chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 7 year old female who on 22-OCT-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot number: 657719/1001U). Concomitant therapy that day included hepatitis A vaccine (inactive) (MSD) and Fluzone (manufacturer unknown). On 22-OCT-2007, " the patient experienced redness and itchiness on her right thigh near the injection site" after receiving the vaccination. No further information was given. The outcome was reported as recovered. There was no product quality complaint. Follow-up information has been received which indicated that the patient had no pre-existing allergies, birth defects or medical conditions. On 26-Oct-2007 (previously reported as 22-Oct-2007) at 3:15 PM the patient was vaccinated in the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 657719/1001U) There was no illness at the time of vaccination. On 27-Oct-2008 (previously reported as 22-Oct-2007) at 12 PM the patient developed a 1 cm red, pruritic area several centimeters around the varicella virus vaccine live (Oka/Merck) injection site. Around 31-Oct-2007, the patient recovered. It was reported that the patient has never had an adverse event following prior vaccinations. Additional information is not expected.
About 20 minutes after receiving the vaccine  was complaining of swollen lips and tongue. EMS was called immediately.  MD present and upon examination lips swollen, oral pharynx red, tongue thick, unable to visualize posterior pharynx.  1 Dose of Epi 0.5ml was administered Sub Q to the pts L upper arm. Patient c/o difficulty breathing.  Vitals were taken and WNL besides an elevated Blood Pressure. Patient became cool and clammy right before EMS arrival. After about 10 minutes EMS arrived and took over care of the pt.  Started IV benadryl and solumedrol.  She was then taken to the Hospital.
Upon f/u return 07/23/19 Provider reported "SKIN: left triceps injection site with well defined bright red circular patch measuring abt 3 cm; mid abdomen with erythematous macular rash. "
30MAR95 awoke w/t105.1; high pitched screams; seen today by MD has URI sx;
administered liquid diluent only portion; administered liquid diluent only portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 13th June 2022, the patient received Menveo. On 13th June 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-June-2022 Reporter's comment: The pharmacist reported that 16 year old male patient who was administered the liquid diluent only portion of the Menveo vaccine.  The diluent was not reconstituted with the lyophilized MenA component.   The reporter did not have the lot number / expiration date information available at the time of call, nor the patient's initials. At the time of reporting, the patient has not been redosed. The reporter gave consent to follow up. Additional supportive information: The diluent was not reconstituted with the lyophilized MenA component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Patient felt sick on 09/29/23 after getting the vaccine.  Was very tired and nauseous.  Claimed she almost fainted several times that night.  Developed a rash on her left side.  Was diagnosed with shingles on 10/4/23.  Was given valacyclovir 1g 1 tid for 7 days.
Headache; Severe abdomen pain; Sternum swollen; Nausea; Hard to take deep breathe; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0171) via an unspecified route of administration in the left arm on 31Jul2021 at 09:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, high cholesterol, anxiety and attention deficit disorder (add) and unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 31Jul2021 at 19:00, the patient experienced headache still as of 07Aug2021, severe abdomen pain, sternum swollen, nausea and hard to take deep breathe. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 06Aug2021, the patient underwent Quickvue via nasal swab and the result was negative. The clinical outcome of the events headache, severe abdomen pain, sternum swollen, nausea and hard to take deep breathe was not resolved at the time of this report.
Information has been received from a health professional concerning a 4-year-old male with reactive airways disease and attention deficit/hyperactivity disorder and a history of myringotomy with no known drug allergies, who on 12-AUG-2003 was vaccinated subcutaneously in the left arm with a 0.50 milliliter dose of varicella virus vaccine live (Oka/Merck) (lot# 644721/0018N). Concomitant vaccination included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) given in a separate site. On 29-JUL-2007, the patient developed chickenpox. There was a rash with less than 50 papular lesions over the whole body that were itchy. The patient was seen in the office on 30-Jul-2007 and at the time some of the lesions were crusting and the patient was afebrile. No laboratory or diagnostic tests were performed. The outcome is reported as recovering. No product quality control complaint was involved. Follow-up information has been received concerning a male. The concomitant vaccination of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot# 644585/1015M) was administered subcutaneously in the right arm. There was no illness at the time of vaccination. On 28-Jul-2007, (previously reported as 29-Jul-2007) the patient developed 75 scattered lesions on trunk, scalp and back. On 30-Jul-2007, the patient was seen in the office and some of the lesions had crusted over. Benadryl was given. On an unknown date the patient recovered. Additional information has been requested.
TOOK VIVOTIF ON DAY 1 AND DAY 2; This spontaneous case (PVX2019-1405) was received from a pharmacist on 31-May-2019. It describes a female consumer who "took Vivotif on day 1 and day 2". She was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took two Vivotif doses on day 1 and day 2.  Action taken with Vitotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vivotif on day 1 and day 2" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif on day 1 and day 2" was considered as not applicable.
C/O SYNCOPE, SEIZURE ACTIVITY X 20 SECS, NAUSEA, NO HX PRIOR ALLERGIES, PROVIDED WATER AND SNACK, SX RESOLVED, NO TRANSPORT.
Mild elevated temperature (100.3 ); lethargy; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: EL3247) via an unspecified route of administration, administered in Arm Right on 12Feb2021 (at the age of 49-years-old) as single dose for covid-19 immunisation. The patient's medical history included asthma and known allergies: NSAIDs trigger asthmatic response. The patient's past drugs include received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: EL3247) via an unspecified route of administration, administered in Arm Left on 22Jan2021 (at the age of 49-years-old) as single dose for covid-19 immunisation. The patient's concomitant medication included montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC) and sertraline hydrochloride (ZOLOFT). The patient underwent lab tests and procedures which included body temperature: 100.3 on 13Feb2021 Mild elevated temperature. It was reported as mild elevated temperature (100.3) onset 27h post dose, and accompanying lethargy. abatement of symptoms 36h post dose. The patient experienced mild elevated temperature (100.3) and lethargy on 13Feb2021 13:00. The outcome of the events was recovered on an unknown date in Feb2021. The patient did not receive any treatment for the reported events.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Pt recv vax on 11/1/98; post vax pt exp stinging at vax site, redness, swelling, hot at site also; tx=hot compress x2 day
Following varicella vaccine developed 2 knots in (L) arm about 5-11-11, on 5-12-11 area red & tender throughout, no systemic sx, red area 8 x 6 cm 2.5 x 1.5 cm and 1.5 x 1 cm indurated regions within red area, no fever.
Patient was diagnosed with Influenza A  and had severe respiratory distress. Was placed on ECMO
I had my vaccination on 01/25/2023. I had a history of a cough on 10/2022 that lingered and I was treated with a steroid in 01/2023. After vaccination 01/25/2023 the cough and wheezing came back. I sought medical attention and I was provided a breathing treatment. I am still having the breathing treatments as of 04/27/2023.
Nurse gave pentacel IM and also gave polio.  Baby needs to get Hep b on next visit to office.
Initial report received from a nurse on 29 Oct 2010: This patient was vaccinated with MENVEO (batch number 091201) on an unspecified date. The patient only received MenA powder component after it was reconstituted with a saline solution. No adverse event was reported.
This case was reported by a healthcare professional (also the mother of the subject) and described the occurrence of gastrointestinal symptoms in a 41-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included asthma. On the afternoon of 22 February 2012 the subject received 1st dose of TWINRIX in an unknown arm. On the evening of 25 February 2012, 3 days after vaccination with TWINRIX, the subject experienced systemic events of gastrointestinal symptom, feces pale, muscle pain and feeling physically bad. At the time of the reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with TWINRIX. The nurse/mother was trying to determine if her daughter should receive the second dose of TWINRIX in the vaccination series. She noted that it was not known who administered the vaccine, but stated that she believed probably a nurse or a medical assistant and not a physician.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient recovered and mom says she was taking him to the doctors office for follow-up
2pm Problem with Thumb trembling while texting 4pm Stomach and Diaphragm and arm muscles making involuntary movements 11pm went to local Hospital ER ER doctor diagnosed Akinesia and sent home and told to take benadryl Benadryl 50mg initial dose and then 25mg every 8 hours Completely resolved within 36 to 48 hours  ( note that patient had been on abilify 15mg daily for 18 days and off for 1 month prior to this event )
10-2-07 Left thigh achy, burning, no redness, no swelling, not warm to touch. Nurse suggested Tylenol, Physician orders Try Advil or Motrin. Sometimes mild heating pad is comfortable. Just needs few days. 10-2-07 called on call Doctor. Reported swelling better. Physician order Tylenol as directed on bottle call office tomorrow. 12:30 10-3-07 Patient called c/o lot of pain over her shot. Leg no better. This 46 year old female presented because she has been concerned about some redness of her leg. She had a shot on Monday. She had a pneumonia vaccine in her thigh. She has not had any fever or chills, but it has been quite sore. She has been putting very hot packs on it and leaving it on for a long time. She is concerned because it is still so sore. She has been taking some Tylenol. She cannot take anti-inflammatories because it bothers her stomach.
This spontaneous report was received from a registered nurse via a company representative refers to an unspecified adult patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017 the patient was vaccinated with a separate doses of VARIVAX, subcutaneous (dose, frequency unknown) (lot number N014366, expiry date May 2019) to prevent chickenpox. On an unknown date in 2017 the patient received a dose of VARIVAX, subcutaneous (dose, frequency unknown) to prevent chickenpox. It was reported that both the vaccines were given out of temperature range inadvertently. The action taken and outcome of the event was unknown. No further information provided. This case is linked to case number 1707USA000191 via same reporter link. Additional information has been requested. Sender's Comments: US-009507513-1707USA000191.
lethargic; uncomfortable; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case is linked to case 2019SA322188 (same reporter).  This case involves a female patient who experienced being uncomfortable (discomfort) and being lethargic (lethargy), while she received vaccine INFLUENZA VACCINE.  The patient's past medical history, concomitant treatment(s), vaccination(s) and family history were not provided.   On 06-Dec-2018, the patient received a dose  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot 3B9Y2 via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious being lethargic (lethargy) and being uncomfortable (discomfort) Unknown latency following the administration of INFLUENZA VACCINE.  No lab test reported.  Final diagnosis was lethargy and discomfort.   It was not reported if the patient received any corrective treatment.  The events being uncomfortable and being lethargic were resolved on an unknown date (the symptoms lasted the weekend).
Immediately after the shot and as I started to stand up I felt pain in my leg joints. As I walked around the store the pain quickly went away. I returned home and within about one hour I had chills all over my body. The chills were almost unbearable and soon I developed a fever of 103.4. I had chills and a fever into the evening and night. The fever and adverse feelings lasted for about 24 hours. After about two days I was fine with only some lingering fatigue.
I had my vaccination on 11/28/2022. I started to have symptoms on 01/20/2023 to include sneezing body aches lethargy and sore throat. I had a PCR test on 01/21/2023 and tested COVID-19 Positive. I was given Tylenol and Ibuprofren due to the counter interactions of Paxlovid with high blood pressure medications. I did relapse and tested COVID-19 Positive for 19 days.
Pt recvd 1 dose of vax on 21APR92 & devel raised erythematous pruritic rash which covered most of body;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient described feeling dizzy about 15 min after the vaccine. We had her lie down, offered her water & gatorade, monitored her. We took her BP and heart rate. We asked her if she could breathe- she said she could breathe ok. BP was 135/85 and heart rate was 79bpm which was normal. We had her continue lying down and complained that she was feeling worse after another 15min and wanted us to call 911. We did, 911 showed up, took her vitals again which were normal. No hospitalization reqd.
extreme hyperness and jittery. Felt wired.  Symptoms calmed down after about 7 hours, but still jittery the next morning.
1st dose - same day -severe body aches in lower back where kidney & liver is located & stiffness in lower back, diarrhea, chills, fatigue, 2nd day- same symptoms but a added cough. Left arm swollen at injection site, red, itchy.  2nd dose- same day- dizziness, severe body chills, left leg ache near the hip & calf. 2nd day- same symptoms but fever 101.0 and shortness of breath. Left arm red and itchy at injection site.  3.Moderna Covid 19 vaccine EUA was used.
Itchy area all over left arm, that occurred the day of the shot and the next day. Then he was fine for 2 days, when he experienced more itchiness in the left arm and some chest pain/heaviness.
At the site of administration, it was red, warm to touch. Patient went to urgent care and they are treating her for cellulitis. They gave her an Rx for CLEOCIN 300mg.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (dose and route unspecified, lot # L010596 with expiration date of 06-APR-2017, lot # K016966 with expiration date of 06-APR-2017, lot # K016966 with expiration date of 10-MAY-2017). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
miscarriage; ovarian cysts/ovarian pain/dysmenorrhea; chronic migraines/headaches; chronic pelvic congestion syndrome; decreased or slow movements; The patient has been unable to engage in activities that a young person her age would normally enjoy; Her educational performance suffered; GERD; The patient endured difficult pregnancies thereafter; rash on her arm; chronic fatigue; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a 14-year-old female patient. Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On unknown dates, the patient was inoculated with the first, second and third doses of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, strength, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date, subsequently after receiving Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), the patient experienced a rash on her arm, decreased or slow movements, headaches, ovarian pain, dysmenorrhea, gastrointestinal problems such as gastrooesophageal reflux disease (GERD), chronic migraines, chronic fatigue, pelvic congestion, and she developed cysts on her ovaries. She was seen by multiple physicians and frequently visited the Emergency Room for these complaints. She suffered a miscarriage and endured difficult pregnancies (pregnancy disorder) thereafter. The first-time patient discovered that her injuries could have been caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was in February 2021. Furthermore, the patient had been unable to engage in activities that a young person her age would normally enjoy. She had suffered chronic fatigue and pain which made it difficult to function. Her educational performance suffered because of her symptoms and daily tasks became burdensome. Moreover, the patient suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering. The outcome of the event of the events was unknown. The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the events of abortion spontaneous, ovarian cysts, GERD, migraine, pelvic congestion, hypokinesia, pregnancy disorder, loss of personal independence in daily activities, educational problem, rash and fatigue were considered to be disabling events. The event of abortion spontaneous was determined to be medically significant event.
Chills / by the next day / had resolved; Headache / by the next day / had resolved; This case was reported by a consumer via call center representative and described the occurrence of chills in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2021 15:30, the patient received the 1st dose of Shingrix (intramuscular). On 1st July 2021 20:30, 5 hrs after receiving Shingrix, the patient experienced chills and headache. On 2nd July 2021, the outcome of the chills and headache were recovered/resolved.   It was unknown if the reporter considered the chills and headache to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for herself. The patient received 1st dose of Shingrix in her left arm and began to feel chills and developed a headache. The patient reported that the next day both symptoms were resolved and she was fine. The reporter did not gave permission to contact health care professional. The reporter did not consented to follow up.
Fever, chills, dizzy, passed out at school, nausea/vomiting
Red spots on his nose, a runny nose and cough reported by mom, starting a few days after shot, resolved spontaneously.
ADMINISTRATION ERROR We had our drive through influenza clinic.  We had volunteers helping in many spots. We administered a High Dose influenza vaccine to this 57 year old.  On 10-03-2022, she denied any adverse events or reactions.
This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection lot# reported as L048466 with expiration date 02-DEC-2017, lot# reported as L045955 with expiration date 17-NOV-2017, lot# L043624 with expiration date 03-NOV-2017 and lot# L048465 with expiration date 02-DEC-2017 (dose and route of administration were not reported). It was reported that vaccines were stored in temperature -7.8 degrees Celsius for 6 hours 47 minutes (also reported as previous temperature excursion), then stored in temperature -7.3 degrees Celsius for 2 hours, 58 minutes and then the back in range (also reported as the total time out of range was 9 hours, 45 minutes). No adverse effects were reported. The call was made because of data logger. Additional information has been requested.