chrisvoncsefalvay/vaers-outcomes huggingface dataset:
like a cramp; started to limp; arthritis in my knee; pain is horrible; I can't walk; weak legs; muscle pain which started in my right arm; needles began in my body; numbness in my arm; pounding heart; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (needles began in my body), HYPOAESTHESIA (numbness in my arm), PALPITATIONS (pounding heart), MUSCLE SPASMS (like a cramp) and GAIT DISTURBANCE (started to limp) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia. Concomitant products included LOSARTAN and SIMVASTATIN for an unknown indication.   On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (needles began in my body), HYPOAESTHESIA (numbness in my arm), PALPITATIONS (pounding heart), MUSCLE SPASMS (like a cramp), GAIT DISTURBANCE (started to limp), ARTHRITIS (arthritis in my knee), PAIN (pain is horrible), GAIT INABILITY (I can't walk), MUSCULAR WEAKNESS (weak legs) and MYALGIA (muscle pain which started in my right arm). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and CORTISONE ACETATE (CORTISONE [CORTISONE ACETATE]) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (needles began in my body), HYPOAESTHESIA (numbness in my arm), PALPITATIONS (pounding heart), MUSCLE SPASMS (like a cramp), GAIT DISTURBANCE (started to limp), ARTHRITIS (arthritis in my knee), PAIN (pain is horrible), GAIT INABILITY (I can't walk), MUSCULAR WEAKNESS (weak legs) and MYALGIA (muscle pain which started in my right arm) outcome was unknown.            Test done were ultrasound, X-ray result stated everything was fine First dose given in left non-dominant, Second dose scheduled for 16Aug2021 , numbness spread to my face, and then to my hands and feit was something that bothered me  yet, (muscle pain) was in the calf, after three days it was stronger, it then hit me in the back of my knee and thigh, numbness is in my left leg now, I have been walking with a walker CROSSLINK TO SON'S AE MOD21-128924
Face, scalp, and sometimes other areas of my body have a burning/tingling sensation.; Face, scalp, and sometimes other areas of my body have a burning/tingling sensation.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20May2021 16:00 (Lot number: EW0177) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sleep apnea" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: TRINTELLIX. Vaccination history included: Bnt162b2 (1st Dose, lot number: ER8731,, Administration date: 29Apr2021,, vaccine location: Right Arm), administration date: 29Apr2021, when the patient was 38 years old, for Covid-19 Immunization. The following information was reported: BURNING SENSATION (non-serious), PARAESTHESIA (non-serious) all with onset 22May2021, outcome "not recovered" and all described as "Face, scalp, and sometimes other areas of my body have a burning/tingling sensation.". Therapeutic measures were not taken as a result of burning sensation, paraesthesia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Trintellix, birth control pills within 2 weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 Since the vaccination. Seriousness criteria-Results in death/Seriousness criteria-Life threatening/Seriousness criteria-Caused/prolonged hospitalization/Seriousness criteria-Disabling/Incapacitating/Seriousness criteria-Congenital anomaly/birth defect all were reported as no. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
Information has been received from a Nurse Practitioner (N.P) concerning a 20 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 16-MAR-2009 was vaccinated with the first 0.5 ml dose of GARDASIL vaccine (Lot # 1702X) intramuscularly. There was no concomitant medication. It was reported that on 26-MAR-2009 the patient the patient developed cervical and inguinal lymphadenopathy. It was reported that the patient also developed "pimple-like bumps" in the groin area. The patient called to the office. There were no laboratory diagnostic tests performed. It was reported that the patient was scheduled to be examined in the office on 02-APR-2009. It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
Full body case of hives, as well as swollen hands, feet, and face. Taking Benadryl, applied cortisone cream, started Prednisone prescription.
hard spot; rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (hard spot) and RASH (rash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20H) 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 02-Feb-2021, the patient experienced VACCINATION SITE REACTION (hard spot) and RASH (rash). At the time of the report, VACCINATION SITE REACTION (hard spot) and RASH (rash) 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.   This case was linked to MOD-2020-016505 (Patient Link).
Pt received vaccine 1030AM today came back to clinic c/o not feeling well since received vaccine coughing, weakness vomiting pt having tremors Epinephrine 1.1000 Sol .5mg given symptoms not improved sent to ER.
Information has been received from a registered nurse and the mother of a 9 month old male who on 10-DEC-2002, 05-MAR-2003 and 10-JUN-2003, received three doses of RECOMBIVAX HB (lot# not reported). Concomitant therapy included PREVNAR. On approximately 06-DEC-2003, the patient was diagnosed with autism when he was only 18 months old. It was unspecified if the patient sought medical attention. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.
4/27 pt irritable, slight fever, 2 spots on face chest, 4/28 fever increased 102.7 , vomited, spots spread over body, some blister like , some solid, red rash, 4/29 rash continued, temp 103. pt fussy crabby.
Redness and warm to touch on the same arm, with some hardening and some discoloration but not at the injection site (about 3 inches away from injection site). Discomfort relieved by TYLENOL taking the following day after the vaccine. Redness, warm, discoloration, and slight hardening still present on day two. Advised patient to see physician for evaluation.
Fever range 100.6 to 103.2 with chills, headache and severe body aches lasting 24 hours. Took acetominophen alternating with aspirin every 8 hours, and increased fluids.  Ended abruptly after 24 hours.
A nurse reported the occurrence of an injection site reaction in a 3-year-old subject of unspecified gender who was vaccinated with diphtheria and tetanus coxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The reporter submitted a report directly to VAERS (local state department reference number C002-025).  The subject had no medical history or concurrent conditions.  The subject experienced no adverse events following previous immunizations.  Concurrent medications were not specified.  On 08/26/2002, the subject received the fourth Infanrix injection (lot DTPA541A9).  On 08/28/2002, the subject developed an injection site reaction characterized by swelling and a 4-cm area of redness and induration.  The reporter stated that the injection site reaction was possibly related to Infanrix administration.  As of 09/30/2002, the outcome of the injection site reaction was unknown.
No further AE; a pattient accidentaly received an expired MMRII dose; This spontaneous report was received from a pharmacist referring to a 19-year-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions and previous drug reactions or allergies was not reported.   On 04-JAN-2021, the patient accidently received an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-R II) lot # R030808, expiration date 24-OCT-2020, at a dose of 0.5 milliliter for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). The reporter had not contacted the patient yet but had not been made aware of any further adverse event, complaints or other information.
Patient received Pfizer COVID vaccine on 1/21/21, 2/8/21, 11/4/21, 5/2/22, and Pfizer bivalent COVID vaccine on 10/19/22. On 12/9/22, patient admitted from SNF to our inpatient facility (med/surg unit) with acute respiratory failure due to COVID-19 pneumonia and acute metabolic encephalopathy. Patient was discharged back to SNF on 12/14/22.
Phone call to MD reporting hives all over at 09:07pm 05/16/2003. No fever no respiratory distress, alert and active. Told to administer Benadryl.
5:55pm- 9/3/2021- swelling of face and throat - took Benadryl 10pm- 9/3/2021- face still swelling- took another Benadryl 8am-8/4/2021- left arm, shoulder and shoulder blade swollen and sharp pain. Benadryl and ibuprofen taken 12pm-9/4/2021- swelling of face gets worse and pain worsens in shoulder. Swelling of shoulder and shoulder blade  area getting worse. Took two Benadryl and ibuprofen. Used cold pack on swollen shoulder and shoulder blade area.  4pm-9/4/2021- swelling still in shoulder and shoulder  blade area. Throat began feeling tight. Took more Benadryl and took Tylenol.  Sore throat begins. 8pm-9/4/2021 no change from 4pm. 12am- 9/5/2021- throat feels tight, pain in shoulder and shoulder blade area is gone. Red rash around injection sight area. Took Benadryl went back to sleep. 4am- 9/5/2021-took more Benadryl- face is swollen, throat feels tight, began coughing, once Benadryl kicked in coughing eased.  8am-9/5/2021- swollen face and dizzy. Took Benadryl.  12pm-9/5/2021- face and throat continue to  swell about 30 min before Benadryl is due. Kept taking Benadryl every four hours.  4pm- 9/5/2021- knot formed above injection sight , still a red rash around  injection sight.  Throat still swelling. Took Benadryl.  8pm-9/5/2021- face and throat swell take Benadryl  12am-9/6/2021- face and throat swell took Benadryl  4am-9/6/2021- throat itchy and sore and nose swollen and stuffy. Took Benadryl 8am-9/6/2021- face slightly swollen, coughing, and sore throat. Took Benadryl. Which helped with the coughing. 2pm- 9/6/2021- face and throat slightly swollen took Benadryl.
None stated.  Shot received in clinic on 10/27/09. Pt presents to clinic 10/28/09 c/o swelling, redness, tenderness warmth to upper and inner right arm p shot (whole upper arm involved not just injection site) Pt referred to PPMD) Pt was on her was at the time just wanted to make us aware.
17x17cm puritic erythema with irregular border on right upper arm at site of administration.
The patient states that she had urticaria on each arm from the shoulder down to her wrist and on the top of each hand. As well as urticaria on her front of her abdomen. She stated she took a cold shower and used over the counter hydrocortisone cream to treat the affected area. Symptoms lasted approximately one hour.
limp, wiped out, slept for over 18 hours, no remembrance of going to the bathroom, fever, diarrhea from 10/4 until 10/10 - still feels poorly
Patient complained of redness in the arm where she received the vaccination. The red area had spread since she received the vaccine and she was becoming increasingly concerned.
Redness soreness around the site, head and neck pain. Treatment- Apply ice alt with heat, ADVIL for pain, call pcp if reaction becomes worse or go to nearest ER.
Regression 18 months of age, lost speech, fine and gross motor skills, autistic, diagnosed high functional autism at age 3 1/2. 2/27/06 Received medical records from Dr. which reveal that patient experienced autism spectrum, Asperger's disease & hyperlexia/ss Received medical records from PCP which consisted only of vaccination record/ss
Developed acute severe Tinnitus R ear and moderate Tinnitus left ear on 1/12/2022. Thought it may be due to amlodipine induction for Elevated BP on 1/11/22. Stopped amlodipine following 2 doses, tinnitus never resolved.  Went institute on 4/5/22. Following the work up I was Informed I had tinnitus second to sensorineural hearing loss. Dr  Handed me an article to review (relating sensorineural HL to COVID-19 vaccination)  and stated that sensorineural  hearing loss may have been aggravated by COVID-19 vaccination therefore I am experiencing tinnitus.
I began to feel like something was stuck down my throat mid-chest area.  I also began experiencing burning in my chest.  When I would eat or drink something it would be painful.  I had bile building up in my throat, but never threw up.  Being upright was more comfortable than lying down.  This happened first during the day, and then two additional times in the evening/late into the night before I called my doctor.  I then called my doctor who diagnosed me with an esophageal ulcer.  I am currently on medication for the ulcer.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with a dose of improperly stored VAQTA (dose, route of administration and lot # were not reported). This vaccine had been exposed to 32F for 2.5 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Lips swelling blisters in mouth eyes swollen glands swollen headache face swelling
p/vax pt exp herpes zoster w/a red linear rash along the C7-T1 dermatomes, running along the child's rt shoulder & upper arm;MD also noted child had linear, minute vesicles, red papules;dermatologist felt poss lichen planus/lichen striatus
Information has been received from a health professional concerning a 6 year old female with an amoxicillin trihydrate/clavulante potassium (Augmentin) allergy who on 01/07/2002 was vaccianted SC with a first dose of varicella virus vaccine live. There was no illnesses at the time of vaccination. On 01/07/2002 the pt developed a "varicella-like rash that followed typical course of disease." Subsequently, the pt recovered. No further info is available.
10 yr old female with history of traumatic brain injury 3 years prior, with residual cognitive delay. Presented for catch-up vaccinations to enter school. No current complaints. Patient was well before, during, and immediately after vaccination. About 30 minutes after vaccination, patient was standing and had syncopal event. She hit the back of her head on the pavement, although the father's story was not clear as to whether she hit with full force or if he partially caught her before her head hit. Pt was unconscious for about 1 min, during which time she had some shaking of her arms and legs. The event was not witnessed by medical personnel. The father carried her back into the clinic. She was awake and crying. She had never had a reaction after a vaccine before and was scared. She was given two juices boxes and 8 oz water, then calmed. She had not had anything to eat or drink since the night prior. All vitals were normal, as was her exam (including her head; there were no signs of trauma). She complained of a mild bifrontal headache. After about 30 minutes of reclining, she sat up and was asymptomatic. She left the clinic but returned about 30 min later with her father. He stated that she had vomited twice, non-bloody, non-bilious. She had not eaten anything and only had sips of water. Her vitals were again normal. She complained of a bifrontal headache again. She was given 12.5 mL acetaminophen by her father and the pediatrician had her lay down. She fell asleep for about 15 minutes, then awoke and vomited twice (clear fluids). At that time, the decision was made to send her to the ER by ambulance. EMS arrived about 10 minutes later. She was no longer complaining of nausea or headache. In the ER, she was examined and observed for 2 hours without any further vomiting or headache. An EKG showed possible right ventricular hypertrophy and non-specific t wave changes. Cardiology reviewed the EKG and suggested that she could be discharged home with an outpatient cardiology appointment scheduled.
This spontaneous report as received from a pharmacist refers to a 77 year old female patient with drug reaction/allergies to opioids/morphine and penicillin. There was no other pertinent medical history. On 21-NOV-2013, the patient was vaccinated with ZOSTAVAX. Dose, route, lot number and expiration date were not reported. Other suspect therapies included PNEUMOVAX 23. The pharmacist was not sure when the patient received PNEUMOVAX 23 because the patient did not receive PNEUMOVAX 23 in her pharmacy (approximately in 2013). Dose, route, lot number and expiration date were not reported. There was no concomitant medication. Approximately in 2013 the patient developed pain, redness and swelling around the injection sites after receiving both ZOSTAVAX and PNEUMOVAX 23. The pharmacist stated the patient mentioned her symptoms lasted for 6 weeks (stop date 02-JAN-2014) following the administration of ZOSTAVAX. The causality was not reported. Lab diagnostic studies were not performed. The patient sought medical attention, contacted pharmacist. Additional information has been requested.
Severe Headache for which over the counter medications could not give me any relief.  It eventually subsided after 48 hours.  But I could not work nor carry out any of my daily activities the first 24 hours.  I also experienced pain at the site of the injection with itching up and down my arm that set in the third day after the vaccination. I also experienced redness that turned my skin bright red and eventually purple on my arm at the site of injection between my shoulder and elbow.  This discoloration of my skin eventually faded to yellow and light brown and faded away by the sixth week after the injection.
Tested positive for COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   No concomitant medications were reported.  No treatment information were reported.  Company Comment: This spontaneous case concerns a 72-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive after administration of the first dose of the Moderna mRNA-1273 vaccine. The patient tested positive for COVID-19 on the same day after vaccination. No further details were provided. The patient's age remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 72-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive after administration of the first dose of the Moderna mRNA-1273 vaccine. The patient tested positive for COVID-19 on the same day after vaccination. No further details were provided. The patient's age remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Initial unsolicited report received from a physician on 12-Oct-2017. This case is linked with: 2017SA199339, 2017SA199365, 2017SA199379, 2017SA199386, 2017SA199397 (same reporter). This case involves a female patient (age not reported), who was vaccinated FLUZONE HIGH-DOSE (batch number: UI845AB, expiry date, dose, route and dose in series and site of administration not reported) on an unknown date. Patient's medical history reported as underlying new diagnosis of Lewy Body Dementia and concomitant medications were not reported. On an unknown date, following the vaccination, the patient's mental status change, had bronchitis which triggered AFIB. On an unknown date, patient got hospital admission. Lab test and corrective treatment was not reported. Outcome of the events were not reported. Documents held by sender: none. Sender's Comments: Patient experienced Atrial fibrillation, dementia, mental status changes and bronchitis after vaccination. Exact time to onset is unknown. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Dizziness, rash around shoulders back/chest, and arms. Short of breath ER gave prednisone, 50mg Benadryl and d/c with steroids
Since 10/13/21 underarm soreness (still present) Since 10/16/2021 have been having daily hot flashes  Starting 12/31 continual breast soreness and nipple sensitivity Heavier than normal menstrual sycle with cramps which never had previously
86 year old lady who has hx permanent atrial fibrillation on HTN, HLP, fibromyalgia, lives independently at senior living facility, presents for weakness, fatigue, dry cough, sore throat, was prescribed ceftin by PMD, was found to have COVID last Monday, presents for further evaluation and was found to be COVID 19 positive on rapid Sars.
Vaccine recieved at 8:10am.  At 11:00 am noticed hives on neck and red.  Throat felt tight so looked in mirror.  Tongue was 3 times typical size!  Ears hot and itching.  Airway compromised.  Tongue continued to enlarge and throat tighter.  Hives on face.
Adverse Events: chills, dizziness, difficulty standing, weakness,confusion,light-headiness Treatment: zosyn,vancomycin,acyclovir Outcomes: spent 8 days in hospital and 5 days in acute rehab recovering.  As of March 17, 2021, under primary physician care due to ongoing occurrences of weakness, sleepiness, nausea and chills.
approx 2 1/2hr p/vax arm became red, swollen & painful;10/7/99 phoned hlth dept & advised to use hot/cold compresses (alternate) & OTC pain relief;pt to hlth dept 10/8/99 arm still swollen & painful;pt had cellulitis & bruising