chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a adult patient who received SHINGRIX for prophylaxis. On 6th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown. It was unknown if the reporter considered the diarrhea to be related to SHINGRIX. Additional details were provided as follows: The patient's age group was taken based on the product indication as no other patient details were provided. The age at vaccination was not reported. The patient received a dose of SHINGRIX yesterday 6th August 2018, after which the patient reported having diarrhea for 8 hours. No further information was reported regarding the event.
Twenty-four hours after the shot, I began feeling achy as if I had the flu. By 5 p.m.,  I was feeling sharp pains in  my arm, collarbone, and neck.  By 9 p.m., I had a rising  temperature up to 102.6. along with chills . This temperature raged until midnight at which point it dropped to normal and my pains abated. It is now two days later and I am still feeling lethargic but without pain  or above normal temperature. However my vaccine arm is now red and itchy in the area of the shot.  I did not call anyone since my temperature dropped but I was almost ready to go to the emergency room if it had gotten higher..
Returned to clinic two days past vaccination with left arm red and swollen from upper deltoid to elbow, swelling has decreased since yesterday. Alternating warm/cold compresses ordered. Also NSAID for children as needed.
flu sx 24hr later-fever, chills, aches-later congestion in sinus & chest;
This case was reported by a nurse and described the occurrence of a positive pertussis identification test in an infant subject gender (unknown) who was vaccinated with diphtheria and tetanus toxoids poliovirus vaccine combined (Pediarix) for prophylaxis. At an unspecified time, the subject received a dose of Pediarix (lot number unknown). At an unspecified time after vaccination with Pediarix, the subject had a pertussis identification test that was positive. The nurse stated that the physician did not think the case was related to Pediarix. She stated that she called to "find out if Pediarix could cause a false positive on the polymerase chain reaction (PCR) for pertussis". The outcome of the events was not reported.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 02 September 2014. A 27 year-old male subject whose past medical history included elevated cholesterol and eczema was found to have acute pericarditis unspecified 19 days after the subject had received on 12 March 2014: an injection of ACAM2000 (lot number, route and site of administration not reported) and on 05 March 2014 received the following vaccines, Typhoid, VICPs (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory date included: a normal Troponin I and a normal Echocardiogram on 01 April 2014. Results of an ECG were not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
pt recv vax 9JUL96 & was inconsolable x 4hr w/high pitched cry lots that day;
coughing; chills; cold; This is a spontaneous report from a contactable consumer (patient).  A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EJ1685, Expiration Date 31Mar2021, via unspecified route of administration, on unspecified date, at single dose for COVID-19 immunization. The patient medical history included blood pressure high. Concomitant medications included unspecified medication for high blood pressure. The patient experienced coughing, chills, and cold on 20Dec2020. The events were non serious. The outcome of the event coughing was unknown. The outcome of the events chills, and cold was not resolved.
pt recvd vax;exp hard knot ("looks like a boil") & redness at inject site 24 hrs later; tx w/ warm compress; redness resolved in 7 days but knot takes longer to resolve;
pt recv vax & pt speech development stopped & was dx as autistic; Annual follow-up received 11/27/00 provided no additional data.
Headache; Dizziness; Nausea; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-SEP-2023, the patient received the 1st dose of Shingrix (right arm). On 06-SEP-2023, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever) and headache (Verbatim: Headache). In SEP-2023, the patient experienced dizziness (Verbatim: Dizziness) and nausea (Verbatim: Nausea).  The outcome of the fever was resolved (duration 24 hrs) and the outcome of the headache, dizziness and nausea were not resolved.   It was unknown if the reporter considered the fever, headache, dizziness and nausea to be related to Shingrix.     It was unknown if the company considered the fever, headache, dizziness and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-SEP-2023 The patient reported next day of vaccine administration she had fever and headache. Her fever went after 24 hours but she was still suffering with headache till time of reporting. She also had dizziness and nausea which was not going. The reporter consented to followup.
Arm where injection was given is described as "looking like I have a tattoo" down to the elbow (black and blue bruising). No swelling or discomfort.
Dr. ordered patient to have a Dtap-IPV injection.  MA drew up Dtap-IPV-Hib  vaccine instead and gave to the patient.  MA did have a co-signer who missed that the incorrect vaccine was drawn up. MA gave the patient the injection with no adverse reaction.
Hot flashes, nasal and chest congestion, occasional trouble breathing,  bodyaches, fever and chills. Difficulty breathing was worse when I would talk too much or move. Treatment has consisted of stress doses of my Hydro Cortizone, ibuprofen, equate cold and flu and Benadryl.
Rash surrounding injection site and spreading over body over course of following weeks. Ongoing at this time.
nightmares; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: FF2589) for 1 day as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NIGHTMARE (non-serious), outcome "recovering", described as "nightmares". Therapeutic measures were not taken as a result of nightmare.  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient not tested for COVID-19 after the vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was not diagnosed with COVID-19.   No follow-up attempts are possible. No further information is expected.
was sick for a few days; got a fever; 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 ILLNESS (was sick for a few days) and PYREXIA (got a fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (was sick for a few days) and PYREXIA (got a fever). At the time of the report, ILLNESS (was sick for a few days) and PYREXIA (got a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   Reporter did not allow further contact
Pt. stated stomach felt queasy; sat down; says her vision was fuzzy; became pale; fainted; assisted to a lying position et fanned; regained consciousness within 1-2 sec.; stated "felt like a dream"; sat up after 5 min. felt faint again; lost color again; laid back down; fanned; talked to staff and family; sat up again after 5min; ate snack good color; strong pulse; stood up - no problems; left.
No effects on day of vaccination, nor into the evening. Morning of 27th woke with headache. Symptoms worsened as the day progressed. Body and muscle aches, extreme fatigue, sleepiness, some difficulty moving around, heart seemed to be pounding harder as I moved, so stayed put  in my chair. About 8 o'clock I had a fever of 101. Drank lots of water. Took Tylenol. Fever faded away. In bed by 9pm. Alternately hot, then cold for several hours but did not have chills. Around 1am temperature stabilized and I slept well. Today, the29th, symptoms gone. Arm not even sore.
Per client phone call, developed a rash on neck extending to ear and face with onset approx 10 days after vaccines administered. Diagnosis by physician as "shingles" - Rx Acyclovir & VICODIN. Acyclovir ordered tid x 7 days/VICODIN as needed and then switched to MOTRIN. Discussed with clinic physician. Suggested follow-thru with VAERS. Pt notified of such.
1. Crying episode for 5 hours. 2. moderate-mild swelling, left thigh and right foot
Pt recv vax on 2/8/99; post vax pt exp red, hard lump, indurated-LA
Covid Arm 3 times; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid Arm 3 times) 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 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid Arm 3 times). At the time of the report, VACCINATION SITE REACTION (Covid Arm 3 times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. The patient had second dose on March 2021.   This case was linked to MOD-2021-182746 (Patient Link).
Patient received incorrect vaccine. Patient received Hep A vaccine rather than Tdap vaccine. Patient was notified of the mistake, was then asked if she wanted the Hep A vaccine as well, patient agreed since it had already been administered. patient now has to return for second Hep A vaccine to complete the series.
I felt dizzy and I vomiting. My blood pressure went down very low. I was given IV fluids.
1/6 - 8 YR OLD PRESENTED TO THE ER AFTER 4 DAYS OF FEVER/MAX 103, GENERALIZED RASH, HA, SORE THROAT, ABDOMINAL PAIN, MALAISE, REDNESS OF HANDS. POSSIBLE COVID EXP 12/24/21, STREP/ COVID/FLU NEG AT DR OFFICE 1/3.   SYMPTOMS PROGRESSED, SENT TO ER-PRIMARY MD CONCERNED FOR MIS-C. UPON EVAL PT WAS ILL APPEARING, FEBRILE, TACHYCARDIC, HYPOTENSIVE 90/40. CONCERN FOR MIS-C VS. KAWASASKI VS. VIRAL EXANTHEM VS. TICK BORNE ILLNESS. ADMITTED TO UNIT FLOOR. REC'D IV FLUIDS, EMPIRIC CEFTRIAXONE, IVIG AND LOW DOSE ASPIRIN PER MIS-C PROTOCOL. 1/7 ADDED IV STEROIDS & LOVENOX.  Blood and urine cx NG >36 hours and at 5 days. Hospital course:  Blood and urine cx NG >36 hours & at 5 days, - Tick studies negative, Pancytopenia improving -Received 2nd dose of IVIG due to being febrile and symptomatic within 36 hours after 1st infusion -Kept on mIVF for hydration -Appetite improved over time -Developed Abdominal pain; abd XR showed prominent liver, inc LFTS; abd US showed diffuse inflammation in the abdomen involving multiple organs -Abdomen pain and LFTs improved over following days, no N/V, constipation or diarrhea  Discharge:  -Follow up with physician within 48 hours of discharge -follow up with cardiology and rheumatology in the outaptient setting -continue with aspirin once a day, steroids once a day and famotidine for belly protection - rheumatology will help taper the steroids, for now continue taking them once a day.
Information has been received from a registered nurse concerning a female patient who was vaccinated IM into the gluteus with a second dose of Gardasil (yeast). It was reported that the patient was vaccinated into the gluteus because her arm was sore for 3 months after the first dose of the vaccine. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
-Pain in right arm--none at time of injection, but developed over a few hours. By next morning, unable to lift full arm more than 6 inches without pain. Pain on contact. -Severe headache --started following morning, took 650mg acetaminophen 3x over 23rd Feb, 2x 24th Feb -Pulsing pain inside right ear -- for a few hours during the evening of 23 Feb -Full body aches/fatigue--Started following morning (23rd Feb) and felt like behind hit by a bus; persisted (to a lesser extent) to end of 25 Feb -Fatigue--started following morning. Slept entire day of 23 Feb. Slept half of 24 Feb.
Patient claims technician injected flu shot into shoulder. She reported joint pain, arm pain, and swollen fingers immediately after vaccination and for several days after. She is now under care and treatment by her PCP.
Lump was noticed; Swollen lymph node noticed in left armpit, soreness in the area; Swollen lymph node noticed in left armpit; Hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 08:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and hypertension. The patient had no known allergies to medications, food or other products. Concomitant medications included labetalol (MANUFACTURER UNKNOWN), ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), salbutamol (ALBUTEROL) and ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C), all from unknown date for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6955), via an unspecified route of administration in the left arm on 04Mar2021 at 14:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021, the patient experienced swollen lymph node noticed in left armpit, soreness in the area began about 2 days post 2nd shot (25Mar2021), lump was noticed 6 days post 2nd shot (29Mar2021) but could've been present sooner. Still present as of 01Apr2021, 9 days post 2nd shot. Only other side effect was hot flashes throughout the first day post-2nd shot which lasted one day. No adverse effects from 1st shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of swollen lymph node, soreness in the area and lump were not recovered while that of hot flashes was recovered on 25Mar2021.  No follow-up attempts are needed. No further information is expected.
Patient was hypotonic and hyporesponsive for approximately 38 hours after vaccine administration. No fever. Woke only 2 times about 30 minutes; was irritable.
Information has been received from a radiology technician concerning an 11 year old female who was vaccinated with Gardasil. Subsequently the patient experienced severe abdominal cramping. It was reported that the patient sought unspecified medical attention. Subsequently, the patient recovered from severe abdominal cramping. No further details were provided. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to a male patient of unknown age. The patient was vaccinated with the first, second and third dose of (Oka/Merck) VARIVAX subcutaneously on 16-APR-2008, 23-OCT-2012 and -07-NOV-2014, respectively (dose and lot number were not reported). Other suspect therapies included the first, second and third dose of MMR II given on 15-OCT-2008, 23-OCT-2012 and 07-NOV-2014, respectively (dose, route and lot number were not reported). There were no known adverse effects. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 24-JAN-2015, the patient was vaccinated with ZOSTAVAX, (lot # and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-JUN-2016, the patient was treated by a physician for a blistering vesicular outbreak which was then diagnosed as herpes zoster or shingles. The patient was prescribed valacyclovir and gabapentin for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pfizer Dose 1 3/10/21 (013A21A) Pfizer Dose 2 4/12/21 (025B21A) COVID Positive 1/31/22  1/31/22: A 60-year-old female with past medical history of interstitial lung disease/idiopathic fibrosing alveolitis awaiting lung transplant, chronic hypersensitive on home oxygen 4 L by NC, hypertension, systemic sclerosis, recent COVID 19 infection December 2021 comes to ED complaining of worsening of shortness of breath.  Patient states that she recent had COVID-19 infection in December 2021, has been having progressive shortness of breath and she saw her pulmonologist last week and was started on levofloxacin on 01/27/2022.  In spite of using levofloxacin she does not feel better.  Having low-grade fevers.  Cough is productive with small amounts of mucoid sputum.  No chest pain.  No sick contacts. Whenever she walks around her oxygen saturation drops into 70s, while on 5 L O2.  A concentrator at home does not allow the oxygen to go up above 5 L.   In the ED her temp was 100.2° F. chest x-ray reported new airspace disease on top of chronic interstitial changes concerning for superimposed infectious process for worsening interstitial lung disease.  ED provider attempted to contact Transplant Department, but did not receive a call back. She contacted the doctor, and he recommended IV ceftazidime for Pseudomonas coverage and IV vancomycin.  2/7/22: The patient known to have advanced a she lung disease with chronic hypoxic respiratory failure oxygen dependent at home, history of COVID-19 pneumonitis, history of scleroderma on immunosuppressive therapy, presented to the hospital with worsen shortness of breath and cough, proBNP was elevated, chest x-ray show worsening bilateral infiltrate, COVID-19 PCR test came back positive.  The patient diagnosed with high likely reinfection COVID-19 pneumonitis with possible secondary bacterial infection and acute on chronic hypoxic respiratory failure that did not require ventilator.  The patient started on remdesivir and dexamethasone and she was on vancomycin and ceftazidime and supportive nebulizer treatment.  The pulmonologist consulted and recommend to continue this medication, patient was on IV diuretics with improvement in her shortness of breath and symptoms, echocardiogram did not show indirect signs of pulmonary hypertension and EF 55%. The patient undergoing extensive lung transplant workup at the Transplant Center.  The patient completed the oxygen walking test and she require 4 L of oxygen at rest and 8 L while ambulating, recommend high concentrated nasal cannula.  Okay to be discharged as pale the palm and follow-up with her pulmonologist and the lung transplant clinic.  Will discharge her on taper steroid, she completed her antibiotic regimen.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-DEC-2016, the patient was vaccinated with improperly stored dose of VAQTA lot # L002717 with an expiration date 02-JUN-2017, intramuscularly for prophylaxis (dose and anatomical location were not reported). There was no adverse effect reported. The administered dose of VAQTA experienced the temperature excursion from 32 to 36 degrees Fahrenheit for 4 hours. There was no previous temperature excursion. A digital data logger was not involved. Product quality complaint (PQC) was not reported. Additional information has been requested.
The patient is reporting that she has had allergic type reactions since her vaccination on and off for the last year.  She experiences bumps from her forehead to the soles of her feet, including swelling of the lips.  She was referred to her primary care physician who elected not to treat her with any medications despite her requesting a steroid to relieve her symptoms.
Very severe joint pain in both knees; This is a spontaneous report from a contactable consumer (Patient). A 91-year-old male patient received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, solution for injection, Lot Number: EL9269), via an unspecified route of administration, administered in left arm on 16Feb2021 at 17:15 (at the age of 91-years) as single dose for COVID-19 immunisation. Medical history included cardiac failure from an unknown date and unknown if ongoing. Patient had no known allergies. Patient did not have COVID prior vaccination. Patient did not receive any other vaccine within four weeks of vaccination. Patient received unspecified medications within two weeks prior vaccination. The concomitant medication(s) were not reported. On 17Feb2021 at 08:00 (next day of vaccination), patient experienced very severe joint pain in both knees. Patient did not receive any treatment for the event. Patient not tested for COVID post vaccination. The outcome of the event was not recovered.