chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional via another manufacturer and described the occurrence of not responding to therapy in an adult female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  Concurrent medical conditions included immunocompromised.  On an unspecified date three years ago the subject received three doses of ENGERIX B (unknown).  At an unspecified time after vaccination with ENGERIX B, the subject experienced not responding to therapy as a titer after vaccination was negative.  At the time of reporting the outcome of the event was unspecified.
As previously reported to VAERS, I developed new onset tinnitus a short time after receiving the 2nd dose of the Pfizer Covid-19 vaccine. Now, just 3 days after the 3rd dose/booster, my tinnitus is significantly worse. At times, it is almost maddening. My ENT provider had already told me there is no cure or treatment of any kind for tinnitus, and that it is likely permanent. I have had no relief from it since it started after the 2nd vaccine dose in February 2021.
102 degree F fever; severe pain and aches; swollen lymph nodes; nausea; This is a spontaneous report from a contactable Consumer, reported for herself. A 21-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm Right on 09Mar2021 15:15 (at the age of 21-years-old) as a single dose for covid-19 immunization. Medical history included covid-19- covid prior vaccination. Concomitant medication(s) in two weeks included escitalopram oxalate (LEXAPRO); paracetamol (TYLENOL); marijuana. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021 19:00, the patient experienced 102 degree F fever, severe pain and aches, nausea, swollen lymph nodes. The patient did not receive any treatment. Outcome of the event was recovering, at the time of this report. No follow up attempts are possible; information on Lot/batch number cannot be obtained.
Dosed at 1430 on 4/4/2017. Migraine onset at 1900 and persisted for 36 hours. Diarrhea onset at 1930 and persisted for 12 hours. Fever/chills onset at 2100 and persisted for 14 hours.
In the day of/following vaccination I experienced arm pain that transitioned into shooting nerve pain through my elbow and down into my wrist. This pain has persisted since vaccination, and is worse with movement of my pinky finger. The vaccination site feels like a permanent bruise. I had tried to allow adequate time for healing and inflammation to go down, before submitting this report. The nerve pain is constant and worse with movement. I never experienced any pain in this arm prior to vaccination on 12/8/21.  (I am unsure of lot # or manufacturer of flu vaccine given in the other arm. I would need to access that information from my patient chart.)
Inconsolable high pitched screaming for an hour & half. None of the typical things that soothed him helped.
9MAY91 t106 R, taken to ER, observed 3 hrs; 11MAY91 dx "tonsillitis, given ATB @ MD's office; t102, listless & lethargic; 12MAY91 MD's office 102, given ATB inject; MD told mom may have a rxn to HIB;
She has pink and brown blood spots on her underwear every two days after the vaccine. Not sure whether blood comes from vaginal or urinary.
developed severe stomach cramps; diarrhea; was very sick; fever over 101; chills; nausea; dizziness; 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 ABDOMINAL PAIN UPPER (developed severe stomach cramps), DIARRHOEA (diarrhea), ILLNESS (was very sick), PYREXIA (fever over 101) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 ABDOMINAL PAIN UPPER (developed severe stomach cramps), DIARRHOEA (diarrhea), ILLNESS (was very sick), PYREXIA (fever over 101), CHILLS (chills), NAUSEA (nausea) and DIZZINESS (dizziness). At the time of the report, ABDOMINAL PAIN UPPER (developed severe stomach cramps), DIARRHOEA (diarrhea), ILLNESS (was very sick), PYREXIA (fever over 101), CHILLS (chills), NAUSEA (nausea) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Patient presented tot he clinic for 2nd dose on 4/22/2021,patient stated she received the 1st dose at our location. We have been in administering Moderna at this location. Second dose administered to patient after verbalizing her first dose was received at least 28 days prior. Patient was administered Moderna on 4/22/2021. I was notified by Data Entry the morning of 4/23/2021 that 1st dose was not documented in EMR. The information received indicated that first dose of Pfizer was given at HD on 1/22/2021.  Supervisor and ordering physician notified, incident report completed and VAERS report submitted
25SEP wheezing & coughing; prescription w/Pred x 5 days Robitussin;
She slept almost continuously for about 18 hours following the vaccines, we had to wake her to eat (which had never happened before). She then began to wake for about an hour and sleep for about an hour for the next 4 days.  When she woke up on day two, she had a few hours where she didn't/couldn't make eye contact with anyone, something very strange for her.  Also, for about 3 days her hearing abilities were reduced, and then they began to come back.  On about day 3 after the vaccines her arms began to shake for about a day and a half. Her eyes were glassy and the whites of her eyes slightly off-colour for about a week and a half.  Digestion upset even now (one month after the vaccines).  She began to spit up very frequently, and large amounts, and had (especially the first two weeks after the vaccines) very painful gas and bowel movements.  One week after the vaccines, she had severe diarrhea and skin from her bottom seemed to have burnt off - with no change in mom's diet other than a reduction in soy around the same time (she is breastfed exclusively).  Two weeks after the vaccines, she had blood in her stool.  It took her three weeks to socialize as she did before the vaccines.  She remains much fussier than before the vaccines and with a much more sensitive digestive system.  We have decided to see natural doctors to help her digestion improve and to help her detox.  Probiotics have been recommended, we will start them tomorrow, and diluted apple cider vinegar.  We will also give her homeopathy to help her detox.  We will not vaccinate again due to these reactions.  We will continue to monitor to determine whether there are any other lasting reactions.  (Also noteworthy is that we called the pediatrician's office on three separate occasions with concerns in particular about the vomiting and digestive issues but were always told to continue waiting, that if she were moving her bowels and urinating that she would be fine.  At one point a nurse recommended that we go to the emergency room (after the blood in the stool), but we decided not to add more trauma to the situation and instead sought alternative doctors to help us.
Achy arm/shoulder-continuing to get worse-range of motion not good-hurts to remove clothes overhead.  Sideways movement at times sharp pain.  Exam area of L upperarm site is tender and warm to touch.
This spontaneous report was received by a pharmacist and concerns a pregnant female patient (age not provided). There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 29-AUG-2018 the patient was vaccinated with M-M-R II for immigration purposes (prophylaxis), (dose, frequency, route of administration, lot number and expiration date were not reported) and according to the reporter the patient was pregnant at the moment of vaccination. It was unknown if the patient sought medical attention, or if any laboratory diagnostic studies were performed.
Elbow swelling; Elbow pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Elbow swelling) and ARTHRALGIA (Elbow pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Joint pain.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced JOINT SWELLING (Elbow swelling) and ARTHRALGIA (Elbow pain). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Elbow swelling) and ARTHRALGIA (Elbow pain) outcome was unknown.            Concomitant product use was not provided by the reporter. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Feb-2021 and was forwarded to Moderna on 16-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Elbow swelling) and ARTHRALGIA (Elbow pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Joint pain.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced JOINT SWELLING (Elbow swelling) and ARTHRALGIA (Elbow pain). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Elbow swelling) and ARTHRALGIA (Elbow pain) outcome was unknown.            Concomitant product use was not provided by the reporter.
Initial report received on 18 July 2012 from the Investigator participating in the the post-marketing study under the reference number M5A16. A case of pertussis disease in a 15-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; received on 19 May 2011, 19 July 2011 and 19 September 2011 (lot numbers not reported) and one dose of DAPTACEL; lot number C4035AA received on 19 June 2012 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 20 June 2012, approximately one day after the last dose. On 26 June 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 27 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 27 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
A vial of Pfizer covid vaccine was drawn up incorrectly by mistake by one of the nurses in our practice, RN.  In turn, this patient was mistakenly given the incorrect dose of the Pfizer covid vaccine by, RN.   Patient was administered 0.25ml instead of appropriate 0.3ml dose.  After discussing this with the manufacturer,  gave patient repeat full dose as soon as possible, as recommended.    Patient was notified of error and agreed to receiving additional full dose, given on 1/26/21 at 9:06am.
Information has been received from a healthcare professional concerning a 45-month-old female twin with no other pertinent medical history or allergies, who on 03/20/2003 was vaccinated subcutaneously in the right leg with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot #64115/0793M). There was no concomitant medication. On 11/27/2005, the patient broke out in red papules, she presented to the physicians' office on 11/28/2005 with red papules on face and new lesions on her legs, no fever. The patient was treated with acetaminophen (Tylenol), calamine lotion, diphenhydramine hydrochloride (Benadryl) and fluids. There was no information provided regarding the present status of the patient. No product quality complaint was involved. The patient's twin sister was also vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and developed an adverse reaction (WASE#0512USA00118). Additional information has been requested.
Shingrix on 12/MAR/19, 14/JUN/19 and 12/AUG/19; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th March 2019). Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 12th August 2019, the patient received the 3rd dose of Shingrix (intramuscular). On 12th August 2019, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 28-Jul-2022 Reporter's Comments: The reporter was the HCP (pharmacist).  A female patient received Shingrix doses on 12th March 2019, 14th June 2019 and 12th August 2019. The HCP had nothing else to report. The reporter had limited information at time of call. Additional Supportive Information: The patient received 3rd dose of Shingrix on 12th August 2019, which led to extra dose administered.
numbness tingling left side of face down to left hand and fingers. Normal neurologic and motor exam findings reflexes normal and hemodynamically stable
This spontaneous report as received from a nurse refers to a 17 year old patient of unknown gender. Medical history and concurrent condition were not reported. On 11-FEB-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Violent onset of chills, fever, diarrhea, gradually better over a week, back to normal after weeks, fever for one day of 100.4.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 02-OCT-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient reports right are pain. Seen by her PCP and referred for physical therapy. PCP comments exam is consistent with adhesive capsulitis.
This spontaneous report was received from a health care worker refers to a patient of unknown age and gender. No pertinent medical history of the patient was reported. On 20-MAY-2014, the patient was vaccinated with MMR II, 0.5 ml, subcutaneously (Lot # h010137; expiration date 17-MAY-2014). No concomitant medications were reported. It was reported that the patient received an expired lot of MMR II on 20-MAY-2014. No adverse effect reported. The outcome was unknown. The reporter reported that one more patient has received vaccination with expired lot of MMR II. This case is linked to MARRS # 1405USA013975 via the same reporter link. Additional information has been requested.
Pt had hives day of vaccine 4/7. Transport to hospital on 4/8 for extremity weakness. Confirmed large vessel ischemic stroke.
Patient reports that she has been having chest pain on and off for the last several weeks described as pressure feeling like an "elephant sitting on my chest", pain usually last for 10 to 15 minutes and usually relieved by nitro, earlier today she had the pain again while she was at home, she noticed that the pain did not go away for almost 4 hours despite taking the nitro so decided to come to the ED for further evaluation.  Upon evaluating the patient reports that pain usually gets worse when she moves around, denies shortness of breath, cough, fevers or chills.  As he is her cardiologist, she had a dobutamine stress echo in June this year that was not diagnostic and did not achieving desired heart rate.  Reports that she had a diagnostic cath in 2015 and she was told it was normal.  Evaluation in the ED included an EKG with sinus rhythm, noted minimal T wave inversion in V1 only, serial troponin 27 ->25, chest x-ray with no cardiopulmonary findings, patient currently admitted under cardiology service for chest pain rule out for stress test VS cath in the a.m.
the sterile diluent for frozen vaccines was mixed in rather than the packaging that comes with the vaccine/ 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 Medical Information (Reference number- 00653853) and transmitted to Sanofi on 23-Jun-2021.  This case involves a six-month-old female patient who was vaccinated with 0.5 mL (total) dose of HIB (PRP/T) VACCINE [ACT-HIB] [lot number UJ425AAA, expiry date25-Jun-2022] via intramuscular route in right vastus lateralis on 23-Jun-2021 for prophylactic vaccination and reported that the sterile diluent for frozen vaccines was mixed in rather than the packaging that comes with the vaccine with no adverse event (product preparation error).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  The caller had a minor patient receive the ACHIB vaccine, however, the sterile diluent for frozen vaccines was mixed in rather than the packaging that comes with the vaccine. The caller did not have patient information available during time of call.  It was a case of actual medication error due to wrong solution used in drug reconstitution (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.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 3:26 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 3:26 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 72.81 for dose administered on 11-Jan-2021. No concomitant medications were reported. Batch number 041L20A underwent temperature excursion on 11-Jan-2021 with temperature 35 degrees Fahrenheit at 02:00 PM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 11-Jan-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported   This case was linked to MOD-2022-566976 (Patient Link).
Tongue and throat started swelling. Taken to ER, IV with 3 medicines, rash on face started while at ER and continued for 3 days.