chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Active side effects from 1st dose(previously reporters): Migraine, vertigo  Side effects after 2nd dose: fever 101, completely numb hand, difficulty walking, difficulty seeing (double vision). As fever reduced through the day these got better. Lasted about 36 hours.  About 6 days from 2nd dose face tingling, hand tingling/numbness that I experienced with the 1st dose came back. It was less intense the 2nd time but definitely present.   Numbness in hands, migraines, vertigo are the lingering side effects that lead to me visiting my doctor.
Caller reports multiple doses of VAXELIS administered since temperature excursion; This non-serious spontaneous report with reference numbers 02197725 / 02197588 was received by partner on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.
pt recv vax 4FEB94 & no significant inc in titer; No further details were provided;
she was "Just not feeling myself - nothing I can even describe in detail, just vaguely not myself; Did not want supper; This is a spontaneous report received from a non-contactable consumer (patient herself). A 78-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: Not available), via an unspecified route of administration on 23Jan2021 to 23Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient reported that on Monday (2 days post-vaccine on 25Jan2021) she was "Just not feeling myself - nothing, she can even describe in detail, just vaguely not myself. Did not want supper so had scrambled eggs and toast and went to bed early. Woke up feeling fine. She hardly ever felt other than fine and she could not think of anything other than the vaccine on Saturday that was unusual. On Sunday, she felt fine and today she feel fine". Treatment was not received for the events. The outcome of the events was recovered on Jan2021.  No follow-up attempts are possible; Information about lot/ batch number cannot be obtained.
No adverse effect. Patient received an expired PROQUAD vaccine. Exp date: 03/06/2018.
Initial and follow-up information has been received  from a healthcare worker concerning a 26 year old female who on 01-OCT-2008 (previously reported as 03-OCT-2008) was vaccinated with a 0.5 ml dose of PNEUMOVAX (LOT# 658673/0990U;  also reported as:  9733401), intramuscularly in the right upper arm.  There was no concomitant medication.  In the evening of 03-OCT-2008 the patient experienced as swollen, itchy bump at the injection site.  The area got larger and on 08-OCT-2008 the patient was seen in the office and the injection site was warm to touch, red and itchy.  The area had radiated down the arm and was about the size of a baseball.  On 13-OCT-2008, the patient experienced fever, swelling at the location of the injection and pain.  The patient recovered from fever, pain and swelling at the location of injection on 27-OCT-2008.  There were no lab diagnostic studies performed.  The patient sought unspecified medical attention.  Additional information is not expected.
Started having respiratory issues ( Shortness of Breath, unable to take deep breaths) and increased generalized muscle fatigue, I believe that the side effects triggered my Myasthenia Gravis and made my respiratory muscles weaker. It lasted for about a week and a half before I started to feel better but I was afraid at one point the shortness of breath was causing a Myasthenic Crisis
I had an episode of FVT. I woke up with my heart racing very very fast. 240bpm when the paramedics arrived. They took me to the emergency room and I was treated for that. It lasted for about 2 hours acutely and since then I've been taking daily medication to keep my heart rate down. I was advised to have a procedure to my heart to prevent this from happening again.   I had the booster on 12/27/21 and felt ill the next day and tested covid positive on 12/28. I had a sore throat, headache, fatigue, not much of a cough, a little runny nose that wasn't very severe. I isolated for 10 days. I would have felt like it was a normal cold if I didn't know i had covid.
Face swollen; Chills; Body aches; Tiredness; Headache; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACE OEDEMA (Face swollen), CHILLS (Chills), MYALGIA (Body aches), FATIGUE (Tiredness) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Augmentin), Irritable bowel syndrome since 09-Feb-2016 and Asthma (Mild) since 01-Feb-1980. Concomitant products included VITAMIN D [VITAMIN D NOS] from 15-Feb-2017 to an unknown date, VITAMIN B NOS and TIMOLOL for an unknown indication.   On 22-Jan-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced CHILLS (Chills), MYALGIA (Body aches), FATIGUE (Tiredness), HEADACHE (Headache) and PYREXIA (Fever). On 20-Feb-2021 at 5:00 AM, the patient experienced FACE OEDEMA (Face swollen). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Myalgia, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) on 21-Feb-2021 for Facial swelling, at a dose of 1 dosage form; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Facial swelling, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at a dose of 1 dosage form. On 23-Feb-2021, CHILLS (Chills), MYALGIA (Body aches), FATIGUE (Tiredness), HEADACHE (Headache) and PYREXIA (Fever) had resolved. On 03-Mar-2021, FACE OEDEMA (Face swollen) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient stated that Diphenhydramine and Fexofenadine did not helped in facial swelling, it was subsided by itself.   This case was linked to INC.-MOD-2021-072797 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Additional VAER form was received on 19-MAY-2021 contains patient's medical history and treatment medications.; Sender's Comments: INC.-MOD-2021-072797:First dose vaccination
Pt received vaccine.  She was being observed for 15 min after injection.  About 5 minutes into her observation time, she alerted the nurse that she was not feeling well.  Nurse went over to talk to her and pt started to seem wobbly in seat.  Pt then fainted and once on the ground, she started having a seizure.  Epipen 0.3mg was administered and 911 was called.  Pt stopped seizing upon receiving epinephrine.  Paramedics and ambulance arrived and pt was taken to the ED.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 76 year old female of an unspecified ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: had tumor removed from neck (Not cancer), and emergency surgery on an unspecified date in 1992, and concurrent conditions included: cancer (on an unspecified date in 2011). The patient doesn't take any medications that affect immune system. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: unknown) dose was not reported, 1 total administered on 22-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 74 years old. No concomitant medications were reported.  On an unspecified date in OCT-2022, 2-3 weeks before reporting, at doctors office the patient tested positive for covid-19 virus test and experienced confirmed covid-19 infection (Symptoms were fever, trouble breathing and cough) and had confirmed clinical vaccination failure. The patient reported that her doctor gave her something and it went away after a week. The patient also reported that vaccine didn't worked for her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection on OCT-2022, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: This case is a duplicate of 20221102512. Additional information was received from patient on 31-OCT-2022. It was determined that Manufacturer Case Number 20221102512 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20221101642.; Sender's Comments: V0: 20221101642-confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Chills, fatigue and muscle pain started the evening of the injection.  I aslo had severe pain at the injection site.  It felt like I had received 1,000 flu shots.    I used and ice pack to the inj site and took Advil.  The following day, 1/16/21 these symptoms continued and I also had a metal taste in my mouth.    By Sun. 1/17/21 the chills had stopped.  I was still experiencing low energy level, the muscle pain was gone BUT, I started having severe breast pain in my right upper breast area which is opposite from the injection arm.  The breast pain continued until Fri. 1/22/21.  I was due for a mammogram and was able to get one Thurs. 1/21/21.  These results are still pending.
developed localized lip swelling; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 7 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIP SWELLING (non-serious), outcome "recovering", described as "developed localized lip swelling". Therapeutic measures were taken as a result of lip swelling.  Additional information: The reporter was a pediatrician calling with a question regarding the Comirnaty vaccine. Reporter was stated that a 7 year old patient of his got the vaccine and then developed localized lip swelling 3 hours later and had no other symptoms. This lasted for a few hours. The patient's mother gave them Claritin and it got better. The caller is asking what he should tell the mother for the second dose. Should they pre medicate before giving it or should they skip it? Caller initially agreed to complete report then, requested telephone number and asked to be transferred. No further details were provided and full details unable to be obtained.  Follow-up attempts are completed. No further information is expected.
Muscle soreness; Trouble moving arm; Trouble walking; This is a spontaneous report from a contactable other health care professional (hcp). This other hcp reported similar events for 3 patients. This is the third of 3 reports.  A 16-years-old male patient received meningococcal group b rlp2086 (TRUMENBA, lot CN1583, expiry date Aug2022, NDC number: 0005010005), via an unspecified route of administration in Aug2020 at 0.5 mL, single (1 injection, dose given twice 6 months apart) for vaccination. There were no medical history and concomitant medications. Reporter stated that they give the vaccine either in the arm or in the thigh if a patient has small arms. On an unspecified date in Aug2020, the patient had muscle soreness and had trouble moving arm or trouble walking if given in the thigh (pending clarification). The outcome of events muscle soreness, had trouble moving arm and trouble walking was unknown.   No follow up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020330145 Same reporter/drug/event for different patients;US-PFIZER INC-2020330359 Same reporter/drug/event for different patients
The day following the first injection, I started experiencing a series of adverse events that have not subsided. Initially, my left arm was swollen and painful, I was nauseated, feverish and had chills, in addition to a persistent productive cough. I went to the ER on 6/24 after symptoms worsened and was diagnosed with pneumonia. I was given a course of Azithromycin and Cefdinir, which I completed. The fever subsided but even weeks after the second dose, I am still experiencing persistent coughing. The pain in my left arm has also persisted and is accompanied with occasional numbness. I am unable to comfortably lay on my left side or firmly grip objects with my left hand because of the pain.
Patient developed a large local reaction of the right arm following anthrax vaccinations in April 2003. Redness, pain and swelling persisted x 6-7 weeks.  On 7 June, she was re-evaluated for ongoing symptoms and was diagnosed with a DVT in the right subclavian vein. The medical record received on 2/24/04 confirms diagnosis of deep vein thrombosis. Also states cellulitis of right antecubital fossa. 60-day follow up on 02/10/04: "Pt has recovered from adverse events."
Developed flat red rash on trunk, no itching or drainage. Dx with pityriasis rosea at urgent care. Rash expected to last 4-12 wks. No tx given.
This 47 year old patient reported good health prior to receipt of AVA #1 on 29 Oct 1999  aboard the ship with lot # "FAV 043". However review of his medical records noted his first AVA was administered 24 Jan 1999. A few days his first vaccination he complained of bilateral ankle and knee pain but attributed it to playing basketball. Motrin 800mg for 2-3 days resolved this pain. He received his second AVA vaccine 19 Oct 1999 with similar complaints of ankle pain to medial/lateral aspects of his ankles. He described both episodes as a sharp (6-7/10) pain with stepping that would radiate up under his patella anteriorly. This lasted a few moments then dulled to a 2-3/10. This discomfort varied in duration with use of Motrin 800 mg. He reported this discomfort now occurred upon awakening in the morning, eased through out the day with activity and movement, then worsened when sitting still at night or relaxing during the day. He also complained of numbness and tingling to anterior portion of his feet extending into his great and 2nd toes with and occasional left lumbar region "ache" he has to stretch out then he feels better.  This discomfort persisted with subsequential AVA vaccines 11/29/1999?, 5 Mar 2000, 17 Nov 2003, and 01 Jun 2004 (duplicate entry on 11 Jun 2004?) with change in status. His discomforts persist as of this interview 04 April 2007. He also complained of bilateral elbow pain of similar description as above with numbness and tingling to fingers left>right following ulnar nerve pattern. Onset reported after dislocation of each elbow in 1992 and 2003.  He was diagnosed with first right then left foot gout in 2004 treated with Indocin and Colchicine.  He has not seen a rheumatologist and is being managed by Family Practice Clinic. He denied any restrictions in activities of daily living or social activities; however he does note limitations to swing while playing golf and stiffness/pain with positional changes throughout the day that changes with the weather (sometimes) and use of Motrin. Review of available medical records prior to and since 1999 vaccinations noted intermittent basketball and/or lifting injuries to various joints (arm/ankle) with diagnoses of tendonitis since 2000. In July 2003 while abroad, he awoke with right foot/toe pain with redness, swelling and MPJ tenderness to the 2nd digit. He was symptomatically diagnosed with gout with periodic flare-ups over the next several years to include his right index finger, left great toe, and right medial ankle and great toe. His bilateral elbow pain, numbness, tingling began after dislocations of each elbow with respective nerve involvement.  His symptoms have not increased however they have not resolved as of 2007. He voiced new complaints of "aching hip" in am that have not been evaluated.
This spontaneous report was received from a 77-year-old consumer reporting on herself. The patient's medical history was not reported. The patient's drug reactions/allergies included "carbamazepine which affects her stomach because of acid reflux (drug hypersensitivity)". Concomitant therapies included cyanocobalamin (vitamin B12)) and an acid reflux pill. On 01-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (strength, lot # and expiry date not reported) dose 1 in the left arm for prophylaxis. On 01-DEC-2018 (reported as within an hour of injection), the patient experienced swelling and soreness at the injection site (vaccination site swelling and injection site pain), and "nerve jerking" in several places in that arm (myoclonus). The patient reported that both day and night her arm felt like "somebody is doing a nerve conduction test" on her and keeps her up at night (feeling abnormal). The patient used salves and creams as a treatment to alleviate the pain, but it was for short time and the pain returned. On an unknown date in 2018, the patient sought medical attention from an orthopedic physician. Outcome of vaccination site swelling, feeling abnormal, myoclonus and injection site pain was reported as not recovered. Causality assessment was not reported.
Patient was given the incorrect COVID given . 2/2/2021 received 1st COVID 19 vaccine  with Moderna  Lot # 011J20A   exp. 5/11/21 3/2/2021 received 2nd COVID 19 vaccine with PFIZER Lot # EL9261 exp. 5/31/21.
Body aches, chills for 24 hours. Treated with ibuprofen, symptoms resolved completely by 48 hours.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The reporter stated that the patient missed their scheduled dose of ZOSTAVAX lot # L046897 (exp. date 23-FEB-2017) 0.65 ml because the vial was received broken at the pharmacy. No adverse events were reported. Product quality issue was involved. Additional information is not expected as the reporter did not wish to be contacted.
lack of effect with Botox Cosmetic; COVID; This is a spontaneous report received from other healthcare professional in response to the mail. This other-HCP reported similar events for 5 female patients have all experienced lack of effect with Botox Cosmetic, and they have never seen that before. This case is for the patient 2.  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation and botulinum toxin type a (BOTOX, Batch/Lot Number: C6700C3; Expiration Date: Oct2023) via an unspecified route of administration on an unspecified date at an unspecified dose and frequency for an unspecified indication. Medical history included covid-19 positive. The patient's concomitant medications were not reported. Reporter was requesting replacement of the vials that were used for those patients. She states Botox cosmetic is not working for 5 patients with the "last three 100 unit vials that we've ordered from you guys". Positive COVID diagnosis is on record and patient got the first dose of her vaccination (possibly Pfizer, but HCP office unsure), and didn't get the second dose due to patient getting COVID. Reporter also wants to order Botox Cosmetic, since "all (she) has left is the vial with some in it" and said she will request Medical Information transfer her to Botox Customer Service after they resolve her inquiry. The patient was not hospitalized or was hospitalization prolonged as a result of the AE. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Based on the known safety profile and limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Covid-19.
Extreme fatigue and sleepiness.  Numbness in 3 right toes and part of foot.
11-20-06 nodule Left groin area. Right groin with 4 3/4 cm shotty mobile nodes, not matted. Left groin with 3 shotty nodes, recheck 10 days or sooner. 11-24-06 axillary adenopathy, inguinal nodes bilateral shotty 3/4 cm. Re check next week-sooner 5-6 on Right femoral, 2-3 on Left not matted. 11-27-06 no real change in nodes. Left thigh with 1cm erythema slight induration. Recheck in a week.
Patient was starting the Covid vaccines he should of gotten the regular 5-11 instead he received the Bivalent  5-11
Itching at injection site, swelling, and a raised welt about the size of a quarter within 2 hours of dose being given. Almost 12 hours later and the welt is still there, but not as pronounced. However, there is also some surrounding swelling, and it is still red and warm to the touch.
Patient received Prevnar 20 vaccine on 12/2/2022 in left arm. She returned to pharmacy on 12/7/2022 and received Moderna Bivalent in right arm and Fluzone HD in left arm. Patient stated after receiving the 2nd shot (Fluzone HD) in her left arm that she has been having pain in her shoulder area. She followed up with her PCP, and was eventually referred to another doctor where she has undergone imaging and physical therapy as well as receive medications for pain/inflammation for shoulder adhesions.
Very bad seizure. Multiple that evening. My son has had nocturnal seizures ever since the first.
Extreme sinus congestion and drainage into throat causing cough. This started 2 months after the 2nd shot on March 13, 2021. I slowly got better by November. The first booster on November 17 2021 brought back the same symptoms and are almost gone now (June 27, 2022) Dr. said a huge number of his patients with the same shots and time frame as mine have exactly the same symptoms.
Tingling in the right side of face; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the right side of face) 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 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling in the right side of face). At the time of the report, PARAESTHESIA (Tingling in the right side of face) outcome was unknown.            The concomitant medications were not reported. The treatment information was not provided. The patient reported that she thinks she got her first dose of vaccine in the first week of April.
Experienced body aches, congestion, weakness, nausea 72 hours post vaccination.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE TRANSVERSE MYELITIS HYPOTENSION 12/21/2022 -- RECURRENCE OF SAME SYMPTOMS
patient developed urticaria approximately 30 minutes after receiving the vaccine.  His symptoms responded quickly and seemingly thoroughly to oral benadryl administered by mom prior to arrival