chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MULTIPLE SKIN ULCERS/ SORES ALL OVER BODY; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1141161 expiry: UNKNOWN) dose and frequency were not reported from an unspecified date to 14-MAR-2022 for moderate to severe rheumatoid arthritis.  No concomitant medications were reported.  On an unspecified date, the patient experienced multiple skin ulcers/ sores all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn on 14-MAR-2022. The patient was recovering from multiple skin ulcers/ sores all over body. This report was non-serious.
Rash of buttocks, legs and posterior arms about 3-4 days after vaccination with MMRV
Visual hallucinations; A spontaneous report was received from a consumer concerning a 81-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced visual hallucinations.  The consumer's medical history included vision loss in the right eye. Relevant concomitant medications provided as eliquis, latanoprost, azopt, rhopressa, fluticasone, losartan, rosuvastatin, metformin, glimepiiride, tylenol, fish oil, cod liver oil, cinnamon, vitamin d3, vitamin b12 and melatonin as needed.  The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 05 FEB 2021. On 12 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12-MAR-2021, the patient began to see pin point, blood colored dots all over his face and hands. He then noticed the pin point dots all over the walls, desk, books, etc.  The patient reported seeing an image and when he would go closer, it wasn't there. He also felt like someone was standing next to him when no one was. The visions would come and go over the weekend.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, visual hallucinations, was considered recovered/resolved on 15 Mar 2021.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Pinched nerve in back; Disc issue in back; Achy and fatigue following second COVID vaccine; Achy and fatigue following second COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy and fatigue following second COVID vaccine), NERVE COMPRESSION (Pinched nerve in back), INTERVERTEBRAL DISC DISORDER (Disc issue in back) and FATIGUE (Achy and fatigue following second COVID vaccine) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced PAIN (Achy and fatigue following second COVID vaccine) and FATIGUE (Achy and fatigue following second COVID vaccine). On an unknown date, the patient experienced NERVE COMPRESSION (Pinched nerve in back) and INTERVERTEBRAL DISC DISORDER (Disc issue in back). At the time of the report, PAIN (Achy and fatigue following second COVID vaccine), NERVE COMPRESSION (Pinched nerve in back), INTERVERTEBRAL DISC DISORDER (Disc issue in back) and FATIGUE (Achy and fatigue following second COVID vaccine) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.  On unknown dates, the patient experienced pinched nerve in back and disc issue in back. In 2021, the patient experienced achy and fatigue following second COVID vaccine.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of pinched nerve in back, disc issue in back, achy and fatigue following second COVID vaccine was not provided for co-suspect RINVOQ.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
No other AE.; he had a patient at the pharmacy who was 52 years old and had received 2 doses of GARDASIL 9 on unknown dates in 2022.; This spontaneous report was received from a pharmacist regarding a 52-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On unknown dates in 2022, the patient was vaccinated with the first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered as prophylaxis (dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) (Product administered to patient of inappropriate age). The patient reported he was due for a 3rd dose, it had not been administered. No adverse events were reported.
Death Narrative: Patient received Covid vaccine on 2/2/21, person reports his legs were more rigid with some sweating the day of the vaccination with leg rigidity that was slowly improving. No other adverse effects reported for following 7 days. Person states he had vomiting episode earlier this week, person states he had no other symptoms before or after the vomiting episodes. On morning of 2/12/21, person reports patient got up ready for breakfast with no issues. She says he asked for chorizo and oatmeal but she laughed and said don't you mean chorizo and eggs. He said yes. They got him into W/C and he was rolling himself into dining room got stuck in hallway. She says he took several breaths then 3 very deep breaths and passed away. She called 911 they took his VS but he has passed. She told them to leave him along no resuscitation.
On day 1, beginning about 13 hours after the vaccination, I began experiencing significant chills (at bedtime). The day after the vaccination (day 2), I experienced mild tiredness and malaise. Late in the evening of the day 2, I had a mild fever of approximately 100 degrees. (My normal temp is about 97.1 degrees.) All symptoms resolved overnight - no symptoms on day 3.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 01-FEB-2016, the patient was vaccinated with an expired doses of PNEUMOVAX 23 (lot # K009107, expiration dates: 21-JAN-2016) (does and route were not provided). Concomitant medication was not reported. No adverse effect was reported and there was not product quality complaint involved. Additional information has been requested.
excruciating pain in my arm from the injection site to my shoulder; Shoulder pain; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced injection site pain and shoulder pain. On an unknown date, the outcome of the injection site pain and shoulder pain were unknown.   It was unknown if the reporter considered the injection site pain and shoulder pain to be related to Shingles vaccine.  Additional details were provided as follows: The case reported by the patient himself/herself. The age at vaccination was not reported. The patient received the 2nd dose of Shingles vaccine 18 months before reporting date and it left patient in excruciating pain in my arm from the injection site to my shoulder. The reporter stated his/her experience was very traumatic. The reporter stated that he/she could not take take it anymore and doctor referred patient to an orthopedist and mentioned he/she did not know what they would find.
fatigue, confusion/disorientation, numbness on rt side of body/face shot administered in lt arm;
Joint pain; Pain in my hands/ pain; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of arthritis (1st dose received on an unknown date, for tolerance refer case US2021AMR066228).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced joint pain and pain in hand. On an unknown date, the outcome of the joint pain and pain in hand were unknown.   The reporter considered the joint pain and pain in hand to be unrelated to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient had arthritis and did some strenuous exercise before getting shingrix vaccine. The patient had joint pain and asked if she could safely take advil or Tylenol after Shingrix dose. The patient did not believe that the pain was related to vaccine. She had pain in hands and was from yardwork. The patient just did not want to compromise the effectiveness of Shingrix shot. No further information was provided. The consented to follow up was unknown.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR066228:Same reporter.
"Moderna COVID-19 Vaccine  EUA"  Hospitalized for SOB and no energy, anemia
Accidentally gave a 0.25 booster dose from a vial that had been left on the counter too long. The vial was marked, I read the lot number but not the time.
August 24 I started noticing my symptoms and I experienced fever that day, as well as sore throat, stuffy nose, occasional fever but not real bad, a little bit of muscle aches, I lost my sense of taste and smell for about two weeks, and a cough that was down in the chest. It felt like a cold but it kind of progressed but I also lost sense of taste and smell. I tested positive for COVID on Friday September 3 and I got my results on September 7 and it was positive. My cough lasted about three weeks. I also had a headache and some achiness and fever on occasion. I did see the Doctor on September 1 and he prescribed Sudafed but I didn't take it but I was taking Tylenol and some decongestant. I also had a sore throat part of the time. July I also had a head cold with stuffy nose and a little bit of fever but I didn't test positive for COVID, it was negative.
Pt states She has developed a severe case of thrush/candidiasis as a result of her Prevnar shot
pneumonia; the vaccine did not prevent shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 06-APR-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles.         On an unknown date, "few months" of receiving zoster vaccine live (ZOSTAVAX), the patient developed and was diagnosed with pneumonia. The vaccine did not prevent shingles, but rather caused the patient to contract pneumonia. As a direct and proximate result of the defective Zoster Vaccine Live (ZOSTAVAX), the patient suffered painful injuries and damages, and required extensive medical care and treatment. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, 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 outcome of the event was considered to be not recovered.  Pneumonia was considered to be disabling.  Upon internal review pneumonia was considered to be medically significant.
28FEB95 pt recvd vax & later that noc, pt became ill-sweating, crying, foaming @ mouth, stiff body, t100; mom called 911; pt rushed to ER; kept in ER several hrs; pts temp not better 2 or 3MAR
has lost 25 pounds; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (has lost 25 pounds) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (has lost 25 pounds). At the time of the report, WEIGHT DECREASED (has lost 25 pounds) 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 medication included a fluid pill, which the patient stated that no longer taking since weight loss after first dose.  No treatment information was provided.  Patient stated that her weight loss had nothing to do with vaccine   This case was linked to MODERNATX, INC.-MOD-2021-138150 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18-JUN-2021 and does not contain any new information; Sender's Comments:  MODERNATX, INC.-MOD-2021-138150:crosslinked; husband case
Upon receiving shot immediately felt light headed. Got better after about 5-10 minutes and left facility. Felt weak and tired throughout day until about 7 pm. Felt fine after that and went to bed. Woke next morning to pain throughout body from torso to head. Specifically, pain in lower right abdomen, severe pain in left kidney, bad headache, and shooting nerve pain in head behind both ears (much like a shingles attack). This persisted throughout the entire day.  Woke up this morning with all symptoms relieved. Currently have a wrung out feeling but other than joint soreness throughout body, most other symptoms have abetted.
This spontaneous report was received from a pharmacist, via Pfizer, referring to a patient of unknown age and gender. Medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 injection (dose, route of administration and lot number were not provided).  On an unknown date, the patient had a localized allergic reaction the size of a football after receiving the PNEUMOVAX23. The reporter also asked if there was any information regarding administration of the PREVNAR13 or any known cross-reactivity with PNEUMOVAX23. No Product Quality Complaint was involved. The outcome of the event was unknown. The casual relationship between the event and the PNEUMOVAX23 was not provided. Additional information has been requested.
The day after my vaccine(1/8/21), I noticed pins and needles/tingling sensations in my left foot and left hand. I have never had this happen before. IT lasted for about 15 minutes that night.  The day after that(1/9/21), it happened again in the evening and lasted about 10-15 minutes.  The morning after that(1/10/21), I had the pins and needles/tingling and a bit of numbness in my left hand that lasted for a few hours.  That evening(1/10/21), I had the sensations again in my left hand, as well as noticing a prickling/itching sensation on both of my shoulders. That lasted for about 30 minutes.   That was the last time I experienced it and have not experienced it again in the last 2 days.
Felt light headed, ringing in her ears, c/o nauseated. BP 110/68 Pulse 68. Removing Jacket. Offered water. Offered oxygen but refused.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 87-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included Influenza vaccine Quadrivalent unspecified season. On 7th August 2018 11:02, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unchanged. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: On 7th August 2018, the patient received flu shot on the left arm as concomitant vaccine. The patient received SHINGRIX vaccine on right arm. The patient stated that at the site of injection and the area below the arm where he received SHINGRIX vaccine was sore and painful. The patient had denied permission to contact their physician. No further details were provided. The patient would follow up with his healthcare provider.
Patient had syncopal episode within a couple of minutes following vaccination.  Patient felt better after resting and drinking some juice, and was released to home.
This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX lot # M027886 for prophylaxis.  Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. This was one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA002307: US-009507513-1708USA002306:
This spontaneous report as received from a healthcare worker refers to a unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored VARIVAX (Merck) (dosing details were not reported) (lot # K016132 with an expiry date of 24-SEP-2016 exposed to 27.7 F for 252.57 hours), (lot # L017142 with an expiry date of 13-MAY-2017 exposed to 24.3 F for 133 hours) and (lot # L026410 with an expiry date of 15-FEB-2017 exposed to 19.9 F for 10.25 hours). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
weakness, myalgias, body aches x3 days, could not get out of bed, called EMS.  +COVID X 5 days ago. hypoxia secondary to covid pneumonia. hold remdisivir due to renal. decadron, zinc.  consider Toci if deteriorates.  gental rehydration. new onset AFIB fro COVID, start lovenox and metoprolol. O2 at 4L.  Sats dropped on 1/24 requiring 15L HF O2. Tocilizumab given. Weaning O2. 3L O2 when Dc to NH.
Patient with COVID vaccinations who admitted with hypoxia and complications of COVID.  Provider d/c note:  "Patient is a 73-year-old male with a past medical history Myofibrillar myopathy type 1-type of muscular dystrophy, history of abnormal stress test 2003 who presents with cough, shortness of breath.  Diagnosed with COVID pneumonia, monitor for signs of superimposed bacterial pneumonia, hold antibiotics at this time.  Sputum culture shows normal oral flora..  Continue dexamethasone x 10 days.  Patient is no longer hypoxic so remdesivir stopped, consider restarting if patient becomes hypoxic again.   CT urogram negative for hydronephrosis but shows some chronic outlet obstruction.  Start Flomax, bladder scans.  Chronic obstructive pulmonary disease changes also noted.  Elevated transaminases, possibly secondary to remdesivir?  Improving.  Consider outpatient CMP."  Discharged to acute rehab unit for physical therapy"
Dizziness, x20secs  several episodes and shoulder muscle aches within 72hrs of vaccine repeat of Sx three days later  Dizziness worse with lying down bending over and changing positions from lying to standing  no sycope
The same of vaccination, I started feeling tired, my left arm hurt and did not feel like myself. I went to bed and I woke up thru the night with fever and I did not wake up until the next day. I was very thirsty. On the 28th, I ran fever and slept all day. Later that evening, I ran fever up to 103.0. My daughter came to give me a home test for COVID-19 and it was negative. I took Tylenol. Today, I feel a little better with a little more energy but I still have the pain in my arm and it's slightly red. I have had these symptoms with every Moderna vaccine. I did not go to the doctor because I felt so sick.
After receiving my shot in my left shoulder on a Tuesday, I had the normal site tenderness, which was present that day and on Wednesday. The second morning, Thursday, I woke up with much more definite shoulder pain, which got progressively worse  during the day. On Friday, I could no longer lift my arm and my range of motion was heavily compromised.  This continued on Saturday and Sunday. On Monday, I made an appointment with my primary care doctor to make sure that this wasn't something more serious, and so I could get a referral to a physical therapist to help alleviate the discomfort. One week in, I have gained back some range of motion, but the pain and discomfort are still there.
A report was received from a health professional on 10/11/02, concerning a 48 year old female vaccinee who experienced an injection site reaction approximately 30 minutes after receiving Fluvirin on 07/10/02. He experienced a red, hot, itchy injection site swelling. There was insufficient information to determine the reporter's causality assessment. 5 other vaccinees vaccinated at the same time with the same batch had the same reaction. See PJP200200500, PHP200200501, PJP20020052, PJP20020053, and PJP200200504. Update (1) 12/10/02: A report was received from a health care professional, the  injection site reaction had resolved at the time of the report.
Few minutes after injection of vaccines mom notified RN that areas near injection sites were raised w/heat and red. Cool compress applied. MD was notified and examined pt. MD notified mom to call back if changed. BENADRYL if itchy.
Approximately 4-5 hours after receiving 1st dose of HIB vaccine at age 3mo, pt developed redness and swelling of full left thigh, hives on chest, and vomiting. Pt was seen in Emergency Dept and given BENADRYL. Symptoms improved, and fully resolved in 3 days.