chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant concerning a 4 year old male with no known medical history or allergies who on 24-JAN-2003 was vaccinated SC in the left arm with 0.5 mL first dose of Varivax (lot # 643594/0808M). Concomitant vaccination administered that day included a SC first dose in the right arm of MMR. There was no illness at the time of vaccination. On 02-AUG-2006 the patient broke out in a rash. It was reported that the patient developed chickenpox with 50 papules scattered on the body. BENADRYL and AVEENO BATH were used as treatment. Medical attention was not sought. No laboratory diagnostic tests were performed. There were no adverse events following prior vaccination. Additional information has been requested.
Per Documentation: ~ 05to 10 seconds after vaccination patient c/o ringing ears; eye burning; nausea; warm; weak @ 1713 BP= 154/81 HR=99 O2 saturations =99% @ 1716  patient reported  that symptoms had resolved  @ 1716 reported cotton mouth/runny nose @ 1717 patient reported feeling better @ 1718 BP: 145/79 HR=97 O2 Saturations= 99% @1728 BP 138/86 HR=100   Per Patient: he has a history of getting dizziness when getting up from seated position to standing position,
Patient began to experience swelling of face, eyes & cheeks around 1:30 AM on 12/5, vaccine administered at 9:00 AM on 12/4. MD prescribed prednisone & felt allergy was to thimerosal.
"within 1 hour I was exhausted, Friday night and Saturday I had severe back aches, chills, fatigue. By Sunday I felt better"
Pt reported body aches and dizziness. Also had a few episode of jerking per mother. Tylenol was administered.
My throat feels like it has swollen.; It feels real tight in the back of my throat; I have a cough drop in; feel like the lymph nodes are swollen; Arm is getting trouble; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection), dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patients medical history and patients concomitant medications were not reported. The patient experienced throat felt like it had swollen, it felt real tight in the back of throat on an unspecified date, the patient could breathe through nose and speak ok. Patient had a cough drop in, felt like the lymph nodes were swollen, Arm was getting trouble on an unspecified date. The patient was using Chloraseptic spray for the cough drop. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Persistent deep sharp pain at vacciation site occurring episodically increased with exposure overhead teaching, initially accompanied by left axillary LAD symptoms x 18 months
This case was reported by a pharmacist via out of hour services and described the occurrence of injection site pain in a adult male patient who received SHINGRIX (batch number JC92P, expiry date 22nd November 2020) for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than 3 weeks after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient was the reporting pharmacist who reported adverse event on GRC after hours voicemail. The patient experienced severe pain at the injection site for 3 days. The patient reported it that it felt like someone hit him with a baseball bat. No other information was provided.
Nausea; Vomiting; Diarrhea; Chills; Sweating; Tired; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0168) via an unspecified route of administration in the right arm on 11May2021 at 12:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative proctitis and blood pressure. The patient had no known allergies to medications, food and other products. Concomitant medications included lisinopril 30mg (MANUFACTURER UNKNOWN) taken from unknown date, for blood pressure and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12May2021 at 09:00, the patient experienced nausea, vomiting, diarrhea, chills, sweating and  tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events nausea, vomiting, diarrhea, chills, sweating and tired was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
got Shot about 8:30; immediately after getting the shot, I had the same feeling as my breath being taken away and the taste  (just like after getting an IV cleaned with saline). Nurses told me to sit up front to be observed and waited 30 minutes. After the 30 minutes, I began getting very warm (went outside to get fresh air); went to vehicle, took mask off face, was still feeling very hot, Face was bright red, lips were very red (looked like I had on makeup and I didn't have any on).  Took 4 children's Benadryl (dissolvable). Went back to work. redness started to go away.  Throughout the morning, I continued having the feeling of breath being taken away and the taste.  It wasn't as bad, so I didn't worry.  My lips were not too swollen, face was still swollen. I have had MANY reactions to food allergies and didn't wanna "cause" a scene. By 1:30, I was in a meeting trying to talk and my tongue started to feel thick and it was harder to talk.    I took 2 adult Benadryl's and tried to work some more to keep my mind off of the reaction.  I ended up being very tired and laid down.  I slept till about 5pm and seemed okay after.  Nothing else was done.  My muscle was sore, no other symptoms.
2nd dose of Pfizer COVID vaccination at 1pm. Had sudden onset itchiness, erythema, difficulty breathing and lip swelling at 7pm. Brought to ED, given epipen and methylprednisolone. Monitored closely overnight, symptoms resolved by AM.
Information has been received from a physician concerning an 86 year old male with mild renal insufficiency who on an unspecified date was vaccinated with the first dose of ZOSTAVAX. Concomitant therapy was not specified. After two days post vaccination, the patient developed rash on his legs. About five days post vaccination, the patient went to Urgent Care because he experienced edema, but had no pain. The physician diagnosed this as small vessel vasculitis. It was the color purple and ran from the feet to the knees as well as the elbows. The outcome was unknown. Additional information has been requested.
No patients experienced symptoms; Improperly stored dose of PROQUAD was administered to the patient on 03-JUN-2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 03-JUN-2020, dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneously, lot # S031705 and expiration date 06-APR-2021 (dose and frequency were not reported) as prophylaxis, which was improperly stored in a temperature of 17.2°F in a timeframe of 14 hours and 2 minutes and reconstituted with a properly stored sterile diluent (STERILE DILUENT MRK INJ HH) was administered to the patient.   It was reported that the call was made due to data logger and no previous temperature excursion occurred.  No adverse symptoms were reported for the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001657: US-009507513-2006USA001639: US-009507513-2006USA001624:
cant see; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (cant see) 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 BLINDNESS (cant see) (seriousness criterion medically significant). At the time of the report, BLINDNESS (cant see) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.  Company Comment : This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time, and no reporter can be contacted for follow-up.; Sender's Comments: This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time, and no reporter can be contacted for follow-up.
Mom reported child developed difficulty walking with both legs in the PM of 2/3/05. Cried excessively and appeared to be pain in both thighs. No fever.
1)fever, chills, body aches, nausea, diahrrea, headache  2) fever, chills, body aches, nausea, diahrrea, confusion, headache, swollen glands, cough, ear aches, night fevers
Left arm hurt numb like feeling . Then overall bad feeling. Anxious from all that. Decided maybe my blood pressure was high. Oh, both ankles swelled a bit when only one does usually after hot days above 70. Tom BP and it was over 200 on top. Ok diastolic . I took an aspirin, BP medicine , water and put ankles up above heart. After about an hour or 2 bp was down to 156 but diastolic was up to high oddly. More rest , another blood pressure pill and by morning top was fine bottom a bit high and by next morning everything in good numbers and arm finally did not hurt any.
had immun @ 9AM by 1015AM high pitched evident; no fever leg slightly, swollen @ sites;
This case was reported by a nurse and described the occurrence of flu symptoms in a 54-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. The patient's past medical history included menopause (had last menstrual period in May 2013). On 27th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th June 2018, less than a day after receiving SHINGRIX, the patient experienced flu symptoms, nausea, fever, headache and chills. On 29th June 2018, the outcome of the flu symptoms, nausea, fever, headache and chills were recovered/resolved. It was unknown if the reporter considered the flu symptoms, nausea, fever, headache and chills to be related to SHINGRIX. Additional details were provided as follows: This case was reported by licensed vocational nurse (LVN). The patient was a retired police detective.
painful swelling & redness whole proximal half of rt upper arm started about 6 hrs p/inj
cried 3-4 hrs p/inject; cry was unstopped during this time;
I got sicker and sicker after each injection. By 3rd injection, trouble with weakness, whole body pain, rash, breathing issues/shortness of breath. My rms/legs were tingling and I fell in store, hit head and was taken to an ER while visiting familt and dx with severe allergic reaction and GuillainBarre Syndrome After each injection, nausea, vomiting, fever, low blood pressure worsening pain, malaise, full body weakness, increasted amt of sleeping MD at ER confident this was related to allergic  "autoimmune response" to vaccine, as I was extremely healthy prior to this vaccine series.
After take the vaccines and got a covid-19; After take the vaccines and got a covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "After take the vaccines and got a covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical course: After take the vaccines and got a covid-19. It is insane. You need more researchers  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial information received on 21-Jun-2018 regarding an unsolicited valid non-serious case received from a doctor. This case involves Child female patient (age and gender not reported) who received a dose of vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique because the aide mixed the ActHib with sterile water and gave the dose and did not use the DTaP/IPV. No Adverse event was reported. 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 and Module VI of the 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. Documents held by sender: none.
On 1/24 patient developed a "scratchy" throat and it felt swollen. She took BENADRYL, and said she was feeling better. On 1/25 she said she felt worse.
Patient called in and stated that she was having fever, soreness and swollen at the area of injection at night after PREVNAR 13 shot. Symptoms improved on 6/24/2015.
Vaccines received 8/25/16 - seen in ED 8/28/16 for "5 cm x 6 cm mild erythema, localized reaction to vaccine." Follow up on 8/30/16 - recovering.
Patient is a 79-year-old pleasant female presents to the ED with complaints of redness swelling and pain localized to the right deltoid area of her right upper extremity.  Patient received COVID19 vaccine (moderna) approximately 2 weeks ago (1st dose) at that site; she states that she noticed this redness and swelling extending down to her right elbow
Oral herpes 1inside mouth began 1/7/2019 lasted about 10 days, herpes in ear, eustachian tube, throat began 1/15/2019. Both on left side lasting 10+ days.
This is a spontaneous report from a contactable nurse through a Pfizer representative. A patient of unknown age, gender and ethnicity received TRUMENBA on an unknown date (sometime between Jul and now, year not specified), at 0.5 ml single, intramuscular, in the arm. Medical history and concomitant medications were not reported. On an unknown date, immediately after receiving the vaccine, the patient experienced feeling faint. Outcome was recovered on an unspecified date. Follow-up (08JAN2016): Follow-up attempts are completed. No further information is expected.
Fatigue; Shortness of breath; Complete heart block; Bigeminal pre ventricular contractions (PVC's); Torsades de pointes; Left bundle branch block; This serious case was reported by a nurse via call center representative and described the occurrence of fatigue in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced fatigue (Verbatim: Fatigue) (serious criteria hospitalization and clinically significant/intervention required), shortness of breath (Verbatim: Shortness of breath) (serious criteria hospitalization and clinically significant/intervention required), complete heart block (Verbatim: Complete heart block) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), bigeminal rhythm (Verbatim: Bigeminal pre ventricular contractions (PVC's)) (serious criteria hospitalization and clinically significant/intervention required), torsade de pointes (Verbatim: Torsades de pointes) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required) and left bundle branch block (Verbatim: Left bundle branch block) (serious criteria hospitalization and clinically significant/intervention required). The outcome of the fatigue, shortness of breath, bigeminal rhythm and torsade de pointes were resolved and the outcome of the complete heart block was unknown and the outcome of the left bundle branch block was not resolved.   It was unknown if the reporter considered the fatigue, shortness of breath, complete heart block, bigeminal rhythm, torsade de pointes and left bundle branch block to be related to Shingrix.  It was unknown if the company considered the fatigue, shortness of breath, complete heart block, bigeminal rhythm, torsade de pointes and left bundle branch block to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-JUN-2023 The reporter reported that a patient received a dose of Shingrix (unknown if it was the 1st or 2nd dose) and she came in 3 weeks after the vaccine was administered presented with fatigue and shortness of breath and was found to have a complete heart block, bigeminal PVC's and torsades de pointe. The patient was admitted and had a heart catheterization done on 29Apr2023. The patient had a pacemaker implanted on 01May2023. The reporter reported that at time of reporting left Bundle Branch Block persists, but PVC's have resolved. Follow up ok via Health Care Provider email in HCP details, vaccine was given by patient's primary care physician so no details about lot, expiry etc were available but HCP said she may be able to get some details for follow up report. The reporter did consent to follow up.
Redness, warmth, swelling and discomfort of left arm from 3 cm distal to injection site to elbow area marked. Patient advised to take Benadryl 50 mg !6 hrs and present to ER if redness moves out side of pen lined area. Pt presented to ER later same day. Prednisone 20 mg QD x 5 days.
About 50 minutes after the vaccine was given, my tongue began to swell and I experienced tightness in my throat and chest and shortness of breath. (This was occurring while I was driving myself home from the vaccination site.)  I administered my Epipen.  And I then drove myself to the Emergency Room, which is near my home.  At the ER, I was injected with cortisone, Benadryl, and Pepcid, and had my heart and blood pressure monitored for about 3 hours and then I was released, with a prescription for 50MG Prednisone (1q/day) and 10MG Pepcid (2q/day) x 5 days (for both scripts).  I finished the prescriptions, but am still feeling some discomfort in my throat and some dizziness.
In late June early July, I had temporary shortness of breath, a scratchy throat, sometimes a sore throat, I had a general sense of body fatigue where I just felt total lack of energy. I did not feel like doing anything. I did not have a fever but when I touched my body with my hand I felt warm like a baked chicken. Not burning hot but just warm. Every time I took my temperature I did not have a fever but I felt warm. I had a mild cough but not all the time. My vision has declined over the last several months. I am still having problems with that. If I see the word Food on a computer or a magazine that will turn into Eccd. Characters that look somewhat alike my eyes will turn them into that word. No one has been able to determine why that is occurring. I did not notice that before I took the vaccine. The treatments I have had is antibiotics because they thought it was pneumonia. That was ineffective. I had to rest and hydrate. That was ineffective. I was given Covid tests, which came back negative. Pneumonia test through x-ray, which came back negative. I have had full blood work and nothing came back related to what my symptoms were displaying. I did not feel like myself late august and early September. All through June and July I would feel 6 days horrible, the 7th day I would feel better, but the 8th day I would go back to feeling horrible. I am still bothered with the eye issue.
This study case was received from the investigator on 04 April 2012. A 31-year-old male subject received the following vaccinations: On 06 January 2012: an injection of ACAM2000 (lot number not reported) and on 14 December 2011: an injection of TYPHIM VI, sanofi pasteur SA, lot number not reported, an injection of ANTHRAX 1 (manufacturer and lot number not reported) and an injection of Hep B Adult (manufacturer and lot number not reported). The subject had a history of elevated cholesterol. On 19 January 2012, the subject had an abnormal troponin I of 00.52, an abnormal electrocardiogram (ECG) and a normal echocardiogram. On 24 January 2012, the subject was diagnosed with subendocardial infarction. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
pt recv vax 26FEB98 & 5MAR98 pt devel 30-50 varicella lesions on the face, trunk & back;pt was afeb;
Fever: 102 (24hrs), chills, skin sensitivity, joint pain, headache, tinnitus, back pain, diarrhea, nausea.
This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to SHINGRIX. Additional details were reported as follows: The patient's wife contacted GSK (GlaxoSmithKline) employee to report that her husband received a dose of SHINGRIX and experienced an allergic reaction (unknown symptoms). The age at vaccination was not reported. The GSK employee reported that the patient's wife stated that she had to go, and disconnected. The writer attempted to contact the caller from the phone number provided, as indicated and left a voicemail to call back GSK including the phone number and the SR Number.
Parent states patient has experienced whole body jerking since the immunizations were given but just reported it on March 24, 2018.
prolonged (1wk+) recurrent nocturnal temp >103 (high 105); starting <36hrs p/vax; no infectious source found
Information has been received from a nurse practitioner concerning a 55 year old male who on 08/16/2001 and on 04/01/2002 was vaccinated with the first (lot # 639195/0523L) and second (lot # 641256/1415L) dose of hepatitis A virus vaccine inactivated, respectively.  Subsequently, the patient "tested positive for hepatitis A."  The reporter did not know whether the test was for IgG or IgM.  It was noted that the first dose administered was from a recalled lot.  The patient sought unspecified medical attention.  Additional information has been requested.
pt recv vax & 20 mins later devel pain @ inj site & several days later had bruising; the pt also reported a matching small bruise in the rt clavicular area, lateral to the inj site; pt describes inj as being placed high in upper arm;