chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unusual soreness of upper arm, shoulder, neck extending to head.  Continued for 2 weeks + post vaccination. Worsening condition of arm receiving vaccine including numbness, tingling, and weakness extending to hand/fingers.  Difficulty sleeping due to pain in shoulder and neck and head.  Condition got worse as time went on (post vaccinated), not better as anticipated!  Currently following up with primary care physician.
High fever (102-103.9) for multiple days, muscle aches, fatigue, heart palpitations, stomach ache, nausea, unable to lift arm, very painful injection site, headache.
Information has been received from a consumer concerning her son who on an unspecified date was vaccinated with a dose of MMR II. It was reported that the patient experienced an unspecified adverse reaction after vaccination. No additional information was provided.
Arm was very sore. Did not have sore with other two. Got sick at Christmas time, out of work for three days. West to Urgent care and received +Covid test in January.
Rash, fever , severe headache for 2 days; exhaustion, body aches continuing on day 4 so far
Immediately after receiving vaccine patient reports numbness at the right arm, just below the elbow.  Patient cleared by EMS, patient Patient advised to call 911 or go to the nearest emergency room for any additional issues as needed.  Also advised to sign up for v-safe.
Momentary blackout on 8/5/2021, followed by continuing daily dizziness and high blood pressure at varying frequencies and duration since that event.
Pt called today, one day after getting her second moderna vaccine, stating that she was feeling nauseas and passed out.  She states she has a history of passing out when feeling nauseas.  She was concerned that the vaccine caused her to pass out.  I explained to her that based on her history, that I did not think the vaccine caused her to pass out.  Encouraged her to reach out to her health care provider if she was concerned.
got ankle sprain and after vaccination she experienced severe pain at that site; Bones in my body hurt; Felt like a nail was driven into my ankle; Took the life out of me; Extreme fatigue; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bones in my body hurt), JOINT INJURY (Felt like a nail was driven into my ankle), FEELING ABNORMAL (Took the life out of me), FATIGUE (Extreme fatigue) and PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ankle sprain in 1965. Concomitant products included LISINOPRIL for Hypertension.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced BONE PAIN (Bones in my body hurt), JOINT INJURY (Felt like a nail was driven into my ankle), FEELING ABNORMAL (Took the life out of me), FATIGUE (Extreme fatigue), PYREXIA (Fever) and NAUSEA (Nausea). On an unknown date, the patient experienced PAIN (got ankle sprain and after vaccination she experienced severe pain at that site). At the time of the report, BONE PAIN (Bones in my body hurt), JOINT INJURY (Felt like a nail was driven into my ankle), FEELING ABNORMAL (Took the life out of me), FATIGUE (Extreme fatigue), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown and PAIN (got ankle sprain and after vaccination she experienced severe pain at that site) had not resolved.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Medical history added. Event added.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program Pfizer First Connect.  A 48-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration in the left arm on 26Dec2020 08:00 at single dose for covid-19 immunisation at hospital. Medical history and concomitant medications were none. The patient came down with covid symptoms on 31Dec2020. On 04Jan021 she saw doctor and tested positive for covid. The outcome of the events was recovering. On 24Dec2020 the patient underwent Covid rapid testing and was negative, on 04Jan2021 it was positive. Was given an antibiotic, Doxycycline Hyclate 100mg to take twice daily on 04Jan2021. The patient wanted to know the time frame to take the second dose or/and if it was okay to proceed with the second dose.
Small red/orange dots over both lower legs and tops of feet progressed from12/16/2019 through 1/6/2020 with increased itching. Dermatologist seen on 12/30/2019.   Triamcinolone Acetonide Cream was prescribed and a biopsy was taken.  Biopsy results on 1/9/2020 suggested  "purpuric lichenoid dermatitis".    Starting on 1/6/2019 the "rash" began to fade and the itching lessened.  The rash and itching have continued to lessen, but have not completely resolved.  On 7/23/2019 after the first dose of Shingrix , a similar rash appeared that was restricted to the tops of feet.  It cleared within 10-14 days without medical attention.
Initial report received from a health care professional on 07 November 2011. This reporter also reported other adverse events which were captured in case number 2011-10823 and 2011-10824. A female patient (age not reported) received dose 1 injection (route and site not reported) of ADACEL, sanofi pasteur Ltd. lot number C2456AA, on 22 May 2006. The patient had no other vaccinations within 4 weeks of the ADACEL. The patient's medical history and concomitant medications were not reported. On 28 October 2011, the patient experienced severe cough, nasal drainage and congestion. The patient was not tested for pertussis. Two other staff members tested positive for IgG and IgM and are captured in cases 2011-10823 and 2011-10824. The outcome was not reported. Two other staff members tested positive for IgG and IgM and are captured in cases 2011-10823 and 2011-10824. Documents held by sender: None.
ED Discharged  3/14/2021 (1 hours) Hospital ED Treatment team Providers Exposure to COVID-19 virus +1 more Clinical impression Covid-19 Screening Chief complaint ED Provider Notes CRNP (Nurse Practitioner) ? ? Emergency Medicine Expand AllCollapse All        ED PROVIDER NOTE           This note was partially completed using voice recognition technology, and was scanned for gross errors; however some errors may still exist.  Please contact the author with any questions or requests for clarification.      Medical Decision Making     64 y.o. female patient who presents the emergency department with nasal congestion, cough, and malaise. Her husband, son and Father all have COVID-19. Patient denies PMH..  Vital signs are stable and reassuring.  Lung sounds are clear and equal bilaterally.  No other abnormality seen on exam.  I elected to get a for panel viral respiratory panel because patient was recently tested and tested negative.  I had concerns for influenza.  This panel was negative.   Differential diagnosis includes influenza, RSV, viral upper respiratory infection, COVID-19, pneumonia, or bronchitis.     Given clear lung sounds pneumonia and bronchitis seem unlikely. RSV, Influenza, and COVID-19 tests are all negative. Suspect a viral URI, but patient has had significant exposure to COVID-19, so I suggested quarantine.   Recommend symptomatic measures for treatment.  Recommend follow-up with primary care physician.  Recommended coming back to the emergency department with any worsening symptoms.      Chief Complaint      Chief Complaint Patient presents with ? Covid-19 Screening      History of Present Illness     Patient is an 64 y.o. female who presents to the ED with for COVID-19 screening.  Patient has been experiencing nasal congestion, cough, and malaise.    No specific aggravating or alleviating factors.  No treatments tried at home.  Reports sick contacts of husband, son, and father. Denies recent travel..     Diagnosis     1. Exposure to COVID-19 virus  2. Upper respiratory tract infection, unspecified type
Information has been received from a nurse practitioner concerning a 20 year old female with drug reactions or allergies reported as none and pertinent medical history reported as none who on 15-SEP-2009 was vaccinated with a first dose of GARDASIL (LOT # 661046/0381x), 0.5 mL, intramuscularly into left upper arm. There was no concomitant medication. On 16-SEP-2009, the day after administration the first dose of vaccine the patient experienced "a weird numb feeling" at the injection site. The patient also experienced muscle twitching on and off in the left upper area, lasting for 1 month. The patient sought an unspecified medical attention. At the time on the report the patient's numbness of the lateral aspect of the left upper arm persisted. The patient had elected to discontinue GARDASIL. There were no laboratories diagnostics studies performed. Follow up information has been received from the nurse practitioner who reported that the patient mentioned her event during the second dose reminder call. The nurse practitioner reported that the patient did not seek medical attention, and that the event was not disabled in any way. The patient would not receive the last two doses in the series. At the time of the report, the patient was "slowly recovering". No further information is available.
two days post vaccination had fever,day after vaccination fell on mouth, no LOC,no vomiting,next day started fever, Tmax 104, on evening of 2nd day of fever had seizure with shaking all 4 extremities, lasted <5 mins as per dad On day of visit 5/3/08 had seizure with jerking of all 4 ext.,eyes rolling back & lip smaking the whole episode lasted >15 mins, diagnosed complex febrile seizure & send to ER, CT scan neg, spinal tap neg, plan is to do EEG & MRI, currently in step down unit, no more seizures 7/25/08-records received for DOS 5/3-5/6/08-DC DX:Febrile complex seizure. Vomiting and diarrhea (resolved). Day after fever had multiple seizures with one prolonged seizure of 30 minutes. Temp 101.5, spiked fevers treated with antibiotics.
severe facial paralysis; This is a spontaneous report from a contactable consumer.   A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 05Apr2021 14:00 (Batch/Lot Number: EW0150) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Other vaccine same date with lot number=EW0170, dose number=2, right arm. The patient stated 9 days later, on 14Apr 12:00 PM, I woke up with severe facial paralysis... I had to go to the ER immediately to determine if I was having a silent stroke, MRI result determine it was Bells Palsy... despite the adverse affect doctors still advised that it was safe for me to take the 2nd shot. Was diagnosed with prednisone to treat Bells Palsy. Doctor or other healthcare professional office/clinic visit and  emergency room/department or urgent care visit. Facility where the most recent COVID-19 vaccine was administered was other. Treatment received as prednisolone. Outcome was not recovered. The case reported as non serious.
Pt first developed dry mouth and dry eyes with 24 hours of her second series of Moderna in March of 2021.  She reported dry eyes and mouth which was confirmed by her dentist and PCP who did autoimmune testing confirming the dx.  She was seen by rheumatology who again confirmed her dx.  Her symptoms were manageable until she received her first booster in 11/2021 (Moderna) .  She stated that within less than 24 hours her dry eyes and mouth were severely impacted with painful eyes and difficulty with mouth care.  Within a week, she developed several painful and extremely itchy blisters on her arms and body.  She was again seen by rheumatologist who considered lupus and she eventually had a BX of her arms which reveal Dermatitis Herpetiformis (DH) as well.  She now has both Sjogren's disease and DH.
Facial Swelling; This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th April 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced facial swelling (serious criteria hospitalization). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the facial swelling was unknown.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination with Shingrix, the patient had  facial swelling and even required admission to in Hospital. The patient had to administered steroid at the hospital. At the time of reporting, the patient came in wanting a second dose and they had it drawn up. No difficulty breathing reported. The reporter did not consent to follow up.
48 hour migraine with speech problems, dizziness, confusion, trouble reading, sensitivity to light, nausea. Extreme head pain in right side of head every week. Trouble walking, falling randomly due to inflamed nerves in legs
A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST 06-Nov-2008. A physician reported that his office received a report of 30 children ranging in age from five to seven years who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Information has been received from a nurse concerning a male physician with hypercholesterolemia who in approximately 2002, "about 7 years ago" was vaccinated with the first 0.5 ml dose of PNEUMOVAX 23 intramuscularly. On 24-FEB-2009 the patient was vaccinated with the second 0.5 ml dose of PNEUMOVAX 23 (Lot # 661529/0868X) intramuscularly. Concomitant therapy included TRICOR and MICRO K. It was reported that on 24-FEB-2009, the patient developed high fever, swelling of the entire left arm and left axillary nodes, and "flu-like symptoms" a few hours after receiving his second dose of PNEUMOVAX 23 on 24-FEB-2009. It was reported that the patient was taking ADVIL and BENADRYL and was recovering. The patient sought unspecified medical attention. Follow up information was received from a registered nurse (R.N.) concerning a patient with no pertinent medical history and no known drug allergies/drug reactions who on 24-FEB-2009 was vaccinated with a fourth dose of PNEUMOVAX 23 (Lot # 661529/0868X) at 14:00. It was reported that on 24-FEB-2009 at 16:00 the patient experienced swelling redness and inflammation at the injection site and down arm; he also experienced decreased function, as well as numbness and tingling down arm. It was reported that the reaction lasted three days before improvement. This is one case of three from the same source. Additional information has been requested.
This medically confirmed health authority report (initial receipt 27-Oct-2014) concerns a female patient. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, the patient developed right and left hand paralysis. Outcome was not reported.  Linked to 2014046394.
Patient is a 57-year-old male who is seen in consultation for evaluation of right arm injection site reaction. Patient states he had the influenza vaccination injection on 10/3/18 in his proximal right upper extremity. Patient states he noticed a reaction in his right upper extremity site of injection in December 2018 which began as a "mosquito bump". Patient states since then the area has become increasingly erythematous. Denies drainage from the lesion. Does report that the area on the proximal right upper extremity is itchy and sore. States the pain is worse with palpation. Rates pain 2/10. Denies fever, sweats, chills, nausea, vomiting. I&D performed, cultures obtained, wet-to-dry dressing BID.
Patient came into pharmacy on 10/3/13 to report adverse reaction. Patients right arm covered on rash/bruise from shoulder to elbow completely circling arm, extending to back of shoulder. Patient was advised to notify MD.
Woke up with a severe migraine at 3:30 am, and again the following night another migraine.  Also had swelling and a red lump at site of injection, with pain and soreness around injection site.
Pt received Varivax vaccine on 10/13/95.  On 10/30/99, pt developed a case of Chicken Pox with over 200 lesions.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a child patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included Vitamin K for an unknown indication. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and Vitamin K at an unknown dose and frequency. On an unknown date, 2 hrs after receiving Hepatitis B vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. In the study done for 673 infants with half PEDIARIX (combo vaccine) and half infants were given the hep B, INFANRIX and IPV separately as in not a combo vaccine. The reporter believed that, a patients who had an adverse reaction 2 hours after the Hepatitis B and Vitamin K vaccine. The reporter pediatrician carried multiple manufacturers for vaccines and from the research the reporter had read on the inserts provided from GSK. It was recommended to not mix manufacturers because there was not testing, for example GSK and MERCK. The reporter wanted to make sure understand this properly so the reporter could make the best decision for his child. The reporter wanted to know, were they ever re-tested for new reactions since the number of administered vaccines had been increased over the past 15 years and when were clinical trials performed. Also because many pediatrician gave multiple doses in one visit but were there safety studies done for multiple vaccines given, for example DTap, rotavirus, Hepatitis B, IPV at the same time. It was unknown if the reporter considered the adverse reaction to be related to Vitamin K.
Achiness started about 10-11 hours after 2nd Moderna shot.  Overnight, achiness continued.  Symptoms were even worse in the morning the next day (18-20 hours after the vaccination). Headache across scalp, pain and swelling at injection site, body aches and stiffness diffusely, significant fatigue, loss of appetite. I had to take the day following the vaccine off work--I stayed in bed most of the day until about 2:30 PM. I did not take any medication/pain medicine and the headache went away around 2 PM (26 hours after the vaccination). Other symptoms improved gradually at that time, too. By 3:00 PM (27 hours after the shot), I felt well enough to file this VAERS report.
ACHES; CHILLS; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a 61 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced aches. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, chills, and tiredness on 11-APR-2021. This report was non-serious.
Information has been received from a nurse concerning her 20 year old daughter with an allergy to hepatitis B (manufacturer unknown) (MSD WAES 0709USA03332) who was vaccinated with a 0.5 ml first dose of Gardasil.  There was no concomitant medication.  Subsequently five days after vaccination the patient became weak, tired and dizzy.  For the first five days the patient felt fine.  The patient visited the office.  At the time of the report "it had been about 10 days since the symptoms started the the patient had not recovered".  Additional information has been requested.
This spontaneous report as received from a nurse who refers to an unspecified group of patients of unknown age and gender. Patients' medical histories were not provided. On an unknown date the patients were vaccinated with improperly stored doses of PROQUAD (dose, frequency, route of administration and indication were not provided) (lot # reported as K008871, exp date: 19-DEC-2015). Concomitant medication was not reported. Firstly it was reported that the PROQUAD was stored at 75 F. The reporting nurse subsequently called back and corrected temperature range in which the PROQUAD was improperly stored at 14.5F. No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
received a box of expired Fluzone high dose for Jun 30, 2022 and gave all 10 doses. with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA400131, 2022SA392579, 2022SA400987, 2022SA400369, 2022SA400371, 2022SA400976, 2022SA401056, 2022SA400981 and 2022SA401104 (CLUSTER).   This case involves unknown gender elderly patient who was given expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] for 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 received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ772AA, exp date: 30-Jun-2022) via unknown route in unknown administration site for Immunization.  On an unknown date the patients developed a non-serious "received a box of expired Fluzone high dose for Jun 30, 2022 and gave all 10 doses. with no reported adverse event" (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.; Sender's Comments:  US-SANOFI-01288883: SAD20220921002678:
Developed chicken pox like lesions primarily on trunk following vaccine.  Itching was the only symptom.  No noticeable fever or malaise.  I have had chicken pox as a child, and received the Shingrix vaccine about a year ago.  This vaccine was administered by a pharmacist.  Treated with calamine and Benadryl.
Pt reported headache, "chattering teeth," soreness at injection site (left deltoid) and soreness extended to left elbow