chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stored in a freezer or refrigerator; This non-serious case was reported by a consumer and described the occurrence of incorrect storage of drug in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced incorrect storage of drug (Verbatim: stored in a freezer or refrigerator). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date 17 Oct 2023: The reporter stated that he/she went to pharmacy, on Sunday to inquire about your RSV vaccine. I The reporter wanted to make sure they had GSK's vaccine and not Pfizer's. The pharmacist pulled the box of vials out of a Styrofoam cooler on the counter. The reporter stated that shouldn't it be stored in a freezer or refrigerator? They weren't actively unpacking it, which led to incorrect storage of drug. The reporter consented to follow up.
At rec center following vigeorous workout, I couldn't catch my breath.  I sat down for about 15 minutes, feeling too dizzy and exhausted to stand. I had no pain, so felt that it was not a cardiac event. I finally felt stable and strong enough to stand, so I carefully did. In a minute or so, as I gained confidence, I walked to the restroom,  then to the locker for my sweats, which I put on and drove carefully the mile home. At 3pm, I am mentally and physically dragging, but able to breathe comfortably. This has never happened to me before.
Breakthrough COVID-19 with symptom onset 8/24/2021: Shortness of breath/difficulty breathing. Hospitalization 8/24/2021. Death 8/24/2021. From Vital Records COD = OBSTRUCTIVE SHOCK, SADDLE PULMONARY EMBOLUS, HYPERCOAGULABLE STATE, COVID 19. Per vital records, Codes include: Not yet coded ; Other Significant Conditions include: MORBID OBESITY PROTEIN DEFICIENCY. Place of death: HOSPITAL-INPATIENT, MEDICAL CENTER; certified by:  PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: PEER COUNSELOR, SERVICE. Dizziness. Pt c/o dizziness while at work. Pt COVID+ 8/9/21 and fully vaccinated. Pt VSS, GCS 15. Ambulatory on arrival. Denies N/V/fever
Developed several hives in a 3" area (size of mayonaise jar) at inject site that DTP was administered.
(Pain and) swelling with a knot where the clavicle meets the shoulder; The vaccine seems to have been injected subcutaneously; Raised, painful red area at the injection site; Raised, (painful) red area at the injection site; This is a spontaneous case, reported by pharmacist to Agency (case ID: SEQ19-04690) and initially received on 15-Oct-2019 with aditional document (case ID: SEQ19-04688, beeing processed together),  concernig a 72-year-old male patient.  The patients relevant medical history and concomitant medications were not provided.  On 13-Oct-2019, the patient was administered Fluad (TIV) [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59 dose: 0.5 ml, anatomical location: deltoid, route of administration: subcutaneous, batch number: 261277, expiration date: 31-May-2020] for influenza prophylaxis.  On the same day, after vaccine administration, the patient developed a pawn on his arm which was a raised, painful red area at the injection site. The reporter mentioned the patient received the injection quite high up in the arm (closer to shoulder) and not sure if it was injected in the muscle. The patient explained the dose seemed to have been injected subcutaneously and experienced pain and swelling with a knot where the clavicle meets the shoulder.  The outcome of the events were not reported.  The reporter assessed the case as non-serious and did not provide causality criteria.  This case is linked with companion case 201905269 due to the same reporter.  Non-significant follow-up reporter by other non health professional from Agency [reference number: SEQ19-05571] on 13-Nov-2019: Additional Agency reference number added. No changes in narrative.  Non-significant follow-up reporter by other non health professional from Agency [reference number: SEQ19-05590] on 13-Nov-2019: Additional Agency reference number added. No changes in narrative.  Company Comment: The patient experienced vaccination site pain, injection site erythema, and vaccination site swelling after incorrect route of product administration with the suspect product Fluad (TIV). Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Incorrect route of product administration is assessed as not related per company conventions. Considering all the above mentioned, causal relationship between the suspect product and all other events is assessed as related.; Reporter's Comments: The reporter assessed the case as non-serious.
Hinchazón en el borde de la axila izquierda, dolor de cabeza, dolor en los huesos, fiebre, escalofríos,  sudoracion excesiva, dolor en parte baja de ambos pulmones.
Itching; Headache; Skin disorder/BUMP UNDER ARMPITS; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), SKIN DISORDER (Skin disorder/BUMP UNDER ARMPITS), PYREXIA (Fever) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 29-Oct-2021, the patient experienced SKIN DISORDER (Skin disorder/BUMP UNDER ARMPITS) and PYREXIA (Fever). On an unknown date, the patient experienced PRURITUS (Itching) and HEADACHE (Headache). At the time of the report, PRURITUS (Itching) and HEADACHE (Headache) was resolving, SKIN DISORDER (Skin disorder/BUMP UNDER ARMPITS) outcome was unknown and PYREXIA (Fever) had resolved.            The reporter's causality for the event(s) of itchiness, bump under armpits and headache with Humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of fever with Humira(adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with Influenza vaccine (manufacturer unspecified). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). 6 weeks after vaccination with Influenza vaccine unspecified, the subject experienced systemic lupus erythematosis flare (SELENA-SLEDAI defined disease flare0. Plasma samples were obtained from the subject on the day of )influenza vaccination and at 6 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using XMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subjects' medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. SLE patients who exhibited disease flare had significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2, and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism for flare, therapeutic selection or development.
At 1809, patient returned to vaccination site as passenger of personal vehicle with complaint of tingling sensation throughout his body that lasted for about 5 minutes.  Patient denied loss of consciousness. Patient had received Janssen vaccination to his left deltoid at 17:56. Patient had reported history of feeling near syncope to vaccinations. Patient?s level of consciousness, stroke scale, and vital signs were assessed. Patient was offered a call for emergency services on his behalf but patient denied emergency services. Patient stated that a mild tingling sensation continued on his left arm but that he did not feel any more tingling throughout his body at 18:10.  At  18:14 patient stated that he wanted to continue to monitor himself at home and he was encouraged to call for emergency services if symptoms continued or worsened. Patient left as passenger of personal vehicle at 18:18 while his friend was driver of their vehicle.
Lower back Sprain. Rest for an hour. Pain subdued but still painfully until this time of reporting (1 and half day after onset). I can bend my back a little bit (40%). Took Tylenol.
Increase in neuropathy symptoms the next day following vaccine including small fiber neuropathy shocking/stabbing sensations and weakness/difficulty lifting left foot.
Was given Quadrivalent flu vaccine, Fluarix, I.M. 1. Hives appeared on inner thighs and then appeared on the remainder of legs. Waited overnight to see if they would go away.  2. 09/16/2013 7:30 am - hives all over body - face, arms, back, neck, chest. Itching. 3. Went to Urgent Care. MD gave me an injection I.M. of prednisone (150 mg) and an RX for prednisone tablets. 4. Per instructions I was to taper off prednisone: on 9/17/13 took 60 mg prednisone; on 9/18/13 took 60 mg prednisone; on 9/19/13 took 40 mg; on 9/20/13 took 40 mg. 5. Hives were gone on 9/18/2013. 6. On 9/21/2013 my toes, feet, ankles, lower and upper thighs swelled hugely - never happened before. 7. On 9/21/2013 went to Urgent Care and MD told me to immediately stop taking prednisone. 8. My legs have been swollen ever since; keep them raised at night and try to keep them up when I sit. This is still ab problem.
100.5 fever, headache, swollen glands, general malaise, body aches and pain and in joints.
c/o rash over cheeks 2 d after vaccination and tingling sensation of upper extremities and lower extremities at the same side of injection.
Redness developed (R) arm 5/4 - blistered area 5/5.
redness, swelling upper rt arm;tender & hot to touch (onset approx 5PM 28OCT97 w/ 2 row long blisters-went away);c/o redness, swelling & pain rt arm;
Patient felt ill around 4:00 a.m. morning after getting shot with nausea and dizziness.  He continued to be vaguely ill until 10/20/21 when he lost muscle control, had shakiness, fever (v to 102.5+), nausea.  E.R. determined he with Covid Viral Pneumonia, with low oxygen levels and abnormal chest x-rays; treated in ER with promethazine, sodium choride 0.9% and oxygen.  He was admitted him to hospital.  Treatment included Remdesivir, dexamethasone, and magnesium
Immediate pain following vaccination. I was told it would "burn," but the pain was more of a constant dull throughout. Pain lasted for 3 days, and would be especially bad (sharp pain) any time I moved my arm that received the vaccination. I was basically unable to move my left arm at all for those days.
after 15 minutes patient fainted and collapsed in store then pharmacist came and patient was awake and breathing and very pale pharmacist was assisting him  then 911 was called and came and took patient to hospital
got the new shot. It was really bad/suspected vaccination failure; It was really bad; had a few blisters; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received original one years ago from reporting date and got massive case of shingle and also had very few blisters).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blister. On an unknown date, the outcome of the vaccination failure, shingles and blister were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient was thankful to the earlier shot.  The patient got the new shot as soon as possible after healing up and stated shingles was really bad and only had a few blisters and so grateful it was not covered in blisters. The patient stated get the shot. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Localized hives, erythema, itchy within 5 min of injection.  BENADRYL 25 mg IM given - symptoms relieved within 15 min of BENADRYL.
I developed Tinnitus during the second week of April 2021.  Thinking it could be related to the Meloxicam I was taking, I stopped taking this drug, however, the Tinnitus has continued.  I have seen an ENT doctor and was told I have hearing loss.  I also went to see an audiologist and was fitted for a hearing aid.
Mother reported episodes of inconsolable crying off and on since vaccine. Also reported warmth and redness at site with edema on 7/20: resolved by time of exam. Brought to clinic because of crying. At that time, was also found to have right otitis media and had fallen while running and hit head during this time.
A report was received from a health care professional on 16Oct02, concerning a 17 month old male vaccinee who was inadvertently administered 0.25ml IM in the vastus lateralis on the 15Oct02. On 15Oct02, the vaccinee suffered a medication error by receiving 0.25ml Fluvirin into the vastus lateralis. The vaccinee had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment. PJP200200609, PJP200200671, PJP200200670, PJP200200669, PJP200200668, PJP200200667, PJP200200666, PJP200200665, PJP200200664, PJP200200663.
Reported on behalf of HCP who administered ROTATEQ to a patient who gagged and spit up following oral administration. Patient is an 8-month-old healthy male who "gagged and spit up everything" following his third dose of ROTATEQ. Dates of vaccina; Reported on behalf of HCP who administered ROTATEQ to a patient who gagged and spit up following oral administration. Patient is an 8-month-old healthy male who "gagged and spit up everything" following his third dose of ROTATEQ. Dates of vaccina; accidental underdose; This spontaneous report was received from a nurse and refers to an 8-month-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (dose, frequency, strength, lot #, and expiry date were not provided), then following oral administration, he gagged and spit up. At the reporting time, the outcome of the events was unknown.  Causal assessment between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.
01/25/22 presents to EC ED for "shortness of breath and concern for asthma exacerbation". PMHx of "asthma, HTN, T2DM, pAF"
Pt recvd 3rd dose of vax on 9JAN92 & 12FEB92 pt tested pos for HIV on Elisa & western Blot tests; pt remained anti-HBs pos; MAR92 pt exp flu-like illness consisting of lymphadenopathy, nausea, anorexia & tiredness;
On 10/20/04 Client complained of painful, red, swollen right arm after PPV23 immunization given on 10/19/04.  Good ROM and blanching.  Saw MD on 10/21/04.  Rx: Ibuprofen; Benedryl.  Tx: cold compresses
Pt inform she had a rash extending from the vaccination site to the elbow. This happened two days after receiving the vaccine. At the time of reporting it, pt didn't seek treatment.
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 2:04 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:08 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 13-Feb-2021 at 2:04 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 63.84 years.  No concomitant product use was reported.   It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  On 13-Feb-2021, excursion time at 09 am temperature was 32, total doses given for the day was 152, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vial was moved to clinic. Vaccine BUD date was 10-Mar-2021 for batch number 031L20A.  Vial was stored on cooler 1, on 20-Mar-2021, Excursion duration at 9 am: 34, at 10 am 30, at 11 am 41, at 12 am 45, at 1 pm 44, at 2 pm 44, at 3 pm 44, at 4 pm 44 and at 5 pm 43.  On 20-Mar-2021, excursion time at 09 am temperature was 34 and at 10 am temperature was 37, total doses given for the day was 184, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vial was moved to clinic. Vaccine BUD date was 08-Apr-2021 for batch number 031A21A.  Vials only punctured right before administration.  No treatment information was provided.
On 2/9/21 patient received her first vaccination in her right arm. She only had a mild headache that afternoon that Tylenol took care of. On 3/2/21, patient received her second vaccination in her right arm. That same afternoon she had a mild headache that Tylenol took care of. On the evening of 3/6 she noticed a slight itchiness on her arm near the injection site. She took 1  24hr Fexofenadine and rubbed 1% hydrocortisone on the affected area. The following day, on 3/7 she noticed the swelling spread and the itchiness was worse and she took another Fexofenadine and used the 1% Hydrocortisone.  As of today, 3/9  the itchiness is slightly better but the swelling & red area is still present.
Pt. given Pneumo 13 vs Pneumo 23 as ordered. Pt then C/O pain at injection site and a rush of fever the next day with nausea and vomiting.
Pt came in Monday, 05/12/03 for Tetanus/Diphtheria shot. States having only Tetanus before without a RXN.  Administerd shot on this date on Right Deltoid. NO S/S of adverse RXN noted at this time. Pt Returns on Wed., 05/14/03 11:00AM C/O tenderness to are where shot was given. Right Deltoid is red, swollen, warm & tender to touch. No fever at this time and able to move right arm with some c/o soreness.  Dr. RX ice-pak to affected area on/off throught the day along with 600mg of Advil. Pt was asked to return on Friday 05/16/03 for F/U. Friday 05/16/03 10:50 A.M. Pt Returned with less reddness & less swalling to Rt. Deltoid area. Pt. C/O tingling and some itching to right arm. Able to move arm with some c/o soreness to arm.  Dr. Rx Benadryl 25mg. Q.4-6hours not exceeding  more than 6 doses in 24 hours and F/U again on Monday 05/18/03.
no additional AE; the dose of VAQTA expired on 14JUN2022 and the patient was administered the dose on 16JUN2022; This spontaneous report was received from an officer administrator referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-JUN-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 injection, administered intramuscularly for prophylaxis (lot #T031202, expiration date: 14-JUN-2022; strength was not provided) (expired product administered). No additional adverse event details were provided.
Information as received from a certified medical assistant (CMA) refers to a 13-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-JUN-2015, the patient was vaccinated with a dose of GARDASIL (lot number K014191 and expiration date 10-MAY-2017) (dose and route not reported) which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.