chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Improper storage and handling; Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced PRODUCT STORAGE ERROR (Improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Feb-2021, PRODUCT STORAGE ERROR (Improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   PA is calling in reference to a previous case (MOD21-023542). Their vaccination site was not following proper storage and handling guidelines from 23DEC2020 to 8FEB2021. He stated that they did a wild net audit and it is possible that about 102 patients were affected, up from 50 that was mentioned in the initial case. They gave vaccination from vials after 6 hours, in some instances it was longer than 24 hours from the time of initially needle punctured.  No treatment medication were reported. Several lot numbers were involved. PA did not have patients demographics or lot numbers at his finger tips.   This case was linked to US-MODERNATX, INC.-MOD-2021-011911 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-May-2021. It contains NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-011911:
PATIENT STATED THAT NOTICIED YESTERDAY AFTERNOON HER LEFT ARM WAS SWOLLEN, RED AND ITCHY AROUND THE SITE OF INJECTION.
Soreness in shoulder lasting 1 month. Pt received vaccine on 9/2/09. Soreness improving 10/7/09.
No signs or symptoms reported.; Medical assistant called to report a temperature excursion that occurred on 3/AUG/2021 and 5/AUG/2021. See case number 02007815 for TE details. ROTATEQ was administered to four patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On an unspecified date in 2021, the patient was vaccinated with a one (1) time dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (concentration, dose number and vaccination scheme frequency were not reported; lot number 1707449, was verified to be a valid lot number with an expiration date reported and established as 28-MAR-2022) for prophylaxis after that the vaccine experienced a temperature excursion of 35.4 degrees Fahrenheit (F) and 35.8 degrees Fahrenheit (F) during a time frame of 15 minutes (cumulative) that occurred on 03-AUG-2021 and 05-AUG-2021 (product storage error). It was stated that no previous temperature excursion was reported. It was reported that the patient did not experienced any signs or symptoms after the administration. No additional adverse event (AE) was reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002968: US-009507513-2109USA002967: US-009507513-2109USA002969:
More than 35 days since first dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No current disease and concomitant medication information were provided. No treatment information provided.
received Hiberix reconstituted with diluent other than supplied; received Hiberix reconstituted with diluent other than supplied; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Hib (Hiberix) (batch number FJ4FX, expiry date 7th January 2023) for prophylaxis.   In January 2022, the patient received Hiberix. In January 2022, unknown after receiving Hiberix, 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient might have received Hiberix reconstituted with diluent other than supplied, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The registered nurse reported that, when pulling out the box of Hiberix noticed that there was 1 diluent of Hiberix without use so she presumed the powder portion was reconstituted with other diluent. There was 1 patient who received Hiberix last week from the day of reporting, but she was not sure if that really happened. The reporter did not have patient's demographics. No Lot number and expiration date were provided regarding diluent portion that was found without the powder vial. The reporter did not consent to follow-up.
Twinrix on 16-Jun-2022, Heplisav-B 22-Jul-2022; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (HEPLISAV-B) and HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The pharmacist reported that a patient received one dose of Twinrix and a dose of Heplisav-B. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Twinrix (for Hepatitis-A), which led to incomplete course of vaccination.
Two nights after receiving my vaccine, I experienced severe hives from my stomach to my upper legs. I went to ER and was given an IV with antihistamines. This cleared the hives and I was sent home and told to take Benadryl. I have not had any other episodes since.
no adverse event; a patient received a partial dose of MMR II because the two year old patient moved their arm while the injection was being attempted.; This spontaneous report was received from a nurse practitioner and refers to a 2 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 18-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) for prophylaxis, subcutaneously, lot # R027999 and expiration date 01-OCT-2020. The nurse practitioner reported that a patient received a partial dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) because the patient moved their arm while the injection was being attempted (incorrect dose administered by product). No adverse effects were reported in the patient.  The outcome of incorrect dose administered by product was not reported.
Information has been received from a consumer concerning his 72 year old wife with diabetes and heart problems and no known allergies who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included Lipitor, Synthroid, metroplol, Glynase Prestab Tablets and excelon. Subsequently, two to three days after vaccination, the pt began to experience a rash, hives and itchiness all over her body. The physician prescribed a lotion and Benadryl to treat the event; however, it has not completely resolved. The reporter indicated that "the rash still flares up all over her body and on her scalp." Unspecified medical attention was sought. The outcome was reported as recovering with sequelae. There was no product quality complaint. Follow up information received on 01DEC2003 from the pt's husband indicated that the pt had tried the lotion and Benadryl to treat her hives as recommended by her physician, but she has still not recovered from her reaction. Additional information has been requested.
Dose of Pfizer given mistakenly in a patient whose first dose was with Moderna (5/7/21). Instructed patient to not pursue any additional doses of mRNA vaccine unless he meets indication for 3rd dose.
sick in bed; This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient reported about being sick in bed for 5 days after receiving the shingles shot. The patient intentionally disconnected the call abruptly. Since the limited information was provided and therefore was unable to clarify details about the 2nd shingles shot. This is one of the 6 cases, reported by the same reporter.
Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves patient of unknown demography who received a dose of expired  vaccine ACT-HIB (lot number not reported and expiration date 18-Nov-2018) via unknown route on an unknown site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event. 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Developed "Covid Arm" one week after first Moderna injection. Area around injection started itching and then I later noticed a large, red, raised circle around the site. It was warm to the touch but did not hurt. The itching comes and goes. The circle got larger over the next couple of days. It does not hurt, but my entire arm feels different. Its not that its asleep or numb, but I feel like my circulation is off even though I can clearly see my fingertips are pink and my veins remain blue.  I feel like I need to keep moving my arm or stretching, like its just a little out of place but I cannot make it go away. I only know what it is and did not go to the hospital after finding articles online about it, but symptoms persist 3 days later.
Pt. had a flu like reaction to Prevnar 20 and came in today to report that he has missed 2 days of work due to fever and tightness in his chest. I advised him to contact his doctor ASAP to be evaluated and go to ED if symptoms get worse.
She presented to the emergency department for evaluation of worsening hypoxia in the setting of known COVID-19 infection and was found to have acute hypoxic respiratory failure with possible secondary bacterial pneumonia for which she is being admitted for further evaluation and treatment.emergency department 11/11, discharged home on dexamethasone 6 mg daily and home O2.  Initially improving, but worsening O2 sats mornings of 11/20 and 11/21, down into the 70's in the morning, did not improve above 89% so brought to emergency department.? Increase dexamethasone to 10 mg x 10 days or until hospital discharge, started on 11/21/21 ? Remdesivir x 5 days or until hospital discharge, started on 11/21/21
Redness and swelling of left deltoid. Minimal warmth to the touch. Full ROM.
Patient started experiencing a headache and back/neck pain, started to have numbness feeling in opposite arm from injection. gave bendadryl and felt better after about 15 min
Rash right arm above injection site, behind right ear  and right side of neck, back of neck and upper back below neck and right shoulder.
On 11/16/21, onset of spontaneous, sporadic urticaria that is currently ongoing as of 12/8/21. Additional angioedema of upper lip on 11/25-26; and of right eye lid on 11/29 and 12/8. Treatment has included Zyrtec, Benadryl, montelukast, prednisone, levalbuterol, clobestasol, and prescription for an EpiPen. Symptoms are improving but still present.
nausea; dizzy; fell; hit my head; fever; lymph node in neck very swollen and painful; lymph node in neck very swollen and painful; fatigue; brain fog; chills; body aches; This is a spontaneous report from a contactable consumer or other non hcp.     A 32-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: ER8729), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 11:30 as dose 2, single for covid-19 immunisation. Medical history included. Concomitant medication(s) included potassium (POTASSIUM); escitalopram oxalate (ESCITAL); loratadine (CLARITINE). Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, on 16Mar2021 07:15 PM (Batch/Lot Number was EN68207) as single dose for covid-19 immunisation.It was Reported that, The patient experienced chills, body aches 13Apr2021 13:00 with outcome of not recovered, brain fog on 15Apr2021 with outcome of recovered , fatigue on 16Apr2021 with outcome of not recovered, fever, lymph node in neck very swollen and painful, lymph node in neck very swollen and painful on 21Apr2021 with outcome of not recovered , nausea, dizzy, fell, hit my head on 22Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23Apr2021 Nasal Swab. Therapeutic measures were taken as a result of chills (chills), body aches (pain), brain fog (feeling abnormal), fatigue (fatigue), fever (pyrexia), lymph node in neck very swollen and painful (lymphadenopathy), lymph node in neck very swollen and painful (lymph node pain), nausea (nausea), dizzy (dizziness), fell (fall) hit my head (head injury).  No follow-up attempts are possible. No further information is expected.
The day after receive injectable H1N1 became dizzy in the shower, fell down, unsure of LOC but did c/o of headache. Rested x 1 hour and then was fine rest of day. Had similar episode with seasonal flu in fall of 08. Had 2 previous injectable flu vaccines without se.
30 minutes after vaccine patient felt chest pressure for 25 minutes that went away. Described feeling loopy. Then after getting the vaccine at 11:17 at 12:20 he developed sharp pain and tenderness behind right thigh. Was seen by working clinic where vitals were stable, ekg and chest xray normal. Was cleared to go back to work and if leg pain continued to Friday to be seen at a quick care. Patient does not have a PCP.
Arm was sore and very warm to the touch around the injection site. Minor swelling.   Had a UTI that started on 6/1/2021. Got treatment on 6/3/2021. Called doctor and was given Bactrim to take twice a day for 7 days. Not sure if this was related or not.
Pt developed a rash, red circular erythema, itchy and tender to site. Pt was treated with Benadryl.
Syncope, nausea/vomiting, left arm swelling/pain/tenderness w/ copious amounts of drainage (exudate), and one small satellite lesion
Information has been received from a nurse practitioner referring to a 60 years old female patient. The patient had no medical history, concomitant medication, drug reactions or allergies. On approximately 26-SEP-2016 (reported as about a week ago), the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously. Following the administration of ZOSTAVAX (specific date unknown, approximately in September 2016), the patient developed an injection site rash "shingles" that consisted of papules. The patient sought medical attention by visiting the clinic. No treatment was given for the events and no lab was performed. The patient had not recovered from the events at the time of reporting. The causal relationship between the events and ZOSTAVAX was not provided. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of local swelling in a adult female patient who received BOOSTRIX. Co-suspect products included TWINRIX and medication unknown. On an unknown date, the patient received BOOSTRIX (injection ) .5 ml, 1st dose of TWINRIX (injection) .5 ml and vaccination unknown at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX and TWINRIX, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was unknown. The reporter considered the local swelling to be possibly related to BOOSTRIX and TWINRIX. Additional information received: The caller reports that a nurse reported adverse events to her about a patient. This patient received 3 vaccines at an unknown date. The caller did not know the name of the 3rd vaccine the patient was given. The patient developed a lump in her arm after receiving the vaccines.
Red & raised area below injection site began approx. 1 week post injection. Itched for several days and then went away.
This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date: not reported), via an unspecified route of administration, on Apr 7, 2021, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date: not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient got second vaccine dose of yesterday (Apr 7, 2021); and today (Apr 8, 2021) he reported soreness in arm and shoulder area. Also, minor body aches and chills. The outcome of events: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Neck pain; Arms were getting hotter; Hands and arms getting redder and hotter.; middle/to extreme pain in the lower body,that then transferred to the upper body; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), FEELING HOT (Arms were getting hotter), ERYTHEMA (Hands and arms getting redder and hotter.) and MYALGIA (middle/to extreme pain in the lower body, that then transferred to the upper body) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced FEELING HOT (Arms were getting hotter), ERYTHEMA (Hands and arms getting redder and hotter.) and MYALGIA (middle/to extreme pain in the lower body,that then transferred to the upper body). On 30-Oct-2021, the patient experienced NECK PAIN (Neck pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, NECK PAIN (Neck pain), FEELING HOT (Arms were getting hotter), ERYTHEMA (Hands and arms getting redder and hotter.) and MYALGIA (middle/to extreme pain in the lower body,that then transferred to the upper body) outcome was unknown.            Concomitant medication was not provided.
Information has been received form a certified medical assistant concerning a patient who on 22-DEC-2009 was inadvertently vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Merck) (lot # not reported) instead of ZOSTAVAX (Merck). No adverse effect was reported. The reporter stated that this was related to staff error and not product confusion. Follow-up information has been received from a medical assistant who reported that the patient was 66 year old. On 22-DEC-2009, the patient was vaccinated with a dose of VARIVAX (Merck) instead of receiving ZOSTAVAX (Merck). The medical assistant stated that a medication error had occurred and not product confusion. The patient did not receive any concomitant vaccination at that time. Additional information is not expected.
Localized rash on chest appeared within 30 minutes of vaccine administration. No signs or symptoms of  anaphylaxis or other immediate allergic reaction besides localized rash. Patient reports that she took oral benadryl when she got to her car after observation period completion, and rash "didn't get worse, but didn't get better". Three days later, on 4/16, during follow-up phone call, she reported she still had localized reaction. She reported that she "still have hives on chest, shoulders, and neck".  She denied any other signs or symptoms of anaphylaxis or on 4/16. She deferred recommended visit to allergist due to lack of health insurance. Outreach attempts since 4/16 have been unsuccessful. Most recent outreach attempt was 4/28.
On 1/13/21 a little after 5:00pm, I experienced sudden itching, swelling, and hives on my left arm at the injection site on my left arm. My arm was warm to touch. I started feeling chest tightness that evening and for the next 2 days I struggled to inhale a full breath. I could only inhale fully when yawning.