chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received a Invalid Fluzone Quadrivalent prefilled syringe vaccine which was exposed at 35 degrees F/No AE; Initial information received on 18-Feb-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12-year-old male patient who received invalid INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] prefilled syringe inadvertently which was exposed at 35 degrees F.  Medical history, medical treatment, vaccination and family history were not provided.  On 17-Feb-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT6719JA, expiry date: 30-Jun-2020] via an intramuscular route at the left deltoid for prophylactic vaccination inadvertently which was exposed at 35 degrees F.  It was a case of actual medication error due to product storage error temperature too low.   Temperature excursion due to something wrong with refrigerator and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] was at 35 degrees F. that went down to 20.9 degrees F. for 6 hours  At the time of reporting, no adverse reactions were reported.  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.
Swelling in lymph node left side where received the vaccine from my left side neck down to breast and then arm pit; Fever 100.6 degrees; I am Nervous and worried getting the second dose; Swelling in lymph node left side where received the vaccine from my left side neck down to breast and then arm pit; Swelling in lymph node left side where received the vaccine from my left side neck down to breast and then arm pit; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0180, Expiration Date: Aug2021) dose 1 via an unspecified route of administration, administered in left deltoid on 25Jun2021 as dose 1, single for COVID-19 immunization (at the age of 46-year-old). The patient medical history included hypothyroid from an unspecified date. Concomitant medication included levothyroxine, liothyronine (NP THYROID) 30 mg for unspecified indication, start and stop date was not reported. On 26Jun2021, the patient experienced swelling in lymph node left side where received the vaccine from her left side neck down to breast and then arm pit, fever 100.6 degrees, nervous and worried getting the second dose. The patient stated that, I received Pfizer first dose on 25Jun2021, and I think that I am having unusual reactions to the Pfizer vaccine (unspecified vaccine), It was yesterday on 26Jun2021. For unusual reactions, Nurse stated, swelling in the lymph node on the left side where I received the vaccine from my left side neck down to breast and then my arm pit and also fever like 100.6 degrees. Patient stated, I have another date about getting the second dose of Pfizer, I am nervous. I am scheduled for the second dose I think it is July, don't remember. I am worried getting the second dose. My husband also received with me the first dose of Pfizer and he is fine (why) only I have the adverse reactions. On 26Jun2021, the patient underwent lab tests and procedures which included fever: 100.6 Fahrenheit. Reporter seriousness for the event was unspecified. The outcome of all the events were unknown.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up (22Jul2021): Follow-up attempts are completed. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of hepatitis B in a 9-month-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline), RECOMBIVAX (non-gsk). On 30 November 2009 and 23 June 2009 the subject received 3rd and 2nd dose of ENGERIX B (unknown), In 2009 the subject received 1st dose of RECOMBIVAX (unknown). On 1 March 2010, 91 days after vaccination with ENGERIX B, 8 months after vaccination with ENGERIX B, 1 year after vaccination with RECOMBIVAX, the subject experienced hepatitis B, not responding to therapy and vaccination failure. This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved.
Patient received vaccines on Monday - later that day developed induration, erythema & swelling of (R) thigh with fever - low grade. Symptoms improved by Wednesday - 2 days later. Used acetaminophen.
This case was reported by a health professional and described the occurrence of chronic inflammatory demyelinating polyradiculoneuropathy in an adult female pt who received hepatitis B vaccine recombinant (Engerix B). On unspecified dates in 2003 the pt received a series of two doses of Engerix B (lot number for first dose ENG5374A2; lot number for second dose ENG5378A2). The reporter stated that, the pt did received other vaccines with Engerix B; however, the concurrent vaccine information was not provided. At an unspecified time following the second administration of Engerix B, the pt experienced chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and was hospitalized. The reporter stated that the pt is apparently now wheelchair bound due to the CIDP and is seeking legal action. The outcome of the events was reported as worsening. Lost to follow up.
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. A report of the case of a female, aged 19-24 years old, patient who experienced Other Anaphylactic Shock, NEC (Serious, since 04-Jan-2012, until 04-Jan-2012) while enrolled in the study. Received Adenovirus vaccine 4-Jan-2012, Lot # 34600018. Event start date was 4-Jan-2012 and the patient was hospitalized for complications, which included medications (prescription and OTC and non-drug treatment, Non-drug treatment), severity was not assessed and outcome resolved and seriousness medically serious. Treatment provided: Epinephrine 0.5 mg x2 injection on 04-Jan-2012. Albuterol oral on 4-Jan-2012, SOLU-MEDROL 60 mg IV started 4-Jan-2012, BENADRYL 25 mg IV started 4-Jan-2012, Guaifenesin-Pseudoephrine 600/60 mg orally Q12H started 6-Jan-2012, Prednisone 10 mg 6 tabs x2 days orally started 5-Jan-2012 and last dose 8-Jan-2012, Ibuprofen 200 mg orally PRN started 14-Feb-2012 and last dose 9-Mar-2012, and Oxygen nasal on 4-Feb-2012. Adverse events within 42 days of vaccination: Evaluation for possible vaccination reaction on 13-Jan-2012- Treatment outpatient visit and medication-outcome, severity, seriousness not assessed; Allergic reactions to immunizations on 18-Jan-2012- treatment outpatient visit and medication-outcome, severity, seriousness not assessed; and history of anaphylaxis Tdap/Hep A- Tele consult on 24-Jan-2012-outcome, severity, seriousness not assessed. The patient also received meningococcal (MCV4P) on 30-Dec-2011 (lot#U4259AA manufacturer PMC), Tdap on 4-Jan-2012 (lot#AC52B075AA manufacture SKB) and influenza on 30-Dec-2011 (lot#UT423AA, manufacture PMC) and IPV on 30-Dec-2011 (lot #G1500 manufacture PMC). At the time of the report the outcome of the AEs were: Other Anaphylactic Shock, NEC: recovered/resolved. The medical history of the patient was not specified. The patient's concomitant medication included influenza vaccine, Diphtheria-Tetanus-Pertussis vaccine, IPV, Meningococcal vaccine. The patient's past medication were unspecified. Action taken with suspect drugs: Adenovirus vaccine - not applicable. Lab tests were not reported. This case was considered serious based on the following criteria: (Hospitalization Required, Other Serious (Important Medical Events)). The medical monitor noted that the causality for the case is Possibly Related to the Adenovirus Vaccine.
Heavy vaginal bleeding a day or so later. The bleeding was like a pouring out of blood so severe that it caused me to need a blood transfusion in the emergency room at hospital.
received 2 doses of Kinrix; patient was supposed to get Kinrix and Proquad; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number MZ379, expiry date 25-JAN-2025) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + POLIO VACCINE + TETANUS VACCINE TOXOID (KINRIX).   On 25-JUL-2023, the patient received Kinrix. On 25-JUL-2023, an unknown time after receiving Kinrix, the patient experienced accidental overdose (Verbatim: received 2 doses of Kinrix) and wrong vaccine administered (Verbatim: patient was supposed to get Kinrix and Proquad). The outcome of the accidental overdose and wrong vaccine administered were 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: 25-JUL-2023 The vaccine administration facility is the same as primary reporter. The reporter consented to follow up via postal. The patient received 2 doses of Kinrix and was supposed to get Kinrix and Proquad, which led to accidental overdose and wrong vaccine administered.
BLOOD CLOTS; This spontaneous report received from a consumer concerned multiple patients (unspecified number of patients) of an unspecified age, sex. The patients weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients experienced blood clots. It was reported that, the reporter had friends, who had blood clots after getting their Janssen covid shots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221162412 and 20221162364.; Sender's Comments: V0: 20230321709- blood clots. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
EXPIRED LOT FL8095 ADMINISTERED. EXPIRED 08/31/2022 AND GIVEN ON 09/20/2022
My joints started aching  on 6/19/21 and continued to get worse for 2 weeks. I had no energy and a constant headache for 3 weeks. My head covered in blisters on 6/19/21, then my right foot became covered in blisters on the 20th and both of my hands started blistering on the 21st. I?m still having a lot more blisters appear every day.
Received 3 adult vaccines, approx 15 minutes later began to feel tingling and swelling of lips (not visible on outside) and sensation of increasing difficulty in swallowing. Had own Albuterol inhaler that she would normally use, took 2 puffs and within 10-15 minutes began to feel fine. Did not have respiratory distress but was somewhat anxious. (Did notice that her inhaler had exp date of 8/09-pointed out to her that she should refill).
Vaccine stored in refrigerator on 22-Sep-2021, expired on 03-Oct-2021 and administered on 29-Nov-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 22-Sep-2021, expired on 03-Oct-2021 and administered on 29-Nov-2021) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 22-Sep-2021, expired on 03-Oct-2021 and administered on 29-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 22-Sep-2021, expired on 03-Oct-2021 and administered on 29-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Information has been received from an RN concerning a 15 month old Caucasian male who on 10/9/00 was vaccinated with a 1st dose of MMRII (lot 630633/0102K) in the left leg. On approx. 10/11/00, the pt experienced redness and induration 4" X 4" and hot to the touch, at the injection site. On 10/13/00, the pt experienced fever. Temperature by ear was 105F. Upon internal review, fever was considered "Other Medical Event". On approx. 10/16/00, the pt developed a rash. Pt received Tylenol and Advil for fever and oatmeal baths for rash. In follow-up, the RN reported that the injection site was swollen and that ice was applied to the site. It was indicated by 9/16/00, the pt recovered. No further information is available.
Pt had swelling, warmth, redness, and slight itching to her left arm - the reaction was not at the injection site - it was further down the patients arm and towards the inside of her arm and elbow.  Pt stated showing symptoms on Sunday 9/16, and when I consulted (immunization coordinator) she stated this was a common ADR and no reporting would be needed. On Monday 9/17 the rash was slightly better, but not resolved and I advised pt to go to MD. The MD was unsure what caused the skin reaction - however, he believes it is related to the vaccine. He gave the patient BACTRIM DS number 20 tk 1 tablet by mouth every 12 hours.
Shoulder pain, hip pain, upper legs pain (all bilateral), low grade fever (101 degrees on 4/4/11 at MD visit), rash on abdomen and both shoulders, pain with lumps in bilateral axillas. Patient has all sx resolved except axillary painful lumps. Patient saw MD on 4/4 with sx and fever.
See attached. I saw her 10/10/11 when her sister was in. Still has a 6cm x 4cm bruise. It doesn't hurt, but it is hard to tell which vaccine. Looks like MMR. I spoke with mom and she said it was her left arm. Unaware which vaccine it was. She couldn't tell me if it was deltoid or back of her arm. But she says its about the size of patient's hand, and hot to the touch. A little bruising. I told her ice and MOTRIN, she said she only had TYLENOL and I said that was fine but it may not work as well. She could have 2 tsp of childrens. I told her to draw a circle around it and to call back in the am and tell us how much bigger it spreads. If it gets too large and she is worried I said nurse is on call and she will talk to her. If it gets too big we need to see her and do a VAERS report. She is still able to move her arm fine, she just doesn't like people touching it.
Narrative:  Patient developed a diffuse area of pruritus over his deltoid that started about 2 days after the initial vaccine and persisted for 2 weeks. It was associated with a change in the skin to a pink color. Denies erythema, induration, swelling, rash, sloughing or any other typical adverse effect from the vaccine. He did not try or apply any therapies.
raised area at injection site; itchy area on injection site; Swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE OEDEMA (raised area at injection site), VACCINATION SITE PRURITUS (itchy area on injection site) and VACCINATION SITE SWELLING (Swollen injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE OEDEMA (raised area at injection site), VACCINATION SITE PRURITUS (itchy area on injection site) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, VACCINATION SITE OEDEMA (raised area at injection site), VACCINATION SITE PRURITUS (itchy area on injection site) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
4/2/15 pt called to report pain, stiffness noted starting evening after received Tdap 3/25/15. Pain with arm movement into rotator cuff area, shoulder, into neck. Pain has persisted for 8 days. Scale 1-10 pain started at 8, now a 4. Ibuprofen 3 tabs and heat help. Has full range of motion. Denies redness, swelling, numbness. States shot given 1 inch below shoulder joint.
Seizure led to patient going to ICU. Still in the hospital and suffering from short term Amnesia.  11/2/09:  Infectious Disease Consultation received for date of service 10/10/09: Dx:  Convulsions consistent with seizure.   Assessment:  Started on Effexor and got a flu shot and began to experience abdominal distension and bloating thereafter, also experienced general aches, nausea and vomiting. The patient was noted to be more fatigued, and a convulsion was witnessed on the day of admission.  The pt. was febrile in the ICU prompting the ID evaluation.   Hyponatremia was noted.  The hyponatremia or intolerance of the Effexor were thought to be the cause of the seizure.    11/2/09:  ICD 9 Codes Received:  780.97, 253.6, 348.31, 304.01, 338.29, 719.45, 276.8, 244.9, 530.81, 401.9, 272.4, 780.39, 383.9, 275.41, 265.2, 300.4, 785.0, 794.8, V43.65.
The patient started having right sided chest pain/rib pain minutes after receiving the 2nd dose of Covid 19 vaccine. When he presented to the medical treatment area he was c/o this right sided chest pain that was worsened by inspiration. The pain was non-radiating and was also associated w/ shortness of breath. He has been experiencing shortness of breath intermittently over the past couple of weeks. The patient denied associated dizziness, lightheadedness, nausea, vomiting, abdominal pain, vision changes. He noted that he has a prior history of DVT and PE, but is not on any anticoagulation medications. He is currently being treated for bacteremia from a dog bite wound and receiving IV antibiotics through a port. He also has hx of CLL, currently on oral chemotherapy medication.
Erythemic, edematous, warm left arm with 3 blisters (small).
15JUL92 recvd Engerix-B & devel muscle aches in biceps that progressed to weakness in both arms & loss of strength in fingers;
"Shaking". Pt reports having meningococcal vaccination at 10am this morning, says he was "not feeling well at the time" due to "going out last night and developing a headache". Pt says while driving home at 2pm he developed "uncontrollable shaking". Pt currently has rigors, c/o back pain and muscle pain. He is fully alert and oriented. Provider was notified.
2nd dose: 65 Days after first; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose: 65 Days after first) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose: 65 Days after first). On 12-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose: 65 Days after first) had resolved.            No concomitant medications were reported. No treatment medications were reported. It was reported by the patient that the second dose was given too fast.
Excruciating pain to the point of unable to move my arm.  I went to the  orthopedic  today  and they diagnosed me  have impingement shoulder
Injection site is bruised. Developed a red, raised rash below the injection site on the 8th day after vaccination. The rash has remained for 3 days so far.  It?s less raised but has spread around the injection site. Developed swollen lymph nodes under the left armpit on the 10th day after vaccination.
Approximately 1-2 minutes after receiving the vaccine patient started feeling faint. Patient requested to lay on the floor and lost consciousness for approximately 3 seconds. Patient came too and still felt light headed and requested to stay laying down. Offered to call ambulance, patient refused. Provided patient with ice back, bottle of water, and some chocolate candies. Patient was responsive and engaging in conversation while laying down for approximately 20 minutes. Patients boyfriend came and picked up patient from pharmacy. Patient states that she has had syncope episodes before with blood draws and other immunizations.
Patient came to urgent care clinic 16 days after vaccination. Patient stated she received the Moderna vaccine on 1/12/2021 and began to develop a rash on her arms on 1/14/2021. Patient stated that she has been to see her primary care provider after onset of rash. Patient was prescribed a steroid injection and a Medrol dose pack. Patient stated that after completing these, the rash persisted and started to get worse. On presentation to urgent care, patient had rash on both arms, across her chest, on the left side of her neck going up to her ear, on her left eye lid and starting on her mouth. Patient's right hand was extremely red and excoriated. Patient gave a history of sebhhoric dermatitis.
fine tremor entire body, lips blue, emesis X1, T 100 (AX) on 7Feb91, Sx con't 8Feb91 T 104 oral. 9Feb91 child recovered, parent did not see MD as instructed
Within 2 hours of vaccination, child developed hives in left leg and on back. Child's left leg turned blue per parents. Child was seen in doctor's office at 3:30 p.m., hives and discoloration gone from left leg, but residual flat hives still seen on back. Dr. prescribed Benadryl x 10 days.
Initial symptoms on the first day were normal - fatigue, elevated temperature,  by the end of the first pain started to describe slight chest pain. Chest pain increased on day 2, by evening it would impact him every time he went up a flight of stairs. He reported pain at 6 on a 10 point scale. Did a virtual visit with doctor. Told to monitor and bring to ER if persists/worsens or is with a fever. Father took him to our medical doctor the morning of the third day.
pt recvd vax; R upper arm red, sore, swollen w/ sl rash appearance even 5 days p/ vax;tx w/ apap & cool compress;