chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 19-year-old female. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-may-2009: Product Complaint Investigation results.
No addittional adverse events; Adult patient received a pediatric dose of VAQTA by mistake on 08-MAR-2022. HCP stated the reason patient is receiving VAQTA is because the patient is going to have a heart transplant; This spontaneous report has been received from a registered nurse, concerning an 47-year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies.  On 08-MAR-2022, the patient was vaccinated by mistake with a pediatric hepatitis a vaccine, inactivated (VAQTA) syringe, administered once as the patient had to undergo a heart transplant (lot number reported and validated as U024504, expiration date reported and stablished as 15-OCT-2022) (strength, exact dose, vaccination scheme, route of administration and anatomical location were not provided) (product administered to patient of inappropriate age). No other adverse events (AE) reported (no adverse event).
Dizziness, weakness, incoherent, slept for most of 11/07/2009.
Extreme menstrual irregularities, pain almost to the point of goin to the ER,  Flow so heavy that mentrual pads/tampon products have to be used hourly.
This spontaneous report was received from a registered nurse regarding an unknown number of patients of unspecified gender and age. The registered nurse reported that doses of GARDASIL (lot number and expiration date not reported0 and PEDVAXHIB (lot number and expiration date not reported) exposed to multiple excursions to 30F since April 2013 (specific time frame unknown), were potentially administered to an unknown number of patients. Additional information has been requested.
muscle aches, headache, occasional nauseousness, chills, fever.  12-15 hours after the injection I had symptoms similar to the worst flus I have ever head in my life. Felt terrible in general with all side effects listed above. my fever reached 103.3° at one point. But that was 6 hours after the last dose of tylenol. I took another dose and iced my forehead and that brought the fever down. I have had similar symptoms with the last 2 shots as well.  My symptoms gradually improved after that and I felt fine (with the exception of a mild headache) around 48 hours after the injection.  Although the duration was fairly short, I would consider my reaction to these vaccines pretty severe. That high of a fever and how horrible I felt scared me a little.
Administered expired vaccine to the patient, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.) in an 82-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. Vaccine manufacture date of expiry reported was 07-Apr-2022. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up document included no new information.
She complained that the vaccine burned at the time it was given. I then noticed that it was given in the subcutaneous fatty tissue of her arm and not the deltoid muscle. Within 2 hours she was complaining that her arm hurt. The next morning (Sat) she said her arm was very painful and had a small red spot were the vaccine was given. By that evening she had a half dollar sized red area and was given Benadryl. The next day (Sun) the red area continued spreading, swelling, and was hot to the touch. The area was from her elbow and up about 6 inches. She was given more Benadryl. By that evening it had spread about 2 more inches upward and an inch more below her elbow. Her primary MD was notified and advised us to go to the ER. The ER diagnosed her with cellulitis and prescribed Keflex 4X/day Sunday around 8:00 PM. Monday the area continued spreading and had wrapped around to the back side of her arm. We elevated, iced it, and gave her more Benadryl. This morning it was about the same or maybe a little less red.
Patient received vaccination prior to recommended interval of 21 days. Patient received Pfizer vaccine 14 days after the initial first dose vaccination. Contacted patient and his mother by phone that vaccination was given to early in error. Notified that patient needs a repeat dose in 21 days. Appointment scheduled for patient on 5/5/2022.
The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via The Agenecy (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310760, 2020SA310759, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via an unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage (latency: same day).  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  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 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.
No additional adverse event reported; Expired vaccine used; This spontaneous report was received from a nurse practitioner referring to a 4-year-old female patient. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 19-JAN-2022, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) rHA (Lot# T023918 and expiration date 09-JAN-2022) (exact dose and frequency were not reported) as prophylaxis. (expired product administered).  No temperature excursions reported. No additional adverse event reported, no further information provided.
Headache; insomnia; polyuria; tired; weird feeling/blah feeling; slight rash at injection site; This is a spontaneous report from a contactable consumer (patient reported herself). A 71-year-old non-pregnant female consumer received second dose of BNT162B2 (COVID 19, Pfizer, Formulation: Solution for injection) via an unspecified route of administration to her left arm on 04Feb2021 08:30 AM at single dose for Covid-19 immunization. Facility type vaccine: Other. The patient's medical history included high blood pressure controlled with medication. The patient had known allergies. Historical vaccine details included first dose of BNT162B2 via an unspecified route of administration to her left arm on 14Jan2021 08:45 AM at single dose for Covid-19 immunization. Other medications in two weeks: Yes. On 04Feb2021 06:30 PM, the patient experienced headache, sleepless night, frequent urination, tired, weird feeling/blah feeling and slight rash at injection site. She did not receive any treatment in response to the events. Outcome of the events was recovered on an unspecified date.  Information on lot/batch number has been requested.
on the left side swollen supraclavicular lymph nodes; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (on the left side swollen supraclavicular lymph nodes) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020 at 6:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (on the left side swollen supraclavicular lymph nodes). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (on the left side swollen supraclavicular lymph nodes) outcome was unknown.        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.   No concomitant medications were reported. Patient has not taken any treatment.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves female patient who was vaccinated with first dose of 1.0 ml IMOVAX RABIES on 17-Oct-2018, and did not come for the rest of the injections. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incomplete course of vaccination. It was unknown whether the patient had any 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 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.
Severe left sciatic nerve pain; This is a spontaneous report from a contactable consumer (patient).  A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 24Sep2021 13:00 (Batch/Lot number was not reported) age at vaccination of 26-years-old, as single dose, for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant and was not pregnant at the time of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Sep2021 13:00 (Batch/Lot number was not reported) age at vaccination of 26-years-old, as single dose, for covid-19 immunisation. The patient previously took ceclor and experienced drug hypersensitivity. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe left sciatic nerve pain on 25Sep2021 05:00. Facility type vaccine: Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Per EMS Report:  66 y/o female complained of anxiety and bad taste in her mouth post vaccination.  Monitored by onsite EMS for 40 minutes.  Symptoms worsened, complained of tongue swelling and difficulty breathing.  Benadryl 50 mg. administered intravenously.  Client refused further medication intervention.  Transported via Fire Rescue to Medical Center at 12:03pm.
26MAR96 8-10AM pt recv vax-PM reddened area on leg site noted;27&28MAR96 had redness,quite swollen & hot;painful (not severe) when pressure applied,otherwise non noted by child;
Warm to touch; Itchy; Rash 4 inches long by 4 inches wide; Injection site some redness; Some tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash 4 inches long by 4 inches wide), INJECTION SITE ERYTHEMA (Injection site some redness) and VACCINATION SITE PAIN (Some tenderness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash 4 inches long by 4 inches wide), INJECTION SITE ERYTHEMA (Injection site some redness) and VACCINATION SITE PAIN (Some tenderness). At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash 4 inches long by 4 inches wide), INJECTION SITE ERYTHEMA (Injection site some redness) and VACCINATION SITE PAIN (Some tenderness) outcome was unknown.            Concomitant medication was not provided. Treatment medication was not provided.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2011, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, lot # and expiration date not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine (vaccination failure, herpes zoster). On an unknown date in 2016, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient had suffered and will continue to suffer ongoing injuries, including by not limited to mental and physical pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. The reporter considered vaccination failure, pain, injury, emotional distress and herpes zoster to be related to ZOSTAVAX.
after pt received immunization, pt's eyes rolled back, pt started shaking, and was very pale, B/P was 82/40, pt felt nauseated, feelings lasting about 20-25 minutes
Large amount of swelling, redness and itchiness at the site of the injection. Additional hives on back.
Vaccine administered after more than 1 temperature excursion; Vaccine 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 (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 4:26 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 4:26 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.15.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09 AM, temperature was 34, on 10 AM, temperature was 37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was 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 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
got an infection; This is a spontaneous report from a non-contactable consumer or other non hcp for a male patient (reporter's father). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number was not reported, Expiration Date: not reported) via an unspecified route of administration on an unspecified date as dose 2, single and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number was not reported, Expiration Date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced "got an infection". The reporter wanted to know if her elderly father can get the 3rd dose of the Covid-19 vaccine. She said that her father got 2 doses of the covid-19 vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Mild
Patient was advised to wait for 15 min. After being in the observation area the patient decided to leave after 5 min of waiting. Patient then returned 5 min later crying stating to the Triage Nurse that her throat was swelling up. Triage Nurse informed her to quickly park her car and proceeded to check vital signs and open EKIT. Site manager was notified and more nurses became aware and started to assist. Blood pressure cuff was placed on patients left arm, and the pulse ox was placed on the left index finger. Triage Nurse asked the patient how was she feeling and if she was having any other reactions. The patient stated that she was feeling dizzy and started shaking. Triage Nurse verified with the site manager that it was ok to give the epi pen. The site manager said to give it and Immediately the triage nurse procced to inject 0.3 mL EPI Pen in the patient's left thigh at 0930. The charge nurse then called the emergency number and EMS arrived at 0933. The triage nurse noticed that the pulse ox was reading 86 and 88 at 0933 and put a nonrebreather on the patient's face with oxygen flowing at 1L.  At 0934 EMS started talking to the patient and started an IV. The pulse ox read 79 and 74 at 0935 and the oxygen was increased to 4L. The heart rate was 125, and the blood pressure was 137/118 @938 and the blood pressure cuff was change and put on the right arm. At 0942 the blood pressure read 154/83 with a heart rate of 122. @0945 EMS procced to transport patient to the hospital.