chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 06-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N014759, expiration date 08-NOV-2017 (strength, dose and route of administration were not reported) for prophylaxis. It was reported that PROQUAD was reconstituted with properly stored sterile diluent (MERCK) lot number N011475, expiration date 08-AUG-2019. The temperature of excursion with PROQUAD was 15 to 46 Fahrenheit degrees during 11 hours and 30 minutes. Previous temperature of excursion was 15 to 46 Fahrenheit degrees for 12 hours and 45 minutes. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1711USA006081: US-009507513-1711USA006110.
Pediarix given instead of Boostrix; Pediarix given to a 14-year-old; Extra dose of DTaP, Hepatitis B and IPV; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 14-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date 15th April 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Kinrix (received dose in 2014), Pediarix (received dose in 2008), Pentacel (received dose in 2009), Dtap vaccine (received dose in 2009), Dtap vaccine (received dose in 2011), Polio vaccine (received 4 doses) and hepatitis B vaccine (received 3 doses).   On 1st March 2023, the patient received Pediarix. On an unknown date, the patient started Pediarix Pre-Filled Syringe Device. On 1st March 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 2-Mar-2023 Reporter's Comments:  HCP called in to report that a 14-year-old patient was incorrectly given a dose of Pediarix when they were scheduled for a dose of Boostrix.  The healthcare provider gave information about the dose and patient. They accepted to be escalated to second line.  Previous vaccination mentioned were Kinrix 2014, Pediarix 2008, Pentacel 2009, 2 Dtap in 2009 and 2011, being a total of 5 Dtap.  Other vaccines include 4 doses Polio and 3 hepatitis B. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patients received Pediarix vaccine, which led to wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered.; Sender's Comments:  US-GSK-US2023034000:Same reporter
Initial and follow-up information has been received from the Merck Pregnancy Registry via a nurse practitioner concerning a 17 year old female who on 26-JUL-2007 was vaccinated with a third dose of GARDASIL.  Subsequently, the patient became pregnant.  The patient's last menstrual period was on 15-Jun-2007 and the estimated date of delivery is 21-Mar-2008.  No adverse reactions were reported.  In August 2007 the patient had an elective termination.  At the time of the report the patient's outcome was unknown.  Upon internal review elective termination was considered to be an other important medical event.  Additional information has been requested.
Tdap (Adacel) Administered 2.11.08, client reports had the shot in A.m. by 2Pm some redness left upper arm; by 5Pm. and that evening pain of entire arm and redness with white spot in center of hand left, it was difficult for her to use the arm. Saw M.D.'s nurse 2Pm. on 2-11-08 told to take Tylenlol and apply ice compress. 2-12-08 5 P.M. phoned client - says still red and swollen left arm.
My daughter fainted and was taken to the ER to be monitored, after going home she began with a fever... this is the day after receiving her rd HPV shot... not sre what other symptoms may arise... too soon to tell.  7/21/09 ER records received DOS 6/2/09. Assessment: Transient loss of consciousness. Patient presents with syncope. Was taking hot shower and felt light headed. Fell, took about 60 seconds to be fully alert, had not eaten. Headache. Dizziness and loss of consciousness.
Pt. states that after receiving the 2nd dose of Phizer 04/22/2021, started to experience symptoms 11/2021 of Memory loss. Primary visit 11/2021, no recommendations. Pt. still experiencing symptoms.
I developed a pulmonary embolism 9 days after getting the vaccine. I had to be hospitalized and was on IV blood thinners and discharged and have to remain on blood thinners the rest of my life.
vomiting; chills; dehydration; elevated blood pressure; slow heart beat; dizziness; shortness of breath; localized abdominal pain; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix (intramuscular). In July 2020, 2 days after receiving Shingrix, the patient experienced vomiting, chills, dehydration, increased blood pressure, heart rate decreased, abdominal pain localized, dizziness and shortness of breath. On an unknown date, the outcome of the vomiting, chills, dehydration, increased blood pressure, heart rate decreased, abdominal pain localized, dizziness and shortness of breath were recovered/resolved.   It was unknown if the reporter considered the vomiting, chills, dehydration, increased blood pressure, heart rate decreased, abdominal pain localized, dizziness and shortness of breath to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the female patient received the 1st dose of Shingrix in July 2020, and 2 days after the vaccination patient experienced vomiting, chills, dehydration, elevated blood pressure, slow heart beat, which lasted 2- 3 days and resolved.         The patient reports localized abdominal pain, which lasted for 1 week and resolved. The reporter consented to follow up.
DELUSIONS; BODY PAIN; HIGH FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included pericarditis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) 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 delusions, body pain, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, delusions and body pain was not reported. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a 55 years old female patient. She had no pertinent medical history and no known allergies. On 24-APR-2015, the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous in the left arm, lot # K020185 and expiry: 27-JAN-2016. There was no concomitant medication. On an unknown date in April 2015, the patient experiened redness and itchiness at the injection site of her left arm. Apart from that, the patient was in the sun on approximately 25-APR-2015 (reported as "on Saturday afternoon") and suspected that due to sun exposure she was also experiencing tingling of her finer (in April 2015). The patient sought medical attention and called the pharmacy. There was no treatment given and no lab diagnostic studies were performed. The outcome of the events was reported as not recovered/not resolved. Relatedness between the events and suspect vaccine was not specified. Additional information has been requested.
I received COVID and Flu injections around 10:40 am on 9/28/23. Ran errands. Arrived home at 1:30 pm. Went downstairs started laundry coming (2:00)upstairs was short of breathe, held rail to climb stairs. Around 3:30 pm went downstairs to move laundry once again short of breathe coming back up.  No appetite had soup at 6:00 pm. Took tylenol for arm pain. At 8:00 pm began to have burning pain on each side back upper spine area. At 10:00 pm went to bed was awaken at 2:00 am on 9/29/23 with burning pain from top of neck to middle back. Could not lay on back or left side. Attempted to sit-up and sleep. Friday morning struggle to get out of bed. Both feet hurt to walk and wobbled to bathroom. Right sore tonsil, voce was whisper. Wobbled to get around ALL day. Hurt to move arround or walk on Friday Feet were never painful before. Hand and fingers hurt/painful. Right Arm very sore and swollen.Rested and took Tylenol. Around 6 pm had a low grade fever of 99.1. Temp at 9 pm 99.1.. At 11 pm went to urinate would have chills for 30 minutes return ing to bed. this happened at 1 am, 3 am and 5 am on 9/30/23. Had slight headache pain in right side of head on Friday. Friday night had same on left side. Right arm now has soreness and itching.
About 30 minutes post vaccination the recipient complained of dizziness and lightheadedness. Recipient was evaluated by an on-site EMT who said vitals were normal with the exception of mild bradycardia.  Patient felt close to syncopal episode and so was transported by ambulance to hospital for observation.
In early Jan, he was seen in clinic and felt to have a mild contact dermatitis with rash restricted to lateral sides of chest and flanks. He was given some kenalog cream and 5 days of oral prednisone (10 mg per day) and he had complete resolution. He has not had a recurrence of this problem. He had no h/o atopic dermatitis or eczema in the past.  He received his primary smallpox vaccination on 30 January 2003 (3 jabs to right deltoid).  He did not develop any systemic symptoms and presented on 8 February for site check.  He reported no symptoms except for local itching and he had a major reaction manifest as some local redness, induration and a whitish blister.  He presented to clinic on 13 Feb for eval of rash in his groin. He stated onset of lesions was 3 days previous (10 Feb) but he denied pruritis, fevers, pain, or malaise. He has not been sexually active. Examination of his primary site revealed a nicely formed eschar. He had a significant macular-papular eruption of many lesions in his pubic area, some with early pustular formation.  There were a few scattered lesions over lower abd/supra-pubic area and at his proximal penis.  Because of extent of number of lesions, we thought this was more likely a regional vaccinia rather than an autoinoculation. However, we had seen about 10 cases of macular-papular rashes after vaccination, all resolved in a few days.  The patient returned for re-examination the next day (14 Feb), and lesions had already progressed to become more umbilicated and pustular.  Photos were taken. No treatment given since he was asymptomatic. He followed up in clinic on 23 Feb and lesions had formed scabs/eschars and it was apparent this was a regional vaccinia. On 26 Feb 03, he returned to clinic again. The initial pubic area lesions again revealed good scabs/eschars. In addition, there were a few newer lesions in the supra-pubic area and on proximal thighs. Patient reported intermittent b
Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 16:30 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received sulfamethoxazole (+) trimethoprim (BACTRIM) for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 19:30, the patient experienced sore throat. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported event. The clinical outcome of the sore throat was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient was asked about getting his Covid-19 vaccine  booster and  Medicare B prompted to ask about receiving flu vaccine.  He said he did not receive his flu shot yet and wanted it with the covid 19 vaccine. His wife called today saying he forgot he already received his flu shot in October.
Not eating, only wants water, lethargic, sleeping constantly, gait is unsteady, wobbly, blank stare, tired.
Information has been received from a physician concerning a 3 month old female who, "five weeks ago," on approximately 11-JAN-2007, was vaccinated with a first 2ml oral dose of ROTATEQ. In the "first week of February," on approximately 01-FEB-2007, the patient died of volvulus. At the time of the report the physician was still awaiting the autopsy report. Unspecified medical attention was sought. No product quality complaint was involved. The patient's experience was considered to be immediately life-threatening by the reporter. Additional information is not expected.  2/27/07 Received t/c from ME office with prelim COD:  1. Infarct of a major portion of the small intestine. 2. Obstruction by congenital fibrous band. Manner of death was natural.  6/5/07 Received Autopsy Report which reveals COD as infarct, major part of small intestine due to congenital obstructing fibrous band, 28 cm distal to the pylorus and 3 cm proximal to the ileocecal valve; and transmural hemorrhagic ischemis changes throughout the obstructed small bowel.  7/10/07-vac rec received.
Pt. experienced swelling at the site of injection, eyes, and lips. Blood glucose levels dropped. Feeling hot and experienced headaches.
flu-like symptoms; This is a spontaneous report from a contactable consumer or other non hcp received via Pfizer sponsored program COVAX Support. This case is for Female patient (wife). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06Apr2021 as single dose for covid-19 immunization. Reporter stated that she and her husband had their 1st dose of the Pfizer Covid-19 vaccine on 06Apr2021 and are scheduled to return tomorrow on 27Apr2021. Patient stated that however, they experienced mild flu-like symptoms, so she wants to know if it is okay for them to take the 2nd dose tomorrow. The outcome of the event flu-like symptoms was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
This spontaneous report as received from a consumer refers to her husband of 67 years old with allergy to fish. Her husband's medical history included rheumatoid arthritis and heart stent surgery about 3 to 4 years ago, for heart problems and methicillin-resistant Staphylococcus aureus (MRSA) infection 3 years ago. The patient's wife was vaccinated with a dose of ZOSTAVAX on 25-JUL-2012. It was reported that the patient started to complain of very bad groin pain, (reporter stated she thought her husband had a pulled muscle in his groin). In addition, her husband developed very painful muscle aches, and pains in his shoulders, arms, headache, low grade fever running about 99 F to 100 F, vomiting. He was very sick. Her husband went for office visit to the doctor this week on Monday but did not have a rash at that time. All kinds of test performed, full blood count (CBC Chemistry), cholesterol all with excellent outcome results. MRSA (methicillin-resistant Staphylococcus aureus) test was still pending results. She stated her husband now had the shingles rash on left thigh and groin area and it was very painful. Her husband was put on an unspecified antiviral medication but she stated the medication made him nauseous. The reporter stated her husband was not on any "immuno compromising medications for his rheumatoid arthritis, not on ENBREL or anything like that." Her husband was not hospitalized. Caller stated she did not expect to transmit the shingles virus to her husband. The outcome of the her husband was unknown. Additional information is not expected. This is one of reports from same source.
Swollen thigh, inability to walk for 12?15 hours, very upset. No treatment.  Ability to walk was regained by the next day.
Profuse sweating started about two hours after dose, then by the evening, arthritis pain everywhere in body.
pt recv vax 23SEP96 & 8MAY97 pt devel varicella consisting of greater than 50. also exp a temp of 103;pt recovered;
Child had some chest pain and SOB before getting vaccine starting approx. 11/16/2009. Vaccine given 11/16/2009. Within 2-3 days increased SOB,chest pain.Now has generalized severe body pain. Labs and CXR normal. Lab today is + for mono.12/17/09 seeing neurologist today and having MRI.Will have a diagnostic referral in January.
Immunization given 10-15-08 in clinic at phys. exam. No reaction W/N 20 min - left clinic RTC 10-16-08. Welts & rash randomly over arms, legs, throat and ABD (A+P). No SOB or fever. Rash is pruritic. Instructed to use Benadryl 25 mg PO q 4-6 hr.
Patient was given a PEDIARIX vaccine and a normal DTaP on 9-22-2008. No reaction.
tested for COVID and result came out positive/ body ache, fever, headache and cough; tested for COVID and result came out positive/ body ache, fever, headache and cough; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration, on 24Dec2020 at single dose as first dose, on left deltoid on 14Jan2021 as second dose at single dose to protect patient from COVID. Medical history included prediabetes and blood pressure high. Concomitant medication included metformin for prediabetes, losartan for blood pressure high. The patient's second vaccine (COVID 19 Vaccine) was just past this 14Jan2021. Then she had a lot of symptoms on 14Jan2021, the patient had like body ache, fever, headache and cough. The patient started to have suddenly with the side effects from the vaccine and then it was fine until yesterday and then she had to go in and get tested for COVID because she had never tested positive and her result came out this morning positive in Jan2021. The patient received Tylenol as treatment. The outcome of events was unknown.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the second vaccine dose and the event onset.
Feeling sick; Stored Vivotif incorrectly at room temperature for about 4 days; A spontaneous report was received from a pharmacist on 05AUG2022. It described a female patient (unknown age) who "stored Vivotif incorrectly at room temperature for about 4 days" (PT: Product storage error) and was "feeling sick" (PT: Malaise). The patient received the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient stored the Vivotif incorrectly at room temperature for about 4 days, then took the first and second dose of Vivotif on an unknown date. Reportedly, she was feeling sick after taking Vivotif. The outcome of the reported events was unknown.  Action taken with Vivotif with respect to "stored Vivotif incorrectly at room temperature for about 4 days" was not applicable and with the event of "feeling sick" was unknown.  Reportedly the reporter did not have any additional information.  Company comment: A consumer stored Vivotif incorrectly at room temperature for about 4 days (product storage error) and was feeling sick (malaise). Further information regarding the events is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of malaise is assessed as possible. Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non-serious as per medical assessment.; Sender's Comments: A consumer stored Vivotif incorrectly at room temperature for about 4 days (product storage error) and was feeling sick (malaise). Further information regarding the events is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of malaise is assessed as possible. Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non- serious as per medical assessment.
Approximately 3 days after I received my booster shot, I began experiencing painful enlarged lymph nodes  under both my arms and around my breasts. So large, I could move them around. I also was experiencing a lump above my left breast that was hard and painful. I could see it when it was inflamed. I took Aleve and the swelling/pain went down. I also used cold compresses and that helped. I am post-menopausal and I started experiencing heaviness and cramping ....like my period was getting ready to start. I never had any bleeding, but that feeling that I was getting ready to start was there. I had seen my OBGYN in September 2021 and everything was fine. He prescribes Activella for me, but I only need to take it PRN for hormonal symptoms (as per my OBGYN). So I've had to start taking that about every 4 days or so to ward off these "menstrual cramps".  Back to the lymph nodes: they would subside and then get inflamed on an irregular basis. I had a Mammogram in December 2021 and told the technician what was going on. She did not see any lymph nodes on my scans and my mammogram came back perfect. I still had this lump on the upper left chest (above my breast). I made an appointment with my primary care provider, 1/13/22. She ordered blood work and an ultrasound. I had the ultrasound on 1/14/22. The results came back as a non-vascularized lipoma. I NEVER had anything like this until after my booster shot.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient experienced spotty vision and mild light-headedness for roughly 5-10 minutes.
Patient developed a rash on the inside of her arm about 2 inches underneath the armpit.