chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Pfizer LOT FT142 kept in fridge BUD. Received 7/26/22 and administered 11/30/22.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium
While, receiving the Covid vaccine with the needle still inserted, felt a significant amount of liquid drip down my arm and unsure how much of vaccine was administered.
Dizziness; Night sweats; Shoulder was sore; Chills; Headache; Fatigue; Body aches; A spontaneous report was received from a Healthcare Professional concerning a 84-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shoulder soreness, chills, dizziness, headaches, fatigued, body aches, and night sweats.   The patient's medical history was not provided. Concomitant medications reported were Rivaroxaban, Omeprazole, Centrum, Vitamins, B12 supplement for drug use for unknown indication.  On 18-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 18-Jan-2021, the patient experienced the events shoulder was sore, chills, dizziness, headaches, fatigued, body aches, and night sweats.  Treatment details included Aspirin.  Action taken with mRNA-1273 in response to the events was not reported.   On 19-Jan-2021, the outcome of events, chills, dizziness, headaches, fatigue and body ache was recovered/resolved. On 22-Jan-2021, the outcome of event shoulder soreness was recovered/resolved. The outcome of event night swats was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Guillain-Barre-Landry Syndrome (AIDP). Presented with paresthesia's, loss of Deep Tendon Reflexes, and proximal > distal LE weakness. Placed on IVIG on 3/4/2021 with improved symptoms of LE weakness but noted residual abnormal sensation
p/2nd dose had a lot of tingling in arm; was tired & not feeling well; consultation w/MD say if tingling do not give next dose; instead have blood for antibody production;
She couldn't move or stand.; And she couldn't talk for 8-9 hrs; She couldn't move or stand.; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection (Lot number was not reported expiry date was not reported) via an unspecified route of administration on an unspecified dose, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 03Jun2021 patient experienced she couldn't move or stand, she couldn't talk for 8-9 hrs and she couldn't move or stand. The outcome of the events was unknown.  Product Complaint: There is no product complaint associated with this case  Information on the batch/lot number has been requested.
she was in bed "for 4 days" after booster; This is a spontaneous report from Regulatory Authority via pharmacy. A contactable nurse and consumer (patient) reported that a 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunisation; tofacitinib citrate (XELJANZ, Expiration date: 30Jun2023), oral from 12Aug2021 to an unspecified date, at 5 mg, twice a day (60/BTL) for an unspecified indication. Medical history included allergy to penicillin, allergy to animal, allergy to horse Products. Concomitant medication(s) included temazepam (capsule, strength: 15 mg) at 15 mg; methotrexate (tablet, strength: 2.5 mg) at 2.5 mg; tramadol HCL (tablet, strength: 50 mg) at 50 mg; vitamin B complex tablet; vitamin D3 (capsule, strength: 10 ug) at ug; estrogens conjugated (PREMARIN, tablet, strength: 0.3 mg) at 0.3 mg; leucovorin calcium (Tablet) at 5 mg. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unknown route on an unknown date as dose 1, single for Covid-19 immunization, received second dose of dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unknown route on an unknown date as dose 2, single for Covid-19 immunization. Patient states that doctor stopped Xeljanz for 2 weeks due to Pfizer Covid booster shot, Patient was scheduled for vacation and did not miss work but states she was in Bed "for 4 days" after booster. The action taken in response to the event for tofacitinib citrate was temporarily withdrawn on an unknown date. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
having some symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having some symptoms) 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 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (having some symptoms). At the time of the report, VACCINATION COMPLICATION (having some symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Severe headache, nausea, weakness, fever and chills.  Only headache remains 2 days later.
This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX (dose, route of administration and lot# were not reported). On an unknown date, two days after receiving the ZOSTAVAX, the patient developed retinopathy in an unspecified eye. No product quality complaint (PQC) was involved. The outcome of the event of retinopathy was not reported. The causality assessment between the event of retinopathy and ZOSTAVAX was not provided. Additional information is not expected as the reporting physician did not want to be contacted.
Achiness, lethargy, fever for 2 days, with arm soreness of 1 weeks duration
Pt recvd vax 22JUN91 & devel redness around inject site;
BELL'S PALSY; This spontaneous report received from a patient via a company representative via concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 31-MAY-2023, the patient was diagnosed with bell's palsy. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of bell's palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230606764- Bell's palsy. The event has an unknown/unclear temporal relationship, and is labeled. There are no other factors more likely to be associated with the event than the vaccine. Therefore, this event is considered consistent with vaccine administration.
1450- pt requested assistance for tachycardia, tingling lips and dizziness. Requesting benadryl, 50mg given PO. VS 128/54, P90, 20R, 98% sat. 1500- increased dizziness, throat tingling. VS 130/89, 104P, 24R, 98% 1508- increased throat tingling, "hard to breath" declines epi or EMS to be called. 1511- self-administered epi pen, EMS notified. 1516- remains light-headed/dizzy, resp adequate at 22/min, O2 sat 98% 1524- speaking clearly, remains fully conscious. Resp regular. Lungs CTA, MM pink. VS 130/70, 83P, 20 R, 98%sat 1530- Await EMS arrival. Pt able to easily talk on phone with family member. Still c/o itchy throat and lips. 1535- EMS here, pt escorted out building with EMS at 1537.
After MENACTRA injection. Child had brief syncopal episode. Lasted about 30 seconds, then alert, normal neurologically.
I already suffer from migraines, Tuesday or Wednesday after I recovered from the normal vaccine symptoms my face went numb , my right side of my body went numb and tingling like as stroke and I had a migraine, I called 911 , Paramedics said I wasn't having a stroke, later that I went to the Urgent care because the symptoms did not go away , they referred me to ER to get an MRI.
DOB: 11/06/1994.  Received her second dose Pfizer vaccine (LOT#: EW0179 EXP: 8/2021) at 1426 on 5/10/21. Patient alerted one of the ancillary at site and stated that she was not feeling well. Ancillary staff alerted EMT Cand EMT. EMT's sat patient down on zero gravity chair. Patient stated that she felt a burning sensation in her chest and her throat about 10 minutes after the vaccine. PHN  arrived on scene and offered patient water and asked EMT to take patients vital signs. EMT took vital signs at 1500. BP: 130/82, HR: 83, RR: 22, O2: 100%. Patient stated that she has a history of anxiety and does not take medications for her diagnosis. Patient was ANOX4, skin warm, normal. Patient stated that breathing slowly, drinking water and talking are her coping mechanisms for her anxiety. PHN asked patient to stay an extra 30 minutes for observation. EMT reassessed patient and re-took vital signs at 1515. BP: 116/65, HR: 62, RR: 20, O2: 100%. Patient stated that she no longer had any burning sensation but still felt anxious. EMT reassessed patient and re-took vital signs at 1530. BP: 111/61, HR: 75, RR: 20, O2: 100%. Patient stated that she no longer felt any burning sensation but still felt anxious. Patient had completed observation time but asked to stay a little longer. Patient stayed 8 minutes extra. EMT reassessed patient. Patient stated she was feeling better and no longer felt anxious. Patient was educated on worsening signs and symptoms of side effects of the vaccine and when to seek help from EMS. Patient verbalized understanding of education. Patient left vaccination site at 1538 unassisted with a steady gait.
2 days following vax pt states awoke AM 3MAR94 w/swelling of baseball @ inject site; called MD & APAP & DPH given; 4MAR94 swellling dec-pain gone;
Client received Moderna 1st dose, then schedule and received a second dose of Pfizer.
Shoulder, neck, arm pain - continuous, no relief. Issues lifting arm in certain positions, turning head, positional pain while sitting, standing, sleeping. Shot given too high up in my arm. Have picture of the bruised site - possible nerve damage/neuropathy
DAY 1 / a few bumps on my calfs, progressing day by day Day 5 / countless bumps, open sores, unbearably itchy on lower legs and healthcare provider completely baffled / no solution 5 weeks later I still have a terrible rash on my legs and arms // very scary
On Mar. 5, 2021, the left arm area of injection started itiching, swelling (from shoulder to elbow) and sore to touch, area of skin was also hot.  Starting Mar. 12th. condition worsen, symtons extended from( shoulder to wrist). I started applying Itich Cream and applyed Ice pack. As of today,  symptons are not as survier, but still exist.  Are these symptons something I should be concerned about? I'm scheduled for second vaccination 03/25/2021.
tsunami diarrhea, nausea and vomiting.. went to er x2 for hydration. tried immodium, antibiotic( unable to keep down). as of this date I am due to see a gastroenterologist for intermittent diarrhea. waiting for appt. this was recommended a few months ago. But as long as i saw an improvement I wanted to wait. But it continues to be a problem. So am waiting  for release of information papers.
got Covid Infection after receiving the Moderna vaccine 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got Covid Infection after receiving the Moderna vaccine 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got Covid Infection after receiving the Moderna vaccine 1st dose). At the time of the report, COVID-19 (got Covid Infection after receiving the Moderna vaccine 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report was received from a consumer via company representative referring to a her daughter: female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, frequency, route of administration and indication were not reported). On an unknown date, the patient developed tachycardia and experienced cardio-pulmonary issues. The outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested.
Information has been received from a health care worker concerning a patient "over 55 or 60 years of age who "two weeks ago" was vaccinated with a dose of Pneumovax 23 (lot # 651399/0486F). Subsequently, the patient experienced redness and swelling at the site of injection. The patient was reportedly recovering. Additional information has been requested.
Patient called pharmacy to report she was having numbness, stiffness, and tingling in her arm that starts and stop but dose not seem to go away. She also reported rash under the left eye, right side of the eye. Patient indicated she was going to see her physician for an evaluation.
I woke up on 04/03/2021 with ringing in my ears. I didn't remember when I mentioned it to my doctor and told him my ears had been ringing since the vaccine. He said it could be from inflammation. I had seen that other people had been reporting it. My doctor said I should probably see an ENT. I saw them around 6 months later around, November of 2021. They said I had hearing loss. They tried me on steroids for 10 days and they did not work. Then I went for a hearing test again and I still had this hearing loss, but it was unequal. So, they had me get an MRI of my brain and now I need to go back this summer. They said I could go get hearing aids and that might help because there is no cure. In October I developed Shingles. I was treated when I visited an urgent care. In January of 2022 at I was diagnosed with Graves' disease.
Normally it's a very mild case but sometimes it a full blown case of the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer and transmitted to Sanofi on 11-Oct-2020.  This case is linked to case 2020SA294157 and 2020SA294125.  This case involves an unknown age patient reported normally it's a very mild case but sometimes it a full blown case of the flu (Influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) 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 not reported.  On an unknown date, (latency unknown) the patient reported normally it's a very mild case but sometimes it a full blown case of the flu (Influenza) after the administration of influenza vaccine.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.
severe headache,  chills, achy bones,  injection site very hard, painful and itchy still. These symptoms were nearly as bad as the ones I had when I had Covid Nov/2020.
Achy muscles, sore skin, dizziness, nausea, headache, full body aches, flue like symptoms, difficulty breathing, chest compression feeling, tightness, lasted all day the following day, headache last fro two days
This si spontaneous report as received from a 63 year old female patient refers to herself. The patient's current condition included stress. On 13-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX injection (route, strength, lot number and expiration date not provided). Concomitant therapies included sulfamethoxazole (+) trimethoprim 800/160. The patient experienced shingles symptoms including rash and pain on torso, after receiving ZOSTAVAX. On 28-DEC-2013 the patient began to experience significant pain in her side. She visited the Emergency Room. On 30-DEC-2013, in the emergency room, she was tested and diagnosed with a possible urinary tract infection, after also being tested for kidney and gallstones. The patient noted that she had no symptoms of urinary tract infection (UTI) but did not think her pain was the result of shingles, until she also experienced a patch of rash on her stomach, which was very sensitive. The rash then also appeared on her back, accompanied by intermittent itch and pain. Urine specimen and sonogram were performed (result unknown). An ibuprofen (OTC product) was given for treatment of events. The patient planned follow-up with her physician to see if anti-virals could be prescribed. The outcome of events was reported as not recovered/not resolved. The relatedness between vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 11Sep2021 as dose 3 (booster), single (Lot number: F3183) at the age of 41 years, in right arm 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: METOPROLOL; LEXAPRO; CLARITIN [LORATADINE]; FENOFIBRATE; FLONASE [MOMETASONE FUROATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Positive COVID test 6 days after testing negative; (2022) Positive, notes: Positive COVID test 6 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details product: COVID-19 Treatment, brand: Plaxovid, treatment start date: 10Jul2022, treatment stop date: 14Jul2022, indication: Treatment of COVID-19. Positive COVID test 6 days after testing negative, patient recovered, No Known allergies, Device timestamp: 22Jul2022.
Headache, NauseaVomiting, "Prick on heart abut once an hour" . Not associated with any other Cardio/Pulmonary sx. Light headed. Fatigue Narrative:
Patient reported Rapid or abnormal heart beats ever since she got the vaccine and been feeling uncomfortable. The episodes are random.
Called by observation nurse to see client who complained of lightheadedness after receiving 2nd dose of vaccine.  Client was alert and talking.  Given ammonia to smell and sips of H2O.  VS BP 73/34, P 66, O2Sat 98%, Client legs were elevated w/ little improvement.  Said she felt better after decreased dizziness.  Vital signs taken at 11:25am: T 94.4, O2Sat 90%, Pulse 59, client appeared less lethargic and did not voice any new complaints.  Given water for hydration as BP was 71/48.  At 11:30am Rescue arrived from previous call made.  Client stood up with ambulance tech and walked to ambulance where she was evaluated.  Dad was with client throughout visit and  with ambulance personnel. Mgr. and writer was informed that client would be going home with her father at 11:47am.
(L) upper arm-large area of redness, blanching and irregular in contour, no pain (Local reaction to immun-no treatment given).
Pt stated that since she has had her 1st dose her blood pressure has lowered. She thinks this could be from the vaccine
Extreme pain shooting down left arm that started after 3 days and has gotten worse every day. Now is unbearable
Patient received the vaccine on 09/15 and woke with a 2 inches long rash on left deltoid injection site on 09/22 morning with swelling and pain on the site
Body aches and chills, no fever.  Felt poorly. Sent home from her shift.
There was a sudden onset of high fever. (over 105). He had difficulty breathing and seemed to be fading in and out.  Prior to and after the fever was brought down he was fine.
PATIENT'S MOTHER CALLED IN ON 12/11/09 STATING THAT PATIENT HAD A RASH TO HIS CHEEKS.  RED IN COLOR, BUMPY.  NO ITCHING, SHORTNESS OF BREATH, OR FEVER.  SAME DAY APPOINTMENT OFFERED, PARENT DECLINED AND SAID SHE WOULD BRING HIM IN IF SYMPTOMS WORSENED.
PATIENT RECEIVED THREE DOSES OF COVID VACCINE ACCORDING TO CITY WIDE IMMUNIZATION REGISTRY.  2 DOSES MODERNA AND ONE PFIZER 1: MODERNA 4/17/2021 2: MODERNA 5/15/2021 3: PFIZER 7/19/21
Pt began an uncontrolled, screaming cry 1 hour post vax. This lasted 4.75 hours, from 11:00-15:45.
This case was reported in a published article, regarding a 60 year old woman, who claimed that the RECOMBIVAX HB (manufacturer unspecified) thimerosal containing caused her three separate autoimmune disorders, she had not proved that she had any of them, a vaccine court special master ruled in a decision made public on 13-APR-2010. The patient claimed she suffered from transverse myelitis (TM), chronic fatigue syndrome (CFS) and systemic lupus erythematosus (SLE). A Special Master said that the patient did not satisfy the diagnosis criteria for those conditions. For example, the special master said that a magnetic resonance imaging (MRI) study of the patient's thoracic spine showed atrophy, instead of a lesion that would have been diagnostic of transverse myelitis. There were no diagnostic tests for CFS, the special master said, but the petitioner failed to rule out conditions that may produce chronic fatigue, including nutritional deficits such as the petitioner's vitamin B12 deficiency. The patient did not raise the possibility of lupus until eight years after filing her initial petition. Special Master said and she failed to establish diagnostic criteria for that as well. For example, the special master said that the patient did not exhibit a malar rash, described as "fixed erythema, flat or raised. Over the malar eminences, tending to spare the nasolabial folds", or a discoid rash, described as "erythematous raised parches with adherent keratotic scaling and follicular plugging; atrophic scaring may occur in older lesions". It was mentioned that "at best, the petitioner fulfilled three of the eleven criteria for a diagnosis of systemic lupus erythematosus". Special Master said. "The three criteria that petitioner satisfied are oral ulcers, hematological disorder and antinuclear antibody. Petitioner must fulfill at least four of the eleven criteria to satisfy the diagnostic criteria for SLE. Thus, the patient did not suffer from systemic lupus erythematosus, a finding that petitioner did not present a preponderant amount of evidence indicating that she suffered from SLE was consistent with the work of her treating doctors. From the period of 1997 to 2007, none of the patient's treating doctors diagnosed her as suffering from SLE. Two of the patient's treating physicians considered lupus and ruled it out". Upon internal review transverse myelitis and systemic lupus erythematosus were considered other important medical events. Additional information is not expected.