chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via other manufacturer and described the occurrence of bursitis in a 59-year-old female patient who received Herpes zoster Shingles vaccine for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of dizziness (the shingles shot was a horrible first dose in October, refer case US2021AMR067287). In January 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced bursitis, dizziness, limbs stiffness, inflammation, and pain in arm. The patient was treated with paracetamol (TYLENOL) and non-drug therapy (Ice Pack (No Medication)). Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the bursitis, limbs stiffness, inflammation and pain in arm were not recovered/not resolved and the outcome of the dizziness was recovered/resolved. It was unknown if the reporter considered the bursitis, dizziness, limbs stiffness, inflammation, and pain in arm to be related to Shingles vaccine. Additional details were reported as follows: Age at vaccination not reported. Patient got 2nd shot of shingles vaccine. Patient stated that post vaccination felt dizzy as a but dizzy like that for 2 days. Patent also stated she was scared to walk, from time to time she felt dizzy in the head.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR067287: Same reporter.
Numb arm; Inflamed arm; Painful arm; Having headache; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numb arm), INFLAMMATION (Inflamed arm), VACCINATION SITE PAIN (Painful arm), HEADACHE (Having headache) and NAUSEA (Nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numb arm), INFLAMMATION (Inflamed arm), VACCINATION SITE PAIN (Painful arm), HEADACHE (Having headache), NAUSEA (Nausea) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, HYPOAESTHESIA (Numb arm), INFLAMMATION (Inflamed arm), VACCINATION SITE PAIN (Painful arm), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved and HEADACHE (Having headache) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant FU: Added reporter email address and Changed outcome of the events from unknown to recovered expect for the event headache
Near death heart arrhythmia (ventricular tachycardia) heart rate about 250 could not breath dizzy faint got to ER where they had to shock my heart to prevent a cardiac arrest admitted to ICU pacemaker/defibrillator implanted cardiac device (ICD) surgically placed in my chest
started her menstrual cycle , which was about 5-6 days earlier than normal.; the beginning of her cycle was heavier than normal and she is currently still on her cycle.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 05Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POLYMENORRHOEA (non-serious) with onset 11Aug2021, outcome "not recovered", described as "started her menstrual cycle, which was about 5-6 days earlier than normal."; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 11Aug2021, outcome "not recovered", described as "the beginning of her cycle was heavier than normal and she is currently still on her cycle.". Additional information: On 11Aug2021, the caller stated that she started her menstrual cycle, which was about 5-6 days earlier than normal. The patient stated that her menstrual cycle has been a very consistent pattern. She also states that the beginning of her cycle was heavier than normal and she was currently still on her cycle. The patient stated that she had heard other women saying that they have had menstrual changes after receiving COVID vaccines as well. Caller asked what information we have regarding menstrual changes after someone receives the Pfizer COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A few hours after obtaining the vaccine, patient reported having shortness of breath, increased blood pressure and chest pain that lasted for a week. Given her history of aortic aneurism I asked her to contact her cardiologist. They had no advice on the issue. Patient had just been evaluated with an ECHO as the aneurism being stable. No follow-up is currently scheduled.
Initial unsolicited report received from a nurse on 28 Sep 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (Batch number: UI678AB, expiration date: 30 Jun 2017, dose, dose in series, route and site of administration were not reported) on 28 Sep 2016. Patient's medical history was reported that Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was gastric bypass and the patient had no known allergies. Illness at the time of vaccination was also reported as no illness as per reporter. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 28 Sep 2016, same day following the vaccination, the patient experienced weakness, slurring of speech and was feeling very sleepy. Laboratory investigations and corrective treatment were not reported. The outcome of events was reported as unknown. List of documents held by sender: none.
red itchy rash appeared the next day on lower extremities, arms, necks, back;
4/13/21 - had reaction after 2 days. Left arm site felt like fire and having severe pain. The following day when she woke up had a huge bumpy spot on both legs and had generalized pain, that evening her bottom lip was swollen. Her son gave her allergy pill and it  helped  andwent away per client. After that incident it  never happened again.
Headache and myalgia - headache developed within 3 hrs and lasted 1-2 hrs; resolved with Motrin. Myalgia developed within 12 hrs and lasted 48 hrs. Motrin and Tylenol were effective
We were explaining the yellow immunization card to her when I noticed that she was not responding.  Her eyes her not focused so I held her shoulder and asked "are you ok?"  Since we were across the counter, I asked a coworker to help run around to corner to support her to a chair.  That was when she passed out.  We got her to the chair and attempted to call 911 when patient came to and said "no, don't call 911, I am ok".  She continued to be in and out of focus for a few more times and recovered.  We asked if this happen before and she said that she get like that with shots and blood draw.  We asked if she had someone to come and pick her up but she said she will be ok and will go home after.  She sat for 30 minutes.  Once, she seemed to return to normal, she left.
sudden onset on intense pain & soreness @ site w/in 2hr;by evening pain was to the point of tears;paralyzed;
This spontaneous report was received from a male patient of unknown age. Patient's medical history and current conditions were not reported. Approximately in 2014 (reported as two and half years ago), the patient was vaccinated with subcutaneous ZOSTAVAX 19400 PFU (lot # and expiry date not reported). Concomitant medications were not reported. Approximately in August 2016 (reported as 3 months ago), the patient developed shingles, rash and blisters. The patient received an unspecified treatment for the events. The patient reported that he had a negative reaction to the medicine prescribed for treatment by his physician and was hospitalized (date, brand, manufacturer, and hospital unspecified). On an unspecified date in 2016, the patient recovered. Causality assessment was not provided. No product quality complaint was involved. The patient had called to ask question about re-vaccination, and not to report an AE. Additional information is not expected since no patient demographic and no physician demographic information was provided.
I woke up at 3:00 a.m., approximately 10 hours after receiving the bivalent vaccine, with the worst pain in my left hip.  I had to get up and take a generic Motrin because I could not stand the pain.  I also heated up a rice bag to put on my left hip and was able to fall back to sleep.  I do experience some discomfort in that hip occasionally possibly from some mild arthritis, but it seemed as though the reaction from the shot settled in the inflammation of that hip.
Woke up on April 7th with a mild headache.  As the day progressed it got worse.  Friday April 9th, went to Health Care Provider, treated me for a sinus infection.  April 15th, went back & she ordered a cat scan on my brain & everything was good.  Today still have headache, it?s not subsiding at all.  I was even given  medicine for migraines.  Not helping at all.  Health Care Provider suggested I file a report.
My immunization certified technician gave  the Pt her 2nd dose of the Moderna COVID vaccine and the Pt lost consciousness shortly thereafter (approximately 10-20 seconds). I was called into the room and when I ran in, the Pt was slumped backwards in the chair. We slowly lowered her to the floor and had her lay on her back. She was uncoscious and not breathing. I shouted for someone to call 911. I tapped her arms and shook her but she was not responding. Having no pulse, I immediately started compressions on her chest. I probably did 15 compressions and when I held my ear against her mouth, I could hear and feel air coming through her mouth. She slowly opened her eyes and my tech and I held her hand until the paramedics came. When the paramedics came, they took her vitals and she was eventually sent home per the paramedics team. She knew where she was and what day of the week it was. PharmD
The pfizer Peds vial was not mixed with diluent.  The patient did not have any reactions. Patient was observed for 15 minutues.
started as a painful arm, with itchy rash around the injection site accompanied by fatigue. Lasted for 2 days. Day 3 there is a slight rash.
ITCHING AND HIVES ONSET 2 DAYS AFTER ADMINISTRATION OF VACCINE
Patient complaint left arm pain next day. Visited doctor then orthopedic surgeon now doing PT. Pt stated patient lost 40% range of motion in left arm. Patient still doing therapy and still no results.
Wheal R arm 5:30am 10/16/09 Wheal R arm tender and bigger 8am, then at 11am red blotches all over body, abdomen and extremities (red, flat rashes) muscle spasm R neck.
pt called clinc 7APR92 c/o pain lt arm, redness @ inject site, warm to touch (4x5 cm area of redness & inflammation); tx Medrol, Seldane, Duricef;
Sore arm; chills; Body aches; Headache; This is a spontaneous report received from a contactable consumer. A 36-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247, Expiry date: unknown) via an unspecified route of administration, administered on Arm Right on 17Feb2021 10:15 (Age at vaccination: 36 Years) as single dose for COVID-19 immunization at Workplace clinic. The patient medical history and concomitant medications were not reported. The Patient had not any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not received any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247, Expiry date: unknown) via an unspecified route of administration, administered on Arm Right on 27Jan2021 10:15 as single dose for COVID-19 immunization. On 17Feb2021 at 08:00 PM, the patient experienced Sore arm, chills, body aches, headache. The patient has not received treatment for the adverse events. The outcome of events was resolved.  No follow-up attempts are needed. No further information is expected.  Follow-up (02Mar2021): Upon follow up from contactable consumer, new information included: confirmation of awareness date as 17Feb2021.
severe allergic reaction to TYPHOID VACCINE; Initial information received on 18-Sep-2019 regarding an unsolicited valid serious case received from Nurse via other company Merck (Non Licensed Partner) in the form of courtesy.  This case involves an unspecified patient of an unknown age who experienced severe allergic reaction to typhoid vaccine (allergy to vaccine), while he/she received vaccine TYPHOID VACCINE.  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 TYPHOID VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious severe allergic reaction to typhoid vaccine (allergy to vaccine) (Unknown latency) following the administration of TYPHOID VACCINE. The patient required hospitalization for this event.  (Other relevant tests included no lab data.)  Final diagnosis was severe allergic reaction to typhoid vaccine.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for severe allergic reaction to typhoid vaccine.  Information on the batch number was requested.  Documents held by sender: none.; Sender's Comments: This case concerns an unspecified patient of an unknown age who experienced allergy to TYPHOID VACCINE produced by unknown manufacturer. The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Within 24 hours of vaccine administration the patient vomited two times, and had six loose stools between May 4-5.
Headache, Myalgia, Fever, NauseaVomiting,  temp 99-100 per patient  Narrative: Patient states symptoms started about 2am 3/17/21  and are no resolving although still feeling fatigue.  Other Relevant History:
10 days post vax the pt experienced severe body ache, low grade fever with chills for 3 days and then rash for 3 days.
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  They accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage. No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 23 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2023: Live significant follow-up received contains patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:master case
I had a off and on temperature/fever, chills, total body fatigue, headache, nausea, sinus and eye pain, and intense arm pain in vaccination arm (right) the day following the 2nd vaccination dose.  On the second day my temperature regulated but I still had a headache, nausea, body fatigue. Noticed heart palpations intermediately throughout the day, while moving, lying down and sitting. On the third day still had a slight headache, slim body fatigue and noticed more consistent heart palpations.   Also started my menstruation cycle on Saturday as well.  Experienced more intense menstrual cramps than normal.  It's the fourth day now and still feel the heart palpations more sporadically than yesterday and intense menstrual cramps. Please note that I already had a irregular heart beat prior too covid but I noticed a significant increase in the occurence of the heart palpations. Normally I only have them once a month or once very few months.  This has been several times a day and on Sunday seemed to be experiencing hourly.
Three days after 2nd dose, health issues started: back pain, neuropathy up arms and chest.  Went to PCP and was sent to a neurologist saw last week.  MRI performed and formal results pending (initial report is that they did not find any tumors/masses).  Had repeat bloodwork and it showed an increase of neutrophils and WBC's.   Was given steroid after vaccine.  Continues to have back pain and neuropathy.
Administered with the vaccine which has been stored in the refrigerator for more than 30 days; Administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jul-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Administered with the vaccine which has been stored in the refrigerator for more than 30 days). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided No treatment medication information was provided   This case was linked to MOD-2021-265357, MOD-2021-265404, MOD-2021-265450, MOD-2021-265462, MOD-2021-265506, MOD-2021-265612, MOD-2021-265657, MOD-2021-265725, MOD-2021-265759, MOD-2021-265768, MOD-2021-265788, MOD-2021-265803, MOD-2021-265950, MOD-2021-265955, MOD-2021-265450 (Patient Link).
Father of patient stated that child had a full body rash. Child received the vaccines on a Wednesday and parents noticed rash on Saturday. Child was taken to an ER where she was given benadyrl. Father did not state if child had a fever or not. Only noticable symptom was a rash. Child was fine after ER visit. Rash went away.
Severe pain/erythema over deltoid/biceps axillary adenopathy. T-99.4 Rx'd ROCEPHIN 1gm & AUGMENTIN 875 mg BID x 10 d 11/6/10 - to ER, increased redness, Rx'd IV Vancomycin, added BACTRIM D.S. 1 BID.
Pt experienced an inject site rxn which included swelling, redness, tenderness & warm to the touch; Tx included warm compresses & Augmentin;
8 days with severe pain in arms upper back, neck headache, muscle aches, joint aches, neasea, flu like symptoms.
Difficulty breathing and chest pain. Elevated CRP. ON STEROIDS NOW. Suspect potential heart (or peri) inflammation.
The next day after the vaccine I developed severe fatigue so bad I couldn't work for about 2-3 days. Elevated temp, upper respiratory like symptoms. I was dizzy and my body just ached really bad all over. I had a headache, SOB and my lungs were wheezing so I reached out to my PCP and a breathing test was performed. The breathing test showed my exhale was not strong and he prescribed me an inhaler. My BP changed resulting in my heart racing at times and just feeling as if I had COVID-19 all over again. 6 months later, I have Arthritis previously but my joints were so sore so an X-ray was done but did not reveal any auto-immune issues.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and genders. Medical history and drug reactions/allergies were not reported. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored VARIVAX (Merck) (lot, dose, frequency and route not reported), Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source (1405USA000349 and 1405USA001551). Additional information is not expected.