chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inadvertent administration of an expired product with no reported adverse event; Initial information was received on 26-Jun-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves 2 years old female patient for whom inadvertent administration of an expired product diphtheria-15/tetanus/5 AC pertussis vaccine [Aaptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 26-Jun-2023, the patient inadvertent received expired product 0.5 ml dose 4 of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (strength: standard, lot number: C5893AA, expiration date: 21-Jun-2023) via intramuscular route in the right thigh for immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event inadvertent administration of an expired product with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
This spontaneous report was received from a medical assistant and refers to a 22-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 30-AUG-2016, the patient received an improperly stored dose of VARIVAX injection (lot # M002063 with expiration date at 12-JAN-2018; dose and route of administration were not reported). The administered dose of vaccine was exposed to a temperature of -3.5 degrees Celsius (C) for 1 hour and 6 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011133.
pt recvd vax; devel chicken pox consisting of 20 lesions along w/ low grade fever; lab eval revealed varicella antibody titer pos; an assoc to varicella vax was unk;
Pt reported mild pain/discomfort after the injection. Pt left the facility. Returned around 7pm. Mother reported that pain increased, and pt had teeth chattering. Pt given ibuprofen by mother and 25mg of benadryl in office and ice pack. Pt declined SOB, wheezing, swelling of face/lips. vs 134/82, 100% o2 room air, 100bpm, 24 rr, t 99.5, LCTA, Heart sounds unremarkable. Site noted to have blanchable area or redness. Pt able to move arm with full rom.  Pt followed up with provider 20 mins later. reported feeling better. pt declined to be reassessed.
About a 11 days after my vaccine.  I started breaking out with hives all over my body.  The hives would swollen and be very large and itchy.  These lasted for about for about 2 weeks.  I went to my doctor about this. He said I was allergenic to the vaccine.
significant local rxn to vax;warmth, edema, erythema, tenderness in 48hr
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment medications was not provided.
Blood sugar went "way high; Sunburn to left arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (Blood sugar went "way high) and SUNBURN (Sunburn to left arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced HYPERGLYCAEMIA (Blood sugar went "way high) and SUNBURN (Sunburn to left arm). On 13-Mar-2021, HYPERGLYCAEMIA (Blood sugar went "way high) had resolved. At the time of the report, SUNBURN (Sunburn to left arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Blood glucose: high (High) High.         No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2021-065348 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up information received : Updated outcome of event (sun burn) from  unknown to resolved.
This spontaneous report as received from a nurse refers to two patients of unspecified gender and age. No information regarding the patients' concurrent conditions, medical history or concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (dose, formulation, route of administration and anatomical location were not provided, lot # M024680, expiration date 18-MAY-2018), for prophylaxis. The VARIVAX was reconstituted with properly stored diluent (lot number and expiration date were unknown). No adverse effects were reported. The VARIVAX was improperly stored for 1 hour in a temperature range between: 6 Fahrenheit degree (F) and 14 F (-14 Celsius degree (C) to -10 C) on an unspecified date. There has been previous temperature excursions and the cumulative time of improper storage was 5 hours in a temperature range of 6 F to 14 F (-14 C to -10 C). No product quality complaint was involved. Additional information has been requested.
The night of the vaccines, the pt fell asleep and when mom put child in crib, the baby arched back and head repeatedly over 10-15 seconds. Unknown if any color changes or if eyes opened or rolled back. No fever. Mom concerned if this may have been a seizure.
ON 7-7-19 PATIENT EXPERIENCED WHELPS ON TORSO AND RIGHT ARM. PATIENT WAS TREATED AT AN URGENT CARE FOR ALLERGIC REACTION. ON 7-8-19 PATIENT EXPERIENCED WHELPS ON LEFT ARM,SWOLLEN LIPS,DIFFICULTY BREATHING AND BLOOD SHOT EYES. PATIENT WAS TREATED IN THE ER FOR ALLERGIC REATION. ON 7-8-19 MOTHER REPORTED ADVERSE REACTION AND SAID SHE WAS DOING BETTER.
On the fourth day I developed intractable nausea and vomiting associated with tinnitus, vertigo and imbalance.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild
On the day pt recvd DTP/OPV/HIB began crying, screaming continuously for approx 3-4 hrs; would stop to nurse bottle & then resume crying; no fever or redness @ areas of immun; MD notified & APAP given;
elevated t102 w/in 6 hrs-lasting 3 days & h/a for 2 days following vax inject;
Person received vaccine then went to the waiting area. Sat with head in hands.  After 5 minutes got red in the face and started crying.  Hands stiffened then started shaking for about 1.5 minutes, then went limp into mothers arms, eyes closed.  No verbal response. Person was transported to ER. Follow-up indicates the person continued to seize in the ER with no control by medication.  Air lifted to a pediatric hospital.  Remained in care for one day.  Discharge Dx:  Psychosomatic pseudo-seizure.  Follow-up
Vaccine Administered on 07/28/2021 at 1:39 PM. At 1:53 PM patient began experimenting nausea and vomitting . Patient was assesed by Dr.  Vitals were taken: Pulse: 86 Spo2: 96% BP: 86/64 mmhg. Per Dr.  ordered  to provide patient with   Zofran to alleviate Nausea vaccines, but patient deferred medication. Per Dr. provided hydration and observe patient for additional (15) minutes. After 15 minute observation Vitals taken 2:10 PM: Pulse: 81 Sp2: 97% BP: 90/64mmhg. Per patient symptons were relieved and per Dr. okay to release home. patient notified if symptoms worsen may go to emergency room.
Medication error, patient came in to get 2nd vaccine, was administered the Pfizer as a second dose, and later noted that she had already had her Janssen in March 2021.  Asymptomatic from any effects.
At 10:00, my left arm ( arm shot) started being asleep. very mildly.
this was my 4th shot. 2nd booster. I had all the usual symptoms but this time I also experienced heart issues, racing heart, almost like a panic attack. I almost called 911 but decided to first do some yoga deep breathing to slow down my heart. this even scared me so much I will not be taking any more boosters
Beginning 12/07/21, around noon, I noticed a quarter- or half-dollar-sized lump (raised about 1/4 inch) on my right arm at the injection site. It was red, hot, and irritated (either itchy or painful, it fluctuated). Tylenol taken as advised and the pain subsided, with the swelling and heat dissipating after a couple of days. Then, on 12/11/2021, we noticed that the site was getting a bit warm again with redness spreading out down my right arm. I don't recall the time however within about a day, it covered most of my upper arm, to about an inch and a half above the elbow. Total area covered was approximately 6-inches wide (with a couple of outside splotches) by 7-inches long (all at the site or below). It is 12/16/2021 and the rash is very light but my arm is still a bit warm and it is a bit itchy when I think about it.
Pt experienced sore arm after receiving Pfizer covid vaccination; This is a spontaneous report from a non-contactable consumer. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as unknown single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient experienced sore arm after receiving Pfizer covid vaccination. Event took place after use of product. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.  Follow-up (31May2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included non-significant information regarding the Pfizer colleague confirming the reported if he was the primary reporter.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
After does 1: 03/24: site of injection swelled up. 3inx2in raised patch, itchy. Went away after 12h; After dose 2: 04/14: chills, evening joint pain and aches, headache; 04/14-04/21: headache and brain fog ; 04/21: extreme exhaustion at 3pm; 04/21: 4:30pm face swelling on left side headache and pressure in head worsened; 04/21: 5:30pm called doctors facility, late night nurse suggested I go to the ER; 04/21: ER visit, Blood work and CT scan came back normal; 04:22: headache worsened, light sensitivity, swelling went down. Face muscles feel fatigued and weak 04/23: after 14h of sleep headache and light sensitivity still present. Pressure still present in face and cheek muscles week.
Patient presented reported increased salivation and a swollen tongue. Pt was taken to consult room. Skin exam revealed 1 hive on left abdomen. Pt took 50 mg PO diphenhyradmine. EMS notified. While waiting with patient in room, tongue had additional swelling and 0.3 mg EpiPen was administered in the L Vastus Lateralis. EMS arrived within a minute after EpiPen administration. EMS evaluated and recommended transport. Pt refused and reported improvement of symptoms. EMS contacted ER physician and provided patient with instructions. Patient observed until 8:05 with no return of symptoms. Ride home was offered and refused. Pt left the store with a bottle of Benadryl with the agreement to contact EMS with any return of symptoms.
Information has been received from a medical assistant concerning a 16 year old female, who on 01-JUN-2007 was vaccinated IM with a 0.5mL first dose of Gardasil.  Concomitant suspect therapy included motelukast sodium.  Other concomitant therapies included ZYRTEC, albuterol, ADVAIR, HISTUSSIN D, AMOXIL and prednisone.  On 19-AUG-2007 the patient was vaccinated with a second dose of Gardasil.  On 01-SEP-2007 the patient found out that she was thirty weeks pregnant.  The patient was seen at the office.  A pregnancy test was performed at home and in the office.  The patient's last menstrual period was approximately in February 2007 and her estimated delivery date was in November 2007.  The patient gave birth in November 2007.  On 08-NOV-2007 the patient was hospitalized due to postpartum depression.  At the time of the report, the outcomes of the patient and the baby were unknown.  Additional information has been requested.
Patient is a 84 y.o. male patient with history of HTN, BPH, CVA, hypercholesterolemia, hypothyroidism, osteopenia, rosacea , rhinophyma presented with weakness and confusion.   Bradycardia Dehydration Acute confusion following fall Generalized weakness Hx of CVA CT head - no acute intracranial process. Moderate old microvascular ischemic changes and age-related cerebral volume loss.  Old lacunar infarcts in basal ganglia bilaterally and left thalamus.  Small bilateral hemispheric subdural hygromas are unchanged. Continue amlodipine and spironolactone Decrease dose of Coreg to 12.5 mg twice daily.     COVID-19 Virus Infection Date of onset of symptoms: 8/26 Symptoms present on admission: Cough, congestion, poor energy, generalized weakness Date of covid positive test: 8/29 Vaccination status: vaccinated Imaging: CXR - no evidence of acute cardiopulmonary disease Oxygen requirements on admission: None Current oxygen requirements: Room air Medical therapy: Prednisone  Prior outpatient treatment: None Consultants following: None Anticipated special isolation end date: 9/7/2022    Normocytic anemia Hemoglobin 10.1, hemoglobin 5 months ago 13.7 No active bleeding  Acute kidney injury, likely prerenal Resolved with IV fluids  Hyperlipidemia Continue statin BPH Continue Proscar and tamsulosin.    Hypothyroidism Continue levothyroxine
Pt reports being vaccinated with pfizer covid vaccine in mid june and again in mid july at a pharmacy. He developed a DVT to his left lower leg less than 1 month after his second vaccine.
CDC Reports: 5 mo infant received DTP/OPV on 19MAR90 and died 20AMR90. Patient was given Tylenol for a low grade fever 3 hrs before death.
Rec'd influenza vaccine 11/13/2001 on 1/20/2001 developed progressive generalized muscle pain, night sweats, fatigue lasting until 11/22/01. No other c/o. Reported to BOH 11/27/01.
I had fatigue, runny nose, congestion and a cough. I took a home COVID-19 Test on October 12. I contacted the pharmacist to see if I was eligible for PAXLOVID. The pharmacist prescribed PAXLOVID and my doctor called me and confirmed it was safe to take it. I took my first dose on October 12. By this time the cough had gotten significantly worse. It took a full 48 hours to see any improvement. All of the symptoms have subsided. It took 5 full days for me to fully recover.
Patient was ask to stay 15 minutes post vaccination - aftger 15 minutes - patient indicated that he is feeling dizziness and He was offered water and continued to be monitored for additional 15 minutes- he continued to feel dizziness per patient. His supervisor was contacted as he wanted to go home- unable to continue work- when ask of difficulty breathing - no ; no sign of hive or rashes - dizziness.
went achy; This is a spontaneous report received from a contactable reporter (nurse).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shot, for influenza immunisation, reaction(s): "no adverse effect". The following information was reported: PAIN (non-serious), outcome "unknown", described as "went achy".  The lot number for BNT162B2 was not provided and will be requested during follow up.
It started hurting and it was a litlte red; It is red; Hot to the touch; Itchy with a rash like hives; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (It started hurting and it was a litlte red), ERYTHEMA (It is red), FEELING HOT (Hot to the touch), URTICARIA (Itchy with a rash like hives) and PRURITUS (Itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination.     Concomitant products included DIGOXIN (DOGOXINE) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced PAIN (It started hurting and it was a litlte red), ERYTHEMA (It is red), FEELING HOT (Hot to the touch), URTICARIA (Itchy with a rash like hives) and PRURITUS (Itchy). The patient was treated with ALCOHOL at an unspecified dose and frequency. At the time of the report, PAIN (It started hurting and it was a litlte red), ERYTHEMA (It is red), FEELING HOT (Hot to the touch), URTICARIA (Itchy with a rash like hives) and PRURITUS (Itchy) had resolved.            Concomitant products also included blood thinners. Treatment medication included cold water application. She also treated it with rubbing alcohol compress a few times a day. The symptoms lasted 5-6 days and then went away.   This case was linked to US-MODERNATX, INC.-MOD-2021-064215 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Live follow up was received on 13-May-2021 and updated event onset date and event outcome, added event, and treatment.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064215:Case for first dose
sore arm after second dose; feels drowsy; has eye aches; not feeling like himself; felt tired on first day after second dose; has headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after second dose), SOMNOLENCE (feels drowsy), EYE PAIN (has eye aches), FEELING ABNORMAL (not feeling like himself) and FATIGUE (felt tired on first day after second dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm after second dose), SOMNOLENCE (feels drowsy), EYE PAIN (has eye aches), FEELING ABNORMAL (not feeling like himself), FATIGUE (felt tired on first day after second dose) and HEADACHE (has headaches). At the time of the report, PAIN IN EXTREMITY (sore arm after second dose), SOMNOLENCE (feels drowsy), EYE PAIN (has eye aches), FEELING ABNORMAL (not feeling like himself), FATIGUE (felt tired on first day after second dose) and HEADACHE (has headaches) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-059655 (Patient Link).
Received 1st shot of SHINGRIX on 5/26/2018. The next morning awoke with severe pain in (R) shoulder and under center of my neck. Pain without relief lasted until 6/6/18 when a rash started in neck in the fold on (R) side. Pain subsided when rash started. Went to ER and Dr. diagnosed me with shingles. Went for PT for 2 wks thinking it was my neck. Went to spine spec. Dr. did 4 x rays - not from neck. Rash increased every day spreading all over my upper back. Dermatologist ordered oral cortisone. (Prednisone 20 mg tab, 2 tabs every morning with food) and topical cortisone (Betamethasone DP 0.05% crm) applied to neck and back 3 x day for 2 wks. Rash lasted for 23 days. My husband took many pictures one each day so I could see how the rash was progressing. I know Dr.'s say shingles ordinarily doesn't cross the spine but the key word here is ordinarily. This was no ordinary rash. I had nothing before the vaccine. No one will ever convince me to get the second shot of SHINGRIX.
Pt was seen 8/9/2005 for routine WCC - per mom's report had h/o URI sx and red eyes and h/o T100.8  In office appeared well with T98.4.  Pediarix, HIB and Prevnar administered.  Child d/c'd with Polytrim opth gtt.  That evening increased temp to 102-103 and had 2 brief ?febrile seizures.  Evaluated by EMS - felt to be OK.  Persistant fever and "spells" - reeval in office 8/11/05 and sent to ED for evaluation.  In ED had sepsis workup and CT scan.  Noted to have UTI. CT negative.  Had several short seizures in ED -- treated with meds and admitted to ICU.  EEG was normal.  MRI was normal.  Urine culture grew >100,000 E. coli.  Child treated initially with ceftriaxone and subsequently TMP/SMX.  Home 8/15/05 on antibiotic, phenobarb and carbemazepine. Discharge Summary received which stated patient experienced bacterial infection and respiratory failure.
Pt c/o feeling like "throat swelling" and difficult to swallow approx 5 min after receiving vaccine. Also c/o nausea, tachycardia and shaking.
Information has been received concerning a 90 year old female, who post vaccination developed cellulitis in her right arm from her elbow to her shoulder and she had chills.
itching and 2 inch size hard knot in my arm at the injection area - then knot subsided and I got a 4 1/2 inch red circle that was hot to the touch.