chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT EXPERIENCING HEADACHES, CHILLS, NAUSEA, DIARRHEA FOR 4 DAYS NOW
After the vaccine, I have a sore arm for 2-3 days. I could not sleep on; I felt bad that night, after that I was very tired and fatigue, I have no energy, my hear skip beat every so often, I had palpitations. I was concerned and visited the doctor, doctor sends me for some test, and they came good. It was after the first shot that I have been very tired. My COVID-19 has been negative. I have not have COVID-19.
The Patient Requested the BiValent Form of the Vaccine and Received the Booster Instead
Started having neurological symptoms (right thigh movement in 2001 and middle finger on right hand in Nov started having pain in back of legs, sweating, muscle spasms, Jan 2002 pain started increasing depressed and confusion. Went to different Dr. was finally diagnosed with Lyme's disease. I have been on different antibiotics since may and developed cyst on the back of my tendons and big amounts and now have spondyparthropathy type ?
08/02/2005 Temperature 102 degrees tympanic fever started evening before.  Motrin 1/2 dropper every 4 hours ordered for fever.  Hives at home. 08/15/2005 temperature 98.8 degrees - follow up.  Fussy - Mother states history of Asthma, albuterol 4 times a day.  08/17/2005 - Temperature 104 degrees - axillary, Motrin give, Mother called health department 08/24/2005 to report this event.
This spontaneous report as received from a healthcare worker refers to a 4 months old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 11-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient developed large blisters on her upper chest and smaller sized blisters on her forehead and hairline on the 8th day after vaccine was administered.
Information has been received from a medical assistant, a physician and the office manager concerning a 5 year old female with no known allergies or past medical history, who on 01-MAY-2007 was vaccinated IM with a 0.5 ml dose of Zostavax instead of varicella virus vaccine live. Concomitant vaccination included a dose of MMR II and poliovirus vaccine (manufacturer unknown). It was reported that the medical assistant (also reported as the nurse) thought Zostavax was the generic for the varicella virus vaccine live. It was reported that there was no prescribing information with the Zostavax vaccine because it was frozen and someone threw it away. It was reported to be "nurse error only." Unspecified medical attention was sought. No lab diagnostics were performed. The patient was not experiencing any known symptoms. There was no product quality complaint involved. No further information was provided. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a medical assistant, a physician and the office manager concerning a 5 year old female with multiple food allergies and a possible tetanus reaction in 2003, who on 01-MAY-2007 at approximately 09:00 was vaccinated IM with a 0.5 ml first dose of ZOSTAVAX (Oka/Merck) (lot # 656412/1476F) instead of VARIVAX (MSD). Concomitant vaccination included a dose of MMR II and poliovirus vaccine (manufacturer unknown). There was no illness at the time of vaccination. It was reported that the medical assistant (also reported as the nurse) thought ZOSTAVAX (Oka/Merck) was the generic for VARIVAX (MSD). It was reported that there was no prescribing information with the ZOSTAVAX (Oka/Merck) because it was frozen and someone threw it away. It was reported to be "nurse error only". Unspecified medical attention was sought. No lab diagnostics were performed. The patient was not experiencing any known symptoms. There was no product quality complaint involved. No further information was provided. Additional information is not expected.
IMMEDIATELY AFTER INJECTION, PAIN AT ADMINISTRATION SITE. NEXT DAY EXPERIENCED BODY ACHE, SORE THROAT, COUGHING. 72 HOURS AFTER DIARREAH, FOLLOWER BY HEART PALPITATIONS & PULSE HIGH AT 102. TINGLING ON EXTREMITIES.
I developed a dry cough that would not go away. I tried an Albuterol Inhaler on January 31, 2023, and that did not work. The cough stopped February 02, 2023, and returned on February 06, 2023, with the same intensity. I was prescribed Advair and the cough subsided.
Body aches, slight fever for about an hour, lethargy, sleeplessness -- all over by hour 26
Vaccinated 5/28 (Friday).  Low grade fever resolved next day.  Two days (Sunday) later developed discomfort and burning in chest.  Thought it was heartburn.  Monday his pain began to feel more sharp and pleuritic.  Pain mostly mid-chest.  Occasional radiation to right upper chest.  6/2 noticed pain more severe when lying flat and improved with leaning forward.  Not short of breath but pain is more severe "at the top of inspiration" F/U cardiology clinic note on 6/8 states ECG from 6/3 more consistent with early repolarization.  There is a planned ECHO in the future.   Very mild case.   Hx did say he felt a little ill prior to vaccine   Clinically diagnosed with normal troponin, no cardiac MRI, mild ECG changes but with elevated CRP and chest pain
PATIENT RECEIVED A FULL DOSE (0.5ML) WHEN THE PATIENT SHOULD HAVE RECEIVED A HALF DOSE (0.25ML) BOOSTER. PATIENT MADE AWARE. NO ADVERSE REACTION REPORTED BY PATIENT.
Nausea and vomiting and diarrhea 8/34-8/27.
Sunday Sept 19 at 2:00 pm sudden hearing loss, headache, dizziness.
At approximately 12:45, patient stated she was not feeling well. Paramedic immediately assisted patient into a chair and assessed patient. Patient was fully oriented and able to follow basic commands and answer questions. Patient denied allergies to vaccine, medications, and food. Patient reported not drinking a lot of water today. Patient then stated she felt dizzy and lightheaded and stated she wanted to lay down. Paramedic placed patient into a wheelchair to transport patient to an area in which she would lay down. Patient placed in recovery position and vitals assessed. Blood pressure was 100/56 mmHg and heart rate of 60 beats per minute. Patient symptoms were not resolving. 911 was activated. Fire Department Paramedics arrived and assumed care at approximately 1:00 PM. At approximately 1:08 PM, patient left facility via ambulance and was transported to Hospital for further care.
experience a reaction/that side of the face slept; experience a hardness the left side of their face only/that bit by bit started to go down,; it was like a numbness/like been anesthetize; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experience a reaction/that side of the face slept), INDURATION (experience a hardness the left side of their face only/that bit by bit started to go down,) and HYPOAESTHESIA (it was like a numbness/like been anesthetize) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTIROXINA [LEVOTHYROXINE] for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced INDURATION (experience a hardness the left side of their face only/that bit by bit started to go down,). 27-Jul-2021, the patient experienced HYPOAESTHESIA (it was like a numbness/like been anesthetize). On an unknown date, the patient experienced VACCINATION COMPLICATION (experience a reaction/that side of the face slept). On 27-Jul-2021, INDURATION (experience a hardness the left side of their face only/that bit by bit started to go down,) had resolved. At the time of the report, VACCINATION COMPLICATION (experience a reaction/that side of the face slept) and HYPOAESTHESIA (it was like a numbness/like been anesthetize) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided. patient want be get the Booster dose .Event like a numbness, like been anesthetize, or having that side of the face slept. Both time 20 minutes after getting the vaccine on the left  arm.   This case was linked to MOD-2022-468944 (Patient Link).
Covid-19 positive with symptoms; Covid-19 positive with symptoms; sore at injection site; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 (Lot number: 3303680) at the age of 39 years as dose 3 (booster) single, administered in arm left, administration date 17Feb2021 09:30 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 27Jan2021 09:30 (Lot number: EL3247) 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: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022 17:00, outcome "recovering" and all described as "Covid-19 positive with symptoms"; VACCINATION SITE PAIN (non-serious) with onset 04Jan2022 17:00, outcome "recovering", described as "sore at injection site". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: Nasal swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, vaccination site pain.
Severe pain (unrelieved by Tylenol) at the injection site with accompanying erythema. No fever.
INFLAMMATION IN JOINTS; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (INFLAMMATION IN JOINTS) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis and Crohn's disease.    No medical history was provided by the reporter.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In April 2021, the patient experienced ARTHRALGIA (INFLAMMATION IN JOINTS). At the time of the report, ARTHRALGIA (INFLAMMATION IN JOINTS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.  No treatment information was provided.
Initial reported adverse events were headache, neuropathy, confusion, homonymous hemiopia in both eyes, sleep-wake disorder, and swelling of the brain. MRI scans also found 3 lesions on the occipital lobe of the brain. While hospitalized for 6 days for complaints of confusion, loss of vision, and nerve pain, the patient went into cardiogenic shock. During hospitalization, patient was initially treated for stroke, but then later MRI scans showed that there was a misdiagnosis once lesions in the brain were noticed and observed. Doctors then newly diagnosed the patient with acute disseminated encephalomyelitis (ADEM). Patient was then treated with high-dose steroids and IVIG. After hospitalization, patient was then scheduled to follow up with the neurologist every week then every month and then every year. Patient was also referred to a physical therapist and neuroophthalmologist.  Patient still experiences symptoms of confusion, vision loss, distorted vision, nerve pain, sleep loss, and sensory dysfunction in the present.
received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 23-year-old female patient who received HAV (Havrix 1440) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 1st February 2023, the patient received the 1st dose of Havrix 1440. On 1st February 2023, unknown after receiving Havrix 1440, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.    Additional Information: GSK Receipt date: 01-Feb-2023. Reporter's Comment: Pharmacy supervisor reported a nurse alerted her that a patient was administered a dose of Havrix which was already expired. Reporter believed this was patient's first dose in the series.  At the time of reporting, the dose has not been repeated. The reporter consented to follow-up. Additional Supportive Information: Patient received an expired Havrix vaccine, which led to expired vaccine used.
swelling in the arm; This case was reported by a physician via call center representative and described the occurrence of swelling arm in a adult 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 swelling arm. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received the 1st dose of Shingrix a while ago and experienced swelling in the arm. The reporter did not consent to follow up. The Doctor said he could not clarify if the dose was administered IM or SQ because he did not administer it and did not know date of vaccination or when the symptoms started and did not agree to follow up and said that a pharmacist had already reported this. This case linked with US2020AMR197578, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197578:same reporter
ADULT PFIZER COVID 19 VACCINE WAS INADVERTENTLY ADMINISTERED TO 5 Y.O. PEDIATRIC PATIENT.  PATIENT  DOES NOT HAVE ANY SIDE EFFECTS AS OF YET
Body aches, Chills, fatigue, joint pain, arm tingling, sneezing.  Took Tylenol and Claritin
nerves are shot; fever of 99.1 F.; her arm was "more sore"; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER (nerves are shot), PAIN (her arm was "more sore") and PYREXIA (fever of 99.1 F.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN (her arm was "more sore"). On 09-Mar-2021, the patient experienced NERVOUS SYSTEM DISORDER (nerves are shot) and PYREXIA (fever of 99.1 F.). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency. At the time of the report, NERVOUS SYSTEM DISORDER (nerves are shot) and PAIN (her arm was "more sore") outcome was unknown and PYREXIA (fever of 99.1 F.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 99.1 (Inconclusive) 99.1.         Concomitant medications on use were not provided.  Action taken with mRNA-1273 was not applicable.   This case was linked to MOD-2021-038084, MOD-2021-038078 (Patient Link).
Fever. Arthralgia. Nausea. Seen at our office following day.
It started on 12/20/2022. I had bad diarrhea. I took Imodium and it took care of it. Then the nausea started. When the Imodium wore off, I started belching really bad and the diarrhea started again. I contacted my doctor, and she thought I had food poisoning but wanted me to take a COVID-19 test. Both came back negative. She put me on a special diet and had me drink Pedialyte and a probiotic. By Christmas Eve, it was getting better and by 12/26/22, it was gone all the way.
A patient received Adacel vaccine 2 weeks apart from one another, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (MI) (Reference number- 00581018) and transmitted to Sanofi on 28-Apr-2021.  This case involves a patient (unknown demographics) who received two doses of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6628AA, expiry date: 04-Apr-2022 and lot U6767AA and expiry date: 31-Jul-2022) via an unknown route in an unknown administration site for prophylactic vaccination 2 weeks apart from one another on an unknown date (inappropriate schedule of product administration).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of actual medication error due to drug dose administration interval too short (latency same day).  At the time of reporting, 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 holders 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.
No adverse effects reported; that were improperly stored./ excursion occurred; This spontaneous non-valid report was received from a vaccine coordinator regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On an unknown date, the patients were vaccinated with improperly doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product storage error) for prophylaxis, lot number N022727, expiration date 12-JUN-2020 (strength, dosage, frequency, and route of administration was not reported). No adverse effects reported.   The administered dose of vaccine experienced the temperature excursion on 25-AUG-2018 with 30 Celsius for 3 hours. Data logger was involved. There were no previous excursions reported.  Follow up information has been received from the reporter, on 29-JUL-2019.   There was an identifiable patient who on 21-JUL-2019, was vaccinated with improperly dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product storage error). On 25-AUG-2018, the administered vaccine experienced the temperature excursion.    This is one of four reports, received from the same reporter.; Sender's Comments:  US-009507513-1907USA015535: US-009507513-1907USA016723: US-009507513-1907USA016725:
Red warm area at site of Flu and Hep A vaccine. No fever. No streaking.
After second dose (Jun, 11 2021) started to having ear pain follow by symptoms like airplane ears. First time it last for about two months. Doctor prescribed steroids and antibiotics. Second time started after booster (Dec 27, 2021). Doctor prescribed steroids for six days.
Sore arm started about 2 hours after injected. In next 2 hours body/ joint aches began.  Two hours later headache and tummy pain began- took NSAID and went to bed. Woke up in morning with 101.1 f fever- chills, tremor, tummy ache, and extreme headache.
Received MMR vaccine 9/13/06. Rash began 9/24/06 seen in office 9/26/06. Diffuse erythematous raised rash on abdomen and eyes.
5 hours after receipt of vaccine, client experienced severe HA which persists. Client experienced red body rash over majority of body associated with diaphoresis and body aches and chills. 72 hours later client began to experience shortness of breath and continued with severe chills with severe sore throat and reported to Emergency Physicians. Client was informed of dehydration diagnosis and advised to report to Emergency room. July 26 client reported to ER, received IV fluids and Toradol for pain and was discharged same day. Today July 28th, client reports HA persists, joints ache 6 on scale of 1 to 10 and severe fatigue.
Pt received Janssen COVID 19 vaccine on 03/09/2021 and received a dose of Moderna COVID 19 vaccine on 03/31/2021. Pt has not reported an adverse reaction.
administered 0.25 ml instead of 0.5 ml to uncompromised adults/wrong dose for Bivalent Vaccine booster dose (underdose); No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (administered 0.25 ml instead of 0.5 ml to uncompromised adults/wrong dose for Bivalent Vaccine booster dose (underdose)) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (administered 0.25 ml instead of 0.5 ml to uncompromised adults/wrong dose for Bivalent Vaccine booster dose (underdose)) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (administered 0.25 ml instead of 0.5 ml to uncompromised adults/wrong dose for Bivalent Vaccine booster dose (underdose)) 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 (administered 0.25 ml instead of 0.5 ml to uncompromised adults/wrong dose for Bivalent Vaccine booster dose (underdose)).    Concomitant medications were not reported.  Reported that patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster. It was reported when first administering Bivalent boosters. So, they assumed the same dose as the second booster, and they were administering 0.25 ml instead of 0.5 ml to uncompromised adults. It was reported that no adverse event was reported. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Same reporter
11 year old female patient received a 1 mL dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 11-year-old female patient who received HAV (Havrix) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 13-JUL-2023, the patient received Havrix 1 ml. On 13-JUL-2023, an unknown time after receiving Havrix, the patient experienced overdose (Verbatim: 11 year old female patient received a 1 mL dose of Havrix). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 14-JUL-2023 No symptoms reported. The reporter consented to follow up via email. 11 year old patient received 1 ml dose of Havrix, which led to overdose.