chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Little lightheaded; Tired; Got the Pfizer vaccines 1st dose-03/04/2021 and 2nd dose 03/24/2021 (less than 21 days in between doses).; Got the Pfizer vaccines 1st dose-03/04/2021 and 2nd dose 03/24/2021 (less than 21 days in between doses).; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (Patient). A 76-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 24Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history included chronic lymphocytic leukaemia (he was diagnosed 14-15 months ago with CLL, He had a spleen that was measuring 22cm and was pushing his stomach out. He has moved from Stage 2 to Stage 0), dental disorder nos, orthopaedic, heart issues from an unknown date and unknown if ongoing. The concomitant medications included ibrutinib (IMBRUVICA) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 04Mar2021 (at the age of 76-years-old) as dose 1, single for covid-19 immunisation. On unspecified date, the patient experienced sore arm, little lightheaded, tired and got the pfizer vaccines 1st dose-03/04/2021 and 2nd dose 03/24/2021 (less than 21 days in between doses). The patient asked that hopefully after the two initial doses and the booster I'm hoping to have some immunity. The patient also asked about data on patients with CLL or leukemia. He was confused, if there is a way to test for efficacy after the vaccine or not. On an unspecified date, the patient underwent lab tests and procedures which included blood immunoglobulin g: the first was an abigg, spike s (was a little arrow to the left less than 1), blood test: good (controlled by Imbruvica), investigation resulted negative (He had the immunity test to check if he gained immunity to the shots, like Corona IGG /Sars Covid 2 IGG spikes both came out negative), lymphocyte count resulted 50-60% lymphocytes, sars-cov-2 antibody test resulted negative (He had the immunity test to check if he gained immunity to the shots, like Corona IGG /Sars Covid 2 IGG spikes both came out negative and the little arrow read to the left of 1.4. and then later were 0.04 and 0.02 readings), sars-cov-2 antibody test: the first was an abigg, spike s (the reading was a little arrow to the left less than 1) and white blood cell count resulted 16k. The outcome of the events was reported as unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
DEEP VEIN THROMBOSIS; RED SPOTS ON RIGHT LEG; This spontaneous report received from a consumer concerned a 66-year-old white and Non-Hispanic or Latino male. The patient's height and weight were not reported. The patient's concurrent conditions included hard of hearing, and other pre-existing medical conditions included, patient had no comorbidities condition, was not overweight and was very healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A and expiry: UNKNOWN) dose was not reported, 1 total dose administered on 22-MAY-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in 2021, about 5 days later after vaccination, patient started getting red spots on both legs, but the spots on the right leg went away later it became worse next day. On an unspecified date, patient experienced the pain which became bad and when reporter looked at it she thought it was cellulitis because it was hot, red and swollen. The Patient had swelling from the knee down and experienced lot of pain in his knee. The patient was sent to outpatient clinic where the ultrasound was done on 02-JUN-2021 and DVT (Deep vein thrombosis) was diagnosed. The blood clot was behind the knee of patient. The patient visited the emergency room but since he had no comorbidities condition he was not admitted and was sent home with medication. The patient was given Eliquis as a treatment drug for the event. The reporter mentioned that the medication was expensive, and the patient was on Medicare and there were programs to help with it. The reporter mentioned that medication can put the patient at risk of kidney failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red spots on right leg on 2021 and had not recovered from Deep vein thrombosis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210607591- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Deep Vein thrombosis- This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Area of swelling and pain approximately 4 in by 5 in. Hot to the touch with a temperature of swelling at 101 degrees Fahrenheit. Dr called and she stated that it looks infected possibly cellulitis.
pt recv vax; pain "shooting down arm into hand"; swelling & heat to lft deltoid; approx 92x92mm area; no redness noted;hx of fever 1st hr p/ vax; tender & painful; edema x 7 days; still sore on 8th day p/ shot;MD suggested ice & ibuprofen;
Local skin reaction at injection site, redness and swelling, few hives. Irritated area measures 2.5 inches long by 2 inches wide. Patient claims it hurts and at touch it is warm and hard. Flushed face and increased tiredness.
11:00pm, Monday, 2/8/2021 began 3 hours of chills (no fever). Next day I stayed in bed entire day with extremely sore joints (ankles, knees, wrists, fingers, shoulders), sore muscles (everywhere), headache (all day and into Tuesday night ), extreme fatigue. Mostly in and out of sleep.  Third day, Wednesday, symptoms mostly gone except for fatigue and headache which lasted for a  couple of  days longer. No fever or nausea at all.  No treatment. Took Advil for headache Wednesday morning.
Left eye central vision loss; Back pain; Hip/Knees pain; Blurred vision; Limping R leg; This is a spontaneous report from a contactable nurse (patient).  A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly administered in Deltoid Left on 21May2021 11:52, at 50-year-old, as single dose (Lot Number: EW0183) for covid-19 immunisation.  Medical history included eye surgeries stagBlue for over 12 years until after the COVID shot. Concomitant medication included influenza vaccine inact split 3v (FLUARIX) taken for an unspecified indication, via intramuscular in right deltoid, at 50-year-old, as single dose (Lot number: 59HN3) on 01Apr2021. The patient had not got covid prior vaccination and had not been tested covid post vaccination. No Known allergies. On 21May2021, the patient experienced blurred vision and limping right leg. On 22May2021(reported as "22May - 24May"), the patient had left eye central vision loss (medically significant and disability), back pain (disability), hip and knees pain(disability). The patient underwent lab tests and procedures which included angiogram: retinal surgeon did angiogram and confirmed revascularization on 2021; Fluorescent Angioscopy: left subretinal revascularization on 27Aug2021; CT (Computerised tomogram) Scan Head Brain: normal and No mass. No stroke on 28Jun2021; Eye pressure: 24 (patient's normal was 10-14) on 27Aug2021; Rheumatoid lab tests: normal on Jul2021; magnetic resonance imaging (MRI) spinal: bulges spondylosis, subcentimeter csf cyst and facet degeneration Disc bulge. Foramen narrowing on 12Sep2021; Hip and Knees X-rays: normal on 28Jun2021. The patient had an emergency room visit for events left eye central vision loss, back pain, hip and knees pain. Therapeutic measures were taken as a result of all events, included: Avastin 1.25mg Eye injection for left eye central vision loss; CT, MRI Physical medicines, ortho referral, oral medicines for pain. The outcome of events left eye central vision loss, Back pain, Hip and Knees pain and limping right leg were not recovered. The outcome of event blurred vision was unknown. The case was reported as serious due to medically significant and disability condition.  Follow-up attempts completed. No further information expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of central tunnel vision , arthralgia and back pain cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101252495 same patient/drug, different dose/AE
This spontaneous report was received from a nurse regarding a 62 years old female patient with an unspecified cancer in remission. On 29-APR-2013 the patient was vaccinated with a ZOSTAVAX (lot number and expiration date not reported), (subcutaneous, single dose, dose not specified). No other suspect therapies were reported, no other concomitant medications were reported. The nurse reported that the patient developed blisters around the injection site after administration of ZOSTAVAX on 29-APR-2013. The blisters developed immediately after the patient left the doctor's office as she was driving to a previously scheduled office visit with her unspecified oncologist. The oncologist prescribed VALTREX. The outcome for blisters around injection site was unknown at the time of the report. No lab diagnostics studies were performed. It was reported that the patient sought medical attention by an office visit. The reporting nurse did not assess the causality between ZOSTAVAX and blisters around the injection site. Additional information has been requested.
<1hour after Varivax, MMR, Hep B, Emesis w/10mm. Then Emesis x3. Father describes him as red and s/w, sleepy. No previous reactions-no known egg allergy, referred to ER. Given steroids and Benadryl. No Epi needed.
ACID REFLUX NIGHT OF VACCINE.  TIGHTNESS OF THROAT FOR ABOUT 45 MINUTES.  TOOK GAVISCON AND WATER.  WRETCHED UP "WHITE STUFF."  HEART PALPITATIONS FOR 4-5 DAYS.  ACID REFLUX STILL ONGOING.
My arm is hurting me and I have already taken two Advil; Having bad pain in my left arm; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old patient received bnt162b2 (BNT162B2), administration date 19Oct2021 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization, reaction(s): "First two were very severe with allergies"; Bnt162b2 (Second dose), for COVID-19 immunization, reaction(s): "First two were very severe with allergies". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Oct2021, outcome "unknown", described as "My arm is hurting me and I have already taken two Advil; Having bad pain in my left arm"; DIZZINESS (non-serious) with onset 19Oct2021, outcome "unknown", described as "Dizziness". Therapeutic measures were taken as a result of pain in extremity, dizziness. Additional information: When probed if this is the first time consumer called in Pfizer Drug Safety, consumer stated, "No, Patient had  gone in already three times, this one is the less severe reaction, the first two were very severe with allergies (event captured as per verbatim) and patient had to take Benadryl (treatment) for that but this one is not severe as the first two that had." (further not clarified appropriately if consumer called in Pfizer Drug Safety earlier, hence report type captured as-initial report), no itching.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX instead of VARIVAX. Concomitant therapy included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, polio vaccine, VAQTA and MMR II. No adverse experience were reported. Additional information has been requested. The patient's sibling had the same (WAES # 0708USA01715).
09/01/21 The patient presents with COVID-19 infection. 36 year old male presents to ED for multiple symptoms, secondary to COVID-19 infection x11 days ago. Pt reports he is experiencing fever, chills, cough, sob, body aches, rigors, loss of taste/smell, and diarrhea. Pt presents to ED today for persistent symptoms. Pt is COVID-19 vaccinated.  Shortness of breath, body aches, congestion, HA, loss of taste and smell. The patient is a 36-year-old male with a history of stage IV non-Hodgkin's lymphoma currently on chemotherapy that presented to the emergency department due to COVID-19 symptoms.  Patient was diagnosed with COVID-19 a on 8/22.  Began having symptoms 3 days prior.Takes oral chemo daily x3 weeks and 1 week. Notes cough, shortness of breath, fevers, chills, body aches, loss of taste and smell and diarrhea.  Has had post-tussive vomiting and notes pain with deep inhalation.  He presented today due to increased symptoms and elevated fever.  Received COVID-19 vaccine in March and April of 2021, Moderna.  On arrival to the ED found to be hypoxic at 86%.  Temperature 103.3° F. Mother and father currently infected with COVID-19.
sharp pains in arm; large knot @ site; area of shot very hot to the touch; pt ended up in ER:
Client stated she can eat cooked eggs. Client given, 25 cc FLUZONE IM, a 1/2 a dose. Within about 30 seconds and 1 minutes; client developed severe SOB, chest tightness and pain; client given epinephrine 0.5 mg (.5 cc) followed by BENADRYL 50 mg IM and 02 2l. By the time the ambulance arrived; she recovered.
Information has been received from a pharmacist (Pharm. D.) concerning a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 30-AUG-2016, the patient was inadvertently vaccinated with an unspecified expired dose of PNEUMOVAX 23 (lot number L002310 with expiration date of 08-JUL-2016 (strength, dose, route of administration and anatomical location were not reported). Other suspect and concomitant medications were not provided. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Syncope the day after vaccine. She has episodes of fatigue, dizziness starting after the first vaccine GARDASIL 5/15. Previously healthy.
at approximately 10:00 a.m., the following day after my injection,  I started to get a headache.  I had it the whole day.  In the evening, I experienced chills all night with no fever. I also experienced fatigue the next day.  The whole day.  I even felt a little lightheaded.
No additional AE; Office manager informed T/E and also administered vaccine ROTATEQ. T/E CASE 02379617. No additional AE/PQC.  ROTATEQ: lOT NUMBER : I879870  exp DATE: 10/15/2023 TIME: 8 Hours 25 Minutes 0 Seconds TEMPERATURE: BELOW 36°F (24.0F) for 2 hours 58 minute; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 18-APR-2023, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (dose not reported) lot number reported as I879870 and expiration date 15-OCT-2023, but upon internal validation was confirmed as 1879870, expiration date 16-OCT-2023 oral for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion was of 24 degrees Fahrenheit (°F) for 2 hours and 58 minutes, -40°F for 1 hour and 47 minutes, 16°F for 1 hour and 40 minutes and 17.6°F for 30 minutes. No other excursions were detected.; Sender's Comments:  US-009507513-2305USA000768:02380645
DIZZINESS/DIZZINESS WHILE MOVING HEAD OR BODY; VERTIGO; FEELING RUN DOWN/GAS ME OUT OR MAKE ME FEEL FAINT; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: possible penicillin allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient reported little to no reaction right after vaccine administration. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 23-AUG-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol. On APR-2021, the patient experienced feeling run down/gas me out or make me feel faint. On 10-APR-2021, the patient experienced dizziness/dizziness while moving head or body. On 10-APR-2021, the patient experienced vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness/dizziness while moving head or body, and the outcome of feeling run down/gas me out or make me feel faint and vertigo was not reported. This report was non-serious.
Initial information received on 31-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA212665, 2018SA212615, 2018SA212638 and 2018SA212648 (Same reporter). This case involves a 7-month old male patient who was vaccinated with third dose of PENTACEL (Batch number: C5529AA, expiration date: 04-Oct-2019 via unknown route in unknown administration site on 23-Jul-2018. Concomitant medications included HEPATITIS B VACCINE RHBSAG (HEPA-B) for Immunisation; and PREVNAR 13 for Immunisation. It was an actual medication error due to inappropriate reconstitution technique. It was reported that a lyophilized powder portion of Act-HIB that was not given from a box of 5 single doses of PENTACEL and the reporter was unsure which one of the 5 patients who received doses from this lot didn't get the ActHIB portion. It was reported that the patient had no reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Pt complained of pustules in mouth (roof & sides) after getting a flu vaccine - several hours later - was itchy - & ached all over - tongue swelled.
Patient given Moderna Covid vaccine that had expired on 04/16/22. Vaccine was given to patient on 04/22/22. Patient declines any SOB, Wheezing, or throat closer. Vaccine manufacture contacted and review has been started. At this time, do not know yet if patient needs to be revaccinated.
received her vaccine @ 3:00pm on 9/7/21.  Around 7: pm  came to tell me she was having problems with her speech.  Then by 7:30 pm she was having trouble breathing.    speech was slurred and was having a hard time getting her words out.  Chest hurt to breathe and her hands were very cold to touch .  Her hands were numb.   was transported by ambulance to the  Hospital.   was admitted to the hospital for 2 days.  Labs, X-RAY,  CT scan,  Doppler done, heart monitor,
pt recvd vax 6SEP95; status epilepticus; 11SEP95 cerebellitis; ?acute diffuse encephalo-myelitis; workup in progress; ? etiology; accompanied by hepatits, DIC, bloody diarrhea;
Immediately after vaccine pt began feeling lightheaded, shakey legs, chest tightness and warmth. Denies tunnel vision, hearing changes and shortness of breath. Pt transported to obs at 1743 via wc. Around 1749 pt states she feels cold, lightheaded when sitting up and persistent chest tightness. Pt declines call to EMS and EMS transportation. She does agree to drive herself to urgent care for further evaluation. Pt states she feels safe to drive. Pt released by self at 1803. Vitals as follows: 1744 BP 134/90 HR 64 SPO2 100; 1749 BP 135/78 HR 65 SPO2 100; 1756 BP 155/87 HR 74 SPO2 100
on Sunday 12/19  I woke up with itchy red circles on both elbows, both knee caps, backs of knees and on one butt cheek.  They were very uncomfortable and continued to get worse throughout the day.  By the end of night I had them on my finger, palms. and wrists.  On Monday morning 12/20 I woke up with swollen wrists, and swollen eyes and welts all over my body.  They started spreading to the bottoms of my feet and that is when I called my doctor.  After speaking with her on the phone I went to ER and was admitted.   I was released on Monday with 3 prescriptions which i did not take on Tuesday.  On Wednesday I woke up with all the same symptoms and swollen lips.  I spoke with doctor again and she told me to get on the methylprednisolone and Benadryl immediately.
On 5/22/18, developed small red bumps on face, neck, injection site.
This case was reported by a consumer and described the occurrence of local swelling in a 50-year-old female patient who received ENGERIX B. Co-suspect products included DTPA and Influenza vaccine. Concomitant products included levothyroxine. On 24th December 2014 13:00, the patient received the 1st dose of ENGERIX B (intramuscular), DTPA and Influenza vaccine. On 24th December 2014, less than a day after receiving ENGERIX B, DTPA vaccine and Influenza vaccine, the patient experienced local swelling, neck pain and pain in arm. ENGERIX B was continued with no change. DTPA vaccine was continued with no change. Influenza vaccine was continued with no change. In January 2015, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the local swelling and neck pain were not recovered/not resolved. The reporter considered the local swelling and pain in arm to be related to ENGERIX B and Influenza. It was unknown if the reporter considered the neck pain to be related to ENGERIX B and Influenza. The reporter considered the local swelling and neck pain to be related to DTAP. It was unknown if the reporter considered the pain in arm to be related to DTAP vaccine. See case US2015GSK043727 for details following vaccinations. Additional information was provided: A patient received her first shot of ENGERIX-B on December 24th. At the same time she received an influenza shot and a Tap shot (details and manufacturers unknown). Beginning 3 hours after the patient received the ENGERIX-B her muscles became sore. Later that day she then felt a ball at the back of her neck (or top of spine) and it was also sore. She felt like all the medicine from the ENGERIX-B went straight to her neck. The patient told the office about being sore and they told her that was normal.