heaves after she took Tylenol and 2 glasses of water. Her mouth immediately got wet, and she ran to bathroom with dry heaves. She thought dry heaves were because she drank so much water after taking the Tylenol. The events were reported as non-serious. The events did not require emergency room or physician office visit. Her fever broke on Sunday (24Jan2021), and she felt better. All her side effects had resolved by Sunday, 24Jan2021. She was scheduled to receive her second Pfizer covid-19 vaccine on Friday (19Feb2021). She asked if there was anything, she can do ahead of getting her second covid-19 vaccine that will help with side effects, since she got so ill after the first covid-19 vaccine shot. She asked if she would get as ill with the second covid-19 vaccine shot as she did with the first covid-19 vaccine shot. She was advised that she would be transferred to Pfizer medical information for further assistance with her question. The patient was treated with extra strength Tylenol (NDC number: unknown, lot number: P120060, and expiration date: Apr2022) 500mg tablet on 23Jan2021. The patient underwent lab tests and procedures which included body temperature: 104 on 23Jan2021 and annual physical with blood work in Dec2020 and everything was fine. The outcome of the events dry heaves and nausea was recovered on 23Jan2021 and all other events were resolved on 24Jan2021.  Follow-up attempts completed. No further information expected.
This case was reported by a pharmacist and described the occurrence of injection site reaction in a 74-year-old patient who received SHINGRIX (batch number GG2GA, expiry date 16th April 2021) for prophylaxis. On 16th November 2018, the patient received SHINGRIX (subcutaneous). On 16th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site reaction and intramuscular formulation administered by other route. The patient was treated with steroid cream. On an unknown date, the outcome of the injection site reaction and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX subcutaneously above the left bicep, which led to intramuscular formulation administered by other route. The patient developed an injection site reaction and was given a steroidal cream.
pt had a positive COVID test on 11/1/21 and was transferred to the hospital on 11/12/21 with respiratory failure; pt steadily declined and was placed in inpatient hospice care on 11/18/21; DNR; given O2 supplementation and IV steroids; comfort measures with morphine and ativan; pt passed away in the hospital
Fever, febrile seizure. Acute otitis infection noted at time of seizure.
Acute on chronic CHF with preserved left ventricular function Persistent atrial fibrillation with elevated ventricular response Coronary artery disease, status post complex PCI. Patient was diuresed with IV Lasix, weight 9 pounds down from admission. Rate control with metoprolol 75 mg daily and Cardizem CD 120 mg daily. Hospital admission and ED visit within 6 weeks of receiving the COVID vaccine
Family arrives for child's immunizations. The "Screening Checklist for Contraindications for Children and Teens" is filled out by mother and verbally reviewed with mom. No contraindications are present. Recommended childhood immunizations are reviewed, VIS statements are provided. Mom has no questions. She consents to her child getting only the Pediarix vaccine at this time. This is child's second dose of Pediarix.Child receives Pediarix immunization IM to Right thigh. "After the shot" instructions are given and reviewed with mom and mom consents to wait in lobby for 15 minutes after vaccine administration. Staff escorts mom and child to exam room and notes four white raised areas with red borders to child's left arm above and below the elbow on the outer aspect of the arm.Lung sounds are clear. Heart rate is 120 beats per minute. Staff examines child's body for other hives, inspecting the trunk of body, arms, legs, neck, face, and behind the ears. No hives present. Child is cooing, babbling and smiling. Child is not grunting, wheezing or coughing. He does not appear to be in respiratory distress. Benadryl 0.2 ml IM to left thigh is given. Child weighs 20 pounds and 8 ounces. Lungs sounds are clear throughout. Apical pulse is 120 beats per minute. Child is babbling and cooing. Child is not grunting, wheezing or coughing. He does not appear to be in respiratory distress. No periorbital edema noted. No swelling around the mouth noted.Mom declines EMS transfer to facility. EMS and family leave the health office. At the time family leaves, the wheals on child's left arm are less raised and the redness is much less. The small raised area on child's abdomen is nearly undetectable.
Salty taste under his tongue; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Salty taste under his tongue) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DYSGEUSIA (Salty taste under his tongue). At the time of the report, DYSGEUSIA (Salty taste under his tongue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was not provided. Patient stated that having a salty taste under his tongue for week.
myalgias, fever, chills, leukopenia & thrombocytopenia;
p/vax pt awoke w/pain rt leg;tried to stand both legs weak & could not move w/o assistance;1hr later to ER c/o numbness in legs & aching in mid/lower back;PE revealed dec sensation w/paralysis @ T7;dx post vaccinal transverse myelitis; 60 day follow-up received on 10/2/00 provided no additional data.
Pulsatile Tinnitus in left ear. Still have it 11 months later. No treatment is effective.
Patient reports going to an urgent care (not affiliated with us) for complaints of injection site pain that radiated from Left arm across chest and back.  Worked up for heart which was negative.
Facial numbness on the right side since Saturday 1/2/2020 woke up to half of my face numb the tip of my tongue   tingled . and pressure on my right eye and I was not able to focus.  I have headaches that come and go. my back is achy since last week and yesterday half of my body felt numb.
Tested positive for Covid on 03/29/2023.  High fever of 101, body aches, congestion, coughing days 2 though 7
Initial unsolicited report received from nurse in the on 19-Sep-2018. This case involves about 15 female patients who were vaccinated with a 0.5 ml dose of ADACEL (Batch number: C5228AA, expiration date: 26-Jan-2019, route and site of administration was not reported) and MENACTRA on an unknown date which had a cold chain break including dose of a vaccine IPOL, ACT-HIB, (Batch number, expiration date, dose, route and site of administration was not reported). The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (Vaccines were moved to a break room refrigerator that was un-monitored). It was unknown whether patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Pt fainted while sitting in line at checkout desk. Pt was taken by w/c to exam Rm - given P.O. fluids - placed in supine pos and monitored for 1/2 hr - provider informed.
Heart palpitations, extreme heart pounding, itching as tingling face, blue lips, loss of breath, chronic center chest pain that has continued for 5 months.
Arm turned red at injection site and hot. There was really no pain and went away within a couple of day but turned red again exactly a week later from injection date. This time it was hard, hot, red, itchy, and bigger. Dr treated it with clindamycin and dose pack of steroids. It got better after a few days. Next, I got a UTI and called my primary care physician. She ordered CIPRO and phenazopyridine. That got better but before CIPRO was finished, I got a crick in my neck that turned into excruciating pain in my neck and was unable to turn head from side to side. At the same time, my left foot became painful, red and swelled. I have been treated for arthritis in that foot 6 years ago with an injection. I have not had any problems with it since the injection.  Dr. treated my neck problem with Robaxin and a steroid dose pack. This seemed to help my foot too temporarily. Neck pain improved but not gone. It was excruciating pain up the back of my scalp at times. I can turn my head some now but it's not back normal. Can't turn it all the way.  Dr. did another injection in my foot but did not work this time. I got worse and I can no longer put any weight on that foot. I have not been able to work since January 20. Have had to apply for leave of absence and short-term disability
Reported Symptoms:  10011232:COUGHING; 10016558:FEVER;  10043088:TACHYPNEA; 10084380:COVID-19 PNEUMONIA;    Narrative: Patient received COVID 19 vaccine in 2021  per history and physical note.   The patient presented to the ED on 5 November 2022 with cough, hypoxia, malaise, shortness of  breath and fever.   The patient was
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 22-MAR-2015, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336 (dose, route and expiration were not reported). The total cumulative hours out of range were 24 hours with 34 degrees C as the lowest recorded temperature and the storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint(PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 5 year old female who 3 years ago, in approximately August 2006, was vaccinated with the only one dose of VARIVAX (Merck). Recently the patient experienced mild case of chicken pox with 6 lesions and one chicken pox developed cellulitis. At the report time the outcome was unknown. Additional information has been requested.
Hypotensive with an altered mental status. Pt was placed supine and IV started with a 500CC Fluid bolus
Information has been received from a registered nurse (school nurse) concerning a child between the ages of 6 and 11 years old who on 13-MAY-1998, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 03-DEC-2007 the patient was experiencing chickenpox. It was not specified how many doses of varicella virus vaccine live (Oka/Merck) the patient received. Medical attention was sought via an office visit with the physician.
SHINGRIX vaccine- About 4 1/2 hours after receiving vaccine I started having body aches and chills. Was miserable all night with significant body aches, chills and feeling a little short of breath. (I have a lung disease IPF). The next day at 11:45 am on 1/17/2019 I had temperature of 99.9 orally at a doctor's appointment and still had significant body aches and malaise. I took three ibuprofen at 2:30 pm on 1/17/2019 and felt some better. That evening around 8 pm I started feeling more achy again and took three more ibuprofen. Still felt achy and bad at 11pm and took Tramadol at 11 pm. Woke up 1/18/2019 and felt some achy and check my temperature and it was 99.4 orally. Still having as I type this some body aches and malaise. I took three ibuprofen at 9 am and it is 12:30 pm on 1/18/2019 and feeling better. I hope I don't have this reaction to the second part of the vaccine.
Diagnosed with new onset cardiac and pulmonary sarcoid.  Symptoms began approximately 5 months after 2nd dose of Moderna vaccine.  No previous sarcoid symptoms or any sarcoid history prior to vaccine.  Sarcoid has been biopsy-confirmed.
Narrative:  This patient received two doses of Pfizer COVID 19 Vaccine in Feb/Mar 2021. The patient tested positive for COVID 19 on 5 Jan 2022. The patient was admitted to the hospital on 5 Jan22 with hypoxia and cough and signs of pneumonia. The patient was treated with dexamethasone and remdesivir. The patient was discharged on 10 Jan 22 in stable condition.
Patient received his first dose on 2/1/21 and was observed for 15 minutes.  He reported that after returning home he has dizziness and weakness that lasted 45 minutes and then resolved without treatment.  He did not seek care. On the day of his second shot (2/22/21) he said he had not taken his blood pressure medication that morning.  His blood pressure was143/98 and pulse 70 prior to vaccination.  At 10 minutes after the injection he reported feeling dizzy and having shortness of breath and feeling dry mouth.  His O2 sat was 98%.  Pulse had increased to 82 and then several minutes later was 110.   He was placed on a monitor but a large size cuff was not available at the vaccination site.  He continued to feel weak and more short of breath, so he was given a dose of epinephrine by autoinjector and EMS was called to transport him to the ER.  At the ER, he was given diphenhydramine and his condition continued to improve.   He was observed in the ER for 3 hours and discharged home.
pt had bouts of crying of undetermined length but unusual for pt persisted x 2 days accompanied by fever high enough to call MD; APAP did not alleviate discomfort or reduce temp; MD prescribed Motrin which did help; pt was seen by MD:
Per Patient: It was actually not a usual sore arm side effect, in the area where the shot was administered.   My arm pit area (under the arm) was swollen and sore. I was advised it was probably swollen gland in my armpit.  It felt like I had a ball under my armpit when I put my arm down next to my side.  It was a very unusual feeling.   I usually have the flu shot, and this is the first time I had this reaction.  It is back to normal now.
Flu like symptoms. Weakness, body aches, headache, the day after some chest discomfort and shortness of breath
Got my second Pfizer Covid shot Friday, by Monday I had a huge blood clot in my neck and also a huge one in my left arm. I am now permanently on a blood thinner because of this.