chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 15 minute observation period, pt. began feeling dizzy and lightheaded while she was enroute to parking area via golf cart accompanied by her mother and a staff member.  Staff member returned pt. to clinic for evaluation, she arrived to clinic at 11:15. Note: Patient speaks fluent English, however a staff member interpreted encounter in Spanish at pt?s request for benefit of her mother.  11:15:  VS (lying):  BP 100/70, P 92, SpO2 99% - c/o dizziness and thirst.  Reports she actually felt transient lightheadedness when she walked out of clinic to golf cart originally.  Has eaten only a small bowl of cereal today.  Skin pale, dry, no rashes, hives, lesions.  No swelling of face, mouth, oropharynx, or neck.  No respiratory distress, lungs clear.   11:20:  Feels better after lying down, drinking water and eating a cracker. Dizziness resolved, still slightly lightheaded with sitting up. Color normal per mother. No swelling of face, mouth, or neck.  No respiratory distress.   11:24:  VS (sitting): BP 110/62, P 88.  Feels ?okay? and wants to go home.   11:30:  VS (standing):  BP 96/68, P 96.  Became dizzy, lightheaded and pale with standing.  Remains oriented x 4, but verbal responses slowed.  No speech deficits, moving all extremities, PERL.  No syncope, LOC, seizure activity.   11:32:  P 98, R 14, SpO2 93%. Remains pale with slowed verbal responses.  No swelling of face, mouth, or neck.  No respiratory distress. Encouraged to take deeo breaths.  EMS called. 11:34: Pallor and rapidity of verbal responses slowly improving upon lying down.   11:37:  VS BP 110/80, P 110, R 15, SpO2 98%.   11:40:  EMS arrived, assessed patient, including repeat orthostatic VS (normal), EKG, and RBG.  Pt. reports she feels better and wants to go home.   11:55:  EMS assessment complete ? pt reports dizziness resolved, states ?just feel tired now?. Wants to go home, declines transport to ED.  Given DC instructions to rest, monitor for side effects, when to call 9-1-1. 12:00:  To car with mother via golf cart with staff member.
PTS. MOTHER WALKED INTO TO CLINIC TODAY,(5/11/05) STATES SHE NOTICED CHILDS ARM TO BE WARM TO THE TOUCH, AND LARGE RED INFLAMED AREA AT SITE SURROUNDING IMMUNIZATION SITE.
There is a flesh-colored maculopapular rash, lesions approx. 2mm, on the right upper leg surrounding the area where the injection was.  It is not only under where the band-aid was.  It does not appear infected.  This is not a typical appearing rash for an injection site reaction given there is no erythema, but the location certainly suggests a localized injection reaction.  I have recommended topical hydrocortisone TID for a few days, general emollient moisturizers, and taking a watch and wait approach.  Red flags of when to be seen discussed. We may need to consider discussion with allergy provider prior to further prevnar injections.
per pt: 4 weeks post vaccination, "shoulder range of motion still slightly decreased, pain occurs at the end of the range of motion; mainly shoulder area"
erectile disfunction,  inability to maintain erection during coitus , no ejaculation , over many events and efforts over two month period
Patient, 64 years old and given second bivalent dose in error.  Patient stated they didn't believe they ever had a bivalent dose so the dose was given, after administration it was caught that the patient had received a bivalent dose in october of 2022. Patient also stated that their doctor had recently told them that they needed a dose of the bivalent covid vaccine.
Pt reports back going out the day following and continuing pain/ swelling until day of reporting on 11-18-19; reports inflamed lower back started which has made it difficult to get out of bed. started in the middle lower back and "roles up from there". pt notices an associating with also experiencing his back going out after last years flu shot.
Left upper thigh swelling, cellulitis with heat production and induration 48 hours after immunization.
Within minutes - shot upper arm hurt. Wrist on shot arm hurt. LOUD Ringing in my ears. Pressure in ears.   Ringing ended day of shot. Wrist hurt for a day. Arm still hurts as of now
Flu like symptoms; headache; body aches; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular in Dec2020 (reported as mid-Dec) at single dose for Covid-19 immunization. Medical history included Covid-19 on an unspecified date in 2020 (before vaccination). The patient's concomitant medications were not reported. It was reported that the patient had been ill with COVID earlier in the year and was glad she could receive the vaccination. The patient reported that she had her first shot in mid-Dec and would soon be getting her second. She wasn't sure if she'd have side effects but indicated the 24hours the hospital gave them after vaccination was adequate for her flu like symptoms mainly headache and body aches to pass. She took some Tylenol and felt fine the following day. The outcome of events was recovered on an unspecified date. It was unknown whether patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was also unknown if the patient received other medications the patient received within 2 weeks of vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
4 hours after patient received vaccine she had symptoms of memory loss and weakness.  She went to ER where they could find no problems, only that her blood sugar was a little low.  The Dr there thought it was not related to vaccine and may be related to hypoglycemic episode.
Patient describes the evening after the vaccine he developed a headache, fever 100.0F fatigue and pain at the injection site which made it difficult to move his arm.
Child had a non-febrile seizure on 2/4/19 that lasted for several minutes. No prior symptoms other than child complaining of being tired. Paramedic arrived and administered oxygen until ambulance arrived. Hospital did EEG and MRI and all came back normal. They said this was just a fluke and if another happened again, they would discuss the possibility of epilepsy.  We were at hospital for about 22 hours.
was sick all winter; Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who was sick all winter (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, 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 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious was sick all winter (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient I had the flu shot two years in a row a few years back. The patient was sick all winter both times also reported that, (never again. The patient won't be vaccinated for anything ever again).   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
This case was reported by a pharmacist via sales rep and described the occurrence of stroke in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced stroke (serious criteria GSK medically significant), numbness, tingling, mental status changes, blurred vision and fever. On an unknown date, the outcome of the stroke, numbness, tingling, mental status changes, blurred vision and fever were unknown. It was unknown if the reporter considered the stroke, numbness, tingling, mental status changes, blurred vision and fever to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced significant stroke like side effects including numbness, tingling, altered mental status, blurred vision and fever after receiving a dose of SHINGRIX, significant enough to warrant an Emergency department visit. The reporter was still in the process of gathering and validating information but he wanted to reach out to see if GlaxoSmithKline had received any reports of stroke like symptoms after SHINGRIX administration occurring elsewhere.
Sore arm; still a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PAIN (still a little sore) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and PAIN (still a little sore). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PAIN (still a little sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient went to doctor the day before getting the shot and doctor prescribed  Zpack & eyedrops for sinus/allergies.  The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: TCR appended on 12-JUL-2021 included outcome of the events.
Hospitalized 11/7/2021; COVID-19 positive 11/7/2021; fully vaccinated  BRIEF OVERVIEW:   Admission Date: 11/7/2021 Discharge Date: 11/9/2021 DETAILS OF HOSPITAL STAY:   HOSPITAL COURSE: Patient is a 61 y.o. male with past medical history significant for coronary artery disease, chronic systolic CHF, depression/anxiety and hypothyroidism who presented to the emergency department with shortness of breath and cough. His symptoms started about 6 days prior to admission.  The patient was found to have acute hypoxic respiratory failure secondary to COVID-19 infection. He had received J&J vaccine on 03/17/2021. CXR showed chronic interstitial thickening.  Due to his hypoxemia, he was admitted to the hospitalist service for further care.   Upon admission, the patient was continued on supplemental oxygen.  He was started on albuterol inhaler as needed, as well as scheduled Decadron (6 mg daily) and Remdesivir.  His oxygen saturations remained stable on supplemental oxygen, and he was requiring 3 L oxygen at time of discharge, which he will require at all times.  He was seen by respiratory therapy care management, who will arrange for home oxygen at discharge.  He was evaluated by COVID at home team, and was felt to be an appropriate candidate for discharge home, with COVID at home team to follow.   He was felt stable for discharge home on 11/9/21.  He will be continued on 7 more days of Decadron at discharge.  He will be discharged on 3 L oxygen at all times.  He should follow-up with his PCP in 1 week.  He will be followed by the COVID at home team after discharge.
A PNEUMOVAX vaccine was given 9/9/10. MA went to hospital 9/10/10 complaining of right shoulder pain and motion. The ER dock said the vaccination was given too high on arm.
No longer smiles or laughs. No longer can hold head up or try to sit up on her own. Clinching of the fist. Spasm/seizures. Extremely fussy. Hates being upright now. No longer can focus on things. Will not play with toys any more. Horrible arching of the back. Pushes her head back. Brain stopped growing at 4 months of age causing fontanelle to close. A few cysts on her brain.
Temperature was from 100.4F to 103F from 17:00 on 9/23/00 to 08:00 on 9/24/00, he was also fussy and did not want to play. Gave him Tylenol and Motrin as directed by clinic. He received a rash on 9/27/00 on his face, legs, arms and back near his waist. Another symptom was that his balance was off when walking. On 10/27/00, he has not had any ear infections until 10/24/00. It seems strange that he gets the PCV (to help prevent ear infections) and then he gets one less than 4 weeks later.
lip infection from believed cold sore; lip infection from believed cold sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  An adult male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: LIP INFECTION (non-serious), ORAL HERPES (non-serious), outcome "unknown" and all described as "lip infection from believed cold sore". Therapeutic measures were taken as a result of lip infection, oral herpes. Clinical course was as follows: A Pfizer employee reported, "Friend was chatting about vacation activity. Vacationers came across a person who I think said were vaccinated and may or may not have covid (did not say definite). One of vaccinated people on vacation got a lip infection from believed cold sore. Is on round 3 of antibiotics." Upon a follow-up, this reporter stated, "The person with lip infection is adult male. Beyond this I have no further details."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Infant developed 104 fever the next day.  (was 101.5 late that evening after vaccination).  Erythema, tenderness left thigh.  Temperature 103.3 in office the next day (7/16/08).  Possible left thigh cellulitis.  Treated with Roephn IM and Keflex.
Heart jumps fast. Hands and foots were very cold but inside body is very hot like on the fireplace. Headache. Muscle pain. Don?t want to eat but diarrhea. After I took Tylenol I felt better.
pt recvd vax & exp hoarseness, chest pressure (felt like a couple bricks on chest; fatigued & icky that evening; next day still felt fatigue & dizziness by 3rd day was ok; has hx of hypertension
Angry red and sensitive rash on face (forehead and left cheek down the neck), vomiting, and diarrhea
The night of  12/13, I felt very tired about 10 p.m., which is an hour and a half before my usual bedtime. When I went to bed, I had trouble sleeping, woke every 2 hours with headache, intestinal discomfort, a couple of times I had dry heaves but didn't vomit. I took a couple of generic Tylenol about 4 a.m.The next morning I could eat only half my breakfast, headache was worse and I generally did not feel well. I lay around until mid-afternoon when I realized I hadn't had any fluids since breakfast. At that time the headache was at the back of my head where it meets the top of my neck.  It felt a little like I'd had a whiplash. After I had some water, I called the Pharmacy to see if there was something I could do to feel better. The Pharmacist I spoke to advised Tylenol and fluids and said to call my doctor if I wasn't better by today. She also gave me the phone number to call to report these problems.  I felt better by evening and was able to eat something for supper, though not as much as usual. I slept OK last night, but continued the tylenol every 6 hours. Today I feel a lot better but I tire very quickly after exertion. Even though I tire easily, I was able to do 7 loads of laundry and walk a half mile outside.
This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a adolescent patient who received BEXSERO. On an unknown date, the patient received BEXSERO (intramuscular) .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant), meningococcal infection (serious criteria GSK medically significant) and influenza-like symptoms. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningococcal infection and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to BEXSERO. The reporter considered the influenza-like symptoms to be almost certainly related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The batch number was unknown. In 2016, the patient received BEXSERO in unknown arm and experienced flu-like symptoms that she described as feeling like she had developed meningococcal disease. This case was considered as suspected vaccination failure, since the exact time to onset for the event and laboratory confirmation of the infection was not provided. In 2016, the events got resolved.
This spontaneous report as received from a Bachelor Science in Nursing refers to an unspecified patients. On an unknown date unspecified patients were vaccinated with GARDASIL (dose, via, lot number and expiration date not reported). There was no concomitant medication reported. Reporter stated that GARDASIL, not stored within proper temperatures ranges and therefore unsupported on an unspecified dates, was administered to unspecified patients on unspecified dates. Additional information has been requested.
This case was considered medically important for the event of too weak to walk. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 30-month-old female patient who turned very pale, was too weak to walk, and lips turned blue. The patient received the first dose on an unspecified date along with a dose of Hepatitis A vaccine (manufacturer unknown). Additional suspect medication included Hepatitis A vaccine. On 13-Jul-2010, the patient turned very pale, her lips turned blue and she was too weak to walk. The symptoms lasted about 10 minutes and the patient recovered. Treatment was not reported. The mother was instructed to contact the physician if symptoms returned. No additional information was available at the time of this report.
This spontaneous report was received from a physician referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions and concomitant therapies were reported. On 02-AUG-2016, the patient was vaccinated with ZOSTAVAX. Route, dose, dose number, lot # and anatomical location were not provided. On an unspecified date in August 2016, after getting ZOSTAVAX injection, the patient experienced influenza like illness (reported as "flu like symptoms such as chills and headaches"). It was not a product quality complaint involved. The outcome of influenza like illness was reported as not recovered. The causality assessment between ZOSTAVAX and influenza like illness was not reported. Additional information has been requested.
missed getting the 2nd dose on the seventh day with no reported adverse event; Initial information received on 29-Jun-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves female patient of unknown age who missed getting the 2nd dose on the seventh day with no reported adverse event after receiving vaccine IPV (VERO) [IMOVAX].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect IPV (VERO) Suspension for injection (lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination. Information regarding batch and expiry date was requested.  It was reported that patient went to local medical department to receive the first dose of the Imovax. When patient returned 7 days later she told they would not give the booster because the initial vaccine should not have been given and said it was a long story. Reportedly patient stated that disease control now recommends 2 doses instead of 3. Patient had non-serious event of obviously missed getting the 2nd dose on the seventh day (product dose omission issue) (latency: 7 day).   Action taken : not applicable.  Outcome: unknown  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 guidelines. 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.
Broke out with shingles after 2nd vaccine/Suspected vaccination failure; Broke out with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient stated that he/she was vaccinated with shingles vaccine and broke out with shingles after second vaccine.  The patient also stated that the 4 percent of the population would have this happen. Follow up would not be possible, no contact details were provided. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR051254:Same reporter. Hearsay case.
Pt recvd vax 17SPE92 later in day had food & shortly began vomiting nonstop; required MD visit; 19SEP pt sleepty w/dec appetite; irritable & cries when awake; afebrile 21SEP; all sx resolved;
Hives (little bumps that were itchy and didn't go away, she used Benadryl and loratidine to minimize the itch); she felt like bugs were crawling over her skin, nerve tingles and cough w/ mucus production.
p/vax pt exp a fever of 102.0;pt was treated w/APAP & Ibuprofen symptomatically;
Immediate Itching at site , tingling in fingers on right hand within 10 mins, tingling in right side -including face and tongue?a few hours after injection, headache evening of injections, body aches through the night, headache continues next day, soreness at injection site