chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have gotten a cold sore on my lip sometimes 2 at a time, pretty much every 4 weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jun2021 10:00 (Lot number: EW0180) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Cold sore" (unspecified if ongoing), notes: Before the vaccine I got cold sores but 1-2 every 18 months or so. The patient took concomitant medications. Past drug history included: Indocin, reaction(s): "known allergies: indocin", notes: known allergies: indocin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0178, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 24May2021, when the patient was 37 years old, for COVID-19 Immunization.  The following information was reported: ORAL HERPES (non-serious) with onset 23Jun2021 12:00, outcome "recovered with sequelae", described as "I have gotten a cold sore on my lip sometimes 2 at a time, pretty much every 4 weeks". Therapeutic measures were not taken as a result of oral herpes.  Additional Information: No other vaccine in four weeks. Adverse event: Every month since 2nd dose i have gotten a cold sore on my lip sometimes 2 at a time, pretty much every 4 weeks. Before the vaccine I got cold sores but 1-2 every 18 months or so. My mom got shingles after Pfizer vaccine too (she had the shingles vaccine about 2 years ago), maybe the gene, she has already filled out this form. Just thought I would let you know, it was not life threatening but it was a pain to have them all the time it seems like, the last as long as a normal cold sore 5-7 days or so. but before my COVID vaccine I never in my life have 2 at one time. It started about a week after my 2nd dose.  No follow-up attempts are possible. No further information is expected.
Immediately following as soon as I got home I went to bed sleeping for 14 hours. I woke up with body ache and chills and felt like I had a fever but didn't. I had heavy fatigue. Sunday same thing and started feeling worse. At night I took a at home COVID-19 test which was negative and I had a 99.6 fever. Monday I woke up feeling worse with a sore throat and running nose. I did PCR and rapid which came back positive. My Doctor put me on inhaler, albuterol and pearls. But I'm just treating with OTC right now. I was probably exposed wednesday 9/14. I'm still feeling ill right now.
Left axillary lymphadenopathy started on day 3 (Sat) now still painful and tender, day 4; Left axillary lymphadenopathy started on day 3 (Sat) now still painful and tender, day 4; Left axillary lymphadenopathy started on day 3 (Sat) now still painful and tender, day 4; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 10:00 (Lot number: EW0173) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL1284, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 23Dec2020, when the patient was 54 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3249, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 10Jan2021, when the patient was 54 years old, for COVID-19 Immunization, reaction(s): "Dose Number: 1 23Dec2020, Dose Number: 2 10Jan2021". The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "Left axillary lymphadenopathy started on day 3 (Sat) now still painful and tender, day 4"; IMMUNISATION (non-serious) with onset 11Nov2021, outcome "unknown", described as "Left axillary lymphadenopathy started on day 3 (Sat) now still painful and tender, day 4". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of lymphadenopathy, lymph node pain.  Additional information: Results of tests and procedures for investigation of the patient: (Test: Nasal Swab, Result: Negative). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  Follow-Up (17Nov2021): Follow-up attempts are completed. No further information is expected.
I woke up the next morning and I was freezing, my body ached all over, I had a head ache and a high fever.
Patient states that around 5pm (later that night) her had was swelling (no redness just swelling) couldn't tell how far up her arm it went and not sure if related to flu shot and swelling did eventually go down on its own.
This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced vial was used beyond the 8 hours travel time (out of specification product use), and off label use. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial was used beyond the 8 hours travel time (out of specification product use) and off label use was not reported. This report was non-serious.
Per hospital event report: "Patient in for office visit on date listed above with Dr.. HEP A vaccine was ordered and administered to the patient before immunization was due. No harm noted, patient notified and instructed that he will need another HEP A booster in 6 months per Dr."
No reaction to adverse event. Pt was given Hep A vaccine too early in Oct 2014. She was to have this redone it has only been 5 months between dose recommended 6 mo.
Developed Erythema Multiforme within a few days of flu mist vaccine.  Developed same reaction one year ago after injectable flu vaccine.
Mom called 24 hrs after immunizations. Immunizations given 4/5/06 around 2pm. Mom reports temp 101.7. Left arm red, hot, swollen. Sx extending from shoulder to 5 inches down. C/o feeling itchy inside arm.
leg where vax given red,swollen, & sore-localized swelling only; parent brought child back to re-check;
I had my (Moderna) first dose yesterday.  Within ~6 hour the soreness level of the shoulder joint (but not especially the site of the jab) zoomed up to intense.  So much so, that simply lifting my arm slow-motion to the level of my eyes caused intense pain spasms.  Last night and this morning were equally severe.  Within the last hour or so, the pain level has diminished a bit.  NOTE: I know how people rate pain is super subjective.  In my case working as a geologist in a quarry a number of years ago, I was struck and pinned by a large boulder.  The ER crew would not give me a pain killer, so that they could monitor how the Jaw of Life was working (it broke, the boulder was too heavy), so I not surprisingly passed out several times from the pain level before being extricated.  Needless to say, this compound fracture of the tibia and fibula accident was a 10 of 10 pain level.  Yesterday's CV-19 jab pain level was an 8-9 of 10.  Nothing I read before yesterday's jab, Fauci et al, prepared me for this pain level.  So, is this normal???  My POV is, I think, atypical in this matter of pain. Should I be concerned about a return to normalcy right now (today / tomorrow) as well as for the second dose??  I HOPE THAT A MEDICAL PERSON WILL RESPOND TO THIS EMAIL - NOT SOME BOILER PLATE WORDS.  If you want more details, feel free to phone me
This spontaneous report as received from a medical assistant refers to a 5 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 31-AUG-2016 , the patient was vaccinated with a dose of improperly stored PROQUAD lot # M012987 with expiration date 12-SEP-2017, therapy type HSA. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011245:
30min after my first injection I had a rash on my forearm, it went aware after about 2 hours then reappeared later that evening that was larger on my arm then disappeared after about 2 hours. I also had a weird taste in my mouth and heavy chest. Yesterday 10/21/21 I had blood work done for my physical, and my THS was high. I have never had high levels of THS. In 2010 my results were 2.720, in 2015 2.690 and today they are 3.970 along with adverse high blood results.
Pt reported feeling dizzy immediately post first dose of Moderna vaccine. Feeling "hot, dizzy & foggy" 2:55p.m. BP 130/92 HR 104  RR 22 94% 02 sat. On assessment alert and talking, intermittent confusion noted with blank stares, difficulty finding words progressively getting worse. EMS activated @ 3:05pm. Finger stick 155. BP 136/86 HR 101 02 sat 97%. Remained alert, intermittent confusion continued. Refused EMS transport to hospital for evaluation. Patient and husband instructed to call 911 if patient not feeling well or worse/ altered mental state not improving. Ambulated out of clinic with husband. AMA.
First vaccine - tenderness in injection site; A 67-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3246) via an unspecified route of administration, administered in right arm on 20Jan2021 10:15 (at the age of 67-year-old) as dose 1, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included Irritable bowel syndrome and osteoporosis from an unknown date and unknown if ongoing. Concomitant medication included tetanus vaccine taken for an unspecified indication on 22Jan2021. Patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other unspecified medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. No Covid prior vaccination. Since the vaccination, the patient had been tested for COVID-19. On an unspecified date, patient experienced tenderness at the injection site. No treatment received for the adverse event. Outcome of the event was resolved with sequelae.  No follow-up attempts are needed. No further information is expected.
Information has been received from a nurse referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L033693 with expiration date of 31-MAY-2017; strength, dosage, frequency and route unspecified) (incorrect product storage). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patients mom called the pharmacy today, and said her daughter is fillling like her arm is numb, She cannot lift her arm up. and its filling tingling. Her daughter got the flu shot yesterday. She said they feel like it was given too high in the shoulder. They went to clinic and clinc told them to go to urgent care. They went  to urgent care to see a doctor. Doctor informed her to start taking tylenol, and they're using heating compression. Doctor also informed the pateint to follow up in couple of days. I asked the patient if there is anyting we can do. she said she just wanted to call us let us know know about the event. Her doctor also said they will do her x ray if her arm doesnt get better in couple of days.
pericarditis; fluid around my heart; fluid around my lung; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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: PERICARDITIS (medically significant), outcome "unknown"; PERICARDIAL EFFUSION (medically significant), outcome "unknown", described as "fluid around my heart"; PLEURAL EFFUSION (non-serious), outcome "unknown", described as "fluid around my lung". Clinical course: The covid vaccine gave pericarditis, fluid around heart and lung. It almost killed the patient.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
It made me really tired and I hurt. It lasted about two or three days. It hit all my weak spots- back legs, hips, hands, arms, and right shoulder. I feel like I still have the pain but I'm not sure if it's from the shot or not. Unsure of vaccination dates/times and lost vaccination card.
Severe arm pain (began 3 hours after vaccination), nausea (began 3 hours after vaccination), inability to move arm (began 4 hours after vaccination), swelling (began 4 hours after vaccination), fatigue (began next day), chills (began next day), headache (began next day), fever (began next day)
Weakness, dizziness, fatigue which initially lasted 4 days, then recurred intermittently for 5 weeks. 1 week after vaccine- nausea, vomiting diarrhea which lasted 3 weeks. Symptoms improved after a total of 5 weeks. In late October 2014, muscle twitching, muscle weakness, recurrent nausea/ulcer symptoms. Muscle twitching and weakness have not yet improved.
Had a flushing reaction to first vaccine. and 5 minutes after second vaccine (2/5/21 ) started having facial flushing, warm and tingling sensation. Went to urgent care.
This case was reported by a pharmacist via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX. Less than one day after vaccination with FLUARIX, the subject experienced injection site pain. The next day, the area was hard (hardiness injection site) and a blister formed (injection site blisters). It was reported that it took a week for the events (issue) to resolve. The reporter indicated that this event occurred with seven patients that received FLUARIX. Linked cases include A0950536A, A0950541A, A0950543A, A0950544A, A0950545A and A0950546A.
SORE ARM; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and fatigue was not reported. This report was non-serious.
Pt. called stating she's having a strange reaction to her shot. Left arm received HD Flu vaccine. Pain scale 4 out of 10. Swollen like a "hive" "one huge blister". Temp 100 degrees.
At about 7:30 pm on July 26, 2002 I found my son laying on the floor in a stare. His body was limp.I immediately picked him up trying to figure out what was wrong. My husband noticed that his lips were blue and that he was not breathing. My husband reached into his mouth to see if he was choking on something.My son started to breathe again. He was acting very tired and was moving slowly, but seemed better.I sat downed and nursed him while I called my pediatrician. I got a hold of another physician in the practice Dr. I explained to him what happened and he said that he would allow something like that to happen once, but if it happened again to take him to the E.R. My son seems fine today (July 27 2002).
3RD COVID DOSE, MODERNA, GIVEN 11/22/21, LOT #027H21B; Pt tested positive for COVID on 8/5/21 in Hospital; no cough, no dyspnea, on RA, lungs clear; dc'd to SNF on 8/10/22; weakness; suffered hypotension with diaphoresis, weakness, slightly lethargic; elevated WBC; requested UA but unable to obtain, gave pt a shot of Rocephin; pt transitioned to DNR/DNI, comfort measures only; he passed away in the SNF (Center for Rehab and Healing.)
arm tight, arm hard; arm  sore; she woke up with her arm 3x its size; arm  itchy; arm  red; headache; arm where she got the injection became swollen; arm where she got the injection became sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (arm tight, arm hard), VACCINATION SITE PAIN (arm  sore), VACCINATION SITE SWELLING (she woke up with her arm 3x its size), VACCINATION SITE PRURITUS (arm  itchy) and VACCINATION SITE ERYTHEMA (arm  red) in a 26-year-old female patient 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 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced VACCINATION SITE SWELLING (arm where she got the injection became swollen) and VACCINATION SITE PAIN (arm where she got the injection became sore). On 16-Oct-2021, the patient experienced HEADACHE (headache). On 21-Oct-2021, the patient experienced VACCINATION SITE INDURATION (arm tight, arm hard), VACCINATION SITE PAIN (arm  sore), VACCINATION SITE SWELLING (she woke up with her arm 3x its size), VACCINATION SITE PRURITUS (arm  itchy) and VACCINATION SITE ERYTHEMA (arm  red). At the time of the report, VACCINATION SITE INDURATION (arm tight, arm hard), VACCINATION SITE PAIN (arm  sore), VACCINATION SITE SWELLING (she woke up with her arm 3x its size), VACCINATION SITE PRURITUS (arm  itchy), VACCINATION SITE ERYTHEMA (arm  red), VACCINATION SITE SWELLING (arm where she got the injection became swollen), VACCINATION SITE PAIN (arm where she got the injection became sore) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
vaccinated 1/27/2021. Tested (+) COVID 5/22/2021. Admitted for 3 days into hospital for decreasing oxygen levels. Case completed initial case investigation but was unable to reach afterwards. Family disconnected my call 3x in attempts for follow up.  Person was not found in local obituaries.
At 8 AM on 5/10/21 I experienced extreme shortness of breath and an elevated heart rate. I could not catch my breath and my heart was ?resting? at approximately 145 beats per minute.  I went to the local ER at which time I was taken back for testing, approximately 10 hours later I was diagnosed with bilateral pulmonary embolism. My legs were checked and they could not locate any other blood clots - just in my lungs.
pt in SNF; tested positive for COVID; treated with antibiotic and antiviral monoclonal antibodies and O2 supplementation via NC; approximately 3 weeks later was sent to ER for evaluation of possible stroke; was sent back to SNF; increase in agitation, weakness, and confusion; became more lethargic and had poor po intake; pt died in the SNF
patient was blurred, sweeting and pale, gave him bottle of water and orange juice and 1/2 banana, turn on van and let him rest for 45min.patient felt better called his friend to pick him up.
Immediately following vaccine administration, a welt-like rash approx. 2 inches x 2 inches developed on elbow area and upper arm. Rash progressed to his head, neck, and lower extremities. Rash was extremely red and raised. .4ml IM of diphenhydramine 50mg/1 ml was administered IM in left deltoid. Child remained in clinic for observation an additional 30 minutes following administration of diphenhydramine. Rash became less red and had begun to improve when the child left. No other problems noted.
got sicker; Initial information received on 21-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced got sicker after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (lot number, expiry date, formulation: not reported) via unknown route in unknown administration site for immunization     On an unknown date the patient developed a non-serious event  got sicker (illness) (unknown latency) following the first dose of  influenza vaccine   Got a flu shot 15-16 yrs ago and got sicker than a dog. Never got another shot and haven't had flu since. Product Name: Product name was not provided. Since this is a public post we are assuming the consumer is referring to the Sanofi flu vaccine  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sicker).  At time of reporting, the outcome was Unknown for the event got sicker.
Received Tdap vaccine IM in Lt upper arm at approx 1025.  At 1033, bagan to feel palpiations.  At 1036, pruritis to arms and neck, eyes began to swell, red rash developed to arms.  Took Benadryl 25 mg p.o. at approx 1040.  Refused medical care.  Symptoms began subsiding within 20-30 minutes.
Pt experienced a nonspecific urethritis with one vesicle. The pt recovered from urethritis. Then pt developed herpes simplex virus (type 2), characterized by tingling and itchy vesicles. The following day the vesicle erupted into one big open sore. The pt nor his family has any known history of chickenpox or Herpes simplex virus type 2.
Initial information received on 13-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 5 months old male patient who was vaccinated with Dtap-IPV portion of PENTACEL (Batch number: UI968AAA, expiration date: 07 May 2020, dose, route was not reported) but did not get the ActHIB portion in left thigh on 12 Dec 2018. The patient's medical history was not reported. Concomitant medications includes PREVENAR at the same time. It was an actual medication error due to inappropriate reconstitution technique. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.