chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Accidentally administered 2 doses of the bivalent booster; Vaccine was stored in refrigerator on 22DEC2022 and administered on 24JAN2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Accidentally administered 2 doses of the bivalent booster), EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 22DEC2022 and administered on 24JAN2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-2023, 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 24-Jan-2023, the patient experienced EXTRA DOSE ADMINISTERED (Accidentally administered 2 doses of the bivalent booster) and EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 22DEC2022 and administered on 24JAN2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Accidentally administered 2 doses of the bivalent booster), EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 22DEC2022 and administered on 24JAN2023) 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 assessments were provided for EXTRA DOSE ADMINISTERED (Accidentally administered 2 doses of the bivalent booster) and EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 22DEC2022 and administered on 24JAN2023).    No concomitant drug information was provided.  It was reported that by the pharmacist that they accidentally administered 2 doses of the bivalent booster doses (6 months - 5 years old) to 2 patients. Vaccine was initially stored in refrigerator on 22Dec2022.  No treatment drug information was provided.  The case was reported for one of the two child patients who had received the vaccine as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706842 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706842:Master case
From initial information received on 9/22/04 from a nurse practitioner regarding an adverse event occurring in the USA, it was reported that a female patient (born in 1979, age at the time of the event not reported) received a booster dose of TD ADS ADULT, lot number U1025AA, administered in the right deltoid and a TUBERCULIN PPD skin test, lot number 007D3P. administered in the right forearm on an unspecified date. Following the administration of the products, the patient also had blood drawn. Approximately ten minutes after receiving the TD ADS ADULT product, the patient experienced a generalized seizure with rigidity and tonic spasms in her legs, arms, and neck. After a minute, the patient became clonic and arched her back. The duration of the symptoms was reported as five minutes. Emergency services was contacted, but the patient refused to go to the emergency department. The patient was fine when seen for a 48 hour follow up visit and she was scheduled to follow up with a neurologist. It was reported that the patient recovered from these events. (OMIC) From additional information received on 28Oct04 from the initial reporter, it was reported that the TD ADS Adult was administered IM and the Tuberculin PPD was administered ID. Both products were administered on 14Sep04 at 11:00AM. The pt reported having a cousin with an adult onset seizure disorder. No other information was provided at this time. From additional information received on 12Nov04 from a nurse practictioner, it was reported that the pt denied further seizure or seizure like activity. Reportedly, the pt has not yet made an appt with a neurologist. The reporter stated that because this facility is not the pt's primary care site, their contact with the pt is limited and for further information direct contact with the pt is probably best.
arm pain in shot arm suddenly began to get worse at 10:00 pm.  ,  severe underarm pain began then also and found swelling like an orange,   swelling lasted 8 days but was decreasing in size.    became very cold and went into violent shaking tremors - 4-6 of those as i lost count.  these violent tremors were from 10:30 pm on monday through 1:45 am tuesday.   i had one other tremor on day 4.  fever for 4 days and spiked on 5th day ranging from 101.8 - 100.3,      severe all over body aching especially right armpit, lower back especially right side and across shoulders,    aching lasted 8/9 days and lessened after 5 days.   pressure on chest which ranged from very heavy to mild and in some form lasted 10 days,   hurt to breath but i could breath.    woke up on night 7 with heavy, painful chest pressure on left side but it subsided in 6-8 hours.     nasty headache began day 2 and lasted several days;    nothing relieved it.  headache for 4/5 days and then off and on for a few days.  i am not prone to headaches.  coughing which lasted several days.  on third day post vaccine had violent nausea one time.    became weak and lightheaded.  no energy and stayed in bed 5 days.   on day six i started getting out of bed for several hours multiple times/day.  weak and very low energy.   exhausted easily.     i had some of these symptoms for 10 days.  the first 5 days were terrible and i was very ill.
Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:51 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 27.93  No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit at  09:00 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 09-Nov-2021. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow up received reporter address updated.
Left side of neck and armpit began to swell, unable to move arm properly, extreme joint aches. After receiving 2nd dose symptoms worsened.
Narrative: Pt was vaccinated in a timely manner in Feb/Mar 2021 but was hospitalized due to positive COVID test 8/20/21--admitted to weakness, experienced hypoxia, improved and was later discharged.
First I got a red rash at the injection site.  It was hot to touch and itched.  About 2? X 4?.  Over the next few days, Arm became swollen and red rash spread and covered entire arm from elbow to shoulder.  Used Benadryl at first, which had no effect.  Took prednisone on the 6th and swelling slowly decreased and went away. Arm was swollen and red for at least a week
Severe pain in the left armpit; Shingles; Pain around the injection site which became more painful; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 28th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 28th October 2020, less than a day after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced injection site pain. On 7th November 2020, the patient experienced axillary pain and shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the axillary pain and shingles were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, axillary pain and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and on the same day experienced pain around the injection site, which lasted for few days and then resolved. On 7th November 2020, patient was diagnosed with shingles and had pain in left armpit. The patient was treated with valacyclovir for shingles 3 tabs once daily for 7 days. The o lot number and expiration date.
About one week from vaccination patient developed a red rash on her arm below the injection site that lasted about 5 days. She reports no fever or other adverse effects. She does get allergy shots, and her allergist recommended her to take benadryl before her next COVID vaccine.
Lack of appetite; Aches; Sleepiness; Lethargy; weakness; Body chills; Sharp pain in her joints (shoulders and knees); Nauseated; fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lack of appetite), PAIN (Aches), SOMNOLENCE (Sleepiness), LETHARGY (Lethargy) and ASTHENIA (weakness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced DECREASED APPETITE (Lack of appetite), PAIN (Aches), SOMNOLENCE (Sleepiness), LETHARGY (Lethargy), ASTHENIA (weakness), CHILLS (Body chills), ARTHRALGIA (Sharp pain in her joints (shoulders and knees)), NAUSEA (Nauseated) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse reaction, at a dose of 1 dosage form once a day. On 08-Mar-2021, DECREASED APPETITE (Lack of appetite), SOMNOLENCE (Sleepiness), ASTHENIA (weakness), CHILLS (Body chills), ARTHRALGIA (Sharp pain in her joints (shoulders and knees)), NAUSEA (Nauseated) and PYREXIA (fever) had resolved. At the time of the report, PAIN (Aches) and LETHARGY (Lethargy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Body temperature: 99-102 degrees f (High) fever.         No concomitant medications reported.    This case was linked to MOD-2021-037190 (Patient Link).
Honestly, I may have recorded things wrong in the check-in. I just had a chest cold that knocked me down for several days. Got tested for COVID and it was negative. Apologies if I accidentally caused a flag to be raised!
fatigue; mild stomach issue; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of bnt162b2 (BNT162B2- PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 01Feb2021 at 09:40 (at the age of 82 year) as SINGLE DOSE for covid-19 immunisation. The patient medical history reported as none and relevant tests reported as none. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication from 01Feb2021 to 04Feb2021. Patient was not received any other vaccine prior four weeks of vaccination. Patient received second dose on 22Feb2021 at 9:40 AM (batch no: EN5318) for COVID-19 immunisation at Hospital and experienced fatigue and neck pain. In 2021 the patient experienced fatigue and mild stomach issue for 3 days. She explains that on Monday she got her first dose. Today she was talking with some and it was mentioned that she had gotten a steroids injection the Friday before the shot was given and that might not have been a good idea. Caller would like to know if we have any information regarding this. It was administered on 10Feb2021, but the lot was left blank. It was explained the steroid shot was before getting the vaccine. Therapeutic measures were not taken as a result of the events. The outcome of the events fatigue and mild stomach issue was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Arm swelled up on top sore and then developed a 3 inch red spot.      I also had chills and preferred continuously all second day
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Concomitant medication was not reported. Patient ID was reported. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Reportedly, in this report the patient was not Eligible. Breakdown of doses were reported as 51 doses from Lot AS7140C, and 60 doses from Lot AS7148B.  Treatment drug was not reported.   This case was linked to (E2B Linked Report). Sender's Comments:
Initially: pain at injection site x 3 days On Day 7... worsening pain at injection site, arm red, swollen and painful to touch. Fever 100.1, joint pain and terrible headache. On Day 8 - rapid Covid negative Treating for suspected cellulitis on left arm at injection site.
p/vax pt face red c/o itching on palms & feet;vitals 97.9, BP 160/80, P92, R20;mild itching;pain @ inj site, diarrhea;flu like sx;
none- administered 12+ dose instead of 5-11 dose. parent contacted to inform of dose error and informed of what symptoms to look for.
Fever of 101.0  F.  Nausea, diarreah. Chills.
child recvd DTP/OPV/HBOC on 18Jan, @ 3 am 19Jan woke up. Had seizures took to ER-was admitted, needed Valium to stop seizures. T increased 104.8 /p seizures. Cultured RSV
28FEB92 pt recvd 1 dose of Engerix-B & 29FEB92 devel a 4x4" rash on chest; no tx was given & rash cleared on 3AMR92; pt will continue w/vax program;
Redness, itching, swelling near inj. site (5 inch length, 3 inch width). Prednisone 10 mg x 5 days.
2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-graded x 2 with poor appetite and recent 6lb weight loss.  2/8/21-APRN updated regarding poor appetite and difficulty chewing as well as downgraded texture of diet. Also informed of increased s/s of discomfort and increased use of PRN Oxycodone for pain. 2/9/21- elevated temp 100.7. 2/9/21 Covid pcr test negative. 2/9/21-N.O.?s APRN BMP, Albumin and Pre-albumin Level in am. 2/11/21-elevated temp 100.4. Covid rapid test negative. 2/12/21- CBG recorded at 517 at 5:20 am. Resident also has an elevated temp of 100.9. Tylenol administered per order. Vital signs include resp 24, radial pulse 134, O2 sat 83%. Supplemental oxygen administered via nasal cannula. Head of bed elevated. DR. notified at time via telephone. Order given for sliding scale for CBG. Guardian updated regarding changes in residents condition, poor prognosis. Guardian requests Hospice eval and admit. Guardian requests comfort care no hospitalization, no IV's, no G-tubes, no labs etc, D/C of Palliative services. ARNP informed. 2/12/21 Acute Telehealth visit with APRN due to increased lethargy, elevated CBG?s despite poor appetite and insulin administration. Resident unresponsive to verbal and noxious stimuli at time of visit. N.O. Morphine sulfate 20mg/ml, give 2.5mg PO/SL Q4hr PRN pain/shortness of breath. 2/12/2021-Admitted to Hospice, Lethargic, diaphoretic, T 98.1 P 130's R 18 O2 high 80's to low 90's via O2 mask at 3L. 2/12/2021- Resident legs and arms noted to feel cool this afternoon, 02 sat was 97% with 02 on @ 3L with mask Noted resident with sob and increased pulse. Prn morphine 0.25ml sl. given with good effect. Resident was less restless and quiet in her bed. Checked on resident several times this shift for needs. Resident noted to not move in her bed @ 8:15pm and noted she was not breathing. Supervisor called and pronounced resident deceased.
Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient had been living in the facility receiving palliative care for pancreatic cancer. Note on 2/1/21 report patient no longer eating and drinking with the patient actively dying. Only comfort measures were in effect.
8:00 AM received second vaccine shot at the Hospital  8:30 checked in with nurse - felt fine - went home  4:00 PM began to notice some injection site pain  6:00 PM some slight lethargy, aches and malaise  10:00 PM above symptoms worsen  12:00 midnight full on aches, pains, chills, shivering, and nausea. Took advil + tylenol and felt better within 24 hours.
Initial unsolicited report received from a Consumer on 27 April 2017. This case involves a 72-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date not reported) by intramuscularly in right deltoid on 05 November 2016. Patient's ongoing illness, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were reported as unknown. On an unknown date, few days following the vaccination, the patient had soreness in the arm and two days later she had accupuncture for the sore arm. On an unknown date, following the vaccination, the patient had an MRI and X-ray, and was found to have a torn rotator cuff and perforated tendon. The patient required ER visit. Other laboratory investigations were not reported. The corrective treatment was not reported. The patient was not recovered from the events. Upon medical review, the case was considered as serious due to important medical event. List of documents held by sender: none.; Sender's Comments: Sanofi company comment dated 03-May-2017: A 72 year old female patient experienced Rotator cuff tear, Tendon rupture and pain in arm few days after vaccination with FLUZONE HD. Time to onset is compatible and all events are unlisted. Patient's medical history, work style, any history of bone spur, concurrent conditions and concomitant medications were not reported. Based upon available information the role of the vaccine cannot be assessed.
About a week after the first Covid shot, I started to get a chickenpox like rash that started on my thighs and progressed down my legs, then to my arms, neck and stomach.  The rash caused an intense itching.  After the second covid shot, the rash became even more intense.  I tried over-the-counter itch relieving medicines to no avail.  Finally I went to the doctor and she prescirbed Methylprednisolone for 6 days.  This seemed to help, but even after the 6 days of treatment the rash is slightly visible and itching can flare up still.   I wasn't sure what had caused the rash as I had done nothing different and it was only my suspicion that it might have been as a result of the Covid vaccination, as I hadn't seen any publicity about a delayed onset of an all body rash  as a side effect of the vaccine.  Today it was in the news, and that confirmed my opinion that I had been having an adverse side effect of the vaccine.