chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling, redness, heat Cellulitis - worsening / spreading over 4 days despite abx. (Keflex) Seen in ED changed to Clindamycin
Rash on my face .. and cheek; Rash on my left side, and my back; Rash on neck, on the back of my neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on my face .. and cheek), RASH (Rash on my left side, and my back) and RASH (Rash on neck, on the back of my neck) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included CALCIUM for an unknown indication.   On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced RASH (Rash on my face .. and cheek), RASH (Rash on my left side, and my back) and RASH (Rash on neck, on the back of my neck). At the time of the report, RASH (Rash on my face . and cheek), RASH (Rash on my left side, and my back) and RASH (Rash on neck, on the back of my neck) outcome was unknown.      The patient received the Moderna COVID-19 booster on Tuesday 02-Nov-2021, in her right arm (the dominant one). On Thursday of the same week, she was woke up with a rash. The patient reported rash on her left side, back, face, neck, on the back of her neck and cheek.  The patient mentioned 3 regular (concomitant) medications as Oteard 20 mg once a day, Laiste 15 mg and Calcium 15 mg twice a day. Also her doctor gave her something for the rash but, she did not remember the name of it.
Information has been received from an office manager concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine (yeast). It was reported that on an unspecified date some time ago (also reported as some weeks ago) the patient passed out while standing at the check out after her first dose. The patient recovered. There were no emergency procedures; she was not injured and no pregnant. This is one of several reports received from the same source. Additional information has been requested.
Feel bad; Feel like the cold; Began to sweat/neck and armpit were sweating; Broke down; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel bad), FEELING COLD (Feel like the cold), HYPERHIDROSIS (Began to sweat/neck and armpit were sweating) and MENTAL DISORDER (Broke down) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Galactosemia.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced FEELING ABNORMAL (Feel bad), FEELING COLD (Feel like the cold), HYPERHIDROSIS (Began to sweat/neck and armpit were sweating) and MENTAL DISORDER (Broke down). At the time of the report, FEELING ABNORMAL (Feel bad), FEELING COLD (Feel like the cold), HYPERHIDROSIS (Began to sweat/neck and armpit were sweating) and MENTAL DISORDER (Broke down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included medication for GALT.  Treatment information was not provided.
I was vaccinated on 5-25-21. I contracted Covid  and got a positive test on 10-25-21. I was very,very ill on 10-24-21. I started an ivermectin treatment prescribed by my doc that day and got the monoclonal antibody infusion on 10-25-21. I felt better after that except I had a lingering bad cough and was extremely tired. on 11-15-21, I started shaking all over, became very weak and had tingling all over my body. I went on for the rest of the night and I vomited about 6:00 am on the 16th. My husband took me to the e.r. where they performed many tests which all came back normal. They said they were concerned that I had a neurological event so they admitted me to Hospital weher they kept me for two days and performed more tests.
No adverse side effects; Patienr received an incomplete dose of MMR II; There appeared to be leaking from the syringe and needle; There appeared to be leaking from the syringe and needle; There appeared to be leaking from the syringe and needle; This spontaneous report was received from a Medical Assistant, referring to a 12 month old patient of unknown gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided.      On 12-FEB-2021, the patient was vaccinated with an incomplete dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) with lot # S039310 and expiration date on 14-FEB-2021 (route of administration, dose and strength were not provided) for prophylaxis. The reporter stated, that there appeared to be leaking from the syringe and needle. It was unknown, how much of the vaccine the patient received. No adverse side effects occurred.
1:35pm- Light headache 2:00 pm Light nausea 5:30 pm headache              nasal congestion              nausea 12-31-2020/5:00 AM  Headache
pt recv vax 14APR99 & 2 days later began having leg & back pain;21APR had onset of ataxia which worsened;adm to hosp 26APR w/ataxia  & diplopia;dx w/post-infectious cerebellar ataxia, possibly secondary to MMR
1 of 8 pts (4-6 yr old range) seen /win the past wk /w severe local rxns, pt had 2 X 3 inch area of redness, tenderness, warmth & low fever.
1436 felt dizzy, was diaphoretic, pale, b/p 90/40, pulse 60 RR 40 99% 02 sat., MOC present. 1437 assisted to floor placed in Trendelenburg position feet elevated. 1439 B/P 110/p, pulse 80, RR 30 02 sat 99 %, alert and oriented , able to verbalize feeling better. No longer diaphoretic, skin color pink. 1444 assisted to sitting position in chair B/P 98/68 RR 32, 02 sat 100%, pulse 76. 1500 B/P 102/64 99% 02 sat 75 pulse respirations even and unlabored, per MOC stated she is feeling better, pt verbalized the same no longer requiring medical care, left with MOC, educated  and encouraged to contact Primary MD if symptoms should return, verbalized understanding.
Has been several weeks, over a month since patient received Zostavax vaccination. Patient reports prolonged arm soreness and has used tiger balm (OTC) to temporarily relieve the pain.
Patient reported to the ED 3 days after vaccination with shortness of breath and chest pain. ST elevation noted and sent to cath lab, CT angio revealed that he could have a small subsegmental pulmonary embolism.
a pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent to a patient, with no AE; a 45 years old patient received Fluzone High Dose Quadrivalent accidentally, with no AE; a 45 years old patient received Fluzone High Dose Quadrivalent accidentally, with no AE; Initial information received on 13-Nov-2020 regarding an unsolicited valid non-serious case received from the other health care professional via Medical Information (MI) (Reference number- 00358658).  This case involves a 45 years old male patient who was supposed to give INFLUENZA VACCINE INACT SPLIT 3V [FLUARIX], but the pharmacist accidentally grabbed and administered a 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] Prefilled Syringe lot UJ567AB, expiry date: 30-JUN-2021 via intramuscular route in the left arm on 06-Nov-2020 for prophylactic vaccination (Wrong product administered, product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No other vaccines given.  This was a case of an actual medication error case due to the event wrong vaccine administered and inappropriate age at vaccine administration  (latency: same day).  It was also a case of overdose. (latency: same day).  No adverse event were noted and no treatments were administered to the patient.  Product used : Used.  Still using product : No.  Was Device Used : Yes.  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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.
No additional AE; Inappropriate dose of vaccine administered; This spontaneous report was received from a pharmacist and referred to a 23-year-old male patient. The concomitant therapy, concurrent condition, drug reactions/allergies, and medical history were not provided.  On 04-JUN-2023, the patient received 1 dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) Syringe as prophylaxis (valid lot# U024832 with reported expiration date 09-DEC-2023, strength and route of administration were not provided) (Extra dose administered). The patient told the pharmacist that he had not received the vaccine previously. However, patient's mother later reported that the patient had received the full 3-dose series starting in July 2016 and ending in June 2017. There was no additional adverse event (No adverse event).
chills; temperature; 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 CHILLS (chills) and PYREXIA (temperature) 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 CHILLS (chills) and PYREXIA (temperature). At the time of the report, CHILLS (chills) and PYREXIA (temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Light headed, nausea, nurse came over because I was so pale. Chest tightness. Don?t feel good at all. Very concerned
Shortness of breath and chest pain starting on 7/29/21, prompting ED visit on 7/31/21 where she arrived hypoxic, tachypnic, and tachycardic. She was found to have bilateral pulmonary emboli and was hospitalized until 8/1/21 for further evaluation and treatment. Patient was placed on 4L of oxygen via nasal cannula and given Lovenox in the hospital. A transthoracic echo was done and revealed no right heart strain. A 6-minute walk test prior to discharge was performed and resulted in patient requiring 2L/min of oxygen with exertion but not at rest. She was discharged with Eliquis, which she was advised to continue for 3 months, and home oxygen. It is important to consider patient's sedentary lifestyle and recent 4-5hr road trips as potential provoking factors as well. She was stable upon discharge.
I have been experiencing intermittent twitches/spasms around my body, especially before sleep at night and in the morning when I wake up. When this first started, it was only my left thumb that would spasm. By the 3rd month following the 2nd dose, I have felt twitches in my arms, abdomen, sides, and chest.  I have also noticed my hair falling out or shedding from the root more than normal.
parent described fever of 104, 105 @ approx 9PM; pt given APAP which brought fever down to 103; no sz; rt leg very swollen & red;
Local arm erythema, swelling and pruritus, fever with secondary desquamation of overlying skin.
Itchy, firm, red area around vaccine site. Approximately 3-4" diameter. Began on 5/1, no treatment given until evening of 5/2 (benadryl lotion applied a few minutes ago)
This spontaneous report was received from a nurse practitioner and refers to a female patient in her 20s (who was the daughter of a receptionist in the office where the nurse practitioner practiced). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, at least a year ago, the patient was vaccinated with an unspecified number of doses of GARDASIL (exact dose, route, lot # and expiration date were not reported). Subsequently, on an unknown date in 2015 (reported as within the past year), the patient regional chronic pain syndrome. This regional chronic pain syndrome had been ongoing for the past year and the patient had seen several pain management physicians. There was no treatment given for the adverse event. The outcome of the event was reported as not recovered. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 15-FEB-2016, the patient inadvertently received dose of ZOSTAVAX, lot # L035283, expiry date 15-DEC-2016 (Strength, dose, route and site of administration were not reported) instead of intended dose of VARIVAX (Merck). No adverse effects were reported. Additional information has been requested.
Contracted Covid after receiving the first vaccine; Contracted Covid after receiving the first vaccine; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunisation.  Medical history included asthma, dry cough due to inhalation from fires over the years.  The patient's concomitant medications were not reported. Contracted Covid after receiving the first vaccine was reported. The patient received the first dose of the Covid vaccine, then contracted Covid. He now had the option to receive antibodies through plasma. Since he had the vaccine, was that still an option? Or was that a no-no? He received the vaccine at work on 21Dec2020. He got sick on 22Dec2020 and he was at home. He didn't feel like eating, and can't lay down because it made it worse to cough. He didn't know what vitamins they were giving him. The patient probably should be in a hospital, but was not. The outcome of events was not recovered.  Information on Lot/Batch number has been requested.
Extreme flair up of joint pain. Worst in one hip/leg on the level of pain of a kidney stone. Could not walk without extreme pain or go down set of stairs. Has improved some but now also experiencing moderate pain in other leg and feet are numb
This spontaneous report as received from a medical assistant via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL, dose 3, 0.5 ml, intramuscular. No concomitant medication was reported. On an unknown date the patient received their third dose of GARDASIL a couple of days earlier than the scheduled date. No concomitant medication was reported. No adverse effect was reported. Treatment was not given for the event. No lab diagnostics were performed. The patient did not seek medical attention. There was no intervention to prevent serious criteria. PQC was not involved. The outcome of events was unknown. Additional information has been requested.
got the shot and got shingles\ suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles shot and 6 months later got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
01-09-2021  Very confused, nauseous, sweating profusely. sent to hospital- admitted with encephalitis, severe cognition decline. 01-13-2021 still in hospital, cognition Improved.
30 SEP 08 VACCINATED. 14 OCT 08 PAPULES FORM ON ARMS AND SPREAD TO ARMS, TRUNK-FRONT AND BACK, BOTH LEGS. SEEN AT MEDICAL CENTER BY DR. ZYRTEC, BENADRYL, MOTRIN.
I got my second dose, I got nausea, vomiting, diarrhea, pain in joints. I was uncomfortable. I took Tylenol and ibuprofen. The next day I felt fine. A week later I noticed swelling around my collar bone. I went to the doctor and they stated it was normal. The following Tuesday I woke up with a headache and it got worse through out the day. It felt like motion sickness. I ended up throwing up. I went home took my temp and it was high. I laid down and took a nap and woke up and felt worse. I went to the ER and they ran test. I still had a fever. They prescribed my Tylenol, ibuprofen, nausea meds. It lasted about 12 wks.
No additional AE reported; HBP reported a dose of VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from an office manager, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 06-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliters (ml) (valid lot number W020540 [expiration date 28-JUN-2024]) (vaccination scheme, and frequency were not provided) for prophylaxis, after a temperature excursion of 41.4 degrees Fahrenheits (F) with a time frame of 1 hour (h) and 58 minutes (min) (product storage error).   No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA007926:02321654 US-009507513-2301USA008267:02321655
Pt at 2 mos received DTaP. Had 48 hours of "startling" (Moro Reflex). These happened in clusters of 5 or 6. Pt ped notified. He stated "she's having a neurologic reaction to vaccine." Chart down plays incident. Pt now with CP-no other known events. Per 60 day follow up: Pt did not recover. Possible CP. No additional comments. Speech delay, feeding disorder (gagging). Annual follow up on 11/17/2003: "Vaccine recipient did not recover from adverse events.  CP-ongoing-LE bilateral."
An expired Covid-19 pfizer vaccine was administered to the patient on 4/26/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient on 5/9. Patient does not plan to get revaccinated at this time.
2-months old patient was given the Fluzone Quadrivalent,no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional (patient's mother) via The Agency (Reference number- 00319850) and transmitted to Sanofi on 16-Oct-2020.  This case involves a 2 month old female patient was given 0.5ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ533AB and expiry date: 30-Jun-2021) once (strength = standard) via unknown route in unknown administration site for prophylactic vaccination on 16-Oct-2020 (product administered to patient of inappropriate age).  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  The patient had no other vaccines.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  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.
Left arm pain (mild-moderate) starting 6 hours after administration. Headache and drowsiness (mild- moderate) starting 3 hours after administration.
Expired engerix-B administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received HBV (Engerix B) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 02-Dec-2022 Reporters comment: A pharmacist reported that the patient received an expired dose of Engerix B. The reporter consented to follow up. Additional supportive information: The patient was administered an expired dose of Engerix-B, which led to expired vaccine used.
Burning pain sensation through muscles in arm around injection site, followed by constant muscle pain. Feels like sore muscles; unable to move arm with normal motion; moderate pain when touched.
pt recvd vax 16MAR93 & exp chest pain, arthralgias, h/a, dizziness, lt arm pain & numbness in ankles; pt seen by at least 9 MD's;
9/6/22 developed a temp, tested positive on Abbott ID Now molecular test- had known covid exposure
17 year old received the first injection of the Moderna vaccine; A spontaneous report was received from a consumer concerning a 17-year-old, female patient who received Moderna's COVID-19 (m-RNA-1273) vaccine.  The patient medical history was not provided. No relevant concomitant medication was provided.  The patient received their first of two planned doses of mRNA-1273 (batch number not provide) on 13JAN2021 intramuscularly for prophylaxis of COVID-19 infection.  On 13-Jan-2021, the patient experienced product administered to patient of inappropriate age.  She went back to receive the 2nd dose and was sent home due to being under 18 yo.  Treatment taken was not reported. Action taken was not reported.  The outcome of event was recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.