chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had an allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (I had an allergic reaction) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (I had an allergic reaction). At the time of the report, HYPERSENSITIVITY (I had an allergic reaction) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported. This case contains information for the 25th of 63 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master Case
2/13/20: Pt reports nerve damage from the shingles vaccine (administered 2/5/2020 7:20pm). Pt reports shot was administered almost at the top of her shoulder. Pt was wearing a sweater and reports she took her arm out of the sweater to get the shot. Pt noted hearing a loud "weird sound" when the shot was given. After describing the type of syringes we use she said it sounded like a broken spring or something. By 9pm she was having so much pain that she called her insurance nurse line, they directed her to call her clinic doctor on call. Pt spoke to the doctor on call, they directed her to the ER because she couldn't even speak at that point because she was in so much pain. Couldn't use her arm at all, so couldn't drive. Had to call her family to come help her. Went to ER with excruciating pain and whole body was shaking up and down. Dr did an ultrasound of her shoulder to make sure there wasn't any blood clot. The doctor removed the band aid from her arm, so patient says they know where the shot was given. Pt states that the ER doctor said maybe the syringe was faulty and the needle was angled. We currently have 80 syringes in our VanishPoint Syringe box, 3mL 25G 1". Ref # 10391. Lot A190101. 2019-01-03. 2023-12-28.  2/11/20 Pt went in to her doctor. Couldn't even lift arm to shoulder level. 2/13/20 Pt can lift arm to shoulder level now, but not all the way up (to get things out of the cabinet). Still having pain. Pt is going to neurology tomorrow 2/14/2020.
A non-serious spontaneous report of dizziness has been received from a physician concerning a 19-year-old patient, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On an unknown date, the patient received FLUMIST. On an unknown date in 2010, the patient experienced dizziness. The outcome of the event of dizziness was unknown.
Patient felt "tired" getting up from chair. Patient was seated and evaluated. Patient has past medical history of DM and did not take metformin today, and did not eat anything today. Was anxious about getting vaccine. Felt better after sitting and able to get up without problems. Felt well enough to return home.
Patient was inadvertently vaccinated below the minimum age.  He/his guardian listed no PCP and did not answer when we reached out to follow-up.
C/O dizziness Right hand tingling O2 Sat 95%, HR 80. Offered cold water states feels better after 5 minutes
By patient report:  Patient visited outside health facility due to upper arm cellulitis.  Received 24 hours of IV antibiotics followed with one week of PO antibiotic course.
Vaccines given on 8/11/09 (Tdap, MCV4 & Varicella). Mother called on 8/12/09 to report swelling, increased (abnormal) discomfort to back of left arm. Took this pt -her son- to ER, the MD called it an adverse reaction as vaccine given in "triceps". Varicella only vaccine given to posterior (R) arm-SQ.
Local swelling and redness after receiving vaccine, redness improved the next day while swelling decrease slightly. No other signs or symptoms reported.
Approximately 6 hours after receiving the injection I started running a temperature of 102.7 and feeling absolutely terrible all over.  Shortly there after I was having such sharp pains in my joints (pretty much all over) that I couldn't get out of a chair without much assistance.  Then I couldn't walk only barely shuffle y feet with my husband holding onto me.  I was very short of breath at this point with a pulse ox reading starting at 76 and finally reaching 88, but would not climb any higher.  I was very nauseous and unable to eat or drink.  The following day my temperature was still running 101, but not continuously.  I still felt bad, but could shuffle walking without assistance and was still nauseous.  I pretty much stayed in a recliner chair all that day, except to try to take a shower, which I really had a feeling I wasn't going to survive.  I went to bed without dressing, because felt so bad.  The next day I felt better, but was so short of breath I had to have a rolling chair to sit in to try to do something in the kitchen.  By afternoon February 15, 2021 I was feeling better, Only shortness of breath when walking and my pulse ox was 92.  Should I take the second Moderna vaccine?
Developed erythematous vesicular lesion/rash in L2-L3 dermatomal distribution of right leg consistent with herpes zoster 3 months after vaccination for varicella.
High fever (101.6), migraine, intense occipital and temporal headache, chills, major body aches, debilitating fatigue, injection pain, armpit pain (same side as injection), nausea, lack of appetite, brain fog.
Subsequent to receiving one dose of varicella virus vax on 04/26/96, this pt developed a rash that consisted of some spots on 07/02/99. There were no complications. Nine days post onset, the pt recovered.
Vomited  Pulse 80  No other sign or symotom of ditress.  Adult present.  Informed to seek medical attention with any furthter problems.
Approx. 30 minutes, post vax, employee complained of burning in head, neck and chest area. Then reaction progressing to SOB, wheezing, neck vein distention and then a full blown anaphylactic shock. Pt treated with albuterol 0.5mg/NS; Epinephrine 1:10000 IV Solu-Medrol 125mg IV; Depo-Medrol 80mg IM; O2 per face mask 1.5 liter; BP decreased to 70/43; cold and clammy. Admitted to Critical Care for observation X 48 hours. Discharged home with condition stable and BP 90/70.
achy back; had chills; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (achy back) and CHILLS (had chills) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 033+21A and 003A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced BACK PAIN (achy back) and CHILLS (had chills). At the time of the report, BACK PAIN (achy back) and CHILLS (had chills) outcome was unknown.            Concomitant medication was not reported. After first dose and first booster and second booster patient had chills and achy back. Treatment information was not reported.   This case was linked to MOD-2022-655853, MOD-2022-655857 (Patient Link).
Pfizer vaccine administered to a child that was 11 y/o 6 months old. Current manufacture recommends for 12 y/o and older.
2 injections of Shingrix Vaccine on the same day; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-JUN-2023, the patient received Shingrix (intramuscular). On 14-JUN-2023, an unknown time after receiving Shingrix, the patient experienced overdose (Verbatim: 2 injections of Shingrix Vaccine on the same day). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter reported that the patient received two doses of Shingrix vaccine on the same day, which led to overdose. The reporter was warm transferred medical information for inquiry. The reporter did consent to follow up. This case had been linked with US2023083881 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023083881:Same reporter
It is now quite itchy, and it is a red circle. Also feels like my 'glands' are swollen under my arm, my armpit is sensitive to touch. Feels swollen.
Modera vaccine and 4-5 hours later noticed I had a hard time focusing with brain fog, headaches, fever, pain and stiffness in neck.
This spontaneous report as received from a doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # not reported) in her shoulder joint on 09-OCT-2012. No other co-suspects were reported. There was no concomitant medications. On 09-OCT-2012, the patient had a sore arm. There was no treatment given for the event. The patient did not seek medical attention. There was no lab diagnostic/studies performed. The outcome of the event was reported as recovered. The relationship between the event and PNEUMOVAX 23 was not reported. Additional information is not expected.
Bad taste in mouth within first 10 minutes.  WIthin four hours, started to experience the following side effects that were consistent for 48 hours and then would come and go for the next 48  hours: sore/hot throat, feverish, uncontrollable shaking, nausea, vomiting, headache, fatigue, muscle pain, ringing in ears, injection site pain/hardness/red/swelling.  Tuesday, May 18 around 11pm started to have allergic reaction symptoms of diarrhea, cold clammy skin, dizziness, red tingly hands/feet, itchiness.  Immediately took Benadryl and symptoms did not progress any further.
Doctor inadvertently administered a 60 years old patient a dose of Fluzone High Dose vaccine, he assumed that the patient was 65 years old/No AE; Doctor inadvertently administered a 60 years old patient a dose of Fluzone High Dose vaccine, he assumed that the patient was 65 years old/No AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 60 years old patient (gender unknown) who was inadvertently administered a dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] by a doctor, he assumed that the patient was 65 years old lot number and expiry date not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Immunosuppression.   It was an actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of report no adverse event was reported.   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 and Module VI of the 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.  Information on the batch number was requested.
48 hr after vaccine anterior chest wall, severe pain radiating into R and L chest and then into central dorsal spine.
c/o nausea, vomiting, temp 99.5 F, chills. Monitored for one hour. Vomiting subsided but continued to complain of nausea, photosensitivity and chills. Declined to be seen at ED. Accompanied home by friend.
Acute onset of pain in right and left shoulders in March 2021 following dose 1 on 3/1/21 and dose 2 on 3/31/21 mimicking  a torn rotator cuff, first in the right shoulder then in the left shoulder and then both shoulders and left arm.  Pain is still acute on left arm injection sites. Went to orthopedic specialist 3/15/21 who did xrays and mri and sound conductive studies and found negative- no biomechanical problems in either shoulder or neck. Did physical therapy for right shoulder for 3/15 through 4/24/21.  No reason found for pain. Referred to rheumatologist on 6/20/21 and again on 7/27/21for possible onset of poly myalgia rheumattica PMR. Testing for PMR were negative.  Tried low dose prednisone and cortisone injections for limited duration relief.
Numbness, tingling, weakness of the left arm where vaccine was given lasting now for 3 weeks.
I had received the Tdap shot in my left arm 12-15-08 at family practice which my arm became very sore 12-16-08 & has been sore every since 1-15-09 which I went to the Doctor whom order it.
All cold flu symptoms - fever (99.5), cough and sense, excessive sweating while sleeping (had to change clothing), fatigue, not much improvement (except for fever).
Erythema, swelling, tenderness and itching at site of injection of TdaP and MENACTRA immunizations, as well as fever to 102 degrees F for 3 days.
This case was reported by a physician via sales rep and described the occurrence of shingles in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician said that he saw the patient one week post SHINGRIX vaccination with shingles. The physician described the outbreak as being in 2 dermatomes. The patient received the vaccine at a pharmacy and not in his office. The physician agreed for contact on follow up.
burning at the injection site; red; there was a lump; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (burning at the injection site), INJECTION SITE ERYTHEMA (red) and INJECTION SITE MASS (there was a lump) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.    Co-suspect product included non-company product MECLIZINE [MECLOZINE] for Nausea.    Concurrent medical conditions included Osteoarthritis.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started MECLIZINE [MECLOZINE] (unknown route) at an unspecified dose. On 13-Mar-2021, the patient experienced INJECTION SITE PAIN (burning at the injection site), INJECTION SITE ERYTHEMA (red) and INJECTION SITE MASS (there was a lump). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Mar-2021, INJECTION SITE PAIN (burning at the injection site) and INJECTION SITE MASS (there was a lump) had resolved and INJECTION SITE ERYTHEMA (red) outcome was unknown.            Action taken with vaccine was not applicable. No concomitant medication was reported.   This case was linked to MOD-2021-061017, MOD-2021-061017 (Patient Link).
Patient received Influenza (High Dose) 3 valent vaccine and Pneumo Conj 13-V (2010 and after) and was then hospitalized "Nausea, Vomiting, Diarrhea with SIRS - Possible Acute Reaction to Vaccines".
Information has been received from a physician concerning a 16 year old female with IMITREX allergy who on 17-MAR-2008 was vaccinated with the first dose of Gardasil. The same day of the vaccination, the patient ran a low grade temperature (99 deg F). The patient also developed lethargy, feeling sleepy, and sore throat. Unknown medical attention was sought in the office. At time of reporting the patient was improving but still feeling tired. No product quality complaint was involved. Additional information has been requested.
she even had the same reaction when she received the first two doses of the Moderna/It clears out her lungs/her asthma was good, then it goes back down; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (she even had the same reaction when she received the first two doses of the Moderna/It clears out her lungs/her asthma was good, then it goes back down) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 022M20A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Protein deficiency (Protein D and C deficiency). Concomitant products included ZAFIRLUKAST (ACCOLATE) for Asthma, RIVAROXABAN (XARELTO) and HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (she even had the same reaction when she received the first two doses of the Moderna/It clears out her lungs/her asthma was good, then it goes back down). On 01-Sep-2021, THERAPEUTIC RESPONSE UNEXPECTED (she even had the same reaction when she received the first two doses of the Moderna/It clears out her lungs/her asthma was good, then it goes back down) had resolved.            Treatment information was not reported  It was reported that patient is asthmatic and she just received the booster shot and had a positive reaction from it.   This case was linked to MOD-2021-306161, MOD-2021-306177 (Patient Link).
Was informed at the time the client was to be seen for booster dose of COVID vaccine that he had recently passed away.  Unable to contact family for more information.
1-2 days after receiving initial dose patient experienced loss of appetite ranging from no consumption to little consumption. Patient was recommended by cardiologist to take vaccination, with her pace maker it made breathing difficult. Patient reported the tiredness making everyday activities, and labor hard. ex. vacuuming, flights of stairs, walking around grocery store etc. Today is 9/9/21 patient is finally able to do semi normal activities like walking around a grocery store.
patient diagnosed with an occlusive thrombus in the right and main portal veins extending thrombus into proximal mid and distal superior mesenteric vein and splenic vein.
Pt returned to the clinic on 6-13-12 with pain and swelling in the left arm which started the day after receiving Tdap vaccine. The swelling was in the area of the injection site. Pt had difficulty with range of motion of the left arm.
Patient had palpitations and feeling of heart pounding lasting several hours on day after as well as 2 and 3 days later. According to mother, heart rate around 115 during the epidodes. 2 days after the vaccine is symptoms were at its peak lasting throughout the day and finally slowing down. 3 days after vaccine administered, last a 2-3 hours.
Patient developed hoarse voice, feeling of tightness in the throat/neck, and feeling of SOB approximately 6 minutes after vaccine was administered.  She was in no acute distress, normal O2 saturation, VSS.  Administered 0.3 cc epi SQ, 50 mg Benadryl IM, prednisone, Solumedrol and an albuterol treatment.  Symptoms resolved.  She was monitored in clinic for a couple of hours and eventually discharged home.
Pt waiting in waiting room after vaccine. Approx 15 minutes after vaccine, pt developed a rash on face & back. Dr. re-evaluated pt & ordered PO ADVIL 200mg & PO BENADRYL. -ADVIL given here & mom instructed to get BENADRYL. Rash was fading on back when he left our office. No problems breathing.
pt recv vax 28AUG97 & 23SEP97 pt w/vesicular rash on face & chest, a sore throat & less than 20 lesions;
According to mother, patient had very fine bumps/rash from head to toe. Noted to have red spots on arms, legs, and trunk. 5/8/15 patient presented to Health Department and informed by PHN to see Dr.  8/8/15 @ 10:30 a.m. mom states Dr. told her this was an adverse reaction to the shots patient was given. Gave steroids.
I have no past medical history, including any vascular/cardiovascular or migraines.  I was in perfect health.  However, I have developed Giant Cell Arteritis affecting my temporal arteries.  My neighbor's daughter, who has chronic GCA, was told not to take the Covid vaccine.
Overall muscle aches, fever, shakes/chills, slightly nauseous about 10 hours after injection, continued thru the night, felt too shaky to hunt for a thermometer, but about 6am I did feel cooler, not shaking, took my temperature and it was 99.1. Assuming it was over 100 for most of 4-5 hours. Temperature taken at 24 hr. after injection was cool, 96.7, but I felt relatively normal after sleeping from 6am - 11:30am. Red itchy sensitive rash has developed since 2 1/2 days after injection at my waist in two areas and continues to be red and sensitive 4 1/2 days after injection. None of these symptoms happened after my first injection beginning of August.
quarter-size knot near but not under the injection site; red area over knot - lasted 2 days intermittent itching around injection site - felt like an insect bite - lasted 5 days very minor symptoms no other adverse effects no fevers, no chills, no muscle aches
04/18/22 presents to ED for "shortness of breath, fever, rhinorrhea and congestion, and cough" "positive COVID test from urgent care". PMHx of "asthma".
On March 25, 2021, I experienced extreme pain and blisters on my back, waist, and the front of my groin. I couldn't even talk the pain was so bad. I was so bad. Calamine lotion, anything topical to relieve the pain. The pharmacist told me to put a pain patch on my skin. I ripped my skin off by doing so. The blisters lasted 2-3 weeks. I waited to receive dose 2 until blisters dissipated. Upon dose 3 and 4 I had a couple of burning blisters but now full on. The burning internally still remains to this day.
urticarial rash rt arm & upper back w/in several hrs of immun; urticarial rash rt upper arm apparent; 14MAy93 9AM; no hx resp sx; irritability; sx have improved over past 2 days;