chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pops, blood and puss coming out long after vaccination; swelling in the left arm pit, injected arm; This spontaneous case was reported by a consumer and describes the occurrence of WOUND SECRETION (pops, blood and puss coming out long after vaccination) and VACCINATION SITE SWELLING (swelling in the left arm pit, injected arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 001B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (swelling in the left arm pit, injected arm). On an unknown date, the patient experienced WOUND SECRETION (pops, blood and puss coming out long after vaccination). At the time of the report, WOUND SECRETION (pops, blood and puss coming out long after vaccination) and VACCINATION SITE SWELLING (swelling in the left arm pit, injected arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient did not remember how long after vaccination patient started with swelling in the left arm pit, injected arm. Patient still got it, and it swells up, pops and puss and blood came out of it. Patient had not seen a doctor and declined providing the vaccination facility contact information. Patient researched on the internet and other people have the same issue as patient had after vaccination. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2023: Follow-Up received contains no new information
Started with flu like symptoms, then waking in the night screaming out in pain and refusing to be touched, then had a seizure on 10/17/2013.
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 13-month-old patient of an unspecified gender, race and ethnicity received three doses of PREVNAR 13, all on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pneumococcal meningitis. Clinical outcome was unknown at time of this report. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative serotype results and vaccination schedule are needed for full medical assessment.
Mo states child became fussy. Denies fever - only taking a few oz of formula at a time 2-3 oz every several hrs. Had taken maybe 9-10 oz in 24 hrs after vaccine. Mo states no urination since vaccine given 5/12. 5/13 PM Mo noticed slight blood tinge in diaper x2. Referred to ER ASAP.
Upper left arm BECAME red, swollen, warm and itchy eight (8) days after inoculation.  Red swollen area  measures 4"by 3".  Also experienced fatigue for several days after receiving the shot but that has cleared up.
the patient describes developing a large red rash and swelling at the injection site.  Also, at the area she describes that the area has an intense itching sensation and warm to the touch.
A report has been received from a Health Professional concerning a 49 year old, Female subject, who had been received Nasal FLUMIST (INTRANASAL). The patient's medical history included SURGERY. Concomitant medications included ANTIBIOTICS for CELLULITIS. FLUMIST (INTRANASAL) started on an unknown date. The patient reported FLUMIST syringe broke in her hand and cut her finger which started on 04-Nov-2014 and bump on her finger. The outcome of the event of BUMP ON HER FINGER and FLUMIST QUADRIVALENT SYRINGE BROKE IN PATIENT'S HAND AND CUT HER FINGER is unknown. The reporter was considered to be non-serious.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with improperly stored PNEUMOVAX 23 (incorrect product storage) (lot # K007826, expiry date 03-FEB-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with PNEUMOVAX 23 was unknown. There was no product quality complaint reported. It was reported that the vaccines were exposed to a temperature of 32.4 degrees Fahrenheit for a cumulative total of 13 hours. This is one of the 3 reports from the same source. Additional information has been requested.
All my teeth began to ache and progressively get worse to the  point I wanted to pull the out. At the same time it felt like my head (in notch immediately forward of middle of ear to ear)  was in a tightening vise.  Then I got hot and cold  but not severely.  Same for dizziness, very mild. I was nasusseous and not able to eat.  I had random muscles pains , none lasting more than a few minutes in any one place. Odd thing was that I felt no discomfort at sight of injection. Next day I felt just as bad but at 8:30pm I felt like throwing up (after having 2 teaspons of vegetarian vegetable soup). However, I only had dry heaves. I live by myself and started to get scared. I called my daughter and took a Tylenol at 9pm. Within 10 minutes the feeling of a vise and my aching teeth felt significantly better. but  stil very fatigued. Next day, today,  I feel much better but still a little foggy headed. I can eat. I can function normally, thank heavens. If I had to take another shot now, I wouldn't. Not even sure I'll take a booster when it comes out . It was very scarey.
This is not an incident report, it is a look-alike packing report (sorry if this is the wrong place). The Hepatitis B Vaccines manufactured by GlaxoSmithKline recently underwent a labeling change. The adult and pediatric vaccines look very similar, and previously the pediatric formulation said "Pediatric/Adolescent" formation on the syringe (this is the mechanism our pharmacists and NICU nurses used to verify they were using the right vaccine). Glaxo has changed the labeling and pediatric formulation no longer states this on the package. The two syringes are different colors, but suddenly our usual safeguard against accidentally switching these syringes is gone and we would like it back.
Shot location began itching and showed a rash.  Then got hives and raised bumps on other parts of my body that itched quite a bit.  Symptoms began about 8 days after my initial shot.  Am currently using Benadryl to ease the  itching.
covid-19; strep throat; This case was reported by a consumer via other manufacturer and described the occurrence of covid-19 in a patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced covid-19 and streptococcal sore throat. On an unknown date, the outcome of the covid-19 and streptococcal sore throat were unknown.   It was unknown if the reporter considered the covid-19 and streptococcal sore throat to be related to DTaP vaccine.     Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's Comments:  The patient received DTaP vaccine and developed Covid 19 and Strep throat.
within 1 hour of receiving vaccination, he developed a cough and body aches. on 10/18/2021 he saw provider and was tested for covid19 + flu a/b and flu B is positive.
"3/6/21 9 pm, had shakes, chills, fever, brain fog, fatigue."
Dizziness, Headache, Myalgia, Arthralgia,  Fatigue, chills, injection site pain and swelling, lightheaded
On January 23,2023; I wasn't feeling well, I had extreme fatigue, sore throat. congestion, coughing. I took a home COVID-19 test that came back positive. I called my doctor to have a telehealth visit. We discussed my symptoms, I was prescribed Paxlovid. I started taking the medication that evening. The next day I had already started feeling better. I would like to thank the people who invented the vaccines.
Vaccinee received Engerix-B rt arm 19JUL90 the next morning awoke w/headache. 30JUL90 paresthesia of the lt arm; entire arm was numb up to face including tongue. Event lasted approx 10 min & went away, without treatment.
This spontaneous report was received from a physician via a company representative and refers to a 12-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date in 2018 (reported as "a few weeks ago"), the patient was vaccinated with GARDASIL 9 intramuscularly (dose, site of administration, lot # and expiration date were not reported) for prophylaxis. A few minutes after the vaccination the patient experienced syncope. She experienced at least 6 syncope episodes since then. The patient sought medical attention by consulting a physician. No treatment was given for the event. The outcome of syncope was reported as not recovered. Causality assessment between the event and GARDASIL 9 was not reported.
42- year female was screened on 13 Jul 2022 and enrolled on 14 Jul 2022 receiving Moderna vaccine at 17:54. The participant is a HIV positive on HAART (Abacavir/Lamivudine/Dolutegravir) . Her vital sign at screening were: BMI 49.6.  On 14 Jul 2022, after vaccination, she was assessed for 15-min past immunization and found to have no immediate reaction to report.  On 17 July 2022, the surveillance nurse for the study received a call from the participant's care taker reporting that the participant was admitted unwell. The care taker reported that the participant travelled on 16 Jul 2022 to an area about 265 km away from study site.   The surveillance nurse advised for the participant to be taken to the facility which would have more options to review and provide care. The participant was taken to Hospital. Upon arrival to the hospital, the participant was assessed to be in need of oxygen support by facemask. Most of the information was from the  participants caretaker.  Late today we were able to establish contact with a medical doctor on the team who briefly reported that the participant came in with difficulty in breathing, and they were still investigating the possible cause. He reported though that the participant is much better and was switched from oxygen by facemask to Nasal prongs. We requested he provides more information on the illness, investigations done, working diagnosis and treatment, which he promised to provide on Thursday 21 July 2022. However he noted that the wanted to do a chest CT but the participant could not afford. We are working on supporting the investigation.  We shall submit more details as soon as we have.
DEATH Narrative:  Patient passed away after Covid Vaccine. 2/8/21: brought to the ER for evaluation for leg weakness and a recent fall associated. He was in a facility- per patient he fell when standing from the bed, he though he could do it and did not ask for help. He has been with hip and pelvic pain since then. The CT/XR shows evidence of lytic lesions, an IR bone biopsy was done and came positive for metastatic bladder carcinoma. 02/17/21: transferred to the facility for PT and pain management, originally for short stay rehab then changed to hospice care. 02/19/2021: received covid vaccine 03/05/21: discharged from facility on home hospice 03/23/21: pt passed away at home Patient with prior covid infection; tested positive last on 9/25/2020. Vaccine did not likely contribute to patient's death, as he was on hospice due to malignant cancer. No evidence of reaction immediately after vaccination or before date of death.
macular erythema and mild swelling at immunization injection site, also mild red, warmth.
Patient was declared deceased on scene of a single-person motor vehicle accident on 09/25/2021. His vehicle left the road with no evidence that he had tried to slow the vehicle or correct course.  An autopsy was performed and the primary cause of death was determined to be giant cell myocarditis (GCM) with contributing factors of hypertensive and artherosclerotic heart disease. Subject contracted COVID in November 2020, and had the Pfizer COVID vaccinations in March 19th and April 9th, 2021.
This spontaneous case, initially received on 04-Oct-2018 reported by other non-health professional and concerns a male patient of an unspecified age. On an unspecified date, the patient was administered FLUCELVAX QIV [dose, route of administration, anatomical location, batch number, expiry date: not reported]. On an unspecified date, after vaccination, the patient experienced Guillain-Barre syndrome. At the time of this report, the outcome of the event was not reported.
METALLIC TASTE; THIRSTY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 11-MAR-2021 03:00 to Left Deltoid for prophylactic vaccination. The batch number was not reported and had been requested. No concomitant medications were reported. On 11-MAR-2021 05:00, the subject experienced metallic taste. On 11-MAR-2021 05:00, the subject experienced thirsty. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from metallic taste, and thirsty. This report was non-serious.
Pt. states that she woke up at 2 am on 1/12/21 with bilateral hand rash/hives and periorbital swelling bilaterally. Pt. states that she used eye drops for eye and advil.
Red ring around vaccination site, itchy and irritable. Did not appear until 3 days post injection
The patient stated that on 6/19/18, he woke up with a rash underneath his breast area. He stated that the rash was bumpy, red and slightly itched. As of today, 6/20/18, he stated that the rash is starting to clear up-it doesn't itch and there are less bumps.
Diarrhea; Nauseated; Tired; No appetite; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration in Apr2021 (3 weeks ago as reported) at a single dose for COVID-19 immunization. Other medications included treprostinil sodium (TYVASO), nasal from 09Mar2021 and ongoing, at 0.6 mg/ml, 4times a day via inhalation for pulmonary arterial hypertension and macitentan (OPSUMIT). Medical history included pulmonary arterial hypertension from 09Mar2020 and ongoing. Concomitant medications included warfarin sodium (COUMADIN SODIUM) and tadalafil (TADALAFIL). The patient experienced diarrhea, nauseated, tired and no appetite in Apr2021. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Rash on body (hives) which occurred 5 hours, post vax. Pt was treated with Benadryl at home. Did not see MD, but reported event by phone.
Arm immediately went numb; finger turned blue and became very cold to the touch; later that night ~6 hours after shot, I began to have very frightening auditory hallucinations for the first time in my life. I heard my dead cat screaming for me, and then later I heard my mother panicked and calling for me to help her (when I went to the opposite side of the house where she lives, she was fast asleep and had not called for me); the next two days I was shivering the entire day, barely able to stand, and incredibly nauseated. My arm also hurt to the point that moving it caused me to cry out in pain. There was no noticeable swelling at the sight at any point.
Narrative: Patient is a 65 year old M vaccinated for COVID with PMH significant for HTN, HLD, type 2 DM, renal transplant (2005) on tacrolimus and mycophenolate, recent SVT, h/o High degree AV block (was on metoprolol and diltiazem recently discontinued), moderate diastolic dysfunction EF 65-70% (ECHO 08/23/21) who was admitted initially on 10/04 to the floor for new diagnosis of COVID 19 PNA. On the night of the 10/04 and the morning 10/05 patient respiratory status worsened with HR rate increased to 140s with intermitted a fib on tele. Patient was thus upgraded to the MICU. Patient had CTA with no evidence of PE. HR improved without any intervention. The patient was transferred back to the medical floor on 10/10/21 and oxygen was tapered off prior to discharge. The patient received 5 day course of remdesivir. The patient completed a 9 day course of dexamethasone prior to discharge. Baricitib not given for concern for superimposed pna while immune suppressed. The patient was also treated for possible superimposed bacterial CAP with 5 days of ceftriaxone/azithromycin. Patient improved steadily and symptoms had nearly resolved at discharge.
Pt received Moderna x2.  Pt tested COVID + on 10/6/21 and admitted to hospital for COVID on 10/6/2021. Pt receiving dexamethasone.
She received her tetanus vaccine ((Td) on 8 February of this year and complains that several hours later developed fever/chills, body aches, and malaise that lasted for the next 7-10 days. She also reports swelling at the vaccination site that extended down the back of her upper arm. She denies hives, laryngeal, pulmonary, GI, and CV symptoms. She tolerated her Tdap vaccine and denies prior adverse vaccine reactions.
hives, headache and fever; hives, headache and fever; hives, headache and fever; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced hives, headache and fever after receiving the first dose of the Pfizer COVID-19 vaccine. She wanted to know if she can receive the second dose of the vaccine. She took some Benadryl for it. She mentioned she is due soon for the second dose, later clarified as, due today (08Jan2021) for the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
bad headache that continued to get worse, body aches, low grade fever and nauseous, today woke up with blurriness and fatigue, feels like pupils dilated and letting in too much light and can't see well.  Taking Tylenol
ACUTE RESPIRATORY FAILURE 3/29/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This case was reported by a nurse via sales rep and described the occurrence of welts in a 7-year-old male patient who received FLULAVAL QUADRIVALENT. On 23rd October 2017, the patient received FLULAVAL QUADRIVALENT .5 ml. On 24th October 2017, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced welts. The patient was treated with ibuprofen and BENADRYL. On an unknown date, the outcome of the welts was not recovered/not resolved. It was unknown if the reporter considered the welts to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The case was reported by a Registered Nurse. The age at vaccination was not reported but it might be 6 year or 7 years. The patient experienced a large raised welt the day after injection that covered either the whole upper arm or upper leg. However, it did not bother or limit activity. The patient still had welt so the nurse recommended ice pack. The reporter reported that they were seeing this a lot with FLULAVAL, but she did not had the specific numbers or information for other patients at the time of the call. This case had been linked with the case US2017GSK165323, reported by the same reporter.
Patient's mother filled out the forms for the patient claiming they were born in 2016. I found out they were born in 2017 after returning to pharmacy to type in the VAR. I changed DOB in system assuming mom was right then insurance rejected for DOB, I called mother and she admitted that she placed 2016 on the forms. so a 4 y/o received a shot. nothing adverse reported, but a 4 year old received ped Pfizer approved for 5-11. I did place a call to the Dr and reported into our internal system.
Patient developed rash and swelling to the face approximately 15 minutes after 2nd covid vaccine was given.  Prior to vaccine, she stated to pharmacist she had swelling at the injection site after first vaccine which is a typical reaction and it was decided to proceed since she did not have an allergic type reaction.  Patient was given 50 mg of liquid Benadryl and asked to remain in the waiting area for an additional 15 minutes for observation with additional check ins.  She did not want to seek additional medical attention and did not want us to call emergency services.  Her throat and breathing was not obstructed.  Her son was available to drive her home.  She stated she did not have any questions or concerns at this time.
I woke up with a headache and a sore arm. As the day progressed I started to feel terrible. Very tired and generally just felt yucky.
4/25/2021 - swollen right arm, 102.4 F fever, moderate to severe neuropathy pain. 4/26/2021 - swollen right arm, 99.4 F fever, pain at injection site 4/28/2021 - covid arm, swollen right arm, pain at injection site 5/3/2021 - swollen lymph nodes accompanied by severe TMJ pain and a low grade fever. Prescribed 4mg of dexamethasone for 5 days. 5/4/2021 - continuation of swollen lymph nodes accompanied by severe TMJ pain and low grade fever. Advised elderberry, Advil 500 MG daily x 3 days, kombucha 4 ounces a day.
2/14/21 -  lower-grade fever/chills/headache, with headache/chills off and on until 3/6/21 2/21/21 - sever headache/nausea/vomiting lasting 4 hours  - diarrhea off and on until 3/6/21 2/26/21 - severe headache/nausea/vomiting/diarrhea - evaluated at Urgent Care, rapid COVID test was negative and was referred to ER for CT of head, which did not show any concerns.
Patient comes in with shortness of breath, admitted with COVID-19 pneumonia. Tx w/abx, steroids, VitC, zinc; pt did not require O2.
Extreme Muscle & Joint Pain; Extreme Muscle & Joint Pain; Swelling; Rash; Pain at injection site; Drowsy as if drugged; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 29Apr2021 at 13:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, osteoarthritis, sciatica and shellfish allergy. 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. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and loratadine (CLARITIN) both for an unknown indication from an unknown date and were unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 08Apr2021 at 13:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 12:00, the patient experienced exhaustion, extreme muscle and joint pain, swelling, rash, pain at injection site and drowsy as if drugged. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events exhaustion, extreme muscle and joint pain, swelling, rash, pain at injection site and drowsy as if drugged were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.