chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very little strength; Joint pain; Headache; Fatigue; Chills; Nausea; Temperature of 102; Loss appetite; Intense body aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Very little strength), DECREASED APPETITE (Loss appetite), MYALGIA (Intense body aches), ARTHRALGIA (Joint pain) and PYREXIA (Temperature of 102) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Asthma since 1950. Concomitant products included ALBUTEROL SULFATE from 01-Jan-2020 to an unknown date for Wheezing.   On 18-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021 at 4:00 PM, the patient experienced DECREASED APPETITE (Loss appetite), MYALGIA (Intense body aches), PYREXIA (Temperature of 102), CHILLS (Chills) and NAUSEA (Nausea). On an unknown date, the patient experienced ASTHENIA (Very little strength), ARTHRALGIA (Joint pain), HEADACHE (Headache) and FATIGUE (Fatigue). On 21-Mar-2021, DECREASED APPETITE (Loss appetite), MYALGIA (Intense body aches), PYREXIA (Temperature of 102), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, ASTHENIA (Very little strength), ARTHRALGIA (Joint pain), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 102 (High) Increased.         No treatment information was provided.  Patient stated that, he have been left with from having been sick from the corona virus is reoccurring pain (and cramping) in his left hand.   This case was linked to MOD-2021-054796 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Updated reporter information, patient demographics, historical condition, vaccine information, concomitant medication, additional event (Decreased appetite) and outcome of the events was updated. On 15-Jul-2021: Updated past medical history (Corona virus in December 2020).
Right after the vaccine my tongue got thick and dry, it was extremely hard to swallow and l lost my voice and it went extremely raspy.  I could still breathe but my bp raised to 150/100.  I was sent to be assessed by the EMTs which everything was fine but I sat with the for evaluation for less than an hour and left.  On the drive home all sylivia returned and the symptoms subsided.
Fever (hot) at the injection site; Rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Fever (hot) at the injection site) and VACCINATION SITE RASH (Rash at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Fever (hot) at the injection site) and VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE WARMTH (Fever (hot) at the injection site) and VACCINATION SITE RASH (Rash at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case is linked to case 2018SA302788 (same reporter). This case involves a 6 months old female patient (reported as 6 month 25 day old) who received single 0.5 ml of vaccine FLUZONE lot UJ005AD (expiry date: 30-Jun-2019) instead of 0.25 ml on 22-Oct-2018 by error. The patient's past medical history and concomitant medication were not provided. It was a case of actual medication error due to Product selection error and accidental overdose. Patient was given 0.5 ml of FLUZONE QIV in error instead of 0.25 ml as the administering physician did not know needle size and gauge. No adverse event occurred. 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 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.
Sharp pain in all of left thigh. Bad burning, tingling, numbness can't sleep from burning pain.
Vaccination at 1500, within 30 minutes Patient complained of redness and itching, initially at face, back and arms.  Diphenhydramine 50 mg administered and kept Patient for 1 hour observation.  VS at 1530:  BP 132/84, HR 99, oxygen saturation 96%.  Lung sounds clear to auscultation anteriorly.  Over the course of 1 hour, itching decreased slightly but no further symptoms developed.  VS at 1630:  BP 138/98, HR 90, oxygen saturation 95%.  Lung sounds remain clear to auscultation anteriorly.  Patient was cleared to leave at 1645.
Initially I had arm pain at the site of the injection.  Over time I noticed I had shoulder pain that was causing me to lose sleep.  About a month from the shot I setup up an appointment with my orthopedic group.  Before my appointment time I thought my arm was feeling better so I cancelled my appointment.  The pain seemed to come back even worse so in April I scheduled an appointment with the ortho doctor.  Ortho doc thought maybe I had a torn rotator cuff so he ordered an MRI.  The MRI came back negative for structural damage but apparently the doctor was able to determine the bursa was inflamed.  I received an injection (cortisone?) today and have a followup in two weeks.
I felt itchiness throughout my body, starting coughing and wheezing, throat felt tight and closing.  I used my epi-pen and then went to the ER where I was given prednisone and antihistamines.  The following day I was still having trouble breathing, tightness in my chest, wheezing, trouble walking due to not being able to breathe and symptoms persisted. I went to urgent care where I was given a prednisone booster and was sent back to the ER.  ER observed me and sent me back home.  I went back to urgent care and was prescribed higher dose of prednisone and singular.  One week later,  I still had trouble breathing, coughing, and tightness in my chest, my doctor prescribed albuterol solution with nebulized to use 4xs a day. 2 weeks later symptoms worsened when I started walking more and was prescribed another round of prednisone and continue albuterol.  Currently, 7 weeks later, my asthma has not gotten better, still wheezing, coughing, unable to walk without struggling to breathe.  My doctor has now referred me to a pulmonoligist.
pt recv vax SEP95 & failed to seroconvert;no further details were provided;
patient developed DVT shortly after recieving the vaccination.  diagnosed on 4/15/2021 symptoms started about one week prior to this.
The patient was seen for COVID-19 vaccinations. The patient identified he had not previously received a COVID-19 vaccine. Upon return to the healthcare facility, when documenting, healthcare provider notes the patient had previously received the Moderna vaccine, but had not received the second dose.  The healthcare provider discussed with staff pharmacist at the healthcare facility who confirms the patient would not require any additional doses of the COVID-19 vaccine, and that the series is now complete. The patient was made aware of the above information. He verbalizes understanding and was instructed to contact healthcare provider at the healthcare facility should he develop any issues in relation to this event.
Varicella Information has been received from a physician and a school nurse concerning an 10 year old male who on 27-FEB-1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was also noted that the patient was vaccinated with a dose of measles virus vaccine live (Ender-Edmonston) (+) mumps virus vaccine live (Jeryl-Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 12-FEB-1996 and 02-NOV-1998. A school nurse reported to the physician that between 24-MAR-2005 and 09-MAY-2005 the child developed a mild case of break through varicella with less than 50 lesion. Unspecified medical attention was sought. The outcome was recovered. A product quality complain was not involved. No additional information is expected.
Pt's daughter called on 10/5/12. Pt c/o itching and redness at site of vaccination. Redness went up to neck. Arm was swollen and painful. Pt contacted MD - took ibuprofen, refused BENADRYL. Followed up with pt 10/6/12. Pt doing better, would not see MD.
Pt recv vax on 11/21/98; on 11/23/98 pt exp exacerbation of MS sx w/ burning sensation from hips to feet; numbness, fatigue, weakness, itching & aphasia; pt to see neurologist 12/23/98
Pt vaccinated with DTP/OPV noticed lt deltoid red & slightly swollen. Mother noticed 3x5 area from the Lt shoulder to lt elbow area with a pale area.
Inner ear was dislodged; Head would go woo while turning in bed; Red spot , big red lump; A little tired; Bad episode of vertigo; Dizziness / "a little dizzy"; Headache; Slight fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO POSITIONAL (Inner ear was dislodged), VERTIGO (Bad episode of vertigo), VERTIGO (Head would go woo while turning in bed), DIZZINESS (Dizziness / "a little dizzy") and ERYTHEMA (Red spot , big red lump) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022IN20A and 022IN20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tooth extraction (bad episode of vertigo starting 12Mar2021 right before a dental extraction.).   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced MYALGIA (Body aches). On 23-Jan-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Slight fever). On 04-Mar-2021, the patient experienced DIZZINESS (Dizziness / "a little dizzy"). On 12-Mar-2021, the patient experienced VERTIGO (Bad episode of vertigo). On an unknown date, the patient experienced VERTIGO POSITIONAL (Inner ear was dislodged), VERTIGO (Head would go woo while turning in bed), ERYTHEMA (Red spot , big red lump) and FATIGUE (A little tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; Physical therapy (Vestibular Therapy) for Vertigo positional and Manual therapy (2 maneuvers were completed in vestibular therapy) for Vertigo. At the time of the report, VERTIGO POSITIONAL (Inner ear was dislodged), VERTIGO (Head would go woo while turning in bed), ERYTHEMA (Red spot , big red lump), HEADACHE (Headache), PYREXIA (Slight fever), MYALGIA (Body aches) and FATIGUE (A little tired) outcome was unknown, VERTIGO (Bad episode of vertigo) had resolved and DIZZINESS (Dizziness / "a little dizzy") had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown (normal) Reports having CT scan and other test that were normal..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported.  Patient  was seen at the emergency department, neurology specialist office and received vestibular therapy.  Action taken with mRNA-1273 in response to the event was not applicable.   Patient had 2 doses of vaccinations, reports episodes of dizziness have returned starting last week   This case was linked to MOD-2021-166578 (Patient Link).
Her arm started to swell; Her arm became red; She had severe fatigue; She wasn't feeling well; Her arm started to hurt again; Her arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm hurt), PAIN IN EXTREMITY (Her arm started to hurt again), MALAISE (She wasn't feeling well), PERIPHERAL SWELLING (Her arm started to swell) and VACCINATION SITE ERYTHEMA (Her arm became red) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes since an unknown date.  On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Her arm hurt).   On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Her arm started to hurt again). On 25-Jan-2021, the patient experienced MALAISE (She wasn't feeling well).   On 26-Jan-2021, the patient experienced PERIPHERAL SWELLING (Her arm started to swell), VACCINATION SITE ERYTHEMA (Her arm became red) and FATIGUE (She had severe fatigue).   At the time of the report, PAIN IN EXTREMITY (Her arm hurt) had resolved and PAIN IN EXTREMITY (Her arm started to hurt again), MALAISE (She wasn't feeling well), PERIPHERAL SWELLING (Her arm started to swell), VACCINATION SITE ERYTHEMA (Her arm became red) and FATIGUE (She had severe fatigue) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant product use was not provided by the reporter. No treatment information was provided.
Syncope: After instructed to sit in the lobby for a 15 minute observation time, the patient walked 20 feet over to my consultation window after a couple minutes reporting lightheadedness/dizziness and requested a seat in my vaccination room. Upon making my way through the pharmacy to open the door the patient collapsed from a standing position to the floor. The patient regained conscience almost immediately after the fall and reported no injuries. EMS was also on scene by coincidence, shopping. The patient declined their assistance.
About 4 weeks after receiving 2nd Gardasil shot, had sudden periods of severe dizziness, extreme fatigue, and malaise followed by muscle twitches and headaches.  All blood tests, chest x-ray and head MRI came back normal. Immediately after 3rd Gardasil shot, experienced facial numbness for 10 hrs.  Also experienced recurring periods of dizziness, fatigue, and malaise with continued muscle twitches.  Blood tests continue to be normal.  Affects seemed to improve about 1.5 months after 3rd shot, but relapse of symptoms occurred within 2 weeks and symptoms persist.  Only treatment so far is vestibular physical therapy to try and relieve dizziness. 1/6/09-records received-office visit 7/31/08-C/O hypertension, bruit thyroid gland. Seen on 8/24/08 C/O 2 weeks of intermittent neck and bilateral shoulder pain. 9/4/08-Last few month C/O heavy menstrual cycles. 11/11/08-Continues to C/O heavy period. assessment menorrhagia.
11NOV92 devel sl fever & leg soreness lt leg; fever appeared to subside & recurred again 12NOV92 in evening; about 9PM became limp, unresponsive, face turned blue taken to ER by ambulance & returned home 1245AM; dx febrile seizure;
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (dose, lot number and expiration date were unknown), which were following a temperature excursion. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
continued sleeplessness since then , fatigue, nightmares ( never had previously, headaches
pt was given vaccine.  Pt was stated to be feeling "whoozy and dizzy" upon vaccination.  After a few seconds, he falls forward and hits his head against the blue curtain(separator) and then to the ground.  I ran to the pharmacy to grab an epipen and ran back. She helped me prop him up a bit and i was ready to inject the epipen but we noticed he was snoring.  It became clear that he had a fainting spell and not an allergic reaction and he came to in about 10-15 seconds after the fall.  We had him sit up right and drink some water and wait in the pharmacy for another 30 minutes until his roommate could come and pick him up.  He refused an ambulance though it was offered.  We made him walk a straight line and checked his balance before letting him leave.  Also recommended that he be checked for a concussion
Had shingles vaccine useless got them/suspected vaccination failure; Got them and scratched my self raw; scratched; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles vaccine useless got them/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got them and scratched my self raw) and scratch (Verbatim: scratched). The outcome of the vaccination failure was unknown and the outcome of the shingles and scratch were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and scratch to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and scratch to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that he/she had shingles vaccine, useless. The patient got shingles and scratched himself/herself raw.  The reporter further stated that big pharm at it again and just screwed the public and what they done best, look at phoney. The reporter further stated that never bought the crap he was selling and covid was the flu. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
A consumer report has been received. The report concerns a 40 year old, male consumer, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 22-NOV-2014. The patient experienced sneezing and nasal drip which started on 22-NOV-2014. FLUMIST Quadrivalent was discontinued on 22-NOV-2014. The patient recovered from the event of sneezing and nasal drip on an unspecified date. The report was considered to be non-serious.
Fever 103F (axillary) for 36 hours, post vax. Mom reported this when administering next immunizations on 4/20/01.
Customer was shopping around the store after flu shot and came to the counter complaining that the center of his chest was hurting. Pharmacist asked if he was having difficulty breathing. Patient responded he was breathing fine but his chest was bothering him and he wanted to lie down. Patient sat down near pharmacy and pharmacist called manager over. Patient said the pain started to get progressively worse therefore making it difficult to breathe so EMS was called. Patient BP 110/69 with pulse 80. Patient states only takes Lisinopril and has never had an ADR to vaccine before. Once EMS arrived, patient stated he felt better when lying on bed. EMS brought patient to ER.
Erythema and induration R deltoid, increased over 90mm X 90mm.
Itching, dry cough, sore throat, headache, sinus congestion, eye redness, myalgia, wheezing inspiratory, tickle in chest, child pruritus.  Symptom started 4 hours after injection. A 36 year old male patient with no known allergies, had received an intramuscular injection in the left deltoid and 4 hours later, he experienced tickle in chest, dry cough, sore throat, injected sclera, myalgia, chills, injection site soreness and rash on his left hand.  It was worth noting that the patient had enlarged tonsils but was not ill at time of the vaccination.  The concomitant treatment was not provided. The patient had already received previous doses of Influenza vaccine. The patient received diphenhydramine hydrochloride (Benadryl) per os as corrective treatment.  The patient recovered on an unspecified date.
Painful cramping center of chest, upper diaphragm moving to the right; Darkened stool; Nausea; Chills for only one night; This is a spontaneous report from a contactable consumer (patient himself). A 73-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 11:45 (Batch/Lot Number: EN2601) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 17Mar2021 11:45 (Batch/Lot Number: ER2613) as single dose for covid-19 immunisation. Medical history included myasthenia gravis, double hernia repaired at age 15 and thymectomy on Jun1973. The patient's concomitant medications were not reported. The patient experienced painful cramping center of chest, upper diaphragm moving to the right, darkened stool, nausea and chills for only one night on 02Mar2021 21:00. No treatment was received for the events. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient received some other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. No allergies to medications, food, or other products. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (post vaccination-Nasal Swab) on 21Mar2021. The outcome of the events were recovering.  Information about batch number and expiration date has been requested.
lump on her left clavicle and posterior cervicle; This is a spontaneous report from a contactable pharmacist (reported for herself). A 16-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the reported stated that the patient experienced a lump on her left clavicle and posterior cervicle. No other symptoms experienced. The outcome of the event was unknown.  Information about Lot/Batch number has been requested.