chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt like she had a weird taste in her mouth; Felt like she had a lump in throat; Tightness in chest; Pain in throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Felt like she had a weird taste in her mouth), SENSATION OF FOREIGN BODY (Felt like she had a lump in throat), CHEST DISCOMFORT (Tightness in chest) and OROPHARYNGEAL PAIN (Pain in throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced DYSGEUSIA (Felt like she had a weird taste in her mouth), SENSATION OF FOREIGN BODY (Felt like she had a lump in throat), CHEST DISCOMFORT (Tightness in chest) and OROPHARYNGEAL PAIN (Pain in throat). At the time of the report, DYSGEUSIA (Felt like she had a weird taste in her mouth), SENSATION OF FOREIGN BODY (Felt like she had a lump in throat), CHEST DISCOMFORT (Tightness in chest) and OROPHARYNGEAL PAIN (Pain in throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was specified.
MAGNETS STUCK TO INJECTION SITE; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: 18-AUG-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-MAY-2021, the subject experienced magnets stuck to injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from magnets stuck to injection site. This report was non-serious.
The pt experienced a prickly rash on face, ears, trunk, legs and arms. Onset approximately 10 hours post vax. The pt also experienced a fever. Saw MD on 4/25/01 to rule out strep. Strep was negative.
Very ill/very sick; Unable to speak; Pain; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very ill/very sick), APHASIA (Unable to speak), PAIN (Pain), MYALGIA (Body aches) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced ILLNESS (Very ill/very sick), APHASIA (Unable to speak), PAIN (Pain), MYALGIA (Body aches) and PYREXIA (Fever). At the time of the report, ILLNESS (Very ill/very sick), APHASIA (Unable to speak), PAIN (Pain), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
first dose/ in September 2019 and 2nd dose in December 2020.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2019).   In December 2020, the patient received the 2nd dose of Shingrix. In December 2020, unknown after receiving Shingrix, 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.  Additional details were provided as follows: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.  No information regarding the vaccine's lot number and expiry date was available.
This spontaneous report was received from other refers to a 5 year old female patient via market research. No concurrent condition or medical history was reported. On an unknown date in 2003, the patient was vaccinated with VARIVAX (Merck) (dose 1, shot, dose and route of administration not provided). No concomitant therapy was reported. On an unknown date in 2003, the patient experienced chickenpox after vaccination but not right after vaccination. The outcome of the event was reported as recovered. The reporter considered the event to be non serious and not related to suspect therapy. Additional information has been requested.
Pt was fussy and cried X 6 hours, post vax. Pt also had a fever. This child is 1 of a set of triplets.
Vaccine expired on 17-Apr-2022 and date moved to refrigeration on 29-Apr-2022 and 04-may2022 vaccine was administered; Expired Moderna Covid-19 vaccine was administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 and date moved to refrigeration on 29-Apr-2022 and 04-may2022 vaccine was administered) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 and date moved to refrigeration on 29-Apr-2022 and 04-may2022 vaccine was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 and date moved to refrigeration on 29-Apr-2022 and 04-may2022 vaccine was administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. The vial was initially stored in the refrigerator on 29-Apr-2022 and 04-May-2022. The vial did not undergo any temperature excursions. No treatment medications was reported.
Patient was given SHINGRIX vaccine instead of BOOSTRIX given in error. Contacted medical rep at GSK and she stated that there was no problem to give BOOSTRIX concurrently w/SHINGRIX. The patient did not experience any adverse effects throughout the day. BOOSTRIX was given in right arm, SHINGRIX was given in left arm.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history, current conditions and concomitant medications were not reported. On an unknown date in JUL-2016, patient received one dose of ZOSTAVAX (unknown lot number) diluted with unspecified sterile diluent as prophylaxis (product preparation error). On 03-AUG-2017 the patient was vaccinated with dose 2 ZOSTAVAX (lot # M042850, expiry date 18-JAN-2018) reconstituted with sterile diluent (lot M019891 expiry date: 11-OCT-2018)  as prophylaxis (overdose). No adverse reactions were reported. The outcome of overdose and no adverse event was unknown.
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient reported anxiety with needles, blood work, vaccines. She experienced lightheadedness, dizziness, and needed to lie down. Bendaryl was given 50 mg and patient recovered. Cold packs applied to back of neck, water given. Likely an axiety induced response.
THIS IS PT'S SECOND DOSE  (1ST DOSE WENT WELL) AND GIVEN BY A GRADUATE INTERN. AFTER RECIEVING THE 2ND DOSE, PT WENT & SAT IN OBSERVATION AREA WITH HER DAD. AFTER A FEW MINUTES. PT STARTED EXPERIENCING DIZZINESS AND NAUSEA. PHARMACIST CAME TO CHECK ON PATIENT & ELEVATED HER LEGS AND GAVE HER SOME COLD PACKS TO PUT ON THE BACK OF HER HEAD. SHE WAS ALERT AND AWARE. SHE DID NOT FAINT. PER PT SHE DID NOT EAT SINCE BREAKFAST. HER PULSE WAS CHECKED AND WITHIN NORMAL RANGE. SHE WAS GIVEN SOME WATER, APPLE JUICE AND SOME BREAKFAST BAR TO HELP WITH HER NAUSEA. AFTER A 10 TO 15 MINS, PT FELT BETTER AND STAYED FOR ANOTHER 10 TO 15 MINS. THEN DAD BROUGHT HER HOME. ON MONDAY 9/20/21 HER PCP WAS NOTIFIED OF THE INCIDENT THEN RPH CALLED DAD TO SEE HOW SHE'S DOING AND SHE IS DOING FINE.
Moderna COVID-19 Vaccine EUA  Developed tinnitus and difficulty hearing (almost as if a descent on an airplane) approximately six hours after first dose.  No action taken at this time.  Monitoring symptoms to see if they dissipate.
Temp of 103.6, severe headache, body joint pain, multiple painful open lesions in mouth and covering upoer palate
p/vax pt exp rt shoulder pain & swelling of the rt hand;MD noted that a reflex sympathetic dystrophy can occur & prescribed advil & applications of heat;pt told MD had recv pneumonia & flu shot @ another clinic in 1/98;pt recovered;
Passed out and went into convulsions, woke up and couldn?t breathe well until albuterol was administered
Extreme dry mouth -- including lips stuck to teeth.  This has continue to this date. I use Biotene dry mouth rinse and lozenges. I did not report immediately because it took a few days to associate the condition with the vaccine.  My dental hygienist stated that she has one other patient reporting this same condition.
Adverse Event is clinically suspected pericarditis.  No evidence of pericarditis on subsequent CMR performed on 10/26/2021.   See clinical summary from 10/26/21
Less than l day after receiving the flu vaccine, I abruptly started having severe neck pain from about the middle of my skull to my shoulder on my left side (the side of the vaccine.)  It was so severe that I took 1/2 dose of Skelaxin that had been prescribed to me for back pain (over a year ago) and went to bed.  The pain persisted so I used a warm compress and continued to rest thinking I must have injured my neck.  I began to suspect that the shot might be related when I started to have some chills. Today, Nov. 5, the neck pain has lessened greatly but still is present. I no longer have chills.
Sudden severe dizziness lasting under a minute in two brief episodes very close together. Then feeling nauseous, right now about 15 minutes later still feeling a bit sick.
Pt recvd Hep B vax & exp vomiting; No further details were provided;
Drowsiness; hot red swelling at injection site with soreness. Next day same symptoms but more severe with 101.4 temp. and severe itching at inj. site + dark skin & eyes with sharp pain in Right side by liver. Strong chemical urine smell upon urinating, lasting 2 days. Followed by ringing in ears; headache; stiff-neck; sore throat and now ear pain on right-side and not sleeping well along with constant headache, sore throat, stiff-neck.
Upon leaving the vaccine clinic I got shooting pain in my hands that went away in about 15 minutes. I took a shower at 6pm and noticed unusual vaginal sensitivity/pain. At 11pm I had shooting pains through out my body that would come and go. I also had severe chills and shaking. Over the course of a few hours the pain became constant and my temperature rose to 102.4. I had pain in my legs, feet, hips, back, jaw. The following day my fever stayed around 100/101 and the pain was in my hips mainly. I stayed in bed most of the day. The pain went away about 48 hours after. I had fatigue 72 hours after and I had to nap during the day for several hours.
In August 2022, after dose 3, she began to experiencing pain from Scoliosis in the muscles, headache, short of breath. She was diagnosed with Scoliosis in September 2022. She has not been able to attend school due to her symptoms. On February 10, 2023 she went to the emergency department due to a severe headache. They gave her intravenous fluids.
The caller also states that she had soreness in her arm after her first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The caller also states that she had soreness in her arm after her first dose".  Additional information: The reporter also states that she had soreness in her arm after her first dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HUSBAND CALLED TO LET US KNOW PATIENT BEGAN TO EXPERIENCE NUMBER FROM HER FINGERTIPS TO HER SHOULDER. SHE THOUGHT SHE HAS EXPERIENCED STROKE LIKE SYMPTOMS. THE NUMBNESS FEELING HAS NOT SUBSIDE.
Information has been received from a physician and a Licensed Visiting Nurse (LVN) referring to multiple unspecified patients. The patients' pertinent medical history and concomitant therapies were not reported. On unspecified dates, the patients were administered improperly stored (Oka/Merck) VARIVAX (dose, frequency and route of administration were not reported, lot # L015048, expiration date 29-APR-2017). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Extreme muscle weakness especially in the legs, mainly quads. Need to use walker to stand and once, standing it's difficult to hold and upright position. This is mostly evident after raising from a sitting position.
Temp off 100.8 at 0430 on 1-12-2021. Chills at that time, body aches. No appetite at 0900 on 1-12-2021 and no energy for rest of the day. Nauseated thru out day. Muscle aches thru out day. No further temp by 1700 on that day. On 1-15-2021 noticed redness and itching at injection site...prior to that arm was just sore-also had cough worsen on 1-12-2021. I have had cough off and on since my positive Covid in December
Rash, ErythemaMultiform & UrticariaPruritus Narrative:
received his first covid-19 vaccine of Pfizer at a local pharmacy in  . On 6/16/21,  came to see Dr.  for swelling above his collarbone that started on 6/15/2021.  Dr.  noted a 1.5-2cm rubbery mobile lymph node in the left supraclavicular fossa. Spoke with  mom,  today and lymph node is still the same size on 6/21/21. Denies any new enlarged lymph nodes or any other symptoms.  Dr.  monitoring for resolution.
Patient states hurts when area is pressed and tender when just sitting. She can feel pain when raising her arm. No treatment per patient. She has been taking tramadol for other reasons.
energetic, hard to get attention, headache, nausea, face redness, loss of appetite, angry, talking to self, imagining things, laughter outburst
patient was administered FLUZONE QIV NP post excursion with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received via health professional on 17-Oct-2022. RA number: 01324986.  This case involves a 62-year-old male patient who experienced patient was administered Influenza Quadrival A-B Vaccine [Fluzone QIV] np post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2022, the patient received suspect Fluzone QIV np vaccine at dose 0.5 ml once via intramuscular route in the left deltoid (lot: UT7701AA, expiry date: 30-Jun-2023) for Immunization post excursion with no reported adverse event (poor quality product administered) at same day latency.  It was reported that "Caller previously reported a temperature excursion See cases: 01324650 and 01324926 for details. Caller stated that she needs to report that 1 patient was administered FLUZONE QIV NP post excursion. This situation is reported as a medication error due to temperature excursion that exceeded the stability data and FLUZONE QIV NP was administered to 1 patient post excursion."  Action taken: Not applicable.  No corrective treatment was received for the event.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
My husband became very sick the day after recieving the shot. He was freezing cold. No matter what he did he could not get warm. He experienced flu like symptons for about 24 hours. This was on Saturday. On Tuesday he died. They said it was a heart attack. He was in excellent health. We had gone to the gym 3 days a week for years. He was doing Cardio on the bike and treadmill for over an hour each time. He never experienced shortness of breath and before the shot was 100 % healthy
Patient stated she had pain in left side of stomach, chest pain, trouble breathing, and chills. Patient stated the symptoms started the morning after the vaccine and have gotten worse over 4 days. Patient received the vaccine 4/20/21 and reported to pharmacy on 4/24/21. Patient stated she took Tylenol for pain. Pharmacist on duty instructed patient to visit an urgent care since her symptoms have gotten worse.
Fever & soreness, redness at site of injection, general all-over flu-like symptoms from time of injection until about 1 week later. Then, I had migraine headaches and nosebleed for a week. Then strep throat, and more severe flu-like symptoms set in and lasted about 2 weeks. Serious loss of stamina, and now having a major and painful, debilitating episode of fibromyalgia that has seriously limited my activities. FMS had been under good control for about 10 yrs, until this. I also have continuing PHN at site of injection.
shot is painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was unknown. The reporter stated that, the shot was painful. The doctor had told the reporter that, he/she can still get shingles but not as bad. The case is linked with US2021AMR222588, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR222588:Same reporter
(L) arm pain, numbness, weakness, tingling, burning, body aches, ringing in ears, seeing "floaters", have seen two doctors & a rheumatologist, as well as blood work & MRI. Very expensive & still not well! Awaiting neurology appt. & further follow ups too. (Currently treated w/muscle relaxers, pain pills & anxiety pills).
Restless sleep over night on the 26-27th.  Upon waking, I had a  uncomfortable ringing in both ears.  Nearly one week into the first week of the vaccine, the ringing remains  constant and allows only  2-3 hours of restless sleep.  As the day progresses, the ringing is louder.  Right ear doesnt seem to be affected.
BARELY WALK; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On 2021, the subject experienced barely walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from barely walk on 2021. This report was non-serious.
Redness at injection site,burning,  itching, area around injection site was raised and became rock hard solid for 24 hours. This was on the 8th day after the injection
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with GARDASIL (lot # not reported). The physician reported that " the patient experienced dizziness while still in the office and this subsided". The patient sought unspecified medical attention. This is one of several reports from the same source. Additional information has been requested.
"I'm sure there are other healthcare providers who have patients who have received [quadrivalent] GARDASIL outside of the recommended dosing schedule; This non-valid spontaneous report as received from a physician refers to unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  The physician stated that there were other healthcare providers who had patients who, on an unknown date, received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis outside of the recommended dosing schedule. The physician did not provide any additional information regarding these other patients and could not confirm any details. The physician refused to provide further information on the other healthcare providers and refused to answer further questions.  The case is non-valid due to lack of patients' identifiers.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA000257: