chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2-4 days after immunization patient developed dizziness, blurry vision (intermittent; ophthalmologist found no abnormalities on exam), and possible POTS symptoms.
Profuse sweating followed by headache and numbness to my head.  After a few minutes my tongue began to swell followed by my lips and face. Was given 50mg PO Benadryl five minutes later a shot from an EpiPen. Trip to ED via ambulance IV Benadryl and Solu-Medrol was administered.  After 3 hrs all swelling was gone and was discharged.
INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 76 year old female. The patient's weight was 200 pounds, and height was 70 inches. The patient's past medical history included peripheral neuropathy, and myasthenia gravis, and concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, nitrofurantoin, and benzylpenicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21AB, expiry: 21-JUN-2021) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced injection site pain. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Negative X-Ray. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site pain. This report was non-serious.
Employee recieved vaccination on 11/04/2010 at approx. 1:00 PM and then retuned to work until 09:30 PM when he went home. Employee states he began feeling signs and symptoms at about 10:00PM described as feverish hot/cold with chills, generalized fatigue, sinus pressure, sharp constant pain in ears. Employee then tried using taking Tylenol and fluids and using ice packs. Employee states s/s elevated around 10:00 PM 11/05/2010. Employee states he did not go to E/R due to having no insurance. Today he states he feels well. 11/8/10
Had covid infection Dec 2020  He received Moderna shot#1 on 2 Apr 2021: received shot, waited 15 min, went home (30 min drive), went bike riding outdoors, stopped riding after 15 min due to cold weather, went inside, while undressing for shower he noted redness of skin from waist up involving trunk and face, called nurse hotline, while talking to her he felt scratchy throat, was advicse to call 911, 911 responded in 5 min, transport to Hospital, arrived ER in 5 min, given IV Benadryl but not epi. VS were nl on admission to the ER. He denies dizziness, sob, cough, wheeze, chest tightness, diarrhea, abd cramping. Flushing improved over a period of five hours, discharged while still residually flushed. Redness fully resolved over two days.   The redness of his skin was similar to what he experienced after an allergic reaction to a food spice in 2003.    He has covid infection in Nov2020, had high fever, lost taste and smell. Self-treated w/ Tylenol at home, had + positive at Clinic (results verified on Database)   Flushing and respiratory sx within an hour of receiving Moderna covid vaccine #1, in setting of a previous clinical infection/positive covid PCR testing in Dec2020, suggests anaphylaxis to Moderna vaccine. He may have developed ab during actual infection that caused IgE reaction to vaccine.  I advised him to avoid further covid vaccines until further developments  He is most likely immune given previous clinical infection and positive PCR testing and receiving one vaccine.  It is unknown how long immunity will last, what current covid ab titers mean, and whether he might be able to take an alternate vaccine in the future. He might merit skin testing with Miralax in anticipation for further PEG2000 containing vaccines in the future.  Fol allergy at Location Note written 25 May 2021 during appointment w/ patient
3 days following tetanus booster vaccine site was hot and tender to touch, erythematous and edematous. The following day, the site was pruritic and the erythema and edema had increased. Seen at the clinic on 11/09/04. Exam: vaccine site with induration, erythema, and increased warmth. No streaking or adenopathy. No systemic symptoms. Symptom: edema at injection site 120mm not beyond elbow, erythema comment: induration at site; area increased on day 4 and 5 post vaccine, pruritus, tenderness.
Myalgia, Nausea Vomiting,  Fatigue, chills Narrative:
Allergic reaction. Took Benadryl, went to ER. Have iv fluids, Pepcid and methylpredisolone
per grandma pt devel rash on forehead 30APR97 pt seen in clinic w/fine macule rash across forehead extending into upper eyelids & across bridge of nose w/mild edema upper eyelids;pt also c/o itching & h/a;
Patient was feeling in good health prior to receipt of vaccination- Patient reported not feeling well  right after receiving the dose; fainted the following day- sought medical care that same day- no issues detected; patient continued to say he did not feel like something was right. Patient  died on June 4, 2021- brain bleed - transferred to different hospital-intraparenchymal bleed ---please note- there are NO LOT NUMBERS WRITTEN ON PT VACCINE RECORD!
Pulling in of arms & legs toward trunk & facial grimacing 3 to 4 times that evening. Continued up to 8-13 a day. No crying, no fever, no LOC. Muscle spasms per MD.
Information has been received from a registered nurse concerning a 63 year old female who on 25-JUN-2008 was vaccinated SQ with a 0.65ml dose of ZOSTAVAX (Oka/Merck) (lot #: 659672/0294X). On approximately 25-JUN-2008, the patient experienced muscle aches and joint pain. The patient told the nurse that her symptoms began almost immediately after she received ZOSTAVAX (Oka/Merck), but the nurse did not know the actual date the symptoms began. The patient has seen more than one physician regarding her symptoms and mentioned she received a cortisone shot. At the time of this report, the patient was not recovered. Additional information has been requested.
consumer reports that husband was given pnu-imune & flu vax @ the same site about 1 inch apart on the same day; pt exp redness & pain @ inject site; also feels weak, lightheaded w/impaired concentration; Egg allergy as a child;
Information has been received from a 59 year old female with no allergies or medical history who on 03-Nov-2006 was vaccinated in the left arm with a first dose of varicella-zoster virus vaccine live. Concomitant therapy included levothyroxine Na (SYNTHYROID), calcium (unspecified), and atorvastatin calcium (LIPITOR). On 03-Nov-2006, immediately after vaccination, the patient's arm swelled "like a baseball" and became burning hot and hard at injection site. She reported that 10 hours later, her arm was "blood red and sore" and was like this for one week. She was reported that on 08-Nov-2006, her left forearm got a rash and since then, "almost everyday" she has a rash and lesions show up 'all over her body". Her body was swollen and itches and the lesions are "huge lumps". They are "not drying up. Unspecified medical attention was sought. She was taking preabalin (LYRICA) for pain and was on steroids. A CBC was performed on approximately 03-Nov-2006 (results not provided). At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information was received from the patient's physician who reported that the patient had an itchy, stinging, painful rash on the right neck, right shoulder, and right back. There was erythema, no crusting or pustules, and the area blanches when touched. She was being treated with preabalin (LYRICA) and prednisone on a decreasing scale and hydroxysine hydrochloride (ATARAX). The physician will check with the patient "in the next day or two". 6/17/10 Additional information indicated that the patient developed arm swelling at the injection stie, a rash on her extremities and back which turned to blisters. Pain and itching were noted. The physician reported that this lasted 10 weeks and the patient recovered. It was also reported that the patient's husband (WAES #0703USA03408) contracted a rash from his wife. No additional information is expected.
pain at the injection site , fever 102. joint pain , swelling of lymp notes, diarrhea . headaches .
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUOXETINE; BUPROPION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: A contributory role of BNT162B2 to event COVID-19 cannot be excluded based on temporal association and available information.
PT REPORTED REDNESS AND HEAT IN THE LOWER ARM JUST ABOVE ELBOW, SHE DIDN'T NOTICE ANY REDNESS, HEAT OR SWELLING AT THE INJECTION SITE. PT FEELS THE SYMPTOMS ARE CAUSED BY INJECTION. GAVE RECOMMENDATION FOR ICE AND NSAID, AS WELL A FOLLOW UP WITH DR.
Pain, light sensitivity, redness, reduced vision in left eye starting morning of 30-Nov and increasing in severity throughout the day.  ER visit evening of 30-Nov diagnosed Iritis, prescribed Cyclogyl for pain overnight.  Follow-up with ophthalmologist on 01-Dec maintained the same diagnosis, prescribed PREDNISOLONE ACETATE 1 % OPHT SUSP DROPS.  At time of report submission symptoms ~ 75% improved.
8 Hours after the Moderna Vaccine, 2nd dose, I began to experience chills and fever. Fever range between 102.0 and 103.0 degrees. A short time after the fever began I began to experience full body muscle pain and cramps, especially on my back, shoulders, and neck. Cramps and pain were severe, I needed to have ice packs applied to try and alleviate the pain. I also began to experience an excruciating severe headache. A few hours after the muscle pain and headache I began having nausea and vomiting. The entire reaction - severe headache, muscle pain and cramps, and nausea and vomiting lasted 40 hours. I went to bed 7pm Saturday evening May 22, the day I received the vaccine (at 11:00am) and was not able to leave bed (except to be sick in the bathroom) until late Sunday morning May 24th.   I've had a history of migraine headaches (prior to age 51). I would say the headache I experienced after my 2nd Moderna vaccine was as severe as migraines that I had to go to the ER for, or even more severe. I felt as if my head was going to explode. I had ice packs around my head and body to try and relieve the headache and muscle pain. I took Advil and that did not help ease any of the symptoms. My family became concerned and encouraged that if I wasn't feeling better by mid day on Sunday May 24th that I should seek medical care. The symptoms subsided late morning on May 24th and I did not seek out medical care. I was exhausted for several days after the event.
about 1 minute after receiving covid vaccine pt had a syncopal episode falling forward out of the chair.  Dry heaves following incident and felt weak after.
The injection site became warm for a few days. No rash no itching, just warm to the touch.
Patient reported unusual muscle tightness that radiated upward and outward toward head and scapula. Pain was worsened with movement, and contact. Tightness and pain resolved on own after 30 minutes.
I was providing Moderna Bivalent Vaccines to our Hemodialysis patients when they are here for patient convenience. Patient had been asked if he would like to receive the Moderna Bivalent booster on Friday - January 20th.  He said he wanted the vaccine. Asked the patient is he had received the Bivalent booster to which he stated "no". This patient is alert and oriented x4.  I had spoke with this patient the week of January 9th to offer him a Bivalent vaccine which we chose to wait to administer as he had just recovered from Influenza. When I was documenting the vaccine in our EMR and checking that the documentation went to all the appropriate screens, I noted in the immunization record that he had received a vaccine on January 17th.  The patient has not had any adverse reactions. I notified both the unit and his primary care provider.
15 hours after vaccine, I woke up with a severe headache and extreme fatigue. 18 hours after vaccine, I showered and felt very dizzy. I thought the water was too hot, so I turned the shower head off and got extremely nauseous. I laid on my bathroom floor for an unknown amount of time. I thought I felt ok enough to get up to get clothes on and wake my mom up. I remember fumbling with the bathroom door and that's the last thing I remember. My mom told me that she heard me say "oh God," followed by a thud. She discovered me lying face down on the dining room floor. My blood pressure was low, as well as my heart rate (47). EMS was dispatched to my residence due to extreme dizziness. Due to the fall, I had a chin laceration requiring stitches, a bruised fifth digit on my left hand, as well as a bruised left hip.
At 2:56pm, associate complained of nausea, lightheadness.  Blood pressure was elevated; 165/102; heart rate 98bpm; SPO2 99% on room air;  Placed in supine position in observation area.  Administered Benedryl 50mg oral at 3:25pm; Blood pressure was rechecked at 3:40pm; 141/91; heart rate 88; associated states she felt improved of all symptoms; associate has been cleared to return home; husband will transport
male patient was administered Daptacel on 03-May-2019 that expired 23-Mar-2019/not had any side effects; Initial information received on 03-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 18 months old male patient who was administered a 0.5ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]on 03-may-2019 that expired 23-mar-2019 lot C5171AA via intramuscular route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB).  It was an actual medication error due to expired vaccine used.  The patient did not experience any signs of any side effects.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Body ache; Fever; Headaches; Tiredness; Itching (full body); This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 04May2021 at 17:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included unknown allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within 2 weeks of vaccination. On 05May2021, the patient experienced body ache for 2 days, fever for 1 day, headaches for 4 days, tiredness for 4 days and itching (full body) for 1 day. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever and itching (full body) was resolved on 06May2021; body ache was resolved on 07May2021 while headaches and tiredness was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
muscle spasms-6 to 8 weeks post 2nd dos vax;hlth dept refused to give 3rd dose when told of event that occurred;
Information has been received from a nurse in a physician's office via a field representative concerning a 74 year old female patient. On 05-NOV-2013 the patient was vaccinated with a single dose of ZOSTAVAX (dose and lot# not provided) subcutaneously. On 25-NOV-2013 the patient developed shingles. The outcome of the event was unknown. The relationship between ZOSTAVAX and the event was unknown. Additional information is not expected as the physician did not allow to be contacted.
The pneumvax vaccine was administered IV instead of IM by mistake at approximately 0830. The patient became febrile (from 37.1 C prior to vaccine up to 38.6 C following vaccine) and had increased respirations and decreased oxygen saturation (87% from 91%) by 0900. Acetaminophen and diphenhydramine were administered and the patient was put on 1 liter of oxygen. Symptoms continued at 0930. By 1100, vitals had returned to normal.
The day after the first dose was taken; the right side of my face is getting  numb, I cannot move the right side of my face, I have a headache and right side of neck hurts
I had the initial COVID19 (Moderna) shots 1 and 2 on 05/01/2021 and 05/29/2021 respectively with no side effects except the location pain and discomfort. On 04-Dec-2021 I received the Moderna booster shot. I was very tired the day of and took a nap but felt relatively fine. I did go to bed and had about 12 hours of sleep. When I woke with some body aches: lower back and neck pain. I was tired and not feeling very well. I decided to stay home. I took my normal morning medications. I normally go out to breakfast. About 1 pm I began to feel feverish and didn't want to move. I also had sinus headache pain behind the eyes. I was in and out of sleep most of the day on the couch. I took Tylenol about 5 pm. I didn't eat anything until about this time when I had chicken noodle soup. I went to bed early, about 10 pm and slept through the night. I woke up this morning and the fever had broken. I was no longer congested, and the back and neck pain had gone. I still had minor muscle aches but am feeling better now about 5:30 pm on 12/06/2021.
URINARY TRACT INFECTION; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced slight headache and urinary tract infection (both events dose number in series 1) when treated with covid-19 vaccine ad26. cov2.s for prophylactic vaccination on /MAR-2021 (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: UNKNOWN) dose was not reported, 1 total, administered in left arm on 12-NOV-2021 (dose number in series 2) for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in NOV-2021, the patient experienced urinary tract infection and slight headache from the booster dose ( both events dose number in series 2). The patient did not have sore arm, so she slept on it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of urinary tract infection and slight headache was unknown. (also mentioned recovered from slight headache) This report was non-serious. This case, involving the same patient is linked to 20211137085.
Patient left the office without any symptoms.  Half hour later Mom called to say daughter was wheezing and claims it felt like something was stuck in her throat.  Doctor advised patient to return to our office.  Upon arrival, patient was wheezing and had a diffuse rash from her neck down to her chest. No swelling of lips or tongue.  10mL of Benadryl was administered in the office and we called EMS to transport to the ER. O2 sats were 97% without O2.
Flu-like symptoms: shivering, 101.7 fever, extreme fatigue, loss of appetite; then 24 hours after those symptoms, cold sores on mouth and face multiple locations.
Brachial neuritis. Pain, weakness, (L) arm 10 day after the shot on 11/8/11.
Pt recvd 2nd dose of Engerix-B @ 420PM on 29AUG91 & @ 437PM exp severe vertigo followed by nausea & crushing generalized h/a; treated w/phenergan; nausea & h/a were gone in 1/2 hr;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot numbers, expiration dates, doses and routes of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
IMBRUVICA OR THE CLL MADE  IT SO THAT THE COVID VACCINATION DID NOT CREATE ANTIBODIES; This spontaneous case was reported by a physician and describes the occurrence of DRUG INTERACTION (IMBRUVICA OR THE CLL MADE  IT SO THAT THE COVID VACCINATION DID NOT CREATE ANTIBODIES) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products IBRUTINIB tablet for CLL and IBRUTINIB capsule for CLL.    The patient's past medical history included No adverse event (No medical history was provided by the reporter).   On 01-Oct-2016, the patient started IBRUTINIB (Oral) dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and IBRUTINIB (Oral) 420 mg once a day. On an unknown date, the patient experienced DRUG INTERACTION (IMBRUVICA OR THE CLL MADE  IT SO THAT THE COVID VACCINATION DID NOT CREATE ANTIBODIES). At the time of the report, DRUG INTERACTION (IMBRUVICA OR THE CLL MADE  IT SO THAT THE COVID VACCINATION DID NOT CREATE ANTIBODIES) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported. Treatment information was not provided. The reporter's causality for the event (s) of "IMBRUVICA OR THE CLL MADE IT SO THAT THE COVID VACCINATION DID NOT CREATE ANTIBODIES" with IMBRUVICA (IBRUTINIB) was a reasonable possibility.
None stated. 4/16/2010 - There was no adverse reaction - so there was no onset date/time.  The child was given double dose of HIB and we were advised to always fill out a VAERS.  Please advise on when to fill out VAERS if other guidelines.
COVID break through case  I received my 2nd booster shot on 04/15/2022 and My COVID  symptoms started on 05/21/2022 with fatigue on Saturday. On the 05/22/2022  - headache, runny nose, fatigue,  body aches, chills, and sore throat. I tested positive on 05/24/2022 with a PCR  at the hospital. Then did several other home test  which were positive on 05/26/2022, 05/31/2022 and 06/02/2022. My symptoms continued till Tuesday 05/31/2022.   I didn't need medication. I followed  some  natural treatments at home.