chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 12 year old female who fell and hit her head on 10/17/00. On 10/18/00, at 06:30, the pt was evaluated in the ER and was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent because of possible basilar or skull fracture. Within 30 minutes of the injection, she developed phlebitis, a pain at the injection site and her temperature went as high as 41.1C. The pt also had marked tenderness at the injection site; induration that measured about 12cm X 7cm and a topical cord with erythematous streaking. The physician relayed a differential dx of possible vaccine induced reaction versus a possible cellulitis versus a possible lymphangitis versus possible thrombophlebitis. The pt was hospitalized, treated with ice packs and ibuprofen. Her symptoms are markedly improved. No further information is available. A 15-day follow up report received 01/22/2001 adds: On 10/19/2000 the pt's initial white blood cell count went from 12,000 to 21,300 with a sedimentation rate of 33.
Clinician who reconstituted vial, reconstituted with 0.8 cc instead of 1.8 cc .
I got the shot and arm was a little sore. After my time period in May on the night of the 7th I started to feel sick. Woke up and was real sick for many days. On May 12th I tested positive for covid. My experience has been different than others I know who had it. Most food tasted rotten or like chemicals or medicine. Lost 20 lbs. Still have little energy. Foggy headed as I forget things easily. And other things.
After my second dose vaccine, I experienced headaches along with nausea. No vomiting. Headaches became migraines and I went to my doctor's office because my headaches were getting worse and I had started to throw up. I also had body aches, nausea and vomiting which lasted three das. My doctor prescribe anti nausea medications, prescribe Zofran, gave me sleeping medicine as well as a Toradol medication.   I also received my first dose injection, lot#: EH9899 on 12-18-2020 at 8am.  I developed headaches for two hours, little bit of nausea for 45 min and had a sore arm.
Immediately after getting the TWINRIX vaccination, (2nd dose of accelerated schedule 1st dose on 2/7/19 at a travel clinic) patient said they felt lightheaded. Pharmacist waited a few minutes and also administered FLUARIX QUAD. Pt was offered water which she drank. Pt mentioned she hadn't had anything to eat and was offered a lollipop which she took. Pt then said her fingers were tingling. Pharmacist asked if she felt any itching, patient said no. Pharmacist inspected injection sites of both arms and there was no swelling or redness. Pharmacist asked patient to continue to remain seated for a few minutes. After pt finished lollipop she said she was feeling much better. Pharmacist asked if she could take her blood pressure. Patient consented. At 12:24P BP was 79/61 with a pulse of 60. She stated that that was about normal for her and that her blood pressure usually runs low. Pharmacist was reluctant to let patient leave but patient assured her she promised she was fine. Pharmacist asked for PCP name and said she would call them to let them know she had this reaction. Pharmacist called patient later about 2:24P and she stated she had "no issues whatsoever" but that she had never had this happen to her after a vaccination. Pharmacist called PCP and told nurse of event and she said she would place a note in the chart.
PT RECEIVED FIRST SET OF IMMUNIZATIONS 06/24/04, DEVELOPED A FEVER OF "107" WAS ADMITTED TO THE HOSPITAL. BLOOD WORK, LUMBAR PUNCTURE AND XRAYS WERE PERFORMED AND RULED OUT ANY OTHER ETIOLOGY. WAS THEN DETERMINED BY THE HOSPITAL THAT WAS A REACTION FROM THE VACCINES. WAS GIVEN TYLENOL FOR 24 HOURS UNTIL DISCHARGED. PT HAD NO SEIZURE ACTIVITY AND NO MORE FEVER.  Nurse follow up on 06/30/04 states: "Per review of hospital discharge summary, this child was admitted and discharged on the same date. Temp. was recorded as 100.6 degrees (not 107 as quoted from family member in VAERS report). Diagnostic impression was fever, status post vaccine administration, and suspected sepsis was ruled out."
Information has been received for the pregnancy registry for GARDASIL from a 20 year old female patient who was vaccinated with the first dose of GARDASIL (lot# not provided) when she was "around one month pregnant".  Subsequently the baby had some complications and when patient was three months pregnant she terminated the pregnancy due to the complications.  Patient was then referred to another physician (name not provided) who told the patient that the complications she had with the baby were probably related to GARDASIL.  Upon internal review, the termination of the pregnancy was considered an other important medical event.  No further information is available.
About five days after receiving my second COVID 19 shot, I started to experience painful swelling in both of my feet and ankles, but primarily my left side. Since the swelling started back in May, my left foot has never been able to go back to its normal size. I am in a state of constant swelling: I start the day a bit swollen and it gets progressively worse during the day. By the end of the day, it is gigantic and difficult to move since the ankle is so heavily swollen.
Syncopal episode appearing as a vasovagal response from receiving the vaccine. Patient fainted and fell back onto her head. Unconscious. When patient woke up she was very confused and alarmed. EMS was called and brought her to the hospital. BP, O2, resp normal
lump on like kind of under my armpit, it is kind of like where my armpit; It is a lump and it is sore; lump on like kind of under my armpit, it is kind of like where my armpit; It is a lump and it is sore; Chills; Headache; Fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 23May2021, the patient experienced lump on like kind of under my armpit, it is kind of like where my armpit; it is a lump and it is sore, on 22May2021 the patient experience chills, headache and fever. It was stated she got the Pfizer shot on Friday and she did experience like chills, headache, and fever all the above, yesterday but then today she has a lump on like kind of under her armpit, it is kind of like where her armpit is and she guess where the strap of her bra meet. Like it is a kind of in that area. It is a lump, and it is sore, and she was just really concerned about. she means she heard about the fever, the chills and stuff like that might occur after vaccination. But she was not aware of the lump. This is the cause for the concern and what should she do. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about batch/lot cannot be obtained.
Catch up IZs given: dtap #2, polio #2, hib #2, PCV #2, hep B #3 ** on chart review, determined that pt had IZs on schedule for 2m, 4m, and 6m. However these did not copy to the state reporting system 'CIS' utilized to determine if pt was up to date on IZ
Per 's description, she experienced a tight throat at 0805 that started moving down, at 0813 started to cough, was sent to ER at 0820 and had shortness of breath, and at 0845 was dizzy and couldn't stand up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9261), in right arm, on 18Feb2021 as dose 2, single (Lot number: EN6200), in left arm and on 08Oct2021 as dose 3 (booster), single (Lot number: FF3590) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obese" (unspecified if ongoing); "Allergy: Scallops" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Jul2002 (ongoing); DICLOFENAC, start date: Jul2021 (ongoing); ALIGN, start date: Sep2020 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that patient received Anti-viral treatment product COVID 19 Treatment, treatment start date on 19Apr2022, treatment stop date on Apr2022, lot number FR7229, indication Treatment of COVID-19.
Pt reported feeling lightheadedness. Pt reports having eaten prior to vaccination today and no hx of anxiety. Pt provided juice and education. Pt was continued to be monitored and 2nd juice given. Pt symptoms resolved by end of 15 min observation period.
ELEVATED BLOOD PRESSURE; RECEIVED AN ENTIRE VIAL OF THE JANSSEN COVID 19 VACCINE INSTEAD OF ONLY ONE DOSE; CHILLS; LOW GRADE FEVER; This spontaneous report received from a health care professional concerned a 36 year. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy, non-smoker, and non-alcohol user, and the patient had no health conditions. The patient experienced drug allergy when treated with cefalexin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: 21-DEC-2021) dose was not reported, 1 total administered to right arm on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient was accidently given an entire vial of the Janssen COVID-19 Vaccine instead of only one dose at the vaccination facility (overdose). The patient had not experienced any side effects at the time of reporting. On the same day, the patient had visited Emergency Department (ER) and her vitals were monitored at ER. Her blood pressure was found to be 190/70 mmHg (elevated blood pressure), Heart rate was 83 bpm (beats per minute), and Oxygen saturation was 98%. The Patient was discharged from the Emergency Department on the same day and experienced a low grade fever (no Temperature recorded) and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elevated blood pressure, and the outcome of received an entire vial of the janssen covid 19 vaccine instead of only one dose, low grade fever and chills was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000194469.  Initial information was processed with additional information received on 23-SEP-2021.The following information was updated and incorporated into the case narrative: Reporter(Pharmacist) added as contact, events(low grade fever, chills) were added, labelling, causality and narrative were updated.; Sender's Comments: 20210943963-COVID-19 VACCINE AD26.COV2.S-elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
No further information is available; A nurse is reporting that a patient received an expired PNEUMOV AX; This spontaneous report has been received from licensed practical nurse (LPN), concerning a patient of unknown age and gender. No information was provided regarding the patients' pertinent medical history, current conditions, concomitant medications and previous drug reactions or allergies.  On 23-AUG-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vial, at a dose of 0.5 milliliter (ml) once administered intramuscularly (lot number S033790 has been verified to be valid, expiration date reported and validated as 02-AUG-2021) (anatomical location of administration were not reported) as prophylaxis. No further information was available (no adverse event).
1OCT93 pt exp genl achiness & nauseated; 4OCT93 bloodwork showed irregular (high) counts; 8OCT93 bone pain (legs); 19NOV93 flu like sx (fever); 9DEC93 dx leukemia; pt exp runny nose, cough, resp infect; treated for bronchitis;
15 hours after SHINGRIX vaccination, pt reports N and V, fever of 100.8 degrees, severe headache, malaise, Symptoms lasted 12 hours, then subsided.
dizziness/When I stand up I can't move right away. I have to wait until the dizziness goes away/dizzy feeling like he a concussion; dizziness/When I stand up I can't move right away. I have to wait until the dizziness goes away/dizzy feeling like he a concussion; dizziness/When I stand up I can't move right away. I have to wait until the dizziness goes away/dizzy feeling like he a concussion; This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of 79-year-old received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration (Batch/Lot number was not reported) on 31Jan2021 (reported as yesterday morning (Sunday)) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 31Jan2021 (reported as starting last night), the patient experienced dizziness/when he stands up, can't move right away. He has to wait until the dizziness goes away/dizzy feeling like he a concussion. This morning he was having the dizzy feeling like he a concussion. He wants to know, if this could be a side effect. He sat and waited for 15 minutes after with no reaction. The outcome of all the events was unknown. There was no product quality complaint (PQC) present.  Information on the lot/batch number has been requested.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
pt recvd vax & devel a generalized fine red body rash & flushing of face, aching & h/a; pt was treated w/APAP & DPH
pt recv vax 21APR97 & the next day exp local swelling from one-half inch below the inj site (larger than a 50 cent piece) that was red, tender & hot;pt recovered;
3 days after vaccination, patient was found down in his home.  Admitted to ICU from the ER with severe sepsis, bilateral pneumonia, acute kidney injury and rhabdomyolysis.  Patient deceased day after hospitalization.
She developed a cold 5 days after. She then developed a red rash in the morning, and it looked like a viral rash. By the time she came home from school she had hives all over her torso. I gave her Benadryl when she woke up because she had hives on torso, face, legs and buttocks. I took her to the doctor and they treated it with Claritin and Benadryl. She is still taking Claritin daily.
I had two shingles shots and still got shingles/ Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had two shingles shots and still got shingles/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 20-JUN-2023 This case was reported by a patient via interactive digital media. The patient had two shingles shots and still got shingles. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 98 years old female patient who received 0.5 ml, 2 doses of vaccine FLUZONE HIGH DOSE on 22-Oct-2018 (injection site unknown, Batch number and expiry date were not provided) and on 25-Oct-2018 in the left deltoid (Batch number: UJ010AC and expiry date: 22-Apr-2019). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. It was a case of actual medication error due to extra dose administered. It was unknown if any adverse event occurred or not following the vaccination. 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 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. Documents held by sender: none.
mom states arm sore from shoulder to elbow, extremely red @ inject site, has 2" to 3" fine rash from shoulder to elbow; referred to MD;
This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. His concurrent conditions, medical history and concomitant therapies were not reported. On 15-NOV-2018, the patient was vaccinated with a first dose of M-M-R II, subcutaneously (dose, lot# and expiry date were not reported) for vaccination against measles, mumps, and rubella. On an unknown date (reported as recently), the patient's serologic testing reported that the patient was immune to rubella and mumps (clarified as having high rubella and mumps titers), but not immune to measles. The patient sought medical attention at the pharmacy. The outcome of the event was unknown. The causality assessment was not reported.
Enormous baseball size swollen lymph node in my right armpit that was very painful; Enormous baseball size swollen lymph node in my right armpit that was very painful; Booster; Other vaccine same date vaccine date 02Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Dec2021 14:00 (Lot number: FJ1161) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 02Dec2021 (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE SODIUM. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9264, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 22Feb2021, when the patient was 37 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9264, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 12Mar2021, when the patient was 37 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 14:00, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 04Dec2021 04:00, outcome "recovered" (07Dec2021) and all described as "Enormous baseball size swollen lymph node in my right armpit that was very painful"; PRODUCT USE ISSUE (non-serious) with onset 02Dec2021, outcome "unknown", described as "Other vaccine same date vaccine date 02Dec2021". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional information: The patient had no known allergies. The patient was not diagnosed with Covid-19 prior vaccination. The patient was not tested for COVID-19 since the vaccination. Onset latency for the events Enormous baseball size swollen lymph node in my right armpit that was very painful was 01 day 14 hrs.  No follow-up attempts are possible. No further information is expected.
Information has been received from a health professional ("medical assistant") concerning an approximately 51 year old male who, on an unspecified date, was vaccinated with a dose of Pneumovax 23 (Lot# 651437/0899F).  Concomitant vaccination included a dose of influenza virus vaccine (unspecified).  Subsequently the patient developed bad swelling of the right shoulder at the injection site.  The medical assistant noted the patient was "in bad condition."  The patient was seen in the emergency room but not admitted to the hospital. It was also reported that the patient recovered (date not reported).  Additional information has been requested.
Nose was running like a faucet; Eyes hurt because of swollen sinus; swollen sinus; CHILLS; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Nose was running like a faucet), EYE SWELLING (Eyes hurt because of swollen sinus), SINUSITIS (swollen sinus), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and CHILLS (CHILLS) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 31-Mar-2021, the patient experienced CHILLS (CHILLS). On an unknown date, the patient experienced RHINORRHOEA (Nose was running like a faucet), EYE SWELLING (Eyes hurt because of swollen sinus) and SINUSITIS (swollen sinus). On 30-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 01-Apr-2021, CHILLS (CHILLS) had resolved. At the time of the report, RHINORRHOEA (Nose was running like a faucet), EYE SWELLING (Eyes hurt because of swollen sinus) and SINUSITIS (swollen sinus) had resolved.            No concomitant medication was not reported. No treatment medication was not reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-122979 (Patient Link).
I woke up the next morning with sciatic nerve pain from my waist down to my toes. I could barley walk or sit. The pains were very sharp. My vision was blurry on and off for two days. I now have had headaches with sharp pain in the back of my head since the vaccine. I have sharp pain in my arms and my hands go numb throughout the day. I also have had chills and feel cold. These symptoms have been happening since the day after the vaccine. I never had these symptoms before.