chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Recipients vaccinated post expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Recipients vaccinated post expiry) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Recipients vaccinated post expiry). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Recipients vaccinated post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that they received the box of vials from the state of Colorado on 14-Oct-2021 and it was frozen when it was received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day.  No treatment information was provided.
Lt arm swollen at injection site 4"x4" red warm to touch. Pt told to take 25 mg BENADRYL every 8 hours. Warm compress to site. Told to go to ER if swelling increases as of 2/12/18. The swelling is almost gone still some redness.
Migraine that started about 2 hours after receiving the vaccine; This is a spontaneous report from a non-contactable health care professional. An adult female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 30Mar2021 as an unknown dose number at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had an amoxicillin-only drug allergy and may have other allergies (as reported). The patient had a migraine that started about 2 hours after receiving the vaccine on 30Mar2021. The migraine has persisted for 3.5 weeks.The event resulted in a visit to the emergency room/department or urgent care and to a doctor or other healthcare professional office/clinic visit. The patient received Toradol injection for pain, with Benadryl and Promethazine and a prescription for Sumatriptan. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of migraine  cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
expired dose of Engerix was given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-day-old male patient who received HBV (Engerix B) (batch number 4G33C, expiry date 19th March 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th April 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 13th April 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The medical assistant reported that an expired dose of Engerix was given to a patient. No symptoms reported. The reporter consented to follow-up.
22MAY92 pt recvd DTP/OPV/HIB/MMR & 28MAY92 mom stated pt had high fever & dec appetite; 29MAY92 pt exp diarrhea; 31MAY92 sz activity @ home w/jerking; pt seen by MD;
Patient said the next morning she had a red rash on her calves. She said sometimes it is hot and sometimes it is itchy. She has been using aloe vera  gel and cortisone cream. I advised her to call her physician since it is not resolved and has been over a week.
Narrative:  rash/itching resolving at time seen by PCP (11-3-2021). Trial of topical Sarna ordered.
3 days after vaccine in the morning developed a seizure, nasal stuffiness and sore throat. One week later had a cough, then fever. 2 weeks later placed on Augmentin ES for sinusitis and Zithromax for bronchitis. Began wheezing 3 weeks after vaccine. started asthma meds. Diagnosed pneumonia. Added Prednisone. Went on airplane, became hypoxic, needed emergency oxygen. Taken to Emergency room. Fully recovered.  4/1/08 Reviewed ER medical records of 12/29/2007. FINAL DX: Pneumonia. Records reveal patient experienced SOB, & feeling ill since vax date w/multiple respiratory illness.  Dx w/pneumonia on 12/24/07.  Completed the antibiotics as prescribed for that.  Currently on antibiotics for sinusitis, nebs & steroids for respiratory problems w/o improvement.  Exam revealed decreased air movement & slight wheezing.
Pt recv vax on 11/12/98; 30 min later pt exp dizziness, vax site red & swollen, tongue numb, headache & tired; tx=Epinephrine
Patient received pneumovax (left arm) and fluzone HD (right arm) immunizations on 12/9/20.  There was no initial problems with injection or injection site during administration of immunizations.  Patient called us 12/11/20 and reported a reaction to injection site on left arm (pneumovax 23).  "A red line 1/4" wide that runs from injection site to under arm and I can't raise my arm over my head."  I then called Merck (manufacturer) and started a line of inquiry into possible causes of such a reaction.  Merch was vague and called it possible cellulitis.  I called patient and relayed their "findings" to him.  He seemed unconcerned and stated he would "keep an eye" on the situation and see a doctor if problem got worse.
She felt awful; Her throat felt weird; crying; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer (patient's mother) reported that a 18-year-old female patient received her first dose of meningococcal group b rlp2086 (TRUMENBA) via unknown routed of administration on unknown date around 3:00 pm at single dose for Immunization. Patient recently recovered from COVID four weeks prior. Concomitant medications were not reported. Later that evening, around 7 PM, she told her mother that she felt awful. She started crying saying that her throat felt weird. She did not experience shortness of breath or difficulty breathing. Her mother administered Advil. No other vaccinations were given at visit. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Started out with heart burn that made you want to die. Every inch of body  hurts really bad with no relief, Having a hard time breathing, feels like someone is sitting on my chest. feels like I have been beat up, pain medication is not touching the pain.  Still experiencing the heart burn two days later.
Intense chills, muscle aches, headache, joint pain in hands and legs, fatigue for 48 hours.
Possible disseminated demyelination from vaccine administration and parasthesias, urinary retention. Treatment=steroids.
Pt and pt's mother presented to Health Department for second dose flu shot. Upon, reviewing immunization record and speaking to pt's provider's office it was disconvered that pt. receivied Fluvirin .5mL IM. This vaccine is only for children 4 years old and older. The patient was 6 months old at the time of the injection given at another facility. I was not the nurse that administered this vaccine but the one that discovered it. It was reported to Dr and my immediate supervisor RN.
On 09-NOV-2018, the patient was vaccinated with the first dose of GARDASIL 9 and on 31-MAY-2019, the patient received the second dose GARDASIL 9; No adverse effects reported; This spontaneous report was received from a pharmacist, referring to a 23-year-old female patient. The patient's medical history, current conditions, concomitant medications and drug/allergies were not reported.  On 09-NOV-2018, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscular for prophylaxis (lot# N015089, expiration date on 20-OCT-2019) (strength, anatomical location, dose and route of administration were not reported).  On 31-MAY-2019, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscular for prophylaxis (lot# N015089, expiration date on 20-OCT-2019) (strength, anatomical location, dose and route of administration were not reported) (inappropriate schedule of vaccine administered). There was no additional information provided.
This spontaneous report as received from an employee refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with M-M-R II (route, dose number, dosage and lot number unknown). Other suspect therapies included VARIVAX (Merck) (route, dose number, dosage and lot number unknown). It was reported the patient received the vaccines too early. No adverse symptoms reported. Additional information is not expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-AUG-2016, the patient was treated at a clinic by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
No other AE reported; The product was stored outside of the recommended storage range and administered to patients; This spontaneous report was received from a pharmacist and refers to a patient of unknown age (reported as adult and over the age of 13 years) and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.  On 12-MAY-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status rHA) (dose and route of administration not reported, lot # T028139, expiry date reported as 15-APR-2022 but upon internal validation established as 15-FEB-2022) for prophylaxis. The administered dose of vaccine was stored outside of the recommended storage range, in temperature of 43 degree Fahrenheit (F), for 21 days. Digital data logger was not involved. The vaccine did not experience any previous temperature excursions. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA003760: US-009507513-2106USA003759: US-009507513-2106USA003761:
Significant event 10/18/2021  36 year old female patient was seen at mobile site and received 1st Moderna Vaccine LOT # 034C21A for clinic. Vaccine Given by LVN. At approximately 1758 patient AAOx4. Patient in observation area for approximately 20 min at 1815 patient called for assistance, myself, RN assessed patient. Patient stated mid back discomfort, denies SOB, chest tightness and throat tightness, no audible wheezing noted. At 1819 Myself, RN reassessed and had Register Tech call 911 due to Patient feeling nauseous, actively coughing, pallor in face and feet noted, patent AAOx4 denies SOB o2 98%, denies chest/throat tightness and no audible wheezing noted, lung sounds clear, no Epi given at this time. Ambulance arrived at 1823, paramedics on site and given report. Patient handed off AAOx4. Ambulance in route to ER at approximately 1825.  RN
-Swollen lymph nodes in two sites, one at back of mid-neck and one at back of right side of neck. -fatigue, exhaustion
child recvd vax 28JUN95 & on 22JUL95 father devel chickenpox;there was no known exposure to chicken pox;child did not develop a rash;a male relative who was in contact w/child devel chicken pox
Possibly given compromised vaccine ( vaccine reconstituted and administered with sterile water instead of manufacturer's diluent). No reported adverse health events by patient, parent(s), or guardian at this time. Staff has reached out to patient's mother and determined patient did not need vaccine for area of travel.   *Item 5 was filled due to form requirement but it is unknown if patient has experienced an adverse health event. This VAERS form is being filled out for documentation and education purposes.   Decision to not revaccinate was determined by local medical team with advice from the medical professional(s).
12Dec97 & 12Jan98 pt recv 1 & 2nd dose of vax. 12Feb98 lab eval revealed neg varicella IgG failure to seroconvert.
Patient stated sweating & feeling hot less than 1 min after shots given s/s lasted 3 min. Resolved after patient laid down.
Sharp, searing pain down my arm at shot time.  For half a day severe aching on left side of body.  Range of motion and pain with moving arm from onset-current.
Generalized lesions head to toe-not palms or soles. On dorsum of hands and feet though.
Patient reported headache-like symptoms with pressure, tightness and extreme fatigue. Patient also reported worsening tinnitus which started 12/22/2020, prior to the vaccine administration date.
Information has been received from a certified medical assistant concerning a 5 year old male with no known pertinent medical history or drug reactions/allergies who on 10-JAN-2006 was vaccinated with a first dose of VARIVAX (Merck) (lot# 651175/0423R) 0.5 ml SQ. On 10-JAN-2006, the patient also received a dose of poliovirus vaccine inactivated (unspecified). On 17-AUG-2009, the patient was vaccinated with a second dose of VARIVAX (Merck) (lot# 664322/0660Y) 0.5 ml SQ. Other suspect therapy included a dose of MMR II (MSD) on 10-JAN-2006 and another dose of MMR II (MSD) on 17-AUG-2009. Concomitant therapy included DTaP. On 29-MAR-2010 the patient experienced chickenpox. The patient's chickenpox persisted. No labs were performed. The patient sought medical attention in the office. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot# M006111, expiration date 18-NOV-2017) (strength, dose, frequency, anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 32 and 35 Fahrenheit degrees (also reported as 34.2 F) for a time frame of 4 hours and 45 minutes; digital data logger was involved. There was not previous temperature excursion for the vaccine. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA002328: US-009507513-1704USA003208:
From telephone contact received on 20/Nov/2002, it was reported that a 45-year-old female had been vaccinated with FLUZONE SV'2002-'2003 USP (lot number U0953AA) on 19/Nov/2002. The patient developed a migraine headache within 2 hours of the vaccination. It is not reported whether the patient recovered.
Patient presented with hives all over the body. Medrol dose pack, zyrtec and aveeno bath prescribed. Patient will follow up with PCP
No adverse event; Dose of Moderna monovalent lot number 038A22A, expiration date 30-Oct-2022 was administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose of Moderna monovalent lot number 038A22A, expiration date 30-Oct-2022 was administered to patient) and NO ADVERSE EVENT (No adverse event) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 038A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Feb-2023 at 1:07 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 24-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose of Moderna monovalent lot number 038A22A, expiration date 30-Oct-2022 was administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose of Moderna monovalent lot number 038A22A, expiration date 30-Oct-2022 was administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose of Moderna monovalent lot number 038A22A, expiration date 30-Oct-2022 was administered to patient).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications was reported.  The vaccine was frozen with no known temperature excursion before being thawed for administration. The vial was initially stored in the refrigerator on 24-Feb-2023. The vial had not undergone any temperature excursions.  No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712705, US-MODERNATX, INC.-MOD-2023-712698 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2023: Follow-up received included no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712705: US-MODERNATX, INC.-MOD-2023-712698:
This case was reported by a consumer via call center representative and described the occurrence of pertussis in a child female patient who received INFANRIX for prophylaxis. On an unknown date, the patient received the 1st dose of INFANRIX. On an unknown date, unknown after receiving INFANRIX, the patient experienced pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the pertussis was unknown. It was unknown if the reporter considered the pertussis to be related to INFANRIX. Additional details were provided as follows: This case was reported by the patient's mother. The age at vaccination was not reported. The patient was scheduled for her 2nd round of INFANRIX shot, however, the mother stated that, the patient possibly had pertussis at the time of reporting. The reporter asked if it was recommended to give the scheduled INFANRIX shot if the patient was positive for pertussis or wait.
A few minutes after patient received vaccinations she complained of having heart palpitations. Patient waited in waiting room for 15 minutes before she notified staff of the symptom. Once patient notified staff of the symptom she was immediately taken to a treatment room and assessed. Vitals including HR, BP, pulse ox were taken. Patient denied any SOB, Difficulty breathing, hives, rashes, generalized pain or anxiety. Patient not diaphoretic or pale. All vitals WNL. Patient also questioned about any previous reactions to vaccinations or heart conditions. Patient stated she had never had a previous vaccine related reaction, however she had experienced heart palpitations previously in 2010. Patient stated the episode in 2010 was not related to vaccinations and that she had seen her PCM for that incident and was no longer taking any medications for a cardiac nature. Patient stated the heart palpitations were lessening in severity and she was feeling better than before. Patient remained in clinic waiting area for a further 30 minutes to  be observed. Patient counseled she should go to the ER to be evaluated and follow up with her PCM.
Vaccine was given approximately 13:00 on 7/23/12. Mother of child states the patients right eye began to deviate to the right with twitching to the right eye brow at approx. 19:00 that evening, lasting for approximately 10 minutes.
bruise at the injection site; black and blue at injection site; some muscles were hit during the injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE BRUISING (bruise at the injection site), VACCINATION SITE DISCOLOURATION (black and blue at injection site) and VACCINATION SITE DISCOMFORT (some muscles were hit during the injection) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2022, 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 28-Sep-2022, the patient experienced VACCINATION SITE BRUISING (bruise at the injection site), VACCINATION SITE DISCOLOURATION (black and blue at injection site) and VACCINATION SITE DISCOMFORT (some muscles were hit during the injection). At the time of the report, VACCINATION SITE BRUISING (bruise at the injection site), VACCINATION SITE DISCOLOURATION (black and blue at injection site) and VACCINATION SITE DISCOMFORT (some muscles were hit during the injection) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact
The vaccine was Shingrix, and this was the 2nd shot on 4/25/2019.  The first was on 2/20/2019 at 3:30 pm.  Dose was .5, concentration 50 mcg.  Injection in upper left arm.  Rash appeared 3 days later behind left ear and spread over the next few days to the left side of head, neck, upper back and left shoulder.  Diagnosis by 3 doctors.  Blisters have faded, but nerve pain remains.