chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician assistant refers to a currently 34 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The patient had no known drug allergies or reactions. On an unknown date (reported as "when she was younger"), the patient was vaccinated with her first dose of MMR II, human serum albumin (HSA) (strength, dose, route of administration, lot # and expiration date were not reported). In June 1999, the patient was vaccinated with her second dose of MMR II (strength, dose, route of administration, lot # and expiration date were not reported) as routine vaccination. On an unknown date (reported as "a couple months ago"), the patient had "titers drawn" with a result "low for measles". The patient sought medical attention and was seen at unspecified facility. The outcome of the event was unknown. The relatedness between the adverse event and MMR II was not reported. Additional information has been requested.
The patient became dizzy immediately after the vaccine was given. His face was pale and he vomited.
Patient reports no reaction near injection site on arm, but swelling and inflammation near lips / cheek after injection about 5 hours after injection. Patient told to take a Benadryl if the swelling gets worse and if worsens further to seek urgent care. No reported breathing issues or throat swelling / closing.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfur" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received nirmatrelvir, ritonavir (PAXLOVID) from 07Mar2023 to 12Mar2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The father of a 3 year old male reported that his son received the 1st dose of Prevnar in June, 2000. Three to 7 days, post vax, the father reported that his son began to experience symptoms of nephrotic syndrome. The reporter also indicated that his son had not been taking prednisone for the past 6 months; however, the son began another course of prednisone due to proteinuria "just before" the vaccination.
Approximately 9 minutes after patient's vaccination she had a vasovagal episode and passed out for approximately 10-15 seconds.  Patient hit her head when she fell to the floor.  Patient placed on gurney and vitals were taken.  Denied any respiratory issues.  Complaining of nausea.  Patient had worked her first night shift and came after her shift to receive her injection.  Patient had stated she was very tired and was closing her eyes while she was waiting after her injection.  Patient had no recollection of passing out.  Complaining of head and neck pain.  BP 98/55, HR 55, 100% O2 sat on room air.  Patient transported to Emergency Department talking to staff.
About 18 minutes after receiving the vaccine, the patient collapsed on the elevator and was unresponsive for a couple minutes. He reported feeling dizzy and nauseated, and he appeared pale. His blood pressure was 103/69, and his heart rate was 52. Of note, he had not eaten breakfast, nor had any water to drink on the morning of the event. He was given apple juice and some crackers, and his symptoms resolved within about 20 minutes.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a physician administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the  ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
her arm was now red, swollen, hot to touch, and painful; her arm was now red, swollen, hot to touch, and painful; her arm was now red, swollen, hot to touch, and painful; her arm was now red, swollen, hot to touch, and painful; This is a spontaneous report from a contactable consumer (child of the patient) via medical information team.   A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection and Lot number was not reported) via an unspecified route of administration on 05Mar2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced her arm was now red, swollen, hot to touch, and painful. She wanted to know if it was normal. The outcome of events was unknown  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Patient received FLUZONE HIGH-DOSE on 9/19/2011. Then 2 days later developed rash throughout body, within time. The rash lasted a month. Patient used Triamcinolone cream and Fluocinonide cream to relieve rash. Patient says one of her doctor has ruled in that this rash is from FLUZONE HIGH-DOSE. Although patient never had any problems with regular dose flu vaccine before.
Symptoms: nasal congestion, sinus pressure, fatigue, and rhinitis - December 31. COVID test - negative  - symptoms lasted a day
Heavy bleeding during second trimester on multiple occasions. Ultrasound and other screening ruled out any other causes for bleeding. Estimated due date 8/14/21.
onset of inconsolable crying, screaming for 4 hr 1/2 hr p/shot given;
High fever Chills and sweats Rash - neck, face, arms, trunk Fatigue
no adverse event; PROQUAD had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 23-AUG-2023, the patient was vaccinated with a 0.5 mL dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # X011437 exp date 18-JUL-2024) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Information has been received from a physician and an office manager concerning a 34 year old female patient who, on 19-JUN-2008, was vaccinated with her first dose of GARDASIL (Lot # 0152X, expire date 09-NOV-2009 and route not reported) in her left deltoid. On 19-AUG-2008, the patient was vaccinated with the second dose of GARDASIL (Lot # 0152X, expire date 09-NOV-2009 and route not reported) in her left deltoid and on 22-DEC-2008, the patient was vaccinated with the third dose of GARDASIL (Lot #, expire date and route not reported) in her left deltoid. The physician reported that the patient while on GARDASIL, had a "weird vaginal discharge". Also the office manager reported that the patient had had chronic vaginitis since receiving GARDASIL (on approximately 19-JUN-2008). The patient did not seek medical attention. At the time of the report, the outcome of the patient was unknown. Follow up information has been received from a physician who indicated that the patient received three doses of GARDASIL between June 2008 and December 2008 on her request, as she was 35 years old at that time (34 years old when receiving first dose). In December 2008 the patient began having chronic heavy discharge that had been resistant to all treatment. No cultures were positive. The physician suspected that the vaccine may have had triggered some type of exaggerated immune or inflammatory response. Multiple cultures and exams had been performed by specialists (results not provided). At the time of the report, the patient had not recovered. No further information is available.
Experienced Optic Neuritis on left eye. A dark brown film covered my left eye, which when looking at a person, I could not see their face and it was accompanied by a blurry peripheral view.  For 3 days, the brown film was light until it became darker and I could not see a person's face and lasted around 3 weeks.
heart rate wouldn't stay elevated all the time; it felt like butterflies in the chest; I missed 4 days of work due to this; I was nauseous during that time too; I was having twinges in my chest; after 30 minutes, my heart rate was at 129 beats per minute/it accelerated to 165 bpm overnight; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (I was having twinges in my chest), HEART RATE INCREASED (after 30 minutes, my heart rate was at 129 beats per minute/it accelerated to 165 bpm overnight), HEART RATE ABNORMAL (heart rate wouldn't stay elevated all the time), FEELING ABNORMAL (it felt like butterflies in the chest) and IMPAIRED WORK ABILITY (I missed 4 days of work due to this) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TOPIRAMATE, MONTELUKAST SODIUM (SINGULAIR), ASPIRIN [ACETYLSALICYLIC ACID] and VITAMINS NOS for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced CHEST PAIN (I was having twinges in my chest) and HEART RATE INCREASED (after 30 minutes, my heart rate was at 129 beats per minute/it accelerated to 165 bpm overnight). In April 2021, the patient experienced HEART RATE ABNORMAL (heart rate wouldn't stay elevated all the time), FEELING ABNORMAL (it felt like butterflies in the chest), IMPAIRED WORK ABILITY (I missed 4 days of work due to this) and NAUSEA (I was nauseous during that time too). In April 2021, CHEST PAIN (I was having twinges in my chest), HEART RATE INCREASED (after 30 minutes, my heart rate was at 129 beats per minute/it accelerated to 165 bpm overnight), HEART RATE ABNORMAL (heart rate wouldn't stay elevated all the time), FEELING ABNORMAL (it felt like butterflies in the chest), IMPAIRED WORK ABILITY (I missed 4 days of work due to this) and NAUSEA (I was nauseous during that time too) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mild hyperreactive airway (mild asthma)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 as anti viral product manufactured by Pfizer taken from 16Aug2022 to 20Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information in the case the reported events Drug ineffective and Covid 19 are assessed as related to suspect drug .
sweating; pain; redness; knot on arm; fever; fatigue; muscle fatigue; Mental Fatigue; flu-like symptoms; arm tenderness/ extreme arm soreness; headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th November 2019, the patient received Shingrix. On 27th November 2019, 1 days after receiving Shingrix, the patient experienced fatigue, muscle fatigue, mental fatigue, influenza-like symptoms, pain in arm and headache. On 28th November 2019, the patient experienced pain, erythema, local swelling and fever. On 29th November 2019, the patient experienced sweating. The patient was treated with paracetamol (Tylenol). On 29th November 2019, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the muscle fatigue, mental fatigue, influenza-like symptoms, pain in arm, headache, pain, erythema, local swelling, fever and sweating were recovered/resolved.   It was unknown if the reporter considered the fatigue, muscle fatigue, mental fatigue, influenza-like symptoms, pain in arm, headache, pain, erythema, local swelling, fever and sweating to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in the left deltoid. The patient took Tylenol 500 mg to treat the pain and fever. Two days after receiving Shingrix, the patient experienced pain, erythema, local swelling, fever and 3 days after experienced sweating. Extreme arm soreness 28th November 2019 On 29th November 2019, friday, the fatigue was gone, the arm soreness was about the same an the redness were not as bad as they were before. On Sunday, the arm was not tender and the redness was fading. Consent to follow up was provided
3 pts received a dose during the excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date 22nd April 2023) for prophylaxis.   On an unknown date, the patient received Boostrix .5 ml. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The reporter informed that their facility had a medication refrigerator excursion occur and patient received the Boostrix dose during excursion. The temperature range was from 35 degree F to 9.5 degree F and total duration was 11 hours. The reporter asked was this Boostrix vaccine was still viable. The vaccine was not a part of a prior temperature excursion. Additional Supportive Information: The patient received the Boostrix dose during excursion, which led to incorrect storage of drug. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR080983:Same Reporter US-GLAXOSMITHKLINE-US2022AMR081065:Same Reporter
Starting about 10 minutes after receiving the vaccine, I started feeling extremely tired. I went to get a smoothie and came home, and slept. The next day I slept. My arm was swollen, puffy and had heat coming out of it. I did the ice pack but it was so sore that I couldn't put the ice pack on it. Then, after the 3rd day I could do the ice pack. My arthritis was flaring up in the wrist, shoulder, hand and elbow. I developed muscle spasms in the back of the arm, front of the arm and the shoulder.
pt recv vax & devel palsy of the sixth nerve; sx included h/a, confusion, & double vision; The reporting MD indicated that the pt was referred by an internist, dx was based on taking the pt's hx & questioning the pt
Received ZOSTAVAX 5-30-14 at 12:30. Started itching that evening, increasingly over past 2 days, also swollen and erythematous (6 cm x 4 cm), warm to touch. No fever/chills, or body aches.
Patient woke up 07/24/21 morning complaining of right eye swollen, puffy, and pink. Swelling went down by 2pm, but orbital area remains very sore, with complaint of "achy eyeball". Patient has used ice packs to reduce swelling and relieve discomfort. Patient reports slight discoloration between right eye and nose. Patient reports left eye is a little sore, but not as bad as the right eye.
ON 6/1/2020 at 3pm PST,My arm were shot was administered was sore. On 6/2/20, 4am PST, I started having a fever and body aches. These persistent for at least 14 hours. I took 1 Excedrin  Around 6am PST but fever persisted, and I had body aches. Took another Excedrin at 10am. Took my temp at noon, it was 101*F. Still had body aches. Took 1 Tylenol at 5pm, And 1.5 hours later,  fever reduced to 100*F, lesser body aches. It is 7:15pm PST, feel less feverish and achy. Arm at shot location still hurts.
Patient said felt dizzy after shots. Sat down at the chair was given water . Said he did not eat, spoke with him later in the day and he said he felt better
Patient developed a 4 x 2" localized reaction on right leg characterized by redness and swelling.
This is a spontaneous report from a contactable consumer and from a contactable physician. A 65-year-old male patient received PREVNAR 13 via an unspecified route of administration in the arm at single dose on an unspecified date in Nov2015. Relevant medical history was not reported. Concomitant medications were none. The patient experienced that his shoulder was hurting and it has been aching for two months on an unspecified date in Nov2015 and sometimes it hurt him through down his hands on an unspecified date. No therapeutic measures were taken as result of the events. No admission to the hospital was required. The patient did not recover from the events. The physician confirmed the occurrence of both events: however, assessed that the PREVNAR 13 was not causally related to the events. Follow-up (01Mar2016): New information received from a contactable physician includes: suspect product (updated suspect product from PREVNAR to PREVNAR-13), case is medically confirmed, and causality (unrelated). Follow-up (02May2016): New information reported from a contactable consumer includes: onset of event shoulder pain, no treatment received for the events, no admission to the hospital. Follow-up attempts completed. No further information expected.
Six Days after began extreme shortness of breath.  Still continueing today seven days after last vaccine. waiting on call from Doctors office today
I had heavy cough, tight chest congestion, low-grade fever, and a headache after going to the beach with a friend a couple of days later. So I went to a local pharmacy on 10/31/2022 to take PCR COVID-19 test which came back positive. I used my breathing candy and sucked on ginger to help rebuild my immunity and get better. Later, my doctor just prescribed me albuterol to use my nebulizer for breathing treatments.
07:00 AM  six days later  12/24/2020  awoke with hives on the right side of face, neck,  and ended up spreading all over the face, neck,  patches  on belly and leg.  ER . ER treated with 40 IV  and  oral Prenazone  40 mg for three days 30, for three days then 10 for three days
VACCINE INJURY/VAXX INJURY; This spontaneous report received from a consumer 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 not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the subject experienced vaccine injury/vaxx injury. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine injury/vaxx injury was not reported. This report was non-serious.
Received Tetanus booster and Hep B shot at 4:30pm on Thursday June 4th.  Woke up at 5:30 June 5th very dizzy.  Called Dr.  He said to wait it out and if it got worst to come in.  He recommended a Benadryl.  I took a Benadryl around 8am.  With 2 hours symptoms disappeared.I don't know the manufacturer...maybe the Dr. would know.
Started having abdominal pain whenever having a bowel movement, fussy at breast, rectal prolapse. Still in the middle of treatment plan with GI doctor.
On 7JUN92 mom states pt had t103; began to give APAP states temp remained between 101 & 102, dec apetite & noted rash today 9JUN92; behind 1 ear, across top of back & forehead; pt was taken to MD dx ear infect & sore throat;
7cm x 12 cm redness and induration at left deltoid. Patient complains of itching. Treatment: Augmentin ES 1 tsp bid x 10 days. Warm compress , antihistamine.