chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doesn't feel good; Tired; Rash on the arm at the injection site; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Doesn't feel good), VACCINATION SITE RASH (Rash on the arm at the injection site), CHILLS (Chills) and FATIGUE (Tired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 19-May-2021, the patient experienced VACCINATION SITE RASH (Rash on the arm at the injection site) and CHILLS (Chills). On an unknown date, the patient experienced MALAISE (Doesn't feel good) and FATIGUE (Tired). At the time of the report, MALAISE (Doesn't feel good), VACCINATION SITE RASH (Rash on the arm at the injection site), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided.
went in for a flu shot, gave her Covid vaccine by mistake; Initial information received on 03-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-hcp (health care professional ).  This case involves an unknown age female patient who went in for a INFLUENZA VACCINE shot, but received her COVID-19 (corona virus disease) VACCINE by mistake (wrong product administered) and died shortly after on an unknown date.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur instead of INFLUENZA VACCINE (unspecified manufacturer) (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered (same day latency).  It was reported "it is happening. Just heard yesterday about a lady who went in for a flu shot, gave her Covid vaccine by "mistake" Told her mistakes happen. She died shortly after."  It was unknown if the patient experienced any additional symptoms/events.  There were no laboratory data/results available.  At time of reporting, the outcome unknown for the reported 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 the 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.  There will be no information on the batch number for this case.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions and allergies were not provided. On 26-OCT-2021, the patient was vaccinated with an improperly stored dose (product storage error) of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter, once,  lot number U019287 and expiration date 15-DEC-2022 (route of administration was not provided) for prophylaxis. There was no additional adverse event reported. Administered doses of vaccine experienced the temperature excursion of 5.7 degrees Fahrenheit (°F) for 6 minutes There was no previous temperature excursion.
Rash.  She was evaluated in the ED.  Diagnosis was hives.  She was given Pepcid, Prednisone and Benadryl.
This spontaneous report as received from a nurse via representative refers to a female patient of unknown age. In October 2006 (unspecified date 8 years ago) the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # was reported as K00454, expiration date unspecified), 1 single shot, intramuscular. No adverse effects were reported with the 1st dose. On an unspecified date in October 2014 the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot #, expiration date unspecified). On an unknown date in October 2014 the patient went to the emergency room but was not admitted for cellulitis at the injection site. The outcome of cellulitis at the injection site was reported as recovered/resolved in October 2014. The patient had sought medical attention. Additional information has been requested.
Patient describes pain and swelling at injection site that is spreading down the arm halfway to the elbow. Patient states that redness is continuing to get larger at 6 days out from vaccination.
Fever as high as 107 degree on 9/12/06, rash on hand, forehead, that progressed to torso, rash pruritic; seen in urgent care on 9/17/06 for rash and given antihistamine.  Called mom 9/18/06 still with rash, no fevers, slight RN.
administrated an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-month-old male patient who received HAV (Havrix) (batch number i4sl4, expiry date 28th January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st January 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 31st January 2022, unknown after receiving Havrix and Havrix 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 details were reported as follows: The Health Care Professional reported that, the patient was inadvertently administrated an expired dose of Havrix which led to expired vaccine used. The reported said no further events were reported. The reporter consented to follow up.
I was not get my period, it has been over 10 months and I started to receive cramps and spotting.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 36-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec 2021, Jan 2022, and Feb 2022. It was reported that the patients have been administered doses while the temperature excursion assessment was ongoing and reported that no adverse reactions were reported by any patients. No treatment information was provided.
Sore arm after few hours Bump or 5 inch by 1 inch on the arm More sore arm after 6 can not lift it or put pressure on it. No other symptoms before I went to sleep I woke up at 2 pm, went to toilet my bedroom shower. Was able to pee. But my arm was hurting a lot. Was hard to stand up from bed ans walking  I don?t remember finishing to pee , and I lost conscience, I did same as a vasovagal , I woke up about 1 min later. My wife was yelling at me but could not hear her. My tension was vers low. I could not stand up. I was checking and before waking up , I was shaking like an epileptic crise Than he took me more than 10 min to recover. I was chilling. Get cold and hot. I had no energy. Could not move. I was about to call 911. But was getting better It look similar to ans orthostatiques hypotension. I did aboi 3 to 4 in my whole life. But never like this one. It was way stonger. It did not happen right after I stand up but after about 1 to 2 min Next days as today. I am doing ok. I have more regular symptoms like headaches, fatigue. And small low back pain No more vasovagal But the one I experience and the effect over 10 min after was very stronge
Within 1 wk of dose #1 a chicken pox like eruption occured (5/6/2021) still having eruptions 6/21/2021 Itchy sores
I had stomach pain after eating that developed  within an hour  to a very hard pain in lower abdomen like all over vs in one place. The next morning  the pain was there like a gas stomach pain with diarrhea.
Patient was observed for about 20 min after the vaccine. She reported no issues. The next day she experienced Nausea and Chills which subsided in 24 hours. She came into the Pharmacy the following day and was feeling much better however her left forearm has some swelling and pain. The site where she was vaccinated seemed fine. She indicated that she would go to the Drs office if she felt the need.
This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients (demographics unknown). On 18-SEP-2014, the patients were inadvertently administered with improperly stored GARDASIL (lot # J006236; expiration date: 25-FEB-2016) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient was given ACTHIB and PENTACEL on the same day medication error due to patient receiving an extra dose of HIB vaccine with no reported adverse event; Initial information received on 19-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA295304(CLUSTER) for same patient.  This case involves a 14 months old female patient who was given HIB (PRP/T) VACCINE [ACT-HIB] and Pentacel on the same day medication error due to patient receiving an extra dose of HIB vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 19-Jul-2022, the patient received 0.5 ml  (dose 4) of suspect HIB (PRP/T) VACCINE, powder and solvent for solution for injection (lot UJ649AA; strength and expiry date not provided) via intramuscular route in the right thigh for prophylactic vaccination  On 19-JUL-2022 on same day it was reported that patient was given acthib and pentacel on the same day medication error due to patient receiving an extra dose of hib vaccine with no reported adverse event (extra dose administered). Reporter asked if there were any concerns about the patient receiving two doses of HIB in the same day.  Action taken : not applicable.  Outcome : Unknown.   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 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.
Information has been received from a pharmacist concerning a female with penicillin allergy with no reported medical history who on 29-JUN-2009 was vaccinated with VARIVAX (Merck) (dose, route and lot number not reported).  There was no concomitant medication.  On 30-JUN-2009 the patient experienced coughing and eye afer redness  administration of VARIVAX (Merck).  At the time of the report the outcome of the patient was not recovered.  Laboratory tests were not performed.  The patient sought unspecified medical attention.  Additional information is not expected.
Pt recv vax on 10/29/98; on 10/30/98 pt exp feeling bad, headache, fever (100-103), swollen neck glands
Post vax, the pt developed hives about 5 inches around site. Patches of hives around area of injection. Itchy.
Put me down; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on unknown date and shots were horrible).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling unwell (Verbatim: Put me down). The outcome of the feeling unwell was resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     It was unknown if the company considered the feeling unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 The case was received from the patient via interactive digital media. The patient reported the shingles shots were horrible. The second shot of shingles vaccine put the patient down for few days. The patient was not sure if he/she will do the vaccine again or not. The follow-up would not required per process.
She could barely sleep her arm  hurts and she woke up screaming; After the second dose she was hurting so bad; Dizzy; After each shot her arm was very sore/After the second dose she was hurting so bad; Tired; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (She could barely sleep her arm  hurts and she woke up screaming), PAIN (After the second dose she was hurting so bad), DIZZINESS (Dizzy), PAIN IN EXTREMITY (After each shot her arm was very sore/After the second dose she was hurting so bad) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included Accident automobile (She was a passenger in a car accident.) and Fusion of vertebra (Currently she had six screws and fusion in her back). Concurrent medical conditions included Blood pressure high (She was taking high blood pressure medication.), Back disorder (She was  taking back problem medication.), Degenerative disc disease, Sciatica and COPD (She was taking oxygen for COPD). Concomitant products included OXYGEN for COPD.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DIZZINESS (Dizzy), PAIN IN EXTREMITY (After each shot her arm was very sore/After the second dose she was hurting so bad) and FATIGUE (Tired). On an unknown date, the patient experienced INSOMNIA (She could barely sleep her arm  hurts and she woke up screaming) and PAIN (After the second dose she was hurting so bad). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INSOMNIA (She could barely sleep her arm  hurts and she woke up screaming), PAIN (After the second dose she was hurting so bad), DIZZINESS (Dizzy), PAIN IN EXTREMITY (After each shot her arm was very sore/After the second dose she was hurting so bad) and FATIGUE (Tired) outcome was unknown.            The patient had no allergies with medications, food and other products.  There was no medical history related to mentioned AE and there was no acute and chronic illnesses at the time of vaccination.  There was no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   The patient mentioned that her left arm  was hurting for 3 months since she got the shot last year. When she went to the hospital, they just prescribe her ibuprofen and did not do much to help. She was putting cream  in the area to help with the pain. She could barely sleep her arm hurts and she woke up screaming. She felt very dizzy and tired every time she got a shot. After each shot her arm  was very sore. After the second dose she was hurting so bad that she decided she had to go to her doctor to get the next shot.   This case was linked to MOD-2022-667455, MOD-2022-667545 (Patient Link).
Began to wheeze adn had difficulty swallowing which got worse and went to ER. Also states eyes appeared bloodshot.
Vaccine given in right buttock, lower area. Buttock very red, swollen two times the left buttocks and very hot to the touch. This was noticed on me on 6/10/04.
Patient just wasn't herself at all on 3/11/97. She really just laid around quietly most of the day. I had told my mother that something wasn't right about my baby. I guess it was around 4 or 5 when patient just stopped breathing. I called 911 and they tried to help me bring her back. She finally came back around after about 2 or 3 minutes. The 60 day follow up states pt had brain surgery twice to help control the seizures. My daughter will never had a real life. The seizures that she has has pretty much determined her life. Pt is so far behind or so developmentally delayed that she could never catch up with her age. I will fight for her rights until the day I die. Add febrile seizure on 03/11/1997 and subsequently seizure disorder (reason for permanent disability) Annual follow up on 11/25/2003: "Vaccine recipient did not recover from the adverse events that were reported for this vaccination.  My daughter still has seizures, even after having 2 brain surgeries.  I feel that the only reason there is a statue of limitation on these shots is because this has happened to a lot more kids.  I also feel the other parents and myself should be accomodating to help take care of these kids."
The next morning I noticed swelling at the injection site, and a red rash about 1.5" in diameter. Then, as the day progressed had pain on the left middle side of my back, and the back of the left knee. It was difficult to bend my knee, was very stiff. This lasted about 5 days. Now, on day 8, the stiffness in the rear of the left knee is almost gone.  The other symptoms seem to have resolved.
Heavy right foot 4/13 in afternoon.  Then Thursday at 2:30am got up to go to the bathroom and had a difficult time walking and returned to bed afterward and had tingling sensation in right arm.  Next morning still felt odd and at 8:00am went to primary and he sent her to the ER room.  They ran many test and then discovered she had a stroke.  There was damage also to the heart.  She had lost all mobility in her right side but has since regained it.    Transferred to hopital for 3 days.  Many test ran.  Never previous heart damage or issue with Blood pressure.    Supplement list cont. - Immune Defense, B, Apha GPC, Theanine
Left arm hurt as soon it was received. The next day it got worse. Limited use of arm, constant and shooting pain. Pain never resided and had to make a doctors appointment.
Pt recvd 4 doses of Engerix-B & had a nonresponse;
Initial misuse report received from a healthcare professional on 27 September 2013. The cases were received on 21 March 2014. This case is linked to case 2014SA040010 (Same reporter after FLUZONE ID). FLUZONE ID was given to a 09-year-old patient. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Initial misuse report received from a healthcare professional on 03 October 2013. A 6 months old patient had received FLUZONE. The patient received 0.5 ml dose instead of 0.25 ml. No adverse event was reported. List of documents held by sender: none.
I received the vaccine on Saturday morning at 11am.  Within ~12 hours of the shot (Saturday night), experienced intense chills and fever (reached 104). Fever was managed through the night and the following day with Tylenol, but varied between 99 and 102 the following day. I had muscle aches and fatigue  on Monday and Tuesday. Mild Chest tightness began Tuesday.
vivid dreams; sound sleeping; vivid thoughts; delusions of flying; feeling "crappy"; fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MALAISE (feeling "crappy"), STRESS (vivid thoughts), ABNORMAL DREAMS (vivid dreams) and BREATH SOUNDS (sound sleeping) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (and hospitalization in November 2020 where he was admitted for 3-4 days and administered plasma and steroid therapies.). Concurrent medical conditions included Dementia (patient was currently having vivid thoughts and dreams, sleeps more soundly, and has delusions of flying airplanes). Concomitant products included MEMANTINE, DONEPEZIL and PRAVASTATIN for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (fever) and MALAISE (feeling "crappy"). On 29-Mar-2021, the patient experienced STRESS (vivid thoughts), ABNORMAL DREAMS (vivid dreams), BREATH SOUNDS (sound sleeping) and DELUSION (delusions of flying). On 07-Mar-2021, PYREXIA (fever) and MALAISE (feeling "crappy") had resolved. At the time of the report, STRESS (vivid thoughts), ABNORMAL DREAMS (vivid dreams), BREATH SOUNDS (sound sleeping) and DELUSION (delusions of flying) outcome was unknown.            No treatment information was provided.
01/21/22 presents to EC ED for "left hip pain s/p fall". PMHx of "CVA. Dementia, left femur fx, htn"
Narrative:  Patient received two doses of COVID 19 vaccine in Mar/Apr 2021. The patient tested positive for COVID 19 on 23 September 2022. The patient presented to the ED with weakness, cough, and post-nasal drip. The patient was admitted with COVID pneumonia, sepsis, and hypoxia. The patient was treated with dexamethasone and remdesivir. The patient was discharged on 27 October with possible post covid syndrome. Reported per EUA.