chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cellulitis in the left leg 7 days after first shot; This spontaneous case was reported by a physician and describes the occurrence of CELLULITIS (Cellulitis in the left leg 7 days after first shot) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced CELLULITIS (Cellulitis in the left leg 7 days after first shot). At the time of the report, CELLULITIS (Cellulitis in the left leg 7 days after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a 45-year-old male patient with no reported medical history, who experienced the non-serious unexpected event cellulitis on the left leg, 7 days after the first dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.  The patient was afraid of getting the second shot.  No concomitant medications were reported.  No treatment medications were reported.; Sender's Comments: Company comment: This is a spontaneous case concerning a 45-year-old male patient with no reported medical history, who experienced the non-serious unexpected event cellulitis on the left leg, 7 days after the first dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pt was admitted on 10/29/06 for febrile illness, fever of 104 with chills. Pt reported receiving flu shot about 10 days prior. Febrile illness was attributed to flu shot vs viral illness. Pt improved and discharged on 11/1/06. Please note patient had 2nd admission 11/8/07 for increased chills, fever this time attributed to pancreatitis with elevated lipase (27,000) with possible viral etiology. Please note with first admission throat culture, urine culture, chest xray and infection at endartectomy site (performed 10/9/06) were all negative. Also there is no further information available on the flu shot, unclear where received or lot #'s. Outpatient chart was checked, no record of administration was found in OPP chart.  4/27/07 Received medicalrecords from hospital which reveal patient experienced endarterectomy of right carotid artery on 10/9/06, day of vax.  On 10/29/06-11/1/06 was admittted to hospital for fever & chills.  Temp in ER was 104.  Tx w/IV antibiotics FINAL DX: febrile illness, possibly reaction to flu shot vs viral.
Pt. received MMR on 1/8/02. Rash on head than body 8 days after MMR Vd with corza. Resolving by 1/21/02- Measles reaction (possibly)
This spontaneous report have been received from healthcare worker who reported that unknown number of doses of VARIVAX (merck) that were stored at -75.3 C for 39 days and 2 hours, may have been administered (date unspecified by reporter). No adverse effect reported. No PQC involved. Additional information has been requested.
two red circles bruised around at the injection site, each circle is like 3 inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (two red circles bruised around at the injection site, each circle is like 3 inches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE BRUISING (two red circles bruised around at the injection site, each circle is like 3 inches). At the time of the report, VACCINATION SITE BRUISING (two red circles bruised around at the injection site, each circle is like 3 inches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
He felt sick from the evening of the shot and then died abruptly the morning of March 17, 2021.    Before the shot he was at the begiining stages of Dimentia and was living at home with his wife.
I started getting symptoms of sore throat. Then I developed a runny nose. I tested positive for COVID-19 with an at home test. On the third day of having COVID-19, my apple watch went off and it was indicating an irregular heartbeat for A-Fib. Having A-Fib was the first time that I have ever experienced that. I was having an irregular heartbeat for 24 hours.
Vaccine administered 11/7/16 in (Lt) Deltoid. Pt returned 11/8/16 for adjunct flu. Nurse (vaccine provider) noted swelling in the area of injection site from 11/7/16. Pt checked in and immediately eval by provider.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 86-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (bivalent), single (Batch/Lot number: unknown) at the age of 86 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "htn" (unspecified if ongoing); "depression" (unspecified if ongoing); "gerd" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Negative, notes: rebound covid positivity after completing course of paxlovid and testing negative for 2-3 days; (Jan2023) Positive, notes: rebound covid positivity after completing course of paxlovid and testing negative for 2-3 days. Therapeutic measures were taken as a result of covid-19, drug ineffective. The patient has not recovered from the event at the time of the report.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE  & COVID-19 and The suspected drug cannot be ruled out.
This case was reported by a pharmacist via call center representative and described the occurrence of buttock pain in a 76-year-old male patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. Concomitant products included FLUZONE HIGH DOSE. On 25th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th October 2018, less than an hour after receiving SHINGRIX, the patient experienced buttock pain, pain in thigh and groin pain. On an unknown date, the outcome of the buttock pain, pain in thigh and groin pain were recovering/resolving. It was unknown if the reporter considered the buttock pain, pain in thigh and groin pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid and FLUZONE HIGH DOSE on the left arm on the same day at the same time. The patient complained of severe tingling pain of buttock, thigh and groin within 4 to 5 minutes of vaccine administration. The pharmacist stated the patient reported feeling better before leaving the pharmacy, but went home so unknown if symptoms resolved at the time of reporting.
Administered Flu shot - IM left arm - within 5-6 mins. pt stood up - sank back into chair became unresponsive - eyes open - head back - urinated appeared to lose consciousness - called 911 - pt unresponsive 2-3 mins - then became aware - very embarrassed - referred 911 needs to go to ER.
Chronic HIves starting after the 2nd dose that continue today.  4 different antihistamines orally daily and monthly Xolair injections keep it under control, but unable to scale back treatment without resumption of symptoms.
Vaccine error - Vaccine administered past its beyond use date. The vaccine stored in the freezer beyond the timeframe recommended by the manufacturer.
tiredness; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of unspecified age had received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: Not reported) via an unspecified route of administration on unspecified date as Dose 1, Single for Covid-19 immunization. The patient's medical history and concomitant were not reported. On an unspecified date, the reporter stated that her husband had experienced tired/ tiredness but no major side effects such as aches and pains. The reporter stated that the patient was due for the second one next week. The reporter confirmed product as COVID 19 Vaccine. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1st dose Oct2019, 2nd 17Oct2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2018).   On 17th October 2022, the patient received the 2nd dose of Shingrix. On 17th October 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: 17-OCT-2022 Reporter's Comment: The patient self-reported this case. Reporter did not consent to follow up. Additional supportive information: The patient received 2nd dose of Shingrix later than recommended interval, which led to lengthening of vaccination schedule.
Her son has a frightening low platelet count; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rare blood disorder" (unspecified if ongoing), notes: Rare blood disorder; "immunocompromise" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PLATELET COUNT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Her son has a frightening low platelet count". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter was a caregiver calling to find out how to give her 17-and-a-half-year-old son the booster dose. she states her son has a rare blood disorder and he was at risk for bleeding if he gets the Covid-19 infection. She states her son received two doses of the Pfizer BioNTech Covid-19 vaccine without any problems, her son received his 2nd dose in Apr2021. She states because he was 17 and a half years old, she cannot get him the booster. she states she would like some guidance to make it happen because the medical people she has been reaching out to have no idea and her son cannot wait another 6 months to get the vaccine, her son has a frightening low platelet count and the Covid infection can drop that even lower because it was already lower than anyone should have. It was upsetting that there was something out there that that could help, and her son does not have access it. She knows the booster has been authorized for people 16 years of age and older but 3 different facilities have told her that the FDA approval was only the first step and none of them will give it to a 17-year-old. She has a follow-up question asking if her 17-year-old son was considered immunocompromise would he be eligible for the booster. She states if her son was eligible for the vaccine who should she contact to get her son the booster dose. her son's hematologist was in full agreement that he should receive the booster, but he did not know how to make that happen before it was approved, and now that it was approved, she still cannot get it for him because will not allow her to make an appointment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rt upper arm, deltoid area became hot to touch w/tenderness, along w/a hard raised rash of 3" inches in circumference around the inj site;reporter states flu vax provided by Wyeth tubex prepared w/ 5/8" for Im shot;
During a flu vaccine clinic for employeesof facility, this employee was inadvertently given expired influenza vaccine.  The vaccine administered was for the 2021-2022 season and expired on 6/30/2022.  The employee was made aware of the this mistake, did not present with any adverse clinical reaction, and will be administered the influenza vaccine for the 2022-2023 season as soon as clinically appropriate.
Merck FBE reported AE on behalf of HCP. HCP reported postpartum patient received first dose of GARDASIL 9 on 11/01/2023. Patient had a syncopal episode, post vaccination in office, and hit her head; patient then went to the ER (FBE did not believe pa; Patient also is now having facial swelling; This spontaneous report as received from a nurse and refers to a 34-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 01-NOV-2023 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided).  On 01-NOV-2023, the patient experienced a syncopal episode, post vaccination in office, and hit her head which resulted in facial swelling. The outcome of syncope and swelling face was unknown. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the events was not applicable.  The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not provided.  Upon internal review event syncope was considered medically significant based on ASTL list.
extremity movement noted consistent w/clonic sz;ordered EEG;ativan & Phenobarb given;LP performed to r/o meningitis;EEG showed discontinuous severe bursts of central sharp waves consistent w/sz;
RECEIVED THE 2ND DOSE OF COVID VACCINE ON 06/09/2021, AND BY 06/10/2021 MY SON HAD DEVELOPED A SWOLLEN LYMPHNODE IN HIS ARMPIT THE SIZE OF A GOLF BALL IN AN OVAL SHAPE.  FEVER  CHILLS SWEATING
Fully vaccinated with NO booster.   COVID infection breakthrough greater than a year after last vaccine!
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Systemic: Joint Pain-Medium, Systemic: Unable to Sleep-Medium, Additional Details: Moderate pain at injection site, muscle became inflammed, then went to forearm then shoulder, has been doing excercises to loosen shoulder, wakes him up during night. He has gone to the MD for annual physical and brought it up, the MD could not find anything
The patient has not experienced any side effects/ No additional AE information provided; Pharmacist reports patient received their first dose of VAQTA in 2017/ did not receive their second dose/ has returned on 8/25/2021 to receive their second dose; Patient Date of Birth: 3/23/2017/ Pharmacist reports patient received their first dose of VAQTA in 2017; This spontaneous report has been received from a pharmacist referring to a 4-year-old patient (at reporting time) whose gender was not reported. The pharmacist did not provide information on the patient's pertinent medical history.  The pharmacist reported that the patient received the first dose of hepatitis a vaccine, inactivated (VAQTA) in 2017 as prophylaxis (formulation, administered dose, vaccination scheme frequency, route of administration, anatomical location of vaccination, lot number, and expiration date were not reported) (product administered to patient of inappropriate age).   The patient had returned on 25-AUG-2021 to receive the second dose of hepatitis a vaccine, inactivated (VAQTA) (0.5 milliliters (ml)) (formulation, route of administration, anatomical location of vaccination, lot number, and expiration date were not reported) (inappropriate schedule of product administration).  The patient had not experienced any side effects; no additional adverse event (AE) information was provided.
I administered the 2nd dose of Moderna vaccine. 2-3 mins later the boyfriend of patient alerted me that patient felt like passing out. I gave a cold compress. Pt was semi-responsive, diaphoretic, felt dizzy, said her fingers were tingling. She was holding her chest and the boyfriend said her HR was elevated. I called 911 and EMS responded, 45 mins later, the patient was fine and left the store
Information has been received from a physician concerning a 7 yea rold male with a history of eczema, asthma and no known allergies who on 09/21/1998 was vaccinated with the first dose of varicella vaccine SC in the right arm. On 06/22/2001, the pt was diagnosed with a clinical case of chicken pox. It was reported that the pt's mother called the physician's office stating that there were red pustules covering the pt's abdomen, arms, legs, and face. Unspecified medical attention was sought. It was further reported that the pt recovered on 06/27/2001. No further info is available.
Student reports positive erythema, positive warmth, positive tenderness, increased edema at site of MMR injection - (R) deltoid that started 3-24-12 at 10:30-11:00 while trying to sleep. Tried Ibuprofen 400mg. Seen at Health Services on 3-26-12 at 3:15 p.m. T: 99.3. (R) deltoid positive edema, positive erythema, positive tender, positive warmth. Student reports improvement since 3-25-12. 3-29-12 11A re-examined. Eryth & edema almost resolved. No c/o pruritus or pain.
Dizziness, Headache, Myalgia, Arthralgia, Headache Narrative: Worsening of chronic dizziness, and left arm pain (elbow, thumb), also had a severe headache on 12/27 (resolved several hours after taking Tylenol).
Patient reports rash on top of feet and smell disturbances-everything smells flowery and metallic.  Pt had covid in February 2021 and had loss of taste and smell that returned a few weeks later.
Patient developed fever on Wednesday July 6 in the evening around 100.6 low grade. He then had mounted a 105 fever on Thursday and on and off 104-105 despite parents giving appropriate doses of fever reducers. Parents went to ER and on the way in his car seat he had a seizure described as both arms and legs shaking for a few seconds, then fell asleep. After 4 days of high fever he developed a rash all over his body and now is vomiting with eating.
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL (lot# K023432, expiration date 18-JUN-2016 or Lot # K011562, expiration date 08-APR-2017) (Strength, dose and route were not provided). Concomitant mediation was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
I started feeling ill on 11/19/2022 I had a sore throat; headache; extreme fatigue; low grade fever 99.1and body aches. I completed a course of PAXLOVID. I have recovered but I do have a lingering cough.
Patient received FLUZONE HD and PNEUMOVAX in right arm 1 inch apart. Patient requested same arm since she sleeps on the left side. Patient returned to pharmacy 3 days later to report a red, swollen, itchy, hot arm. Irritated area was on the lower inside and back of right arm near the elbow. Patient stated that the irritation started shortly after the immunizations were given. Per patient, the irritation  began near the injection site and moved down her arm over the next few days. Upon seeing the patient's reaction on day 4, patient said she was doing better at this point , however, I advised the patient to be seen. I also counselled the patient the NSAIDS, APAP, and ice could be utilized to ease symptoms.
I am a 66 year old female and received my first Shigrix vaccine 10/23/2023 at approximately 3:20 pm. Woke up that night around 4:00 am (10/24/2023) and felt a slight swelling in my throat which I was not overly concerned about because I thought I was sleeping with my mouth open, and my throat became dry. HOWEVER, it also felt like my lips were swollen. When I looked at myself in the mirror, I realized that my lips were swollen but I did not really worry about it too much at that point. I stayed up deciding if I did feel worse or needed to go to the hospital it would be smart not t be sleeping. I never felt that I needed medical attention, so I did not go to the hospital that time. It has now been two weeks since I first noticed the swelling in my lips. They are still swollen and it is bothersome. I decided to "search" it and found there are mild side effects of Shingrix which include "mild allergic reaction." The article further states, "These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist. Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect after receiving Shingrix and want to tell the FDA about it, visit". This is how I got to this site and am now filling out this information. The article further states the following can occur in mild side effects: "swelling under your skin, typically in your eyelids, lips, hands, or feet" or "swelling of your mouth, tongue, or throat, which can make it hard to breathe". (Copied from article) I will contact my doctor's office on Monday, November 13, 2023 to find out if there is anything that can be done to relieve the swelling in my lips. I'm very concerned about returning in two to six months to take another dose of the Shingrix vaccine. NOTE: When I was 5 years old, I received the Smallpox vaccine and had a severe allergic reaction to it. (Severe redness that was rapidly spreading outward from the site on the upper part of my left thigh. It pretty well covered my entire thigh and moved across my lower abdomen. I was treated and kept at the hospital until it was cleared up.) I can't help but wonder if that is somehow related to this reaction.