chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a parent of a patient (consumer) on 12 October 2006. A 16 year old, female patient experienced pain, redness and swelling at the injection site, 102F fever, headache, muscle aches, joint pain, nausea and vomiting, 4 hours after she received Imovax (lot number Z0401-1) intramuscularly in the right deltoid on 17 September 2006. The reporter stated the signs and symptoms became worse with each dose and now the patient had acid reflux and bilateral bursitis of both hips. At the time of the report, the patient had not recovered. The patient received previous doses of Imovax (lot number not provided, intramuscularly in the left deltoid on 27 August 2006, Imovax (lot number Z0316-2) intramuscularly in the right deltoid on 27 August 2006, Imovax (lot number Z0316-2) intramuscularly in the left deltoid on 03 September 2006. Follow up information received on 12 December 2006 from the mother. The patient was exposed to a bat. Per the mother, the patient is still experiencing injection site redness, and the injection site is hot, swollen, and extremely painful where the patient received the first RIG and Imovax injection on 20 August 2006 (bilateral gluteal region). The patient is having difficulty walking and bending her legs. She has lost approximately 20 pounds since beginning the rabies post exposure series, due to constant nausea and vomiting. She is now taking Nexium daily. The patient was prescribed Celebrex for two weeks with no relief. The patient had been attending physical therapy for the past month with no relief from the pain. The patients physician was trying to rule out trochanter bursitis, and the patient is to follow up with her physician on 14 December 2006. MRIs and X rays were performed and were unremarkable. The patient's rabies vaccine schedule was as follows Imovax and RIG, lot number not available, administered on 20 August 2006. Imovax, lot number not available, administered on 23 August 2006 (not 27 August 2006 as previously reported), Imovax, lot number Z0316, administered on 27 August 2006. Imovax lot number Z0316, administered on 03 September 2006. Imovax lot number Z0401-1, administered on 17 September 2006. This case has the same reporter as case 200602767.  11/27/2007 MR received from rheumatologist for OVs beginning 4/19/2007 to 11/5/2007 with working DX: spondyloarthropathy.  Pt reports 7 month hx of  hip and back pain beginning 9/2006.  Pain is constant, worse at night, interfering with sleep and worsening. PE (+) for tenderness at both trochanteric bursa and SI joints. Decreased flexion and abduction with pain on both hips R>L. Increasing trochanteric bursitis and SI pain noted 8/30/07 with some pain relief from meds.  Knee pain noted 10/5/07  dx: peripatellar tendinitis.
FLUBLOK QUADRIVALENT was administered to a 17 year old male/no AE; Initial information received on 03-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old male patient who was vaccinated with 0.5 mL INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (batch number and expiry date not reported) via unknown route in unknown administration site on an unknown date for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  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 and Module VI of the 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.  There will be no information available on batch number for this case.
Developed Guillain-Barre Syndrome following second dose of Pfizer COVID-19 vaccine. Within 12 hours of vaccination, I developed a strong fever, body aches, and fatigue. These acute symptoms resolved within 24-36 hours. In the days following that I had increasing dizziness, ringing in the ears, and a sense of lethargy. Within 5 days of vaccination, I had a 2 inch by 2 inch area of total numbness, on my left arm below the injection site. On the twelfth day I developed rapid-onset muscle weakness in both legs, with progressive loss of sensation, pins and needles, tingling, and muscle twitching. Over the next two days these symptoms progressed upwards to my torso, arms, neck, jaw, and scalp. Autonomic nervous system was also affected, with fluctuating blood pressure, and strange sensations in chest. Muscle symptoms peaked three days after initial onset of weakness in legs, and I never lost the ability to walk or move, and never required hospitalization. But there has been a slow and fluctuating recovery over the following 6 months, with gradual improvement of symptoms, but not yet a complete resolution.
It was reported that a 68 year old female patient received a Fluzone SV '01 -'02 vaccination, lot #UO677AA in her right deltoid on 08/11/01. Approximately thirty minutes, later she came back to the clinic with severe right shoulder pain radiating to her elbow. The RN recommended a warm pack and Tylenol. Further information is requested.
Rash started 3/13,  stuffy nose, congestion cough, sneezing on 3/14, rash progressively got worse. Small, red itchy bumps all over arms, chest, shoulders, back. Very itchy.
On April 4, 2021 I was admitted to the hospital for multiple blood clots in both of my lungs.
Approx. 24 hours, post vax, pt developed temperature of 104F. Motrin given and temperature decreased to 100F. Mother states is giving every 4 to 6 hours. When Motrin wears off, temperature increases again. Has been going on X 4 days. Call to mother on 4/1/01, said pt ill X 2 days and temperature did not exceed 104.9F.
The patient received the flu vaccine at 10 AM. Patient reported no previous reactions to flu shot other than localized redness/swelling. Patient advised to check in 20 minutes post vaccine. Patient had shortness of breath and hypertension about 10 minutes following the vaccine. Patient has an underlying disease state of Lupus, has had anaphylaxis due to antibiotics in the past. Patient self-administered EPI-PEN that is carried at 10:22 AM, 911 was called. Nurses monitor vitals and remained with the patient as pressure improved. Vitals at 10:25 AM - BP 160/90 and Pulse 72; 10:28 AM - BP 122/80 and Pulse 88; 10:30 AM - BP not taken, Pulse 82. At 10:28 paramedics arrived and was transported to hospital.
Swelling (lt) deltoid area with redness 1 1/2-2" circular & painful.
Mother sts. pt. started having some redness to (L) arm 10/20/08 p.m. increased redness swelling on 10/21/08 - 10/22/08 warm to touch swollen across bicep of (L) arm with white ring took pt. to ER @ 2:30 pm on 10/22/08 - Given SEPTRA susp bid.
Diarrhea; Pfizer Covid Vaccine Dose and Moderna Covid Vaccine Dose both administered on the same day, 21APR2021.; This is a spontaneous report from a contactable other healthcare professional.   A contactable other healthcare professional (Pharmacy technician calling on behalf of the pharmacist) reported for a 38-year-old male patient that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0161, Expiry date: 26May2021) via an unspecified route of administration on 21Apr2021 at 19:00 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration from 21Apr2021 at 19:30 (Lot number was not reported, Batch number: 002C21A, Expiry date: 14Oct2021) to 21Apr2021 19:30, at dose 1, single for covid-19 immunisation (NDC# 80777027399). The patient medical history was not reported. Concomitant medications included gabapentin (GABAPENTIN) and pramipexole (PRAMIPEXOLE) taken for unspecified indications, start and stop dates were not reported. On 21Apr2021, the patient experienced diarrhea and Pfizer covid vaccine dose and Moderna covid vaccine dose both administered on the same day, 21Apr2021. No investigation assessment. No treatments. Caller states they had an instance where a patient received a dose of the Pfizer vaccine and Moderna vaccine dose on the same day and enquired if there were any adverse reactions to look for or any steps they need to take. No history of previous immunization with the Pfizer vaccine considered as suspect. States he may have gone to the doctors office because he needed refills for his medication but she was unsure. No ER or physician office visit. Additional vaccines administered on same date of the Pfizer suspect was Moderna Covid Vaccine. No prior vaccinations (within 4 weeks). He did mark he had a reaction to vaccines before, nothing specific, just checked yes. Outcome was resolved on 22Apr2021 for event diarrhea and was unknown for the other event. The action taken in response to the events for covid-19 vaccine mrna (mrna 1273) was not applicable.  No follow up attempt are possible. No further Information is expected.
Received 1st Pfizer dose 3/25 Received 2nd Pfizer dose 4/6 Experienced light headache, nausea, sore at injection site for 1 day.
Patient received DTaP and IPV in left thigh on 2/27/07. She presented with 6-7cm erythema and induration in the left thigh on 2/28 and was given 1gm Rocephin and Cefzil. Six hours later, mother reported that the redness was increasing. She was hospitalized and treated with Rocephin, Clindamycin and Gentamycin. Erythema resolved in 4 days.  04/16/2007 MR received for a hospital admission of 2/28/07-3/4/07 for c/o increasing redness and swelling at the injection site on her left lateral thigh.  Area of redness, swelling and warmth increased despite initial IM Rocephin and po antibiotics.  Pt. vomited po antibiuotics.  Minimal diarrhea.  PE:  WNL except for obesity, vaginal erythema with a yeasty smell, and the 10x 18 cm area of erythema with swelling and heat.   Discharge DX:  Lower extremity Cellulitis status post vaccination administration. Obesity. History of heart murmur.  Vaginal candidiasis.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender who on 07-MAY-2015 was vaccinated with an expired dose of ZOSTAVAX (dose and route were not provided), lot # K003599 and expiration date on 13-MAR-2015. No adverse effects reported. Additional information has been requested.
A 13-year-old female patient at the end of the immunization began to feel dizzy and sweaty. Following this event, he was sent to the observation and treatment area.
This report describes swollen knees of a 40 year old male who received Lymerix. This report was received from the vaccinee, who is a physician. The vaccinee engaged in recreational running. He self-administered 3 injections of Lymerix; the 3rd was given 1 month, rather that 1 year, following the 2nd injection. Dates of vaccine administration, as well as, vaccine lot numbers, were not recalled by the vaccinee. Approx. 6 months, following the 3rd injection, he experienced the acute onset of bilateral knee pain. The pain soon progressed in intensity and prevented him from participating in recreational running. The pain was described as a diffuse aching' however, it never extended to the popliteal fossa, did not radiate, and did not affect other joints. It sometimes localized deep to the patellas. The knee pain worsened with activity, but there was no diurnal variation in the severity or character of the pain. No erythema was noted. "Slight" intermittent local warmth was noted around the anterior aspect of the left knee. He reported that there had been slight swelling of both knees, but no effusions had been noted. He did not experience fever, morning stiffness, or constitutional symptoms. The vaccinee had not been evaluated by a physician other than himself. Bilateral knee x-rays were reportedly normal. No lab evaluations were performed. The vaccinee treated himself with rofecoxib (Vioxx), celecoxib (Celebrex) and Glucosamine; Glucosamine therapy was continued for over a year. None of the treatments were affective and the bilateral knee swelling, pain, and warmth persisted as of 7/13/01. The adverse events of knee swelling, pain and warmth do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the 6/28/00, letter. Additonal info was received on 07/24/2001. Although the vaccinee denied pre-existing arthritis when reporting his symptoms, he said that he experienced an increase in arthritis symptoms following receipt of LYMErix. The vaccinee told the manufacturer that he had not been evaluated by a physician other than himself, but he told the other manuf. tha the had "sought unspecified medical attention. No outcome was provided.
The day after I had my injection I had a very bad headache and body aches. I also developed a very hard hot spot around the injection site that was about 7 in long and 4 in wide.
pain; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 06Apr2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 06Apr2021 20:00, outcome "unknown", described as "pain". Additional Information: After receiving the 2nd dose of the Pfizer COVID Vaccine, patient exhibited symptoms last night before the call at 8pm. Patient is asking what medication he can take for the pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Myalgia, Arthralgia, Fever, fatigue, sore throat Narrative:
This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Feb2021 09:45 (Batch/Lot Number: EN6206) as 1st dose, single dose for COVID-19 immunization.Medical history included insomnia (will take something to help her sleep if she has trouble sleeping, but does not take any regular medications and was a healthy person).The patient concomitant medications were not reported. There was no prior vaccinations within 4 weeks. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 15 Mar 2021 (Batch/Lot Number: EN6206) as 2 nd dose, single dose for covid-19 immunization. The patient reported that she got the 2 shots of the COVID-19 vaccine. On 22Feb2021, after vaccination on same day the patient had severe pain in left arm (started the same day that she received the first dose of the COVID-19 vaccine). The pain has gotten worse, and she would like to know how long she can expect for this continue. The patient was really athletic and does a lot of sports but cannot do many things because of the pain in her left arm. The patient reported that whoever gave her the first dose of the COVID-19 vaccine said that the needle was defective and maybe this was the cause of the pain. Caller reported that she asked whoever gave her the first dose of the COVID-19 vaccine if the shot was still effective and the individual informed her that all the vaccine material was administered to the caller. It was reported that, she knew that when the nurse gave her the shot for the first dose of the COVID-19 vaccine, something happened there and when she took it out, she said the needle was defective to the person standing next to her administering vaccines. It was reported that after a couple weeks of her arm hurting, she talked with her doctor, her doctor said that the arm pain was better than COVID-19 and that it will go away, but the arm pain has continued. Her physician referred her to physical therapy, but she has not started physical therapy yet as she needs to call to make an appointment. Caller reported that she cannot sleep on her left side because her arm was so painful. She does not have any position that she can sleep on her left side and she was a side sleeper and cannot sleep on her left because her arm was too painful. Caller reported that she was vaccinated not to get the disease. The outcome of event severe pain in left arm was not resolved. The outcome of event the needle was defective was unknown.
Slight headache; Chills; 101.6 degree fever; Dose number 3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2 (BNT162B2), administered in right arm, administration date 29Dec2021 at 12:30 (Lot number: FD7218) at the age of 59 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: None; Known allergies: No. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EP7534; Administration location: Right arm), administration date: 01Apr2021, when the patient was 58 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: ER8734; Administration location: Right arm), administration date: 22Apr2021, when the patient was 58 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021 at 12:30, outcome "unknown", described as "Dose number 3"; HEADACHE (non-serious) with onset 30Dec2021 at 00:15, outcome "recovered" (30Dec2021 at 08:15), described as "Slight headache"; CHILLS (non-serious) with onset 30Dec2021 at 00:15, outcome "recovered" (an unknown date in Dec2021), described as "Chills"; PYREXIA (non-serious) with onset 30Dec2021 at 00:15, outcome "recovered" (an unknown date in Dec2021), described as "101.6 degree fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, chills and pyrexia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Commencing approximately 12 hours after receiving dose began having chills and slight headache and then within an hour had a 101.6-degree fever, the fever and chills lasted several hours and started to wane. The headache lasted 8 hours. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
This non-serious medically confirmed spontaneous report (initial receipt 20-OCT-2014) concerns a male patient. On 20-OCT-2014, the patient received excursion AFLURIA (batch number T51608). It was reported that a total of 5 boxes of AFLURIA pre-filled syringes were kept in the fridge and the temperature gauge was knocked over and red 47 degree Fahrenheit for 12 hours. Three excursion vaccines were administered. (Refer to cases 2014045852 and 2014045856). Outcome was not reported. Reporter's comments: The reporter believed that the patient was fine.
Information has been received from a Registered Nurse (R.N) and a Physician for the pregnancy registry for GARDASIL concerning a 17 year old female patient who was a heavy smoker, with anemia during her pregnancy which was treated with oral iron supplements who in March 2008 (also reported as almost 2 years ago) was vaccinated with the first dose of GARDASIL (Lot # not reported). Concomitant therapy included prenatal vitamins (unspecified) and FLUVIRIN. It was reported that the patient became pregnant. The patient's last menstrual period (LMP) was 10-SEP-2008 and her estimated date of delivery (EDD) by LMP was 17-JUN-2009, however was corrected to 08-JUN-2009 by early ultrasound. On 01-JUN-2009 (at 39 weeks gestation) the patient delivered a female neonate weighing 2690 gm/5lb and 15 ounces by C-section for non-reassuring fetal heart rate. The patient tested positive for group B strep and was treated with intravenous ((IV) antibiotics (name not provided) during labor. The baby's apgar scores were 7 at one minute, 8 at five minute and 9 at ten minute. It was reported that two days after birth, prior to discharge home, the baby was transferred to a Neonatal Intensive Care Unit (NICU) for a seizure like episode (not further specified). The physician did not have any record of the baby's exact or final diagnosis. He did note that the baby was not hospitalized for a long period of time and did not believe she was on any medication. The patient's last menstrual period was on 10-SEP-2008 and her estimated delivery date was on 08-JUN-2009 which was corrected by early ultrasound. Upon internal review, C-section for non reassuring fetal heart rate was considered to be an other important medical event.  Additional information has been requested.
Parents mother states that shortly after first covid vaccine patient was experiencing headache, bilateral leg and arm pain. Mother states that it worsened after the second dose given 10/18/2022.
Info has been received from a physician concerning a 17 month old white male, with no medical history and no allergies, who on 10/04/04, was vaccinated with a 1st SC dose, in the left arm of varicella virus vaccine live. It was noted that there was no illness at the time of vaccination. On 3/29/05, in the morning, the pt experienced 10 erythropapular vesicular lesions. The pt had 2 oral lesions and some on his trunk. It was reported that the pt had no fever and was not ill appearing. Additional info is not expected.