chrisvoncsefalvay/vaers-outcomes huggingface dataset:
supposed to get a Men B vaccine today ,however another dose of MENQUADFI instead with no reported adverse event; Initial information received on 24-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old female patient who was supposed to get a Men B vaccine today ,however  she got another dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] instead with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    In August 2022, the patient received 1st dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot number not reported via unknown route in unknown administration site as Immunization. On 24-Aug-2022 she also received dose:2, 0.5 ml of the same vaccine (lot U7294AB, Exp date: 24-May-2023) via intramuscular route in the left deltoid as Immunization.  On 24-Aug-2022 (latency: same day) the patient developed a non-serious event "supposed to get a men b vaccine today ,however another dose of menquadfi instead with no reported adverse event" (wrong product administered) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 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.
After the first two doses, I felt fatigued but it went away after just a couple of days. The day after the third dose, I felt extremely fatigued and really confused. I am having a really hard time remembering things. I feel just generally impaired but I have not taken anything to be impaired. I am to the point I don't feel safe driving right now.
This case was reported by a physician and described the occurrence of a female subject aged between 60 and 69 years old testing hepatitis B surface antigen positive following vaccination with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. The subjects medical history and concurrent conditions were not reported. Concurrent medications included blood pressure medication. In October 2006 the subject received primary course of Engerix B at 40 mcg. Lot number and expiration date were not reported. In November 2006, following vaccination with Engerix B, the subject was tested and found to be hepatitis B surface antigen positive. The event was unresolved at the time of reporting.
Got PENTACEL Friday, 3/23, Sat, 3/24 - Very fussy, Tmax 100.3, vomited x 1 Sat night. Sunday 3/25, Possible seizure activity including extending arms and short staring spells, went to hospital, admitted overnight for observation.
Information has been received from a physician concerning an 11 year old female patient who on 15-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant vaccination included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). The physician reported that post-vaccination, the patient complained of headache and that her arm was cold at the injection site. The patient was given ibuprofen (ADVIL) and felt better. The patient was sent home. At the time of the report the patient was recovering. The patient sought medical attention at the physician's office. Additional information has been requested.
On 30-Nov-2017, the patient received the first dose of Rabipure (Inactivated Rabies Virus Vaccine, Batch number 641011E) and the first dose of co-suspect vaccine Ixiaro (Batch number JEV16D22B), both administered at an unknown dosage regimen, unknown route of administration and for an unknown indication.  On 13-Dec-2017 (13 days after the first dose- inappropriate schedule of vaccine administered), the patient received the second dose of Rabipur (Inactivated Rabies Virus Vaccine, Batch number 64111E) and first dose of Nimenrix at an unknown dosage regimen, unknown route of administration and for unknown indication.  On 12-Jan-2018, (43 days after the first dose- inappropriate schedule of vaccine administered), the patient received the third dose of Rabipur (Inactivated Rabies Virus Vaccine, Batch number 641011E) at an unknown dosage regimen, unknown route of administration and for an unknown indication.  On 19-Jan-2018, the patient received the second dose of co-suspect Ixiaro vaccine (Batch number JEV16F288) at an unknown dosage regimen, unknown route of administration and for unknown indication.  On an unknown date during Christmas Days in 2018, approximately 347 days after receiving the last dose of Rabipur and 340 days after the last dose of Ixiaro vaccinations, the patient developed cold problems with flu-like symptoms, limb pain, resting tremor of the hands *(explicitly coded as 'Tremor of hands)*, angiofibroma in the facial area *(explicitly coded as 'Angiofibroma')*, sleep disorders and migraines. Initially, a suspected diagnosis of an autoimmune reaction after vaccinations was revealed.   On 18-Jan-2019, approximately 1 year after receiving the last dose of Rabipur, the patient was diagnosed with chronic fatigue syndrome and myalgic encephalomyelitis, which made the patient incapacitated and is now suing for vaccination damage.  The reporter did not provide outcome for the events of chronic fatigue syndrome, myalgic encephalomyelitis, *resting tremor of the hands and angiofibroma in the facial area*.
The patient stated that she had facial swelling and swelling of her arm consistent with the type of reactions she gets when she gets stung by bees
The PT received Td-88 on 11/30/02 for a Laceration. The PT's left deltoid became swollen and painful. As of 12/10/02, her arm is improving, but still sore and warm to the touch & she has muscle pain when she uses that arm. She is scheduled to see the doctor during the week of 12/16/02. *Follow-up report on 1/22/03: Follow-up info. (12/27/02), another health professional had not spoken with the PT personally yet, but she spoke with the physician who saw the PT after PT came in for her follow-up examination. According to this physician, the PT's left shoulder was getting better. It was still a little tender around the left deltoid but that it had no swelling. She had no further concerns regarding this PT.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On unknown dates, the patients were vaccinated with ZOSTAVAX for prophylaxis. Concomitant therapies included sterile diluent. On unknown dates, the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. Sender's Comments: US-009507513-1708USA012861.
Still feel horrible; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Still feel horrible) 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 FEELING ABNORMAL (Still feel horrible). At the time of the report, FEELING ABNORMAL (Still feel horrible) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.
On 10/27/11 patient received FLUZONE vaccine Lot UT437AB exp 6/30/12 into right deltoid. On 10/29/11 called back and said that skin under bandage looks infected. Patient stated that has infection of the skin. Tried to reach pt on 10/31/11 for more info no response.
pt recv vax 2SEP97 & 12SEP97 pt devel a rash on inj site which was the size of a 50 cent piece or dollar, 5 to 6 lesions & exp the arm getting hard;
Child got DTaP, IPV in (R) arm on 7/9/08, then that evening became red and swollen. Improved 7/11/08 and prescribed Keflex for probable cellulitis.
baby was received a PENTACEL vaccine, medical assistant administered the DTaP-IPV portion only due to misunderstanding/ no AE; DTaP-IPV portion twice within 2 days/ no AE; Initial information was received on 23-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Agency (Reference number- 00653789) and transmitted to Sanofi on 23-Jun-2021.  This case involves a four-month-old female patient who was vaccinated with 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ425AAA, expiry date not reported) via intramuscular route in left thigh on 09-Jun-2021 for prophylactic vaccination and DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE [lot number not reported and expiry date not reported] via unknown route on an administration site on an unknown date for prophylactic vaccination and reported that baby was received a PENTACEL vaccine, medical assistant administered the DTaP-IPV portion only due to misunderstanding with no adverse event (product preparation issue) and DTaP-IPV portion twice within 2 days with no adverse event (Inappropriate schedule of product administration).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  Caller stated PENTACEL was ordered DTAP and IPV was given not the ACTHIB. Caller stated there was a misunderstanding at the office as for the mixing, nursing staff believed that the MA had administered 0.4% saline (diluent for ActHIB) only, so a dose of PENTACEL was reconstituted appropriately and administered. Caller stated the patient came back and received the correct PENTACEL. Caller wanted to verify safety for the patient.  It was a case of actual medication error due to product preparation issue and inappropriate schedule of product administration (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient received vaccine 5 days before the due date for the second dose in the series, which was 1 day out of the 4 day grace period.
Janssen COVID-19 Vaccine EUA Ten weeks ago I had A LOT of nasal mucous draining into my mouth during the night, couldn?t breathe, coughing. This went on for 4 days, so I went to the GP, took a COVID and Strep Test, both negative. I had and still have: a very difficult time swallowing any food or drinking water because I have a very irritated throat when I breathe, with throat pain going from the bottom of my neck up to my ear (earache). I?ve lost 7lbs. over the last ten weeks, 5?5? 93lbs. GP suggested an ENT. ENT did an XR Esophagram, CT Sinuses Fusion wo contrast and a CT neck soft tissue w contrast/creat. Everything OK. Sending me on to a swallow therapist on June 30th.
Began w/screaming & crying around 3:30pm. Only brief periods of quiet. Vomited x1. Started to quiet around 5:30pm. Vomited again about 8:30pm but since then, eating well & acting normally.
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated intramuscularly with a dose of GARDASIL. There was no concomitant medication. Sometimes last week (approximately 10-MAY-2010), the patient fainted. The patient did not seek medical attention. At the time of the report, the patient recovered from fainted. Additional information has been requested.
Extremely lethargic in early evening and for 3 days. Headache 3/14, 3/15, 3/16. Nausea 3/15, 3/16, 3/17.  Eyes irritated, red and mild burning 3/17 to present. Wheezing 3/14 to present. Mild cough 3/16 to present. Mild rash on torso from waist to face 3/20 to present.
Patient received 0.25 mL of Bivalent dose instead of 0.5 mL; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 mL of Bivalent dose instead of 0.5 mL) and (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis .No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 mL of Bivalent dose instead of 0.5 mL) and (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 mL of Bivalent dose instead of 0.5 mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.  For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received 0.25 mL of Bivalent dose instead of 0.5 mL).  No concomitant medications were reported. It was reported that, the nurses had no standing orders other than what they had for the second booster, when first administering Bivalent boosters. So, they assumed the same dose as the second booster, that was they were administering 0.25 mL instead of 0.5 mL to uncompromised adults. No adverse events were reported. No treatment medications were reported.
x2 days-red, swollen, hot to touch and pain in the armpit. On-call nurse evaluated and instructed her to seel appt w/PCM.
This spontaneous report was received from a pharmacist and refers to a 31 year old male patient. The patient had no drug reactions or allergies. He was a smoker. The patient's concurrent conditions included elevated liver enzymes. On 06-SEP-2016, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 (lot# and expiration date were not provided), intramuscular, concomitantly on the same arm with influenza virus vaccine (unspecified). The patient had no concomitant medications. On 07-SEP-2016, the patient developed fever. On 08-SEP-2016, the patient experienced redness, swelling and tenderness at injection site. On 09-SEP-2016, the patient visited an office, where he was diagnosed with cellulitis. Lab diagnostic studies were not performed. The patient was ordered a 7 day course of KEFLEX, per pharmacist. At the time of the report, the patient was still recovering from the adverse event. The relatedness between the cellulitis and PNEUMOVAX 23 was not provided. Upon internal review, the event of cellulitis was considered to be medically significant. Additional information has been requested.
ill effects of full-blown shingles, symptoms were severe, Dr. diagnosed shingles.; taken to the ER as he hadn´t eaten or drank anything; This case was reported by a consumer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in November 2021).   On 28th February 2022, the patient received the 2nd dose of Shingrix. On 1st March 2022, 1 days after receiving Shingrix, the patient experienced shingles and feeding disorder. On an unknown date, the outcome of the shingles and feeding disorder were unknown.   It was unknown if the reporter considered the shingles and feeding disorder to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter's father. The patient lives in an assisted living facility. The age at vaccination was not reported. On 1st March 2022, the patient started suffering the ill effects of full-blown shingles.  The patient's symptoms were so severe, the reporter decided to have him taken to the emergency room on 1st March 2022 evening as he hadn't eaten or drank anything, or taken any of his normal medications. The reporter contacted the pharmacy that administered the vaccine and they informed the reporter it was Shingrix and that the manufacturer was GSK. The patient's doctor had diagnosed that he had contracted shingles.  She can also attest to the fact that he was not suffering from any ill effects of shingles before he received the vaccine. The reporter asked for refund his cost of the shots.
vasovagal like response <2; hypotensive; basilar sililance, anaphylactoid like react;
Immediately after receiving the 2nd Moderna vaccine the arm  bled and there was a knot on the arm that was approximately 1 cm in diameter and 1 cm in height. The patient was given a cold compress and monitored for 30 minutes and had no further symptoms in that 30 minutes.
Fever, seizure-like activity, 24 hours, post vax, PCV #2 on 10/30/00. Fever, seizure-like activity, 48 hours, post vax, PCV #3 on 1/31/01.
3hrs of cont inconsolable crying 1 1/2-4 1/2 hrs p/shot;normal behavior there after
Difficulty breathing; Heart rate was higher than normal; Nerve pain in her left and right hip arm and her ankle; Throat felt narrow, swollen; Chest were tight,chest heaviness that has lasted two weeks; Jaw was tight; Neck was stiff; Left arm felt heavy and hard to lift around the wrist area she did not have much strength; Left eye it's also hurting; A spontaneous report was received from a Consumer concerning a 63-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pharyngeal swelling, chest discomfort, jaw tightness, neck stiffness, left arm discomfort, difficulty breathing, heart rate was higher than normal, nerve pain in her left and right hip arm and her ankle, and left ocular discomfort.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 025120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 10-Jan-2021, the patient experienced the events throat felt narrow and swollen, jaw and chest were tight, neck was stiff, left arm felt heavy and hard to lift around the wrist area she did not have much strength, chest heaviness that has lasted two weeks, difficulty breathing, heart rate was higher than normal. On an unknown date, the patient continued experiencing increased heart rate. nerve pain in her left and right hip arm and her ankle, and her left eye was also hurting.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, pharyngeal swelling, chest discomfort, jaw tightness, neck stiffness, left arm discomfort, difficulty breathing, nerve pain in her left and right hip arm and her ankle, and left ocular discomfort was recovering/resolving. The outcome for the increased heart rate was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Chills, sweats, weakness, lethargic, low grade fever.  Ibuprofen and Tylenol.  Symptoms continue after 4 days.
suspected vaccination failure; Was vaccinated, had shingles twice; 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, unknown 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: The reporter was the patient. The age at vaccination was not reported. The patient was vaccinated and had shingles twice. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
neckache & malaise; no known fever lt arm aches; tires during day & feels lightheaded-dizzy; was advised to take a APAP product; advised to call MD as sx have been present for a wk;
On or about 3-4 days later, I woke up in the middle of the night and from my shoulders bilaterally all the way down to my fingers. I had muscle spams, pain, swelling. It was the worst pain I've ever been in. When I got to the hospital, I was panic-stricken and they did everything and referred me to a neurologist. By the time I saw the neurologist, my legs started to be numb and he tried everything to find out what happened. Told me I was the weirdest case because it was throughout my whole body. The pain never stopped because it was in my entire arm, my shoulders. I ended up having surgery on my left arm and it didn't help. I was then referred to a Rheumatologist and was diagnosed with osteoarthritis and rheumatoid arthritis. And I'm currently undergoing treatment.
high fever & fussy x 3 days, diarrhea x 1 wk;
rashes all over me/ they are on both legs, and top of his head, arm, elbow, and his back (on the left side); This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored program. A male patient of an unspecified age received dose 1 and dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), both given via an unspecified route of administration on an unspecified dates as dose 1, single and dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified dates, the patient had both of his Pfizer COVID-19 doses, but they left him with "rashes all over me" (as reported). The reporter stated that he's already being treated (unspecified treatment) for the rashes, but that they are on both legs, and top of his head, arm, elbow, and my back (on the left side). Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Upon waking up the morning after shot, left arm was in pain.  The pain got progressively worse in the following days to where I couldn't lift it from my side & pain radiated from elbow to shoulder & lower neck.  Now, more than 2 weeks later, pain is still extreme & range of motion limited.