chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via sales rep and described the occurrence of headache in a 51-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date without any adverse events). On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced headache, general body pain, fever, generalized rash and patchy rash. The patient was treated with BENADRYL. On an unknown date, the outcome of the headache, general body pain, fever, generalized rash and patchy rash were recovered/resolved. The reporter considered the headache, general body pain, fever, generalized rash and patchy rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient did not receive any concomitant vaccines. The pharmacist stated that the patient had headache, body aches, fever and rash over her entire body. Most symptoms had resolved within a few days but the rash took longer to resolve. The patient had remaining splotches of rash that lasted longer. The physician did not agree to follow up from GlaxoSmithKline.
Due to discrepancy in records, 3rd MMR given.  No adverse events reported.
Information has been received from a nurse for GARDASIL, a pregnancy Registry Product, concerning a 19 year old female who on 29-FEB-2008 was vaccinated with the third 0.5mL dose of GARDASIL intramuscularly. Concomitant therapy included "Tetanus shot". Subsequently, she became pregnant. On 11-NOV-2008 the patient delivered her baby and both the mother and the baby were fine. No adverse effect reported. No lab diagnostics studies were performed. Follow-up information has been received from a licensed practical nurse, for GARDASIL, a Pregnancy Registry product, concerning a 19 year old female patient with no medical history and no concurrent medical conditions and a history of 1 pregnancy and 1 live birth with no birth defects or infant complications in previous pregnancy. Who on 29-AUG-2007 and on 02-NOV-2007 was vaccinated with the first and second doses of GARDASIL. On 29-FEB-2008, the patient received the third 0.5 mL dose of GARDASIL intramuscularly. Concomitant therapy included Tdap and prenatal vitamins (unspecified). On 11-NOV-2008 the patient had a cesarean section due to prolonged labor and delivered a normal, healthy female baby with no congenital anomalies weighing 7 pounds, 4 ounces, 20 in length, head circumference 33cm, and APGAR score of 9/9. There was not complication during pregnancy, and not infections or illness during pregnancy for the patient. There was not diagnostic test during pregnancy. Upon internal review, prolonged labor was considered to be an other medically important event as it resulted in a cesarean section. Additional information is not expected.
Within 2 hours I started feeling similar symptoms to when I had covid. Fever of 100.6, intense body aches and pains, headache, congestion, muscle cramping, brain fog, nausea, and sensitivity to temperature.
Chills, weakness, mental fog, shooting pains in various parts of the body, trouble concentrating, lips quivering and hands shaking
Event occurred after 2nd dose. Patient was diagnosed with COVID Remdesivir, Tylenol Discharged Home
Large lump appeared at injection site 8 days later. Slowly turned rash-like, painful, and began itching. Rash got worse until 3/20/21. Arm still slightly  painful at site upon palpation as of 3/22/21, but rash was gone. I also developed cold symptoms at the same time the lump appeared and suffered with the symptoms for 5 days
This lot number had an expiration date of 9/30/2022. Manufacturer stability data indicated stability and efficacy through 10/19/2022 therefore no need to notify pt and revaccinate.
Sore Throat after First Dose; Achy after First Dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat after First Dose) and MYALGIA (Achy after First Dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore Throat after First Dose) and MYALGIA (Achy after First Dose). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat after First Dose) and MYALGIA (Achy after First Dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.    Reporter did not allow further contact
Severe nausea; Violently vomiting; Fever; Extremely achy from waste up; Could not move my left arm; Could not move my left arm. It also had a massive lump that was dark black and blue for a week with a red welt underneath it; My back was in so much pain; a pimple resemblance/ almost looked like measles; a pimple resemblance/ almost looked like measles; This is a spontaneous report from a contactable consumer (the patient). A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 30135BA) via an unspecified route of administration in Left arm on 12Sep2021 16:00 at age of 41-year-old at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination. No COVID tested post vaccination. No other vaccine in four weeks. The patient began with severe nausea that evening then began violently vomiting for 2 days (events start date:12Sep2021 22:30). Was running fever, extremely achy from waste up. Could not move her left arm. It also had a massive lump that was dark black and blue for a week with a red welt underneath it. She thought the aches were normal, but her back was in so much pain. She finally decided to look at it and was horrified that it was covered from top to bottom with a pimple resemblance/ almost looked like measles. Some had white heads they varied in size and were so painful. Events start date: 12Sep2021 22:30. The next morning her left thigh began getting them along with her face and chest. She had to go to her primary that Wednesday where he gave her IV steroids. It was 27Sep2021 and her back, chest and face are still a mess. She was fearful her back will scar due to the amount that was covered and that it was not going away. Her doctor did not want her getting the second dose not does the pharmacist who she went to speak with and show the reaction to that Thursday. Need more room to write. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment "IV steroid" received for the events. The outcome of the events was not recovered.
NauseaVomiting Fatigue, Body aches, swollen lymph nodes Narrative:
2 days p/vax pt exp lt chest pain;5/27/99 c/o numbness -fingers, feet x 1 wk, dec energy, SOB, rt upper lip numbness; 5/31/99 GBS (progressive polyneuropathy w/facial palsy)
Mom states that child woke up this morning at 4:30 AM with a "blotchy" rash on his face, back and all over his body.  He did not have a fever or any difficulty breathing.  No previous illness.  Itchy, but manageable, went to school today.  The injection site was also a bit reddened as well, no complaints of arm pain or discomfort.  He has had FLUMIST in 2013 and 2014 without any problems.  This is the first flu injection that he has had.
Severe chills. Very bad shaking. Vomiting. Received flu shot at 7:00 p.m. Woke up at 2:00 a.m. with chills and vomited. Vomited 2 more times within 10 minutes, still experiencing severe chills. All symptoms seem to pass after 1 hour.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 07-JAN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N020016 and expiry date 17-JUL-2019) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Patient had come in today, after talking to a nurse hotline about a possible allergic reaction to the vaccine. I guess the symptoms had been worse at first the day after the shot, but had decreased in severity when patient presented. Red left deltoid around injection area, about 6 inches in diameter. Patient reported that it felt hot and was itchy, but no other central symptoms and after using a topical gel (pt was unsure what she used) it had helped with the itchiness. Instructed patient to follow up with MD on Monday about event (and possibility of second shot in 2-6 months) and to take an anti-histamine for further symptom reduction.
On January 24, 2018, within a month of receiving the HPV vaccine, patient developed a mild rash and left calf pain. Called the pediatrician office, they wanted to see her immediately thinking it was a blockage in vein. That was negative. Rash got worse. It was all over both legs and feet. Pediatrician referred us to Rheumatologist. Rheumatologist believed it was Henoch-Schonlein Purpura which is caused by a virus. He advised me that in order to definitive prove it was HSP, then 9 vials of blood would need to be taken. Rash got worse, was all over both legs up to groin and down to feet. I called Rheumatologist and requested blood work. The blood tests came back good making HSP the final diagnosis. Patient has to undergo urine and blood pressure checks for 6 months to check for kidney damage. I asked both pediatrician and Rheumatologist if related to HPV vaccine, they said no. I find that hard to believe. Patient is due for her 2nd HPV vaccine and I don't know if I should consent to it or not.
leg swelling; ultrasound showed an occlusive clot in her femoral artery; femoral vein clot; had pneumonia; fever; developed chills; then chest pain; shortness of breath; This is a spontaneous report from a contactable physician. An 82-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER CORONA VIRUS VACCINES-COVID-19), dose 2 intramuscularly administered in the right arm on 04Mar2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization.  Medical history included hypertension, hypothyroidism and osteoporosis. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER CORONA VIRUS VACCINES-COVID-19) on an unspecified date for Covid-19 immunisation. Concomitant medications included levothyroxine sodium (SYNTHROID); calcium; acetylcysteine, calcium levomefolate, mecobalamin (METAFOLBIC PLUS); losartan; hydrochlorothiazide; denosumab (PROLIA) and trazodone; all indication, start and stop date were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that in the evening of the vaccination (04Mar2021), she developed chills and fever, then chest pain and shortness of breath. The physician obtained a CXR (chest x-ray) on the patient on 04Mar2021 and found that she had pneumonia. She was treated with levofloxacin and prednisone. The physician rechecked her in one week and gave her Kenalog injection and Rocephin injection. The physician rechecked her on 22Mar2021 and she was improved, but she returned to the office 12Apr2021 with left leg swelling. The ultrasound on 12Apr2021 showed an occlusive clot in her femoral artery. The patient was admitted to the hospital (Apr2021) for 1 day and placed on heparin, then sent home on Eliquis. The adverse events resulted in doctor or other healthcare professional office/clinic visit and the patient received treatment which included antibiotics and steroids for pneumonia and blood thinners for the femoral vein clot. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events leg swelling, occlusive clot in her femoral artery and femoral vein clot were recovered on Apr2021 while the outcome of the other events was recovered on 22Mar2021.  Information about lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events peripheral swelling, peripheral artery thrombosis and venous thrombosis limb and the suspect drug BNT162B2 cannot be excluded.The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.
ENTIRE VACCINE VIAL ADMINISTERED; OFF LABEL USE; 1 VIAL WAS USED TO VACCINATE 9 CONSUMERS; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On 07-APR-2021, the subject experienced entire vaccine vial administered. On 07-APR-2021, the subject experienced off label use. On 07-APR-2021, the subject experienced 1 vial was used to vaccinate 9 consumers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from entire vaccine vial administered, and the outcome of off label use and 1 vial was used to vaccinate 9 consumers was not reported. This report was non-serious.
Burning; Itchy; Very painful; Developed a rash similar to my flare on his arms; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BURNING SENSATION (Burning), PRURITUS (Itchy), PAIN (Very painful) and RASH (Developed a rash similar to my flare on his arms) in a male patient of an unknown age who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Burning), PRURITUS (Itchy), PAIN (Very painful) and RASH (Developed a rash similar to my flare on his arms). At the time of the report, BURNING SENSATION (Burning), PRURITUS (Itchy), PAIN (Very painful) and RASH (Developed a rash similar to my flare on his arms) outcome was unknown.            Concomitant medication was not provided. It was reported by reporter that her husband had experienced rash on arms similar to her flare. It was itchy, burning and very painful. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750334 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750334:Wife case
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 13 years old adolescent patient and unknown gender. On 30-JUL-2014 the patient was vaccinated with a dose of improperly stored GARDASIL 120 Y (lot J009788, expiration date 17-MAR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Mild
This spontaneous report as received from a pharmacist refers to a 69 year old non-pregnant female patient with drug reactions/allergies to latex specified as "bandaid glue". On 01-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (route, dose and frequency not reported, lot # K005797, expiration date 21-MAR-2015) in the right deltoid and FLUVIRIN (route, dose, frequency and lot # not reported) in the left deltoid. On 01-OCT-2014 (also reported as last night) the patient experienced arm pain at injection site on right side. It was clarified to be severe muscular pain with redness (01-OCT-2014). The patient rated her pain as a 10 on a scale of 1 to 10 (on 01-OCT-2014). The patient reported to pharmacist that she could not sleep due to pain in her arm (on 01-OCT-2014). On 02-OCT-2014 (also reported as this morning the patient's pain was rated as an 8. There was no treatment given for the events. The outcomes of the events were reported as not recovered/not resolved. The patient sought medical attention by contacting the pharmacist. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
p/vax pt w/flu sx, aches, h/a, rt arm swollen, pain, muscle aches; sl improved 10/8/99 coached child game;10/9/99 travel from home-elev temp, pain rt arm;to ER-motrin; in evening had sz, T107, hosp workup
Red, painful arm, rash - lasted approximately 1.5 days. Patient took OTC pain relievers for treatment.
Sodium levels dropped dangerously low; Passed out; Dizzy; Hit my head; Headachy; This spontaneous case was reported by a consumer and describes the occurrence of blood sodium decreased (Sodium levels dropped dangerously low) and loss of consciousness (Passed out) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 15-Mar-2021, the patient experienced (Sodium levels dropped dangerously low (seriousness criterion hospitalization), Passed out (seriousness criterion medically significant), dizzy, Hit my head and Headache. The patient was hospitalized from 24-Mar-2021 to 26-Mar-2021 due to BLOOD SODIUM DECREASED. At the time of the report, BLOOD SODIUM DECREASED (Sodium levels dropped dangerously low) was resolving and LOSS OF CONSCIOUSNESS (Passed out), DIZZINESS (Dizzy), HEAD INJURY (Hit my head) and HEADACHE (Headachy) outcome was unknown.      Treatment medication included intravenous sodium.. She was being monitored through blood samples and she was fine on 29 Mar 2021, she will have to do it one more time in a week.; Sender's Comments: Based on the current available information and temporal association between the use of the product and onset of the events of blood sodium decreased, loss of consciousness, dizziness, and headache, a causal relationship with the events cannot be excluded. Head injury was due to dizziness.  Headache is consistent with the product safety profile.
Pt received MMR vaccine on Tuesday 4/14/15 that evening (L) arm was sore. Pt was seen 4/16-15 at the center Dr seen pt. (L) arm was red in color, warm, inflamed, and itched. No treatment was given. (SM) Ice package given to pt.
Injection site raised, firm area (size of quarter); redness but no streaking; extreme tiredness, chills, headache, neck pain. Patient went to walk in clinic and provider believed her to be having a localized allergic reaction to the COVID vaccine. She was given a steroid injection, and started on oral steroids.
Golf ball shaped, sized swelling, redness, and itchy - after 4 days just STARTING to disappate.
I was advised by the healthcare professional that the vaccine would be a  painful injection and soreness for a while after. So I expected the pain at the time of injection and afterwards. My mother was terminally ill with cancer and as the primary caregiver, my focus was her and I endured the pain, thinking it would eventually go away.  My mother transitioned in May.  I began researching whether it was common for the pain to last this long.  That is when I learned that is in fact uncommon. By June it had already begun to effect my sleep and my ability to get dressed in the morning. It is painful to rotate my arm to include reaching behind me, reaching up and extending my arm. The pain radiates down my arm to my elbow. In August 2022 I brought my concerns to the attention of my PCP who prescribed anti inflammatory and pain med, Xray and PT.
Extreme pain traveling from injection site to all joints in the arm, making arm movement very painful and restricted.  Hand is swollen.
Flulaval administered IV instead of IM; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a adult patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th December 2022, the patient received FluLaval Quadrivalent 2022-2023 season (intravenous) and Flulaval Tetra Pre-Filled Syringe Device. On 14th December 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date :14 DEC 2022 Reporters comment:  Pharmacist called to report that a nurse gave a Flulaval QIV intravenous instead of intramuscular by error. Pharmacist believed that the patient involved was an adult. No other details were available at the moment of this call. Did not consent to follow-up. Additional supportive information: As patient received Flulaval quadrivalent intravenously instead of intramuscular, which led to intramuscular formulation administered by other route.
Patient stated that 4 days after vaccination she experienced headache, flushing, nausea, diarrhea and fatigue
41 hours after vaccine, I woke up to my heart pounding and I was trembling like I was having an anxiety attack; 41 hours after vaccine, I woke up to my heart pounding and I was trembling like I was having an anxiety attack; This is a spontaneous report from a non-contactable consumer. A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3247), via an unspecified route of administration on 19Jan2021 00:30 at SINGLE DOSE at right arm for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient previously took amoxicillin and experienced Allergy. On 21Jan2021 05:30, 41 hours after vaccine, I woke up to my heart pounding and I was trembling like I was having an anxiety attack. I was not anxious. I called my doctor. The patient did not receive treatment for the events. The outcome of the events was unknown.     No follow-up attempts are possible. No further information is expected.