chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hard time hearing; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (hard time hearing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOACUSIS (hard time hearing). At the time of the report, HYPOACUSIS (hard time hearing) outcome was unknown.            No relevant concomitant medications were reported.  No treatment details were reported.
THE NEXT DAY POST ADMINISTRATION PATIENT FELT THE ARM WAS VERY SORE TO THE PAIN SHE HAD TO TAKE A LOT OF TYLENOL. SHE WAS ALSO TIRED AND HAD LOW GRADE FEVER. AS OF 10/03/21 SHE SAID SHE ALSO HAD REDNESS AROUND THE INJECTION SITE.
Diarrhea & t103 R 15APR92, low grade temp through 19APR92; Seen by MD 22APR92 for continuing diarrhea & temp dx virus;
G62.9 NEUROPATHY 2/1/2023 ASHD NATIVE CORONARY ARTERY W/O ANGINA PECTORIS
7 days after injection, injection site began to swell, have heat, and redness.  Immune reaction progressed to 3" x 5.5" area of redness and heat on day 10. Lymph node on left arm were swollen and causing pain and pressure down the left arm from day 9 to day 11. Beginning on day 10, increased OTC anti inflammatory/pain relief medications.
was extremely sore to the touch; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (was extremely sore to the touch) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (was extremely sore to the touch) and HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, PAIN (was extremely sore to the touch) and HEADACHE (Headache) 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 Concomitant medications were provided
3 days after 1st shot Severe joint pain (Similar to RA),  muscle pain, Headaches that lasted from 4/9/21 to 5/13/21 when I was taken to the hospital where it was found I had a  Venous Stroke. Multiple doses of steroid,  and Tylenol until the stroke, then I don?t recall what I was given in the hospital but now I am on 80mg of staton, 81mg of aspirin, 1mg of folic acid
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient had no pertinent medical history and/or drug reactions/allergies reported. On 30-AUG-2016 the patient was vaccinated with ZOSTAVAX lot # M018453, expiration date: 28-JUN-2017, .65 ml, subcutaneous in an unspecified arm. Concomitant medication was not provided. The pharmacist reported that the patient had received an unspecified flu vaccine in the opposite arm on 30-AUG-2016. On an unspecified date, the patient experienced pain at the ZOSTAVAX injection site which wakes her up at night. The patient sought medical attention and it was reported that she contacted her pharmacist on 18-NOV-2016. No treatment was given for the event. The outcome of the ZOSTAVAX injection site pain which wakes her up at night was reported as not recovered/not resolved. Causality assessment was not provided. A PQC was not involved. No further information was provided. Additional information has been requested.
Febrile illness, headache, < diarrhea starting 5 days after injection.
Excessive Vomitting all sunday.  Minor Soft Stool. (also ate a half a can of peanuts. Doctor contributes vomiting to the peanuts as I have been having stomach issues for about 2-3  months. Doctor thought it was a good idea to report it anyway.)
1/5/21: FEVER T-MAX 103.5F, SWEATS, CHILLS, MALAISE, GENERAL MUSCLE PAIN, SEVERE HEADACHE, NAUSEA, VOMITTING, DIARRHEA, DIZZINESS/ VERTIGO, BLURRED VISION, RINGING EARS, SORE THROAT, INCREASED HEART RATE, INCREASED BLOOD PRESSURE, O2 SATURATION DECREASE, SEVERE CHEST COUGH ? LASTING OVER A MONTH  7/27/21: T-MAX 104F, SWEATS, CHILLS, MALAISE, GENERAL MUSCLE PAIN, SEVERE HEADACHE, NAUSEA, VOMITTING, DIZZINESS/ VERTIGO, BLURRED VISION, RINGING EARS, SORE THROAT, INCREASED HEART RATE, INCREASED BLOOD PRESSURE, O2 SATURATION DECREASE, JOINT PAIN ? LASTING OVER 3 DAYS
Fever; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. In March 2020, 12 hrs after receiving Shingrix, the patient experienced fever and upset stomach. On an unknown date, the outcome of the fever and upset stomach were recovered/resolved.   It was unknown if the reporter considered the fever and upset stomach to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix. The patient experienced upset stomach and fever. The adverse events were resolved 4 days later. The reporter did not share which arm the vaccine was administered. The reporter did not consent to follow-up. For tolerance of a 2nd dose of Shingrix refer case US2021AMR063193.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063193:Same reporter.
Abd pain - vomiting/nausea. Redness/lacy rash to injection site & warmth. Fever to 101. Brief period of SOB. Increased blood sugar to 413 then mid 200s. Presence of ketones in urine due to N/V. Rx ZOFRAN, bland diet.
Guttate Psoriasis, small red/pink spots all over abdomin, given steroid cream from GP, have not completed treatment, unable to keep under control at this time.
chills, swelling & redness @ site w/induration 4.5 x 7cm; nodes not enlarged; tx w/Cephaloxin;
Patient received TWINRIX vaccine w/o incident. After walking away from immediate shot area, patient lost consciousness and fell.
Recieved yellow fever vaccine and oral typhoid vaccine on 6/20/08.  Mother called on 6/27/08 and left message with RN, stating that patient was running fever of 101F and was complaining of achiness and headache when she took the oral typhoid and had just finished the last of the doses that morning.  Mother stated that this happened with each typhoid dose.  RN then came to me with the information and we looked at the side effects for each vaccine on the VIS's and returned mother's called telling her that the symptoms patient was having were within the possible side effects for the vaccines according the VIS but as we were not able to see her daughter if she felt that she needed medical attention to call her daughter's Dr or take her to the ER.  I spoke with the mother 7/1/08 and she stated that she spoke with a friend who is Dr of infectious diease and he told her to bring patient to ER where she was admitted and given IV antibiotics, mother was not sure which antibiotic she was given but patient was discharged 6/30/08 to home and was apparently doing well.  Mother was at the gym and she was unable to talk long. 7/21/08-records received for DOS 6/27/08 presented to ED with E/O fever and not beeling well. Symptoms began today, loss of appetite, muscle aches, fatigue, skin rash. Throbbing global headache associated with nausea. Clinical impression:fever possible typhoid.
after receiving first vaccination, she has had 3 Office visits with reports of headaches to L temporal area and elevated BP. at 3rd OV, she has now been diagnosed w/ HTN and medications started.
herpetic rash on right hand. acyclovir 800mg 5 times daily x 7 days
stability information for Adacel, exposed to 27Farenheit for more than 3 hours and the vaccines were also administered, no AE; adacel was given to patient of 18 months of age, no AE; Initial information received on 01-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA172697, 2020SA174880, 2020SA174885, 2020SA174942, 2020SA174941, 2020SA174940, 2020SA174906, 2020SA174932, 2020SA174911, 2020SA174910 and 2020SA173110(same reporter).  This case involves 18 months old male patient who was vaccinated with the DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], that was exposed to 27 Fahrenheit for more than 3 hours and the excursion occurred due to temperature of the refrigerator was manually changed.it   Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 14-May-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE  (lot U6621BA and expiration date :22-Mar-2021) via unknown route in unknown administration site as prophylactic vaccination.  It was an actual medication error case due to Product storage error temperature too low and inappropriate age at vaccine administration.  No adverse event reported at the time of reporting.  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 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.
This patient is experiencing chills with sweating going in cycles. No coughing but does feel slightly short of breath. His wife was just diagnosed with Covid 19 yesterday. They have both been vaccinated.. symptoms starting 10/26/21
Information has been received from a consumer concerning his 15-month-old daughter with no known allergies and no past medical history who on 03/07/2002 was vaccinated in the left arm with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #640562/1374L). There was no concomitant medication and no illness at the time of vaccination. Shortly after vaccination, the pt developed a high fever of 103 degs. F for several consecutive days, was extremely tired and had an extremely large swollen gland behind her neck that was hard. It was reported that she could barely keep her head up. The pt was rushed to the ER several times and saw her physician several times. Follow-up info received from a physician indicated that the pt's symptoms began on 03/12/2002 when the pt developed a fever, was slightly less active and had a decreased appetite. On 03/26/2002 the pt had a stiff neck and a "swollen gland, 2 cm firm left post auricular area". An ultrasound of the gland (date unknown) showed 3 solid nodules without fluid. On 03/15/2002 a lab/diagnostic study "sygm" was reported as normal. Lab tests performed on 03/26/2002 revealed a white blood cell count of 23.6, a blood segmented neutrophil count of 70%, a blood hemoglobin of 10.6, a whole blood hemacrit of 31, a blood culture which was negative and a urine culture was also negative. Studies performed on unknown dates revealed that a chest X-ray was negative and a body temperature measurement of 102.5. The pt was treated with amoxicillin trihydrate (+) clavulanate potassium (Augmentin) 600. The fever resolved on an unknown date. The gland did not change in 8 days, but was nearly resolved by 04/08/2002. It was reported that there was a history of a cat being in the pt's house and the doctor noted possible "cat scratch disease," but there was no history of a definite scratch by the cat. Ultimately the pt recovered, date not specified. Additional info is not expected.
fever; headache; This case was reported by a nurse via sales rep and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were unknown.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. No other information was provided. Consent to follow up was provided.
Skin rash, red bumps started at legs and spread to trunk. CALADRYL lotion. Oral BENADRYL and TYLENOL.
Pt had mild rash to bilateral upper extremities/forearm w/burning sensation. Benadryl 25mg PO given @ 1248. BP 119/76; HR 76; RR 18. 1255 rash on forearms resolving.  Pt was stable and no rash at 1pm & was released from vaccination site
In January 2022 after the first booster I had a head cold for about three weeks.  I had a headache.  I was also exhausted and have been the same fatigue as of today.  I also had back pain.  In May I was in bed for three days with back pain and abdominal pain.  I went to the ER and I learned it was my appendix.   I was put into ICU because I also had septicemia.  They put drains in my belly.  They did not remove my appendix.  I continued with drainage tubes after returning home and had them removed after about a week.  I have been less functional than normal since then.  My knuckles hurt.  My hip also hurts so bad I can barely walk.
Patient developed erythema multiforme on 06/12/2005.  Fever for 3 days prior to rash.  Fever at time of visit 98 or 99.  Benadryl 25mg/10ml by mouth every 6 hours as needed.  Benadryl creme apply to rash.
Initial unsolicited report received from a consumer via other company (Pfizer) (manufacturer report number: 2017279885) on 05-SEP-2017. This case involves a 79-year-old male patient who was vaccinated with a dose of TETANUS TOXOID (batch number, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medication were not reported. On an unknown date, following vaccination, it was reported that patient developed allergy to tetanus toxoid. Lab tests and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
MAKING HIGH PITCHED SOUND, THROAT CLOSING , SHORTNESS OF BREATH , COUGHING , NASAL CONGESTION , NAUSEA , VOMITING , DIARRHEA , ABDOMINAL PAIN , DIZZINESS , TACHYCARDIA - BLOOD PRESSURE WAS 189 / 108 & STAYED THAT HIGH FOR QUITE A WHILE , INCREASED SECRETIONS IN THE NOSE  VERY, VERY SICK FROM 08:00 AM THURSDAY, DEC 9 UNTIL SAT , DEC 11  , WAS IN BED FOR TWO DAYS
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, current conditions, drug reactions/allergies and concomitant medications information were not provided. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L039638, expiry date: 23-AUG-2017) (incorrect product storage). Medical assistant reported that the vaccine reached 32F for 28 hours and 30 minutes. A data logger was used and the vaccines were back in range. There were no prior excursions. No adverse experiences were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient states she woke up at night vomiting, with cold chills, feverish, and fatigued.  Patient stated that adverse events resolved at 10am the next morning.
Fever began at night time. Mom gave Tylenol but it provided no relief. Fever 102.8 per ER report at 00:00 hours. Received Tylenol and Motrin in ER. F/U at PCP in 2 days.
Vasovagal. Patient diaphoretic with decreased responsiveness. Resolved on own. Water and juice given. Normal vitals. Observed for 30 minutes and asymptomatic when released. Declined EMS
Muscle pain; injection site pain; insomnia and could not sleep the whole night; had a little loss of balance; severe chills and the chills got worse; severe headache; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK9231), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (lot EL0140) on an unspecified date for COVID-19 immunization. Patient reported that he wants to give a follow up on the second vaccine. On 13Jan2021 21:00, the patient experienced severe chills and the chills got worse and he had a severe headache. On an unspecified date, the patient had muscle pain and injection site pain. He said that he had insomnia and could not sleep the whole night and he also had a little loss of balance. The patient does not know if he was running a fever or not. He said that he took Tylenol that night and rested the next day and took Tylenol the next day and he was fine now. Patient said that he did not work yesterday, but started working today and physically, he was feeling fine now. The symptoms were similar to the shingles vaccine, but the shingles vaccine symptoms were a little milder. Outcome of events was unknown.
The night after the injection, I has terrible leg cramps in bith legs. Two days later my arm swelled up from my elbow to my shoulder at the injection site, red, hot, painful, itchy, swollen.  I have "Covid Arm"
? Caused ITP  Severe drop in platelets to 24 over 2 months
Splitting headaches, chills, all over body pain, extreme fatigue, sharp bone pains, couldn't eat or have a bowel movement for 4 days, bad heartburn, inflammation, hard to hold anything (joints and bones in hands/feet were very sore), sweating, felt very hot at one point but my husband said my body was ice cold, complexion was super pale. All of this was in a course of 4 days. Now I am just really inflamed and having major joint pains, last Tuesday my femur felt like it was going to pop out of my right knee and was limping that evening. The following morning it was ok. I am going to PT twice a week. My physical therapist and my chiropractor think that my connective tissue disorder and the inflammation is causing me to still have issues with my joints and my Raynaulds. Last Friday (1/14/22) my raynaulds was really painful and red on the left hand's pinky and ring finger. Its never painful and usually its white when it happens.
PATIENT RECIEVED 0.25ML INSTEAD OF 0.5ML DOSE
Started feeling achy and run down at appx 10:00pm that night.  At around 3:30 am have severe chills and fever of 102.8.  Took Advil around 8:00am next morning.  I wanted to take it sooner but I felt too sick to even get out of bed to get the medicine or water.  Fever went down but stayed low grade for a few more hours.  I felt very weak and run down.  Fever was gone by that night, but I had a horrible headache and stomach ache.  The headache and stomach upset lasted for four days.  The fatigue lasted about 5 days.
Right arm at injection site, area warm swollen and sore. 3 inches in diameter. Pt is applying ice, to injection site area.
15-20 minutes after administration of IM injection, experienced Elevated heartrate, blood pressure, pale, diaphoretic, immediate loose stool, fainting feeling.  Taken to ER and IV fluid given wide open, in trendelenburg position.  Body shaking uncontrolabily from waist down.  Sent home after a few hours and required return to ER in approx 4 hours for same symptoms.  I took Benadryl 50mg by mouth and experienced short term relief.  Admitted to hospital and have experienced anxiety/shakey feeling inside since vaccine.  11/13/09 & 11/16/09:  ED Records, Hospital Records and Discharge Summary received for date of service 11/5/09.  Dx:  Vasomotor vagal reaction to influenza injection.    Assessment:  Presented to ED with palpitations, generalized shaking, and feeling like she was going to pass out.  She was treated in the ED and sent home.  She returned and was tachycardic with a pulse of 130-sinus rhythm.  Admitted for telemetry monitoring. On the floor, HR 90, decided reaction was over and discharged to home.
Persistent sores at injection site continuing at 5 days. Low grade headache started on 3/16 following 1st exercise following vaccination and continues..
Hospitalized 8/9/22-8/11/22 SOB, HA, dyspnea, cough, tachypnic, hypoxia, PNA, fever,
Developed a red warm raised inflammation at injection site that grew in size from a quarter within 1hour of injection to size of my palm by 2 days.; Section stayed red warm and raised for 3-4 weeks; Section stayed red warm and raised for 3-4 weeks; Soreness and tender to touch.; Soreness and tender to touch.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 15:30 (Lot number: 30135BA) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Insulin resistance" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: TIROSINT; METFORMIN; CYTOMEL. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False,, Prev dose lot number: EL3248,, Prev dose lot unknown=False,, Prev dose administration date=08Jan2021 , Prev dose number=2, Prev dose vaccine location=Right arm), administration date: 08Jan2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "On dose 1 and 2 of Pfizer Covid vaccine, saw a much smaller red warm spot about quarter to half dollar in size", "On dose 1 and 2 of Pfizer Covid vaccine, saw a much smaller red warm spot about quarter to half dollar in size", "1st dose:22Dec2020;2nd dose:08Jan2021", "1st dose:22Dec2020;2nd dose:08Jan2021"; Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False,, Prev dose lot number: EK5730,, Prev dose lot unknown=False,, Prev dose administration date=22Dec2020 , Prev dose number=1, Prev dose vaccine location=Right arm), administration date: 22Dec2020, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "On dose 1 and 2 of Pfizer Covid vaccine, saw a much smaller red warm spot about quarter to half dollar in size", "On dose 1 and 2 of Pfizer Covid vaccine, saw a much smaller red warm spot about quarter to half dollar in size". The following information was reported: VACCINATION SITE INFLAMMATION (non-serious) with onset 18Nov2021 16:30, outcome "recovered with sequelae", described as "Developed a red warm raised inflammation at injection site that grew in size from a quarter within 1hour of injection to size of my palm by 2 days."; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 18Nov2021 16:30, outcome "recovered with sequelae" and all described as "Section stayed red warm and raised for 3-4 weeks"; PAIN (non-serious), TENDERNESS (non-serious) all with onset 18Nov2021 16:30, outcome "recovered with sequelae" and all described as "Soreness and tender to touch.". Therapeutic measures were not taken as a result of vaccination site inflammation, vaccination site warmth, vaccination site erythema, pain, tenderness.  Follow-up (23Feb2022): Follow-up attempts are completed. No further information is expected.
Immediate burning at injection site. Pain in arm. Pain then traveled up into neck and down my side along ribs. Next day (today) body aches and fever, still occurring.