chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body is swollen; in the whole body, mostly on my shoulders, and i have like balls on my both; body ache on mi interior; Very bad headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (body is swollen), HEADACHE (Very bad headache), MYALGIA (Body ache), ARTHRALGIA (in the whole body, mostly on my shoulders, and i have like balls on my both) and MYALGIA (body ache on mi interior) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included THYROID for Thyroid disorder.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced HEADACHE (Very bad headache), MYALGIA (Body ache) and MYALGIA (body ache on mi interior). On 11-Apr-2021, the patient experienced SWELLING (body is swollen) and ARTHRALGIA (in the whole body, mostly on my shoulders, and i have like balls on my both). At the time of the report, SWELLING (body is swollen), HEADACHE (Very bad headache), MYALGIA (Body ache), ARTHRALGIA (in the whole body, mostly on my shoulders, and i have like balls on my both) and MYALGIA (body ache on mi interior) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is taking Tylenol since 10-Apr-2021.
No additional AE.; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a medical assistant, referring a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.  On 15-AUG-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot number 1879870 has been verified to be a valid lot number, expiry date 16-OCT-2023) indicated as prophylaxis (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccine was stored at a temperature of 34.5 Fahrenheit (F) for a time frame of 1 hour 7 minutes and 0 seconds, there was  a previous temperature excursion of 66. 7 F for 13 hours 52 minutes and 0 seconds.  No additional adverse event were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA005936: US-009507513-2210USA005917: US-009507513-2210USA005916:
I WAS GIVEN  Remdesivir BY IV THERAPY. IT GAVE ME SEVERE PAIN IN AND AROUND THE AREA OF MY LIVER. IT HAS CAUSED MY LUNGS TO TEND TO FEEL STIFFER AND I GET RESPIRATORY INFECTIONS EASIER.
This case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age group was not provided, but was selected adult as per the vaccine indication. The health care professional (HCP) reported that the patient developed shingles after receiving initial dose of SHINGRIX. No further details were available at the time of report.
10 days after receiving the MMR vaccine my daughter became very fatigued and had excessive thirst, drinking 4 or more liters of water per day. On day 11 she developed a severed pain behind her eyes. She said it felt like the connection between her eyes and her brain were being squeezed. The pain increased when she turned her head or turned her eyes. The fatigue and thirst continued. She also had low appetite. On evening of day 12 I called her doctor. Ibuprofen was recommended. On the morning of day 13 I spoke to the doctor again and she suggested we go to the emergency room. She had a thorough examination but they decided not to do a CT scan. They gave her IV TORADOL and compazine to reduce any inflammation and pain. The medication made her headache better but made her very sleepy for the next 15 hours. On day 14 she developed a flat red/pink rash on her face, neck and chest. As well as raised bumps and redness on her hands. The lower part of her face was puffy. She also complained of a mild sore throat. Her nose was runny for days 13, 14 and 15. On day 15 she complained of a sore on the side of her tongue. I finally looked at on day 16 because it was making it hard for her to talk or eat. It was white bump with a blue center. On day 16, 3/3/19, she started having pain in the joints of one finger on each hand. On day 17 she woke up with both hands being puffy and all finger joints being very painful. Each symptom resolved in about 3 days.
At 1715, Patient stated she felt tightening of her chest. At 1724:  BP= 137/81, HR= 78, O2 Sats RA= 98%, RR= 18, Temp= 35.7;  at 1754: BP= 152/94, HR= 77, O2 Sats RA= 97%, RR= 18, Temp= 36.3
I got a shot for shingles and after a year / I got the shingles./ suspected Vaccination failure; I got a shot for shingles and after a year / I got the shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient got a shot for shingles and after a year or so experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Patient tested positive for COVID-19 after completing the full Pfizer vaccine series, 65 days after 2nd dose.   Patient received 2nd dose of COVID vaccine on 1/19/21 .   Tested positive on 3/25/21.   NOT hospitalized. My son was sent home from school due to exposure with a positive COVID classmate. My husband then tested positive the following day.  "nasal congestion, runny nose, headache, new loss of taste/smell symptom onset date: 3/25/2021"
1/5 (Wed): No initial reaction immediately after injection, other than minor itching at injection site 1/5 (Wed Night): Pounding, rapid heart beat night of injection date-- to the degree that it was noticeable while trying to fall asleep 1/6 (Thurs): Soreness at injection site, which is consistent with previous doses. No other symptoms of "illness" during day. Just feeling of being "wired"-- much like night before while trying to fall asleep.' 1/6 (Thurs Night): Evening brought "expected" side effects: Some tiredness, and fever-like mental state. (Foggy, slow minded.) 1/7 (Friday): Fever-like and flue-like symptoms gone. Strange soreness in arms and hands while cleaning.  1/7 (Friday Night): Noticeable pressure and mild discomfort in chest.  1/8 (Saturday): Mild pressure and discomfort in chest persists. No shortness of breath though. "Lump" in chest noticeable when bending over to touch toes (stretching). Occasional cough, but might just be dry air.  Will see health care professional if symptoms not gone by Monday, 1/10/2022.
Patient received 1st dose of Pfizer on 4/8/21 Lot EW0151 and was registered through employer with DOB.  Patient received 2nd dose of Pfizer on 4/27/21 Lot EW0172 with same birthdate.  After she received vaccine, vaccinator questioned her further about date of birth and patient admitted birthdate was not correct but a different year - meaning she was 15 at time of vaccination.  Patient had no adverse effect from receiving vaccines but is under the age authorized for.
second dose > 35 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose > 35 days after first dose) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 032H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose > 35 days after first dose). On 06-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose > 35 days after first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment details were provided
Dizziness, burning in chest. Reports hx of anxiety, burning in chest/throat lightheaded.
4 hours after shot experienced extreme fatigue, achy body and headache. 8 hours after shot experienced green colored stool - still had green colored stool up to 36 hours after shot. Injection site still sore 3 days after shot.
Grandmother brought child in and the right thigh was red and swollen at the site of injection. It is red all over the thigh with a quarter sized bruise at injection site. The pt experienced limping. Use Benadryl and cold compresses if needed. By the next day, the child was doing much better. After a few days the child was ok.
patient received a expired dose of FLUBLOK QUADRIVALENT vaccine/ No AE; Initial information was received on 14-Sep-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case is linked to cases 2020SA251862 and 2020SA250807. (Same reporter)  This case involves a 44 year old female patient who received an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided. The patient did not receive any concomitant vaccine.  On 12-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [prefilled syringe, lot number: unknown to reporter (UTR) as the expired vaccines were taken away before reporter could write down, expiry date 30-Jun-2020] via an intramuscular route at the left arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used. (latency: On the same day of vaccination)  At the time of report, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
One dose in Mar2022, other in 25Feb2023; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old male patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22nd September 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in March 2022 ).   On 25th February 2023, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 25th February 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comment: The patient came in this Saturday was given a another dose of Twinrix. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  Additional Supportive Information: The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.
persistent, low-level tinnitus in both ears, but more pronounced in left ear.  it's particularly noticeable when I'm in a quiet place (e.g., in bad at night).  also have more sensitivity to loud sounds, like music, TV at high volume.
Hospitalized 11.20.21;  COVID-19 positive (11.19.21);  Fully vaccinated Admission Date: 11/20/2021 Discharge Date: 11/21/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Generalized weakness COVID-19 HOSPITAL COURSE: PT is a 84 year old male with PMH of spinal stenosis, chronic pain and weakness, PVD, HTN, DMt2 long term insulin use, afib on eliquis who presented with acute generalized weakness and fall at home. He was sent to ED for evaluation.  Patient tested positive for COVID-19 and reported mild symptoms.  No hypoxia.  Patient was agreeable to regeneron infusion and received this on 11/21.  He is vaccinated. Patient had mild renal insufficiency and received 1 L of IV fluid with improvement.  He was eating and drinking well. Patient's outpatient physician and pain physician were concerned patient may require MRI due to fall and increased lower extremity weakness.  However, weakness most likely secondary to COVID and dehydration. Patient's weakness significantly improved during his stay back to his baseline.  Patient had no concerning findings or focal findings on neurological exam warranting urgent MRI.  Patient also severely claustrophobic and would require general anesthesia and would not recommend this unless urgent given COVID-19.  This was explained to family and patient who were agreeable with holding off on MRI and can be pursued outpatient on a routine basis.  He was seen by occupational therapy who recommended to discharge home with assist.  Home healthcare was set up by care management. Patient was noted to have low normal blood sugars during admission.  After extensive conversation regarding his home diabetes regimen it was found that patient is taking toujeo10-20 units in the morning and 10-20 units at night but not tell how he is deciding this. Able to state he would not give this for a low blood sugar.  On the med list in his wallet he has written toujeo 120 units nights. On outpatient office notes toujeo 50 units nightly noted.  Discussed significant concerns regarding how patient is outpatient is administering Toujeo with patient, wife, and daughter over the phone.  Discussed he is likely having low blood sugars at home with his hemoglobin A1c of 6.5.  They note he has lost weight over the last 2 years which may be contributing to this.  Will discontinue Toujeo on discharge.  Patient should continue to check his blood sugars twice a day and bring log to his family physician to further discuss his diabetes regimen.  He can continue Jardiance and Trulicity. Patient also admits to being very forgetful but states but ?I never for get my medications?.  Discussed that with patient's short-term memory deficits this is a concern and he would benefit from neuropsych testing.  Recommend outpatient neuropsych testing and information provided in depart.  Discharge instructions reviewed at length with patient, wife, and daughter over the phone.  Patient will discontinue Toujeo.  Home health care set up as well. Patient discharged home in stable condition. Discussed one of the daughters attending all doctors visits.
Irregular Bleeding; Fatigue; heavy spotting; This spontaneous case was reported by a patient and describes the occurrence of INTERMENSTRUAL BLEEDING (heavy spotting), MENSTRUATION IRREGULAR (Irregular Bleeding) and FATIGUE (Fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) injection for Birth control.    Concurrent medical conditions included Type 2 diabetes mellitus and Anorexia (eats "like a squirrel"). Concomitant products included VITAMINS NOS and CYANOCOBALAMIN (B12-VITAMIIN) for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) (unknown route) at an unspecified dose. On 03-May-2022, the patient experienced INTERMENSTRUAL BLEEDING (heavy spotting) and FATIGUE (Fatigue). On an unknown date, the patient experienced MENSTRUATION IRREGULAR (Irregular Bleeding). At the time of the report, INTERMENSTRUAL BLEEDING (heavy spotting) and FATIGUE (Fatigue) had not resolved and MENSTRUATION IRREGULAR (Irregular Bleeding) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) not anemic.         It was reported that patient was due again on 17-May-2022 for DEPO-PROVERA dose but decided to quit birth control all together because it was making her feel terrible.  It was reported that patient had been having heavy spotting and fatigue since 03-May-2022 and states that it was like having general, regular periods every day and has been bad since 03-May-2022. Patient had consulted with her HCP for the events.  Patient reported that she had all three Moderna Covid-19 vaccines and had complaints of irregular bleeding that resolved after a couple of months.   Patient reports that she read that the above could happen with the Moderna Covid-19 vaccine.  No treatment medication were reported.
Severe vomiting, diarrhea, pain in injection site, tired feeling, drowsiness, sleeping more or less than usual, headache, muscle pain, joint pain outbreak of psoriasis effecting 30% of body, cough with production of phlegm,
Aching joints/she had knee joint pain/she had hip joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Aching joints/she had knee joint pain/she had hip joint pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021H21B and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Aching joints/she had knee joint pain/she had hip joint pain). At the time of the report, ARTHRALGIA (Aching joints/she had knee joint pain/she had hip joint pain) outcome was unknown.            No concomitant medications was reported.  No treatment drug details was reported.   This case was linked to MOD-2021-406400, MOD-2021-406408 (Patient Link).
Mother calls in to Health Dept. today & states that child got her vaccines here on 12-16-11 & on 12-26-11 started running a fever & on 12-27-11 child started get red rash on face, chest & abdomen area. Has given TYLENOL for fever which has gotten up to 101.0 only once. States rash does not itch & it does not seem to bother her.
A Pfizer covid-19 vaccine was inadvertently administered for dose #2. Client had received a Moderna covid-19 vaccine as a 1st dose on 02/04/2021.
Pain started in bicep mover to tricep the joint of scapula, moved back to bicep. Little better limited arm movement. Treated with ibuprofen.
The child was vaccinated with the Pfizer-Child Covid-19 vaccine, everything was mixed correctly.  Unfortunately, we missed calculated the 10-week BUD window and gave the vaccine outside the BUD by five days.  Spoke to the child parent.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccine, the physician told to patient 2 days ago of reporting date, could get shingles. It was possible had shingles on left side of head and neck. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
10 minutes after vaccine right arm started hurting, got warm all over, slightly light-headed. 0945 HA started. B/P 118/78, P-87, 02 sat 99%ra,r-18. Reports ate a small snack this am but not a meal. Pt given water offered snack but refused. 1000 started feeling better reports ready to go home and has a driver in the car. b/p 120/76, p-83, 02 sat 99%ra, r-18. Pt instructed to f/u with MD as needed.
Received TWINRIX A and B on 30 Oct. and 6 Nov. at your office. Mild joint and muscle pain started 5 days after first shot and progressed to  severe joint pain in shoulders, knees, elbows within a few days of second shot. Called office on 15 Nov. Nurse had not heard of such reaction and could not provide help. Pain became debilitating while I was out of country. Visited my primary care doctor day after return, 25 Nov. A 5 day course of prednisone gave some relief but severe pain gradually returned after course ended. Doctor put me on stronger longer second prednisone course after 2nd visit to his office on 4 Dec. which also provided relief. Tapering down prednisone now and joint pain is coming back. Extensive blood tests show all normal except inflammation markers which are all way above normal. I have gone from active athletic to almost not being able to function. I am calling GlaxoSmithKline to report adverse reaction Monday. Maybe they have some answers. Any information you can provide to help would be greatly appreciated as well.