chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion of punctured IPOL was 8.7C for 10 minutes due to unknown causes and administered with no reported adverse event; temperature excursion of punctured IPOL was 8.7C for 10 minutes due to unknown causes and administered with no reported adverse event; Initial information received on 15-Sep-2022 regarding an unsolicited valid non-serious case received from a health professional. GMI Inquiry Number: 01281017  This case involves a 6-year-old female patient to whom post-excursion administration after temperature excursion of punctured IPV (VERO) [IPOL] was 8.7c for 10 minutes due to unknown causes and administered with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown onset, it was reported that temperature excursion of punctured ipol was 8.7c for 10 minutes due to unknown causes with no reported adverse event (product storage error).  On 19-Aug-2022, the patient was administered punctured IPOL post-excursion at dose 0.5ml once via intramuscular route in the left thigh (lot: T1E872M, expiry date: 10-Oct-2022) for prophylactic vaccination with no reported adverse event (poor quality product administered) at same day latency.  This situation is reported as a medication error due to administration post excursion and temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.   Action taken: Not applicable.   At time of reporting, the outcome was Unknown for both events.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 12 years old patient who was vaccinated with the vaccine MENACTRA (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to wrong vaccine administered. It was unknown if any adverse event occurred or not following the vaccination. 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.
Right lateral leg with 4x5 erythematous, indurated, warm patch. No influence, No tender. Immunization reaction vs cellulitis. Treated with KEFLEX.
This case was reported by a other health professional and described the occurrence of axillary pain in a male patient who received Meningococcal ACWY Vaccine (potential MENVEO) for prophylaxis. Co-suspect products included GARDASIL for prophylaxis. On 3rd August 2010, the patient received Meningococcal ACWY Vaccine (potential MENVEO) (intramuscular) and GARDASIL (intramuscular). On 4th August 2010, 1 days after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced axillary pain. In August 2010, the patient experienced swollen lymph nodes. On an unknown date, the patient experienced mass, swelling and tenderness. On 7th August 2010, the outcome of the axillary pain, mass, swelling and tenderness were recovered/resolved. On an unknown date, the outcome of the swollen lymph nodes was unknown. It was unknown if the reporter considered the axillary pain, mass, swelling, swollen lymph nodes and tenderness to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional details: Age at vaccination was not reported. It was unknown if the reporter considered the axillary pain, mass, swelling, swollen lymph nodes and tenderness to be related to GARDASIL. Initial information was received from other health professional via regulatory authority on 25th March 2019. Axillary pain, mass, swelling, swollen lymph nodes and tenderness.
After I received the vaccine I had a high fever of 100.9 degrees, aches, chills, headaches, tiredness, and later on I felt like I had hair loss. I also had tiredness that is still continuous. I went to the doctor and they ran tests. I am recovered from everything except the tiredness. I'm easily worn out and have no energy. I could be sitting down watching TV or playing a game and I would just fall asleep. It has never been that bad before.
I felt not well soon after the vaccine was administered (Saturdat, Nov. 3).  I was awoken with a pain in my arm at 4 am the next morning. I ran a fever of 101-102. I went to the ER and my wbc was 15,000.  I was released with levoquine.  The hot, red sore on my arm, at the injection site, was spreading and I returned to the hospital.  My white count was 18000. I was placed on vancomyacin and zosyn.  the symptoms partially remitted. I was then transferred to Zyvox (first IV and then orally) and lovoquin again and was released from the hospital on Thursday.  there was a discussion about inserting a PIC line, but I was opposed to that without a better explanation as to why one was needed. The red area appears to be resolving. I have advised Health care of this event and have urged them to report it.  11/21/2007 MR received for DOS 11/5-8/2007 with D/C DX:  Cellulitis to the LUE.  Leukocytosis with bandemia, resolved.  Diabetes mellitus Type II, HTN, Hypothyroidism, Increased LFTs. Pt noted pain and swelling to LUE and feeling feverish following Pneumovax.  Pt seen in ER and txd with abx and d/cd on po abx, but with worsening cellulits sx and elevated WBCs, she was subsequently admitted.  PE (+) for erythema, tenderness, induration and warmth at pneumovax injection site.   Pt's WBCs decreased with abx tx and pt was d/cd home.
Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 31-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, UNK. In 2022, the patient experienced PAIN (Pain). In 2022, PAIN (Pain) had resolved.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event with Humira was a reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-621085 (Patient Link).
Extraneous dose of MCV4 was administered to the patient. This was the patient's third MCV4 vaccine. The patient did not report being in distress after receiving the vaccine. Currently attempting to reach the parent to notify them of the extra dose. The MCV4 dose was accidentally administered instead of Hepatitis A, so the patient will need to return for the Hepatitis A vaccine.
The following morning 3/6/21 after receiving my first dose, I woke up @9am with chills and then turned into a fever. 10 minutes later I felt my heart pumping fast and hard as I was laying down. I checked my heart rate with my pulse oximeter and it was at 130 as I laid down and it suddenly started beating faster and faster until my heart rate went as high as 200bpm. I immediately called 911 and they checked my vitals upon arrival. My heart rate was consistently at 150 during their arrival and blood pressure was at 180/*** (unsure of second #). I refused that they take me to ER, and got a ride to urgent care where they took X-rays of me and gave me IVs and Tylenol. X-rays were normal and their diagnosis was adverse effect to COVID19 vaccine. My heart rate started to normalize the day after I went to urgent care, but took me 3-4 days to feel back to normal.
I had a horrid reaction to my second covid shot. I got it on Monday 3/15 and was fine Tuesday. I even walked for an hour on he beach with the dogs so I said ?this wasn?t that bad? ON THE MORNING OF 3/17. I woke up about 3 AM with a fever OF 104 and basically an inability to stand. I tried to get ofF the bed to go pee and fell to the floor from which I could not get up as I had no muscle control or ability to lift myself uo and using a small ladder t took a long time for me to be able to manage to get on my feet with my wife  assistance.  On the way to the bathroom i banged into walls almost falling again.  told me later I looked as though I had a stroke. I made it back to bed and my temp was 104.  Then 20 minutes later the process started all over again it?s me falling to the floor and not being able to get up. This time when i was finally  and my O2 at 80  heart rate 112 was able to get up after about 7 tries I again walked into walls making it to the bathroom. This whole process happened one more time but this time i took a cool shower to cleanup and get my temp down.  Got back to bed and took a Vicodin along with two Advil.  I woke up at 10 am. No fever, able to stand and walk no problem  I sure hope this is over. but tonight will tell. form Item below is checked patient died and there was no death
headaches began immediately after vaccine and after 3 months presented with altered mental status at medical facility.  consulted for mastoid fluid associated with multiple cranial sinus thrombosis (sagittal, transverse, sigmoid, and right proximal jugular thrombosis.)
Information has been received from a nurse practitioner concerning a female who was vaccinated with the first 0.5ml dose of GARDASIL. "A week after the vaccination, the patient developed a fever and nausea". The patient was taken to the emergency room. At this time of reporting, the patient's status was unknown. The ER doctor informed the patient that he believed it was more of a flu thing rather than a reaction to GARDASIL. Follow up information received from a nurse practitioner followed up with the patient and it turned out that her symptoms were not related to GARDASIL. She ended up having salmonella. No further information is available.
itching all over; This is a spontaneous report from Team. A contactable consumer (patient) reported that a 68-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration on 13Jan2021 as single dose in left arm for the COVID-19 vaccination. Medical history was ongoing back pain. Concomitant medication reported was oxycodone as 5 mg, as needed for back pain. Consumer WAs calling about the Pfizer COVID-19 vaccine and said she took her first shot on 13Jan2021 and she also takes Oxycodone when she has a backache, which she hasn't taken for a while, and she took some and now she had itching all over. She said can Oxycodone have some kind of affect if she has had the vaccine. Caller said she know it expires Dec2021 and was 5mg, it was a liquid one, it was red medicine that comes in a bottle. Caller said she doesn't have her vaccine card with her to provide information from it. She said that she was given her first dose injected in her left arm. Caller said they have not had any other recent vaccinations or started any new medications. Caller stated she took Oxycodone liquid 5 mg and wanted to know if there will be an interaction with the Pfizer covid 19 vaccine. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
Patient received the Moderna Bivalent booster vaccine. She did not have the primary series yet. Patient was monitored and tolerated the injection well with no complaints or complications.
A few days after receiving the vaccine I developed a red spot around site (rash) and became very itchy and warm to the touch with swelling and pain
This spontaneous report was received from a health professional referring to multiple patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, (J012567, expiration date: 30-JAN-2016; K006682; 17-DEC-2015), dose and route of administration were not provided. No adverse effect reported. This service request was first opened on 30-JUN-2015, when a pharmacist called to report a vaccine temperature excursion but any adverse event was reported at that time. However, this adverse event was reported on 11-AUG-2015, during a call back by this healthcare worker. This is one of several reports received from the same source. Additional information has been requested.
pt reported fatigue, joint pain, body aches, and chills on day 1 and 2 Narrative:
Information has been received from a nurse concerning a male who on an unspecified date was vaccinated with the first dose of VARIVAX (Merck) (lot number, route and site not reported).  The patient developed 50 varicella lesions 2 weeks later after getting vaccination.  The patient had sought unspecified medical attention.  He recovered on the unspecified date.  Additional information has been requested.
Patient got her Spikevax vaccination on 10/17/2023 at our facility. I administered it to her in the right arm, and at the time and for 15 minutes later everything was fine. Her daughter was with her and took her home and all was fine. 12 hours later she felt as if she were having a stroke and could not see, was shaky, and couldn't walk. Her daughter called the paramedics and she was hospitalized. Her condition resolved and she was released from the hospital and steadily improved after that. She is fine now.
Received 2nd dose of covid vaccine at 11 weeks, 6 days. Had follow up normal ultrasound at 12 weeks, 2 days. Missed miscarriage noted at 15 weeks, 1 day. Last measurement of baby noted to be 12 weeks, 6 days. Closely monitored during first trimester with no abnormalities noted. Normal ultrasound at 12 weeks, several days after baby stopped growing with fetal demise at some point there after
A few hours after the vaccin I became aware of numbness on the left forearm that extended from the left forearm down the side of the arm near the thumb and forefinger  area down to the wrist area.  I had no weakness or loss of function but it was numb.  I was seen in the ER where they did a visual check and was advised to monitor and if it worsened to contact my PCP.  And after about 3 days I noticed it had resolved with no new symptoms since.  I also had  really intense joint and muscle pain also.
This spontaneous report as received from a other health professional refers to a pediatric patient of unknown age and gender. On 16-AUG-2013 the patient was administered an adult dose of VAQTA. The first dose of VAQTA was administered on a prior unspecified date. No adverse effect reported. Additional information has been requested.
No adverse effects reported.; an unspecified number of unspecified patients were administered doses of VARIVAX which were improperly stored.; Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent(manufacturer unknown).  On 01-SEP-2017, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were unknown, lot # M049127, expiration date:15-DEC-2018, lot # N010107, expiration date:28-MAR-2019) for prophylaxis(Incorrect product storage).   Administered vaccine experienced the temperature excursion of -14 celsius degree to -10 celsius degree (-14.2 celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint(PQC) was involved.    This is one of several reports from the same reporter.  All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful.  Follow up information has been received from an other reporter concerning a 18 month old patient. On 12-SEP-2017, the patient vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018) for prophylaxis(Incorrect product storage).  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-1709USA002098:
Information has been received from a registered nurse concerning a male child who was vaccinated PO with a first 2 mL dose of RotaTeq vaccine after 12 weeks of age. No adverse effects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. This is one report of several from the same source.
Approximately equal to 10 mins after receiving the flu vaccine the patient started vomiting. There was no reaction at the injection site. No fever, chills or SOB. Pt says she usually gets dizzy when she get a shot or sees a needle. She had just eaten.
This spontaneous report as received from a physician' medical assistant, a nurse refers to a 2 months old patient. The patient was vaccinated with the first dose of 2 ml ROTATEQ (lot# unspecified) orally in July 2012, "at 2 months of age". It could not be verified that the entire 2ml vial of ROTATEQ was administered. Concomitant medications included PREVNAR and PENTACEL. It was reported that the patient got vaccination. Child developed "neon green" foul smell stools, a fever and chills and was taken to the unspecified local urgent care center, but was not hospitalized. Child was given dextrose, electrolytes (unspecified) (PEDIALYTE) for treatment. The child was sick for 7 days but was recovered. Additional information has been requested.
Chills, Aches, Slight fever (100.5F), Fatigue. First Noticed around 10:30 AM 3/3/21, I would not classify these symptoms as Severe at this time. But did leave work as a precaution.
contracted COVID-19; contracted COVID-19; Inappropriate route of vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "contracted COVID-19"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate route of vaccination". Clinical course: A male patient with a history of asthma reported in market research that he contracted COVID-19 about two weeks after their Pfizer COVID-19 booster shots.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300180836 Same reporter, different drug/patients.;US-PFIZER INC-202300180962 Same reporter/ drug different event for different patients.;US-PFIZER INC-202300180963 Same reporter/ drug different event for same patients.;US-PFIZER INC-PV202300080379 Same reporter/ drug/ event for different patients.;
Information regarding PREVNAR 13 was received from a healthcare professional regarding a one of six patients who experienced excessive redness the size of a softball or larger. The patient received a dose in 2010. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered in 2010. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced excessive redness the size of a softball or larger in 2010. The injection site was treated with application of heat and MOTRIN with subsequent resolution the next day in 2010. As of 31 Aug 2010, it is unknown if the excessive redness at the resolution site in these children have resolved. No additional information was available at the time of this report.
Low grade fever, chills, extreme fatigue.  After sleeping all night, I awoke feeling OK.
Right arm with slight discomfort day after injection. 3 days later it started to swell and has been progressively getting more swollen. On day seen 12/9/03 5cm of induration/warmth. Zyrtec 10mg po qd. NSAID, Keflex 500 po tid for 10 days, pt to phone follow-up.