chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion Menactra Vial that was left out overnight at room temp of 72 degree F, no AE; Initial information received on 14-Jul-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Adult female patient which was MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6575AA and expiry date: 08-May-2020) temperature excursion menactra vial that was left out overnight at room temp of 72 degree (product storage error).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.   This was potential medication error case due to incorrect product storage. It was reported that Menactra Vial that was left out overnight at room temp of 72 degree this was considered a Human error.  At the time of reporting, it was not reported if the vaccine was not administered or not  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.
Received vaccine on 1/6 at 0800pm 1/7 - 730am woke up with a very soar arm, difficult to move. 10am felt  very tired, like I was about to catch a cold. 12pm felt cold, had a temp of 99.9 F 3pm was very tired, chills, mild nausea, temp 100.8 F - took tylenol at this point 1000mg. Tylenol helped reduced fever and chills. Still continued to feel very tired and had no energy. Stomach continued to feel sensitive and had very little appetite.  10pm - fever returned 100.6 with chills - took another dose of 1000mg tylenol and went to sleep.  Through out the night was hot and cold.  1/8 7am - I woke up had temp of 100.1F - no chills, still very tired, arm still very sore. Did not take tylenol. 9am  - temp now 99.7 F - still very tired 10am - temp now 98.6F - nausea resolved, still had no appetite. Very tired, body felt sore and left armpit hurt when I moved, I noted no lymph nodes.  Remainder of day I remained fever free, but continued to feel very tired and took a few naps. (this is not my norm, I do not nap). By dinner time appetite was better but stomach still felt tender.  1/9 - woke up feeling great, lots of energy, even went for a jog. Arm still a little sore.
Started with chills fever. Had flu like symptoms,joint pain headaches fatigue achy Just SICK all over. Nasal congestion.
awoke during noc-crying & very hot to touch-took to tub immed et bath et gave APAP p/1 hr took t103; very restless w/crying throughout the noc;
Fever, Angioedema, SkinRash, Rash, UrticariaPruritus & HYPOtension Narrative:  2nd Vaccine 2/3: within 3 hours developed itchy rash all over, high fever 102.5 and went to ER, was admitted 2/5 discharged 2/6, blood pressure kept dropping was given IV fluids and steriods, and her legs are still swollen, hands cannot make a fist, she was swollen everywhere.
Patient is a 52 year old male with PMH of psoriatic arthritis, non Hodgkin's lymphoma, gout and HLD who was seen in the 12/2/21 for cough, fevers and fatigue and was discharged home on albuterol and Ceftin. Patient was diagnosed with covid 11/23/21, received monoclonal antibodies on 11/26/21, was started on Prednisone on 11/29/21 by his oncologist. Patient was seen in the ED 12/2 for c/o increasing weakness, cough, and because he was not feeling better he came to ED, received treatment and was discharged. As per patient, he receive a call today telling him to come back to the ED because he had positive blood cultures. Patient denies nausea, vomiting, fevers, chest pain and shortness of breath.  In the ED, blood cultures were repeated, one peripheral and one via mediport. ID was consulted and patient was started on Rocephin 2gm.
Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 07-SEP-2021; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 07-SEP-2021) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 07-SEP-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 07-SEP-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 07-SEP-2021).    Concomitant and treatment medications were not provided. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021 and best used date was reported as 30-Jul-2021. The patient did not report any side effects.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case
Mild Flushing/itchiness, blood pressure dropped for a few moments, slight dizziness for a few minutes, then about 15 minutes after symptoms abated then Istomach felt uncomfortable, and  a headache started about 45 minutes after injection.
Initial report received from patient on 15 September 2010. This case is not medically confirmed. A 52-year-old female patient had received an intramuscular right deltoid injection of ADACEL (lot number not reported) on 01 September 2010. Eight days after vaccination (09 September 2010), she began having a problem with her ears that was described as a sensation of being underwater. She was evaluated by her physician to have 50% loss of hearing in both ears. She denied having any pain, fever, sinus problems, or facial nerve problems. Per the patient the symptoms come and go. No relevant diagnostic tests or laboratory data were performed. The patient had no concurrent illnesses at time of vaccination, and had no reported medical conditions; however she was taking concomitant medications of MOBIC, BONIVA and HCTZ. Indications for medications were not provided. At the time of this report, the patient had not recovered. Documents held by sender: None.
flu within 2 weeks after receiving a flu shot; Initial information was received on 11-Oct-2020 regarding an unsolicited valid non-serious social media case from a patient.   This case was linked to case 2020SA289370 (same reporter).  This case involved an unknown demographic patient who experienced flu (influenza), after receiving INFLUENZA VACCINE.  The patient had received influenza vaccine in the past for prophylactic vaccination and experienced flu within 2 weeks post vaccination. The patient's medical history, past medical treatment(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza), within 2 weeks following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
Feverish; headache; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the right arm on 25Mar2021 at 14:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, fatty liver disease and COVID-19. The patient took unspecified medication within two weeks. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19.Since the vaccination, the Patient had not tested for COVID-19. On 26Mar2021 at 14:00, the patient experienced body aches, feverish and headache. The patient did not receive treatment for the reported events. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events body aches, feverish and headache were recovering.   No follow-up attempts are needed. No further information is expected.
the patient had a resurgence of Covid symptoms on day 10 - mainly congestion; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (the patient had a resurgence of Covid symptoms on day 10 - mainly congestion) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had previously received a COVID-19 vaccine.     On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (the patient had a resurgence of Covid symptoms on day 10 - mainly congestion). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 23-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (the patient had a resurgence of Covid symptoms on day 10 - mainly congestion) was resolving.            No concomitant medications were reported.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  It was reported that the device date was 29-May-2022.  Company Comment: This spontaneous case concerns a 44-year-old, female patient with no medical history reported who experienced the unexpected, non-serious, adverse event of special interest of COVID-19 which occurred on unknown interval after receiving the third dose of mRNA-1273 vaccine. There was no information regarding the first two doses of COVID-19 vaccine. Patient developed COVID-19 on unspecified date and was treated with 5-day course of Nirmatrelvir, Ritonavir (Paxlovid). Clinical presentation of COVID-19 was not specified however it was reported that COVID-19 symptoms recurred 10 days after the onset of event. The clinical course, diagnostic investigations, and treatment details after recurrence of symptoms were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 44-year-old, female patient with no medical history reported who experienced the unexpected, non-serious, adverse event of special interest of COVID-19 which occurred on unknown interval after receiving the third dose of mRNA-1273 vaccine. There was no information regarding the first two doses of COVID-19 vaccine. Patient developed COVID-19 on unspecified date and was treated with 5-day course of Nirmatrelvir, Ritonavir (Paxlovid). Clinical presentation of COVID-19 was not specified however it was reported that COVID-19 symptoms recurred 10 days after the onset of event. The clinical course, diagnostic investigations, and treatment details after recurrence of symptoms were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.
lightheaded dizzy diaphoretic, monitored in EMS room then discharged in stable condition home
May 14 I started having vaginal bleeding and the next day I started passing large clots. I went to the nearest ER because of the blood and pain. It was not part of my normal mistral cycle which caused concern. I was diagnosed with acute blood lost anemia, and I was admitted on May 15 for 24 hours. They did the hematoma test because my numbers dropped, and they wanted to give me some medication because I lost so much blood. I was put on a large dose of Medroxyprogesterone and I was scheduled for a hysterectomy.  Hysterotomy on May 25,2021 the day after discharge my doctor wanted to do the surgery herself but she had maxed out on hours labor wise and wasn't able to do the surgery. I have had a number of things happen right after the surgery.  I'm unsure if the things that I have been dealing with are do to the hysterectomy or the vaccine. chronic Pain  constipation  Gerd Hypertension IBS Insomnia Sleep apnea  low testosterone in female  Obesity  Ospeopedina  Pelvic Floor dysfunction in female  Hospitalized for suicidal ideation 6 wks later  June 21 COPD
2 wks s/p vaccine administration, developing circumferential erythema with streaking.
Patient stated she had some mouth numbness and tingling 5 hours post vaccine.  It resolved.
Patient started (o) typhoid-Vivotif at approx 24 hr after 1st capsules, Felt "heart racing (+) increased dizziness" Attempted to reach Pt to tell her to hold further but she took 2nd dose with similar response. Then d/c'd-symptoms stopped-no other c/o. Didn't follow up P.C.P
c/o h/a & dizziness;having chills;did not check temp;chest was tight & had trouble breathing;seen by MD;arm warm, dry, dried lesions x 2 on lip;mucoid type exudate;throat w/some erythema & mucoid exudate;BP 130/80, P100, R20;T101.8;
No additional AE; temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On 01-APR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (strength, dose and route were not provided; frequency-5; lot# was T028139 and expiration date was 15-FEB-2022) involved a temperature excursion for prophylaxis (product storage error). No additional adverse event was reported (no adverse event).               The administered dose involved in a temperature excursion at - 58 degree Fahrenheit (F) to 5 degree F (9.5 F) for 0 hours 45 minutes 0 seconds and 11 degree F for 1 hour 0 minutes 0 seconds. There was a previous temperature excursion at 9.5 degree F for 0 hours 45 minutes 0 seconds. It was detected by a data logger.   This is one of the 7 cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA002470: US-009507513-2104USA003267: US-009507513-2104USA003266: US-009507513-2104USA002475: US-009507513-2104USA003265: US-009507513-0503USA00121:
Whole body ache after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Whole body ache after 2nd shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Whole body ache after 2nd shot). At the time of the report, MYALGIA (Whole body ache after 2nd shot) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Day of shot, roughly 8 hours later, I was suffering from chills, nausea, confusion, exhaustion, fevers. These ended after I slept through the night, waking up feeling better.  Minor arm pain near injection site, lasting over 5 months so far. Have not felt these pains before the shot, or have I felt similar pains in any other location of my body for any other shots I've taken before.
they gave me meds for anti viral and nerve pain; they gave me meds for anti viral and nerve pain; Appears to have allergy to antiviral and pain nerve meds; Suspected vaccination failure/I have had shots, but I still get shingles; Get shingles 3 times, it's worse than the others; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles two times).   On an unknown date, the patient received Shingles vaccine. In June 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced nerve pain, viral infection and allergy. On an unknown date, the outcome of the vaccination failure, nerve pain and viral infection were unknown and the outcome of the shingles and allergy were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve pain, viral infection and allergy to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had shots, but he/she still get shingles, always in the same place.  This was the third time and it was worse than the first two times, the patient got them. The patient got them in June and still have had them. The patient did not knew what to do. The patient went to physician in June and they gave him/her medication for anti viral and nerve pain. The patient stated that it appeared that he/she have had an allergy to them. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. In worst approach, viral infection event was coded as per narrative it seems that patient had viral infection for which medication was given and also allergy was coded in worst approach considering that patient was relating it with target disease.
Information has been received from a mother concerning her 7 year old daughter with no past medical history who on 11/03/1998 and on 09/13/2001 was vaccinated with a first and second dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  There was no concomitant medication.  It was reported that the patient now has either measles or chickenpox because she has bumps all over her body.  The mother reported that the physician not sure if patient had an allergic reaction to the vaccine or if she really has measles or chickenpox.  It was reported that the patient had blood drawn up and is currently waiting for the results of the test.  Unspecified medical attention was sought.  No product quality complaint involved.  The patient was considered to be not recovered.  Additional information has been requested.
Patient fainted just after injection of the PREVNAR 13. She was unconscious for a few seconds. Received cold compresses initially, then cool water later. She has a history of fainting during blood draws and injections and anxiety. Treated patient and she remained under watch for next 20-30 minutes. Patient stated she was fine when she left, just a little drained from the anxiety buildup.
left arm had swelling pain [7] on 0-10 scale pain into arm pit unable to move my arm site was red swelling larger than my hand cupped over it ,I used warm cloth soft massage and Aleve small mass still remains in the arm. fever and just not feeling well for 3 days. I also has a flu shot in the right arm the same day not reaction to it
Dizzy; Head ache; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizzy) and HEADACHE (Head ache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy) and HEADACHE (Head ache). At the time of the report, DIZZINESS (Dizzy) and HEADACHE (Head ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
"Moderna COVID-19 Vaccine EUA" I experienced fatigue, headaches, body, joint, and muscle aches, along with chills and a fever of 100 degrees.  I took Tylenol, used cold compresses on my head, moist heating pad on my joints and got plenty of rest. These symptoms lasted 24 hours.
The first 12 hours just a sore arm; approx 12 hours in and I had a severe migraine and nausea with vomiting. I haven?t sought medical treatment yet because it?s the weekend and nothing is open.  Also body aches and chills and stomach cramps which are severe at times.
administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported. Treatment information was not provided.
These side effects lasted about 24 hours:  fever-101, chills,  pain ,swelling and redness at injection site, swelling/ knot the size of orange, throwing up, very tired.  The pain and swelling of injection site/ arm lasted about a week.  My mom tested positive for covid=19 on 1/15/2021.  She had a negative covid test on 1/22/2021. She received the 1st Moderna vaccine on 2/24/2021 in which she had the above side effects.  the 2nd vaccine is supposed to be given on 3/24/2021.