chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt little sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient felt little sick after receiving flu shot. Apparently it was normal. It was reported as day after, the patient felt ok.
Child received immunizations on 07/27/04, 4-5 days later fever 99.7. Rash resembling measles rash started 6 days after MMR shot on forehead, then thighs and abdomen. No treatment. Mother advised Tylenol for discomfort and fever, TLC and to watch for lethargy, respiratory signs and symptoms, etc. 08/10/04: I called and pt's rash gone.
Pt initially tolerated administration and did not complain of vision changes, dizziness, nausea. Pt discharged from exam room ambulating independently with her Mother. Made it out of the clinic space and into the building foyer when syncopal episode began. Pt did not fall per report from Mother. Pt  transported back to clinic space, vital signs checked, PCP came to bedside. Juice provided and patient discharged without incident.
eceived a box of expired Fluzone High Dose for Jun 30, 2022 and gave all 10 doses. with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA392579(CLUSTER).  This case involves Elderly of an unknown gender patient who was given expired  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] for with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ772AA, expiration date: date: 30-Jun-2022) via unknown route in unknown administration site for Immunization.  On an unknown date, the patients developed a non-serious "received a box of expired Fluzone high dose for Jun 30, 2022 and gave all 10 doses. with no reported adverse event" (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.; Sender's Comments:  SAD20220921002678:
This spontaneous report was received from a physician concerning a 14 years old female patient. The patient was vaccinated with the first 0.5 ml dose of GARDASIL (lot not reported) on 22-OCT-2012. The patient was vaccinated with the second 0.5 ml dose of GARDASIL (lot not reported) on 28-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient's last menstrual cycle was on September 2012 and it had not come back. Physician reported that the patient had a negative pregnancy test. She still had not had cycle. The outcome of the event was not recovered/not resolved. The relatedness for the event was unknown for GARDASIL. Additional information has been requested.
Patient received a second dose of Moderna Bivalent on 02/17/2023 initial one was received on 11/11/2022.
This report was originally reported by a RN concerning a 51 year old female patient who on 5/23/02 was vaccinated intramuscularly with a first does of hepatitis B recombinant (yeast).  Concomitatn therapy included an intramuscular first dose of hepatitis A vaccine (Havrix), (lot# VHA720A4); an intramuscular dose of typhoid vi polysaccharide vaccine (TYPHIM VI); a subcutaneous dose of yellow fever virus vaccine live (YF-VAX), and an intramuscular dose of diphtheria toxoid/tetanus toxoid. Additional concomitant medication included chlophoniramine, conjugated estrogens/modproxyprgesterone (Prempro), vitamin E, vitamin C, folic acid, calcium plus vitamin D, and vitamin B-12. On 5/23/02, two hours post vaccination the patient developed a swollen tongue, "mild" swollen of the throat and itching. The patient was seen in the local emergency room, where a physician made a diagnosis of "allergic reaction suspected to vaccines." The patient was treated with steroid (NOS) and antihistamines (NOS). The events resolved on 5/28/02. The patient received her second injection of hepatitis A vaccine (Havrix) (lotVHA720A4) on 11/20/02. She was premedicated with two unspecified medications for two days prior to receiving the second injection of hepatitis A vaccine. No adverse event occurred. "The reporting nurse considered the allergic reaction to be possibly related to each of the vaccine administered on 5/23/02. The nurse stated that the tongue swelling was life-threatening. Additional information has been requested." Reported on 02/27/2003: "Follow-up #1 correspondence received 02/12/2001 from Merck:  The patient's initial is A.S. not A.T. as previously reported.  It was also confirmed that case WAE60212USA02398 is a duplicate of WAES030IUSA02787.  No additional information was provided.  This case is closed.
Mom noticed the injection site to be red, raised, blotchy, warm and painful. Questioning what she can apply/ or recommend. Came into the office,  diagnosis dermatitis; apply Hydrocortisone + Benedryl bid; if fever and or increasing redness and warmth/streaking occurs, will call after hours for abx.
She is unable to work; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that a 79-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Strength: 0.5ml, Lot: 1391693) via an unspecified route of administration on 17Dec2019 at 0.5 ml single for immunisation. The patient medical history and concomitant medications were not reported. The patient was unable to work on an unspecified date. The outcome of event was unknown.
Large, red area 8cm round with hard, purple center of 2cm in center, lasting 2 1/2 wks. Still as of 2/3/03, has "lump" palpable at injection site, fever, itching and painful. Still have lump in left arm.
A 10-year-old was accidentally  given a Pfizer booster shot (0.3 mL) from one of the 12-years-old and up Pfizer vaccine vials. As a result, the incorrect pediatric dose was given to the patient.
Patient came to me asking me to give her a shot.  I was under the impression she wanted a flu vaccine.  I pulled the vaccine and proceeded to give her the shot.  I informed her her arm would be sore from the flu vaccine.  She stated to me she was wanting the COVID vaccine not the flu.  She had already had the flu vaccine 2 weeks ago on 10-11-2023.  I apologized for my mistake and went to inform my supervisor.  Patient made the comment "I wanted the high dose anyway" but wasn't eligible due to age.  Patient reassured me it would be ok, again I apologized for my mistake.  I checked on patient about an hour later, she said she felt fine
Severe nausea, lightheadedness, 102.5 degrees Farenheit fever, fatigue.
7/11/21 Awakened by a sharp pain in lower right side at 8 am. increasing gastrointestinal upset throughout the day and into the evening along with an unquenchable thirst despite drinking a lot of water. 7/12/21 mid morning began to experience my allergic reaction to ingesting artificial sugar: metallic taste in mouth, very dry mouth, despite drinking water, tingling of mouth and tongue and subsequent swelling. Skin on lips began to peel off with tongue pressure. a second dose of advair was necessary and I was prepared to use rescue inhaler. some of these symptoms subsided around midnight, which is when i noticed a smell in my nose that was very like nail polish remover. 7/13 skin hyper-sensitive to temperature
Pt complaining of severe in posterior upper right arm. Went to MD's office. MD didn't see anything. Palpitated tenderness in arm. Pt. sent to E.R. ER said she had a hematoma. Pt still in pain.
Initial unsolicited report received from a consumer on 12-Oct-2017. This case involves 68-year-female patients of unknown age was vaccinated with dose of FLUZONE HIGH-DOSE 0.5 ml via intramuscular route, (batch number, expiry date, dose in series and site of administration were not reported) on 05-Oct-2017. Patient's medical history and concomitant medications were not reported. On 05-Oct-2017, following the vaccination, patient immediately felt a hot sensation at the injection site, the area became inflamed to about a 3 inch circle and 1/4 inch swelling. After 1.5 days the warm feeling moved up her shoulder and into her neck. On an unknown date, the patient's memory became faulty and she was disoriented. Lab data and corrective treatment were unknown. The event outcome was recovered (after 4 days) at the time of reporting. List of documents held by sender: none.
Pt arrived in immunization clinic on 22 Aug am stating traveling same day in the evening and needed his yellow fever vaccination.  Was administered and pt left clinic.  Pt returned about 15 minutes later complaining of chest pain.   Brought back to treatment room.  Pt stated that feels like he was wheezing and SOB and then pt started vomiting.  Epinephrine auto injector immediately given and provider called.  Wheezing per auscultation noted.  Pt wheezing and SOB improved quickly although continued with chest pain.  Pt taken to emergency room for evaluation of chest pain.
Breakthrough case admission after 2 vaccines Moderna 1/29/21 Lot# 037K20A;  Moderna 2/26/21 Lot# 037K20A
BRUISING IN THE INJECTION ARM; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced bruising in the injection arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bruising in the injection arm. This report was non-serious.
This case was reported by a consumer via interactive digital media and described the occurrence of Bell's palsy in a child patient who received unspecified Influenza vaccine for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown.  It was unknown if the reporter considered the Bell's palsy to be related to Influenza vaccine. Additional information received as follows: The age at vaccination was not applicable for this report. The reporter heard that the patients were getting the flu shot and then they were coming in with Bell's Palsy. The reporter's grand daughter of age 8 years had a chicken pox shot and got Guillain Barre Syndrome. The patient was recovered after a couple of months. That was 2 years before the reporting time. The patient was slurring and could barely walk. Till the reporting time, the patient's mother was upset over what happened. The hospital would not admit it was the shot.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot#: not reported). Subsequently the patient fainted after receiving the GARDASIL injection (no known which dose in the series). Patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
About 4 weeks following second Pfizer COVID 19 vaccination dose, I woke up in the morning with extreme virtigo and tinnitus in both ears, but worse in the left ear.  Rested for about 6 days thinking it was viral.  Went to Urgent Care on 6/25/21, diagnosed with ear inflammation/infection on left site, tinnitus.  Places on meclizine for dizziness and doxycycline for infection.
1 of 2 children vaxed from the same lot who exp a fever;pt recvd vax 1FEB95 & devel a high fever 102-103 x 3 days following vax;pt recovered;
Initial unsolicited report received from consumer (patient's mother) via other company (Pfizer) (Manufacturer Report Number: 2016553075) on 13-Dec-2016. This case involves a male patient (onset age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unspecified date, unspecified timeframe (reported as one month ago) following vaccination the patient experienced cold. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Today 9 days after injection the injection site is swollen,red, and a little itchy
103 fever, severe chills, body aches, severe headaches, wheezing, coughing (x 48 hours)
HANDS SO PAINFUL SAT THERE RUBBING THEM NEARLY CRYING; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced hands so painful sat there rubbing them nearly crying. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hands so painful sat there rubbing them nearly crying was not reported. This report was non-serious. This case, from the same reporter is linked to 20221243356, 20221243606, 20221243261, 20221245881, 20221245816 and 20221245969.
Diarrhea; Muscles are real twist; This is a spontaneous report from a contactable consumer (patient). An 84-year-old patient received 1st dose of BNT162B2 (Age at Vaccination was 83 years old, COVID Vaccine, Batch/lot number: EL1283, Expiry Date Unknown) on 15Jan2021 at single dose on left arm for covid-19 immunization. Relevant medical history was Chronic kidney disease, Blood pressure high. Concomitant drug included Lisinopril at 20mg a day, Felodipine at 10mg a day, Metoprolol 25g twice a day. I don't know what's going on but I think it's diarrhea for a week after took the first one but it's better now, but my stomach got, my muscles are real twist. They really tighten up in my stomach or something because diarrhea was so long. No Treatment. Patient received second Vaccine (Batch/lot number:  EL9264) on 05Feb2021. Outcome of the event diarrhea was recovering, for other event was unknown. No follow-up attempts are needed. No further information is expected.
Fever, stomachache, nausea, shivering, and diarrhea. I felt these symptoms 5 days after my vaccination.
blister outbreak on top / roof of mount with swelling after 1st vaccine burning/tingling of both lips with blister formation, itching/burning under nose and corner of left mouth after 2nd vaccine swelling, cramping, pelvic pain right > left with "needle like" sharp pain after 2nd vaccine  - improvement in blisters after Acyclovir but recurred so, not complete resolution  - pelvic symptoms are intermittent without treatment
contracted pneumonia 10 days after vaccination.  I am not sure if it is related or not, but pneumonia is listed as a severe problem for the chicken pox vaccination.  She had high fever for 6 days (starting 10th day after vaccination) and lethargy.  I took her to the hospital and Dr. found she had pneumonia.  She was treated with Zithromax antibiotic.  She is still running a fever after 5 days of antibiotics.
HEADACHE; FELT TIRED; MUSCLE PAIN; NAUSEA; WHOLE BODY HURT; URGENCY TO POOP; JOINT PAIN AND HURTING IN KNEES; This spontaneous report received from a patient concerned a female of unspecified age. 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced whole body hurt. On APR-2021, the subject experienced urgency to poop. On APR-2021, the subject experienced joint pain and hurting in knees. On APR-2021, the subject experienced felt tired. On APR-2021, the subject experienced muscle pain. On APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle pain, joint pain and hurting in knees, and whole body hurt, and the outcome of headache, felt tired, nausea and urgency to poop was not reported. This report was non-serious.
I had sore shoulder, extreme tiredness; I had sore shoulder, extreme tiredness; I soon had "crinkle' sounds in my left ear; mild tooth/jaw pain on the left side of the mouth; mild tooth/jaw pain on the left side of the mouth; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received first dose of bnt162b2 (BNT162B2, Lot number EL1283), via an unspecified route of administration on 13Jan2021 12:00 at SINGLE DOSE on Left Shoulder for COVID-19 immunisation. Medical history included artery disease, sleep apnea, acid reflux. No known allergies. Concomitant medication included amlodipine (AMLODIPINE), armodafinil (ARMODAFINIL), rosuvastatin calcium (CRESTOR), clopidogrel bisulfate (PLAVIX), potassium (POTASSIUM). The patient reported i soon had "crinkle' sounds in my left ear, mild tooth/jaw pain on the left side of the mouth on 13Jan2021 15:45; had sore shoulder, extreme tiredness on 14Jan2021. The event outcome of had "crinkle' sounds in my left ear was not recovered, outcome of other events were recovering. No treatment was received for event. The consumer also reported his wife had slow onset of left earache, and she soon had "crinkle' sounds in left ear, and both experienced mild tooth/jaw pain on the left side of the mouth. If she had not matched he symptoms, he would not have attributed these two things to the vaccine. No Covid prior vaccination, no Covid tested post vaccination.
At approximately 4 PM on 2/25/22 Pharmacist opened a vial of Pfizer (orange cap) vaccine and withdrew 0.2ml. The vaccine and quantity were verified by pharmacist and the dose was given. At approximately 5PM pharmacist realized that the vial from which the dose had been drawn had not been mixed with diluent prior to withdrawing the dose. The patient's mother was notified and made aware that the potential for local and systemic adverse effects may be greater per the CDC.
Numbness on left side; Arm, Leg and Face, Started in afternoon, by evening I couldn't walk.  Went to ER, they determined it wasn't stroke, I was admitted, symptoms were gone next day and I was discharged.  Two days later, symptoms started coming back and with a severe headache.  Went to ER again and they treated me for the pain.  Most symptoms stopped after a few hours, but facial numbness remained and remains today.  It's never gotten better.
Starting 7/18 has sinus congestion, proceeded to get heavier along with mild headache , sought treatment at urgent care 7/20, asked if I should have Covid test, they said no.  Turns out 7/27 my son was diagnosed positive with my same symptoms + Loss of Taste, I went back to the same urgent care as seen on 7/20 and tested positive.  Mild symptoms, no fever, no breathing difficulties or loss of energy? Self quarantined as instructed until 8/30.
Night of vaccine (2/13) headache and body ache; Morning after (2/14 am) site injection swollen, red, and hot. body was weak, headache; Night after (2/14 pm) nausea, headache, injection site swollen, hot to the touch, and red. lymph nodes swollen (right armpit); Two mornings after (2/15 am) throwing up (4 times), injection site more swollen, hot, swollen lymph nodes (right armpit), body was clammy; Two evenings after (2/15 pm) injection site swollen, hot, swollen lymph nodes (right armpit), body was clammy; Three mornings after (2/16 am) injection site swelling increased, red, hot, swollen lymph nodes (right armpit), redness line from site to right armpit into a red circle
I have had headaches every day since I received the vaccination that last most of the day. There is a constant pressure in my head that moves around all areas, from the back base of the head, to the sides, temples, forehead/sinus regions. It is from waking until sleeping. Not incredibly intense, but constant. I have difficulty sleeping through the night and have not slept well since, either. I have also experience blurred vision. I have also experience bruising on various parts of my body including my arm, abdomen, and toe nails. My quality of life has suffered tremendously and I wish I hadn't gotten the vaccine.
The second day after the shot I was really tired. I also had a strange sensation on my face. A couple of weeks after I started to have insomnia. I kept waking up scared.  I started to have a flare up of my Arthritis. I still have feelings of tiredness, headaches and my back has been really flared up. I have a disability with my spine being crooked. The pain has been a lot worse than normal. I have been visiting the Chiropractor frequently three weeks after my shot. I did not have as much back pain before the vaccine.
Pt did not report any symptoms. Received bivalent covid booster after already receiving bivalent 09/30/2022.
Information has been received from a RN concerning an adolescent male patient who was vaccinated with a dose of varicella virus vaccine live. Several years later, the pt presented to the medical office with a mild case of chickenpox. No other symptoms were reported. Prescription drug therapy was not required. The reporter mentioned that the pt's sibling and about a dozen other pt's also developed a mild case of chickenpox post vaccination with varicella virus vaccine live.