chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore right injection site arm after second Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right injection site arm after second Moderna Covid-19 vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 028421A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-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 VACCINATION SITE PAIN (Sore right injection site arm after second Moderna Covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (Sore right injection site arm after second Moderna Covid-19 vaccine) outcome was unknown.            No concomitant medications were provided by the reporter  No treatment information were provided by the reporter   This case was linked to MOD-2021-390773 (Patient Link).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2013, the patient was inoculated with ZOSTAVAX at a health clinic as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 08-SEP-2014, the patient was treated at a health clinic for herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Initial unsolicited report received from a consumer (patient) on 13-Mar-2017. This case involves a female patient (onset age not reported) who was vaccinated with a dose of FLUZONE HD (Batch number, expiration date, dose, dose in series, site of administration were not reported) via intramuscular route on an unspecified date in December 2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as autoimmune disease; hepatitis, lupus and osteoarthritis. Illness at the time of vaccination was not reported. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On unknown date in Dec 2016, following the vaccination the patient developed pain in the shoulder where the vaccine was administered and the pain moved down the arm into the fingers and both arms were then effected. It was reported that the patient was previously diagnosed with osteoarthritis and was stable for 20 years, everything was exacerbated after receiving the flu vaccine. Relevant laboratory investigations and corrective treatment was not reported. The outcome of the event was reported as Unknown. List of documents held by the sender: None.
Pt received three injections on 2/28/03. On 3/1/03 she developed headache and swelling in L arm with temp to 100.0 degrees on 3/3/03 swelling is still present from shoulder to hand. Paunful-no redness. Advised to call family Doctor-I will call mom back. On 3/5/03, pt saw MD who states swelling was normal and advised no rx. 3/12/03 I phoned mom and condition has resolved.
Arm pain; Body aches; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and general body pain. On an unknown date, the outcome of the pain in arm and general body pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm and general body pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2023029285   Additional Information: GSK Receipt Date: 21-Feb-2023 Reporter's comments: The patient received a dose of Shingrix and experienced arm pain and body aches. The reporter consented to follow-up with health care professional (pharmacy). Additional supportive information: For tolerance of second dose, refer case US2023029285.; Sender's Comments:  US-GSK-US2023029285:Same reporter
The reporter causality is not provided to FLUMIST. A pharmacist reported loss of appetite, headach, severe myalgia, extreem malaise, low-grade fever, childs, and slight nasal congestion in a female patient after received a Flumist vaccination, This 10 year old female with a history of seasonal allergies received FluMist at the reporters pharmacy on Nov 12 2004. The reported onset date for the events was Nov 13 2004. The events continued for six days with the first four days more severe thatn the latter. The patient received acetaminophen and ibuprofen for treatment and recovered on Nov 18 2004
No adverse reaction patient tolerated well, dose given from vial that was in the fridge longer than 30 days.
Approximately five minutes after 1.0 ml injection into left deltoid, patient complained of feeling like she had something in the back of throat that could not be cleared and a metallic type of taste in her mouth. Patient continued to have these symptoms but was not in any apparent distress. Patient reported at 1320 that the feeling of something in the back of her throat had reduced substantially.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Weakness-Mild, Additional Details: MODERATE/SEVERE SYNCOPE REACTION FOLLOWING DOSE 1 OF 2 PFIZER COVID-19 VACCINE.  PER PATIENT AND PATIENTS MOTHER,: BELIEVE THAT ANXIETY LIKELY CONTRIBUTED TO REACTION.  PATIENT WAS EVENTUALLY TAKEN VIA AMBULANCE TO ER AS PATIENT IMPROVED FROM EVENT, BUT CONTINUED FEELING UNWELL AT PHARMACY.  AWAITING LAB RESULTS FROM ER VISIT, BUT PATIENT HAS RECOVERED FULLY AS OF 7PM 07-27-2021 AND INTENDS TO RECEIVE DOSE 2 OF 2 WITH ADEQUATE PREPARATION/PREVENTION OF SYNCOPE.
At about 6 pm (I think) I fell asleep. I woke up at approximately 11 pm and was very disoriented to time and to surroundings.  I had no idea what had transpired since about mid-afternoon including whether I had eaten, or taken my medication.  I could not walk in a straight line and had to hold onto things to maintain my balance.  I tried to fix my medications for the weeks and became totally confused.  It was a small task that I simply could not comprehend.  I was not nauseous and was not dizzy.  I. finally ate something because I knew I should.  I felt totally wiped out.  It was as if I was having a stroke. I went to bed and by morning the symptoms had abated except for being tired and achy and a bit of a headache (which is not unusual).
Every joint in my body hurt, I could hardly get up and walk.  My toes even hurt.  Today Monday 4/19/2021 I feel much better. I also itched  at the site where I had gotten my shot.
Pt was very nervous about vaccine. Tried to pull away during administration. After shot was given pt was alert and talking. Minute later pt put his head down to look at what the pharmacist believed was his phone. Caregiver alerted team pt was not responsive. Pt had fainted. Pharmacist rushed out and revived pt. Pt was again alert and talking and answering questions. Pt was given orange juice and monitored. Pt was alert and able to function under his own power at the end of the observation period.
Stiffness in right shoulder/ stiffness at the location of the injection; Tightness in her shoulder; Tenderness at the injection site but not painful; This spontaneous case was received on 05-Sep-2022 from other non-health care professional (consumer) via Agency (reference numbers: SEQW22-04055, with additional information received on the same day from other non-health professional via Agency (reference number: SEQW22-04070) (being processed together) and concerned a 54-year-old, female patient.   The patient's medical history was not reported. The patient was not taking any concomitant medications.   On 04-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose 0.5 mL; route of administration: intramuscular (IM); anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On the same day, after receiving Flucelvax Quadrivalent, the patient experienced stiffness in her right shoulder. There was no pain, redness, or inflammation around the site, only general stiffness at the location of the injection. No treatment measures were made associated with the event.  On an unspecified date in Oct-2022, the patient experienced tightness in her shoulder and tenderness at the injection site which was not painful.    At the time of initial reporting, the patient was recovering from the event of 'stiffness shoulder'. As reported, it was still ongoing but resolving as the day went on and she was using her arm.  The outcome of the events 'joint tightness' and 'vaccination site tenderness' was not reported.  The reporter did not provide causality assessment.   This case was assessed as non-serious.  Company comment: A 54-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same day, after receiving the vaccine, the patient experienced stiffness in her right shoulder. There was no pain, redness, or inflammation around the site, only general stiffness at the location of the injection. The patient also reported tenderness at the injection site which was not painful. Causal role of the suspect vaccine is assessed as possibly related, due to plausible temporal relationship and no alternative aetiology reported.; Sender's Comments: A 54-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same day, after receiving the vaccine, the patient experienced stiffness in her right shoulder. There was no pain, redness, or inflammation around the site, only general stiffness at the location of the injection. The patient also reported tenderness at the injection site which was not painful. Causal role of the suspect vaccine is assessed as possibly related, due to plausible temporal relationship and no alternative aetiology reported.
Started getting pain in calf. Blood clot ruled out. Now in both legs with no idea why
Covid19 breakthrough.  1st Vaccine received on 01/18/2021.  80 y/o with PMHx of COPD/Home O2 dependent 3LNC, lymphoma, HTN, DVT, Arthritis persents to ED with c/o not feeling well for past few days, post nasal drip and weakness.  CXR-no acute.  O2 increased to 4L.  Pt started on Remdesivir and IV steroids.
sore throat; swollen tonsils; elevated heart rate; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), TONSILLAR HYPERTROPHY (swollen tonsils) and HEART RATE INCREASED (elevated heart rate) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), TONSILLAR HYPERTROPHY (swollen tonsils) and HEART RATE INCREASED (elevated heart rate). At the time of the report, OROPHARYNGEAL PAIN (sore throat), TONSILLAR HYPERTROPHY (swollen tonsils) and HEART RATE INCREASED (elevated heart rate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications and treatment medications were reported .
The night (Thurs) the vaccine was administered pt reports fever and chills. The following 2 days (Friday & Saturday) the patient reports itching.  She reports starting benadryl capsules 2 caps every 6-8hours. By Sunday she reports welts and swollen hands, feet, and face.
Patient came in today on 05/18/19 to report she had shivers, rash , for 2 hours . The rash is still on her body. She feels fine otherwise and will let her doctor know at next appointment.
DISCHARGE DIAGNOSES:  1. Acute on chronic respiratory failure with hypoxia secondary to sepsis realated unknown type of bacterial pneumonia of RLL (HCAP due to admission last month) 2. Pt refused treatment, requested hospice 3. Decompensated heart failure 4. Acute on chronic anemia supratherapeutic INR 5. COVID-19 positive   HOSPITAL COURSE: 80-year-old woman with a complex past medical history of TIA, CKD stage IV, COPD, chronic bronchitis, chronic back pain, chronic A. fib on chronic anticoagulation, anxiety and depression and ICM with an EF of 40% who presents via EMS for worsening shortness of breath.  She has been treated for 3 exacerbations of her COPD from October to December with marginal improvement of her symptoms.  Of late she was started on Levaquin on 12/142021 when she presented again to the emergency room on 1222 with weakness and diarrhea felt to be may be C. difficile or another enteric pathogen but those were negative.  She was hospitalized and required TCU prior to going home for which she returned 1/7/2022.  She presented very hypoxic, very weak, INR was significantly elevated and hemoglobin dropped again.  Patient was refusing any intervention of antibiotics for PNA,  to reverse her INR or replace her iron stores with a blood transfusion.  She had requested that she was ready to go to heaven and did not want any further treatment or interventions.  Her family was notified and they to agreed and supported her decision for end-of-life cares.  A family cares conference was performed with social worker, care transition team and family members and patient was placed on hospice to support her wishes. Death pronouncement was on 1/14/2022 at 2114
Patient received 2 doses of Pfizer vaccine on 2/13/21, and 3/6/21, and was hospitalized for COVID acute respiratory failure and COVID pneumonia on 12/12/21
Covid Vaccine was administered high up the left arm, near the shoulder. Upon administration, the pharmacist noted my arm "twitched".   The next day I had normal arm soreness.  One week later I woke with significant shoulder pain and could not move my arm in any direction. The pain radiated down my arm to my elbow and hand and was near constant. I was barely able to sleep, shower, dress.  I contacted my doctor a few days into the incident when the pain was not getting better and we discussed the possibility of it being SIRVA (shoulder injury related to vaccine administration). She advised taking over the counter NSAIDs (Motrin - 800mg -3X) for a week to see if it resolved.  It did slowly get better over the course of the next two weeks. I was able to wean off of the Motrin and my shoulder is now back to 99% function.
After 15 month vaccines, my son's hair fell out. He lost about 75% of his hair. No treatment as doctors are confused as to why this happened. Hair is beginning to grow back.
Sometime in November I started feeling my heart fluttering and racing for no reason. Sometimes briefly and sometimes all day. I contacted my physician and was placed on a heart monitor for 14 days and prescribed metoprolol and that seemed to work for a short period of time. I had an annual exam and the dosage was increased. I removed the heart monitor yesterday and am waiting for the Cardiologist to review the report. I also want to note that my last COVID 19 vaccine was Pfizer and the other doses have been Moderna. There were no issues with previous vaccines.
Vaccine was given on 3-13-18, two days later on 3/15/18 started with low grade fever and vomiting.
Received Sputnik vaccine on 27-May-2021 and Moderna vaccine on 26-Aug-2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received Sputnik vaccine on 27-May-2021 and Moderna vaccine on 26-Aug-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SPUTNIK V (At Argentina) on 27-May-2021.    On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received Sputnik vaccine on 27-May-2021 and Moderna vaccine on 26-Aug-2021). On 26-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (Received Sputnik vaccine on 27-May-2021 and Moderna vaccine on 26-Aug-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.   It was reported that the patient came in to receive Moderna Booster after receiving second dose of Moderna vaccine on 26-Aug-2021  Treatment information was not provided.
Syncopal episode consistent with vasovagal, immediately upon administration of HPV-9, which was shortly after administration in contralateral arm of TDaP. Prompt recovery. Then received MCV4.
Fever; Chills; Diarrhea; Feel crappy; no energy; wonder felling of all that; Feel crappy; no energy; wonder felling of all that; This is a spontaneous report from a contactable consumer reporting same event under the same product for two patients. This is one of two reports:  A 76-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: EW0169, Expiry Date: Not Reported), via an unspecified route of administration on 15Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. This is the 1st case out of 2 cases. When probed for concern consumer stated patient was seventy  (not clarified)  patient and her husband had a shot on Thursday and it is  just really not consoled (not clarified) so I mean we had the fever  chills now diarrhea a day now today is the first day We just feels like crap. No energy so I just do not know how long that last. On 15Apr2021, the patient experienced fever, chills, diarrhea, feel crappy; no energy; wonder felling of all that. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021444690 same reporter/drug/event, different patient
Patient received a booster dose from a vial that was punctured more than 12 hours before; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose from a vial that was punctured more than 12 hours before) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose from a vial that was punctured more than 12 hours before). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose from a vial that was punctured more than 12 hours before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was reported.  It was reported that the vial was initially stored in refrigerator on 29 Oct 2021 and vial was punctured on at 08:45 am and didn't undergo temperature excursion. The vial was exposed to room temperature range (8 to 25 degree Celsius/ 46  to 77 degree Fahrenheit) only while being drawn up.
When I woke up in the middle of the night on Feb 8th,  I had a headache and my body ache all over. Then since that time, for the next last month, I have had nausea, loss of appetite, extreme fatigue, swollen joints, dizziness, and malaise. It is completely effecting my ability to do basic normal activity. There are periods that I will have for a couple of hours, every other day, or on the third day, that I feel better. And then it comes back. But those periods seems to be related to food. I feel a bit like on a roller coaster. Some days I feel really bad, and other days I have a couple of hours, I feel really good. It's just up and down. I have spoke to the doctors, and they said if I am having a reaction to the booster, it's going to take 1 to 3 months to settle down. I was feeling better until I had the vaccine. I also have chronic diarrhea.
Patient received second booster shot but was not eligible. He is under 50 years of age,  has type 1 diabetes but is not  immunocompromised.
Coma; blood sugar decreased; diarrhea; nausea; Sickness; dehydration; This spontaneous case was reported by a consumer and describes the occurrence of COMA (Coma) and BLOOD GLUCOSE DECREASED (blood sugar decreased) in a 55-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.     Concurrent medical conditions included Type 1 diabetes mellitus and Vitamin B12 deficiency.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION COMPLICATION (Sickness), DEHYDRATION (dehydration) and NAUSEA (nausea). On 31-Mar-2021, the patient experienced COMA (Coma) (seriousness criteria hospitalization, medically significant and life threatening), BLOOD GLUCOSE DECREASED (blood sugar decreased) (seriousness criterion hospitalization) and DIARRHOEA (diarrhea). The patient was hospitalized from 31-Mar-2021 to 03-Apr-2021 due to BLOOD GLUCOSE DECREASED and COMA. On 03-Apr-2021, COMA (Coma) and DIARRHOEA (diarrhea) had resolved. At the time of the report, BLOOD GLUCOSE DECREASED (blood sugar decreased), VACCINATION COMPLICATION (Sickness), DEHYDRATION (dehydration) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Blood glucose: decreased (Low) Decreased.         Treatment for the events were not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-102981 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.