chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited case received from a Pharmacist on 12 Oct 2016. this case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847.2016SA189848 . This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Batch number: UI669AA, Expiry date: 30 Jun 2017 dose and site of administration was not reported) intramuscularly on 03 Oct 2016. The patient medical history Illness at time of vaccination, Pre-existing physician diagnosed allergies, birth defects, medical conditions and any other vaccinations within four weeks of vaccination was reported as unknown. The patient concomitant medications were not reported. On 04 Oct 2016, one day after vaccination the patient shoulder swollen, red, firm and hot to touch with pain affecting my ability to grip tightly with my left hand and raise may left arm above my shoulder. Size of indurations 6.5 cm x 5 cm. And on an unknown date the patient felt occasionally achy when lift arm above shoulder. (Grip strength decreased, Injected limb mobility decreased, Induration, Inflammations, pain and Vaccination site reaction). The patient required emergency room (ER) visit. The patient lab tests and corrective treatment was not reported. The outcome of the event was reported as unknown at the time of this report. (It was also reported as on 07 Oct 2016 redness significantly subsided and sight is warm, not hot). List of documents held by sender: none.
Patient experienced  slight dizziness and headaches  while waiting   in waiting area post vaccination.  He had not eaten anything the entire day which may have contributed to him feeling dizzy  and was given bottle of water. He felt better after waiting 30 mins in waiiting area.  Patient was called at 3pm and he was fine .
FLUVIRIN vaccine given to patient sitting in chair, relaxed. No complaint upon vaccination. After pt. was vaccinated he got up and walked across room, then he started to feel lightheaded. He sat in chair, pharmacist assisted him and brought him water to drink. Pt. was very pale & slightly incoherent for about 10 minutes. Pt. was able to stand and walk out of pharmacy after about 20 minutes.
Sarcoidosis - diagnosis June 25, 2021  Myocarditis - diagnosis July 12, 2021
Swelling at injection site, becoming increasingly larger every day until going to doc 01/14/2016.  Also headache.  Site is warm to touch, swollen and around 2" diameter.
Around March 2023, I went in for a kidney biopsy. At this time, I was diagnosed with Pneumonia and the Flu. I was in the hospital for a whole week. They treated the symptoms. I retained a lot of water. I shredded 20 liters of water the week I was in the hospital. I was on oxygen. I was on bed rest and moved around as much as I could. I did not have any surgeries or go into ICU. They were constantly drawing my blood. I was discharged to home oxygen, I had home occupational therapy and home physical therapy for 10 days. I was not steady on my feet and physical therapy helped get some of my muscle tone back. I followed up with Dr.
pt recvd vax 5AUG93 & w/in 10 seconds, pt was noticeably lethargic & limp w/head rolling; no loss of consciousness observed by MD for approx 40 mins; hospitalized overnoc for observation;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Jun2023 as dose 4 (booster), single (Lot number: GJ3268) at the age of 45 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Metabolic Syndrome X" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 03Oct2023 to 07Oct2023.  No follow-up attempts are possible. No further information is expected.
10/14/2021: Upon shot, immediatie pain in injection site(differed from other shots). Approximately 25 minutes after the shot, pain throughout entire left arm and numbness/tingling in fingertips. Approximately 35 minutes after the shot, sweating and several minutes of shortness of breath. Pain in entire left arm and numbness/tingling in fingertips did not subside.  10/15/2021: Pain in entire left arm and numbness/tingling in fingertips entire days.  10/16/2021: Was awoken to burning/stabbing pain in left arm, neck, shoulder, and back area. Pain affected entire mobility drastically. Was limited in movement and incapacited from normal mobility.  10/17/2021: Was not able to see doctor on 10/16, so went to Clinic. Was prescribed muscle relaxers and 800mg Ibuprofen. Pain was still present, mobility only slightly improved. Numbness and tingling continued. 10/18/2021 through 10/22/2021: Movement/mobility continued to improve. Took the prescribed medications every day as prescribed. Did not participate in normal workout/gym/cardio routines; Took the week off to rest body. 10/23/2021 through 10/24/2021: Stopped taking prescribed medicine. Felt much better. Movement/mobility close to back to normal.  10/25/2021: Woke up with sorness in shot injection area. Entire left arm, shoulder, and neck sore... just not de-mobilizing like last time. Took prescribed muscle relaxer.
Client reports he had flu-like symptoms starting on 07/21/21. Client is still experiencing increased fatigue, headache at night, and dizziness in the morning
Mom states on the way home from clinic /p recving DPT/OPV pt broke out in "whelps"(approx 10-15min).States pt had no resp. diff-Mom states called MD @ ofc & was told to give APAP.States whelps did not resolve until next day.Pt on cough meds
This spontaneous report as received from a vaccine coordinator refers to and refers to unspecified amount of patients of unknown ages and genders. On an unknown dates, the patients were vaccinated with a dose of M-M-R II lot # M007279, expiration date 09-FEB-2018 for prophylaxis, which were stored in the range of 9 celcius degrees to 25 celcius degrees for 21 hours and 30 minutes. No previous temperature excursion was reported. No adverse effects were reported.  Concomitant therapies included sterile diluent(STERILE DILUENT). Digital data logger was involved. This is one of several reports from the same source.; Sender's Comments: US-009507513-1708USA005286:
J02.9 - Pharyngitis, unspecified etiology R10.84 - Generalized abdominal pain
Severe muscle reaction, entire deltoid involved.  Inability to use left arm, any muscle movement causes severe  extreme pain.  Left limb must be assisted by unaffected arm to avoid any left deltoid activation. Complete loss to range of motion.  Soar at rest, as expected with any vaccination.
got 1st Moderna vaccine on 1/2/21, no particular SE ; developed bright red itchy area on 1/11/21 approx 2+ inch diameter
Accidently administered an expired Hep A vaccine to patient. She did not have any adverse symptoms at the time.  No treatment given.
Pt reports dysuria and difficulty urinating for 4-5 days. Couldn't void yesterday. No fever at home, but had low grade temp in ER. Denies grossly bloody urine. Urine was cloudy.   Pt dx with COVID on 12/27/21. States some lingering cough, but mild.
Heavy chest cough, fever, chills, body aches, slight nauseated feeling, problem sleeping,, got better Saturday but then same symptoms returned Saturday night and continue today, joint pain, muscle pain
5/13 46y.o. male with HX of Bipolar, Homelessness, Medication on compliance presented to the ED yesterday for suicidal thoughts. He was positive for COVID-19 on 5/8/22 during admission for acute psychosis 5/8-5/11. 5/15 Pt refused IV, refused IV fluid, stated, "I'm not suicidal, I'm homicidal." 5/17 Pt feels great, denies any dyspnea chest pain cough fever or chills. Denies any homicidal or suicidal ideation, will be discharged home today.
Breast cancer diagnosed 3/2000. Multiple joint pain, stiffness and insomnia.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 04-JAN-2018, the patient was vaccinated with M-M-R II, intramuscularly (strength, dose, frequency, lot# and expiration date were not provided) for prophylaxis. Other suspect therapies included sterile diluent (MRK). No adverse effects were reported.
Varicella - Information has been received from a physician concerning a 2 year old female who in 1998 was vaccinated with one dose of varicella virus vaccinelive (site Unknown).  In 200 the patient developed chicken pox.  The patient sought unspecified medical treatment.  Additionally, it was noted that 2 other patients waes 00033123 and 00040359 experienced similar reactions.  Additional information has been requested.
serious lower stomach pain; soreness in injection arm.; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN LOWER (serious lower stomach pain) and VACCINATION SITE PAIN (soreness in injection arm.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was Reported.     On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced ABDOMINAL PAIN LOWER (serious lower stomach pain) and VACCINATION SITE PAIN (soreness in injection arm.). At the time of the report, ABDOMINAL PAIN LOWER (serious lower stomach pain) and VACCINATION SITE PAIN (soreness in injection arm.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 07-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN LOWER (serious lower stomach pain) and VACCINATION SITE PAIN (soreness in injection arm.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was Reported.     On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced ABDOMINAL PAIN LOWER (serious lower stomach pain) and VACCINATION SITE PAIN (soreness in injection arm.). At the time of the report, ABDOMINAL PAIN LOWER (serious lower stomach pain) and VACCINATION SITE PAIN (soreness in injection arm.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
SOB (similar to asthma attack) that persisted. Pt went to ER and was administered epinephrine, Benadryl and steroids.
Patient received her vaccination and proceeded to the waiting area with her parents.  A few minutes later we were called out to the waiting area where  the patient was passed out in her chair.  About 10 seconds after I arrived she woke up and was very pale.  EMS was notified.  We took the patient to our clinical services area and I stayed for observation.  EMS arrived and took the patients blood pressure and it was low.   The patients mom informed us that the patient gets very worked up when getting vaccinations and had not eaten a lot of food that day.  At the instruction of EMS we got her food and some water.  After 15 to 20 minutes her color got better and her blood pressure normalized.  Her parents decided that she did not need to go to the hospital and they left together.
pt devel urticaria 24 hrs p/inject-Td but was on Ceclor @ the time;
1st dose Rotateq given @ 2 mo 2/2/07 2nd dose Rotateq given @ 4 mo 4/6/07 Intussusception 6/18/07 no Rotateq given @ "6 mo" checkup done @ 6/29/07. 10/10/2007 VAERS report submitted with MR attached. Infant with PMH of intussusception in 6/2007 presented with crying and abdominal pain on 10/3/2007.  A therapeutic enema was given with successful reduction of the ileocolic intussusception. 10/24/2007 Vax record received.  Rotateq Lot # 0403F added to database, otherwise correlates with VAERS submission. 11/05/2007 MR received for DOS 6/17/2007 for D/C DX Intussusception. Child presented to ER with vomiting, abdominal cramping x 12 hrs. Pt had a bloody stool in The ER. Pt had barium enema which sucessfully reduced the IS. D/Cd home same day in good condition. Repeat IS with BE reduction 10/3/07 as above.
Starting having headaches 2 hrs after 1st vaccination. Took Tylenol and it helped but headaches continued till 7-8pm.
SAME SYMPTOMS; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced same symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of same symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20230406811.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). On 2nd April 2018 09:30, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and erythematous rash. The patient was treated with TYLENOL. On an unknown date, the outcome of the pain in arm and erythematous rash were recovered/resolved. The reporter considered the pain in arm and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left deltoid. The patient developed arm pain within 24 hours after injection which lasted for 5 to 6 days then resolved. The patient took TYLENOL for the pain. The health care professional stated that it was quite intense pain and was mildly debilitating. The patient also developed a delayed pink rash that came on 4 to 5 days after she was administered SHINGRIX and lasted for 4 days.
frequent urination/increase urination; soreness at injection site; gurgling on stomach; headache; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (frequent urination/increase urination), INJECTION SITE PAIN (soreness at injection site), GASTROINTESTINAL SOUNDS ABNORMAL (gurgling on stomach) and HEADACHE (headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 13-Jan-2021, the patient experienced POLLAKIURIA (frequent urination/increase urination), INJECTION SITE PAIN (soreness at injection site), GASTROINTESTINAL SOUNDS ABNORMAL (gurgling on stomach) and HEADACHE (headache).   At the time of the report, POLLAKIURIA (frequent urination/increase urination), INJECTION SITE PAIN (soreness at injection site), GASTROINTESTINAL SOUNDS ABNORMAL (gurgling on stomach) and HEADACHE (headache) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: NNI On 12-Apr-2021: Patient doesn't need further follow-up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 26-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot # L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This is a non-serious spontaneous case from a physician in the USA who reports a patient developed full body hives:  (Unlabelled, USA) after receiving FluMist.  The reporter did not provide causality between event and FluMist vaccination.  This case is submitted according to the VAERS Safety Surveillance accelerated reporting agreement for FluMist. At approximately 6pm on 12/14/2004, a 15 year old male received FluMist intranasally and developed full body hives approximately 7pm.  The patient received Benadryl (diphenhydramine) and responded well.  He was also given an oatmeal bath.  The patient recovered on 12/16/2004.
Fever - up to 102 - lasted until yesterday - it was back down to normal yesterday. He has had a sore arm - at injection site; the arm also was hard - a lump that was a little bit  palpable  - which is gone now; - body aches - gone now, chills, difficulty swallowing. He didn't have trouble breathing, but he felt his throat tighten when he swallowed (still has this); upper right abdominal pain - that is the real bad symptom still. His eyes hurt when he moved them around. Fatigue. He's been glued to the couch since Friday. I had given Advil and Tylenol. After the prolonged fever, I eventually called into the doctor's office. The pediatrician said it was common and said to wait it out but seek treatment if it got worse. He is able to eat but is awful nauseous. He is eating what sounds good. The pain stays the same when he eats.
pt stated felt dizzy about 3 or 4 mins p/receiving MMR vax, became unconscious & grunted, rt hand tightened into a fist & turned outward, head & neck turned up & to rt, lost bladder control, unresponsive to voice or touch 30 sec; felt tired
Five minutes after vaccination, patient c/o "coldness" in throat and chest.  A few minutes later, pt state he felt like his throat was swelling.  Heart rate was normal, and patient did not appear to be in distress.  Taken to the ER for further evaluation.  Lot # ER2613, 1st dose.    In review of hospital system, patient was brought to ED for evaluation on 3/30/21 and per ED Provider;   "Patient has no signs of a true allergic reaction.  No hives or rash.  No intra oral or perioral swelling.  Uvula is not swollen.  We observed the emergency department for an hour no symptoms.  On my evaluation through her recent with a complaint him on sign some her that in signs and symptoms that would warrant return to the emergency department.  I staffed this patient supervising physician.  He agrees to follow-up with his PCP or return if he worsens.  He is discharged in good condition"
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 23-APR-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H02002, expiry date 08-AUG-20150, with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient was administered first dose of menactra in Sep-2021 and was re-administered on 16-Feb-2022 with no reported adverse event; Initial information was received on 16-Feb-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 administered first dose of Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] in Sep-2021 and was re-administered on 16-feb-2022 with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In September 2021, the patient received a dose of suspect meningococcal a-c-y-w135 (d conj) vaccine (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site and On 16-Feb-2022, the patient was re administered with the suspect at the dose of 0.5 ml once (batch number: U6951AA and expiry date: 06-Jun-2022) in unknown administration site all for prophylactic vaccination. Information on batch number of first dose administered is requested.  On 16-FEB-2022 the patient developed a non-serious patient was administered first dose of Menactra in sep-2021 and was re-administered on 16-feb-2022 with no reported adverse event (extra dose administered) (latency: approximately: 5 months) following the administration of Meningococcal a-c-y-w135 (d conj) Vaccine.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event extra dose administered.   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.
? failed vaccine response developed fever, shortness of breath, aches, cough 1/2 and 1/4/10 - seen in ED 1/5/10 positive H1N1.