chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RN accidentally gave a 23-year-old patient the senior dose (Fluad) of flu vaccine instead of Flucelvax.  She did not realize it until after the clinic had ended. Patient was contacted on 10/9/2023 at 2:33 PM and notified of the error. He reports that he has had no adverse symptoms and "no problems." He expressed appreciation for being notified. He said, "I appreciate your letting me know. I haven't had any issues."
It is in my neck muscle/had a stiff neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset Oct2022, outcome "unknown", described as "It is in my neck muscle/had a stiff neck". The event "it is in my neck muscle/had a stiff neck" required physician office visit.  Additional Information: It was reported that patient had the Pfizer bivalent booster on 15Sep2022. This would be my 5th Pfizer shot. Since Oct, had a stiff neck and other issues on the left side where patient had the shots. Patient had paid out so much money to get to the bottom of it and was going for trigger point shots at the end of Jan. At this point, the Ortho specialist feels it was in patient neck muscle. We thought it could be from raking leaves and other yard work but patient had never had any issues before. Going to contact the CDC next.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
First shot no problems. Second day after second shot, fatigue, could not get warm, redness and heat at the injection site.  Diminished appetite.  Body aches. Third and fourth day after shot redness and itching at injection site
Had DPT and Pneumovax on 4/20/06 within 24 hours developed pain, swelling, redness at site of Pneumovax and temp 103.7, fever lasted until 4/24.
Right arm swelling after pneumococcal 23-valent on 3/26/2020 DX cellulitis of right upper arm.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2013, at approximately age 75, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The patient claimed damages as a result of: injury to himself and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
pt seen as walk-in on 19APR99;stated recv pneumovax & arm was red & tender;upper rt arm red over 4x6inch area w/induration @ upper edge measuring 2" in diameter;pt started on dicloxacillin for cellulitis;
Severe swelling, Redness, itchiness, tenderness and discomfort. Patient was instructed to use benadryl topically, ice pack and take Tylenol is necessary.
patient was administered Moderna vaccine while temperature excursion assessment was ongoing; patient was administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patient was administered Moderna vaccine while temperature excursion assessment was ongoing) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patient was administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patient was administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter confirmed that patients had been administered doses while the temperature excursion assessment was ongoing.  No treatment medication was reported.
Discharge Provider:  Primary Care Provider at Discharge: Admission Date: 1/6/2023 Discharge Date: 01/07/2023 COVID positive date: 01/06/2023 Chief Complaint Patient presents with ? WEAKNESS         HOSPITAL COURSE     Patient is an 88-year-old man in admitted to hospital with generalized weakness in the setting of COVID infection. Patient was admitted January 6, 2023 for evaluation with physical therapy and occupational therapy. Upon presentation the patient was found to have stable vital signs and overall unremarkable labs. He was a bit confused and disoriented on his presentation. As he was COVID positive it is likely that this viral infection as source of the patient?s symptoms. He is not hypoxic and has had symptoms for couple of days without a candidate for Decadron or remdesivir patient did work physical therapy and occupational therapy on January 7th is recommended patient return home with home health care. This time he is clinically stable. Patient is oriented x4 and would like to return home.
pharmacist administer vaccine to 9 patients. It looks like the lots are expired; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pharmacist administer vaccine to 9 patients. It looks like the lots are expired) and NO ADVERSE EVENT (No adverse event) 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 EXPIRED PRODUCT ADMINISTERED (pharmacist administer vaccine to 9 patients. It looks like the lots are expired) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pharmacist administer vaccine to 9 patients. It looks like the lots are expired) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (pharmacist administer vaccine to 9 patients. It looks like the lots are expired).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were provided.  There were no specific dates when administration occurred, but they had the lot number, and it was before 13 Jul 2023 and Lot numbers were AS7165B, 020H22A, 021H22A, 017H22A. The patients were fine.   Dosage text for suspect product was reported as unknown.  No treatment medication was provided.  This case contains information for the patient 2nd out of 9 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-734387 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734387:Master case (Patient 1)
Pt developed fever to 103 and had a seizure lasting 2-3 minutes. Was seen at hospital. Normal blood tests seizure occurred approximately 7pm 3/3/03.
Pt waited 10 min after receiving YF-VAX + ENGERIX-B. Pt had reaction of SOB and urticaria app. 15min after he left FLAS. Pt was treated with 50mg IM right diphenhydramine.
Numb Wrist and hand area -lasting until 12/31/2020, still a bit swollen  2 bloody noses 1 at home around 11pm,12/31/2020- at work around 1pm Chest Rash 12/30/2020 at 6pm
stroke; neuropathy; post herpetic neuralgia; cardiovascular event; vision problems; hearing problems; balance problems; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or about 10-AUG-2015, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date, shortly after receiving zoster vaccine live(ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster, post herpetic neuralgia, stroke, cardiovascular event, vision problems, hearing problems, balance problems and neuropathy. As a result of these symptoms, patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of zoster vaccine live(ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered all events to be disabling and related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, the events of stroke and neuropathy were considered to be medically significant.
Patient received the Bivalent Moderna vaccine before completion of primary vaccination series. The patients first primary series dose was given on 10/25/2021. Per CDC recommendations, the patient was also given the Monovalent Moderna vaccine on the same day after receiving  the bivalent vaccine.
Injection siite tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Injection siite tenderness) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TENDERNESS (Injection siite tenderness). On 04-Mar-2021, TENDERNESS (Injection siite tenderness) had resolved.            No treatment information was reported. no concomitant was provided   This case was linked to MOD21-045818.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Contact address updated
Hematoma (L) thigh. Treatment: TYLENOL 1.25ml q 4-6 hrs and warm compresses 3-4x day for 10-15 minutes.
03/24/2021 in the morning 8;00AM- My chest felt heavy. As the morning went on my neck started getting weaker. It was difficult to hold up my head. I called up the doctor at 10:45AM. I was feeling tightness when breathing. I had a nasal drip going on. The nurse said to go to the urgent care to local hospital. They did a complete work out on me. I was there for a couple of hours. I started felling better slowly by slowly without any kind of medication. They found  right bundle branch on my EKG.
2 days p/vax pt devel significant diarrhea & dehydration, T103.6 required hosp & IV fluid mgmt;
Information has been received from a pharmacist via a company representative referring to a 62 years old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown. On 02-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date unknown) subcutaneously. On 06-SEP-2016, the patient experienced a red, bumpy rash. No treatment was given for the event. The patient had sought medical attention. The patient did not recover from the event. The causal relationship between the event and ZOSTAVAX was unknown. Additional information has been requested.
COVID breakthrough case. I received my 1st booster shot on 11/23/2021 and my COVID symptoms started on 03/14/2022 I had sore throat, body ache and fever, and little cough. I did home test on the same day which was positive. And the doctor provided me with a referral for PCR test which was also positive. I called through tele health and the  doctor prescribed me with Tylenol and Mucinex. I took it for few days and I was back to normal.
2 days p/vax pt c/o legs hurting, couldn't walk, ankle edema (no local rxn); took pt to MD 27APR92 dx infection; notified clinic 28APR92 suspected rxn to vax;
wheezing, hives, nausea, 5 minutes after DTaP, IPV, MMR.  Treated with Benadryl, Albuterol, Nebulized, no known allergies
Case number PHEH2014US019007 is an initial spontaneous report received from a consumer (pharmacist) on 19 Sep 2014. This report refers to  44 year old female patient. Her past medical history and concomitant medications were not reported. On 18 Sep 2014, she was vaccinated with a dose of FLUVIRIN (batch number: not reported) by her colleague. After the vaccination, half of the FLUVIRIN dose ran down her arm. It was also reported it felt like someone squeezed an alcohol pad down her arm. No adverse events were reported following the maladministration and medication error (vaccine underdose and inadvertent exposure to vaccine).
Pt received Tdap on 3/8/12 as part of her annual exam. A few hours after vaccine administered she began to feel "fuzzy" and was tired. On 3/9/12 she woke up & (L) axillary was swollen & painful. (L) deltoid was also painful. No rash or fever.
Started with fever, headache and chills, 1/15/2011 fever, chills, diarrhea, paleness, tongue while frothy coating, hives appeared that evening.  Sunday- slight fever, hives, chills, paleness, tongue felt prickly, while frothy coating on tongue- took Benadryl on 11/15/11 evening, and was started on Prednisone 11/16/11.
fever, chills, headache, fatigue, weak, nausea, no appetite, vomiting (the first day), dizziness, body aches and pains
Arm pain (injection site and gravitating to left elbow), generalized weakness, severe headache, breathing difficulty (mild wheezing), flu-like symptoms, joint pain and increased sweating, on set of symptoms, one hour to twelve hours after injection.
ITP - Platelet count dropped to 17k. Have been on Promacta since July 2021.
Resident extremely confused. BP 125/66; Pulse 124, Temp 99.7; 02 at 92% (around 10:00a.m.) BP 138/84; Pulse 125, Temp 99.5, O2 at 95% (around 1:00p.m.)
Patient was given High-Dose 65 and older vaccine and patient is only 63 years old. Patient was asked if name and date of birth on form was correct, and patient confirmed, but it was not the correct patient. Patient was also asked if he was to get the 65 and older flu shot, which they confirmed as well.
Anaphylactoid Rxn, Local rxn at injection site, SC Epi, PO Prelone, Benadryl.  10/24/06 Received medical records from clinic & hosptial which reveal patient had well child visit on day of vax with only phimosis noted as a problem.  CBC done at that visit revealed WBC 9.9, plts elevated at 408, low MPV 7.4 and elevated mono count 0.8.  Next clinic visit was 8/21 s/p hospitalization for probable anaphylaxis s/p vax.  Symptoms had resolved except for urticarial rash on neck & upper chest.  Dx: anaphylactoid reaction to vax & was referred to immunologist./ss 10/24/06 Received medical records from hospital which reveal patient admitted 8/19/06 with dx: angioneurotic edema, cellulitis of hand, topical dermatitis.  Had itch rash at nape of neck & swelling of lips & tongue x 1 day & swollen, tender left deltoid where he had received all vax.  CBC revealed WBC of 17.5.  Given SQ epi & oral Benadryl.  Admitted for overnight observation & further management which included IV antibiotics, & oral Benadryl & prednisone.  D/C next AM on oral antibiotics, prednisone, benadryl & epi pen for PRN use./ss
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose beyond 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 22-Aug-2022 9:00 AM and administered on 23-Aug-2022 9:00 AM) and NO ADVERSE EVENT (No Adverse Event) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B22A) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2022 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose beyond 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 22-Aug-2022 9:00 AM and administered on 23-Aug-2022 9:00 AM) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose beyond 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 22-Aug-2022 9:00 AM and administered on 23-Aug-2022 9:00 AM) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose beyond 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 22-Aug-2022 9:00 AM and administered on 23-Aug-2022 9:00 AM). Concomitant medication was not provided. It was reported that patient was administered with First booster dose. The vial was initially stored in the refrigerator on 15-Aug-2022. The vial was first punctured at 22-Aug-2022 at 9:00 AM and the vaccine was administered on 23-Aug-2022 at 9:00 AM. The vial was stored post puncture in room temperature. The vial did not undergo any temperature excursion. For roughly 24 hours vial was exposed to room temperature range. Treatment information was not provided.
no detectable titer p/series in JUL94;serum sample done on 23NOV94;will take addl ID booster dose
Provider informed me that medical assistant injected patient with COVID vaccine Moderna on Friday 03/19/2021 but the syringe was defected and popped off from the needle. Provider stated that content of vaccine did not appear to be injected at all. Provider evaluated the patient and order the dose to be repeated.
6 days after receiving the first dose, I suddenly noticed a circular area of redness, swelling, and itchiness around the injection site. 3 inches in diameter. It has been 5 days and is still mildly red, swollen, and itchy.
After 15 min observation pt felt dizzy, drank water waited an additional 15 minutes and felt better
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L043213, expiration date 28-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. No product quality issue was involved. Administered dose of vaccine experienced the temperature excursion of low -28 degrees Fahrenheit for 5 hours on 22-APR-2016. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pain, burning, warmth, redness, cellulitis at injection and below injection site- Keflex and Prednisone for 10 days.
I felt awful the day after the 2nd vaccine but the started feeling better. But then a few days later I got a lot worse. Swollen lymph nodes in left collarbone area, extreme whole body pain
cold sores; This case was reported by a other health professional via call center representative and described the occurrence of cold sores in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient expereinced cold sores after receiving a dose of Shingrix.
throat swelling; tightness; This is a spontaneous report from a contactable consumer (patient herself). A 56-years-old non pregnant female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 08:15 (at the age of 56-years-old) as dose 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included asthma, anxiety depression, chronic fatigue and fibromyalgia. The patient received other unspecified medications in two weeks. The patient had unspecified known allergies. The patient received the vaccine in a hospital. The patient did not receive other vaccine in four weeks. On 04Mar2021 12:00 (reported as mid-day today), the patient experienced throat swelling, felt it around her neck in the evening and tightness but no sore throat. There was no treatment received for the adverse event. The patient did not experience covid prior vaccination nor was tested for covid post vaccination. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Swelling @ inject site; Arm became painful noted tingling in lt hand & numbness in arm; To ER heaviness @ shoulder & drawing feeling @ lt ear lobe down lt arm; Sharp pains lt breast, cont numbness in lt arm; Inject site area warm to touch;