chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported  No Treatment medication reported   The vaccines was  stored in freezer,  out one to two vials were taken out and placed in fridge each day as needed. Around 500 patients received the vaccine.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot number: 0698Z; expiration date: 28-APR-2011) on 18-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On 18-DEC-2012 the patient received expired ZOSTAVAX injection. No adverse event was reported. No treatment information was reported. Additional information has been requested.
Outbreak of Herpes Simplex.  10 blisters around mouth, one blister on right side of face and one blister at injection site.
dime-sized area of erythema -> 5cm in diameter area of erythema over 48 hrs after vaccine administration, consistent with dx of cellulitis -> tx w/clindamycin x5 days (PCN-allergic w/anaphylaxis rxn)
Patient received wrong dose of flu. Instead of 0.25ml patient received 0.5ml.
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 4 months old male patient who received vaccine FLUZONE QUADRIVALENT. The patients past medical history and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) (Lot number, expiry date and dose not provided) on 11-Oct-2018. On 11-Oct-2018, the patient received a 0.25ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259NA, expiry date 30-Jun-2019 via intramuscular route in the right thigh. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that FLUZONE QUADRIVALENT 0.25mL prefilled syringewas administered to a 4 month old patient/ did not result in follow up visit/treatment. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender- none.
Swelling of injection site and pain in muscle from injection, unwell feeling for two days, nausea for two days and diarrhea for one day, muscular aches and pains .
Patient stated he had to go to the emergency room due to "severe" bloody stools.  ER doctor stated it was unlikely related to vaccination but couldn't rule it out.
Pain in left arm. She can't lift her arm; It's very painful. We read the package, and it said pain could last for three days, but it has been a month now. It is now getting worse. Now if she leans on that arm it hurts. This is the first time in her life that she has experienced something like this.  She went to the doctor a few days ago. The doctor dismissed the idea that the swine flue caused this problem, saying pain only lasts three days. The doctor had an x-ray done. The doctor said it is osteoarthritis. My mother will see a physical therapist next week to treat her condition as an osteoarthritis issue.  However,
As the flu vaccine was being administered the patient indicated it was hurting. After the injection was complete she stated that she felt dizzy. I instructed her to take a seat at which time she became pale, and collapsed to her right. I informed a technician to call 911 and hand me an emergency epinephrine pen. I laid the patient on her back and tilted her head to open her airway. She was unresponsive, with a faint pulse and so I administered epinephrine. She became responsive within 10 seconds of epinephrine administration. I noticed that she urinated following the event, at which time the patient and myself realized she had seized as well. EMS arrived and took her to the ambulance for further evaluation.
It appears pt is having a reaction around the area of flu shot. Going to be evaluated for cellulitis/mrsa awaiting office visit notes
After the 2nd dose on 4/2/21 i became violently ill for 3days.  I had vomiting and diarrhea that lasted for approximately 16 hours, severe headache,  nausea so bad that i had trouble keeping down water. On the 4th day i was able to keep down water, sips of coke and pedlite.  The energency video doctor told me to take Benadryl and prescribed something to settle my stomach.  I was so weak and slept continually for a couple of days.  After 6 days since the vacination   My stomach is still uneasy and i am weak, but starting to do daily chores again.
Fever 104 Nausea  Headache Pain in joints Pain in body Sore muscles Fatigue
After the vaccination, as the days passed, the food began to smell strange. It has already reached the point that I feel that smell in the taste. Food and liquids taste like metal to me. Some foods like bread I can't tolerate.
I was exposed by my daughter the week before. I took her to the doctor and she was diagnosed 01/05 with the flu and COVID-19 and a sinus infection. I took her home and got her medications. I thought I had already been exposed so I had not put a mask on in the car. That was on a Thursday, so on Sunday 01/08, all of a sudden in the morning, I got a scratchy throat that progressed during the day. I sent a message to my doctor on my online patient portal. I came in the next day so I could test for COVID-19 and flu. I tested negative on both. At that time, I started to have a cough. That's when my doctor gave me the prescription for Bromphen cough syrup. She also gave me a prescription for home COVID-19 kits and I picked those up. She said in two days to test again and see if I was negative or positive. She said I may have come in too soon. She also said if my other family members were sick to contact her as well. Wednesday, I did do one of the COVID-19 tests at home. It wasn't too clear to me at the time but it was positive. I took a picture and let her know I needed to come in to double check. I went and tested again in the office and tested positive again on 01/12. She gave me a prescription for Paxlovid and an antibiotic. I took those and she told me to stay away from my husband for 5 days as well. We wanted to be careful. I called home and told my daughter so he could get his stuff out of the bedroom and move into a different room in the house. He stayed completely away from me and my daughter brought my food to me. I did really well and got up every morning. Once I started taking Paxlovid, my symptoms started getting better. I was also taking Zinc to help with recovery. I sat in my room and did activities to keep my mind occupied. It was hard staying away from my daughter and husband. I would say I had a mild case of COVID-19. When I was done with the medication, I felt great. My last Paxlovid was the morning of the 6th day. I went ahead and stayed in my room all day just in case. I did come out of the room to do some laundry to wash sheets, and I had a mask when I left my room. By 01/19 I was out of quarantine and started eating meals again with my family. We made a lot of changes in the household. Everything is done with precaution. My husband did not move back into the bedroom until 01/20 because he was cautious. Over time he started to feel comfortable being around again.
On 1/21/21, 2"X2" red area noted on left arm,  below the vaccination site. It is warm and itchy. No pain, good ROM to left arm.  Apply ice and took acetaminophen.
Extreme swelling and pain of left arm, to the point where it is 2x the size of the right arm in some places. The skin in the left armpit is extremely red and peeling whereas the right armpit is unchanged, so it's unlikely it's a reaction to soap or deodorant. The injection site itself is very red and swollen but it's to be expected. As time goes on from the vaccination date the swelling is getting worse, and the pain is more localized to the armpit instead of the entire arm.
Severe rashes all over the body. Patient is currently on following medications since 03/13/2021: 1. Cetirizine  10mg 1 tablet daily 2. Famotidine 20 mg 1 tabled daily 3. Prednezone 10mg tablet - 5 tablets day 1,&2 ,4  tablets day 3&4, 3 tablets day  5&6, 2 tablets day 7&8, 1 tablet day 9&10 4. Triencinolone acetonide 0.1% ointment
administered only the liquid portion; administered only the liquid portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 26-Jul-2022 Reporter's Comments: The patient was administered only the liquid portion of the Menveo vaccine. The reporter consented to follow up. Additional Supportive Information: The patient was administered only the liquid portion of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
At about 6:00 PM on one evening in September 2022, I experienced extreme exhaustion, which was stronger than my usual fatigue. This persisted until bedtime. During the night, I developed a severe, deep, nonproductive cough. The cough and fatigue lasted for about five days. For the first three days, the fatigue was extreme, and then it began to let up a bit afterwards. After the fifth day, I felt pretty close to normal again. On the second day of my symptoms, I took a home antigen test and got a positive result. I called my doctor and got a prescription for PAXLOVID, which I began taking that day. The cough lasted for maybe four or five days before it ended, and it remained nonproductive. I took PAXLOVID for the prescribed five days, and by the time I finished it, I felt pretty much normal again. The cough and the fatigue were gone. The PAXLOVID left a metallic aftertaste. I never lost my sense of taste or smell during my bout with COVID-19.
Pt has 2 inch x 2 inch bruise to area. Pt reports arm had bigger bruise a few days after receiving vaccine. No hardness, swelling, redness, or warmth to area.
Redness, swelling & itching the day of lasted a couple days, then came back on the 8th day & has gotten worse & spread since.  It looks awful...the itching is on & off & sometimes cortisone cream doesn?t help.
Pt recvd 3 doses of Engerix-B & did not respond; pt recvd 4th dose of Engerix-B 9AMR92 titer results pending;
Within 1 hour of vaccine tingling in left hand and left foot.  Is much better, however, still not entirely resolved. Within 8 hours of vaccine and lasting 2 days: headache, nausea, chills (no fever), fatigue, body aches
Immediate left arm soreness, traveling into left arm and into neck.  Now, after over 9 hrs. pain exists;  General tiredness occured about 2 hrs. later;  Approx. 4 hrs. after injection, severe nausea, dizziness, headache, paleness and clamminess, profuse sweating, extreme muscle weakness.  Patient sat on edge of bed for about 5 minutes with fan directly on.  Then laid down in bed and slept for 3 hrs.  After awakering, nausea, tiredness and weakness still present.  Next morning, nausea (though not severe), muscle tiredness, and fatigue continues.  Soreness in arm, shoulder and neck continues.
6 month old received immunizations of DTap, hepatitis B, rotavirus, HIB, PCV, and IPV on 5/04/2009.  Had 5 minute generalized seizure and when presented to Pediatric ER noted to have fever to 101.3 degrees.  Patient fully recovered back to baseline while in emergency department.  Discharge diagnosis was febrile seizure.
got covid; got covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got covid". Caller (consumer) needs some information on how long she will need to wait to get her 2nd booster dose when at a quarantine. She mentioned that she is due for the 2nd booster and got covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 28-OCT-2013, the patient was inoculated with ZOSTAVAX by a physician at the physician's office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2014, the patient was treated by another physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
moderna left deltoid. Pain down left arm and numbness started right away, persist 2 weeks later.  Also loss of range of motion and stiffness/pain in left shoulder
Continue to randomly experience irregular heartbeats which are so erratic they cause black outs, difficulty breathing, chest pain, and vomiting. I have had irregular heartbeats twice in the past but nothing as severe as these and never on a "regular basis" as I have them now.
Patient was given 3 vaccines she described feeling sick after Tdap and MENACTRA had been given and then dizzy after GARDASIL was given BP was 70/50 at that time
01:25 pm: Patient felt lightheaded and warm (despite being cold prior to vaccine since it was "cold" inside), breathing was normal. Patient was still seated but legs were elevated. Patient given cool cloth to put on her forehead/neck.; 01:30 pm: Patient was still lightheaded, was slightly pale and had clammy hands. Blood pressure via automatic blood pressure monitor with arm cuff on the right upper arm was 63/47 with a pulse of 41. Breathing was normal. No signs/symptoms of anaphylaxis, therefore NO Epi-pen was administered. Patient was lied down with legs slightly elevated.; 01:32 pm: 911 was called. Patient states her right arm, primarily her right hand was tingly with loss of feeling. Patient reports no pain.; 1:38 pm: Patient reports blurred vision. Patient is pale and still a little lightheaded. Patient reports only having some yogurt today and no history of hypo/hyperglycemia. Blood pressure via automatic blood pressure monitor with arm cuff on the right upper arm was 100/70 with a pulse of 62. Breathing still normal. Still no signs/symptoms of anaphylaxis, therefore NO Epi-pen was administered. ~01:40 pm EMS arrives and leaves building to parking lot with patient on stretcher at ~01:50 pm.
Developed urticaria without other systemic symptoms. Suspect of DTaP as most redness was around that injection.
Pt recvd vax & 10 mins p/vax exp a more intense muscular pain from the trapesium muscle to the neck across back; pain also included some elbow pain; pain had lessened & was only in neck & shoulder; No fruther details were provided;
The patient experienced swelling of arm, developed fever on Sunday 12/15/13. His PCP prescribed Prednisone and I spoke with patient 12/18/13 -> pt feeling much better.
A non-serious spontaneous report of FLUMIST on face and possibly in eyes was received from a pharmacist concerning a 25-month-old female. Neither relevant medical history nor concomitant medications were reported for this patient. On 14-Oct-2011, the patient turned her head when FLUMIST was administered and some of the spray/mist got on the patient's face and may have reached the patient's eyes. The patient's eyes were flushed. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's post-marketing commitment for the indicated population of 2 years to 59 months of age.
Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 2 out of 25.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Mater case, Patient 1; Reported Cause(s) of Death: Cancer
12/26/2020 Chills, headache, fever 105.00, occasional dry cough, throat tickle, body aches. 12/28/2020 low grade temperature- fever, occasional dry cough.
a 5 month and 9 days female patient received a dose of Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number Z9NZ2, expiry date 3rd December 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th July 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 12th July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: Medical assistant reported that 5 months and 9 days old patient received Kinrix mistakenly, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Information has been received from a physician concerning a 72 year old female patient, with type 2 diabetes mellitus, hypertension, hyperlipidaemia and with drug reaction/allergy to alendronate sodium (WAES# 1206USA04609) allergy and penicillin allergy, and a history of chickenpox in childhood, who on 06-JUN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 672932/0599AE) (route not reported), 1mL (also reported as 0.65mL), in left deltoid. Concomitant therapy included ASA 81mg, ALEVE prn, metformin 500mg twice a day and lisinopril (manufacturer unknown) 10mg daily. Physician reported that on 07-JUN-2012 the patient experienced severe back pain. The doctor was unable to see her, so she went to the Emergency Room and was released. The patient went back to the Emergency Room on 16-JUN-2012 and was diagnosed with disseminated zoster rash. On 18-JUN-2012 the patient back to Emergency Room and was admitted with a severe rash and facial edema. The patient was given acyclovir and was now markedly better and improving remarkably quickly. Additionally physician reported that on 21-JUN-2012 the vesicle/lesion sample obtained. Also the patient had innumerable lesions-of diffuse bilateral vesicles rash to face, arms, trunk and legs; disseminated zoster rash bilateral, involving face, trunk and legs. Physician reported the patient had not recent exposure to chickenpox and shingles. Additional information is not expected.
Loss of bladder control in approx 20 min lasting approx. 12 hours. Chills, cramps in arms, hands, legs & feet 3-4 hrs. Weakness, mental status change - 30-60 sec following morning.
Dizziness, loss of range of vision in left eye - couldn?t focus vision, numbness/tingling in left leg and arm.  Sudden headache onset. I thought I was having a stroke but decided to rest for a couple hours. Vision improved after waking. Numbness lessened but did not completely clear for a week.
Headache, Myalgia,  weakened eye clarity, arm soreness, Narrative: N/A