chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN; LOSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19.  Additional information: The patient received Paxlovid for the treatment of COVID 19, start date is 19May2022 and stop date is 24May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
MMR administered 2 hrs later devel erythematous maculopapular rash on face, trunk & extremities some hives by report; no other sx, no rash @ site of inject; also got HIB; given DPH;
No additional AEs; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report was received from health care worker and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 24-AUG-2022, the patient was vacicnated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # W003118 with expiration date: 13-JUL-2023 or lot # W015191 with expiration date: 27-OCT-2023 - exact lot # not specified) administered for prophylaxis (strength, and route of administration were not provided). The vaccine was stored at 11.3 degrees Celsius (C) for 34 minutes. There was no previous temperature excursion and no additional adverse events (AEs) were reported.
No additional adverse events.; Caller is HCP reporting that patient received third dose of GARDASIL 9 earlier than recommended. Dates of administrations are 27AUG2021, 02NOV2021, 28JAN2022.; This spontaneous report was received from a medical assistant referring to a 43-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 27-AUG-2021, the patient was vaccinated with the first dose of HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, subsequently on 02-NOV-2021, she received the second dose and on 28-JAN-2022, the patient was vaccinated with the third dose (inappropriate schedule of product administration); all administered as one dose for prophylaxis (exact doses, strengths, anatomical injection sites, lot numbers, expiration dates, and routes of administration were not provided). No additional adverse events were reported.
Felt like Fainting; Headache; Pain on the Injection Site; A spontaneous report (United states) was received from other health care professional concerning a 65-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, pain on the injection site and felt like fainting.  The patient's medical history was not provided by the reporter. Concomitant medications not reported.  On 05-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On the same day, patient experienced events, headache, pain on the injection site and felt like fainting.   The treatment information was not reported.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events, headache, pain on the injection site and felt like fainting were resolved on 06-Feb-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
LEG PAIN; STOMACH PAIN; PAIN DURING THE INJECTION; This spontaneous report received from a patient concerned a female of unspecified age. 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 was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced pain during the injection. On 09-APR-2021, the subject experienced stomach pain. On 13-APR-2021, the subject experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg pain, and the outcome of pain during the injection and stomach pain was not reported. This report was non-serious.
extreme brain fog 8 days post vaccine - had it a little after shot for day and a half came back very strong have had it all week intermittently.  Shaky, racing heart, high BP all intermittent,  gastrointestinal upset, headache, feeling run down, trouble breathing but lungs fine Disruptive to working, thinking daily life feel very weird on and off
She got her vaccine, had sore arm after injection and felt it at that time.  Felt it all the way to her finger tips and then disappeared.  When she went to bed she felt all through the night her arm hurt and she was thirsty.  This morning she got up, took her kids to school and then had body aches, chills, back hurts, arm hurting, and everything on her body hurts.  She has loss of appetite.  She stated that she had COVID in January and this feels similar to having that.  She has not taken anything for her symptoms yet.
doesnt remember if she received third dose of gardasil 9, 10 years ago, when she was 13 years old; doesnt remember if she received third dose of gardasil 9, 10 years ago, when she was 13 years old; This spontaneous report was received from a pharmacist referring to a currently 23-year-old female patient. Her concurrent conditions, medical history, concomitant medications and drug reactions/allergies were not reported.  On an unknown date in 2009 (also reported as ten years ago), it was unknown whether she was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, unit, route, lot # and expiration date were not reported) (inappropriate schedule of product administration and circumstance or information capable of leading to medication error). The patient reported that she does not remember being vaccinated with third dose. The outcome of inappropriate schedule of product administration and circumstance or information capable of leading to medication error was unknown. No product quality complaint (PQC) was involved.
On 03/29/2002 at 4:30am the pt developed a fever of 103 deg. F., swelling and redness on right thigh that spread to calf. ER visit on 03/30/2002 "infection on right leg" and was given Keflex and Benadryl. On 04/03/2002 pediatrician vistit. Temp normal. Redness at right thigh IM site only "cellulitis." On 04/05/2002 pediatrician visit. Symptoms resolved. Antibiotic Keflex continues.
Pt presents to clinic 6 days after vaccine c/o warmth left upper arm. 15 x 15 cm area of redness/warmth left upper arm. Dr. evaluated. Prescribed antiobiotic but pt declined. Wants to speak to his primary doctor who returns to office 4/26/23.Declined phone visit appt with PCP in 1 week. Message sent to PCP.
Student had a fever of >103.0 and then had a seizure, transferred to hospital via ambulance.  Remained in hospital overnight.  Mother stated that child has appointment with a neurologist. 11/4/09:  Vaccination record received, VAERS updated.
mom reports fever of 101-102, welts, blotches, hives, & diarrhea for 4 days p/vax; not seen by MD, mom phoned p/sx subsided;
suspected vaccination failure; my face broke out; 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. 4 weeks after receiving Shingles vaccine, the patient had to get a Tuberculosis test.  CDC said you need 6 weeks between the 2.  The patient's lower half face broke out and he/she wanted to strangle the np bitch who never asked the right questions, like did you receive any vaccines recently. 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 of shingles were not provided.
Information has been received from a registered nurse concerning an approximately 25 year old female who in November 2008, was vaccinated with the first dose of GARDASIL. On 21-JAN-2009 the patient was vaccinated with the second dose of GARDASIL (lot # not reported) 0.5 ml. On 23-JAN-2009 the patient experienced rash and itching on her trunk and side of neck. Subsequently, the patient recovered from the events. "They advised her not to get the third dose". The patient sought unspecified medical attention. Additional information has been requested.
I started with a cough and that got progressively worse until I started throwing up. After throwing up I felt like I could not get enough air for about 40 mins. I had a Abuteral inhaler left from fighting bronchitis so I took a few puffs of that and started to feel a little better. Through the night I continued to throw up a few times and having a lot of coughing.  The next day mt throat was on fire and could not really talk. I am assuming this was from all the coughing and throwing up.
Patient was given the 0.1 mL of the Pfizer 12+ yrs, vial reconstituted with 1.3mL diluent.
Site red, warm, indurated, slightly tender. Feels better after ibuprofen. Recommended: Benadryl, ibuprofen and ice to the site.
TWO SMALL SWOLLEN, TENDER AREAS FOUND ON THE SIDE OF THE NECK AFTER RECEIVING THE FLU SHOT.  WENT TO THE DOCTOR AND RECEIVED STEROIDS; PROBLEM RESOLVED AFTER ONE AND A HALF WEEKS.  SHE WAS TOLD NOT TO TAKE THE FLU SHOT NEXT YEAR.
Patient says the injection site has been itching/irritated since day of immunization.  The itching and redness has continued to increase and spread down the arm towards the elbow.  I, the pharmacist, referred patient to her PCP.  She stated that she had already had contacted them and that they asked her to come in.  I encouraged her to follow through with that.  She did not want me to contact the doctor.
Hives and severe burning pain (Head to toe, internal and external) for 4 months after vaccine. Patient has sarcoidoisis and the immune system is reacting very strongly.
2 years old patient received ROTAETQ; patient received ROTATEQ and was later diagnosed with rotavirus and esperienced seizures; patient received ROTATEQand was later diagnosed with rotavirus; This spontaneous report has been received from consumer and refers to a 2-year-old patient.  The patient's concurrent conditions, medical history, concomitant therapies and previous drugs reactions or allergies were not reported.   On an unknown date in 2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (strength, lot number, and expiration date were not provided).  On 28-MAR-2022, the patient was diagnosed with rotavirus (rotavirus infection) and experienced seizures. The causal relationship between therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and rotavirus infection and  seizures and the outcome of the events were not reported.  Upon internal review, seizures was determined to be medically significant.
Cellulitis - admitted 9/9/12 - 9/11/12, received IV clindamycin.
Felt like she'd been hit by a truck; couldn't move; This is a spontaneous report from a contactable consumer. This Female consumer (patient) reported that a female patient of unspecified age received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EW0179), via unspecified route, on 08Jun2021 as 2nd dose, single dose for covid-19 immunization. The patient received historical vaccine bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EW0179), via unspecified route, on 18May2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. The concomitant medications were not reported. The patient stated that they all got the second shot on Tuesday, 08Jun2021 and waited 15 minutes, also stated that after first time they made them wait for 30 minutes but the second time it was 15 minutes. She stated on Wednesday, she felt like she'd been hit by a truck and said she couldn't move and took Flu Dayquil, went to bed, said they gave her some food, and she was ok in the afternoon. Caller stated she stopped the paramedic in the middle of the road, and they took her wife and mother to the hospital, they asked her if she was ok. Caller said she was fine and to worry about them. Caller stated her mom was swelled and her wife. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
HAD FEVER, redness and site is warm to touch was treated on 12/22/15 Septra 800 mg -160 mg 1 tab BId.
Patient received flu-shot on 10/15/20 in the afternoon given by employee health staff while at work. Two hours after the administration, patient started feeling a burning and pin-prick sensation over the L deltoid region where she had received the shot but she did not examine it. Seven hours after administration that same day, she changed her clothes to take a shower and noticed the erythema and blisters to the region of the vaccine administration. She later had to put an ice-pack over it for comfort. The appearance of the skin lesions remains unchanged the next morning 10/16/20 when she presented to employee health clinic. In clinic, the exam of the L deltoid region showed 3 non-contiguous areas of erythema/purpura/edema, with the largest area measuring 9 cm X 3 cm. This largest area of erythema also has two overlying clear fluid-filled bullas, with the larger bulla measuring 4 cm X 2.2 cm and the smaller bulla measuring 1 cm X 1 cm.  Patient reports sensation of burning and pin-prick pain overlying the affected skin region that is worse with touch. Denies any shortness or breath or any other symptoms.
Administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The vaccines were stored in freezer , they take out one to two vials and placed in fridge each day as needed.  No treatment medications were provided.
cutaneous hypersensitivity in left arm  red circle 3" itchy, tender on vaccine area and armpit
Intense fever, chills, headache night one and continued for 48 hours. For 5 additional days my joints and bones hurt so much that I could barely walk or stand.  Intermediate nausea for approximately 5 days post vaccine.  Joint pain continues currently on a daily basis 5 weeks post vaccine.
Patient is now deceased (12.30.21);  Hospitalized (12.24.21);  COVID-19 positive (12.23.21); Fully vaccinated Admission Date: 12/24/2021 Date of Death: 12/30/21 Time of Death:  4:30 PM Preliminary Cause of Death: COVID-19 virus infection DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxia [J96.01] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1] HOSPITAL COURSE: Patient is a 83 y.o. male with past medical history significant for B-cell lymphoma recently on chemotherapy (opted to forego the last treatment due to side effects), previous pleural effusions attributed to B-cell lymphoma which required drainage, chronic diastolic heart failure, coronary artery disease, persistent atrial fibrillation, recurrent DVTs, hypothyroidism, pulmonary fibrosis, BPH who presented for this hospitalization with worsening cough and shortness of breath for the past several days, most likely symptom onset sometime between 12/15-12/20 and has been diagnosed with COVID-19 pneumonia. In the ED, chest x-ray showed interval decrease in lung aeration with worsening bilateral airspace disease consistent with COVID-19 pneumonia.  Patient was requiring 5 L oxygen via nasal cannula on admission. Oxygen requirements worsened, and patient was broadened on steroids to 40mg IV solu-medrol bid.  D-dimer increased to 13,000 and then 23,000. CTA negative for PE but positive for consolidating airspace disease. Bilateral dopplers negative for DVTs. Continued on Xarelto, started on HAP treatment on 12/27 with Vancomycin and Cefepime, planned for 7 day course. Also started additional diuresis with 40mg IV lasix bid (up from home regimen of 40mg PO bid). Pulmonology was consulted early in hospital course had multiple goals discussions with patient.  Patient worsened and family was adamant that he could not be intubated. He was changed to Comfort measures and passed on 12/30/2021 at 1630
This is a spontaneous report from a pharmacist/mother referring to her 15 year old daughter. On 4/11/00 at 13:00, the pt received her 1st IM, right deltoid, dose of Havrix. One day later, on 4/12/00, the pt was feverish and achy with fatigue. On 4/13/00, her fever was higher 102F and symptoms were persisting. No treatment was given. The most recent information, received on 4/13/00, reports the condition of the vaccine as ongoing.
Patient noticed warm sensation and upon inspection was very swollen and red.  Not particularly painful or irritated.  Warm and somewhat swollen.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, medical history and concomitant therapies of the patients were not reported. On unknown dates over an unspecified period of time,  the patients were vaccinated with an improperly stored dose of ROTATEQ orally, with either lot number M038728 and expiration date of 25-APR-2018 or M011832 and expiration date of 25-JAN-2018(strength and dose were unknown) for prophylaxis, which was stored from 32 Fahrenheit degrees (°F) to 35°F for 15 hours and 30 minutes. There was  previous temperature excursion. However, the temperature excursions were not detected by a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA010439:  US-009507513-1705USA010440:
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was provided.
About a week after shot area for very itchy and a bit hard and swollen and warm. Light red patch about circular about 2 inches in diameter around shot site. A bit painful but mostly itchy and swollen very suddenly today.
Pt was suppose to give patient HPV vaccine and accidently gave her a Pfizer vaccine which would be a 3rd dose. 2nd dose vaccine was given to patient about 2 months ago.
Pt left clinic with mom approx 5 minutes after being seen in clinic ear pain at 2:30 pm and also received four immunizations including HPV (Gardasil), Tdap, Menactra and Varicella.  While waiting for valet to bring vehicle, pt told mom she felt nauseous and then fainted and fell backward, hitting her head on the sidewalk. Pt came back to clinic and was upset and crying and had a knot on the upper back portion of her head. The nurse practioner seeing the pt was notified and an RN performed a neuro check which was wnl and ice pack was applied before sending pt to have skull films performed. Pt returned to clinic and was observed for another 30 minutes before releasing to go home with mom. At 2:00 am, mom called triage line because pt was vomiting. Pt was advised to go to ER and did so where a CT Scan was performed which mom reports was WNL so they were sent home.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Fainting episode lasted under 3 minutes. Patient fully recovered. No complications. Patient recovered in MC side B drank water and ate some crackers. Patient stated she did not eat all day. Episode occurred around 1830. Patient rested until 1930. Cleared to drive self home. Last BP 112/80 HR 68 O2 100%
Initial unsolicited case received from a health care professional (medical assistant) on 17 Aug 2017. This case is linked with 2017SA152887 same reporter. This case involves a four months old male patient, who was vaccinated with first dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) date of Aug-2017 (on 11-Aug-2017 one patient or 14-Aug-2017 ). The patient also received a dose of VARICELLA VACCINE (LIVE) (VARICELLA), and a dose of MEASLES, MUMPS AND RUBELLA VACCINE (MMR) (Batch number, expiry date not reported, dose in series unknown, site of administration not reported) both vaccines were administered via intramuscular route on an unknown date. The patient had no illness at the time of vaccination, and pre-existing physician diagnosed allergies, birth defects, medical conditions were not provided. Concomitant medications were not reported, and any other vaccinations within 4 weeks of vaccinations was unknown. On an unknown date, following the vaccinations, the patient developed redness and swelling at the injection site. The patient was seen in the emergency room. No relevant laboratory examinations were performed. As a corrective treatment the patient was encouraged to do warm soaks and diphenhydramine hydrochloride (Benadryl). The outcome of the event was unknown. List of documents held by sender: none.