chrisvoncsefalvay/vaers-outcomes huggingface dataset:
upcoming scheduled dental surgery; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH DISORDER (upcoming scheduled dental surgery) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TOOTH DISORDER (upcoming scheduled dental surgery). At the time of the report, TOOTH DISORDER (upcoming scheduled dental surgery) outcome was unknown.            The treatment history was not reported. The concomitant medications was not reported. The patient was undergoing dental surgery after both of the doses of The Moderna COVID-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow-up received on 09-sep-21  with event updated, route of administration and gender of patient deleted in the Follow up document.
Patient developed fevers day after shot. Next day, started to have persistent chest pain/pressure, fevers resolved but chest pressure persists.
Pt developed aching muscles, shoulder joint pain, decreased range of motion of shoulders, swelling at injection site, and fever 24 hours post vax.
It started as moderate pain in the right side of my mouth and face.  Throughout a couple of days, the pain increased to a severe level.  After being evaluated by a dentist and oral surgeon, I saw an ENT specialist that assumed that the shingles caused the pain.  I was given a prescription for antiviral medication and steroids.   The day after seeing the ENT specialist, the pain became unmanageable.  I sought help at a local hospital's emergency room.  I was given a prescription for a nerve medication and an injection of an NSAID.   Symptoms began approximately three weeks after receiving the second vaccination.  I still have intermittent bouts of the following on the right-hand side of my head:  pain in my mouth, twitching on the face, burning sensations in the mouth and on the lips.  I also experience some sporadic episodes of tenderness throughout my head.   None of these symptoms were present before the vaccination.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unspecified date, the patient was vaccinated with improperly stored dose of ZOSTAVAX (strength, dose, route of administration, lot # and expiration date were not provided). No adverse effect was reported. Additional information has ben requested.
This case was reported by a consumer and described the occurrence of general body pain in a 62-year-old male patient who received SHINGRIX (batch number DK74P, expiry date 6th March 2020) for prophylaxis. On 2nd March 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 3rd March 2018, 1 days after receiving SHINGRIX, the patient experienced general body pain and fever. On 4th March 2018, the outcome of the general body pain and fever were recovered/resolved. It was unknown if the reporter considered the general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: There was no follow and targeted follow up requested.
Very sore arm and not getting better; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: Very sore arm and not getting better). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-OCT-2023 The case was received from the consumer via interactive digital media The patient received Arexvy and had very sore arm and not getting better. The follow-up could not be possible as no contact details were available. This case was linked with US2023AMR151220 and US2023AMR151221, reported by the same reporter for different patients.; Sender's Comments:  US-GSK-US2023AMR151221:Sme reporter US-GSK-US2023AMR151220:Same reporter
Itchy ear, throat tightening, red watery eyes, upset stomach, BENADRYL given at 5:50 pm shot given at 3:15 pm. 30 minutes later taken to hospital - overnight stay - still in hospital as of 9/3/13 9:30 AM.
Raised red rash on all 4 limbs, buttocks, and private area. Rash was very itchy. Dr. was called and benadryl given. Child was not taken to the Dr.
Information has been received from Licensed Practical Nurse (LPN) concerning a 19 year old sexually active female who in April 2008, an unspecified date in November 2008 was vaccinated intramuscularly with the first, second and third 0.5 mL dose of GARDASIL respectively (Lot# were not reported). Concomitant therapy included (ORTHO TRI-CYCLEN). On 09-APR-2009 the patient underwent pap smear showed mid dysplasia. At the time of report, the patient was not recovered. Additional information hs been requested.
This spontaneous report as received from a Nurse Practitioner refers to 4 patients of unknown age. On an unspecified date The patients were vaccinated with, 0.65 ml ZOSTAVAX that had been stored in a refrigerator for over 72 hours (lot number unspecified). No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. It was unknown if the patient had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
1  1/2 WEEK AFTER VACCINE HAD HEART PALPATATIONS THAT LASTED 45 MINUTES. PATIENT STATES SHE HAD THIS HAPPEN ONCE BEFORE MANY YEARS AGO BUT ISN'T SURE IF ITS THE VACCINE OR NOT. ALSO HAD PAIN, SWELLING, AND RASH AT THE INJECTION SITE.
Initial unsolicited report received from a consumer on 27-Oct-2016. This case involves a 55-year-old female patient who was vaccinated with a dose of Flu shot (batch number: unknown, expiry date and route of administration: not reported) in the abdomen on 03-Oct-2016. Illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications includes PRALUENT (alirocumab) for cardiovascular. On 03-Oct-2016, few minutes post vaccination, "all of a sudden patient got sick". On an unspecified date, post vaccination, the patient experienced cold and congestion. On 25 Oct 2016 (reported as Tuesday) 22 days post vaccination, the patient had "little bitty rash on arm" like a patch of little red bumps. Lab test and corrective treatment was not reported. On an unspecified date, the patient recovered from the event "little bitty rash on arm" (reported as gone now) and outcome of the other event was not reported. Documents held by sender: none.
Course of the Hospitalization:  05/18/2021 Today the patient was seen examined.  Patient denies any chest pain, shortness breath, nausea, vomiting or diarrhea.  Patient is in good spirits such time.  Patient has any changes to vision/hearing/taste/smell.  Patient will follow-up with his cardiologist from the hospital. Patient was told if he any discomfort in his chest, changes to vision/hearing/taste/smell go immediately to emergency room for further workup and evaluation as necessary.   Patient was discharged on Pepcid 20 milligrams to be taken twice daily for next 14 days.  Side effects, risks, benefits of medications discussed great length.  I asked the patient to discuss with the pharmacist any questions comments or concerns he may have both this medication as well.       Admitting ER Note: 23-year-old male presenting to emergency department for evaluation of chest pain.  Reports pain started 2 nights ago.  He received his 2nd COVID vaccine early Saturday morning, by Saturday night started having symptoms including chest pain.  Other symptoms resolved the chest pain has persisted, and waxing and waning.  Was seen at urgent care and found of ST elevations on EKG and sent to emergency department.  While here in the ED again found to have ST elevations in anterior leads with reciprocal changes inferiorly.  Troponin elevated to 11. Bedside echocardiogram performed by myself and cardiologist negative for tamponade or significant hypokinesis.  Patient will require admission for further management and evaluation.
When doing state inventory, notices count was off, a dose intended for child was found to have been given to an adult. Patient will be contacted, Staff member was informed of error. VFC dose replaced.
Low grade fever and chills for 24 hours. Severe body aches for 24 hours. Very sore injection site slowly improving after 24 hours. Red splotches and slightly itchy rash near injection site developed after 48 hours and are still ongoing.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 49 year old female. 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: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958423, 20210958321, 20210958993 and 20210958249.
The day after receiving my vaccine, I felt very sick, very tired, achy, and a low-grade fever. I had a headache the following Monday 01/17/2022, and on 01/24/2022 I woke up and noticed I had a rash on my stomach, back, my arm, and it was spreading all over my body. My scalp and everywhere was itching; so I started taking anti-histamine Benadryl and Zyrtec to help reduce the itching and rash. I contacted my PCP on the 24th and had a virtual health who advised me to take the anti-histamines until I could see a dermatologist. I saw my dermatologist on 01/27/2022 who said diagnosing rashes would be hard, so he prescribed a topical cream to help reduce the spreading and to use if the anti-histamines weren't helping. I was also advised to see an allergist later this month to see if I had an allergic reaction to the vaccine.
High fever. Pain at the injection site. Numbness in the arm and severe pain in the arm for 3 days.
Pediatric patient (5 year old)  received doses of HIB and PCV-13, which is not recommended by the CDC guidelines. 5 years and older do not receive HIB nor PCV-13 vaccines.
redness / at the injection site; area turned a brown color / There is still a slight brown discoloration at the site; skin sloughing off like that of a burn; excruciating pain when the vaccine was injected / felt like acid was being injected into her arm / soreness / at the injection site; itchiness at the injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 16th October 2020, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced injection site erythema, injection site discoloration, injection site itching and slough injection site. On 16th October 2020, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site itching and slough injection site were recovered/resolved and the outcome of the injection site discoloration was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site discoloration, injection site itching and slough injection site to be related to Shingrix.  Additional details were provided as follows: The case was reported by the nurse for herself.   The patient felt excruciating pain when Shingrix was being injected into the left arm. It felt like acid was being injected into her arm. The pain stopped after the needle was withdrawn.  There was soreness, redness and itchiness at the injection site. The soreness and redness lasted a few weeks but the itchiness last 4 months.  The area turned a brown color and the skin was sloughing off like that of a burn. There was still a slight brown discoloration at the site at the time of reporting. The reporter did not consent to follow up.
pt recvd vax; fever 104-105 following immun w/in 12 hrs;gen convuls/sz about 18-24 hrs p/ vax; febrile sz;at er, LP done nl; CSF findings;
pt states covid vaccine was given too high, pain came on hours later and was very severe, she says she saw a dr who said vaccine was given too high based on bandaid , dr says should resolve by monday per pt
chills; headache; This is a spontaneous report from a non-contactable consumer (patient). This adult male patient reported that received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number:), via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: Unknown) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination. It was unknown if patient COVID tested post vaccination. On an unspecified date, the patient experienced chills and headache. It was unknown if the patient received any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number could not be obtained.
Information has been received from a nurse concerning a 17 year old female who on 23-JUL-2008 was vaccinated with the first dose of GARDASIL (lot # 659964/1978U) via IM. Concomitant therapy included unspecified birth control pill. Later the same day, she experienced pain in her whole arm lasting for 2 weeks and swelling, a big throbbing lump, at site for a few days. She sought medical attention in office. No treatment required. Additional information has been requested.
immun given 23FEB93 mom stated pt started w/fever of 106 & rash over arms & stomach mainly-not over entire body; seen in ER & dx w/roseola; pt had fever over weekend 5-7MAR & then started to imrprove;
Experienced excruciating lower abdominal pain starting on March 9th, frequent bowel movements (at times diarrhea). Have had frequent painful bowel movements since March 9th.  Then on March 27th experienced extreme lower abdominal pain with bleeding and clotting in urine. Went to the ER, WBC was 17.2 and Catscan showed inflammation in colon and diagnosed with Mild to Moderate Acute Pancolitis.
Mild left arm soreness first two days from 1/30/21 to 1/31/21. Painful swelling of left deltoid, redness, subjective fever, fatigue, body aches from 2/05/21 to 2/09/21
Urticaria multiforme: raised red and purple lesions triggered. The doc diagnosis of Henoch-Schonlein purpura (emenously) and given massive doses steroids over phone.
patient was administered flu vaccination on 10/14/2008 within started experiencing headaches which could not be relieved with medicine. this continued along with a fever until hospitalization was required on 10/20/2008.Viral meningitis was diagnosed upon admission.3/19/09-records received dor DOS 10/22-10/27/08-DC DX:Viral meningitis, nausea, vomiting, headache, depression. Presented to ED with headache, nausea, vomiting. Flu-like symptoms started week ago, headache associated with fever, neck pain sensitivity to light and blurred vision, headache exacerbated by any movement, light noise and position. 3/27/09-records received for DOS 11/25-12/4/08 and 12/12-12/15/08 DC DX: HSV-2 meningitis. Presented with fever, chills, headache, nausea, vomiting diffuse back pain and right medial forearm and finger numbness. Began feeling ill 1 month prior following flu shot. Myalgias, malaise and generalized pressure like headaches, tinnitus and nausea. Episode of aphasia.  Acute kidney injury secondary to acyclovir induced crystalline disease.
fever; not able to sleep all night; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (fever) and INSOMNIA (not able to sleep all night) in a 34-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In October 2022, the patient experienced PYREXIA (fever) and INSOMNIA (not able to sleep all night). At the time of the report, PYREXIA (fever) and INSOMNIA (not able to sleep all night) outcome was unknown.            No concomitant medication information provided. Reporter wanted to know if patient can take Tylenol. No treatment information provided.
Soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic kidney disease (CKD), high blood pressure (high BP), high cholesterol and massive heart attack. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), clopidogrel (MANUFACTURER UNKNOWN) and cinacalcet (MANUFACTURER UNKNOWN); all taken for unknown indications from an unknown date and unknown if ongoing. On 12Mar2021 at 16:00, the patient experienced soreness at injection site. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event soreness at injection site was resolved with sequelae on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Lightheadedness beginning about 48 hours after vaccine, continuing to at least 78 hours after vaccine. Headache beginning about 16 hours after vaccine, continuing to 24 hours after vaccine.
right arm was very sore and warm, along with my lymph nodes of that arm, my glands were swollen and I had chills starting at around 1239am after the shot and continued the entire day after the shot as well. I had a severe headache that lasted 3 days off and on and my glands were swollen. My left ear hurt and my throat was sore the entire day after getting the shot. I had severe muscle aches the day after the shot and the night of the shot. I had stomach cramps and threw up once. I was very tired and slept the entire day following my injection.
Cellulitis (R) arm diagnosed by covering provider on 8/25/07. Treated with Keflex 1000mg PO BID x 7 days
started to feel chills, headaches, body aches, felt like he had a fever; started to feel chills, headaches, body aches, felt like he had a fever; Had all flu like symptoms; Tested positive for Covid-19; started to feel chills, headaches, body aches, felt like he had a fever; started to feel chills, headaches, body aches, felt like he had a fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm), CHILLS (started to feel chills, headaches, body aches, felt like he had a fever), HEADACHE (started to feel chills, headaches, body aches, felt like he had a fever), MYALGIA (started to feel chills, headaches, body aches, felt like he had a fever) and PYREXIA (started to feel chills, headaches, body aches, felt like he had a fever) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) and PARACETAMOL (TYLENOL) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced INJECTION SITE PAIN (sore arm). On 23-Jan-2021, the patient experienced HEADACHE (started to feel chills, headaches, body aches, felt like he had a fever). On an unknown date, the patient experienced CHILLS (started to feel chills, headaches, body aches, felt like he had a fever), MYALGIA (started to feel chills, headaches, body aches, felt like he had a fever), PYREXIA (started to feel chills, headaches, body aches, felt like he had a fever), INFLUENZA LIKE ILLNESS (Had all flu like symptoms) and COVID-19 (Tested positive for Covid-19). At the time of the report, INJECTION SITE PAIN (sore arm), CHILLS (started to feel chills, headaches, body aches, felt like he had a fever), HEADACHE (started to feel chills, headaches, body aches, felt like he had a fever), MYALGIA (started to feel chills, headaches, body aches, felt like he had a fever), PYREXIA (started to feel chills, headaches, body aches, felt like he had a fever), INFLUENZA LIKE ILLNESS (Had all flu like symptoms) and COVID-19 (Tested positive for Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        No treatment information was provided.    Reporter did not allow further contact
pt recv vax 20FEB97 & on 21FEB97 pt devel severe swelling & tenderness w/some reddening of the tissue @ the site of inj;tx w/ATB;
Patient received the COVID vaccines on 2/14/21 and 3/9/21. He was admitted to the hospital on 8/17/2021 with a Dx of COVID-19