chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer (also the subject) and described the occurrence of pleural effusion in a 70-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccinations included pneumonia vaccine (non-gsk); manufacturer unspecified; unknown; unknown given on 6 October 2011. Concomitant medications included Hormone replacement therapy and VALTREX. On 6 October 2011 at 12:00 the subject received a dose of FLULAVAL (unknown, left arm). On 9 October 2011, 3 days after vaccination with FLULAVAL, the subject experienced pain in arm and chest, fever, chills and body pain. On an unspecified dates in October 2011, the subject experienced pleural effusion, atrial fibrillation, liver enzymes "out of whack", shortness of breath, acute muscle spasm, chest tightness, vomiting, diarrhea and "bloating in stomach and intestine". She reported she had a pacemaker placed as a result of the "cardiovascular side effects". The subject reported she was hospitalized twice due to the side effects. The first hospitalization was from 22 October 2011 to 25 October 2011. The second hospitalization was on 1 November 2011 and she was discharged 3 weeks later. At the time of the report, the subject was taking prednisone. At the time of reporting the outcomes of the events were unspecified.
The adverse event is that a benign pericardial congenital cyst that I have had for my 60 years of life and has been monitored for 10 years with no change in size or anything related to it , woke up, doubled in size and ruptured on January 30th. The cyst was imaged on August 2021 and was still dormant, however on January 10,2022 I woke up to signs related to the abscessing cyst. Was told to see a CT surgeon on January 14 that it was life threatening. While waiting for the surgery date with the surgeon to have it removed the cyst ruptured on January 30th. The cyst was removed on 2/11/2022 however not without more complicated outcomes for the rest of my life. As of today, I am healing from a posterior lateral thoracotomy due to this event and a lobectomy removing the right lower lobe of my lung.  100,000 people have pericardial cyst and <1% abscess. After looking back to last fall I started having Signs and symptoms about 4 weeks after the booster that something was wrong with my heart. The cyst was already doubling during those weeks and month and I was not aware of it till January 10,2022 that I had an issue.
Blurry vision in right eye within 36 hours of the third dose.; 3rd dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Oct2021 (Lot number: FF8841) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes Type II" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Pre dose product=COVID 19,, Pre dose brand=Pfizer,, Pre dose brand unknown=False,, Pre dose lot number=EN6206,, Pre dose lot unknown=False,, Pre dose administration date=10Mar2021, Prev dose dose number=2,, Pre dose vaccine location=Right arm), administration date: 10Mar2021, when the patient was 68 years old, for Covid-19 immunization; Bnt162b2 (Pre dose product=COVID 19,, Pre dose brand=Pfizer,, Pre dose brand unknown=False,, Pre dose lot number=EL9267,, Pre dose lot unknown=False,, Pre dose administration date=10Feb2021, Pre dose dose number=1,, Pre dose vaccine location=Right arm), administration date: 10Feb2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Oct2021, outcome "unknown", described as "3rd dose"; VISION BLURRED (non-serious) with onset 11Oct2021, outcome "not recovered", described as "Blurry vision in right eye within 36 hours of the third dose.". The event "blurry vision in right eye within 36 hours of the third dose." was evaluated at the emergency room visit. Therapeutic measures were taken as a result of vision blurred.  Additional information: The patient was treated with Steroidal drops. Prior to vaccination the patient had no covid, post vaccination the patient was not tested for covid and no known allergies were reported.  No follow-up attempts are possible. No further information is expected.
Fever of 102 - wheezing - then on 9/27/2011 at 9:00 pm developed full body rash - not relieved with Benadryl -
chills; cough; cold; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), NASOPHARYNGITIS (cold) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse reaction.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced COUGH (cough) and NASOPHARYNGITIS (cold). On an unknown date, the patient experienced CHILLS (chills). At the time of the report, COUGH (cough), NASOPHARYNGITIS (cold) and CHILLS (chills) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Reporter did not allow further contact; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded. Chills is consistent with the known safety profile of the vaccine.
During a recall phone call, Mother stated infant was sleepy, irritable, and difficult to arouse for a couple of days after 1st set of immunizations on 02/09/2005. No follow-up actions taken.  Mom stated after 2nd set of immunizations on 04/21/2005, child vomitted approximately 2 hours after shots and "screamed and irritable for 3 days like colic". Otherwise child is a very content, happy baby per mom. Difficult to console with low-grade temp. (<101 degrees F). Mom gave Tylenol to child and she was still irritable. Child has recovered per mom. Instructed to consult with child's doctor for following immunizations.
Swelling and redness of left upper arm from above shoulder to elbow. 7/14/06 seen by family MD, Treated with Benadryl and Tylenol and ice. 7/17/06 completely recovered.
Patient received a Pfizer dose (first dose) on 8/29/2021.  He then came in for a second dose but was given Moderna (0.5ml) as his second in the series, in error.
Patient received the vaccine around 7:17pm on Wednesday, May 26th, 2021. She waited for 30 minutes after receiving the vaccine. She reported a funny/metal taste in her mouth and upon investigation, case reports showed this is a possible side effect of the Moderna vaccine. The reports said this was a self-limiting side effect with an unknown cause. The patient did not report any other side effects such as pulse rate, sweating, nausea/vomiting, headache, anaphylaxis, etc. Patient did not seem concerned. She called a week later to report that she had a stroke 72 hours later on Saturday, 5/29, in the evening. She reported experiencing a similar taste change when she received the contrast dye during her CT scan. She also had muscle cramps prior to the stroke. She is now out of the hospital and can no longer walk.
Vertigo; Heartbeat was high; Sweating; This is a spontaneous report from a contactable consumer (patient).   A 61-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 22Feb2021 at 10:00 (Lot Number: EN6198), at the age of 61 years old, as 1st single dose, for COVID-19 immunisation. Medical history included asthma ongoing since he was an infant, skin cancer from 2018, suspected COVID-19 in Feb2020 (no fever, no test done), and ongoing allergy for which he was getting unspecified allergy shots that he reacts to, but he was supposed to react to them (he stated it is the appropriate response). The patient's concomitant medications were unspecified, with the patient stating that he did not think any of his medication would have anything to do with the reported events. Historical vaccination included the pneumonia shot several months prior to BNT162b2 vaccination. Past drug history included reaction to levofloxacin (LEVAQUIN) in 2009, for which the patient went to ER by ambulance for treatment. The patient stated that on 22Feb202, as soon as they gave him the first shot, his heartbeat was high, he was sweating, and having vertigo that lasted for 3 days. No Emergency Room visit was needed. On 28Apr2020, a COVID-19 test was negative. The patient recovered from vertigo, difficulty breathing, heart beat high, sweating on an unspecified date. The patient received the 2nd single dose of BNT162b2 on 15Mar2021   Follow-up attempts are completed. No further information is expected.
PATIENT STATES ARM (SHOULDER) IS STILL HURTING AFTER THE INJECTION A MONTH AGO.
The next morning after receiving the vaccine, she began to experience facial swelling and redness that progressed to severe swelling, itching in her neck, chest and face by the next day.
2nd dose Nausea, severe  headache , severe muscle pain  in legs, buttocks, ankle joint pain , itching at sit L arm; , could not left left arm, stomach ache, eye pain, delirious, feeling extremely tired and unwell, loss of appetite, chills , swollen glands at throat, sore throat. Weakness, confusion, eye pain. Dizziness.
itchy red skin on throat and ears, patient self administered Epipen that she owned. Once she was home she took Benadryl and Zyrtec and symptoms went away that evening
Child had fever 103, and screaming episode for more than 3 hrs following lst DTP/OPV immunization.
FUSSY THE EVENING OF THE VACCINATIONS THEN STARTING 4/14/10, HAD DIARRHEA 5-8 TIMES PER DAY.
Rash & UrticariaPruritus Narrative:  Developed circular ~3x1 inch ovoid rash around the site of the injection 2 days after the vaccination. Rash persisted for 10 more days prior to resolved and was described as pruritic, painful to touch, erythematous, indurated, and warm to touch. No therapies tried or applied. No hives, sloughing, or other adverse effects noted.
Chills and tremors two weeks after vaccination.  Possible aggravation of underlying psychiatric disorder including anxiety, desire for a drink and additional anxiolytics medication, suicidal ideation.  Sleeplessness. Not absolutely certain these were related to the vaccine although I was doing well before it.  Dr.  suggested it might be an allergic reaction or unspecified cause.
On 01/17/2001 the nurse reported that she thought the patient had chicken pox with lesions on the patient's face and a runny nose. The patient had not felt well on 01/16/2001. The patient sought unspecified medical attention. The reported noted that the problem resolved and that the patient did not have chicken pox. Additional information has been requested.
Injection site was warm, encapsulated, inflamed, tingling and well defined, over reaction  Swollen under my left underarm   Started  about a week later after I received my first dose 1/13/21 and 1/14/21 Went to urgent care that Friday evening 1/15/21
Systemic: Fainting / Unresponsive-Mild, Additional Details: After adminstration during obeservation period, patient briefly fainted fell from chair and scraped head slightly. Patient sat up on own back into chair, gave some water and did some deep breathes to help relax. Continued to observe no further symptoms, patient was anxious before adminstration.
reported tingling in bilateral arms post vaccine ,  set of vitals were in normal range after comfort measures were taken discharged to home
pt recvd vax 10MAR93 & UA on 7JUN93 showed 0-1 WBC & 0-5 RBC; UA 30AUG93 showed 2+ blood; No further details were provided;
About 45 minutes after receiving my vaccine I started feeling a tightness in my throat. I then became lightheaded and shakey. I was driving so I pulled over and called 911 who transported me to Hospital. The tightness and pressure moved down to my upper chest area also and my hands were tingling. I was given benadryl, pepcid and prednisone at the ER. About 30 minutes later I was feeling much better except for a scratchy throat. I was sent home where I slept the majority of the rest of the day. The next day I woke up with a very sore arm, very tired and a headache. Today the injection site is still a little sore and I have a headache.
pt called to state he had developed a fever that night after the vaccine.  He called the next morning and stated his fever was 102 that day and that he had taken 650mg of APAP. Pt has kidney failure so he could not take any NSAIDs. He was told to have a cool bath and continue APAP every 6 hours.  Called pt the next day, his fever had reduced to 100 that day.  He said he had been resting and sleeping a lot to try to combat the fever.  Spoke the the patient 3 days later and he said his temperature returned to normal the 3rd day.
Swelling, soreness, red and warm to touch, spreading to shoulder and arm centered on injection site.
the day after my son received his men b vaccine, he got mono. High fever, body aches, sore throat, muscle aches, fatigue and headache
Received report from family friend that patient passed away on 11-21-16, unknown cause of death.
The patient returned to the aid station at around 10:30, complaining of swelling on his tongue and itchiness in his throat. Upon assessment, it was determined that he was experiencing an anaphylaxis reaction to the yellow fever vaccine, indicated by the redness at the injection site. The patient also displayed redness on his face with tongue and airway swelling. HR was slightly tachy at 98 bpm, and RR was short and shallow, around 24 breaths per minute. 50mg of IM Benadryl was administered at 10:42, and the patient expressed he experienced some relief. EMS arrived at 10:55, and the patient was transferred to the ED at 11:00.
miserable pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose on an unknown date, refer link case US2023AMR043599).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: miserable pain). Rechallenge with Shingles vaccine was positive. The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR043599   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by the patient via interactive digital media. The patient got the shots, first one hurt but second one was miserable pain.  But hopefully he/ she would not get shingles. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR043599:same patient
Cold lie symptoms lasting for over two weeks include chills, sore thought, coughing, and a constant sense of dehydration.
Approximately 1 in radius of the injection site became red, very warm, hard, and very sore. My tongue also became slightly swollen requiring Benadryl and observation.
Felt terrible, with fever of 104; Chills; Couldn't move arms or legs; Profound soreness and tiredness in her body.; Tiredness in her body.; felt terrible/she felt like she'd been hit by a truck; Intense Headache; Diarrhea with a strong smell; Stench/burning in her nose; Stench/burning in her nose; This is a spontaneous report from a contactable physician. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 08Apr2021 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to coconut flavor. 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 COVID-19 vaccine. Concomitant medications were not reported. The patient previously received codeine (MANUFACTURER UNKNOWN) and oil (LAVENDER OIL) for unspecified indication from unknown date and experienced drug allergy. On 09Apr2021, the day after the vaccine, the patient felt terrible, with fever of 104, chills. The next day her fever and chills passed, she felt like she'd been hit by a truck, couldn't move arms or legs, profound soreness and tiredness in her body. This improved, but then had 4 days of intense headache. The patient also experienced diarrhea with a strong smell which had been persistent since 4 days after the vaccine. The patient had stench/burning in her nose that was persistent at all times, had been worsening over time. Currently, at the time of this report, the patient was having 3-4 times per day diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. On 09Apr2021, the patient underwent lab test and procedure which included body temperature and the result was 104 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt terrible, with fever of 104 and chills were resolved on 10Apr2021. The clinical outcome of the event headache was resolved on an unspecified date in Apr2021, after the duration of 4 days; while that of the events couldn't move arms or legs, profound soreness and tiredness were resolving. The clinical outcome of the events stench/burning in her nose and diarrhea with a strong smell was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
approx 4 weeks after vaccine shot, pericarditis pain and symptoms. no treatment, just endured and restricted activity until pain lessened after 10 - 12 days.  shot creates fluid in heart, so will discontinue further COVID vaccines of any type. No COVID to date.
This spontaneous report was received from a physician referring to an 18 year old patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported) later than they were supposed to. No adverse effects were reported.
Either later that night or the next morning she was in major excruciating pain, couldn't move her arm, and had 3 quarter sized hives on her arm that she had both the Fluvirin flu shot and the Pneumovax pneumonia shot in.  Later that day or the next morning her whole upper arm was red and the hives were red raised areas.  She saw a physician who prescribed her a couple pain medications- I do not know the names of them though.  Now she feels fine and have recovered fully.
stomachache; hotness; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomachache), FEELING HOT (hotness) and VOMITING (vomiting) 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 ABDOMINAL PAIN UPPER (stomachache), FEELING HOT (hotness) and VOMITING (vomiting). At the time of the report, ABDOMINAL PAIN UPPER (stomachache), FEELING HOT (hotness) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Patient received PNEUMOVAX sub cu in out aspect of (R) upper arm. She experienced local reaction 25x8cm with swelling erythema and tenderness.
Patient reported she began having ulcers in the mouth and a swollen lip which she believes is from the vaccine. Pharmacy counseled patient and reported while it is a possibility, most reactions would have had a faster onset and would have included different area and not localized to the mouth. Pharmacist counseled patient to report it to her physician to confirm if the doctor would recommend the second dose.
Moderna COVID-19 Vaccine EUA  Fever, chills, nausea, fatigue, body aches
Heart racing; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el9261) via an unspecified route of administration at left arm on 31Mar2021 at 17:00 (62-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included ongoing atrial fibrillation (afib) and allergies to phenothyazines. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On  01Apr2021, the patient experienced heart racing. Patient stated since he has afib, caused a problem for a day. Scared to get second dose. Since the vaccination, the patient has not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
7 mos male with onset of generalized urticaria and fever, swelling of hands and feet 24 hrs after being given Prevnar vaccine.  Was also introduced to whole milk for first time same day of symptoms-yet milk RAST test negative as of 8/2/04.
Redness, itching, swelling and fever at injection site and rash extending from deltoid to elbow on left arm.
3rd booster received 10/25/21 - 10/29 symptoms started w/ a swollen  upper lip, which progressed to swelling of lower lip, then chin with a nasty rash and then by Sunday 10/31 my throat was starting to get thick and swollen so I went to Urgent Care.  They diagnosed me with Contact Dermatitis, unspecified trigger and prescribed me prednisone and benadryl. Took the prednisone as prescribed.  11/5/21 was the first day without any prednisone and by that evening I broke out in hives all over my torso, which continued to spread rapidly down my whole body and my throat again stated to get thick and swollen so I had to go to the E.R.  They gave me some type of IV steroids and again prescribed me prednisone and an epi pen and told me to see an allergist. I have not introduced anything new to my body but the vaccine.  No change in my diet, lotions, soaps, nothing. Went over all of this with the Allergy doctor my Primary referred me to and he believes it's due to the vaccine.  He has other patients with similar issues since getting their vaccines and again the vaccine is the only new or foreign thing I've put in my body prior to these issues starting.
During the night of the same day he received the vaccine, the patient c/o dizziness upon waking in middle of night. He passed out and went to the ER. Also c/o headache that started several days after the vaccine - This headache still comes and goes.