chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin begin to peel; pinkish rash on the left deltoid and the upper left arm; Feel discomfort; This is a spontaneous report from a contactable healthcare professional via a Pfizer sales representative. A 67-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration in the left deltoid on 05Sep2019 at the age of 66 years at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2019, the patient began to feel discomfort following administration. Three to four days later, patient notice pinkish rash on the left deltoid and the upper left arm. Slowly faded away. The rash lasted through 17Sep2019 at which time the skin began to peel. There was no damage to the skin. Patient treated himself with ALLEVE and Prednisone for minor discomfort. The outcome of the event of pinkish rash on the left deltoid and the upper left arm was recovered on 17Sep2019 while unknown for the other events. The information on the batch number has been requested.
Myalgia, Arthralgia, Fever, NauseaVomiting, SORE ARM, STOMACH UPSET Narrative:
Could not sleep at all, up all night.  Had a headache and sore arm. She woke up at 3:30 am, 4:30 and 5:00  trying to get me up for work. I get up for work at 5:50.  At 5 :30 she said she was going into the truck to wait for me.  She came back into the house at 6:00 looking for my grandson, that does not live with us.  She was very disoriented and felt dizzy and lightheaded...I told her to go to bed and rest.
pt rcvd vax; pt devel maculpapular rash on upper arm & body;
Post herpetic neuralgia; Broke out in a painful rash on his stomach and back diagnosed with herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for prevention shingles. On an unspecified date, the patient broke out in rash on his stomach and back.  As a result the patient presented to a medical provider and was diagnosed with herpes zoster and postherpetic neuralgia. The patient continued to suffer the effect of these events.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
My son fell to the ground and had convulsions on the floor for about 10 seconds.  Then, for the next hour, he could not move his muscles and had slurred speech.
The patient had reddish rash at injection site. Patient also had a little fever and pain. Patient talked to his primary doctor over the phone and the doctor sent him antibiotic, Azithromycin 250mg pack.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown demographics. The patient was vaccinated with the first and second dose of GARDASIL about a year apart. No other co-suspects were reported. No concomitant medications were reported. Dosing details and the lot number were not specified for both. No adverse effects were reported. Additional information is not expected.
Red erythema on lower (L) arm below injection site. Occurred night of Flu shot. Currently has erythema (Red/Purple color) w/Heat, no pain, about 5 inches x 3 inches in size.
Redness at site began 3/18/18. The redness area increased in size on 3/19/18. Arm very sore, hardened, and somewhat swollen. On 3/20/18, 8 cm x 8 cm size of redness. More mottled looking.  3/21/18, still sore but no redness.
PATIENT CALLED OUR STORE TO REPORT HE WENT TO THE EMERGENCY ROOM REGARDING HIS LEFT ARM, WHICH HAD A RED, SWOLLEN SPOT FOLLOWING THE ADMINISTRATION OF 3 VACCINES ON THE 17TH. HE REPORTED THAT STAFF WAS UNDECIDED IF HE HAD AN INFECTION OR AN ALLERGIC REACTION.
Patient stated they had soreness on arm the following day near the fatty tissue area. Red blotches were form on top where shoulder was. No itchiness, just redness and sore.
Pt given quadracel at 18 months - vaccine meant for 4-6 years of age, No s/s at this time.
Chills, sweating, 102 fever, headache, body aches.  Fever went down with ibuprofen but would come back after 6 hours.  Lasted for about 24 hours.
Developed COVID symptoms 7/28/2021 and tested positive for COVID 08/11/2021
Angular cheilitis on both corners of "my" lips; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 19Apr2021, approximately 2-3 days after receiving the second dose, the patient suddenly had angular cheilitis on both corners of his lips. The patient never had this occur before in his life. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event angular cheilitis on both corners of "my" lips was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from the patient's mother and refers to her son (unknown age). The patient's current conditions, medical history and concomitant medications were not reported. On 08-APR-2016, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly. On 08-APR-2016, the patient experienced unspecified seizure moments after receiving his first dose of GARDASIL 9. Treatment was not given for adverse event (AE). The patient sought medical attention by contacting physician. Product quality complaint (PQC) was not involved. The outcome of the event was unknown. The reporter did not provide causal relationship between the event and suspect therapy. Upon internal review the event was considered as medically significant, serious. Additional information is not expected, as the reporter did not wish to be contacted further.
The patient developed chest pain and shortness of breath three days after vaccine administration on 2/21/22, and these symptoms progressed to significant chest pain prompting an ED visit early on 2/23/22 with subsequent admission to the hospital.
inadvertently gave Arexvy to a pregnant patient; Given to patient under 60 years of age; inadvertently gave Arexvy to a pregnant patient instead of Abrysvo; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: inadvertently gave Arexvy to a pregnant patient), inappropriate age at vaccine administration (Verbatim: Given to patient under 60 years of age) and wrong vaccine administered (Verbatim: inadvertently gave Arexvy to a pregnant patient instead of Abrysvo). The outcome of the vaccine exposure during pregnancy, inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt date: 02-NOV-2023 The pharmacist stated patient was around 45 years old.  The pharmacist stated a colleague inadvertently gave Arexvy to a pregnant patient instead of Abrysvo, which led to inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy. The pharmacist was not at work at the time of this call and did not had access to the patient chart, so details such as patient date of birth, vaccine information such as lot, and date of administration were not available.  The pharmacist consented to follow up from safety via postal.
Information has been received from a nurse practitioner concerning a 15 year old female who was vaccinated with the second dose of GARDASIL (lot # not reported) 0.5ml intramuscularly. Concomitant therapy included SUDAFED taken that morning. On 18-FEB-2009 "the patient got very pale, curled up into the fetal position, and fainted". Later on the patient was conscious and "lying on sofa" In the doctor's office. Patient sought unspecified medical attention. No lab diagnostics studies performed. Events improved after stopping therapy and reappeared after reintroduction. Additional information has been requested.
The pt noted that approx. 8-9 hours, post vax, a red finely dispersed rash on arms, abdomen, on back between shoulder blades, scalp and lower leg. She called ER and was instructed to take Benadryl 25mg po q 6 hours prn for rash/itching. Took at 21:00 on 10/23/01 and at 04:30 on 10/24/01. Reported incident to Employee Health at 11:00. Call to regular physician.
22w at time of 1st shot and 25w pregnant at time of 2nd shot. No issues with health, due date is Nov 27th. A week after 1st I had tachycardia in the morning 2 days in a row with shortness of breath. No treatment and did not see a Dr. About 16 hours after 2nd dose I had tachycardia  all day with shortness of breath and major fatigue. Later that evening I also had chills, mild headache and muscle fatigue in legs. No treatment and no dr seen. Next day I was fine but I am concerned about any heart related issues now. I have a cardiologist appt sept 28th.
Patient 38 year old female. was supposed to receive her bivalent booster. MA got confused and gave third dose of pfizer (Gray Cap). Pt already received first and second dose of pfizer (Purple Cap), on 5/5/21 and 5/26/21. Third dose of Pfizer given by MA instead of Bivalent Booster- Staff with Coaching of staff.   Outcome: Provider contacted patient and aware to return in 2 months for Covid Bivalent (Around 3/26/23)
soreness of the arm; a "lump" on the armpit of the arm; a swelling of her lymph node under the left arm pit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 21Nov2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness of the arm"; SWELLING (non-serious) with onset 28Nov2021, outcome "not recovered", described as "a "lump" on the armpit of the arm"; LYMPHADENOPATHY (non-serious) with onset 28Nov2021, outcome "not recovered", described as "a swelling of her lymph node under the left arm pit". Therapeutic measures were taken as a result of pain in extremity, swelling, lymphadenopathy.  Additional information: One week later on 28Nov2021 the patient experienced a "lump" on the armpit of the arm, she received the vaccine in along with soreness of the arm.  No follow-up attempts are possible. No further information is expected.
Within 10 minutes of receiving the Gardasil vaccination (she also received a flu shot in the other arm) patient said she felt like she was "going to pass out".  The nurse had patient lay down on the examination table and brought up the leg support.  Patient's eyes rolled back in her head, her legs twitched, and she stopped breathing.  She was unconscious for about 20 seconds.  When I started screaming that Patient was not breathing, the nurse called a code in the office.  Staff came with the equipment, but by that time patient had regained consciousness.  When she did "come to", patient felt that she was going to vomit.  She did not vomit, but remained very weak and had to be transported to the car by wheelchair, and was then assisted into the house by her older sister.  Patient slept for about 4 hours after the incident.
mild superficial cellulitis left upper arm. Ordered Keflex, TMC ointment 0.1%  and cool compresses
THIS IS THE PfiZYER VACCINE SHOT #2.   right arm very sore, lymph nodes in right arm and right groin area very sore, tongue tingling and feeling raw , sore throat, severe body tremors, very cold but no fever, very severe pain in upper left abdominal, shortness of breath due to pain, headache, fatigue, muscle pains
Arm hurt where injected for 48 hours after shot; Swollen lymph node; Painful under right arm after shot; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non- pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number; Er2613), via an unspecified route of administration in the right arm on 25Mar2021 at 16:15 (at the age of 28-years-old), as single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number; En6199), via an unspecified route of administration in right arm on 04Mar2021 at 16:15 (at the age of 28-years-old), as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 04:00, the patient experienced hurtful arm where injected for 48 hours after shot, swollen lymph node and painful under right arm after shot. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events vaccination site pain, swollen lymph node and armpit pain was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
On Sunday, September 18th, I started having clammy sweats during the day. At night at 2AM, I woke up with severe pain in my chest. It felt like my heart was being squeezed. I went to the emergency room and they did blood work and an EKG. They said I had not had a heart attack. I followed up with my doctor later on Wednesday the 21st and during that time, I was continuing to have a squeezing pain feeling around my heart. I was also having the clammy sweats and having shortness of breath. My doctor sent me to have an echocardiogram on the 22nd and that came back fine. There was no problems. On Monday the 26th, she had me go do a pulmonary CAT scan and I didn't have a blood clot. For the last two weeks, I have been resting and not doing a lot. It's been progressively getting better. At 1:30 today, I'm going to see an infectious disease specialist. They thought maybe I had torn a chest muscle from my Ehlers Danlos, but it didn't explain the clammy sweats throughout my body. We don't know if it's due to the vaccine since it was 10 days after or if it was long COVID, so I will be seeing the infectious disease specialist today. I'm getting better, but I still experience the clamminess and shortness of breath when doing certain activities. I've just been feeling weak and I feel like I don't have as much stamina.
Cellulitis of left leg Start clindamycin powder for reconstitution 75mg/5ml.
6 days p/vax pt started w/fever 101 & rash, & conjunctivitis;27MAY97 pt cont to devel new lesions for 5 days;rash covered entire body including ears, mouth, throat & vagina;pt was given bath used med for itching;
Patient received ANTRAX and Typhoid on 12 Mar 09. Smallpox on 19 Mar 2009. Patient found out this month that she was pregnant when she received the vaccines. States she had no problems at this point.
arm reactions; arm soreness; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (arm reactions) and PAIN IN EXTREMITY (arm soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (arm reactions) and PAIN IN EXTREMITY (arm soreness). At the time of the report, VACCINATION COMPLICATION (arm reactions) and PAIN IN EXTREMITY (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.
Case number PHEH2011US009359 is an initial spontaneous report received from a consumer on 10 Nov 2011. This case refers to a 71-year-old female patient. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into her left arm on 01 Oct 2011. She experienced pain approximately three hours after injection. She continued to have pain in left shoulder and arm at the time of this report although she had used BIO FREEZE, seen the chiropractor, etc. and still she had no relief and could not raise her arm comfortably. She stated that she had spoken to her treating physician about her symptoms.
Patient got a fever of 102.7 the afternoon of 2/19/2022. She was given a home Covid test and it was positive.  She was taken to Convenient Care and given an antigen test that came back negative but the PCR test was positive.
p/vax 8APR98 pt could not lift arms or close hands;this is the 1st time pt had these sx;they came & went p/vax;pt has been dx w/rheumatoid arthritis;
Severe swelling in right knee; unable to walk.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 19Mar2021 at 11:00 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history and allergies to medications or foods or other products were reported as no. Concomitant medications received within 2 weeks of vaccination included WELLBUTRIN, CRESTOR from an unknown date for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 00:00, the patient experienced severe swelling in right knee and unable to walk. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events severe swelling in right knee and unable to walk was resolving at the time of this report.  Information about lot/batch number cannot be obtained. No further information is expected.
tingling, numbness of whole lt side of body, unable to sleep lasted 2 days;
accidentally received an expired dose of ACTHIB with no adverse event reported; Initial information received on 10-Nov-2021 regarding an unsolicited valid  non-serious case received from a other health professional and non-healthcare professional via (Medical Information- 00852604).  This case involves a 4-months old male patient who was accidently vaccinated with expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On 09-Nov-2021, the patient received a second 0.5ml {total} dose of suspect HIB (PRP/T) VACCINE (lot number not reported and expiry date Oct-2021) via intramuscular route at an unknown administration site for prophylactic vaccination (also reported as administration site was thigh).  It was reported "Doctor asked if the dose should count as valid or if the patient should be re-vaccinated. Doctor states that he does not have the lot number or expiration date for the ACTHIB available because the nurse that administered the expired ACTHIB has left for the day. Doctor states that he will contact Medical Information tomorrow if he is able to obtain that information. Doctor also states that he may be contacted for the information if needed."  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  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 batch number for this case.
Patient called our pharmacy today and said that she had a seizure the day she was given the vaccine.  Patient said she has a history of seizures and takes seizure medications.  It is unknown what caused the seizure.  Patient was directed to their physician with questions about receiving further vaccinations.
When getting my COVID19 Booster, yesterday, I asked the pharmacist if it was normal for my arm to still be hurting from my last vaccine and I showed her where it was hurting which was the place it was given.  She told me that it isn't normal and that the injection was not given in the correct spot; it was low and back of the deltoid, where it should have been given.  She told me that I should report this so it is on file.  It hurts to raise my arm and to move it forward and backward.
redness with elevation/swelling and itching to injection site. progressively spread to a larger area per caller.
Information has been received from a physician concerning a 11 year old female patient who on 05-JAN-2012, was vaccinated with the first 0.5 ml dose of GARDASIL (lot number and route not reported). Secondary suspect vaccine included a dose of AFLURIA (manufacturer unknown) (lot number, dose and route not reported) on 05-JAN-2012. Concomitant vaccines included MENACTRA on 05-JAN-2012 and DTAP on 05-JAN-2012. The physician reported that on 29-JAN-2012, the patient was evaluated by a physician for complaints of weakness and paresthesia in the patient's legs. The patient was referred to another physician and the patient was diagnosed with acute transverse myelitis. The patient was admitted to the hospital. The patient was attending physical therapy. At the time of the report the patient was improving. This is one of several reports received from the same source. Additional information has been requested.
severe pain to the right arm fever 102 for at least 4 days  body aches  muscle aches