chrisvoncsefalvay/vaers-outcomes huggingface dataset:
now a day behind on 2nd dose of the rabies vaccine. AE due to her now being off the administration schedule with no reported AE; Initial information received on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Adult female patient who was behind on the 2nd dose of the rabies vaccine. Adverse event due to her now being off the administration schedule with no reported Adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Sep-2022, the patient received a standard Dose 1 of suspect RABIES (HDC) VACCINE (Strength: standard) (Frequency: once) (lot number: not reported but has been requested) via unknown route in unknown administration site for Immunization.  On an unknown date the patient who was behind on the 2nd dose of the rabies vaccine. Adverse event due to her now being off the administration schedule with no reported Adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] (routine immunisation schedule incomplete) (unknown latency).  Action taken with RABIES VACCINE (IMOVAX RABIES) was not applicable.  At time of reporting, the outcome was Unknown.  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 guidelines. 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.
I am unsure of an accurate time, her new symptoms didnt start until after the second vaccine in the series of three. On 2/23/09 she was vaccinated and on 2/25 the symptoms started and have not gone away. Syncope several episodes, nausea, tunnel vision, muffled hearing, tingling limbs, dry mouth, burning sensations, overall "weird feeling/somethings not right" extreme fatigue, leg muscles contract or something and she cannot bend it until it stops.
This case was reported by a consumer via call center representative and described the occurrence of hives in a 62-year-old male patient who received SHINGRIX for prophylaxis. On 5th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced hives, pruritus and chronic urticaria. On an unknown date, the outcome of the hives, pruritus and chronic urticaria were recovered/resolved.  It was unknown if the reporter considered the hives, pruritus and chronic urticaria to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 61 years or 62 years. The case was reported by the patient for himself. Within a few weeks after the vaccination, the patient started breaking out in hives. The patient started experiencing chronic urticaria that flared up with itching at random times. The patient saw his allergist and it was thought due to food products. The patient visited the emergency room. The patient provided the consent to follow up. For tolerance to the 2nd dose of SHINGRIX, refer case US2019GSK054229.
Sore Arm; Feeling I had Phylum in Throat; Could Not Eat; Sore Lymph Nodes Right Armpit; Could not lift the arm; Tender to the touch Right Armpit; Cough for 1 minute; Extreme Ache Entire Body; Burning up Fever 100.3 F; Muscle Ache; Nausea; Feeling Warm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling Warm), LIMB DISCOMFORT (Sore Arm), PRODUCTIVE COUGH (Feeling I had Phylum in Throat), FEEDING DISORDER (Could Not Eat) and LYMPH NODE PAIN (Sore Lymph Nodes Right Armpit) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced FEELING HOT (Feeling Warm). On 13-Feb-2021, the patient experienced LIMB DISCOMFORT (Sore Arm), PRODUCTIVE COUGH (Feeling I had Phylum in Throat), FEEDING DISORDER (Could Not Eat), LYMPH NODE PAIN (Sore Lymph Nodes Right Armpit), LIMB DISCOMFORT (Could not lift the arm), AXILLARY PAIN (Tender to the touch Right Armpit), COUGH (Cough for 1 minute), PAIN (Extreme Ache Entire Body), PYREXIA (Burning up Fever 100.3 F), MYALGIA (Muscle Ache) and NAUSEA (Nausea). The patient was treated with AZELASTINE (nasal) at a dose of 1 dosage form. On 15-Feb-2021, FEELING HOT (Feeling Warm), LIMB DISCOMFORT (Sore Arm), PRODUCTIVE COUGH (Feeling I had Phylum in Throat), FEEDING DISORDER (Could Not Eat), COUGH (Cough for 1 minute), PAIN (Extreme Ache Entire Body), PYREXIA (Burning up Fever 100.3 F), MYALGIA (Muscle Ache) and NAUSEA (Nausea) had resolved. On 27-Feb-2021, LYMPH NODE PAIN (Sore Lymph Nodes Right Armpit), LIMB DISCOMFORT (Could not lift the arm) and AXILLARY PAIN (Tender to the touch Right Armpit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Body temperature: 100.3 (High) Fever 100.3F. On 13-Feb-2021, SARS-CoV-2 antibody test: positive (Positive) Antibody test was reactive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received on 21-Jul-2021 contains significant information. The primary reporter mailing address was updated. The relevant medical history and the  lab data was added.
nauseated & sweaty 10min after first dose.  Stable vitals. No respiratory distress.  Symptoms resolved.
Rec'd vac on 4/3/08, day after pain and knot in rt arm to neck.  1 wk later pain in joint of elbow and shoulder.  Throbbing pain in arm, cannot write for long periods, have arm spasms and weakness in arm.  Having migrains and can't slep due to pain.  Reported to Emp. Health 4/21/08 sent to see IM MD on 4/30/08.  Was given tramadol 50 mg and OTC topical analgesic to apply 3 to 4 times a day.  Will follow up in 2 weeks.
Pt complain of should pain and decreased range of movement the next morning. Took Mobic without benefit. In process of getting x-ray, or possibly MRI, blood test.
It started after the last vaccine I received on April 17th of 2021. Before the vaccines I used to walk or run at least 6 days a week. I am a volunteer and they do an annual fundraiser event for tutoring and other expenses. I volunteer each year at this event by making Tamales and I usually make 12 dozen but because of the impact of the vaccine, this year, I was able to make 9 dozen tamales. The impact of this vaccine also impacted me mentally and in turn, impacted my family because I wasn't able to perform or make big milestones such as taking my kids to school, attending my daughter  graduation last year in May of 2021 or my son's college graduation of this year, May of 2022 because of the pain I was in. I wasn't able to prepare meals or do daily tasks for my two younger children and the burden was left on my husband to do these daily tasks due to the pain that was caused by the vaccine. This also impacted us economically and financially because we were left with many hospital bills in which I visited due to this pain and it has been hard because on top of medical bills we still had to provide food to the table for our children. For me, it was hard to go to work with this pain that the vaccine caused me. My husband had to reach out for help financially to his boss to be able to help with the financial cost that we were left with. I went to the local clinic very frustrated, and desperately asking for help as well as other medical places. Instead of giving me help to fix the pain that I was feeling, they gave me medications for anxiety that didn?t help me with the pain that I was feeling. I was told I was going crazy. Because I was ignored multiple times by several doctors and humiliated, I have been left with more long term pain and have mentally been impacted as well as my family. Side effects included; chills, join pain (I still have), decreased appetite, cough, horrible menstrual periods (One of the worst pains to experience), decrease appetite, bruises, jerky movements on my breast (again, one of the worst pain), chest pain (I still have it), trouble breathing, fast heartbeat (another one of the worst), panic attacks, pale skin, burning all over the body, warmth around the arm, rashes, weakness that I could not get up on my own for several weeks, needles in the upper back, itchy underarms and breasts, a cramp in my chest because the of the spike protein that the vaccine has caused that lodge.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-NOV-2015 19:00, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L004754, expiry date: 10-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 11.2 (2 hours 28 mins) and 2.6 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Patient's daughter states she received the vaccine Saturday morning and in the afternoon she came down with flu symptoms and passed away that day from complications from the flu.
extreme redness and itchiness on arm where shot was given and very high fever and pain in back
Wide spread rash, swelling, and pain on left arm which all appeared on 3rd of June-15. June 4th saw Dr and treatment was to apply hot & cold compress.
Received immunizations on Wednesday 10/10/18 at noontime, Thursday 10/11/18 became achy and feverish, with chills, next morning felt fine, Friday afternoon 10/12/18 started to feel achy again. As of today 10/15 hips and legs still ache. Also developed a rash on arm around immunization site. Still red today but no longer raised.
Hospitalized 12/6/2021; COVID-19 positive 12/6/2021; fully vaccinated+ booster(per H&P booster received but unable to locate documentation of booster given)  HISTORY OF PRESENT ILLNESS Patient is a 88 y.o. male with past medical history significant for essential hypertension, history of prior alcohol use disorder, GERD, who presents to the emergency department today from his independent living facility for evaluation of generalized weakness, poor appetite, and inability to care for himself at home.   The patient developed COVID-19 symptoms around Thanksgiving.  He is vaccinated.  He also has received his booster.  He tells me he has had no appetite and has felt quite weak.  He has not been eating or drinking much for several days.  Tells me he has not been making much urine either.   He lives in independent living, uses a walker or cane to ambulate typically. He asks me multiple times if he can go home, but then agrees when I tell him I am concern he is too weak to go home.  PLAN Covid 19 infection Symptom onset 12/2 Vaccination status: vaccinated + booster Not requiring oxygen CXR independently reviewed, negative for acute cardiopulmonary process  Does not meet criteria for decadron or remdesivir  He does qualify for the monoclonal antibody, will text the monoclonal antibody line for him tonight, so they may reach out tomorrow. Will need the info sheet. Monitor daily covid immunology labs VTE prophylaxis with subcutaneous lovenox IS q 1hr while awake, prone positioning prn  12/8/2021 note: Dispo: Anticipate d/c 12/9. Frequent discussions between patient, care manager and patient's family members about safe discharge plan since patient is in independent living with virtually no services. Family is unable to provide supplemental care for him while he is in quarantine due to their concerns of transmitting to immunocompromised family members. Will have PT/OT re-evaluate in the morning. Currently recommending home with home health services. Care manager aware of situation  Patient discharged home on 12/9/2021
Patient received Pfizer COVID vaccine on 3/16/21 and 4/6/21. On 12/30/21, patient tested positive for COVID. On 1/2/22, patient admitted to our facility med/surg unit with acute respiratory failure due to COVID-19, viral sepsis and acute metabolic encephalopathy (hx of epilepsy). As of today (1/5/22), patient is still admitted in our med/surg unit receiving dexamethasone and remdesivir.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. On unknown dates the patients were vaccinated with improperly stored doses (number of doses unspecified) of RECOMBIVAX HB (dose and route not reported, lot # L033343 with expiration date 13-SEP-2017). The reporter mentioned that the vaccines were stored at 52.2F for 2 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Mom noted rash that looked like hives on legs, knees and axilla. Treatment: Benadryl. No other symptoms. Rash lasted approximately 2 days. Bruised-like appearance: palpable purpura.
pt recv vax 30JAN97 & 5 days later on 4FEB97 pt exp a negative rubella titer;
rosacea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ROSACEA (rosacea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rosacea.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ROSACEA (rosacea). The patient was treated with DOXYCYCLINE for Rosacea, at a dose of 1 dosage form. At the time of the report, ROSACEA (rosacea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter.
Headache; Elevated temp; Chills; Fatigue; Sore Throat; Nausea; Horrible diarrhea; Racy heart; Dehydration; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08Mar2021 at 13:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, atrial fibrillation (AFIB) and obesity. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ) for high blood pressure, rosuvastatin calcium (CRESTOR; 5mg) for high cholesterol, apixaban (ELIQUIS) and diltiazem (MANUFACTURER UNKNOWN) for atrial fibrillation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received penicillin and experienced allergy. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021 at 12:00, 4 days after getting the vaccine, the patient ended up becoming ill for a week with headache, elevated temperature, chills, fatigue, sore throat, nausea, horrible diarrhea, racy heart from dehydration. The patient spoke with the pharmacist and contacted her cardiologist. Headache was gone after a week. The patient was quarantined at home for 10 days. The patient had bouts of the feeling of nausea at the time of report. The adverse events result in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events elevated temperature, chills, fatigue, sore throat, nausea, horrible diarrhea, racy heart, dehydration and headache was resolved on an unknown date in Mar2021 and event nausea was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
slurred speech; dizziness; headache at the top of the head; weakness on arms; sleepiness; low blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 34-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration in Arm Right on 04Aug2021 14:15 (age at vaccination 34years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing If Covid prior vaccination: Yes. There were no concomitant medications. The patient has Known allergies reported as unknown. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks and Other medications in two weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced slurred speech, dizziness, headache at the top of the head, weakness on arms, sleepiness, low blood pressure on unspecified date in Aug2021. The clinical outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
While giving COVID-19 Moderna vaccines, a total of 11, the first 2 patient's accidentally were given a dose of 0.3mL Epinephrine (pre-filled syringes). According to the anaphylaxis guidance from CDC, there should be at least 3 doses of Epinephrine on hand and available for anaphylactic reactions due to the COVID-19 vaccination. Prior to administration, there was (1) bag of (11) 0.5mL pre-filled Moderna vaccine and (1) bag of (2) doses of 0.3mg/0.3mL Epinephrine, both being properly labeled on the outside of the light-protecting bags. Once being at the administration site, the administrating nurse had accidentally administered the Epinephrine syringes to the first two patients, thus, ending the round of vaccines with 2 extra doses of Moderna vaccine.
Between 5 and 10 min following injection break out in pruritic red rash. Face, head and few on chest, Benadryl given rash gradually left.
delirium; Fever of 100.8; chills; flushed; overall soreness; deltoid pain; This is a spontaneous report from a non-contactable consumer. A 50-year-old male patient received BNT162B2 (lot# unknown) on 03Feb2021 01:30 PM at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient experienced Fever of 100.8, chills, flushed, overall soreness, delirium, and deltoid pain on 04Feb2021 04:00 AM with outcome was Recovering. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient experienced dizziness, nausea, itching. BENADRYL was given. Itching and nausea had improved by the following day.
itchy; like pain; hot to the touch; big red welt at the injection site; Started to get red the same day of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (like pain), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE URTICARIA (big red welt at the injection site) and VACCINATION SITE ERYTHEMA (Started to get red the same day of the injection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (like pain), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE URTICARIA (big red welt at the injection site) and VACCINATION SITE ERYTHEMA (Started to get red the same day of the injection). At the time of the report, VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (like pain), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE URTICARIA (big red welt at the injection site) and VACCINATION SITE ERYTHEMA (Started to get red the same day of the injection) outcome was unknown.            Concomitant and treatment medications were not provided by reporter.
14 1/2 x 12cm area of erythema noted on Left upper ventral leg with 1 x 1.5cm black border around white center with injection site centrally.  Sx 36-48 after injection.  Cold compress and benedryl Q-6hrs.
warm to the touch, lasted 4-5 days; redness; big red patch in the right arm, lasted 4-5 days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH ERYTHEMATOUS (big red patch in the right arm, lasted 4-5 days), FEELING HOT (warm to the touch, lasted 4-5 days) and ERYTHEMA (redness) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (big red patch in the right arm, lasted 4-5 days), FEELING HOT (warm to the touch, lasted 4-5 days) and ERYTHEMA (redness). At the time of the report, RASH ERYTHEMATOUS (big red patch in the right arm, lasted 4-5 days), FEELING HOT (warm to the touch, lasted 4-5 days) and ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided by the reporter.
No adverse reasons occurred. Resident was transferred to our facility from Hospital. She had not received any Covid vaccinations prior. The hospital was supposed to give her the first dose of the primary series. Instead they gave her a dose of the Pfizer Bivalent Booster.
9/18/09 12:30 AM woke up with nausea, muscle aches and HA - mild rx.  6:00 AM FBS 160 usually in the 90's in the AM.  Called her M.D. who told her to take TYLENOL and have this form filled out.  10:00 AM HA beginning to subside, no more body aches has not checked sugar but "thinks its ok."  Physician did not want pt to come to office.