chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 years old patient recieved vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old patient recieved vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old patient recieved vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old patient recieved vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment information was mentioned.  Company Comment: Based on current available information about patient age and lack of adverse events for the only event of Product administered to patient of inappropriate age the causality is Not applicable event and case are Non-serious.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: FU received on 13-Aug-2021 and added second dose vaccination details.; Sender's Comments: Based on current available information about patient age and lack of adverse events for the only event of Product administered to patient of inappropriate age the causality is Not applicable event and case are Non-serious.
Swelling, redness and warmth to injection site/LD. Instructed pt to apply cold pack, OTC med for pain.
Received 2nd COVID vaccine on 1/9/2021.  On 4/11/2021 developed headache, loss of taste/smell, and nasal congestion.  Tested positive for COVID.
Patient developed a lump at the injection site on her left that continued to grow and fill with fluid. We noticed the swelling about a week after the shot was given. It looked like an abscess or cyst and grew about the size of a pea until it popped and the fluid drained out like a pimple. We took her back to provider and had a culture done. Provider prescribed Mupirocin while we waited for the results. We applied the ointment a couple times a day. It did not help reduce the redness or swelling. Results came back from the culture as non bacterial. The site would drain a little bit periodically for about a month. Then it continued to improve slightly until the site eventually scarred. 8/9/18 We took patient see another provider for an ear infection. While we were there we showed her the lump from the vaccine reaction. We had her next dose of the PENTACEL on 8/16/18 in her right thigh. Lot number C5550A - Sanofi. We had the same reaction. This time the lump grew bigger at a faster rate and seemed to be more tender when the site was touched. This one grew to about the size of a quarter. We had an ultrasound on both lumps and it came back as "inflammation". This was after the first injection site was almost healed and the second injection was just starting to flare up. We saw another provider on 9/18/18. She said it was inflammation, and that we should wait and see what happens. It drained more and left a scar. We saw a Dermatologist, and he said that it is one of the worse vaccine skin reactions he has seem. He recommended seeing an Allergist. Dermatologist prescribed Triamcinolone ointment. We put that on her leg twice a day. This seemed to bring the fluid to the surface and it explode with creamy discharge. We called the dermatologist and he said it was the inflamed fat cells draining. We then went to see an Allergist, on 11/13/18 for an initial consultation. He applied a patch test on 12/10/18. We went back on 12/12 for allergist to look at the test site, and again on 12/14 to remove the patch test. Everything came back as negative for allergies. He recommended not doing any future doses of the PENTACEL until we figure out what is causing the reactions. At our check up with provider on 1/22/19 provider recommended calling the CDC to see if they had any other information. Today 3/7/19 I called CDC and they told us to report to VAERS. 3/19/19 I have the report put together and submitted.
expired dose of Adacel was inadvertently administered to a patient; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 11 years old male patient who received an expired 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U5726AA, expiry date: 11-Jul-2019 via intramuscular route in the right deltoid on 16-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  It was a case of actual medication error due to Expired vaccine used.  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.  Documents held by sender: none.
This spontaneous report as received from a pharmacist refers to a 73 year old patient of unknown gender without known drug allergies. On 13-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # L026033 exp 27-MAR-2017, intramuscular. At an unspecified time post vaccination (November 2015), the patient experienced muscle pain in arm and was unable to lift their arm. The patient sought medical attention by contacting the pharmacy and a physician. At the time of this report, the outcome of paresis and myalgia was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
ears were popping like as if being on an airplane and they were constantly ringing; vision was blurry like there was a film over it and as if things were grayed out; felt the room spinning; closed his eyes and fell asleep and woke up much later in the evening feeling a little bit better.; felt very dizzy again and was back to his original symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt very dizzy again and was back to his original symptoms) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fracture. Concomitant products included DOLUTEGRAVIR SODIUM, LAMIVUDINE (DOVATO), PREGABALIN and MODAFINIL for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (felt very dizzy again and was back to his original symptoms) (seriousness criterion disability). On 20-Mar-2021, the patient experienced TINNITUS (ears were popping like as if being on an airplane and they were constantly ringing), VISION BLURRED (vision was blurry like there was a film over it and as if things were grayed out), VERTIGO (felt the room spinning) and SOMNOLENCE (closed his eyes and fell asleep and woke up much later in the evening feeling a little bit better.). At the time of the report, DIZZINESS (felt very dizzy again and was back to his original symptoms), TINNITUS (ears were popping like as if being on an airplane and they were constantly ringing), VISION BLURRED (vision was blurry like there was a film over it and as if things were grayed out), VERTIGO (felt the room spinning) and SOMNOLENCE (closed his eyes and fell asleep and woke up much later in the evening feeling a little bit better.) outcome was unknown.            No treatment information was provided. This case concerns a 55 Y/O M with a serious unexpected event of dizziness and nonserious unexpected vertigo, tinnitus, blurred vision and somnolence.  Event onset on day 2 after second dose mRNA-1273. Event outcomes unknown. Based on 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-057827 (Linked Report).; Sender's Comments: This case concerns a 55 Y/O M with a serious unexpected event of dizziness and nonserious unexpected vertigo, tinnitus, blurred vision and somnolence.  Event onset on day 2 after second dose mRNA-1273. Event outcomes unknown. Based on 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. US-MODERNATX, INC.-MOD-2021-057827:First Dose Case
Saturday: Redness surrounding injection site, size of a 50 cent piece. Sunday and Monday: Redness, warmth from mid upper arm to upper deltoid (approx 5in).
This is a 56 year olf female with PMH of HTN, MS, multiple UTI's in the past, Chronic urinary retention, Seizure disorder, and Constipation , presented to ED for weakness and letharginess. Noted to be hypotensive in ED, started on pressor support and transferred to ICU, noted to be COVID positive
patient complaining of arm pain since getting her 2nd dose. states that the pain is from her shoulder down to her hand. has been taking OTC pain meds
I had 3 major things that happened I had high body temperature feeling EXTREME redness on the skin that lasted for 3 hours, day 2 I had very high heart rate the lasted for about 18 days. Angioedema Intense facial swelling that started right away after the vaccine.
Prolonged fever (5 days), fatigue, severe body aches (could barely walk at first), chills, loss of appetite, sore throat, headache.
Expired Vaccine used; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Product storage error). On 19-Nov-2021 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 19-Nov-2021, PRODUCT STORAGE ERROR (Product storage error) had resolved. On 19-Nov-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided
Dizziness, severe HA, chest pain, back pain, swollen lymph nodes, stomach ache, metallic taste in mouth. Fatigue
second dose greater than 34 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose greater than 34 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose greater than 34 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose greater than 34 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication provided. No concomitant medication provided. Patient received first dose of Covid vaccine in December and was concerned if patient could get 2nd dose or does it need repeated .
Patient came back to pharmacy 1 week and 1 day after receiving ZOSTAVAX. She showed me one small lesion on her forehead that was red and burning. She stated that the area around injection and all around upper arm was itching and burning one to two days after injection. She also had a lesion on each shoulder blade but they are going away.
No additional AE reported; Healthcare provider reports the administration of ROTATEQ involved in a temperature excursion to a 4 month female patient on 12SEP2022. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp): ROTATEQ:  Lot: 174242; expiration date: 11-SEP-2022; This spontaneous report was received from a nurse referring to a 4-month-old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 12-SEP-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot #1742429, expiration date not reported, but upon internal validation established as 11-SEP-2022, for prophylaxis (dose, strength, and route of administration were not provided) (product storage error; expired product administered). Temperature and time frame was 2 Celsius degree (C) to 8 C (8.8 C) for 11 hours 57 minutes and 0 seconds. The previous temperature excursion was reported as not applicable. No additional adverse event was reported (no adverse event).
6/29, runny nose, cough, 6/30, got tested with a rapid antigen COVID 19 test positive. That evening I had headache, sore throat, nausea, vomiting, hallucinating, tongue turned blue. On the morning of 7/1 I saw a doctor who prescribed PAXLOVID in addition one for pain morning and evening, a throat lozenge, one was a nasal drops, one was to break up mucus and one was for cough suppressant morning and evening. Fever peaked at 101.7. Throat hurt so bad that unable to eat or drink except for medication for 4 days. Congestion ended after the 5th day. I had a cough for a few additional days. On 7/7, a rapid antigen test positive, the same day, 7/7 a PCR test was negative.
Patient called with concerns about his arm below the injection site.   It was swollen and red.  Hot to touch and sore.  Just above the elbow bend.  Not at the injection site.  Complained about it like that the following date from injection.  No other symptoms described.  Just alerting us because he knew we probably needed to report it.  He was instructed to monitor with ice, ibu, and possible HCZ cream if needed.  If got worse or no better, then seek medical help.  Follow up with patient on 9/10.  Pt stated that his arm was ok and swelling almost all gone.  The only thing he did was ice and took a little asa.  No problems and was not concernend.
According to medical records: patient's mother noted change in stool from mustard yellow to loose, dark green stool on 7/7/09. This was prior to the 4 month rota vaccine, but presumably she also received her 2 month dose. Diarrhea continued into her hospitalization, and ultimately was identified as rotavirus, vaccine-strain. 11/25/09 Hosp. recs received for date 9/11/09 to 10/2/09. DC DX: severe combined immunodeficiency secondary to ADA deficiency. DX: rhinovirus, rotavirus, periorbital cellulites, pneumocystis pneumonia, Adenosine deaminase deficiency. Pt presented w/ diarrhea to ER, pt admitted for further eval. after assessment revealed multiple medical dx. while in hosp. pt received IVIG treatment and is to cont. after dc.
Vaccine influenza given to child that is intended for ages 3 years and up. Child had a 102 degree fever and drowsy, reduced on its own. No treatment.
Information has been received from a physician concerning a female who on an unspecified date was possibly vaccinated with once 0.5ml dose of GARDASIL (lot # not reported). On an unspecified date the patient developed a local reaction. Her upper arm was red and swollen with fever of 101 degrees F. The reaction lasted for one week. The physician was not sure if it was GARDASIL or another company's vaccine. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Community acquired pneumonia; Shortness of Breath; Influenza A; This serious case was reported by a physician via sales rep and described the occurrence of community acquired pneumonia in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 17-SEP-2023, the patient received the 1st dose of Arexvy. In SEP-2023, less than 2 weeks after receiving Arexvy, the patient experienced shortness of breath (Verbatim: Shortness of Breath) (serious criteria hospitalization) and influenza a virus infection (Verbatim: Influenza A) (serious criteria hospitalization). On 25-SEP-2023, the patient experienced community acquired pneumonia (Verbatim: Community acquired pneumonia) (serious criteria hospitalization and GSK medically significant). The outcome of the community acquired pneumonia, shortness of breath and influenza a virus infection were not reported.   The reporter considered the community acquired pneumonia to be related to Arexvy. It was unknown if the reporter considered the shortness of breath and influenza a virus infection to be related to Arexvy.     The company considered the community acquired pneumonia to be related to Arexvy. It was unknown if the company considered the shortness of breath and influenza a virus infection to be related to Arexvy.   Additional Information: GSK Receipt Date: 17-OCT-2023 Patient over 60 received a dose of RSV vaccine at the pharmacy. Patient presented at the (unspecified) on 25th September 2023 with primary complaint of shortness of breath. Patient was admitted to hospital within 1-2 days of immunization for RSV with primary diagnosis of community acquired pneumonia.  Patient was tested for influenza more than one time. The second test showed positive for influenza A. The patient was discharged on 27th September 2023. Advanced registered nurse practitioner that treated her was not certain if patient received AREXVY or ABRYSVO because they were vaccinated at the pharmacy. The reporter consented to follow up.
Marked swelling, redness, warmth and tenderness to immunization site. Treated with Motrin, Benadryl and Keflex.
Pt reported dizziness, symptoms worsened and observer laid pt down on the floor.BP 80/54, No loss of consciousness.  Pt developed chest congestion and verbalized throat felt like it was closing. EPI 0.3mg administered and 911 called.
Information has been received from a registered nurse concerning a 65 year old female with no pertinent medical history or drug reactions/allergies who on 17-OCT-2006 was vaccinated with Pneumovax 23 (lot # 651400/0618f) 0.5 ml IM in left deltoid. No concomitant therapy. On 17-OCT-2006, in the afternoon, the patient experienced pain in her arm after being given Pneumovax 23. The patient sought medical attention. The patient reported she "cannot move her arm and it feels as though her arm was broken". No lab diagnostic studies were performed. At the time of reporting the patient had not recovered. Additional information has been requested.
Information has been received from a consumer concerning her now 11 year old nephew who on an unspecified date was vaccinated with a dose of MMR II. It was reported that the patient developed autism "from MMR II". It was reported that he was fine before the vaccine was given. Upon internal review, autism was determined to be an other important medical event. It was also reported that the patient's brother developed autism after vaccination (WAES # 0904USA00813). No further information is available.
Pt to ED on 3/1621 with : "pt c/o left sided chest and rib pain. pt states that other symptoms along with the pain started today. Pt is c/o SOB, numbness and tingling in bilateral upper extremities, bodyaches and "feeling cold." PT dx with PE of unknown origin
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.  It was reported that total 19 patients received expired vaccine out of which 3 were males and 16 were females.  It was reported that 10 vials out of 15 doses each were stored in a freezer whose temperature range was at all times from  24.3 degree Fahrenheit to 24.7 degree Fahrenheit.  The healthcare provider mentioned that they always had the freezer between this temperature range. Two vials were used to administer to healthcare provider's office employees. All doses were injected intramuscularly in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  The reporter informed that, the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt..  The patient did not experience any adverse events after receiving the booster dose of vaccine and the healthcare provider was informed that the vaccine could be used until the date of expiration.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow-up received contain significant information outcome of the event of product storage error and narrative updated.