chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had dormant lymph nodes from early childhood. After the vaccine, they have engorged with a lot of pain, severe headaches, swelling, and cold; Patient had dormant lymph nodes from early childhood. After the vaccine, they have engorged with a lot of pain, severe headaches, swelling, and cold; Patient had dormant lymph nodes from early childhood. After the vaccine, they have engorged with a lot of pain, severe headaches, swelling, and cold; Patient had dormant lymph nodes from early childhood. After the vaccine, they have engorged with a lot of pain, severe headaches, swelling, and cold; Patient had dormant lymph nodes from early childhood. After the vaccine, they have engorged with a lot of pain, severe headaches, swelling, and cold; This is a spontaneous report from a contactable consumer, the parent. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not reported) via an unspecified route of administration in the left arm on 24May2021 at 14:15 (at the age of 17-years-old) as a DOSE 1, SINGLE for COVID-19 immunisation. Medical history included lymph node disorder (reported as Patient had dormant lymph nodes from early childhood). The patient previously had penicillin for unknown indication and experienced penicillin allergy. The patient did not receive any medication within two weeks of vaccination. 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 four weeks prior to the vaccination. It was reported that patient had dormant lymph nodes from early childhood. On 26May2021 at 13:00, after the vaccine, they had engorged with a lot of pain, severe headaches, swelling, and cold. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.No therapeutic measures were taken as a result of the events.The clinical outcome of the events was not recovered. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient is a 13 year old male who presents to the office for pain of right axillae x 3 days, swelling of right axillae x 1 day. Pain began 24 hours after receiving first covid19 vaccination in right arm. He received pfizer vaccine. Clinical exam is notable for tenderness and swelling in right axialle, diffuse erythematous flat macular rash on right chest wall. Swelling of chest wall likely is adenitis possibly due to covid19 vaccination.
swelling, pain, and sensitivity in right side of collar bone as well as under arm that is getting progressively worse
Large area of swollen redness appeared 2 days after getting vaccinated. Was given acetaminophen 325 mg, to take 1 tab Q 6 hours and ice packs to apply TID.
Information has been received from a physician and a registered nurse concerning her four year old female, family member, with an allergy to sulfa, no illness at the time of vaccination and reported to be in "otherwise good health" who, at one year of age  on approximately 06/27/1997 was vaccinated with one dose of varicella vaccine. Subsequently, on approximately 05/17/2001, the pt developed a "ver severe case of chicken pox with approximately 50 lesions on the left leg" around a DTP and polio vaccine injection site given on 05/09/2001. The pt sought unspecified medical attention. The pt also developed cellulitis following vaccination with DTP, MMR and poliovaccine given concomitantly with tuberculin purified protein derivative. Follow-up info received from the physician indicated that the 50 pox lesions around the left thigh lasted 5-6 days, crusted over and resolved. The pt recovered on 05/24/2001. No further info is available.
Shot was given the MCV4 on 7-14-06; Foster mother did call md; pt. almost went to the ER but was monitored at home. Mom did inform her pediatrician.  Pt. had shortness of breath, sore throat, paleness, stomach cramps, weakness, dizziness, fast heartbeat,and a fever per foster mother. Foster mother reported this information to us on her next visit 4-27-07. She gave me permission to fill out this form. Mom believes it was the MCV4, not the Tdap that caused the symptoms.
Pt. seen in pediatric clinic for silver dollar size area on right thigh/vastus lat. of redness, warmth, swelling and small pea size nodules x 3 palpated in that location. Father reports became noticeable the day before on 6/2. Pt. was put on BACTRIM for 10 days for diagnosis of cellulitis. Provider called pt's mother today 6/6/16 and mom reports inflammation resolved, area has almost completely "healed" with only a bruise remaining. Pt. been tolerating ABT well.
Patient is a 66 year-old obese Caucasian male patient, with known medical history as stated below, presenting to the emergency department via air transport as a transfer for evaluation and treatment for progressive symptomatic COVID-19 disease.  He was noted to be hypoxic at 86% on RA at the OSH with easy recovery with application of O2 BNC.  His primary concern is that of a substantial and irritating cough.    Constitutional: Positive for chills and fatigue.  Respiratory: Positive for cough and shortness of breath. Negative for chest tightness.    Over the course of his admission, he had worsening respiratory status requiring higher levels of O2 in order to maintain goal saturations. He was admitted to the ICU on 9/12/21 because of his worsening respiratory status which required intubation.    After he was intubated, he continued to decline and required pressors to maintain his saturations. Family was called at this time to discuss goals of care and asked to come in given his worsening status. He was on maximum vent settings with persistent hypoxia and was unable to maintain MAP goal despite being on 3 pressors. He was made a DNR at this time and after family arrived, it was decided to pursue comfort care only and extubate.   Patient deceased
Headache, nausea, diarrhea, hot flashes, mild fever, loss of concentration/focus, fatigue, muscle aches. 12/23-1/9 (present)  2 virtual dr visits, recommended Tylenol and rest
Patient complaint of feeling lightheaded after injection, also reports headache. Vitals were checked today (8/28/13), BP-stable, temperature normal.
This was my second shot.  I did not have covid arm for the first, but I am experiencing that for my second dose.  I also had chills and tingling in my fingers and toes- it felt like frostbite- when I experienced chills.  For about 36 hours I seesawed between fever and chills, experienced nausea, headache, muscleaches, and fatigue.  I also had no appetite.  I am still  experiencing a rash and pain at the injection site.
Pt recv vax on 11/16/98; on 11/18/98 pt exp red vax site
This case was reported by a physician and described the occurrence of an injection site reaction in a pt who received DTAP (Infanrix) for prophylaxis. On an unspecified date, the pt received the 4th dose of Infanrix. At an unknown time post-immunization, the pt experienced an injection site reaction characterized by swelling, redness and itching. A healthcare professional was consulted regarding the events. The events resolved after an unspecified period of time. Comment: The reporter indicated that three subjects experienced these events following receipt of Infanrix Lot # DTPA594A2 for the fourth dose in the immunization series. However, the subjects are not presently identifiable.
Low grade fever, severe headache, chills, body aches, nausea, for 4 days
This spontaneous report as received from a physician refers to an 11 year old female patient. Concomitant conditions and other relevant medical history were not reported. The physician informed that the patient was vaccinated on an unspecified date in approximately 2011 (also reported as "when she was 9 years old") with the first dose of GARDASIL (intramuscular injection, dose 1, 1 DF, route, lot #, anatomical location not reported). Then the patient presented herself in office, on 08-SEP-2014, and received the second dose of GARDASIL (Intramuscular injection, dose 2, 1 DF, route, lot #, anatomical location not reported). No adverse effects reported. Additional information has been requested.
Zostavax arm - injection site warm to the touch/swollen to the size of a half dollar. Fluzone arm - injection shot slightly inflamed. Arm hot to the touch and growing in size. No systemic side effects/signs of anaphylaxis.
rash on the torso; canker sores; This case was reported by a consumer via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received Shingrix. On 5th December 2019, 3 days after receiving Shingrix, the patient experienced rash. In December 2019, the patient experienced aphthous stomatitis. On an unknown date, the outcome of the rash and aphthous stomatitis were unknown.   It was unknown if the reporter considered the rash and aphthous stomatitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that on monday bofore the day of reporting, the patient received Shingrix vaccine and in the morning after got out of shower on the day of reporting experienced rash. The patient reported that, at the time of reporting the rash was not itchy and painful. The patient asked, if it was common to develop a rash on the torso or canker sores after receiving the shot. Less than a week after vaccination, the patient experienced aphthous stomatitis. The patient reported that, would call to the physician if the symptoms worsen and did not care to give out that in formation online.
never received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in early 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The case was reported by the patient for herself. The age at vaccination was not applicable for this report. The patient never received the 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up.
On 10/1/01, pt had left neck stiffness; soreness at site of injection since 9/2/01 which is better now but still has some pain on left neck and upper shoulder. #2 given today. Pt also had TB skin test ID in the RA, 1 previously.
The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; This spontaneous report was received from a nurse, referring to a child patient between 1 and 2-year-old of an unknown gender. The patient's pertinent medical history, previous drug reactions, allergies, or concomitant medications were unknown by the reporter.  On an unspecified date, the child was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, 1 dose administered subcutaneously, as "routine vaccination" (lot number S027459 which has been verified to be valid, expiration date reported and validated as 02-MAR-2021) (vaccination scheme and anatomical site of injection were not reported).  On an unspecified date (also reported as "within 1-10 days of administration"), the patient experienced fever (pyrexia) and rash. According to the nurse, it could be chickenpox (varicella). The patient sought medical attention, however, no treatment was given for the events and the patient did not have any laboratory diagnostics or studies performed.   The outcome of the events pyrexia, rash and varicella was reported as recovered. The causal relationship between the abovementioned events and therapy with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) was not reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA001874: US-009507513-2007USA001872: US-009507513-2006USA008951:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL 9, (lot#, expiration date, total dose and route unknown). The pharmacist reported that on an unknown date the patient may have delayed her second dose of GARDASIL 9 as she received a flu shot. No adverse effects were reported. No additional information is available. Additional information is not expected.
This spontaneous report as received from a pharmacist, via company representative, refers to few unspecified patients. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, strength, site and route of administration not reported). On an unknown date the patient experienced a welt approximately 1-2 inches in diameter around the injection site after receiving ZOSTAVAX. The outcome of event was unknown. The relatedness between ZOSTAVAX and event was not reported. This is one of two cases from the same reporter (other case MARRS # 1402USA003972). Additional information has been requested.
Covid; Covid; pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 16Aug2021 12:00 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Covid"; PNEUMONIA (medically significant), outcome "unknown", described as "pneumonia". The patient took shot and got Covid, Pneumonia 1 week later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from an office manager (medical assistant) refers to a patient of unknown age and gender. On 18-DEC-2013 the patient was vaccinated with the first dose of oral ROTATEQ. The oral ROTATEQ was improperly stored. It was exposed to temperature of 32F for 32 minutes on 02-DEC-2013, then 32F for 24 minutes on 03-DEC-2013, then on the same day 03-DEC-2013 at 31F for 8 minutes, then 33 F for 19 minutes on 04-DEC-2013, then 33 F for 34 minutes on 17-DEC-2013. No adverse effects reported. This is one of four reports received from the same reporter. Additional information has been requested.
Redness in arm at injection site with edema. Redness continues to increase at least 4x3 area at the moment
2hr p/vax child was gasping for air;to ER by amb;adm overnight (prev had a gasping episode-a couple of weeks before shots);family Md thought it was from shot @ that time;
2 weeks after booster, EXTREME ITCHING all over body and  Red blotches,  lines and streaks all over body randomly coming and going in different spots.
a patient inadvertently received two doses of Fluzone Quadrivalent three weeks apart/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via Medical Information (MI) (reference number- 00296454) and transmitted to Sanofi on 01-Oct-2020.  This case involves a 18 months old female patient who inadvertently received two doses of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] 0.5 mL prefilled syringe on 09-Sep-2020 lot number and expiry date not reported via an unknown route and site and then another dose (0.5 mL prefilled syringe, lot number: UJ427AB, expiry date: 30-Jun-2021) via an intramuscular route in the left thigh on 29-Sep-2020 three weeks later (extra dose administered) for prophylactic vaccination.  The patient's past vaccinations included FLU vaccine in 2019 with 2 doses spaced appropriately.  The patient's medical history, medical treatments and family history were not provided.  Patient received no concomitant vaccinations.  It was an actual medication error case due to extra dose administered (latency: same day).  The patient did not experience any adverse effects but she had not talked to the mother on 01-Oct-2020.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the lot number for this case.
pulmonary sarcoidosis; This is a spontaneous report from a contactable consumer from medical information team for a Pfizer sponsored program (005570). A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), administration date May2021 as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COMIRNATY (first dose), administration date: Apr2021, for covid-19 immunisation. The following information was reported: pulmonary sarcoidosis (medically significant) with onset Sep2021, outcome "unknown", described as "pulmonary sarcoidosis". Patient had the Pfizer 2 dose Covid-19 vaccine in Apr2021 and May2021. By September, patient noticed trouble swallowing, talking, and breathing. After several CT scans, doctors had determined that patient had pulmonary sarcoidosis. It's patient belief that this diagnosis was directly related to the vaccine. Patient asked if there had been any other such reports of these side effects.  The lot number for bnt162b2 was not provided and will be requested during follow up.
After her observation she returned and grabbed neck stated hard to swallow and tight   positive cough and hives   1 amp epinephrine given and had to repeat as symptoms came back  then 911 called
Systemic: Exhaustion / Lethargy-Severe, Systemic: SHINGLES-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe
Pt lost vaccination card and asked us to make a new one. After giving her a Pfizer vaccine, it was realized that she received Moderna for her 1st dose. Pt had no complaints and left after 30 minutes of observation.  Patient Name: If needing medical record, please contact via email:
Acute shoulder pain in the arm vaccine was received. Evaluated by 2 different Orthopaedics - both with same diagnosis- brachial neuritis
Patient developed swelling of the right lower extremity 2 days after receiving her second dose of Covid-19 vaccination (Moderna per patient report). Evaluated for this issue 4 days after onset of symptoms, ultrasound showed DVT of RLE.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (administered after 30-day use-by-date) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 027H21B) for COVID-19 immunization. No medical history reported. On Feb 21, 2022, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 21, 2022, patient administered expired product (administered after 30-day use-by-date). At the time of the report, administered expired product (administered after 30-day use-by-date) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Beyond-use-date of the vaccine was Jan 16, 2022. The vial (initially stored in the refrigerator on Dec 17, 2021) did not undergo any temperature excursion.
mom gave APAP immed following & q 4 hrs x ? days when awake; pt took nap upon arriving home woke up crying; cont to cry for 7 days; MD felt pt had poss react to DTP;
We had asked for the Pfizer 6mo-5 year Covid vaccine. Instead we were given the Moderna Covid vaccine. Patient experienced  vomiting,  joint stiffness, swollen groin lymph nodes
Headache, Rhinitis, Sneezing, Body Aches, Odd Back Ache continuing through today
w/in 3-5min of vax devel a single hive @ the inj site;PMD ordered cool compresses & DPH;
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified date, the RECOMBIVAX HB had a temperature excursion of 48 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". On 21-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10 Pk 5mcg/0.5ml SDLLokCap Ped" which had a lot number of K018986 and expiration date on 03-APR-2016 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
None. Pt was given a DTaP and Pediarix in error; should have received only Pediarix.
partially torn tendon, bursitis, and tendonopathy in left shoulder as diagnosed per MRI ordered by physician on 8/29/22 (Dr. D.O.)
Patient reported for second dose of Moderna vaccine. Pfizer was administered by mistake. No adverse events reported by patient to date.
Within 15 seconds after Gardasil injection, client began jerking, fell forward and slumped to floor, loosing consciousness for approx. 20 seconds.  Client was positioned on floor with head on pillow and legs elevated and 911 called. Upon regaining consciousness, alert and oriented, talking, no memory of incident.  EMS evaluated and gave grandmother option to transport to Trinity ED.