chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; Information has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not reported.   In or around August 2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX), for its intended purpose of preventing shingles (dose, route of administration, anatomical location, lot number and expiration date were not reported).   In or arounf July 2018, the pt was diagnosed with shingles by a physician. The pt's outbreak lasted several weeks and caused severe pain and suffering. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the vaccine. As a result of using zoster vaccine live (ZOSTAVAX), the pt suffered serious, severe, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt also claimed to have incurred and would continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The reported event was considered to be not recovered, and related to zoster vaccine live (ZOSTAVAX).
This case was reported by a pharmacist via sales rep and described the occurrence of pancreatitis viral in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced pancreatitis viral (serious criteria GSK medically significant) and abdominal pain. On an unknown date, the outcome of the pancreatitis viral and abdominal pain were unknown. The reporter considered the pancreatitis viral and abdominal pain to be unrelated to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. One week following the dose of SHINGRIX, the patient complained of abdominal pain and visited his primary care physician. The patient was diagnosed with acute viral pancreatitis, which resulted without complications. The reporter did not think the illness was due to the vaccine. The reporter agreed to be contacted for follow up.
This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 50 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 53 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 8. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience. ; Sender's Comments:  US-009507513-2207USA004701:
Hives.  Some as big dots scattered around chest; others in clusters on both sides of torso; started around 5pm after shot.  Also felt throat enlarged (ie when yawned felt blocked/not as clear).   As days went on, more appeared.  Hives are still there a week later (went to Medical center Monday Dec 20)--and have become more--especially small spots all over stomach and back.
vision loss; damage to cornea of right eye; herpes zoster; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 26-DEC-2014(at approximately 60 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) by a health care provider (HCP) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster, damage to cornea of right eye and vision loss. The outcome of all events was unknown.   Upon internal review, vision loss was determined to be medically significant.
Developed rash approx. 2 wks after receiving 3rd HPV vaccine.  Rash on arms, legs & feet.  Mother reports cl. states she had slight rash after first and 2nd shots as well, but did not tell anyone.  Was given Benadryl & mother states rash is fading.  Did not go to doctor.
Had stenosing tenosynovitis in left thumb. That cleared up with home treatment. Now have stenosing tenosynovitis in right thumb. Went for treatment and was prescribed naproxen 500 mg 2 x daily, prednisone 10 mg dose pack, antibiotics. Helped for awhile and now back where I was with initial pain and difficulty with the right thumb.
Patient received initial influenza vaccine on 9/7/2023. Duplicate influenza administered in error on 9/28/2023. Patient, physician, and manufacturer made aware at time of event. No adverse events.
A few hours after my vaccination, my arm became extremely sore and was extremely sore all night, and remained so the next day. I have a high pain tolerance, but my arm felt as if it had received a powerful injury, and was hard to lift without using my other arm.  I also had a slight fever the next day, chills and muscle aches and fatigue. I am normally very active, but spent the day in bed. The next day I felt much better although my arm was very sore for another day or two. Then, the evening of the 21st of Feb., my arm, at the vaccination site became very itchy and was painful to touch in that area. I slept well but woke with the same itchiness, and soreness, and now tonight, Feb. 22nd, that area is still itchy and a bit sore. But I have not had the swelling and redness that I am reading about with Covid arm.
Patient stated that she was having shooting pain in right arm (from wrist to shoulder) about 10 minutes after she received her vaccination. She said it was difficult to twist her arm.  The daughter reported patients right hand was even cold to the touch. These are the only symptoms being experiences. Patients daughter drover her to the emergency room for observation to rule out any other possible events. I called and spoke with daughter at about 6:30p and there had been no change.
Pt with febrile seizure on 2-01-18 after receiving 15 month vaccines. Mom noted jaw moving side to side (2-3 min) and looked blue around her mouth, sounded like she was choking on her spit. Was sitting up, seemed like she was reactive to mom, looking at her and moving her arms. Ambulance came and she was not fighting and out of it - post ictal period. No fever noted in office (had vaccines) but temp in ambulance found to be 101. Went to ER (arrived to ER at 13:50PM) and was back to herself and no tests done since she had previous febrile seizure x 1. Has been acting like nl self since. Temp today 99 Temporal scan.
I have an IUD and I haven't had a menstrual cycle in 3 years. after my vaccine I had 2 menstrual cycles in the period of a month. I also experienced extreme PMS symptoms including extreme irritation, cramping and suicidal thoughts.
Hand and feet numbness started 6/6, developed progressive leg weakness, slurred speech, nerve conduction studies done  by neurologist. Dx: Guillain Barre. 60 day Follow-up Information 23-AUG-2006: She is making gradual improvement. She no longer needs a wheel chair, but does need crutches.
Patient arrived to get Booster shot and said that 1-2 days after his second Moderna shot that he experienced chest/heart pain for 4 months.  he got second shot on 5/10/2021.  he did not seek out a doctor but spoke to a relative who was one.  He was told by that doctor that it was probably Periocarditis.  He only spoke to the doctor over the phone and never sought followup with a doctor citing insurance issues.  I strongly recommended he go to clinic that day but he said he would wait.  I told him given what he has told me that I would not be giving vaccine booster and recommended he see a cardiologist.  he said he was ok currently.
So that night my heart started pounding really fast and I wasn't sleeping really well. My heart rate was in the 40s and then went up to the 100s. The next day my heartrate was still elevated but not as much. I went to the doctor and did a EKG test and it was normal but still higher than my usual.
This is a spontaneous report from a contactable nurse. This is fifth of the six cross linked reports from the same reporter. This reporter called for a male patient (rage and age unknown) who received  PREVNAR13 on an unknown date at an unknown dose. The relevant medical history  and concomitant medications were unknown. On an unknown date, the patient experienced irritability fever and inconsolable crying. Relevant laboratory data were unknown. Last action taken with vaccination in response to events were not applicable. Therapeutic measures taken in response to event were unknown. At time of reporting clinical outcome of the event was unknown. Follow-up (06JUN2011) This is a follow-up spontaneous report from the same contactable nurse. The nurse reported that she had only reported on one patient, but had receive five letters, for the same patient, in error. As a result, five cases were erroneously created regarding the same patient. There is actually only one patient and one valid case (201111773).
RIGHT LOWER EXTREMITY CALF PRETIBIAL ANKLE AND FOOT SWELLING AND PAIN, REDNESS, SORENESS, TENDERNESS, AS PATIENT STATES, STARTED WITH SXS. APRIL 3RD, 18 HOURS AFTER GETTING HER SECOND COVID SHOT, PATIENT WORRIED THAT THIS IS TRULY A SIDE EFFECT REACTION TO COVID VACCINE
Patient reports she started coughing around 4:00 P.M. and felt like something was stuck in her throat that she could not get out. She then started having wheezing, felt short of breath, had body aches. At 9:00 P.M. took a Benadryl and was able to go to sleep. The next day, 09/18/2012, she did not go to work, felt wiped out. Ate toast for breakfast and went back to bed, around noon awoke and had soup for lunch and went back to bed. Patient reports she started feeling better in the evening around 8:00 P.M. on 09-18-2012.
Headaches, chills, sweating, and some swelling. Member took multiple Tylenols to subside the pain. The same symptoms occurred again on 4/7/2014 but intensified. 4/8/2014 she was unable to attend work due to the above symptoms along with swollen eyes and tingling in the arms and legs.
a bit of shortness of breath; A spontaneous report was received from consumer, concerning herself, a 71 -year-old  female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bit of shortness of breath.  The patient's medical history was reported as known. Concomitants reported included Metoprolol, Tamsulosin, Gabapentin, metformin, fenofibrate, losartan were known.  On 8-Feb-2021, the patient received their first two of two planned doses of mRNA-1273 (Lot number: 024M20A), in the arm of COVID-19 infection.  On 8-FEB-2021, she experienced bit of shortness of breath.   Action taken with mRNA-1273 in response to the events was not reported.  The event, shortness of breath, was not reported.
Pt received vaccine on Thrs. Friday pt complained about sore body and flu symptoms. Saturday pt developed redness, soreness, swollen site about 4 inches in diameter. Told pt to apply ice, take APAP and go to ER if symptoms worsen.
Pt received VZV and Hep A immunizations on 07/29/09. Mom called to office on 07/31/09 stating had swelling at injection site. Pt brought into office and assessed. Red, raised, swollen oval area. 5 1/2 cm x 6 cm noted on (R) upper arm area of VZV injection. Cool compresses, MOTRIN, triamcinolone.
pt recvd vax 24SEP92 & oon 25SEP92 exp soreness, redness, & moderate swelling which resolved in 48 hrs in the fleshy part of arm; following vax recalled being vaxed w/pneumococcal vax 2DEC91; no further details were provided;
Pt was standing upright & turned around & lost consciousness; prior to episode, no evidence of sx activity; arm shattered from shoulder to elbow; had been warm;
vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team,   A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "vertigo" (unspecified if ongoing), notes: I suffer from vertigo pre covid and it got worse during early 2020; "it got worse", start date: 2020 (unspecified if ongoing), notes: it got worse during early 2020. Concomitant medication(s) included: MECLIZINE [MECLOZINE] taken for vertigo. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "recovered", described as "vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had".  Additional information: He had a general question about the Pfizer vaccine and impact of curing vertigo. Again curing it not causing it, if there was any links to case studies or general information about it. He suffer from vertigo pre COVID and it got worse during early 2020. He noticed every time he have gotten the vaccine he finally feel clear headed and not having a serious case of vertigo as he previously had. Meclizine 25mg has had no impact anymore it feels like, he had 5 shots already of.  Follow-up attempts are completed. No further information is expected.
Information has been received from a 20 year old female as part of the Merck pregnancy registry with no drug allergies or medical history for GARDASIL, who on 30-JAN-2009 was intramuscularly vaccinated with the first dose of GARDASIL because she thought that she was not pregnant.  There was no concomitant medication.  Her LMP was 02-DEC-2008.  On 08-FEB-2009 she discovered she was pregnant.  As of 08-FEB-2009 it was unknown if the patient would still continue the GARDASIL injection and the result of the fetus being exposed to GARDASIL in utero was unknown.  Follow up information received from an office staff who confirmed the patient was last seen in the office in February 2009, when her pregnancy test was confirmed.  Additional follow up information was received from the patient who stated that she had a healthy, normal baby who was doing well and was now eight months old.  She stated that she had no complications during her pregnancy, but she was induced at full-term (induction indication not provided).  She had a vaginal delivery of a 71lb female on 01-OCT-2009.  Additional information is not expected.
Came to ER with c/o N/V and mild cough. Found to have covid Pna.
Patient reported developing/noticing a red itchy area, firm under the skin at the site of the injection.  She noticed it about 7 days after the vaccine.  It as slightly itchy.
20 minutes after receiving vaccine, employee experienced facial/eye edema, feelings of shortness of breath, chest redness. Treated in ER with EPI PEN, steroids, BENADRYL.
The following morning i got my period, the flow is very heavy which isn?t normal and the last day of my period was 8 days prior to receiving the vaccine. I wasn?t due for another 2.5 weeks
4 days of nonstop headache, aching & pounding head, soreness in the joints & muscles throughout the entire body. Small sharp shooting pains in what feels like in the muscles of my legs & arms that come & go.
Information has been received from a consumer concerning her now 15 year old daughter who was vaccinated with "one dose" of a MMR II "when she was about 24 weeks old". There was no concomitant medication. Subsequently, "after getting the vaccine" the patient experienced feverish and sick. The patient mother's reported the symptoms were improve after stopped therapy and thought the combination was a little too much for a child. The patient was recovered (unspecified date). It was not specified it the patient sought medical attention. Additional information is not expected.
vaccines have undergone several temperature excursions and have been administered to patient; No adverse event; vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed or tested positive for COVID-19.    On 28-Aug-2022 at 12:44 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2022 at 12:44 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines have undergone several temperature excursions and have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and have been administered to patient).    Patient received vaccine in deltoid.  Concomitant medication list was not provided. It was reported that refrigeration excursions identified, vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022.state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation No adverse reactions reported to their knowledge for any of these patients. Storage condition at the time of the excursion was refrigerated. Individual vials or unbroken cartons were 2 unbroken cartons 20 vials. Vial was moved from freezer to refrigerator on 07-Sep-2022. Vials were not visualized.  Treatment information was not provided.
This spontaneous report was received from a register nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-MAR-2011, the patient received the first dose of GARDASIL (dose, route, lot number and expiration date were not reported) for prophylaxis. On 10-APR-2017 and on 12-JUN-2017, the patient received the first and second dose respectively of GARDASIL 9 both vaccines had lot #M037770 with expiration date of 01-JUN-201 for prophylaxis (interchange of vaccine products). No adverse effects reported. Additional information has been requested.
approx 30hr p/inj, lt arm became swollen to elbow, sore & hot;low grade temp-but reached 102; 10 days later, arm OK, recurring low grade fever
Swelling, redness, heat, itchiness, and pain at injection site (cellulitis to right thigh).
Fatigue Headache Muscle pain Chills Joint pain Low fever Swollen left arm lymph nodes
Headache, Sedation, Myalgia, Fever, NauseaVomiting, chills Narrative:
Redness and swelling to upper arm (deltoid), DTaP and IPV given in this site.
Had vivid symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (Had vivid symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (Had vivid symptoms). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (Had vivid symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment information was not provided.
This case was reported by a consumer via call center representative and described the occurrence of bedridden in a female 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 year after receiving SHINGRIX, the patient experienced bedridden, bronchitis, cold, sickness, difficulty in standing and activities of daily living impaired. On an unknown date, the outcome of the bedridden was recovering/resolving and the outcome of the bronchitis and cold were recovered/resolved and the outcome of the sickness, difficulty in standing and activities of daily living impaired were unknown.  It was unknown if the reporter considered the bedridden, bronchitis, cold, sickness, difficulty in standing and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Almost six months before the date of reporting the patient received 1st dose of SHINGRIX. The patient got sick that she had been dreaded for the second dose of SHINGRIX. The patient was completely bedridden for a week, and only a little better the second week. The patient could hardly stand up long enough to prepare something to eat, or even take a shower. Last month from the date of reporting, the patient got over a bad cold and bronchitis. The patient was retired and mentioned that did not miss two weeks of work. The patient did not want to receive second dose of SHINGRIX because of the horrendous side effects experienced early. The patient asked what would happen if second dose was missed.