chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; Fever/Had a body temperature of 99.9F; Just arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported), via an unspecified route of administration on 06May2021 at the age of 63-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported), via an unspecified route of administration on 15Apr2021 as single dose for COVID-19 immunization and she had lost her voice and had hoarseness. The patient got second dose of the Pfizer vaccine on Thursday afternoon (06May2021). And she did find as far as side effects that day and the next day, just arm was a little sore. But now today (08May2021) she woke up feeling kind of body achy, she took her temperature, and it's 99.9F, for her that's high because normally her temperature only went like 97 point something. So she was wondering and read the fact sheet that given to her with the vaccine but she did not see for it said how long after one get the vaccine, get the side effects could possibly come up. So she was wondering if it's normal, but still, stated, she had a fever. She wanted to know how long usually side effects last. The patient underwent lab tests and procedures which included rapid test negative on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
pt recv vax 19APR99 & 20APR99 devel diarrhea;no fever, no site pain, no rash, no problems w/bread (yeast) child has been going to school but today reports got hepatitis from shot;child is yellow today;
High fever 1 AM on 11/23/2001. Taken to hospital. Diagnosis of Urosepsis.
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient had second vaccine in series and fainted. fell face forward from chair and hit cheek and left eyebrow area. patient was laid down and told to put feet on chair. blood pressure and heart rate were lower than noraml. patient was monitored for blood pressure and heart rate until vitals normalized. patient and careprovider declined emergency services offered.
adult received 2nd dose of Engerix B, 10mcg; adult received 2nd dose of Engerix B, 10mcg; received 1st dose 8/13/2021, 2nd dose 11/12/2021; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 28-year-old male patient who received HBV (Engerix B 10 mcg) (batch number LM992, expiry date 13th December 2021) for prophylaxis.   Previously administered products included Engerix B 20 (received 1st dose on 13th August 2021, batch no: 4EA77, expiry date:11th September 2022).   On 12th November 2021, the patient received the 2nd dose of Engerix B 10 mcg. On 12th November 2021, unknown after receiving Engerix B 10 mcg, the patient experienced underdose, adult use of a child product and drug dose administration interval too long. On an unknown date, the outcome of the underdose, adult use of a child product and drug dose administration interval too long were unknown.  Additional details were provided as follows: Nurse practitioner reported an adult patient received 2nd dose of Engerix B of 10mcg, which led to underdose and adult use of a child product. The patient also received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule Till the time of reporting, patient did not receive 3rd dose of Engerix B. The reporter consented to follow up.
05/16/2022 I had a sore throat, headache and fever. I also had a little diarrhea. 2 days later I had nausea and more diarrhea. I had a positive COVID test on 5/19/2022. I had a telehealth with my PCP on 5/19/2022. He ordered a monoclonal antibody therapy infusion which I had on 5/21/2022 at 09:30am. I got marginally better. I continue to isolate for 10 days until 05/27/2022. I still had diarrhea and nausea. I walked around the house and swept the floor. I began feeling real sick again and had to go to bed. I had 100.4 fever, more diarrhea and nausea. That evening I did a telehealth visit. The doctor suggested I had a COVID rebound and was prescribed Zofran and told to treat the symptoms. I still have a lot of diarrhea and am very weak.
Flu like symptoms two hours after shot:  congestion, coughing, sore throat, fever, mussel aches and red eyes.
Rash/discoloration on fingers/ DEC., APR/Dermatologist. APR/POS. ANA Test. Nov./noticed breathing diffulty on exertion 11/20/09. May/pain/muscles, joints, swallowing/to rheumatogist. Conf. auto immune disorder. Patient is good health before shot. Feel injection triggered autoimmune disorder. Follow up - Adverse onset date 11/24/09 shortness of breath in gym class.  Connective tissue disease/lupus suspected. Manufacturer and lot number - I no way of knowing mass vaccination at high school  this info. not given.
20 min after dose - eye swollen on side of body where vaccine was received 18 hrs after dose - fever, nausea, fatigue, headache, cough, swollen glands (fever lasted 6 hrs) 36 hrs after dose- rash on chest, pain on side of body where vaccine was received increased
tested "positive" for covid 19 (unknown covid 19 symptoms); tested "positive" for covid 19 (unknown covid 19 symptoms); This is a spontaneous report received from a contactable physician. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as single for covid-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as single for covid-19 immunizations. The patient's medical history included rheumatoid arthritis. Concomitant medications included Xeljanz XR (tofacitinib citrate) for rheumatoid arthritis from NOV2020 to ongoing. On an unspecified date, patient tested "positive" for covid 19 with unknown covid 19 symptoms. The event did not result in hospitalization; however, she quarantined herself for two weeks. The patient completed the covid 19 vaccine shots, with no missed doses of (Xeljanz XR) reported while receiving the vaccine. MD was aware. The outcome of events was unknown.    Information about lot/batch number has been requested.; Sender's Comments: Based on the known safety profile and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Covid-19.
About 24 hours later patient developed high fever over 103 degrees, had fever for 3 days and also developed full body raised, red rash from head to toe, eye were red and swollen, runny nose, swollen tonsils and decreased appetite. All symptoms lasted for about 1 week. rash looked identical to measles and symptoms as well.
Pt is 23 YOM at vaccination site, status post Johnson and Johnson vaccination, pt states he has a hx of fear of needles where he has ?passed out in past? from other medical procedures, pt states he returned to chair after receiving vaccine and began to feel light headed and dizzy, where he then fell to ground off chair, pt believes he may have syncopized however is unsure because he ?woke up right away?. Pt skin initially pale and clammy, but quickly had color return to face and extremities. Pt can recall events in entirety, is alert and oriented x4 and states negative head/neck/back pain, negative blurred vision, negative vomiting but + nausea/dizziness, which resolved after approx 3 minutes, initial systolic BP in 90?s but improved to 130 once seated, pt states eating full breakfast, with BGL of 106 mg/dL, pt initially denied transport to hospital but after brief period of time began to feel dizzy again and agreed to transport, due to reoccurrence of SBP in 90?s, IV placed in RAC 1:1 with NSL given KVO, pt 3 lead sinus rhythm without ectopy, upon arrival of ambulance full report given to EMT who assumed care of patient
Scratch; Underdose; accidental exposure to product; This case was reported by a nurse via call center representative and described the occurrence of scratch in a 15-month-old male patient who received DTPa (Infanrix) (batch number 5553K, expiry date unknown) for prophylaxis.   On 5th June 2019, the patient received Infanrix. On 5th June 2019, immediately after receiving Infanrix, the patient experienced scratch, accidental underdose and accidental exposure to product. On an unknown date, the outcome of the scratch, accidental underdose and accidental exposure to product were unknown.   It was unknown if the reporter considered the scratch to be related to Infanrix.  Additional details were provided as follows: The patient received dose of Infanrix in the unknown thigh. The reporter inadvertently given a partial dose of Infanrix to the patient, which led to accidenatl underdose. The nurse who was administering the vaccine was not holding the patient well, and when the patient moved, the needle came out of his leg, causing a scratch. it was unknown how much of the vaccine was successfully given, there was some vaccine remaining in the syringe. The reporter reported that, it was unknown, in which led the vaccine was given. The nurse who administered the vaccine to the patient, canceled the order in the documentation system.
I have a wide red trail leading from the injection site.... it kinda zig zags down my upper arm - it warm/hot to the touch.
8JAN92 vomiting onset 615PM x 7 until 830PM woke w/fussiness @ 430AM; mom did'nt take temp even though advised to by MD; t99.3 ax; mom reports dayc states a lot of gastroenteritis in other children staying there;
Muscle ache in injection site and down the arm, last hours sometimes and days sometimes. I take ibuprofen but does not relieve the pain.
Pt received FLULAVAL 2009 / 2010 formula. No reaction or adverse reaction noted. (vaccine for ages 19 and over).
heart attack; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. This reporter is patient's sister.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack". Clinical details: patient's alive but reporter didn't know if heart attack was from the shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Severe joint pain, severe headache, neck pain, nausea, temperature of 103, chills. Symptoms lasted about 24 hours.
Shingles after Shingrix; lesions; pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles, skin lesion and pain. On an unknown date, the outcome of the shingles, skin lesion and pain were unknown.   It was unknown if the reporter considered the shingles, skin lesion and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced Shingles, lesion and pain after receiving Shingrix. The reporter consented to follow up.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 17-FEB-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Headache. Chills, achiness, highest fever 101.2 on 7/28/17. At site of injection, red, sore, swollen, itchy. Symptoms began on 7/27/17 pm with headache and then chills/fever. The next day the site was red, swollen, sore and itchy. These symptoms lasted through the morning of 7/31/17.  The site was finally getting better on 8/2/17. I purchased and started taking L-Lysine on my own on 7/29/17 one or two times a day and Vitamin C also.
Patient states she experienced chest pains several hours after the injections that subsided and no treatment was needed. About 3 weeks after immunizations, patient reported flu symptoms, fatigue and needle-like pain all over her back that she states resolves with continued ibuprofen. No other pain in her extremities, no shortness of breath or any other issues.
Approximately 5 minutes after receiving second dose of Moderna, pt developed SOB. Pt with no tongue/lip/throat swelling or rashes. Pt denied sensation of throat tightening or chest pain. Pt reported hx of COPD, but denied SOB prior to receiving vaccine. Pt was tachypneic with a respiratory rate of 26-30/minute. Other vital signs were a BP of 131/57, HR of 70, and saturating at 100% on room air. Medical emergency team responded. MD recommendations were for transfer to emergency department.
Redness, swelling, pain in Left arm, nausea and stomach pain, fatigue, fever, chills, general myalgia. 6/11/2019: Follow up received from patient: Lot number unavailable.
I received my second Vaccine in question on Tuesday 9/21/2021 at 08:00am. I felt fine for around 8-10 hrs. On the same day I got a headache on the back of my head and my neck was hot. I began to feel a bit loopy and slightly dizzy. I had extreme exhaustion but could not sleep due to the things i was feeling.. When I got home that same evening around 8:00pm I began to have heart palpitations and I  my entire chest  felt pins and needles(similar to when your arm falls asleep) I also had difficulty breathing and had a tightness in my chest. This went on the rest of the night into the next day. The following day symptoms began to subside. Towards the evening of the following day Wed 9/22/2021 i began to feel a bit better but something still doesn't feel right. Today as I write this I still feel exhaustion as well as extremely loopy, hard to focus. Chest still feels a bit weird and it feels like I have to work to take breaths.
Two weeks post vax, the patient presented with complaint of fever, myalgias, and nausea.
Information has been received regarding a case in litigation from a lawyer, an elderly female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2015, at approximately 67 years of age, the patient was administered the ZOSTAVAX vaccine at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Information has been received from a physician concerning a 5 year old female who in 1999 was vaccinated SC with a dose of varicella virus vaccine live (lot # 631305/0728J). On 12/29/03 the patient developed breakthrough chicken pox. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that the patient's brother developed chicken pox after vaccination. Additional information has been requested.
Patient called and said she asked for the wrong vaccine. She wanted to get the covid vaccine but asked for the flu vaccine by mistake.  She had her flu shot a couple of days prior.  Patient was ok, no adverse events or additional medical care.
p/vax pt devel chickenpox & was covered from head to toe;also exp a dec diet & dec activity;pt was treated w/colloidal oatmeal (aveeno baths) & acyclovir for 5 days;
The patient had redness and rash on the left upper arm possibly related to the PNEUMOVAX vaccine.
2nd dose given less than 1 month after 1st; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 49N3S, expiry date 24th August 2023) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 26th June 2022, the patient received the 2nd dose of Shingrix. On 26th June 2022, unknown after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 24-Jan-2023 Reporter's comment: The patient received first dose of Shingrix on 7th June 2022 and the second dose was administered on 26th June 2022.  Pharmacist informed that patient did not report adverse events. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional supportive information: the patient received 2nd dose on 26th June 2022 and received 1st dose on 7th June 2022, which led to drug dose administration interval too short.
1025- Pt sitting in chair in observation area fell head first to the floor.  VS - BP 02/64 O2 95% RA P43.  Pt stating he felt dizzy and fell forward. C-spine stabilized, AAOx3. EMS activated. Ice for head provided. Pt stated normal resting HR 50-60bpm.  Pt stated only had protein shake for breakfast at 0800; 1030 - VS - BP 108/60 02 98% RA P43 AAOx3; 1036 - VA - BP 32/79 O2 96% RA P70 AAOx3; 1037 - Concord FD/EMS Arrival; 1045 - VS - BP 119/78 O2 99% RA P67 AAOx3 - EMS evaluated/ signed off declared no transport/ Pt discharged to self; 1545 - Contacted DHHS to report incident - left message for PH Nurse on Duty; 2/13 @ 1035 - Spoke w/, RN at DHHS.
Arm is swollen sore hot to the touch has a rash.  Pain is radiating down to my hand and up my shoulder. Also no appetite since the vaccine combined with dizzy spells. I?ve been to the ER twice thought it was anxiety but it?s becoming to consistent for anxiety.  Feel like my blood pressure is going up and down.  ER assumed it was anxiety because that?s what I thought it was at first. Normal doctor did virtual visit today and said it all seems to possibly be a reaction to the shot.
Wheezing, shortness of breath, cough, sore throat, fever and chills.
The patient was given the Monovalent vaccine instead of the Bivalent vaccine.  No adverse signs or symptoms.
This spontaneous report as received from a physician (M.D.) refers to a female patient of unknown age. In 1996 the patient was vaccinated with M-M-R II dose 1. In 1999 the patient was vaccinated with M-M-R II dose 2. The patient was seen at the local health department and had developed measles. The outcome of measles was unknown. Additional information is not expected.
L lateral brachial inferior marked erythema measuring 7cm x 4cm x 4cm tender to palpation/urticaria/blanching spreading.  Pseudo-cellulitis.
This case was reported in a literature article and described the occurrence of idiopathic thrombocytopenic purpura in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 1 day after receiving Meningococcal ACWY-CRM vaccine, the subject developed idiopathic thrombocytopenic purpura. Serious criteria included GSK medically significant. The outcome of idiopathic thrombocytopenic purpura was unknown. It was unknown if the investigator considered the idiopathic thrombocytopenic purpura to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of idiopathic thrombocytopenic purpura (ITP) in a patient aged between 11-and-21 year of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of a self-controlled post licensure safety that evaluated the safety profile of quadrivalent meningococcal conjugate vaccine in a large cohort aged 11 to 21 years. The patient belonged to the risk window. [In this study, the risk window was 1-42 days: time period in which it was hypothesized that the risk of events might be affected by vaccination-following index vaccination (first dose of vaccination)]. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 30 September 2011 and 30 June 2013, the patient received MENVEO (administration route and site unknown; dosages unknown; batch number not provided) at a participating medical centre. On an unspecified date, between 1 and 42 days post index vaccination, the patient developed ITP. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of ITP and MENVEO. The authors concluded that "This observational study was not intended to provide conclusive evidence of causality. Rather, it detected potential temporal associations between MenACWY-CRM vaccination and adverse events. With nearly 50 000 individuals vaccinated with MenACWY-CRM included in this study, we observed a temporal association between occurrence of Bell's palsy and receipt of MenACWY-CRM concomitantly with other vaccines. The association needs further investigation because it could be due to chance, concomitant vaccination, or underlying medical history predisposing to Bell's palsy". This is 1 of the 8 valid cases reported in the same literature article.