chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose on 27Oct2020 and 2nd dose on 11Jan2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th October 2020).   On 11th January 2022, the patient received the 2nd dose of Shingrix. On 11th January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter did not have any patient details or lot number, expiration date of dose 2 at time of call. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. This case has been linked to the case US2022103219 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022103219:Same reporter
Nasal congestion, dyspnea, hives, feet and finger swelling 3 days after moderna covid-19 vaccine.  Hives and dermatographia has persisted.
Patient reports experiencing a change in vision approximately 15-20 minutes after receiving the Shingrix vaccination.  Patient reports fluttering/wavy lines in the perphery of her right eye.  Also reported numbness or tingling in her left hand and on the right side of her head.  Symptoms resolved within one hour.  Patient made an emergency room visit to address symptoms.  She made a visit to an optometrist.  Patient reports that the ER ruled out stroke and that the optometrist reported the retina/ocular nerve appeared normal.
Patient states his left ankle and heel are swollen and hurts and can not step on it, it started on 08/06/21 , patient took prednisone for the inflammation but no improvement
Client reported lightheadedness and empty feeling in chest immediately after vaccination.  Visibly crying and reported feeling anxious.  Vital signs cleared by on site EMS.  B/P 140/90.  Client monitored for 45 minutes.  Client reported, "I feel better."  Exited site, awake, alert and oriented.
Right arm below injection site red, warm, swelling 4 x 5". Pt did not inform provider right mastectomy. MD notified and appt made for 10/24/03. Benadryl and Tylenol given.
Red, circular /defined borders about 3.5 inches in width and 2.5 in length; Pain around my deltoid; Traveling to my shoulder and scapula; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Red, circular /defined borders about 3.5 inches in width and 2.5 in length), VACCINATION SITE PAIN (Pain around my deltoid) and ARTHRALGIA (Traveling to my shoulder and scapula) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Allergy to antibiotic (Allergic to Doxycycline) and Allergy to antibiotic (Allergic to Bactrim).    On 08-Jan-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red, circular /defined borders about 3.5 inches in width and 2.5 in length), VACCINATION SITE PAIN (Pain around my deltoid) and ARTHRALGIA (Traveling to my shoulder and scapula). At the time of the report, VACCINATION SITE ERYTHEMA (Red, circular /defined borders about 3.5 inches in width and 2.5 in length), VACCINATION SITE PAIN (Pain around my deltoid) and ARTHRALGIA (Traveling to my shoulder and scapula) had not resolved. Not Provided          Concomitant product use included biologics.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.; Sender'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.
No adverse event; number of doses were administered BUD in different dates to pediatric patients from 6 months to 11 years:; number of doses were administere BUD in different dates to pediatric patients from 6 months to 11 years; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (number of doses were administered BUD in different dates to pediatric patients from 6 months to 11 years:), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (number of doses were administere BUD in different dates to pediatric patients from 6 months to 11 years) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR9236B, AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (number of doses were administered BUD in different dates to pediatric patients from 6 months to 11 years:) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (number of doses were administere BUD in different dates to pediatric patients from 6 months to 11 years). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (number of doses were administered BUD in different dates to pediatric patients from 6 months to 11 years:), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (number of doses were administere BUD in different dates to pediatric patients from 6 months to 11 years) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (number of doses were administered BUD in different dates to pediatric patients from 6 months to 11 years:) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (number of doses were administere BUD in different dates to pediatric patients from 6 months to 11 years).    No concomitant medications were reported.   It was unknown if patients experienced any adverse events.  No treatment details were reported.
I was fine until developing a rash on my arm, just beneath the injection site 6 days post injection
Chronic migraines since 2007. Multiple neurology appointments and medication. Missed work and lessened quality of life.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 09-MAR-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Patient noticed rash forming on both arms approximately 15 minutes after vaccination. Reported that rash was itchy and had a burning sensation. Provider recommended that patient go home and take diphenhydramine for the reaction and seek urgent care if SOB developed. Vital signs were normal.
Body aches and coughing/congestion. Treatment was 60mg prednisone/day & Lagevrio for 5 days each.
Redness, swelling, area warm to touch, painful, erythema 12 by 8.5 centimeter at left thigh. Treated for cellulitis with KEFLEX, treated for pain with TYENOL. Has follow up.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in an adult female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. In July 2016, less than a week after receiving BEXSERO, the patient experienced injection site pain, injection site erythema, injection site irritation and injection site lump. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site irritation and injection site lump were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site irritation and injection site lump to be related to BEXSERO. Additional details were provided as follows: This case was reported by a registered nurse via an email to the sales representative, who called to report it to the Medical Information. The age at vaccination was not reported. The reporter stated that, an employee in the store where reporter's clinic was located received the BEXSERO vaccine three weeks ago from reporting date (not by their office). After a week, the patient came to ask about injection site pain, localized tenderness and erythema after BEXSERO vaccination, which reporter suggested should resolve. At the time of reporting, the reporter walked to the patient and the patient stated that she still had a lump under the skin in the injection site. The reporter did not assess it, but wondered what he might say, whether injection site irritation more of an issue with BEXSERO and when should the patient return to the provider who gave her the injection.
1-7-15 Mom calls. Gold ball sized red spot rt. leg. No pain. Able to walk. instructed to circle area and warm soaks, BENADRYL. Call if bigger. 1-8-15 Saw physician. Red swollen area rt thigh 8 cm x 4 cm. Put on KEFLEX 250 mg TID x 10 days.
Rash over abdomen, back, thighs, neck, arms. Red flat rash. Temp 98.2.
On day following vaccinations patient had fever to 100 F, malaise, slept several hours in AM and PM.  Fever resolved by following AM.  Friday June 7, 2002 patient again had fever up to 100 F, followed the next day (6/8/2002)by very faint rash to face, torso and extremities that became more pronounced by 6/9/2002.  Patient continued with fever from 6/7/2002 resolving 6/10/2002 AM.  Rash remains to date.  Fever treated with Tylenol and Ibuprofen prn.  Reporting since MD office staff stated that do not report since events are within expected events or norm.
Could not walk after receiving the second dose; Felt dizzy after receiving the second dose; Had no stability after receiving the second dose; Headaches after receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could not walk after receiving the second dose), DIZZINESS (Felt dizzy after receiving the second dose), BALANCE DISORDER (Had no stability after receiving the second dose) and HEADACHE (Headaches after receiving the second dose) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced GAIT DISTURBANCE (Could not walk after receiving the second dose), DIZZINESS (Felt dizzy after receiving the second dose), BALANCE DISORDER (Had no stability after receiving the second dose) and HEADACHE (Headaches after receiving the second dose). At the time of the report, GAIT DISTURBANCE (Could not walk after receiving the second dose), DIZZINESS (Felt dizzy after receiving the second dose), BALANCE DISORDER (Had no stability after receiving the second dose) and HEADACHE (Headaches after receiving the second dose) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medication was reported.  Treatment information was not provided.   This case was linked to MOD-2021-036491 (Patient Link).
Vaccine was given "Beyond Use Date" of 6/19/23.  Not expired.  Healthcare provider informed. Moderna contacted and assessed vaccine to be viable.  No known health complications for patient.
PHARMACIST INADVERTENTLY GAVE PATIENT THE PEDIATRIC PFIZER DOSE INSTEAD OF THE JANSSEN BOOSTER DOSE. WHEN NOTICED, INFORMED PATIENT, FOLLOWED CDC GUIDELINES AND IMMEDIATELY READMINISTERED THE CORRECT jANSSEN DOSE
Went home and couldn?t stay awake. Took nap, got up around 6pm and went to dinner with family. About 9pm I got a dull headache centered in forehead. It continued for the next few days. Fatigue lasted a week. Had a hard time staying awake after I got home from work to even make dinner.
After the initial dose, pt was sitting at the waiting room for about 5 minutes and then approached a technician complaining about dizziness and headache. The technician went out of the pharmacy to assist her. At that moment the patient lost consciousness and fell to the floor. The technician caught her on the fall. At that moment, after giving an injection to another patient, I went to help the fallen patient. She was unconscious for about 5 seconds and then  afterwards complained of extreme headache. During this whole time 911 was called. Water was given to her and advised pt to stay on the floor until help arrived.  Once paramedics arrived she requested not to take the ambulance and went home with her husband. She had not taken her epileptic medication the morning prior to vaccine and had a history with the paramedics.
17 YEAR OLD RECEIVED 2 DOSES OF MODERNA COVID-19 VACCINE. 2/1/2021 LOT # 007M20A 3/3/3021 LOT # 030A21A NO ADVERSE EFFECTS REPORTED
Low grade fever 100 1800 12/30/20. Fever 103, chills, body aches 0100 12/31/20. Low grade fever 12/31/20 until 1400 Had to take Tylenol to break fever and relieve headache.
Three days  after receiving the shot I woke up with fever sores all over my bottom and top lips.   I  put Abreva  on it.  The next day, I woke up and both lips were swollen, the left side of my face was swollen and the left side of my lip was twisted to the left.  I contacted my allergist and spoke to him online and sent pictures.  He advised me to take Benedryl  every 4 hours or Zyrtec twice a day.  If it got worse call back.  That evening some of the swollen ness went down.  Little by little each day the swollen went down but the cold sores remained.  By Saturday which is today  the swollen ness is all gone but all the cold sores are remaining and are painful.  I am continuing to take Zyrtec  and treat the cold sores with cream.
Fever of at least 101 degrees F, all over muscle aches, sore all over, chills beginning night of injection, continuing until evening of next day. Has treated with ibuprofen and had some symptomatic relief of fever. Initially took temperature and had reading of 104 degrees F day of injection, but thinks she pushed the wrong button on her thermometer.
Within 5 minutes after receiving the vaccination, the patient fainted.  He was probably unconscious for 10-15 seconds per patient.  He then presented as very pale and sweating.  He also complained of being nauseous.   The paramedics were called and he was taken to the hospital for evaluation.
Pt. states that after receiving the 1st dose of Jansen J&J 12/08/2021, started experiencing symptoms 12/09/2021 of fever, nausea, itchiness, and hives throughout the body. Itchiness noticeable in the throat area. No noted Primary visit/communications.
Few hours after injection lethargic. Slight headache started. At 14 hrs after injection, upon waking, top of head felt like it exploded off. Severe headache remained until full 25 hrs after injection. Full day of lethargic feeling nauseous with headache  but no fever.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 20-JAN-2015, the patient was vaccinated with first dose of GARDASIL (dose, route of administration, site, lot# an expiry date were not reported). On 23-MAR-2015, the patient received the second dose of GARDASIL (dose, route of administration, site, lot# and expiry date were not reported). The patient was in the office at the day of the report (on 23-JUL-2015), to receive the last third dose in the series. The patient would be getting the third dose of GARDASIL 9 (dose, route of administration, site, lot# and expiry date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish the further contact.
This is the new covid vaccine  Severe diarrhea lasting for 4 days Stiffness Headaches
Began developing diffuse red blotches throughout, including face, arms, legs and trunk. No difficulty breathing or respiratory distress. Went to ER, given Benadryl and hydrocortisone ointment.
A few hours after receiving vaccine, my heart started palpitating and would not stop. I have never experienced anything like this. I have NO previous medical problems and take no medications.
Within 20 min of vaccine - nauseau, dizziness, earache, muscle ache and weakness, feverish and site pain. Lasted approx. 48 hrs. Bed rest, liquids
It was reported in a published article that a 19 year old male patient, with no significant medical history and a dental history of minor conservative treatment with no previous gingival or periodontal involvement, who was vaccinated with a dose of measles virus vaccine live when he was nine years old. Subsequently, ten years after the vaccination, the patient developed measles and was hospitalized. Upon admission, the patient was febrile (39 degrees C), fatigued, and had reported oral pain and discomfort. On examination, a maculopapular rash was noted on the trunk, body and extremities. Severe keratoconjunctivitis was present in both eyes. A few cervical and submandibular lymph nodes were enlarged and tender bilaterally. Intraorally, tiny, white plaque-like papules (Koplik spots) covered the buccal mucosae and severe oral ulcerations were present on the lip. The marginal gingiva were inflamed with microabscesses present in acute necrotizing gingivostomatitis (ANUG) -like pattern. Pericoronitis was evident bilaterally in the mandibular third molar areas. The patient reported that the oral lesions preceded the appearance of the maculopapular skin rash and keratoconjunctivitis. Viral cultures were taken from the area of the operculum and confirmed the presence of the measles virus. The diagnosis was also supported by the increased titer of the measles virus antibody. The fatigued patient was instructed to rinse with oral chlorhexidine 0.12% mouthwash twice a day and maintained a soft diet. No antibiotic treatment was recommended. One week later, all oral lesions had disappeared. At a month follow up no remaining oral signs and symptoms were present. A copy of the published article is attached as further documentation of the patient's experience.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The physician reported that on 15-AUG-2013 the patient was vaccinated with a fourth dose of GARDASIL (lot number, dose and strength not reported). The first dose of GARDASIL had been administered on 07-JUN-2011, the second dose of GARDASIL had been administered on 23-AUG-2012 and the third dose of GARDASIL had been administered sometime in June of 2013. No adverse event was reported. There was no other information to report. Additional information has been requested.
Pt cleared the 15 minute waiting period and returned to work. After 30 minutes from injection of vaccine patient came back to clinic complaining of dizziness, nausea and chills.
felt dizzy-vision diminished p/vax;BP 1-4/80, HR 92, skin pale;c/o h/a;vasovagal response for MMR;
Headache started around 2 hours, 26 hrs later fever and chills started, following that intense muscle spasms and joint pain and swelling, stomach pain,  dizziness,  black spots in vision. I am on day 5 following vaccination and have the following symptoms. Chills with no fever, drenching sweats, dizziness, continued headache , neck pain, joint swelling, tingling in feet and hands,  redness and rash at injection, stomach pain, sores in nose and mouth. I have been put on Prednisone for Lupus flare.
Fever up to 103 on the night of vaccination and continued until day of office visit 2/16/15.
Vaccine administration error.  It is suspected that the vaccine was administered with a 1/2" needle syringe instead of a 1" needle syringe.
Information has been received from a health care worker concerning a 65 (also reported as 66) year old male patient who on 10-JAN-2008 was vaccinated with Zostavax (Oka/Merck) (dose, frequency, route not specified).  On 14-JAN-2008, the patient was seen in the ER and was admitted for a cardiac condition but he has full blown shingles.  The patient was not admitted because of the Zostavax (Oka/Merck).  The patient's date of birth is 21-FEB-1942.  The called is interested in the VZV analysis by PCR.  There was no product complaint.  On 14-JAN-2008, the physician was contacted for follow up and offered the VZVIP.  The physician reported that the patient had a history of MS and was on interferon intermittently.  He also had a splenectomy in the past.  He explained that the patient was vaccinated "last week" with Zostavax (Oka/Merck) by his primary care physician.  The patient developed shingles on 13-JAN-2008 and had a rash, right thoracic area, T-8.  He explained that the patient was doing fine with his herpes zoster.  The patient also had CAD and had a stent placed previously.  He explained that the patient started to have chest pain so he was hospitalized to evaluate further.  The VZVIP was discussed with the physician and he indicated he would look at the packet of information.  On 15-JAN-2008, additional information was received from a physician.  The physician reported that the patient had a medical history of multiple sclerosis for the last 15 years.  It was reported that the patient's daughter came down with shingles on 05-JAN-2008 on her face, not in her eye.  The patient broke out with shingles rash on intercostal nerves on 14-JAN-2008.  On 15-JAN-2008, patient developed chest pain and went to the hospital and was admitted.  The patient underwent cardiac catheterization and it was normal.  On 16-JAN-2008, a call was received from another physician regarding the patient.  He reported that the patient was now home from the hospital.  The physician indicated he was interested in the VZVIP.  On 18-JAN-2008, the patient was contacted and he explained that the physician gave him information regarding the VZVIP.  He explained he currently had "full blown shingles" and would be happy to have someone obtain a sample.  He explained he had MS, and it was difficult for him to go places.  He indicated that his physician mentioned that it was "borderline" whether he should have received the vaccine, "but wanted to help with science and also other patients with MS".  He indicated that he did not have a doctor's appointment scheduled in the near future.  No further information is available.
Information has been received from a physician concerning of his daughter a 25 year old who on an unspecified date was vaccinated with a dose of VARIVAX (Oka/Merck) (Lot # unspecified).  Subsequently, the patient developed chicken pox 10-14 days after she was vaccinated.  It is unknown if the patient sought medical attention.  At the time of reporting (02-DEC-2008) the outcome of the patient was unknown.  This is one of several reports from the same source.  Additional information has been requested.