chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sick as a dog; Runny nose; coughing; sneezing; scratchy throat; wants to sleep all the time; woken up by uncontrollable jerks of the upper body from waist up; was like restless legs but upper body only; sore arm in the injection arm with a knot about the size of the egg; sore arm in the injection arm with a knot about the size of the egg; tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick as a dog), RHINORRHOEA (runny nose), COUGH (coughing), SNEEZING (sneezing) and OROPHARYNGEAL PAIN (scratchy throat) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (sick as a dog), RHINORRHOEA (runny nose), COUGH (coughing), SNEEZING (sneezing), OROPHARYNGEAL PAIN (scratchy throat), SOMNOLENCE (wants to sleep all the time), DYSKINESIA (woken up by uncontrollable jerks of the upper body from waist up), RESTLESSNESS (was like restless legs but upper body only), VACCINATION SITE MASS (sore arm in the injection arm with a knot about the size of the egg), VACCINATION SITE PAIN (sore arm in the injection arm with a knot about the size of the egg) and FATIGUE (tired). At the time of the report, ILLNESS (sick as a dog), RHINORRHOEA (runny nose), COUGH (coughing), SNEEZING (sneezing), OROPHARYNGEAL PAIN (scratchy throat), SOMNOLENCE (wants to sleep all the time), DYSKINESIA (woken up by uncontrollable jerks of the upper body from waist up), RESTLESSNESS (was like restless legs but upper body only), VACCINATION SITE MASS (sore arm in the injection arm with a knot about the size of the egg), VACCINATION SITE PAIN (sore arm in the injection arm with a knot about the size of the egg) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: hasn't gotten the results (Inconclusive) hasn't gotten the results.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Theraflu, Theraflu Severe Cold & Cough Express Max Liquid.  No concomitant medication were provided.
Information has been received from a physician concerning a female pt with an unknown medical history who on 18Jul1983 was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was reported that the pt failed to seroconvert to rubella. The titer was drawn and the pt was immune to measles and mumps but not to rubella. Previous vaccinations included a dose of measles virus vaccine live  (Moraten)  on 10Jul1977, a dose of mumps virus vaccine live (Jeryl Lynn) in Feb1977 and a dose of rubella virus vaccine live (HPV-77)  on 19Sep1977. Additional information has been requested.
By the end of day after the shot was administered into my  left arm I began to itch near and on the  injection area.  3 days later the area were shot was given began to turn red and 5 days later I notice swelling in that area and the itching continues.  On the 6th day the  itching subsided however the swelling remains.
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored PNEUMOVAX 23 (Lot #, dose and route were reported). No symptoms were reported. This one of the several reports from same reporter. Additional information has been requested.
MASSIVE STROKE AT AGE 54 - 3/26 received vaccine began feeling weak and light headed.  Saturday - 3/27 Was still feeling light headed fell down a few times - Sunday 3/28 - Woke up immediately had massive vertigo within minutes could not breathe or swallow was taken by ambulance to medical center  - Diagnosed with Massive stroke in a VERY RARE PART OF THE BRAIN - Modulla controls balance- SO MUCH MORE.....My sister is lucky to be alive.
Chills, Weakness, Headache, Insomnia, Arm Pain. Chills was the worst. Note nothing but some arm pain on first dose.
Initial misuse report received from a healthcare professional on 27 September 2013. The cases were received on 21 March 2014 at GPV. Two patients received dose of FLUZONE  which was expired in last season (no other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Information has been received from a physician concerning a female (age not reported) who on an unspecified day was vaccinated with a first dose of Gardasil (lot # unknown) injection. On an unspecified day the patient was vaccinated with a second dose of Gardasil (lot # unknown) injection. On an unspecified date, "the patient's legs started to shake and she felt dizzy and faint after receiving the second dose of Gardasil. Medical attention was sought. The patient had to stay in the office for an hour to make sure she was alright". At the time of reporting the patient recovered on an unspecified date. No further adverse event information was provided. Additional information has been requested.
I had the bad flulike symptoms starting at 10pm the day of the shot all night long, with an extremely severe headach for the next 24 hours (to 11pm on 10/6/22).  For 10/7, 10/8 and continuing today, 10/9, I have been extremely naseous, food or drink doesn't taste right and i become very winded with a tightened chest feeling with any exertion.
"pt recv vax 10MA & Td & hep b were given to pt in opposite arms;pt went out to front desk & fainted;woke up immed, laid dow for 20min & was OK to go home;"
Got her 2nd booster & it was full dose of the Moderna Covid-19, instead of the half dose; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (Got her 2nd booster & it was full dose of the Moderna Covid-19, instead of the half dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2022, the patient experienced OVERDOSE (Got her 2nd booster & it was full dose of the Moderna Covid-19, instead of the half dose). At the time of the report, OVERDOSE (Got her 2nd booster & it was full dose of the Moderna Covid-19, instead of the half dose) outcome was unknown.            No concomitant medications were provided. The patient got her 2nd booster, & it was full dose of the Moderna Covid-19, instead of the half dose. The pharmacist told the patient that they only have the full doses, so the patient got the full dose. No treatment medications were reported.
Patient came in the store 9/6/19 around 11am and asked to talk to me, the pharmacist on duty. He explained that a few days prior (2 days prior on 9/4/19) he had come in and received 2 vaccinations that day and that his arm was sore that night but last night into today (9/5 into 9/6) the arm had some localized swelling/redness. He showed me his arm and it did have a section of redness but it was much lower than the typical vaccine administration site. It was just above the elbow and seemed to go fully around the arm. Upon looking in the computer and the patient profile, it was documented that both vaccines (Pneumovax and Fluzone HD) were given in the same arm. I asked the patient if that was correct and he confirmed that they were both given in that arm (left). Patient denied it being itchy, painful and also denied difficulty breathing or any other majorly concerning symptoms. He stated it was just red. I suggested the use of benadryl which the patient bought from OTC and I asked him to go home and take the medication and I would call him later in the day. I called around 4:45pm and the patient said he did take the benadryl but the redness was still there and unfortunately seemed to have spread towards the elbow (not towards the injection site). I recommended that the patient get looked at by an urgent care or ER. He stated he felt ok and would monitor it tonight and go get looked at tomorrow. In my professional opinion, the chances this is a result of the vaccines would be low given that it is quite a distance below where the vaccines were administered.
My arm is swollen, red and is very hot to the touch. It is also very hard and the size of a softball
This spontaneous report was received from an administrator and refers multiple patients of unknown ages. On unknown dates, the patients were vaccinated with VARIVAX lot # M035141 or lot # M048200 for prophylaxis. Concomitant therapies included sterile diluent. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA001720.
Patient reported swelling of her lips, mouth, and face beginning around 9:30PM. Patient stated that it progressively got worse as the night went on. Patient stated that it was hard for her to swallow.  Patient stated that the areas that were swollen were "rock hard." Patient stated her "left arm was swollen, but not terrible." Patient stated she took Benadryl, ibuprofen, and Tylenol and that the swelling "calmed down" at about 3AM. Patient stated that the swelling had gone down the next day, but that it began to swell again around Noon on 12/30/21. Patient stated she continued to take Benadryl, ibuprofen, and Tylenol for 5-6 days as the swelling would continue to come back after the Benadryl would wear off.  Patient stated the swelling was worse at night. Patient stated 1/3/22 was the first day she did not have swelling. Patient did not seek medical treatment.
p/vax pt devel an area of redness, swelling & induration approx the size of the mom palm @ inj site;pt recovered;
Boostrix -Administration of an expired dose.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 90-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 57GJ2, expiry date 29-MAY-2023) for prophylaxis.   On 05-JUN-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Boostrix -Administration of an expired dose.). The outcome of the expired vaccine used 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: 05-JUN-2023 The reporter was a medical assistant. The reporter wanted to know how to proceed with the patient. The reporter did consent to follow up. The patient received a Boostrix which was already expired, which led to expired vaccine used.
Pt vaccinated with DTP/HBV within the first 24 hrs, fever 103.5 (axillary), eyes seemed to roll back while sleepy in AM w/twitching, jerking, shaking. Cried all night > 4-5 hrs. Inject site 3-5CM. Swollen & tender. Arm swollen x2 days.
Injection given in long head of right triceps muscle. Site became very painful and swollen from elbow to armpit. Skin was taught and cherry red.  Area itched and I developed headache and general discomfort/uneasiness for about 30 hours. On day two, the swelling migtated to the inside of the right elbow. Redness and headache persisted.
Information has been received from a healthcare worker concerning an unspecified number of patients of an unknown age and gender. medical history and concurrent conditions were not reported. On an unknown date in 2015, "since 07-JAN-2015", the patients were vaccinated with improperly stored GARDASIL injection (lot # H021861, expired date as 09-OCT-2015; lot# K023432, expired dates as 18-JUN-2016; lot# K003520, expired date as 20-NOV-2016; lot# K006124, expired date as 02-FEB-2017) (strength, dosage and route were not reported). No adverse effects were reported. This is one of several reports that received from the same reporter. Additional information has been requested.
Patient with day 2 post vaccination with moderate/severe localized erythema, swelling, warmth, induration and pain to (R) deltoid. Progressive spread of erythema per marked line in past 24 hrs. Covered for potential cellulitis secondary to recent vaccines.
Dizziness & weakness, N/T. "Severe headache.  My worst day was 8 days after shot.  But I felt like I had the flu. Also could not focus. Felt like I had memory loss.  Had a covid test to make sure I did not have that
Patient was seated and received immunization, stayed seated, then had syncope episode while seated, falling forward.
27JAN97 45mm knot w/redness around area;some warmth;pt reports soreness;reports area was worse a/today;
Pt experienced extreme pain and shoulder immobility in left arm starting late afternoon after receiving her immunization.
2 hours after the administration of the vaccine, the left side of my face briefly started to tingle. I slept for 6 hours, and when I woke up, the left side of my face was noticeably having pins and needles. I took 25 mg of oral Benadryl and slept for another 7 hours, and when I woke up, my left arm and leg were experiencing pins and needles. The left side of my face was completely numb, and I felt like that side was being pulled down toward the floor. The left, posterior side of my head felt very tingly, and I had a pounding headache behind the left eye that worsened with light.  My boyfriend noticed my smile being different, and after looking in the mirror,  I decided to go to ED. They were concerned about Bell's Palsy, but with the extremity involvement, they changed my plan of care to a migraine response from the vaccine. I received an MRI, IV Compazine and IV Toradol. My headache went from a 6/10 to a 2/10 after that treatment, but it came back soon after my discharge.
BODY ACHES; HEART RACING; HEADACHE; FEVER; TIRED; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced heart racing. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 102.3 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, heart racing, headache, fever, and tired. This report was non-serious.
Chills, Fever 101.9 & Delirium. Fever reduced with Tylenol, & delirium started clearing 5-7 hours later while at the ER.  Patient was back to normal after sleeping several hours.  Doctor advises not to get 2nd shot.
Pt was vaccinated with Moderna Covid-19 on 14JAN21 developed a sore L arm that was initially resolved within 1-2 days. Beginning on 23JAN21 pt developed an itchy, patchy, and achy rash around injection site on L deltoid. Pt was then seen at the clinic on 25JAN21 where she was prescribed Cephalexin 500 mg #28 taken QIG and Benadryl 25mg T1-2 Q6H. Sx did not resolve by 26JAN21 and was seen in clinic for a follow up, the rash visually looked better with decreased redness and swelling,  although the patient began experiencing H/A after beginning the Cephalexin. Pt instructed to continue with current medications and to F/U on 28JAN21. Pt was seen for F/U where rash had increased in size, itchiness and burning sensation. Pt was Diagnosed as having Erythema Multiforme of the L Deltoid and began taking a new Rx of Prednisone 40 mg for Sx. Pt informed to F/U if Sx worsen or are unresolved by 29JAN21.
Pentacel described as the ActHIB portion being reconstituted with sterile water 0.5 mL and the DTap-IPV portion not administered; Initial information received on 03-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old female patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that Pentacel described as the Act-Hib portion being reconstituted with sterile water 0.5 ml and the DTaP-IPV portion not administered (product preparation issue). Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 03-Jan-2020, the patient received a third dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via intramuscular route in unknown administration site.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was unknown if the patient had any adverse event 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.  Information on the batch number was requested.
Covid Arm started yesterday (2/21/21) evening.  Bright red circle, two finger width, hot and itchy.  It has increased in size today (2/22/21).  I did put Benadryl cream on it last night and today.  Main complaints- Hot, itchy, hard to the touch.
Pt states symptoms initially started with tingling to the right ear/right cheek/right eye later in the day on Saturday, 10/16/2021 and by the next morning his face and upper lip and area behind both ears were very  swollen, tender and hot. Later Sunday his L Arm was swollen, hot and red. He  also reports that he had a bad rash to his face, behind ears, neck arms, chest  and groin with itching and progressively worsened on Monday. Pt also reports he  was nauseated, vomiting and diarrhea on Sunday - still continues and requesting  something for nausea.  He reports that he had to take off work on  Monday and Tuesday and started at working at home on Wednesday. He states the  worse part now is he has a burning sensation to face, neck, chest, arms and  genital. Reports cold showers and cetirizine twice daily has been providing some  relief.
After 15 minutes I was released. No sooner than I had left my lips started tingling. I went to grocery store about 1/2 mile away; shopped for a few minutes, maybe 20 minutes. My face started burning like the worse sunburn you ever had. I called my physician's office at 2 p.m. and they worked me in. He prescribed Hydroxyzine 25 mg tablet, 1-2 tablets 4 times a day as needed for itching. The itching started in the doctor's office. It was just my face, now it is my face and arms. I have been taking one (1) pill every 6 hrs. Even taking the 1 pill the itching doesn't stop. I guess I need to take 2. Current time: 10:20 a.m. 3/18/21
Palpitations Narrative:  Employee received vaccine at 8am on 12-29. 45 minutes later experienced flushed feeling, heart palpitations, chest pain. See in urgent care at work, EKG showed ectopy. She was sent to the nearby emergency room, where she was monitored and given iv fluids, oxygen and tylenol. She is feeling better today one day later, and will have follow-up with cardiology. Vaccine administration may have set off underlying predisposition for PVC's, ectopy. Was aware of PVC's previously but well-controlled on diltiazem. Has now been switched to metoprolol.
pain at the injection site; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2021, the patient received the 1st dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received a dose of Shingrix and experienced pain and redness at injection site and that resolved the next day. The reporter did not provide demographics. The reporter did not consent to follow-up.
Provider ordered MMRV to be given.  Child was administered MMR instead.  No known adverse event, only administration error.
Hives on trunk, legs and face within 24 hours of the vaccine.  No other known new or concerning exposures.
Pt had encephalitis 2 wks p/OPV seemed to recover completely but now has foot drop. Neurologist questions whether secondary to polio.
dies from Gardasil vaccine injuries; 3 years of suffering; This information was obtained from a website and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On an unknown date, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (dose, route of administration, lot number and expiration date were not provided). On an unknown date, the patient experienced unspecified injuries. On an unknown date, the patient experienced an unspecified adverse event, which caused suffering lasting 3 years. On an unknown date, at the age of 19 years, the patient died of the unspecified injuries. It was unknown if the autopsy was performed. The outcome of the unspecified adverse event was unknown.  The reporter considered the event of unspecified injuries to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The relatedness between the unspecified adverse event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.; Sender's Comments:  US-009507513-1910USA012728: