chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness, warmness, itching, area got larger over 6 days.  Reminds me of when I took allergy shots 20 years ago.  Benadryl cream for insect bites and itching.   Started out size of nickel, now the size of my palm. Plan on calling doctor tomorrow, Monday, March 22, 2021.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. Since 08-JUL-2015, the patients were vaccinated with unknown doses of (Oka/Merck) VARIVAX (route was not reported, lot # L004650, expiry date: 11-FEB-2015), which were exposed to temperatures outside of the recommended range. Concomitant medications were not reported. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had a sore throat, loss my voice, running nose, and fatigue. I saw my doctor and I tested negative for strep and COVID-19. He suggested over the counter medications. I was sick for a week. Then I got another cold 04/09/2023. I had a sore throat and sneezing. Now I believe it is turning into a mild sinus infection.
Soreness after vaccine given. Patient woke up in pain which was not relieved by ice or TYLENOL. Left deltoid is tender and swollen.
salty taste in my mouth and I can't get rid of it/metallic taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (salty taste in my mouth and I can't get rid of it/metallic taste) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02UM20A) for COVID-19 vaccination.     The patient's past medical history included Smoker (He is a smoker(1.5 packs/day)).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DYSGEUSIA (salty taste in my mouth and I can't get rid of it/metallic taste). At the time of the report, DYSGEUSIA (salty taste in my mouth and I can't get rid of it/metallic taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a licensed nurse practitioner concerning a patient of unknown demographics. The patient's medical history and concurrent conditions information was not provided. On 11-NOV-2013, the patient was administered with expired dose of ROTATEQ. The reported lot# was 0382AE and expiry date was 20-OCT-2013. No adverse effect was reported. No product quality complaint (PQC) was involved. Same reporter link: 1311USA002302. Additional information is not expected.
Father reported child had seizure like episode lasting several seconds while driving home from clinic. Called clinic and was advised by nurse to go directly to ER. Spoke with father after ER visit. Doctor did not feel he had a seizure and he was determined to be in good health.
This spontaneous report as received from a other certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patient were vaccinated with a doses of incorrectly stored GARDASIL lot # J003727, expiration date 07-NOV-2015. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt exp 36hr hx of fever following DTP/HIB/OPV; t107.4 R digital reading; 2nd night p/DTP; Impression: extreme pyrexia, poss viral synd, lt OM; rx Rocephin; Dx-Roseola
24 hrs after varicella mom called stated pt has quarter size reddened area to (L) upper arm where varicella was given
Body Ache, sore Throat, High Fever, Shivering Headache, Dizziness, Pain on site of Injection, Ichy & Bumpy for few days. Off work for 2 days - Treated with cold meds, Advil.
patient sat and waited 15 minutes with her mom after first pediatric covid vaccine they then proceeded to walk around the store and then came back after about 10 minutes and said patient had fainted and threw up in the bathroom, they got some water I had them sit for another 10 minutes at which time they were feeling better and left for home
On July 16, started with chest pains and inflammation. These continued for several weeks On Week of July 18, cardiac symptoms such as intense fatigue, rapid heart rate, indigestion, sense of fullness occurred On July 30, went to ER with heart palpitations that woke me up. Heart rate was 125 Nothing of significance was found at ER and symptoms of heart palpitations  and rapid heart rate continued resulting in impaired ability to work and function normally. On Aug 16 at 4am, woke to a buzzing and quaking in my heart. Went to ER. Nothing of significance was found at ER. Went home after 13 hours. Rapid heart rate continued off and on until August 31
Awakened 1:30 a.m. 08-06-2020.  Muscle pains all over.  Unable to sleep rest of night.  Took no med.  Felt like a bad case of flu but without fever all  that day into the night.  In bed some of the time.   Awakened 08-07-2020 feeling good but rather weakened.
pt admit to hospital 10/24/21 with COVID (tested positive on 10/17/21) s/p receiving 2 doses of Moderna 2/25/21 & 3/24/21
patient fainted after administration.  He was sweating, pale and nauseous.  EMS was called and patient was released to EMS.
Didnt get the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didnt get the 2nd dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, LEVOTHYROXINE, CHLORTALIDONE, OMEPRAZOLE and FAMOTIDINE for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didnt get the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Didnt get the 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     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.   Treatment history was not reported.
SEVERE MUSCLE ACHES; PAIN AT INJECTION SITE; Headache; Fatigue; CHILLS; FEVER; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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, expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced severe muscle aches. On 06-MAR-2021, the subject experienced pain at injection site. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe muscle aches, headache, fatigue, and chills on 07-MAR-2021, was recovering from pain at injection site, and the outcome of fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210318167 and 20210320117.
2 WEEKS POST VACCINE - JOINT PAIN BEGAN WITH EDEMA RIGHT WRIST.  EDEMA HAS BEEN INTERMITTENT.  PAIN IN JOINTS CONSTANT BUT INTENSITY CHANGES (JOINTS AFFECTED WRISTS AND KNEES).
temperature excursion for ROTATEQ; This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On 02-APR-2021, the patient's were vaccinated with inappropriate stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally lot# 1691299 and expiration date of 21-DEC-2021 (strength and dose were not provided) for prophylaxis. The temperature excursions were the following: Temperature (0.7°C) for 54 hours and 45 minutes; (8.6°C) for 47 hours 15 minutes. There was no previous temperature excursion. The call was registered due to a data logger. The adverse event report was filled precautionary.   This is one of several reports received from the same reporter
Erythema and induration in left shoulder size 20x15cm tender. Sign of infection warm, no LNS and localized area at site of injection. At site of hep A #2 and TD #3. Pt afebrile in clinic 98.2 on Tylenol. In am ? Rocephin 1gm given today with 7 day Keflex trmt (pos). pt to return to clinic if sxs increase, ER precautions given by MD>
PT developed an itchy rash 2 days after receiving 1st dose of BEXSERO vaccine. She also has arm pain, chills, fatigue, felt feverish.
Shot delivery was great, felt a little soreness in arm  that evening then started to get a headache. Developed sore throat and tiredness day later.  08 march went to ER due to headach at hospital. 12 March started to develop extreme flu like symptoms. Joints hurt. No fever. Whole body felt like skin had sunburn and hurt to touch. By 13 March it was extremely hard to walk up and down the stairs.  Took over the counter Mucilex and Vick's thera- flu for pain and headache. Went to the Clinic on 15 March because I still had symptoms. MTF put me on 10 day quarantine and tested me for covid. Test results were Negative, but stated I still need to quarantine.
11 days after 1st injection I had several hundred red itchy bumps appeared on back, neck, arms, abdomen, legs, and in mouth . Visited w/ primary Dr and was put on a steroid (prednisone), Pepcid and a steroid cream.
30 minutes post vaccine patient started to feel dizzy, stayed for an additional 15 minutes had VS done and dizziness subsided.
He states that the next day on Monday he experienced back pain that went down to his legs; He states that the next day on Monday he experienced back pain that went down to his legs; Received his second dose of the Pfizer BioNTech COVID-19 vaccine last Saturday 17APR2021 at 9:45 and reports that the next day  (Sunday) in the afternoon about 5:00, he had a fever; This is a spontaneous report received from a contactable consumer. This 56-year-old consumer (patient) reported for himself that the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) on 17Apr2021 at 9:45 for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for COVID-19 immunization. As per the description, it was reported that he received second dose of the Pfizer BioNTech COVID-19 vaccine last Saturday 17Apr2021 at 9:45. Then he reported that the next day (Sunday i.e 18apr2021) in the afternoon about 5:00, he had a fever. He states that the next day on Monday i.e 19Apr2021 he experienced back pain that went down to his legs. He reports he got over the counter Tylenol for this and reports he normally does not take medications like this. He states that with the pain, he cannot stand for long periods of time and reports that the pain was still bothering him when he stands on his feet. Caller would like to know if this has been reported by others with the vaccine. He was concerned with how long this will last and does not know if he should go see a doctor about it, as he stated he does not actually have a primary care doctor. The outcome for the event fever is recovered/resolved in Apr2021 and for the event back pain and pain in extremity was unknown.  No follow up attempts are needed. Information about lot/batch number cannot be obtained.
Within 10 minutes after the vaccination, there were some body tremors and dizziness, then she lost vision, hearing and ability to speak for a few seconds, followed by difficulty breathing and a feeling of her heart ?jumping out of chest.? Eventually, she recovered, but her right hand (not the injection arm) still has involuntary tremors, which has not gone away.
On 11/20/10 patient noticed a red area over (L) upper arm, slightly swollen & warm to touch. By 11/22/10 when patient came into clinic, area had expanded to measure 8.5 cm length, 8.0 cm wide, slightly raised. Also c/o itching.
Pt was given FLUZONE immunization in error, instead of PREVNAR 13. Pt has not experienced any adverse symptoms as of yet. Per moms description.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Aug2021 13:15 (Lot number: FC3181) at the age of 17 years as dose 1, single and administered in arm left, administration date 06Sep2021 14:30 (Lot number: FD8448) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "if Covid-19 prior vaccination: Yes" (unspecified if ongoing), notes: if Covid-19 prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious) with onset 14Aug2021 14:00, outcome "unknown", described as "elevated heart rate"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "Since receiving Covid-19 vaccine started to have an elevated heart rate. After first dose it was in high 90 then after second dose it was in 100th". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, condition aggravated. Additional information- It was reported that patient had no medical history. No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a physician via company representative refers to a 13 year old male patient. On 27-JAN-2014, the patient was vaccinated with first dose of GARDASIL lot # J012212 (dose and frequency were not reported) intramuscular. Concomitant therapies included FLUARIX and T-DAP. On 27-JAN-2014, 2 hours after receiving the vaccination the patient experienced rash from head to toe. The patient sought the medical attention and reported to the physician during the follow up appointment to receive the second dose of GARDASIL. It was reported that on an unknown date, the patient visited the unspecified emergency room and received steroids (manufacturer unknown). On 28-JAN-204, the patient recovered from rash from head to toe. It is unknown if the patient received dose two and/or three in the series of GARDASIL. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
at apt 12/8/22 the pt was giving the incorrect dose .25ml of the moderna bivalent vaccine, i called the pt to make him aware, pt has a f-u apt schedule in 1 month and can repeat vaccine booster at that time. approved by provider
One hour after my vaccine I started to feel lightheaded as if I was going to pass out, I was sweating hard and had shortness of breath, I felt flush as though I was hyperventilating. The next few days I felt fatigued and was experiencing extreme body aches as though I was ran over by a truck. I was breast feeding at the time and my baby seemed to be experiencing the same symptoms I was having. I was an initial participant in the first vaccine roll outs so I did not escalate my care to a physician beyond a telehealth appointment.
Shingles in the right upper arm; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   On 2nd December 2019, the patient received the 1st dose of Shingrix and PREVNAR. On 5th December 2019, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and Prevenar in her left arm. The patient  was diagnosed with shingles in the right upper arm. No additional information was provided. The reporter consented to follow up.
Patient started having swelling and redness at site of immunization on 07/29/19, 3 days after injection. The area measures 5 cm x 9 cm and is tender to touch and painful when she walks. Patient and mom advised to use MOTRIN for pain, ice pack for swelling and BENADRYL if itching begins.
After the vaccine patient complained about change in vision not able to see things, sweating ,dizzy. As per patient request called 911.By the time ambulance came patient felt better and did not want to go to hospital . As per patient he felt okay after 20 minutes or so..
Started with foot drop and loss of coordination in the left foot. Over the next couple days I continued to have difficulty walking without putting thought into each step. Soon I had numbness in my right foot. By Halloween I could hardly walk for more than twenty minutes without loosing much control. I also experienced incontinence. After seeing a doctor I was sent to the ER for an MRI. The results came back irregular. I also experienced extreme fatigue during these episodes. Eventually I gained control in my left leg but to date I am still experiencing numbness in my right foot. I also developed optic neuritis in my right eye near the middle of November. The fatigue still continues to come and go.
pre beat regarding my heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Apr2021 09:00 (Lot number: ER8734) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood Pressure" (unspecified if ongoing); "COPD" (ongoing); "congestive heart failure", start date: Aug2010 (ongoing); "Cardiac arrest", start date: 03Jul2020 (unspecified if ongoing), notes: 5 days in hospital, went in 19Aug for ablation ended up with a inflatable pace maker/defibulator; "Cholestrol" (unspecified if ongoing); "tired", start date: Mar2021 (unspecified if ongoing); "Blood Thinner" (unspecified if ongoing). Concomitant medication(s) included: DOXYCYCLINE taken for pneumonia, pulmonary oedema; AMLODIPINE taken for blood pressure measurement, start date: 15Apr2021 (ongoing); ASPIRINE taken for blood viscosity increased (ongoing); ATORVASTATIN taken for blood cholesterol (ongoing); CARVEDILOL taken for blood pressure measurement (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Time: 09:00 A.M, Anatomical Site: Left arm , Route: Intramuscular, Batch/Lot Number: EN6208), administration date: 12Mar2021, when the patient was 60 years old, for COVID-19 immunization, reaction(s): "Got sick", "pain in in the injection site", "Lung infection", "fluid in left lung"; Flu shot (Location: Left arm, Location: pharmacy), administration date: Jan2021, for Immunization.  The following information was reported: EXTRASYSTOLES (non-serious) with onset 15Apr2021, outcome "unknown", described as "pre beat regarding my heart".  Additional information: Vaccination facility information was available. Vaccination Facility Type: Other. Patient got a flu shot at (pharmacy name) over 2 month prior to my first COVID shot. To whom it may concern, patient would run the events out foe you as best as patient could. Patient got the first dose 12Mar2021, worked at a food bank with an old guy that had a cold. Got sick 25Mar went to urgent care 26Mar to 31Mar and was prescribed doxycycline for fluid in my left lungs. Got 2nd dose 02Apr2021 still felt sick. Saw (Name withheld) 15Apr and found out about pre-beat regarding my heart. Got prescribed amlodipine for blood pressure in Mar as well but patient quit taking it after 5 days cause it made patient felt tired. Patient's question was pre-beat tied to vaccine? Thanks for the shot, Patient was glad get it, just thought maybe you should know my circumstances. No relevant test patient was aware of. As patient had stated in previous letters. Patient's prebeat condition occurred in the same time period as starting amlodipine. Patient was not a doctor or a scientist, it might have been your shot maybe not if patient had my choice between current condition and slowly having the air deprived from May. Patient would choose the shot as patient believed vaccine saved lives.  No follow-up attempts are possible. No further information is expected.
Given shingles shot at clinic on 9/27/13. Had a bad allergic reaction. High fever on early morning of 9/28/13. Felt headachy, nauseous, and left eye teared for about 12 hrs.
PATIENT CAME IN TODAY AND DESCRIBED HAVING A SWOLLEN, PAINFUL UPPER ARM. AREA OF REDNESS/SWELLING AS OF 8/11/22 WAS LOCALIZED TO ABOVE LEFT ELBOW AND WAS APPROXIMATELY 4IN x 4IN. PATIENT SAYS PAIN AND SWELLING WERE EVIDENT THE MORNING FOLLOWING IMMUNIZATION BUT THAT OVER THE LAST COUPLE DAYS HAD DECREASED. GAVE PATIENT OPTIONS TO EITHER WAIT AND WATCH FOR FURTHER SWELLING OR TO CONTACT HER HEALTH CARE PROVIDER FOR A VISIT. TOLD HER WE WOULD WRITE UP VAERS FOR DOCUMENTATION. PATIENT AT THIS TIME DECLINED TO SEEK FURTHER MEDICAL ATTENTION.
Pfizer-BioNTech COVID-19 Vaccine EUA tiredness, headache, muscle pain, chill, joint pain, fever, nausea, felling unwell, random body itch...  All present, to moderate degree (i.e.- 5 on a scale of 1 to 10 )
When they are trying to give the medication to the patient and pulling the syringe out the medication is leaking. Caller would like to know if the patient received the proper amount of dose or not; When they are trying to give the medication to the patient and pulling the syringe out the medication is leaking. Caller would like to know if the patient received the proper amount of dose or not; When they are trying to give the medication to the patient and pulling the syringe out the medication is leaking. Caller would like to know if the patient received the proper amount of dose or not; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A 41-year-old female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), in Sep2023 as dose number unknown, single (Lot number: HH7595) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE DISCHARGE (non-serious), INCORRECT DOSE ADMINISTERED (non-serious), SYRINGE ISSUE (non-serious) all with onset Sep2023, outcome "unknown" and all described as "When they are trying to give the medication to the patient and pulling the syringe out the medication is leaking. Caller would like to know if the patient received the proper amount of dose or not".   Additional information: The pharmacist called and stated that they are giving the new COVID-19 vaccine (BNT162B2) to the patient. When they are trying to give the medication, and pulled the syringe out, the medication was leaking. The pharmacist would like to know if the patient received the proper amount of dose or not. Further stated that when they tried to administer the vaccine, it was leaking out. The pharmacist wanted to know if the patient should receive another dose.
2mm by 2mm induration at injection site with pain in deltoid. Patient is having headaches and some horseness. No fever has been present.