chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tired or heavy feeling 5 days after 1st dose; Red itchy area at vaccine site after 1st dose; Red itchy area at vaccine site after 1st dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red itchy area at vaccine site after 1st dose), INJECTION SITE PRURITUS (Red itchy area at vaccine site after 1st dose) and FATIGUE (Tired or heavy feeling 5 days after 1st dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Red itchy area at vaccine site after 1st dose) and INJECTION SITE PRURITUS (Red itchy area at vaccine site after 1st dose). On 01-Mar-2021, the patient experienced FATIGUE (Tired or heavy feeling 5 days after 1st dose). At the time of the report, INJECTION SITE ERYTHEMA (Red itchy area at vaccine site after 1st dose) and INJECTION SITE PRURITUS (Red itchy area at vaccine site after 1st dose) had resolved and FATIGUE (Tired or heavy feeling 5 days after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
pt states that he started getting chills, fever, fatigue and headache that lasted around 24 hours.  Pt no longer has these symptoms and has not contacted his PCP.
I started having a severe headache that Sunday night. The next morning when I woke up, I had a scratchy throat with some coughing. Tuesday, I started having a fever and fatigue with all the other symptom still present. Wednesday I still had all symptoms, so I decided to go to the urgent care. When the urgent care too my temperature, it was normal.
Right upper arm was swollen for a week.  I now have shoulder pain in my right shoulder that was not there prior to the covid shot.  My right arm is still tender around the shot injection site and it has been over 6 months.  My right shoulder will get a sharp pain sometimes when I try to lift it up over my head.
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-APR-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
About 5 seconds after administration of the vaccine, the patient began to feel extremely dizzy. The patient did not lose consciousness, but could not safely stand. After about 5 minutes of waiting with the patient, he insisted he was no longer dizzy, and that he wanted to leave. After assessing his balance and his vision, it was determined he was no longer experiencing symptoms. The patient was monitored as he left to ensure he was stable.
Presented with complaints of progressively worsening shortness of breath.  Patient was recently diagnosed with COVID-19 3 days prior to the admission. COVID-19+ pna; tx w/abx, steroids, O2, zinc; pt did not improve w/ tx; pt made DNR followed by comfort care & subsequently expired.
Arm experienced sever swelling over approximately 18 sq. inches. Hot and tender to touch. Difficulty breathing, with tightness of the chest experienced for 48 hours after symptom onset. Physician prescribed course of prednisone (20mg 2x a day) as well as icing of the affected area, 600 mg of ibuprofen every 6 hours, rest and fluids.
Pt received dose No.1 Pfizer vaccine at 9:10  in left arm. Stood up immediately after injection, felt dizzy then stepped back and either tripped off or fainted and fell on left side. Did not lose consciousness, sat up then moved to chair.  9:15 am BP checked after fall 138/78. Water was offered.  15 mins check Pt is sitting up, denies dizziness, no nausea  30 mins check Pt sitting up denies dizzines, nausesa "feels fine"  Walked to car with mom  Mother admitted patient has previously fainted with previous vaccinations. Mother did not disclose this prior to vaccine administration nor during registration
Patient was given influenza vaccine on 11/30/2020 but vaccine was given in inappropriate site. Vaccine was given in inner thigh rather than outer thigh area. Injection site clearly visible on inner thigh. Patient was brought into clinic on 12/2/20 with swelling, redness and pain in left thigh.  On 12/3/20 the symptoms had worsened.  Patient parent contacted provider for further instruction.  Patient was given antibiotic and steroids for possible reaction to vaccine.  As of 12/5/20, patient's symptoms had improved.
I have 2 red spots on my left inner upper  arm that haven?t gone away. They do not itch, hurt, or burn.  I had a booster  on 12/20/21 in my right arm and later also developed 2 red spots on my right inner upper arm.  They seem to have increased in size after sitting in the sun 2 days ago. All the spots look like someone grabbed me on my arm or look like a faint burn from something.
Fever of 99.8 headache Ache in upper left arm - soreness extending from just above the elbow to the shoulder
Patient said she has skin infection following the immunization. She has to go to ER to get an antibiotic prescription to treat the infection. She believes that the "Inject-Safe Barrier Bandages Injection Site Bandage" is the reason for the infection.
extreme somnolence started 7 days after Proquad MRI nl EEG nl spinal  tap nl 6/27/07-records received from facility for DOS 6/8-6/9/07-DC DX: Somnolence and mild encephalopathic reaction to MMRV vaccine. Several day history of vomiting and lethargy. Mental status changes. No fever.
Numbness in wrist and joints and 5cm x 7cm swelling at site of shot on 4/6/2000 at 14:00.
2 days after vaccines were given patient awoke unable to bear weight on left leg.  Mom called healthcare provider to inform that  he has been army crawling around the house for 2 days starting 2 days after getting his vaccines.  She can see a red lump on his leg from one of the vaccines but no streaking or sign of infection.
Sx came around 1 pm on 6/26/12. They include redness, swelling, Lt. arm pain & at site. Pt. seen at 212 urgent care 6/26 & followed up with Dr. on 6/27/12.
After the 3rd and 4th doses, had headache, increased irritability and increased photophobia which lasted for weeks. Better each progressive day. Irritability and photophobia are not unusual for this client according to her but ? were increased.
Sore arm, tight, painful day of vaccine. Next day since early morning, headache and nausea, body aches all day; after 7:00PM projectile vomiting  5x within the hour. Nausea, body aches, headache persisting no medications have been taken.
experience severe flu-like symptoms; Ache/entire body aches; Fever; nausea; chills; extreme fatigue; lightheadedness; headache; diarrhea; This is a spontaneous report from a contactable pharmacist. A 52-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 16:45 (Batch/Lot Number: EW0161, Expiration date was not reported) (at the age of 52-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There were no known allergies reported. Historical vaccine included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 15:00 (Batch/Lot Number: ER8732, Expiration date was not reported) for covid-19 immunisation. The patient did not have covid prior to vaccination and was not tested for covid post vaccination. On 17Apr2021 10:30 am, the patient experienced experience severe flu-like symptoms, fever, nausea, chills, extreme fatigue, lightheadedness, headache and diarrhea. It was reported as approximately 18 hours after dose 2 (Saturday 17Apr2021 10:30am), the patient began to experience severe flu-like symptoms including entire body aches, fever, nausea, chills, extreme fatigue, lightheadedness, headache, diarrhea that lasted 3 days. Recovered at 90% by tuesday, 20Apr2021. Lingering lightheadness and headache on day 4. The patient received treatment with Tylenol 1000mg q6h x 4 days. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Approximately 15 minutes after receiving vaccine she started feeling shaky, clammy, itchy, KP 3-25-09 nauseous, & became diaphoretic & light headed. Vital signs after onset. 98.4 - 115 - 120/60 - 24 noted hives.
Had abnormal mentrual cycle following 1st dose of vaccination.  Had Normal cycle before dose from 6/3/21 thru 6/6/21.   Started bleeding again 6/28 thru 7/1/21.  On 7/10/21 had sore left breast with pain in nipple specifically.  On 7/13/21 was feeling sad, anxious, depressed, tender breasts and started spotting again.  It is now 8/9/21, and regular period is late.  I had history of break thru bleeding only 2x before episode after vaccination and it was after intercourse.  Otherwise normal periods all my life since age of 13
Very violent behavior; Very weak; Started saying crazy stuff that did not make sense; Slept a lot; Severe dreams; Hallucinations; A spontaneous report was received from a consumer concerning an 89-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and started saying crazy stuff that did not make sense (speech disorder), slept a lot (hypersomnia), had severe dreams (abnormal dreams), hallucinations, very violent behavior (aggression) and was very weak (asthenia).  The patient's medical history, as provided by the reporter, included COVID-19 in Mar-2020.  Products known to have been used by the patient, within two weeks prior to the event, included gabapentin, apixaban, pantoprazole, furosemide, carvedilol, tamsulosin, potassium, hydrocodone, metformin, zinc, vitamin d3, vitamins NOS, ascorbic acid, rosa canina fruit, magnesium and probiotics NOS.  On 06-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 016M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.    With the first dose of the vaccine, the patient experienced the patient experienced delirium, hallucinations and confusion.  On 06-Mar-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 029A21A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 06-Mar-2021, within four hours after the 2nd vaccination, the patient started saying crazy stuff that didn't make sense, slept a lot and had severe dreams and hallucinations. The patient had very violent behavior and was reaching for things and eating things that were not there and was very weak.   No treatment information was provided.  Laboratory information included CT scans.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events, saying crazy stuff that did not make sense (speech disorder), slept a lot (hypersomnia), had severe dreams (abnormal dreams), hallucinations, very violent behavior (aggression) and was very weak (asthenia), were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Caller had his 1st Pfizer vaccine dose on 3/24/21 and "had a mild sore left arm."; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 12:30 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypogonadism", start date: 2018 (unspecified if ongoing), notes: Had been giving himself Testosterone shots since 2018. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Mar2021, outcome "recovering", described as "Caller had his 1st Pfizer vaccine dose on 24Mar21 and "had a mild sore left arm".  Additional information: He has never had any problems. He is methodical about giving shots in his thigh. He had no problem with first vaccine. His arm was a little sore, but no big deal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a other health professional refers to a 71 year old female patient. On 07-JUN-2017 the patient was vaccinated with ZOSTAVAX lot # M032141, .65 ml, subcutaneous for prophylaxis. On JUN-2017 the patient experienced vaginal lesion, herpes simplex test positive, herpes simplex and vulvovaginal pain. The outcome of vaginal lesion, herpes simplex test positive, herpes simplex and vulvovaginal pain was reported as recovered/resolved. {Additional information has been requested. / Additional information is not expected.}
No additional AE/PQCs reported; improperly stored VARIVAX was administered/ temperature: 19 Fahrenheit degrees for 5 hours; This spontaneous report was received from a patient of an unknown age and gender, who was reporting on themselves. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 07-DEC-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # T015999, expiry date 08-MAY-2022 (dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine experienced temperature of 19 Fahrenheit degrees (range reported as 14 to 46 Fahrenheit degrees) for 5 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse events were reported.
This spontaneous report as received from a physician refers to a 15 year old female patient. No concomitant medications were reported. On 01-MAR-2013 the patient was vaccinated with the first dose of GARDASIL lot # 0420AE, expiration date December 2014, intramuscular in the left arm. Shortly after the vaccination on 01-MAR-2013, "she almost passed out and lost consciousness. The patient became pale and sweaty, she involuntarily urinated on herself, her heart rate dropped to 42, and her blood pressure was 112/80. The patient went to the back of the office to lie down and her heart rate increased to 89, her blood pressure was 120/78, and in five minutes she was back to normal status" on the same date and recovered. The patient did not received treatment for the adverse events. Upon internal review lost of consciousness was considered as an other important medical event. Additional information has been requested.
Husband received the monovalent vaccine/Husband received Monovalent as 3rd booster dose; We are frustrated; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FRUSTRATION TOLERANCE DECREASED (We are frustrated) and WRONG PRODUCT ADMINISTERED (Husband received the monovalent vaccine/Husband received Monovalent as 3rd booster dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Husband received the monovalent vaccine/Husband received Monovalent as 3rd booster dose). In September 2022, the patient experienced FRUSTRATION TOLERANCE DECREASED (We are frustrated). At the time of the report, FRUSTRATION TOLERANCE DECREASED (We are frustrated) and WRONG PRODUCT ADMINISTERED (Husband received the monovalent vaccine/Husband received Monovalent as 3rd booster dose) outcome was unknown.            No concomitant medications were reported.  Patient received third Moderna booster.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-647556 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2022: Follow up received and patient details, additional event and narrative update.; Sender's Comments: US-MODERNATX, INC.-MOD-2022-647556:same reporter.
nausea, fever, chills, muscle aches Narrative:  Took OTC Motrin
Chills for approximately 24 hours after Dizziness, overall weakness, and tiredness with inability to sleep (ongoing, 6th day) Swelling of the face, particularly left side more affected (noticed on 6th day after injection) Bad taste in mouth and dryness Eye sockets darkened, more so in the left eye (noticed on the 4th day after injection; ongoing)
On 1/5/04 pt recv'd DTaP, IPV, PCV and Comvax. That night mom states pt had pain and swelling in both legs. Fever 103 deg. Mom treated with Advil and alt with Tylenol.
Patient erythimic streaking and a 15mm purulent colored papule. treated with Bactrim (1) 2 tabs po BID
Information has been received from a Medical assistant concerning a 75 year old male patient who in May 2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). On 07-FEB-2011, the patient reported to the practice with shingles. Treatment included VALTREX 1 gram BID x7 days, LYRICA 75 mg TID and VICODIN prn for pain. At the time of the report the patient had not recovered. Additional information has been requested.
Information has been received from a pharmD concerning a 61 year old male with no pertinent medical history, drug reactions/allergies or concomitant medication use who on 05-OCT-2007 was vaccinated intramuscularly (site not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot # 658075/0962U). On 06-OCT-2007, post vaccination, the patient developed severe pain and a swollen arm. The patient rated his pain as between 4 to 5 out of 10 at rest and 9 out of 10 during movement. No lab diagnostic test were performed. The pharmD did not know if the patient had been administered pneumococcal 23v polysaccharide vaccine prior to this dose. The patient received unspecified medical attention and recovered on 10-OCT-2007. This is one of several reports with the same source. Additional information has been requested.
Vesicular rash noted on back 22 days post vaccine Diagnosed as shingles; Vesicular rash noted on back 22 days post vaccine Diagnosed as shingles; This is a spontaneous report from a contactable other healthcare professional. A 39 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 10:45 (Batch/Lot Number: EF8732) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing, drug hypersensitivity to Penicillin, sulpha from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced vesicular rash noted on back 22 days post vaccine diagnosed as shingles or Herpes Zoster on 19Apr2021 20:00 with outcome of recovering. The patient had to visit physician office. Therapeutic measures were taken as a result of the events with Valtrex  Follow-Up (15Sep2021): Follow-up attempts are completed. No further information is expected.
pt cancelled her second dose appt on 2/13/21. when clinic inquired as to why, she states she was diagnosed with bells palsy shortly after her first dose. She was diagnosed with a primary care provider.
Information has been received from a consumer concerning her friend's son who on an unspecified date was vaccinated with a dose of MMR II.  It was reported that the patient became non verbal.  At the time of this report, the outcome was unknown.  It was not specified if the patient sought medical attention or not.  Upon internal review, non verbal was considered to be other important medical event.  This is one of several reports received from the same source.  No further information is available.
Patient says that her arm has been sore (barely able to lift up) and swollen, since she had gotten the shot and still is today 3/17/22, so it has been over a month.
Moderna COVID-19 Vaccine EUA.  - Within 20 minutes of injection on 26-April-2021, pain at injection site and soreness in upper left arm.  Soreness and pain spread throughout the left arm  from shoulder to wrist, radiating from the injection site, and persisted extensively for the next 54 hours, at which point it began to subside.  At 72 hour mark after injection, only localized, minor tenderness and pain at injection site remains.  - Within 4 hours of injection on 26-April-2021, overall whole body pain, aches, and soreness exhibited and persisted for 50 hours. During that period, the two overnight periods were accompanied with night time sweats and chills experiences and lack of consistent good sleep.  - Approximately 20 hours after injection on 26-April-2021, pain (dull constant pain, as well as sharp shooting pain) in lower left abdomen was experienced and continued for 14 hours).  - Majority of adverse reactions were resolved or subsided significantly within 72 hours of injection. - No doctors visits or medication (not even over the counter pain meds) taken.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2016, the patient was inoculated with ZOSTAVAX at a medical office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated at a medical office for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
After the patient received the vaccination they were instructed to sit in the waiting room for 15 minutes. The vaccinating pharmacist checked the patient and she said her lips were tingling/numb. The vaccinating pharmacist came and got me in the pharmacy. I talked to patient, she said her breathing was fine but felt like she was floating. She began to become incoherent and at that point we got her on the floor and called 911. I did not talk to the EMTs. They transported the patient out of the waiting room.  We reached out to patient after she returned home she is feeling better and may of just had a panic attack. She is making an appointment with her primary care provider.