chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers unspecified number of patients of unknown age and gender who on 24-NOV-2015 were vaccinated with improperly stored VARIVAX (Merck) [lot # L001334, Expiry date: 10-JUN-2017, Lot# L001334, Expiry date: 13-JAN-2017]. No adverse events were reported. This case is one of the two reports received from the same reporter. Additional information has been requested.
Rash at sight of injection 24 hrs after shot. Also size of golf ball, feels like hard tissue at the site of injection.
Within 2 hours: - Pain at injection site (resolved) - Swollen and painful breast (ongoing) - Left flank pain (ongoing) - Pounding heart (resolved)  Within 2-4 hours: - Body aches (ongoing) - Fever  (periodic) - Fatigue  (ongoing) - Nausea  (resolved)  Within 12 hours:  - Chills (resolved) - Diarrhea (resolved) - Stomach pain (ongoing) - Fecal incontinence (resolved) - Burning when urinating  Within 4 days: - Severe pelvic pain (ongoing)
feels like shingles except blister; Right arm hot and swollen at injection site; hot injection site; Itchy painful , 3 inch in circumference rash; painful rash; Hives on forearm, feels like shingles; Itchy, painful, nerve pain right arm; Low grade fever; Tired; Patient received 2nd dose on 14-apr-2022 in her right arm, she states 1st dose was given a year ago.; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix (1st dose received 1 year before the date of reporting).   On 14th April 2022, the patient received the 2nd dose of Shingrix. On 14th April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 15th April 2022, the patient experienced low grade fever and tiredness. On 19th April 2022, the patient experienced vesicular rash, injection site swelling, injection site warmth, itchy rash, pain, hives and nerve pain. On an unknown date, the outcome of the vesicular rash, injection site warmth, itchy rash, pain, hives, nerve pain and drug dose administration interval too long were unknown and the outcome of the injection site swelling was not recovered/not resolved and the outcome of the low grade fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the vesicular rash, injection site swelling, injection site warmth, low grade fever, tiredness, itchy rash, pain, hives and nerve pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-Apr-2022 Reporter's comments: This case was reported by the patient. The patient received Shingrix in her right arm. One day after receiving Shingrix, the patient experienced low grade fever and tired. Five days after receiving Shingrix, the patient developed an itchy painful, 3 inch in circumference rash. On right arm, she felt like nerve pain. The patient had hot, swollen injection site, hives on forearm. The patient felt this like shingles except the blisters. The patient was referred to the healthcare professional. The consent to follow up was given. Additional Supportive Information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of interval between vaccine doses.
7/9/13 Pt's father sent in a question on pt's my chart attaching a photo of patient's arm. Patient's Dad states that the reaction, which is rash, started on the day the vaccine was given. Spoke with patient's Dad 7/12/13, as per Dad, it got better and was completely gone.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 57-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) and (batch number ZX3YA, expiry date unknown). On 3rd April 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, the dose was an unknown dose. On 3rd April 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In April 2018, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional information was received as follows: The health care professional reported that SHINGRIX was inadvertently administered by subcutaneous route instead of intramuscular route which led to, inappropriate route of vaccine administration. The reporter reported that the patient experienced local injection site reactions at the site of the vaccine administration. No further information was provided. The reported batch number of SHINGRIX (ZX34A) did not exist in sales data and it was updated to ZX3YA.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown. On 09-DEC-2010, the patient was vaccinated with improperly stored VARIVAX, dose number 2, lot # 666869/0469Z. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Intussusception 2 wks after receiving 2nd ROTATEQ.  9/1/09 Hospital records received DOS 6/28/09 to 6/29/09. Assessment: Intussusception. Patient presents with acute onset of vomiting, bilious. Vomited 17 times. PO intake decreased, decreased wet diapers. Red colored urine. Dark green stool. Fussy. Fever, malaise, fatigue. Dry lips and mouth. Dehydration. Barium Enema administration with reduction of intussusception.  10/2/09 ICD-9 Codes: 560.0 Instussusception, 780.79 Malaise and Fatigue, 780.60 Fever, 787.03 Vominting w/o nausea.
I was given a TDAP vaccine - unknown name or brand in the left arm intramuscularly. The description in my patient summary only describes it as "TDAP Vaccine Age 7+ IM".  I also received a flu shot listed in the patient summary as "Influenza Vaccine Quadrivalent Age 3 Yrs Plus + IM" on my right arm. I began to feel malaise hours after receiving the vaccines. When I woke up morning (2/17/20) - 3 days after receiving the vaccines, I  felt a lymph node on the inside of my upper arm -near the armpit crease swollen/hard and tender to the touch. When I got up I looked in the mirror and noticed that the skin over the lymph was hot pink in color. There was also stiffness in the muscles of the upper arm. This has persisted all day and into the evening.
Suspected vaccination failure; All / got Shingles; Quarantine from the rest of us; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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), shingles and quarantine. On an unknown date, the outcome of the vaccination failure, shingles and quarantine were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and quarantine to be related to Shingles vaccine.  Additional details were provided as follows The age at vaccination was not applicable. The reporter stated that, all who took Shingles shot got shingles and was quarantine from the rest of them. When it was aksed to the patient if he/she would like the shot, the patient said no. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Patient mistakenly received 0.25 mL dose as his 2nd Moderna dose. Informed patient regarding the mistake and that another dose of 0.25 mL needs to be administered. Patient agrees and verbalizes understanding. Patient received a second dose of 0.25mL, thus patient received a total of 0.5mL as his 2nd Moderna dose. Patient waited an additional 15 minutes after receiving the second dose of 0.25mL.
No adverse event; Pharmacist is calling to report that 2 adult patients received Expired Bivalent booster beyond 12 hours post puncture.Dose administered >12(US) hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received Expired Bivalent booster beyond 12 hours post puncture.Dose administered >12(US) hours post puncture) and NO ADVERSE EVENT (No adverse event) in an adult 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. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received Expired Bivalent booster beyond 12 hours post puncture.Dose administered >12(US) hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received Expired Bivalent booster beyond 12 hours post puncture.Dose administered >12(US) hours post puncture) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received Expired Bivalent booster beyond 12 hours post puncture.Dose administered &gt;12(US) hours post puncture).    Concomitant product use was not provided by the reporter.  On 21-Dec-2022 2.5 ml vials were initially stored in the refrigerator.  On 27-Dec-2022 at 2:30 P.M, vial was first punctured.  On 28-Dec-2022 11:30 A.M vaccine was administered  Vial was exposed to room temperature (8° to 25°C or 46° to 77°F) for 21 hours.  Vial did not undergo any temperature excursions.  Treatment information was not provided.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-693180:Master case (patient 1 of 1)
In the beginning of the year, I was cutting wood and did not wear my face covering. I had an allergic reaction that caused me to produce excess mucus. I was unable to sleep because I was coughing and hacking. I went to the doctor and received a steroid shot to help with the reaction. I was given antibiotics and am currently on the last couple of days of days that and am finally able to sleep.
stiffness/stiff; weak/whole body was weak; Flu like symptoms/almost like he has the flu; body ache/side was hurting/achy/hurting/aches and pain/still aching; he felt really sick, headache, weakness; had a flank something on the side- a muscle on the side was inflamed or something; joints are sore; couldn't bend over and couldn't pick anything up; back hurts; can hardly breathe; kidneys hurt; chest hurts; lungs hurt; moping around; he felt really sick, headache, weakness; This is a spontaneous report from a contactable consumer. A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in right shoulder on 23Feb2021 as dose1, single for covid-19 immunisation. Medical history included cancer from Oct2020 to 12Feb2021 (The patient had cancer back in October. Verbatim: Became cancer free, was diagnosed with lymphoma cancer). Concomitant medication included hepatitis C medicine and products radiation from unknown date to oct 2020. Patient did not had relevant Tests. The patient took the vaccine and was fine a couple of days after that , on 26Feb2021, Patient had a reaction, he felt really sick, had headache, he became stiff, had aches and pain, almost like he had the flu. Patient whole body was weak and hurting, he was moping around and he was not that type. The patient side was hurting so he went to the Emergency Room and they said he had a flank something on the side- a muscle on the side was inflamed or something. The patient could not bend over and could not pick anything up, his back hurts, his lungs hurt and he can hardly breathe, his kidneys hurt, his chest hurts, but he was able to walk around. The patient still had aching and his joints were sore. The patient went to the hospital 26Feb2021 and took the medicine at the hospital, reporter was not sure tylenol, aspirin or codeine for the patient side. The patient was feeling better on 03Mar2021. patient was never admitted to the hospital, he only visited the emergency room. History of all previous immunization with the Pfizer vaccine not considered as suspect. No additional vaccines administered on same date of the pfizer suspect. No Prior Vaccinations (within 4 weeks)or AE following prior vaccinations. The outcome of the event side was hurting was recovering, for flu like symptoms, weak, short of breath was not recovered and for rest all it was unknown.   No follow-up attempts are possible. No further information is expected
Shot (Tdap) was given 3-5-08. On 3-12-08 patient began to report that her arm (L) felt "heavy". Also felt that her B/P was high. B/P: 140/98 which she reported was high for her. Encouraged her to go to ER. She went to ER 3-12-08. Had a Cat scan which she reports was fine. Reported that they were unable to do an MRI due to the MRI machine being broken. She was released home. Family reports her condition worsened on 3/13/08 and 3/14/08 while at home. Her "thought process and speech were broken and her (L) arm and (L) leg weakened." They took her back to ER 3/14/08. Per family on 3/18/08 the physician diagnosed her with encephalitis. "No other cause was found but the injection. He thinks it was the Tetanus part of the shot," stated her husband. VAERS filed. 7/30/08-records received for DOS 3/14-3/21/08 and rehab 3/21-4/1-08 DC DX Encephalitis. Left hemiparesis/hemiplegia. Episodic myoclonus. Episodic aphasia. adverse effect corticosteroid, adverse effect major tranquilizer. Long QT syndrome. Developed left sided weakness and sensory changes along with expressive aphasia on 3/14/08.Subsequently developed steroid psychosis. C/O photosensitivity and light sensitivity. At time of discharge continued with crural weakness and required a walker.
Past 9 months I have been having histamine release issues. Allergy testing, etc.  has been done and there are no concrete reasons for the mast cells to release histamine when eating or around strong odors.
I received the injection on Friday noontime and had a normal redness and tenderness that the Pharmacist informed me about.  Later that evening, throughout the night, and today my upper right arm is very tender and swollen - shoulder to elbow.  I stopped by pharmacy and spoke with the Pharmacist who said that this was very unusual and I should report it to you folks.  While the swelling makes my bicep look great, the swelling and tenderness keeps me from using it much.  I have no other symptoms.  Additionally I will use my portal to inform my primary physician.
Dad noticed small pinpoint rash on child's neck and face approximately 10 minutes after the administration of vaccinations.  Child assessed by nurse at that time.  Child was crying on and off during the administration of vaccines and during assessment.  Bp 110/80, P 120 , afebrile, and respirations normal as well as lung sounds.   Small amount of scattered petechiae seen on nape of neck and face.  No other abnormalities noted.  Child calm and mental status alert.  Concerned parents wished for child to be transported to local hospital for further observation and assessment.  Ambulance transported child and parent to local emergency department where child was treated with oral ?steroid? and ?Benadryl.?  Mom was given a ?Benadryl? prescription upon discharge from ED and instructed to give every 6 hours.   Discharge instructions included seeing child?s MD the next day for further assessment and workup.  Mom stated that MD took a lab test (CBC/lead), which was sent to lab, and stated that child was ?fine.?  Spoke with mom the next day and she stated that lab work came back ?normal? and that the petechial ?rash? was almost all gone.  She had not given child Benadryl at home.
Went to physician due to leg being swollen, red and hot and was referred to Hospital on 5/18/2022.  Hospital did ultrasound and discovered 4 out of 5 veins clogged and did CT scan which showed pulmonary embolism in lung. Stayed overnight and released on 5/19/2022.
pt recv vax & approx the end of FEB98 pt exp arthralgia;12MAR98 pt was given 2nd dose of vax;
First day - dizziness, headache, temperature: 37.5 (paracetamol) Second day - flu syndromes, temperature: 40.0, sinus headaches, runny nose (paracetamol, ibuprofen) 3rd-6th day - temperature: 37-38, flu, runny nose, strong sinus headaches, cough (ibuprofen, aspirin - but not together) 7th - 10th day - runny nose, cough, sinus headaches, temperature back to normal (aspirin) 11th day - high blood pressure (160/100), strong sinus headaches 12-14th day - blood pressure 130/90, sinus headaches
COULD NOT GET UP FROM BED; BODY ACHING VERY BADLY; RUNNING A FEVER; HUGE HEADACHE; This spontaneous report received from a patient via a company representative concerned an 18 year old of unspecified 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: Unknown) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On JUN-2021, the patient experienced could not get up from bed. On JUN-2021, the patient experienced body aching very badly. On JUN-2021, the patient experienced running a fever. On JUN-2021, the patient experienced huge headache. On JUN-2021, Laboratory data included: Body temperature (NR: not provided) 38.5 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the could not get up from bed, running a fever, body aching very badly and huge headache was not reported. This report was non-serious.
Feels bad, felt bad; Plaque psoriasis aroung belt buckle; Pain in arm, arm sore; Tiredness, felt run down/tired; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Feels bad, felt bad), PSORIASIS (Plaque psoriasis aroung belt buckle), PAIN IN EXTREMITY (Pain in arm, arm sore) and FATIGUE (Tiredness, felt run down/tired) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-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 ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced FEELING ABNORMAL (Feels bad, felt bad), PSORIASIS (Plaque psoriasis aroung belt buckle), PAIN IN EXTREMITY (Pain in arm, arm sore) and FATIGUE (Tiredness, felt run down/tired). At the time of the report, FEELING ABNORMAL (Feels bad, felt bad), PAIN IN EXTREMITY (Pain in arm, arm sore) and FATIGUE (Tiredness, felt run down/tired) had resolved and PSORIASIS (Plaque psoriasis aroung belt buckle) was resolving.            No concomitant medications were reported. No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-624769 (Patient Link).
Information has been received from a physician concerning a 16 year old female who on 07-DEC-2007 was vaccinated with the first dose of GARDASIL. Concomitant therapy included influenza virus vaccine (unspecified) and meningococcal vaccine (unspecified). On 21-JAN-2008 was vaccinated with the second dose of GARDASIL. On 21-JAN-2008, two hours post vaccination the patient experienced nausea, vomiting and headache. On approximately 23-JAN-2008, two days post vaccination the patient experienced problems with vision in her right eye. The patient did not have AE after receiving the first dose of GARDASIL. On an unspecified date the patient recovered. There was no product quality complaint involved. Additional information has been requested.
No other issues or concerns noted.; Per caller the product has been stored in the refrigerator since 20-APR-2022. Date of administration: 22-APR-2022.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided.  Per the reporter, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (lot# W004694, expiration date 08-AUG-2023) had been stored in the refrigerator since 20-APR-2022. The temperature was 45 degrees Fahrenheit (F). On 22-APR-2022, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot# W004694, expiration date 08-AUG-2023; strength, dose and route were not reported) for prophylaxis (product storage error). The time frame of the excursion was 120 hours, and the reporter called to check stability of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD). It was reported that there was no previous temperature excursion. No other issues or concerns were noted.
I had a patient, that came in to the pharmacy today, 10/19/2019, that received her 2nd shingrix vaccination on Thursday 10/17/2019, woke up Friday morning with an inflamed arm. I looked at her arm and it was a 6x6 inflamed area on her left arm distal to the injection site. The injection site had a hard knot. I felt the area and it was warm to the touch. She said that she had taken Tylenol and has used an ice pack to help relieve the fever in the inflamed area. I asked if the 1st injection of the shingrix back in July had caused her any issue, she said that is did not. I advised her to keep taking the Tylenol, keep an eye on the area and to call us if it doesn't resolve in the next day or two to three days.
Beginning at approximately 08:00 on 17 August, my heart rate began to climb from my normal resting heart rate of 56 bpm.  By 19:00, my resting heart rate was exceeding 105 bpm.  My resting heart rate remained above 105 bpm until around 01:36 18 August, when it began to decline.  My resting heart rate was back to normal by around 13:36 18 August.  The highest resting heart rate observed was 128 bpm for several minutes while laying in bed.