chrisvoncsefalvay/vaers-outcomes huggingface dataset:
change in voice; blurry vision; light headed; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurry vision), DIZZINESS (light headed), FATIGUE (fatigue) and DYSPHONIA (change in voice) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VISION BLURRED (blurry vision), DIZZINESS (light headed) and FATIGUE (fatigue). On an unknown date, the patient experienced DYSPHONIA (change in voice). At the time of the report, VISION BLURRED (blurry vision), DIZZINESS (light headed), FATIGUE (fatigue) and DYSPHONIA (change in voice) 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 reported.  No treatment information was provided.
pt had chicken pox the same evening of the day was vaxed; 1 wk later devel pneumonia along w/idiopathic infantile spasms;
Patient presented to clinic on 5/6 with erythematous maculopapular rash on neck, chest, abdomen, legs and arms. She was afebrile at the time. No relief with OTC benadryl. Patient given IM Kenalog injection. Patient presents 5/7 with worsening rash, fatigue, low BP, and fever. Rash has same distribution. BP 88/50, and temp 37.4C upon arrival to clinic. No evidence of Stevens-Johnson syndrome. Patient was then transferred to hospital for fluids and treatment. At hospital, patient was given IV dexamethasone and benadryl with fluids. Discharged with oral prednisone. Patient came in for follow up on 5/11 feeling a lot better and rash has faded.
This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On 04-DEC-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N015477 with expiration date 18-MAY-2019, for prophylaxis (dose and route of administration were not reported). Concomitant therapies included sterile diluent which was properly stored. No adverse effects were reported. It was stated that the vaccine was exposed to a temperature between 15 to 46 Fahrenheit degrees with a time frame of 63 hours. No previous temperature excursion was reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1712USA002726: US-009507513-1801USA001110.
Headache, UrticariaPruritus, Sore arm on day of vaccination 1/20. Chills & fatigue starting 1/22.  Narrative:  Per nursing report: "first dose of Moderna on 1-19-21. ... On Wednesday she c/o sore arm. Friday she states had swelling and itching of right arm with headache and chills. ...She states the rest of the weekend and Monday she did not feel well and felt fatigued and sluggish so she called in. ...She is at work today and states feeling better."
Mom had immunization record showing previous dose about 6 years ago and reported no reaction at that dose.  They were instructed to stay in the building for at least 15 minutes after administration.  About 50 minutes after administration, mom called back to say she thought his throat was swelling.  It felt like a lump in his throat.  He had just finished a chai tea for the first time, and she wasn't sure which was causing the reaction.  I instructed to take him to the ER immediately.   Upon follow up after ER discharge, mom said she thought symptoms started about 30 minutes after administration.  He was also feeling nauseous, but she had given him ibuprofen on an empty stomach and wasn't sure if that was due to vaccine or ibuprofen.  He was treated, monitored, and sent home from ER and doing well.
Increasingly severe indigestion, low-grade fever, flu-like symptoms, tingling fingers, anemia, upper body joint and muscle pain (hips, backbone/spine, neck, shoulders, throat, jaw, cheekbones) progressing from mild to severe upper body muscular pain (neck, jaw, shoulders, arms) fatigue, anemia.  May through July diagnosed with Lyme Disease.  Treated with Doxycycline 21 day prescription 08/19/2003.  Currently seems to be recovering, but no recovered.
Kinrix that was stored outside of the guidelines within the package insert; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: Kinrix that was stored outside of the guidelines within the package insert). The outcome of the incorrect storage of drug 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: 18-Jul-2023 The health care professional called to state that a patient was administered a dose of Kinrix that was stored outside of the guidelines within the package insert.  The reporter stated that the dose reached a maximum temperature of 10.8 celsius.  The entire excursion lasted was 1 hour 3 minutes 0 seconds. The patient demographics were unavailable at this time.  The reporter noted that no other adverse events were occurred.  No additional adverse event or product quality complaint. The patient received a dose of Kinrix after temperature excursion, which led to incorrect storage of drug.
Dose 2 a month late; This case was reported by a pharmacist via sales rep and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received TWINRIX 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. Concomitant products included TWINRIX. On 12th January 2022, the patient received the 2nd dose of TWINRIX 1 ml and TWINRIX Pre-Filled Syringe Device. On 12th January 2022, 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Twinrix, later than the recommended schedule, which led to lengthening of vaccination schedule. No adverse event was reported but the patient did not return on recommended schedule for dose 2:
waking throughout the noc if rolling over on arm; loss of nl use of arm w/o pain; sharp, shock like pain when moved certain ways; cannot reach up; caved in look under arm pit; difficult time putting on coat or clothes;
pt devel t104 & a  rash all over body; taken to ER pt was given Pediaprophen & examined by MD;
PERIOD CAME 6 DAYS EARLY; CHILLS; ARM PAIN; HEADACHE; EXTREME TIREDNESS; FEVER; PAINFUL SHOT; STRANGE TASTE IN MOUTH WHEN GETTING SHOT; TROUBLE WITH WORDS; TROUBLE WITH HEARING; TROUBLE WITH SMELL, BURNT TOAST; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 22-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-OCT-2021, the patient experienced strange taste in mouth when getting shot, trouble with words, trouble with hearing, trouble with smell, burnt toast, experienced chills, arm pain, headache, extreme tiredness, fever, and painful shot. Laboratory data included: Body temperature (NR: not provided) 100.7, 96.6 shortly after shot. On an unspecified date, the patient experienced period 6 days early. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme tiredness, and the outcome of strange taste in mouth when getting shot, painful shot, fever, trouble with words, trouble with hearing, trouble with smell burnt toast, chills, headache, arm pain and period 6 days early was not reported. This report was non-serious.
I was in the exam room for a total of 20 minutes. I was issued the hepatitis B shot in my left deltoid. The nurse stepped out of the room. Within about 3 minutes affects from the shot set in. My hands immediately became sweaty and my heart rate on my garmin watch dropped from 80 to 41 BPM. I passed out and fell off the exam table onto the floor. I woke up on the floor alone in the room. I repeatedly tried to get myself off the ground. Finally did and layed back on the exam table. Nurse finally came back, i notified her what had happened. She said "i dont know" and sent me on my way to leave the clinic.
Within 15 minutes of vaccination, pt complained of trouble breathing and an itchy throat.  Within a few more minutes the patient was completely covered in hives and facial swelling was noted.  30 minutes after vaccine was administered 0.3 ml of epinephrine was administered.  Within 60 minutes of vaccine administration, patient was feeling better and swelling and hives had subsided.
Patient was receiving Pfizer Bivalent vax during his in-clinic appointment at clinic instead of Moderna 2nd dose to complete his series. Pfizer Bivalent vaccine incorrectly administered for the primary series.   Patient is aware and feels good, no symptoms. Per CDC guideline: Do not repeat dose.
VASOVAGAL SYNCOPE:  After receiving HPV9 vaccine, family was advised to wait 15-20 min.  Patient and his Gfa did NOT wait and proceded to check out.  At that time, patient became dizzy and fainted.  Gfather could not catch him and he hit his head on the wall at check out.  Per staff who witnessed his fall, he was immediately conscious tho sl disoriented.  After about 10 min he was able to stand and was assisted to room#2 where he was placed supine on the exam table.  Examined by NP.  HR 80, RR 28, BP 112/68, SaO2 98%.  Lungs clear.  HR steady. Abrasion to left forehead--c/o pain with palpation.  Mild swelling.  Ice pack applied.  Abrasion to left lower outer orbit.  Fundascopic bilat WNL.  Palpation to left orbit - denied pain.  EOM equal.  PEARLA.  Patient  reported nothing to eat since about 7a this morning (poptart).  No lunch.  After resting about 10 minutes, was able to sit up without dizziness.  Given 2 oz coke.  Tol well.  Denies HA with exception of where abrasions are.  Tylenol 15 ml given po.  Was able to stand without dizziness.  Gfa instructed to monitor for next 6 hours, rousing every 1-2 hours if he naps.  Incr pain, vomiting, change in LOC, or concerns--to call on-call number or go to ER for eval.  Gfa agreed.  Was able to walk unassisted to vehicle and denied ongoing dizziness
Patient received the Pfizer vaccine 28 days following the administration of the Moderna vaccine. The Moderna vaccine was given at a different location than this dose of Pfizer. Patient sat for the  recommended 15 minutes for observation. He stated that he felt fine and left for home with his father. Both the patient and his father were told that getting one dose of each is not ideal but that there is no medical concerns associated with this. Told the potential side effects are the same for both vaccines. Told that there is no need for a second Pfizer. Will still be considered fully vaccinated in 2 weeks.
Shaking of the hands and legs while being in extreme pain and uncontrollable. It started in the morning and got worse overtime throughout the day.
3 days after vaccine given, patient had small red bumps on his leg. The pedi had told us if he had a reaction it would be around the 4rd day. By the next morning the spots were much worse-larger and darker red. By the evening of the 19th the large red spots covered his face, arms, and legs. His joints were so swollen he couldn't stand he started running a fever of 102 F. By April some spots had faded, others blistered and popped, and scabbed. It was not until the middle of September that all spots were gone. Our pedi diagnosed it as HSP and says it's unrelated but I disagree I have lots of pictures if you would like to see.
Patient experienced debilitating weakness and nausea. She was bedridden for two full days before recovering.
Pt was very apprehensive, didnt want to get the vaccination. I calmed him down and had him relax when I gave him the shot. He even made the comment it wasnt as bad as he thought. Then he told me he was feeling lightheaded. So I got his dad to come into immunization room with him. As soon as the dad came in, he told the dad he was lightleaded and then he started stooping down on the chair and his eyes rolled backwards, he started falling to floor and the dad caught him. His arms got stiff like a board.  This all happened in a matter of a few seconds...as I was about to have the intern call 911...patient woke up, and was like what just happened to me. It was like he woke up from fainting.  He looked a little pale. After 20 minutes, to make sure he was ok. His parents decided to take him to ER to make sure hes ok.
Claimant alleges she was issued a Pfizer COVID-19 vaccine. The next day, she had a fever, trouble breathing, and had to be taken to the ER.
Looked like a cellulitis; Hypersensitivity; A spontaneous report was received from physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis and hypersensitivity.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unspecified date, prior to the onset of the event, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced side effects that almost looked like a cellulitis, a medically significant event and would like to know if hypersensitivity occur to this patient or if they develop it.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, cellulitis and hypersensitivity was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
head, neck, facial swelling and redness with burning skin.  Nausea, body aches.
Achy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PANTOPRAZOLE and ZOLPIDEM for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Achy). At the time of the report, MYALGIA (Achy) had resolved.            No treatment medications were provided.   This case was linked to MOD-2021-042699 (Patient Link).
"Sore Throat with golf ball in it", Headache, slight fever, generalized aches/pain. Seen at Urgent care and given Toradol for pain. Chest and lungs clear at examination but later reports shortness of breath.
This is a 59-year-old female patient with past medical history significant for hypertension, hyperlipidemia, insulin-dependent immediately just type II, tobacco use disorder, and chronic kidney disease who presented to the emergency department with left sided extremity weakness, left sided facial weakness, and slurred speech for 1 day.  Patient states that she woke up at 3 AM to find that her left side was weak stating that her leg "would not move".  Patient stated that it is associated with left-sided diminished sensations as well as slurred speech that started at the same time.  She noted left-sided numbness. She denied having any headaches, visual disturbances, vertigo, chest pain, palpitations, presyncope, or syncope. She denies having any recent fevers or chills.  The patient is a daily tobacco user. Of note, the patient received her second Pfizer COVID-19 vaccine yesterday.
Myalgia CHILLS, FATIGUE, ARM SORENESS Narrative:  Other Relevant History:
suspected vaccination failure/had the shot and now has a bad case of shingles; bad case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In August 2022, unknown 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 20-Aug-2022 Reporter's comment: The case was received from the patient's wife via interactive digital media. The reporter reported that she hate to burst the bubble, but getting the shot did not guarantee that you will never had them. The patient had the shot and now had a bad case of shingles. The reporter stated that they thought they were safe too, surprised. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
I got the "Covid arm" twice, after first and second injection.  First did not come on until day #11 after vaccination, second only after 3 days.  Besides this were chills, extreme tiredness, a sort of "brain fog," general aches and pains with the second shot and knees weak and feeling like a rag doll which lasted a couple days.  Several episodes of urgent diarrhea with the first dose.  First "Covid arm" lasted 8 days, the second just 4.  With both, there was an almost constant feeling of queasiness.
Right arm-entire circumference of upper arm swollen, erythematous, slightly indurated. Treated with Keflex 250 mg TID  X 7d
Patient complaint of "warm feeling" in chest and feeling anxious. Nurse checked vitals, monitored for 15 minutes and check vitals again. Vital signs within normal limits. Patient stated warmth in chest completely resolved. Patient monitored for 30 minutes total, the discharged to home.
fever 104 started 9SEP97;drowsiness;sleeping all time;ATX 2X day for 5 days started on 9SEP97;
GENERAL BODY PAIN; VACCINE EXPOSURE DURING PREGNANCY; FEVER; CHILLS; This spontaneous pregnancy report received from a consumer concerned a 31 year old female. The patient's weight, height, and medical history were not reported. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021, the subject experienced general body pain. On 13-APR-2021, the subject experienced vaccine exposure during pregnancy. On 13-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced chills. The date of the subject's last menstrual period and expected delivery date were not reported. Laboratory data included: Pregnancy test (NR: not provided) positive. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from general body pain, fever, and chills, and the outcome of vaccine exposure during pregnancy was not reported. This report was non-serious.
Fever immediately after the H1N1 Mist that lasted overnight and went away the following morning.
Left shoulder pain since 2/6/21 Scapular winging since 2/11/21 Left shoulder weakness 2/11/21 Muscle fasiculations since 2/28/21
My blood sugar plummeted below 40 continuously for four days. My endocrinologist was made aware as was my PCP.
developed a little fever of 100.7; slight diarrhea; arm was sore; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm was sore), PYREXIA (developed a little fever of 100.7) and DIARRHOEA (slight diarrhea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included MULTIVITAMINS [VITAMINS NOS], LISINOPRIL, EZETIMIBE, SIMVASTATIN (VYTORIN) and FISH OIL (OMEGA 3 [FISH OIL]) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 23-Jan-2021, the patient experienced PYREXIA (developed a little fever of 100.7) and DIARRHOEA (slight diarrhea). On 22-Jan-2021, PAIN IN EXTREMITY (arm was sore) had resolved. On 23-Jan-2021, PYREXIA (developed a little fever of 100.7) and DIARRHOEA (slight diarrhea) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Body temperature: (High) 100.7 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included Ibuprofen.