chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red and blotchy spots to the arm of injection site; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1283), via an unspecified route of administration on 13Jan2021 13:00 at SINGLE DOSE at arm right for COVID-19 immunization. Medical history included Chronic Lymphomatic Leukemia (CLL), and Heart attack in 2016. The patient's concomitant medications were not reported. The patient had the vaccine 4 hours ago and her whole arm down to the fingers is blotchy red as well as where the injection was given, it's her whole arm, just blotchy red dots. She received the First Dose at 1PM Eastern Time and probably about 2 and a half hours later is when the blotchiness appeared. The patient was experiencing red and blotchy spots to the arm of injection site. Redness and blotchy coloration appear to be under the skin down to her hand and wrist. She asks if this is a normal side effect. She has had no positive test for Covid Before the Vaccine. She has had No Antibody Tests. She has had No issues with vaccines in the past. The outcome of the event was not recovered.
No additional AEs reported; underwent a temperature excursion and then were administered to patients; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-JUL-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) 0.5 milliliter (lot # T012808 was confirmed to be valid, expiration date: 14-APR-2022; route of administration, anatomical location were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (lot # T040418 was confirmed to be valid, expiration date: 01-DEC-2022 00:00; route of administration, anatomical location were not reported); both for prophylaxis. The administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) underwent a temperature excursion of 50.31 degrees Fahrenheit (F) for 1 hour. The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of -14.4 degrees Celsius (C) for 15 minutes. There were no previous excursions reported for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II). Previous excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was -11.36 C for 6 hours. No additional adverse effect was reported.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA003331: US-009507513-2108USA003248: US-009507513-2108USA003333: US-009507513-2108USA003334: US-009507513-2108USA003335:
Rash x 3 days itchy, looks like hives went to facility on 2-5-10 was seen by a physician hives all over itchy was given Rx of Prednisone for reaction to H1N1.
1 wk post vax, child had fever of 103 and had a seizure.  Child was take to ER, An ECG showed no abnormalities, treated for fever.
This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age and gender. On 05-APR-2013 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 672425/1607AA, expiration date 13-JAN-2013 and route not reported). No adverse effect reported. Additional information has been requested.
patient received a booster dose (0.25ml) when she should have received a full 3rd dose as she is immunocompromised.
Symptoms often described as covid arm. Itchy red and hardened area where vaccine was injected.
Severe cramping, then vomiting then diarrhea, then more vomiting.  He is still in the floor sick after 8 hours of this.  Is throwing up plain water.
Syncope and Sweating.  Laying down and water.  Fully recovered after 30 or so minutes.
about 10 minutes after vaccination, patient walked up to pharmacy window and stated felt lightheaded/dizzy and then passed out (pharmacist braced fall as best as possible, pt did get scrape on arm) - was down and not responsive for ~30 seconds, then became alert and oriented. Pt sat up and BP taken (139/87), EMTs came about 2 minutes later and BP 140/100, blood glucose also taken and was 86 at this point. Patient was conversing with staff and drinking water. After EMT evaluation pt did not want to seek further treatment.
This spontaneous report as received from a healthcare worker refers to an unspecified number of children of unknown age and gender. No medical history and current conditions were reported. On an unknown date the patients were vaccinated with oral, ROTATEQ lot # K009900, expiry: 04-MAY-2016 (dose and route was unknown), which was improperly stored. No adverse effects were reported. No product quality complaint was involved. The outcome of the events was unknown. Additional information has been requested.
PATIENT WAS GIVEN A PFIZER BOOSTER VACCINE THAT WAS SLIGHT OUT OF RANGE  DUE TO EXPIRATION TIME OF STORAGE AND EFFICACY
The pt experienced a large reddened area around the injection site, which was approximately 1 inch long and 1 1/2 inch wide, warm to the touch, no complaint of fever, no complaint of pain at site on arm.
patient in waiting period post vaccine - received at 1738 p. Approx 6 pm, pt complained of not being able to take a deep breath. Was anxious prior to receiving vaccine. Skin warm, dry and pink. RR 18, BP  150/86, HR 72. States doesn't feel bad, but  was restless and states I cant take deep breath. Refused ED, asked patient to wait for additional 20 minutes or so. Gave water/snacks. After 20 minutes, pt reported feeling better and wanted to leave.
Recieved vaccine in L arm at 1015am At 1020 began to experience tongue tingling, "funny" feeling in mouth and throat nonspecifically. Chest pressure intermittently. Dry eyes, nausea, and slight dizziness all intermittently. Denies any chest pain, trouble breathing, tongue or lip swelling, dysphagia, numbness, or weakness. Gave Benadryl oral 50mg at 1050, showed slight improvement in all symptoms, but all symptoms were still present intermittently. Advised ER for further evaluation of suspected allergic reaction and to further evaluate and manage her symptoms (such as her chest pressure). She refused. She understands risks of not going include worsening condition or death. She will go to ER if her symptoms persist. She should NOT get the next vaccine without consulting allergist first. She was stable upon leaving.
After the hep b vaccination, the pt complained of trouble breathing, throat swelling with trouble swallowing. The pt was given Benadryl. Her blood pressure was 110/60. She was transported to the hospital and released home.
Syncope with what appeared as a short seizure.  Patient placed flat on floor and at that time he asked "Where am I"?  Respiration good, pulse good, no discoloration, no swelling , and not cold or clammy.  While tending to patient a tech-in-training called 911.  First responders arrived approximately 5 or 10 minutes later and followed up with the patient.  He states he has never had a reaction to a flu vaccine but does not like to see the shot being given.  He said that he could feel the medicine going into his muscle and it made him feel weird and doesn't remember anything after that until he asked "Where am I"?  He stayed another 10 minutes and said he felt fine.  His brother drove him home.
In a large area of left torso and left buttocks, a burning and stinging sensation just as if had a bad sunburn; In a large area of left torso and left buttocks, a burning and stinging sensation just as if had a bad sunburn; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep7533) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to food, medications, or other products. 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 vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6207) via an unspecified route of administration in the left arm on 11Mar2021 at 12:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. On 13Apr2021, the patient experienced a burning and stinging sensation in a large area of left torso and left buttocks, just as if he had a bad sunburn but there was no visible redness or rash. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. On 13Apr2021, the patient underwent polymerase chain reaction (PCR) COVID test and the result was negative. The clinical outcome of the events in a large area of left torso and left buttocks, a burning and stinging sensation just as if had a bad sunburn was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Daily intermittent dizziness. I have also gone from having maybe 1 headache every 6 months prior to vaccination to 3-4 headaches a week. My blood pressure has always been on the low side of normal but after vaccination is now high
vision loss; other zoster related injuries; Information has been received regarding a case in litigation from a lawyer and refers to a currently 71-years-old patient of unknown gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 01-JAN-2015, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, route, lot # and expiration date was not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequent (unspecified date), the patient was treated by a physician and other healthcare providers at a healthcare facility for the following injuries resulting from Plaintiff's zoster vaccine live (ZOSTAVAX) use: vision loss and other zoster related injuries. At the reporting time, the outcome of the events was unknown. Both events were related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event vision loss was considered to be medically significant.
Headache, Fever, chills, joint pain, Narrative:  headache was severe, symptoms lasted 48 hours NOTE- pfizer vaccine was administered at another facility:
I tested positive for COVID-19 12/20/22. I had a terrible headache, sore throat, and low-grade fever. I contacted my doctor and was prescribed Paxlovid. The major symptoms lasted for about two days, but the rest of the symptoms lingered for about four days. I feel like I have recovered but the symptoms from my other aliments are worse than normal.
Vaccine given on 01/15/2003.  Pt was in good health prior to receiving vaccine.  Approximately 2 weeks after vaccine, swollen lymph nodes.  Lymph nodes remained swollen but pt began having left shoulder pain after exercising on 02/18.  On 02/19 seen by provider and diagnosed with Leukemia.
Information has been received from a health professional concerning a patient who stated she had received a dose of pneumococcal vaccine 23 polyvalent in February 2001, when she received her tuberculin purified protein derivative, however nothing was documented in the chart about the patient receiving pneumococcal vaccine 23 polyvanet in February 2001. On 03/27/2001 the patient was vaccinated with a dose, presumably the second dose of pneumococcal vaccine 23 polyvalent. On 03/28/2001 the patient experienced swelling and redness of the upper arm. The patient was given prednisone and Benadryl and recovered. Additional information is not expected.
Patient passed out, fell to floor, got up in sweats, shaking. Patient was given water, orange juice, BP taken, BP rose with second reading, called paramedics, patient was checked out by EMS and was ok after 30 or so minutes. patient was able to go home by himself.
EXCESS SWEATING; FATIGUE; RUNNY NOSE; SORE THROAT; SNEEZING; A spontaneous report has been received from a consumer via the regulatory authority in regulatory authority concerning a 2 year old male patient with height of 96 centimetres and with weight of 13 kilograms.    No medical history was reported. No concomitant products were reported.    On 13-Nov-2020, the patient started receiving a treatment with Fluenz Tetra (influenza virus vaccine live, intranasal), via nasal route, for influenza immunisation.     On 14-Nov-2020, the patient experienced sore throat (preferred term: Oropharyngeal pain), sneezing (preferred term: Sneezing), fatigue (preferred term: Fatigue) and runny nose (preferred term: Rhinorrhoea). On 15-Nov-2020, the patient experienced excess sweating (preferred term: Hyperhidrosis).     At the time of reporting, the event of sore throat, sneezing and fatigue was ongoing. At the time of reporting, the event of excess sweating and runny nose was improving.     The events were considered serious (important medical event) by the reporter.; Sender's Comments: Oropharyngeal pain, sneezing and hyperhidrosis are not listed in the company core datasheet of Q/LAIV. Underlying rhinorrhoea could be contributory to the event of sneezing. Due to limited information on the circumstance leading to the events, clinical course of treatment given, relevant medical history, concurrent conditions, concomitant medications, other risk factors (underlying infections), detailed etiological and diagnostic workup, imaging studies, it is not possible to make conclusive assessment of the causal relationship of the events and the suspect drug.
Information has been received from a patient's mother concerning her 17 year old daughter with penicillin allergy and a history of erythematous multiforme (about 10 years ago) who was vaccinated with the first dose of GARDASIL on 04-MAY-2007, she received the second dose of GARDASIL on 06-JUL-2007 and then received the third dose of GARDASIL on 06-NOV-2008. Vaccinations also received on 04-MAY-2007 included a first dose of Hep A (manufacturer unknown) and a second dose of Hep A (manufacturer unknown) on 06-NOV-2007. Concomitant therapy included YASMIN and vitamins (unspecified). It was reported that the patient started complaining of extreme back pain that went from the head down to the spine in May-2008 and then on 22-SEP-2008 the patient started to have vision loss in her one eye, which eye was unspecified. The patient was then admitted to the hospital on 06-OCT-2008 because of the vision problem, she could not control her bladder, very moody, tired, extreme head and back pain. At the hospital she had spinal test done. MRI of her brain and spine, and numerous blood work was done. The patient was diagnosed with optic neuritis and is totally blind in the one eye, and was then sent home from the hospital on 11-OCT-2008. It was reported that the patient still was having problems with the back pain, she also had short term memory loss, she falls a lot, and had tingling and numbing of the hands and feet. It was noted that the patient still had most of the symptoms and they were trying to rule out multiple sclerosis. The patient's mother reported that lot # that she had was 655165/1425F, but she was unsure what dose that lot # was for. At the time of the report the patient had not recovered. Additional information has been requested.  1/06/09 Received hospital medical records of 12/16-12/17/2008. FINAL DX: blurred vision left eye, not optic neuritis; optic neuritis right eye.  Records reveal patient seen for loss of vision in right eye beginning 9/08 & tunnel vision left eye beginning 12/16/08.  Did not feel well day before admit & had bloody nose then developed tunnel vision left eye w/halos, nausea, photophobia, phonophobia, lightheadedness.  Exam revealed pain in eyes w/blurred double vision.  Neuro-ophtho consult done.   Tx w/steroids initially but d/c when neuroophtho determined not optic neuritis after review of MRI which revealed abnormality of right optic nerve.  2/18/09 Received hospital medical recods of 10/6-10/11/2008. FINAL DX: right optic neuritis Records reveal patient experienced right side visual change, fatigue, 8# wt gain, intermittent feet, back & wrist pain, urinary urgency & frequency.  Had been seen by PCP, chiropractor, neurologist & optometrist who noted pinhole & referred.  Exam revealed right cranial nerve II & III impairment w/vision 20/200.  LP done.  Tx w/IV steroids, no improvement & d/c to home on tapering oral steroids.  Was to f/u w/neurologist & PCP.
5JUL 8-10AM pt recv vax & 2PM high pitched screaming started & lasted until 7JUL a/showed any improvement;pt was seen by pediatrician & given med to attempt to alleviate this but mom said it was ineffective;had swelling in lt leg;
Within 5 minutes, burning and swelling in throat, cramps and diarrhea, flushing and hot neck and face, rash on chin and face. Responded to Benadryl and Ventolin.
Extreme chills starting around 10:00 pm.  Awakened at 3:00 am with violent vomiting for 30 minutes.  Unable to stand.  Remained in bed with chills and nausea until late morning.  Unable to eat but drank liquids.  Able to stand and eat lightly by afternoon.   After 24 hours lightheaded with unsettled stomach.  Returned to normal after 72 hours.  Had similar reaction to second dose of Moderna vaccine
I awoke terrified in the middle of the night with my heart POUNDING. My mental state was one of impending doom, that something terrible was about to happen. Somehow I knew that I could calm my heart rate by doing yoga breathing, so I began to take intentional, long, slow breaths. This indeed calmed me. I have NEVER experienced anything like this, never had an anxiety attack (if this was indeed what was happening.)
LEFT RIB PAIN; GROGGY; LEGS FEEL HEAVY; PULSATING MUSCLE LEFT ARM; FEELS LIKE BUG CRAWLING THROUGH SKIN; BODY ACHES; CHATTERING TEETH; SEVER BILATERAL LOWER LEG PAIN; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included mild infection of covid 19, and headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced groggy. On 10-APR-2021, the subject experienced legs feel heavy. On 10-APR-2021, the subject experienced sever bilateral lower leg pain. On 10-APR-2021, the subject experienced pulsating muscle left arm. On 10-APR-2021, the subject experienced feels like bug crawling through skin. On 10-APR-2021, the subject experienced chattering teeth. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-APR-2021, the subject experienced left rib pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left rib pain, fever, body aches, and headache on 12-APR-2021, was recovering from sever bilateral lower leg pain, had not recovered from pulsating muscle left arm, feels like bug crawling through skin, legs feel heavy, and groggy, and the outcome of chattering teeth was not reported. This report was non-serious.
pt was seen 11AM for well baby exam-vax given w/no problems;mom lived close by-took pt home for nap;pt was taking bottle of juice & started shaking body, arms & legs sl stiff & then slept for a few mins w/in 20mins p/vax; seen again no temp
Redness and swelling to injection site (DTAP), 7cm X 8cm at 2 days, post vax. Rechecked on 7/27 and 7/28/00; examined by provider.
Swelling, itching, dull pain in area of shot, highness of throat. Lasted for and is still going on for a week. 7 days after the shot.
Case number PHEH2011US05993, is an initial spontaneous report from a nurse on 04 Oct 2011: This report refers to an adult female patient. She was vaccinated with FLUVIRIN 2011/2012 (batch number 1102101) intramuscularly on 02 Oct 2011. On 03 Oct 2011, she experienced a herpes breakout. Outcome of the event was not reported.
8 x 10 cm injection site erythema, warmth, tenderness, central clearing.
This is a spontaneous report from a Pfizer-Sponsored Program, from a non-contactable consumer reporting for himself. This male patient of an unspecified age, race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration in Mar2015 for immunization. The patient medical history and concomitant medications were not reported. The patient experienced bad hives and he became photo sensitive in Mar2015. Therapeutic measures (over the counter medications) were taken as a result of bad hives but they did not help. The patient was not recovered from bad hives, outcome of photophobia was unknown. No follow-up attempts are possible. No further information is expected.
2wk p/vax pt devel a high fever & felt really sick;no further details were provided;
What started was the bleeding. I usually have a regular amount of menstrual cycle. But when it started it was very excessive. It was about 4 weeks non stop heavy bleeding. then once it stopped, It would start back after 2 weeks. My hemoglobin also started to stop. I had a episode of dizziness and I fainted. I had to go to the hospital. My symps did continue after I came back home.  I spoke with a cardiologist and prescribed an iron transfusion- it took care of the symptoms.  After my booster, It started again. I started to have heavy bleeding again. That was also followed by fatigue.
9-27-13 - AFLURIA # R55808 Exp 6-30-14 approx. 15 minutes post injection, experienced facial numbness and (L) arm weakness took BENADRYL 25 mg PO several times throughout next 48 hours - symptoms resolved.
Bell's palsy diagnosed at ER on 9-10-14 vaccination on 9-8-14, symptoms 9-9-14.
Chills. Spontaneous recovery after about 1 hour. Sores in the injection region. Spontaneous recovery after two days.
pt recv vax; red pimple 1 wk p/ vax w/ pain; irregular raised, erythematous tender lesion; hemangioma; dx of pyogenic granuloma;
Pt recv vax on unknown day; post vax pt exp vax site rx of redness & swelling; 1 wk post vax pt exp flu;tx=Benadryl
Several hours after the shot my face, ears, neck and below the neck area  became bright red and extremely hot. This disappeared after around 45 mins. Each day for the next 6-7 I had 5-10 minute recurrences, sometimes mostly my ears. ( I also had fatigue, but that's a normal reaction.). I had this same reaction after my second shot 8 months ago, but I don't recall that it persisted past the day of the shot.
Spreading redness and itching, treated with Keflex 500 mg QID X 10 days.
Pharmacist gave expired vaccine of PNEUMOVAZX 23 to me.  Vaccine expired 3/19/2016, vaccine given 04/20/2016.
Administered 0.5 mL of FLUZONE to 2 year 3 month old child instead of 0.25 mL.
I just described in detail on a previous page. I have Peripheral Neuropathy and nerve damage in my lower legs due to the Covid Vaccine.
Severe pain in right shoulder and upper arm (on-going). Inability to use right arm for normal activities of daily living -- for example, dressing and bathing (3 weeks duration). Low-grade fever (circa 99.4 degrees) through 10/08/2017.
Developed chills, fever 100.6, achy, nausea, hurt to move several days, sleepiness, fatigue, achy joints. Fever broke 12/19/20. 1/20/20 fever 99.3. 12/24/20 Working but still fatigued.