chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; backache; aches in both knees; sore at injection site (left arm); tender/painful lymphnode under left armpit (site of injection); This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: EN5318, Expiration Date not reported) via an unspecified route of administration, administered in the left arm on 20Feb2021 10:00 (at the age of 71-years-old) as dose 2, single for COVID-19 immunisation. Medical history included asthma, eczema, interstitial cystitis, prediabetes and scallop allergy. The patient previously took nickel and experienced allergy to metals; and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: EN5318, Expiration Date not reported) via an unspecified route of administration, administered in the left arm on 30Jan2021 10:00 (at the age of 71-years-old) as dose 1, single for COVID-19 immunisation. The patient received unspecified concomitant medications within two weeks of receiving BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue, backache, aches in both knees, sore at injection site (left arm), and tender/painful lymph node under left armpit (site of injection) on 20Feb2021 18:00. No treatment was received as a result of the events. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
pt recvd vax & devel sx of vomiting, fever of 102 R, lethargy, rapid breathing & hands, face twitching approx 1 hr p/vax; parents took pt to ER;
This spontaneous report was received from a nurse and refers to a 4 year-old female patient. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 26-JUN-2017 at 17:14, the patient was vaccinated with improperly stored VARIVAX, in the right thigh (lot # M047662 with the expiration date of 02-DEC-2018; second dose, exact dose and route of administration were not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). The patient was concomitantly vaccinated with a dose of VAQTA. No adverse event was reported. The administered dose of VARIVAX experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1706USA009938:
Rash started on both wrists and then spread to inner thighs, sides of trunk, top of feet, back of legs, back of knees, upper arms, bra area and both breasts. Almost all areas itch, some worse than others. BENADRYL 50 mg po q 4 hrs ATC WA helps the best. It does not make me sleepy. I get a buzz from it. I take Chlor-Trimetron at HS so I can sleep, but it is not very effective. I stopped the Atarax 25 mg po at HS that Dr. prescribed after I fell trying to get to the bathroom on Monday, April 22nd at 1:30 AM. It was not very effective in decreasing the itching anyway. Dr. tried to prescribe Prednisone for me, but I declined as Dr., my osteoporosis physician, had always told me to never take steroids. I was so miserable by Tuesday that I emailed Dr. and asked him if this warranted an exception. He said I should not suffer any further in the wake of this advancing rash and take the Prednisone, it would not hurt my bones. The topical Triamcinolone Acetonide 0.1% steroid cream was not effective at all. I stopped it after about three applications. The most effective topical has been Nivea Lotion with Clove Oil, a remedy that I used from my hospice and palliative care days. Ice/ cooling packs have also been very soothing and once I get an area numb from the cold, it usually does not itch for 1-2 hours. Shingrix shot given on 4.18. Shingrix Representative said that out of the 30,000 people in their clinical trials, NO ONE has reported a rash like mine - except those experiencing anaphylaxis. Digest Gold i capsule po tid, 4.18-4.20 (3 days). Dr. who recommended it, does not believe it caused the rash. Their representative said that rashes were common. However, the rash should have dissipated after 24 hours as that is the longest that the enzymes last. The digestive enzymes in the product are to assist the gut in getting rid of toxins and cleanings the GI tract - thus helping heal SIBO (Small Intestinal Bacterial Overgrowth). TRU Niagen ii caps po q AM 4.18-4.20 (3 days). Dr., who recommended it, does not believe it caused the rash. The representatives here were not forthcoming. They would not give me any information about their rash rates. I am still trying to find out more information from them. Dr. thought I should continue to take Epicor, which I have taken since 12/17 to improve my immune health. I met with my family physician, Dr. on 4/24/19. Based on the limited data that he had at the time, his best guess was that the rash was caused by the Shingrix shot, although he has not seen rashes in other patients. He prescribed a Prednisone taper which is beginning to provide relief.
Patient developed swelling and redness in the face, tightness in the chest, and nausea in the stomach.
lost vision completely in one eye; rashes; severe headaches; hair in her eyebrows fell out; Initial information received on 08-Oct-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional.  This case involves a seven-year-old female patient who lost vision completely in one eye (Blindness unilateral), had rashes (rash), severe headaches (headache) and hair in her eyebrows fell out (madarosis), while she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient lost vision completely in one eye (Blindness unilateral), had rashes (rash), severe headaches (headache) and hair in her eyebrows fell out (madarosis) (unknown latency) following the administration of INFLUENZA VACCINE. Event blindness was assessed as medically significant. The patient was hospitalized for these events for a week.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome was unknown for all the events.  Information on the batch number was requested.; Sender's Comments: This poorly documented case concerns a seven-year-old female patient who experienced Blindness unilateral, rash, headache and madarosis after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. Moreover, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Around 1 month after receiving my second dose I began to experience frequent (10-12 per minute) heart palpitations and occasional chest pain. Went to see my primary care physician who ordered lab work and a cardiac monitor. The cardiac monitor showed frequent isolated PVCs. Cardiac markers were not drawn with the lab work so the results came back as normal. I was started on Toprol XL with no relief. After a follow up visit on 5/21 I requested to be referred to a cardiologist. The cardiologist recommended an echocardiogram. By the time I was able to schedule the echo my symptoms had resolved. The echo showed no abnormalities. My palpitations stopped on 6/11/21.
Patient states he received his 2nd COVID vaccine last week and the day after he developed a fever, chest tightness myalgias.  States that he has a device at home and checks his heart rate and monitors an EKG and states that it told him he had PVCs at that time.
Throat felt swollen; chest tight, hard to breathe. Then hours after felt weak, nauseous, fever
Fatigue (over 7 days); loss of appetite; weight loss; heavy anxiety; elevated heart rate; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 09:00 (Lot number: FD8448) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penecillin" (unspecified if ongoing), notes: Known allergies: Nickel, Penicillin; "Known allergies: Nickel" (unspecified if ongoing), notes: Known allergies: Nickel, Penicillin. There were no concomitant medications.  The following information was reported: FATIGUE (non-serious) with onset 21Aug2021 11:00, outcome "recovered" (28Aug2021), described as "Fatigue (over 7 days)"; DECREASED APPETITE (non-serious) with onset 21Aug2021 11:00, outcome "not recovered", described as "loss of appetite"; WEIGHT DECREASED (non-serious) with onset 21Aug2021 11:00, outcome "not recovered", described as "weight loss"; ANXIETY (non-serious) with onset 21Aug2021 11:00, outcome "not recovered", described as "heavy anxiety"; HEART RATE INCREASED (non-serious) with onset 21Aug2021 11:00, outcome "not recovered", described as "elevated heart rate". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, decreased appetite, weight decreased, anxiety, heart rate increased.  Additional information: There was no covid prior vaccination and covid was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
PERIPHERAL NEUROPATHY 8/14/2022 ATHEROSCLEROSIS OF BILAT CAROTID ARTERIES PERIPHERAL NEUROPATHY 8/14/2022 ATHEROSCLEROSIS OF BILAT CAROTID ARTERIES
I tested positive for COVID-19 the morning of 10/05/2022. I contacted my doctor's office and had a telehealth visit with them the following morning. I was prescribed Paxlovid which I began on 10/06/2022. I was on the medication for 5 days. My symptoms were relatively mild with the exception of Thursday and Friday. The symptoms were body aches, fever of around 100 degrees, and very bad headache.
Pt recvd 3 doses of Engerix-B & following 3rd dose exp hives in the areas of tight clothing;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN; ZYRTEC ALLERGY; SIMVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Within hours of receiving my 5th COVID booster shot, I began to have severe breathing problems and severe pain in my chest,  I was admitted to the Hospital and after many test it was determined that I did not have a heart attack but instead I had pericarditis which is inflammation of the heart sac tissue.  I now take colchicine 6mg and I am beginning to feel better.
For confirmation of diagnosis. Dr. was the one who told me I needed to report this. Within an hour of getting my second vaccine (Pfizer) my right eye started hurting. Vision started to get blurry, eye was red, and it was painful. I had my grandmother visiting at that time, and thought that maybe it had just been irritation from wearing contacts, so I unfortunately waited to see Dr.. When I finally saw Dr. he said it was Iritis, which is usually caused by an inflammatory disease. I have not been diagnosed with any inflammatory diseases. We attempted Prednisolone eye drops for a while and it didn't clear up the Iritis. Then he switched to Durezol and after a week or more the inflammation went away. I have not had any further issues related to my right eye or an Iritis inflammation since.
Within 24 hours of receiving the vaccination at her place of employment, the patient reported fever, chills, and body aches.
Have some really sharp abdominal pain;; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 23 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: ABDOMINAL PAIN (non-serious), outcome "unknown", described as "Have some really sharp abdominal pain;".  Additional information: Patient had some really sharp abdominal pain; That is like a little more serious than just feeling crummy; Really sharp pain in her stomach. She had no health issues at all, she was not allergic to anything.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm was incapacitated for nearly a week after the initial injection. Arm could not be lifted more than a few inches away from torso, and pain felt like severe deep cramping constantly. No bruising or mark at the site of the injection just severe muscle pain that affected all movement and sleep.  After one week I regained more mobility but still had severe pain in the shoulder muscles around injection site. At the 3 week mark I have more mobility but still struggle with a full range of motion and lifting anything more than a few pounds.
ON 8/5/21 THE PATIENT NOTICED AN OBLONG BRUISE ALONG HIS LEFT BUTTOC AND FELT HE SHOULD REPORT IT.
large area of swelling on arm, below where vaccine was placed. It was swollen, red, itching, and burning. Applied ice and steroid cream. Took apap and antihistamine. Rash remains in same state as of today 1/28/21 only improvement in burning sensation. Additional itchiness on scalp and body beginning on 1/26/21 and persisting as of today 1/28/21.
Started with a small red circle on my arm and then it spread.  I took 2 Benadryls on 01/08/2021 and the red blotch started to fade and was completely gone by 01/11/2021.
Came in 11/4/08 @ 5pm to vote and show me his arm had usual mild pain from shot then on Mon 10/27 started to get red rash it seemed swollen. We was fishing for a few days so did nothing. Rash worsened- got blisters and down arm. (flexor surface mainly). One patch ^3" diameter on red base lesion coalesced and blisters flattened and look like white plaques now. Also has a patch 2" red papules. Referred to MD-ER staph or strep infection. ? shingles cellulitis. Don't feel related to flu shot.
Red area around vaccine site  and swelling under arm. Took Benadryl and iced area. Cleared up in 3-4 days
Information provided by patient as follows.  I do not have access to urgent care notes to provide that information.  ALLERGIC REACTION TO VACCINE.  SWELLING IN INNER AND OUTTER BOTTOM LIP.  THROAT AND EARS ITCHY AND THROAT FELT TIGHT. DIFFUCULTY SWALLWING. WENT TO URGENT CARE AND RECEIVED STERIOD SHOT.
Small bruise at injection site after 1 day. Itching and minor swelling of site at day 8. Red oval about the size of an egg at day 9.
Arm at injection site began itching, became swollen, reddened and hot to the touch. Developed headache as well.
Tinnitus; Joint pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient 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 25Mar2021 at 12:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. 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 concomitant medications included omeprazole (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN) and unspecified multivitamins; all from unknown dates for unknown indications and unknown if ongoing. On 31Mar2021, the patient experienced tinnitus, joint pain and fatigue. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tinnitus, joint pain and fatigue were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 04Nov2021 14:30 (at the age of 51 years old) (Lot Number: FF2593) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history was not reported. No pregnancy at time of Vaccination. Concomitant medication included influenza vaccine (FLU) on 12Oct2021. No other medications the patient received within 2 weeks of vaccination. The patient previously received the BNT162B2, first dose (Batch/Lot No: EN6208) on 12Mar2021, second dose (Batch/Lot No: EW0150) on 02Apr2021, both in left arm at the age of 50 years old for Covid-19 immunization. The patient experienced felt extremely dizzy on 05Nov2021, the vertigo (dizziness) was accompanied with vomiting on 05Nov2021, nausea on 05Nov2021, fever on 05Nov2021, chills on 05Nov2021, injection site pain on 05Nov2021, body aches on 05Nov2021, physical inability to get out of bed on 05Nov2021, feeling tired on 05Nov2021. Clinical course: She took her Covid booster shot at around 2:30 on Thursday afternoon (04Nov2021). About 10 hours later, she felt extremely dizzy. The dizziness continued the whole of the next day where she was unable to get out of bed. The vertigo (dizziness) was accompanied with vomiting every time she stood up to go to the bathroom. She was unable to keep down any food or water for the entire next day. She is an otherwise healthy person but she needed physical help to get to the bathroom all of Friday (05Nov2021). On Saturday (06Nov2021), the nausea went away but the vertigo persisted mildly. It is now Monday (08Nov2021) and she is still feeling tired and not back to her usual self. In addition to the vertigo and nausea, she did have fever, chills, injection site pain and body aches. The most debilitating symptom was the vertigo and nausea. Her husband informed the primary care doctor about the reaction and they wanted me to get admitted in the hospital for IV fluids. But, they decided against it due to her physical inability to get out of bed. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been has not tested for COVID-19. The outcome of the event nausea was recovered on 06Nov2021, of the other events was recovered with sequel. Follow-up (11Nov2021): Follow-up attempts are completed. No further information is expected.
Started with a headache that over time worsened.  Seen at PCP office  on 5-4-2021 and then again on 5-5-2021.  Sent to ER for further care.
Moderate pain in the left arm. First injection was in the left arm and the second was in the right arm.
Ear pain, lymphadenopathy, sinus congestion, headache, injection site swollen, painful x 3 days
Very painful hard lump in deltoid muscle with redness, warmth, swelling. Chronic shoulder pain has persisted since then with involvement in arm back and front of shoulder and breast.
Hives, itchy skin, itchy throat within 5 minutes,  took benadryl
Her arm was sore afterwards. But the next day in the evening it started turning red near the injection site. Then the 2nd day the redness went lower down the arm towards the elbow (towards the inside of the arm) and it was really itchy and hot.  Did not hurt.  She asked if she could take benadryl to help it. I said yes it is ok to take, but that she should call her doctor if it gets any worse.
This spontaneous report was received from a nurse concerning a patient of unknown gender and age. On 15-JUN-2015 the patient was inadvertently vaccinated with a dose of improperly stored PROQUAD (Merck) (Lot# K018143; expiration date: 10-APR-2016) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
3yo child developed H.Influenzae meningitis on 1APR91; Rec'd vax in JAN91; Currently doing fine;
Hives  Rash all over body  Itch all over body  bumps  raised skin swelling
Nausea for 3-4 days after 1st shot; Fever  for 3-4 days after 1st shot; Chills for 3-4 days after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea for 3-4 days after 1st shot), PYREXIA (Fever  for 3-4 days after 1st shot) and CHILLS (Chills for 3-4 days after 1st shot) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced NAUSEA (Nausea for 3-4 days after 1st shot), PYREXIA (Fever  for 3-4 days after 1st shot) and CHILLS (Chills for 3-4 days after 1st shot). In August 2021, NAUSEA (Nausea for 3-4 days after 1st shot), PYREXIA (Fever  for 3-4 days after 1st shot) and CHILLS (Chills for 3-4 days after 1st shot) had resolved.            No Concomitant and Treatment medication were reported.   This case was linked to MOD-2021-331006 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This case concerns a 42 year-old, female patient with no relevant medical history, who experienced the expected non-serious adverse event of chills, nausea and pyrexia. The event occurred on unknown date approximately 3 or 4 days after the first dose of Spikevax (Moderna COVID-19 vaccine) according to narrative. The rechallenge was positive for the events of chills and pyrexia as this events have resolved after the first dose and then recurred after the second dose. For the event nausea, the rechallenge is negative since it is not described after the second dose. The events are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.