chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial 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 concomitant medications, concurrent conditions or medical history. On 20-APR-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015, the patient was treated at a family physician's office for a severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Stomach Ache, Scratchy Throat, Stuffy Nose, Tired, Chills, Achy, Fever, Lack of hunger
9:28 C/O numb tongue, itchy head and face. Self administered Children's Liquid Benadryl 10 ml 9:34 PO2 99%, P 109/86 repeat, BP 139/74  9:36 PO2 99%, P 85 BP 159/89 9:39 Itchy face/head 10:13 Ok stable
02/28/2022 I ended up in the ER due to heart palpitations. I've had heart palpitations, blood pressure issues and tunnel vision. I've also been having chest pain. I'm being told that mechanically there is nothing wrong with my heart and they are trying to figure out what is causing the chest pain and heart palpitations. I wore a MCOT (wearable monitor) for a week and it showed PVTs and tachycardia. They did an echocardiogram but that indicated there were no blockages so they are currently trying to figure out the root cause. Since this problem has started I have visited the ER numerous times and they have done numerous tests and they should all be in my medical records.
sleepy; limbs stiffness; ache; tiredness; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (sleepy), MUSCULOSKELETAL STIFFNESS (limbs stiffness), PAIN (ache) and FATIGUE (tiredness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleepy), MUSCULOSKELETAL STIFFNESS (limbs stiffness), PAIN (ache) and FATIGUE (tiredness). At the time of the report, SOMNOLENCE (sleepy), MUSCULOSKELETAL STIFFNESS (limbs stiffness), PAIN (ache) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
This spontaneous report was received from a physician concerning a 19 year old female patient. The patient did not have medical history, concomitant medications or drug reactions or allergies. On 13-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9, intramuscularly, lot number reported as L026602 with expiration date 19-OCT-2017 (dose, strength and anatomical location were not provided). On 22-APR-2016, the patient was vaccinated with the second dose of GARDASIL 9, intramuscularly, lot number reported as L026602 with expiration date 19-OCT-2017 (dose, strength and anatomical location were not provided). On the same date, following the second vaccination, the patient experienced syncope and "jerking seizure like movements" that lasted for 10 seconds. The patient recovered from the reported events on the same date (also reported as "the patient's present condition is fine"). The patient sought medical attention with the reporting physician and laboratory diagnostic studies were not performed. The causal relationship between syncope and "jerking seizure like movements" with vaccination with GARDASIL 9 was unknown. Upon internal review, the event seizure was determined to be medically significant. Additional information has been requested.
Patient received the Moderna vaccine as second dose in vaccine series, but first dose was utilizing the Pfizer COVID vaccine.  No specific adverse events have occurred, but given that a vaccine administration error occurred, I am submitting a VAERS report.
Arm soreness and headache within the hour of getting the shot.  The arm soreness abated after a day or two, but the headache has continued NON-STOP ever since.  OTC headache medicines Tylenol, Naproxen, Aspirin do not make the headache stop.  Tramadol 50mg, Toradol 10mg, Topamax 25mg don't even temporarily relieve the headache.  Amoxicillin  125Mg has been prescribed to help with any possible immune deficiency.
The patient received her flu vaccine at 4:50 PM & states she started to receive muscle soreness radiating from her shoulder to her neck later that evening. She reports the pain is unrelieved by ADVIL. She states the  next day the stiffness continues.
Patient came in a week with a red stripy rash at injection site. Patient already had dry skin. Patient was told to go see PCP.
Patient reported severe pain in both arms and legs beginning on Friday, 5/18/18 in the evening. Patient reported taking 1 dose of an unknown new medication for infection/bacteria on Friday, 5/18/18 in the evening around the time the pain started; medication name is unknown and was dispensed by a pharmacy. Patient went to the Emergency Room on Saturday, 5/19/18 around 5am. ER doctors instructed patient to take TYLENOL. Patient reported taking 1 tablet of TYLENOL at 4pm and 1 tablet at 10pm which made him feel better and he went to sleep. Patient reported severe headache on Sunday, 5/20/18 in the morning. Patient visited primary care MD on Monday, 5/21/18 due to continued pain. Per patient, primary MD gave the patient a prescription for ibuprofen 600mg for pain and swelling. Patient reported visiting primary MD on Wednesday, 5/23/18. Patient stated he continues to have some pain in his arms and reported taking ibuprofen 600mg.
Within 10 minutes of observation post-Pfizer COVID vaccine. Pt c/o itching to lower back. The RN visualized redness along pant line, approximately palm sized. Waited 5 minutes with continued observation and patient stated continued itchiness but h/o multiple allergies. Denies SOB, no oral swelling noted, RR even and unlabored. Assessed torso with no further significant hives but previous still visible. Pt given 25 mg po Benadryl. Pt requested to go home, denied acute distress, states she has Zyrtec at home. Pt with coworker who stated pt will remain with them for next few hours and they would monitor her symptoms. Pt given s/s to monitor for, when to go to ED if acute symptoms, and to notify MD of possible allergy. Pt agreed with Plan of Care.
- Emergency room visit on 3/16/21 for local reaction to immunization (COVID vaccine). Had redness and warmth at injection site on left deltoid. Had similar reaction on 3/4/21 - with initial vaccine,  but it went away. Per chart notes in emergency department - "3 cm circular area of erythema with mild warmth at the left middle deltoid area without significant induration or fluctuance. Skin otherwise pink, warm and dry."  - Patient reports visual disturbances - seeing shadows at times, fuzzy lights, etc. States her blood pressure dropped - normally runs much higher - and pulse went up. Patient still feeling nauseous today. Had pressure in the back of her head which has nearly resolved.
Initial misuse report received from a healthcare professional on 08 July 2013. It was reported that a child was administered only DTAP-IPV portion of PENTACEL. No more information was provided regarding the patient. No adverse event was reported. Documents held by sender: none
pt recv vax & reported rash around where inj was given;mom told by MD that rash was sometimes a rxn;19NOV97 mom reports rash is spreading to leg arm, stomach & back;
Information has been received from a physician concerning a 3 year old female, with no allergies or medical history, who on 1/30/03 at 14:000 was vaccinated in the left lateral thigh with the first dose of varicella virus vaccine live (lot # 643588/0804M). The physician reported that on 9/15/04 the patient developed 100-150 lesions all over the body. She was diagnosed with a moderate case of varicella but no laboratory/diagnostic tests were performed. The physician also reported that interestingly enough she also developed erythema multiforme with that. At the time of this report, 12/8/04, patient's outcome was unknown.
Diarrhea in the morning, fatigue, and headache after that during the next three days. Slight fever also on and off during those three days. By the fourth day, the symptoms were clear. Self-care, nap and resting at home. I may have taken Ibuprofen for headache.
Patient received the Flu vaccination at work. In the Left deltoid and it was sore and painful but the symptoms got worse over the next 6 weeks. Her main complaint is left deltoid pain. She denies any fever or chills.
Large red circular area at injection site. Slight pain and feels slightly warm.  Noticed on 1/27/2021 and was vaccinated on 1/13/2021 and no reaction at time. No temperature.
Fever started 8 days after vaccines, rash developed 10 days after vaccine; no anaphylaxis, fever as high as 102.
Red itchy area developed 24 hrs after vaccination. Report received 10/2. Patient described previously diagnosed allergy to thimerosal-did not inform vaccinator of this. Also did not report latex allergy at time of vaccination.
Two days after the first vaccine,  on 1/14/22, patient urinated 3-4 times in the evening and it was bloody in appearance.  He is on a weekly infusion of Casimersen and parent does a weekly UA at home with strips and used those to check his urine at this time and protein was 100 mg/dL.  No pain, fluid retention or any others symptoms noted.  The next morning,  urine appeared normal and protein level back to trace,  which it is on occasion with infusions. There was nothing different in diet or routine, other than vaccine, that could be related and parent has never seen his urine this color or protein this high. His care team was notified and consulted prior to receiving second vaccine on 2/5. They documented findings in his chart but did not report. Once PCP was notified of the reaction on 2/5/22 we asked parent to send a summary of what had occurred to ensure it was reported.  To date,  there have been no issues following second vaccine.
Patient presented with dyspnea.  He was found to have multiple subsegmental PEs as well as DVT and started on heparin --- > Xarelto. His mild AKI on presentation resolved. ED visit and hospital admission was within 6 weeks for receiving the COVID vaccine.
Suspected Vaccination failure/My mom got the vaccine, still got a really bad case of shingles; Still got a really bad case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 25-May-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The patient was the reporter's mother. The patient got the vaccine and still got really bad case of shingles. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Rash at the injection site almost down  to elbow and around to the underside of the arm with extreme itching. Started 5 days after injection at initial injection site, was as big as tennis ball and has increased substantially every day since. Used cortisone to subdue itching but went to pcp Dr to examine the site. She prescribed cetirizine and cephalexin for 5 days. Itching has stopped but rash is still large and present. Will revisit with Dr on 2/25/2021.
This spontaneous report as received from a female physician of unknown age via a company representative refers to herself. The patient's medical history was not reported. On an unknown date (reported as years ago), the patient was vaccinated with GARDASIL on month 0, month 2 and month 6, intramuscular for prophylaxis and it hurt. She had injection site pain and it was hard to lift her arm afterwards for a day or two. The outcome of events was reported as recovered/resolved (date unspecified). The patient did not receive any treatment. The relatedness between the events and GARDASIL was not reported.
Twitching of upper left arm Twitching of left abdominal side Fever and swelling of clavicle bone on left side, protruding, tender and with fever Passing face numbing others maybe more expected: fatigue/soreness for about 1-2 days after the shot was given.
Vaccine given 10/30/03. Mom noticed hives on 11/1/03 and 11/2/03. Hives were gone by 11/3/03. Mom states may have had hives on Friday 10/31; doesn't know since was with dad that day.
After my first and second Moderna shots my heart raced and 3 weeks after the second shot I started to retain body fluid from heart failure and Edema. also my mother died 3 weeks after her first Moderna shot and also my aunt (her sister) died 3 weeks after her Moderna shot.
This spontaneous prospective pregnancy report as received from a physician refers to a 21 year old female patient with pregnancy and food allergies but no drug allergies. The patient's medical history included chickenpox twice and shingles once. On 06-FEB-2013 the patient was inadvertently vaccinated with a dose of 0.5 ml VARIVAX (Merck) (lot # H018015, expired date 10-JAN-2014) subcutaneously. Concomitant medication included prenatal vitamins. The physician noted that an unspecified medical assistant at the office had given the VARIVAX (Merck) to this pregnant patient without medical orders. The patient was pregnant with LMP of 12-JAN-2013 (reported as 12 weeks and 2 days) and EDD of 19-OCT-2013. Initial exposure to VARIVAX (Merck) was at 3 week(s). There was no lab diagnostics studies performed. At the time of reporting, the pregnancy and outcome were unknown. The patient sought medical attention at physician's office. Follow-up information was received on 10-NOV-2014. The reporter stated that the patient changed providers during her pregnancy, and they did not follow-up on the pregnancy and they knew nothing about the outcome. The patient left their practice due to receiving VARIVAX (Merck) while pregnant. Additional information is not expected.
Left deltoid soreness, radiated to left neck and ear area, followed my immobility of left upper arm, sever  painful joint aches, especially to weight bearing joints and long bones,  mild facial swelling, mild SOB, headache, dizziness
Meniere's attack; Anaphylactic reaction; Started passing out; doesn't feel well; Tired; light headed; A spontaneous report was received from a Consumer concerning a 85 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction (anaphylactic reaction), started passing out (loss of consciousness), Meniere's attack (Meniere's disease), tired (fatigue), light headed (dizziness) and doesn't feel well (malaise).   The patient's medical history included allergies to citrus and bee stings. Concomitant product use was not provided by the reporter.  On 15 FEB 2021, immediately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 15 FEB 2021, immediately post vaccination, the patient got an anaphylactic reaction and started passing. The patient was transported to the emergency room where medication was administered and an echocardiogram (ECG) was performed (results not provided).  On 17 FEB 2021, the patient contacted physician who instructed to take Tylenol three times a day and nausea medication as needed. The patient only took one pill.  On 21 FEB 2021, the patient had a terrible Meniere's attack which caused patient to feel dizzy and was hospitalized. On an unknown date in FEB 2021, the patient returned home but couldn't get over it. Patient reported feeling very tired, lightheaded and unwell.  Treatment information included famotidine, Ativan, Zofran, Tylenol and nausea medication.  Action taken with mRNA-1273 in response to the events was unknown.  The events Meniere's attack, tired, lightheaded and doesn't feel well were considered not resolved. The event started passing out was considered resolved on 15 FEB 2021. The outcome of the event anaphylactic reaction was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Right arm swelling, redness, itching, painful at vaccine site. Bicep swollen. Notes fingers were swollen in the A.M.
Child seen on 11/04/08 for PE/Imms @ Clinic.  Due to time constraints, Pt and family sent to Imm Clinic for vaccinations.  6 vaccines given (DTaP, Hep A, MMR, Var, TIV flu, IPV) divided btwn. bilat. thighs without incident.  Parent called Well child clinic on 11/7/08 seeking advise re: pain in legs "child won't walk".  Parent instructed to use ACTM for pain control and call on 11/10/2008 if child still with symptoms.  Parent called on 11/10/08 seeking advise for leg pain again.  Parent instructed to continue using ACTM and seek care with child at MD office.  Child seen on 11/11/08 @ MD office with continued sx. Per parent, was told "nl. S.E. of vaccines".  To "cont. with pain control efforts and encourage walking, to return to clinic in 1 wk. if no better".  Parent reported "no fever, no reddness/swelling @ sites" noted after date of vaccination. "Pain worse in front of R leg, child won't run or jump, just walks slowly."
Significant and radiating muscle pain at the injection site, progressing outward over time. Persistent fever above 102 F beginning ~15 hours after dose and persisting for 48 hours; accompanied by fatigue Reduced fever over next 24 hours, but still ~100 F.
The next day I felt a numbness throughout my whole left side. Not debilitating, but, noticeable. Still, today, my left arm, and sometimes up through my neck to cheek, it's tingly. After about 3 weeks,  my arm will randomly twitch next to the shot area. Also, a headache for 3 days.
PARENT STATED CHILD TOOK A FEVER APPROX 24 HOURS FOLLOWING VACCINATIONS BY SEIZURE.  CHILD WAS TAKEN TO BAPTIST HOSPITAL TO RECEIVE TREATMENT.  WAS RELEASED AND SCHEDULED TO HAVE A BRAIN WAVE TEST DONE.  PARENT WILL CALL WITH UPDATE ON TESTS RESULTS.  11/24/09 Medical records received for DOS 6/23/09-6/24/09 Final DX: Syncope, fever, dehydration, viral syndrome C/O syncope, fever. Arthralgia, nausea, sinus congestion. Seizure. Fatigue.  Aches. R/O meningitis.
fever 103.8, rash was ill x 4 days; 7 days follow-up completed on 19JUN92; Pt recovered;
Sharp electric pain that goes some inches up her right leg; Sharp electric pain in her right ankle; In the injection site she has a red stripe (not rounded as usually you would get from a shot), it is a 2 inch by 5 inch oblong red stripe; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sharp electric pain that goes some inches up her right leg), ARTHRALGIA (Sharp electric pain in her right ankle) and VACCINATION SITE ERYTHEMA (In the injection site she has a red stripe (not rounded as usually you would get from a shot), it is a 2 inch by 5 inch oblong red stripe) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A, 027A21A and 019821A) for COVID-19 vaccination.     Concurrent medical conditions included Systemic lupus erythematosus. Concomitant products included PREDNISONE for Systemic lupus erythematosus.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE ERYTHEMA (In the injection site she has a red stripe (not rounded as usually you would get from a shot), it is a 2 inch by 5 inch oblong red stripe). On 15-Oct-2021 at 4:00 AM, the patient experienced PAIN IN EXTREMITY (Sharp electric pain that goes some inches up her right leg) and ARTHRALGIA (Sharp electric pain in her right ankle). At the time of the report, PAIN IN EXTREMITY (Sharp electric pain that goes some inches up her right leg), ARTHRALGIA (Sharp electric pain in her right ankle) and VACCINATION SITE ERYTHEMA (In the injection site she has a red stripe (not rounded as usually you would get from a shot), it is a 2 inch by 5 inch oblong red stripe) outcome was unknown.            Treatment medication was not provided by the reporter.  The patient did not experience any adverse events after first and second dose.
10 days after the shot the arm became very hot, red, swollen and very itchy.  It lasted about a week. It was hard.  The swollen area was at least 5 inches wide and wrapped around top of arm.   Arm was swollen by a few inches, noticeably larger upper forearm.
PIN AND NEEDLED PAIN ON LEFT SIDE OF FACE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAY-2021, the subject experienced pin and needled pain on left side of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pin and needled pain on left side of face was not reported. This report was non-serious.