chrisvoncsefalvay/vaers-outcomes huggingface dataset:
booster; Was diagnosed with COVID-19 on 1/6/2022.; contracted COVID-19; Fever (103.50F); very sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Relevant medical history included: "lung tissue scarring" (unspecified if ongoing); "underlying genetic condition" (unspecified if ongoing). The patient's concomitant medications were not reported. It was reported that patient was at high risk due to an underlying genetic condition and lung tissue scarring. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; SUSPECTED COVID-19 (medically significant) with onset 06Jan2022, outcome "unknown", described as "Was diagnosed with COVID-19 on 1/6/2022."; DRUG INEFFECTIVE (medically significant) with onset 06Jan2022, outcome "unknown", described as "contracted COVID-19"; PYREXIA (non-serious) with onset 05Jan2022, outcome "unknown", described as "Fever (103.50F)"; ILLNESS (non-serious) with onset 05Jan2022, outcome "unknown", described as "very sick". The patient underwent the following laboratory tests and procedures: body temperature: (05Jan2022) 103.5 Fahrenheit.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 27-APR-2012, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-OCT-2013, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed valacyclovir and gabapentin for management of his painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment with monetary damages. 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.
nonocclusive deep vein thrombosis (extending from  upper femoral vein to  Popliteal vein in left leg,, ) pulmonary embolism affected  left pulmonary lobe) - no heart damage or pulmonary infarct; Was hospitalized at Hospital on Saturday 4/10 and discharge is scheduled for 4/13.
Immediately after Hep B injection, patient felt flush and nauseated.  When patient got home, 30 minutes later, vomited x2.  States red blotches appeared on chest and face.
Started with a raspy throat in the evening; coughed all night; took cough drops; didn't help;
Woke up feeling extremely cold. Called out and put on an electric blanket. Kept waking up throughout the night. Then started feeling overall pain when moving and exhaustion.  Symptoms were gone by 1/13/2021
Information has been received on 30-JUN-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 17-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M035696, expiration 07-NOV-2017 subcutaneous for prophylaxis which was improperly stored.  Concomitant therapies included sterile diluent (STERILE DILUENT) lot number M026304 expiration 13-MAR-2019. The pharmacist confirmed that no adverse events were present for the patient. The vaccine was stored at temperatures of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 24 hours 30 minutes and at temperatures of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 8 hours 39 minutes. The pharmacist reported a previous temperature excursion but did not have the details. The call was made due to a data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA004031:
Information has been received from a nurse concerning her 11 year old daughter with a history of fibromyalgia who on 10-APR-2007 was vaccinated with a first dose of Gardasil (lot number unknown) injection. On 10-APR-2007 the nurse reported that "2 and a half weeks" after her daughter was administered with Gardasil, her daughter experienced pain all over her body. Medical attention was sought. The patient was prescribed VICODIN for the pain. At the time of the reporting, patient has not recovered. No further information was provided. Additional information has been requested.
2/23/2021 Right side of body went numb ~10 minutes, went away.  8/25/2021 felt sick, dizzy, tired was better in the morning.  8/30/21 ~9am right arm tightness, tingling, numbness.  Felt like blood pressure cuff around my arm, felt like cold liquid in my arm.  Called nurse line, instructed to go to ER.  Spent 8/30/21 and 8/31/2021 in the hospital being evaluated for a stroke.  Discharged with diagnosis of Paresthesia.  9/1/2021 woke to left arm tingling, numbness, right arm also numb.  9/2/2021 woke to both arms numb, tops of thighs numb, felt like a band around rib cage.  Went to ER as symptoms progressing, tightness in chest began.  Diagnosed with Gerd and Paresthesia.  Given prescription of Sucralfate. Prescription of Sucralfate did not help  Evening of 9/2/2021, felt like heart was being squeezed. I have been seeing a Neurologist for treatment.  Tightness of diaphragm has gotten better. Symptoms of numbness in feet, lower legs, hands, lower arms continues.  Sometimes, the feeling is more of pins and needles. Sometimes my upper arms feel tight. Tightness in chest continues, squeezing at times, palpitations at times.  Rib cage tightens at times.
Headache, Sedation, Myalgia & Arthralgia Narrative:  Other Relevant History:
SWEATY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced sweaty. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweaty. This report was non-serious.
Had injection on 9/21, and noticed that within 24 hours had swollen lump underneath the left arm.  This swelling did leave within 24 hours.  Since injection, left shoulder has been hurting and has now noticed pain with lifting arm above head.  Range of motion has decreased in left arm.
Woke up the next day with a horrible case of gout in R great toe. Resolved in 2 days.
Information has been received from Pfizer, Inc. [2016385284] on 17-AUG-2016 via a consumer. A patient's mother reported her daughter was vaccinated with GARDASIL and experienced alopecia (MARRS # 0901USA02690). The patient's mother reported that according to the internet 2000 girls had the same problem (alopecia) (MARRS # 1608USA010994), 200 died (MARRS # 1608USA011010) and 65 had neurological problems and they were in wheelchairs. No further information was reported. Neurological problems and they were in wheelchairs was considered to be disabling. Additional information is not expected. Information was received via a business partner.
pt recvd vax & had t 104; very fussy; screaming for 24hrs; bulging fontanelle; dec appetite; ear infection dx next day; started on bactrim & completed tx;
Patient filled out pre-screening form in complete and all questions were answered "no".  Pt wife called to inquire regarding the questions on the form and how he answered because he is having full body severe myalgias after obtaining his flu and Shingrix dose.  pt is paraplegic and she informed us that he should have answered "yes" to a couple of the questions.  Advised pt wife to take pt to seek further diagnostic care with a physician.  She will monitor his pain level to decide if she will take him in urgently to ER or wait to call me/neurologist on Monday if they don't have on call #.  Called pt wife to follow up on pt's condition on 9/22 - pt wife, has informed me that she did not end up taking him in yesterday and today he is doing just fine.
Skin feels warm; Skin feels hard; Skin itching; Red rash on site of administration; A spontaneous report was received from a  consumer concerning herself a 85 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red rash on site of administration/vaccination site rash, skin itching/vaccination site pruritus, skin feels warm/vaccination site warmth and skin feels hard/vaccination site induration.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced red rash on site of administration and skin itching. She also says that her skin feels warm and hard. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, red rash on site of administration, skin itching, skin feels warm and skin feels hard were unknown.
vesicular, erythematous lesions over the right upper face and neck, right back, right waist right lower groin region.  Hot, itchy rash started on face, and neck (4/20), and proceeded to erupt on back and waist 2 days later(4/22).  Doctor's visit on 4/25 - initially suspected poison ivy.   Prescribed: predniSONE (DELTASONE) 10 MG tablet; Take 6 tabs day 1,2; 5 tabs day 3,4; 4 tabs day 5,6; 3 tabs day 7,8; 2 tabs day 9,10; 1 tab day 11,12, 1/2 tab day 13,14  Dispense: 43 tablet; Refill: 0  Rash continued to spread to right groin area.  Second Doctor visit 4/29. No longer suspecting poison ivy, instead shingles like reaction to vaccine.  Continued course of prenisone along with oral benadryl.  Rash on hip healing but still present as of 5/12/22.
No adverse event Patient received an additional dose of Hep B He was following an alternate vaccine dosing schedule due to perinatal exposure to HBV and an additional dose of Hep B was given when he was given a combination vaccination
On the same afternoon that the vaccine was given, 03/27/2018, patient started to generally not feel well. The next day, 03/28/2018, his temperature went up to 104 and he began to cough and had general fatigue. He began taking OTC medication for his fever and symptoms. By the evening of 03/28/2018, he noticed that the site where the vaccine was administered was sore, puffy and red.
Hypoglycemic; shaking; feeling tired; stomach upset; Diarrhea; Feeling lightheadedness; A little emotional; feeling loopy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset), DIARRHOEA (Diarrhea), DIZZINESS (Feeling lightheadedness), EMOTIONAL DISTRESS (A little emotional) and HYPOGLYCAEMIA (Hypoglycemic) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GI upset and Vertigo. Concurrent medical conditions included Pre-diabetic. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and DILTIAZEM for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach upset), DIARRHOEA (Diarrhea), DIZZINESS (Feeling lightheadedness), EMOTIONAL DISTRESS (A little emotional) and FATIGUE (feeling tired). On 06-Jan-2021, the patient experienced HYPOGLYCAEMIA (Hypoglycemic) and TREMOR (shaking). On an unknown date, the patient experienced FEELING ABNORMAL (feeling loopy). On 06-Jan-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (stomach upset) had resolved and DIZZINESS (Feeling lightheadedness), EMOTIONAL DISTRESS (A little emotional), HYPOGLYCAEMIA (Hypoglycemic), TREMOR (shaking), FEELING ABNORMAL (feeling loopy) and FATIGUE (feeling tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Blood glucose: 78 low. On 07-Jan-2021, Blood glucose: 74 low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, very limited information regarding this event (hypoglycemia, tremor) has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, very limited information regarding this event (hypoglycemia, tremor) has been provided at this time.  Further information has been requested.
rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash 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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-JUL-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient asked was a rash common after receiving a Shingles vaccine shot. Additional supportive information: The follow-up would not possible as no contact details were available.
10 days following the second dosage of the Pfizer vaccine, patient developed Bell's Palsy. While we are unsure if it was related to the vaccine, we wanted to report the condition in hopes of helping others  in the future.
My left arm is swollen, red, itchy and warm to the touch. There is a small amount of pain also
Heavy Menstrual Bleeding; Has not had her Period since 2018,Within hours after the first shot she had her Period; Muscle spasms; Sore Left Arm; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy Menstrual Bleeding), MENSTRUAL DISORDER (Has not had her Period since 2018,Within hours after the first shot she had her Period), MUSCLE SPASMS (Muscle spasms) and PAIN IN EXTREMITY (Sore Left Arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy Menstrual Bleeding), MENSTRUAL DISORDER (Has not had her Period since 2018,Within hours after the first shot she had her Period), MUSCLE SPASMS (Muscle spasms) and PAIN IN EXTREMITY (Sore Left Arm). On 18-Apr-2021, HEAVY MENSTRUAL BLEEDING (Heavy Menstrual Bleeding), MENSTRUAL DISORDER (Has not had her Period since 2018,Within hours after the first shot she had her Period), MUSCLE SPASMS (Muscle spasms) and PAIN IN EXTREMITY (Sore Left Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided Treatment information was not provided Patient stated that she didn't have a period since 2018   This case was linked to MOD-2021-163948 (Patient Link).
7/29/2022- Presents to ED, c/o weakness and cough. Afebrile, BP210/88 and RR-29. Covid + test. CXR:bibasilar linear atelectasis. Ordered remdesivir. AKI, creatnine 1.4, stop Lasix. Admit for CHF exacerbation in setting of Covid.  8/1/2022. Continue remdesivir, Creatnine down to 1.1 . VSS afebrile. No 02 use,  8/12/2022- NA level down to 123, rectal temp 94. CT head negative. Bear hugger. Ordered IV cefepime and Vacno for Septicemia.  8/15/2022- AKI resolved, VSS. Continue cefepime and vanco.  8/17/2022-D/C to SNF, 7 dasy of cefdinir and doxycycline. VSS.
Case number PHEH2016US029329, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 57 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml intramuscularly on 01 Nov 2016 following temperature excursion at 52 Fahrenheit for 1 hour on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34 Fahrenheit and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2 Fahrenheit three times over the course of 12 hours. Vaccine had been administered. It was unknown if the vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
Pt c/o dizziness with hot & cold flashes at about 1015.  Trtmt: BENADRYL 50 mg PO 3/4 hr. after injection. 6/6/08-records received for ER visit DOS 5/19/08-Assessment:allergic reaction. C/O dizzy, felt hot and cold flashes. Weak all over. One of several children from same school.
9/24/19-redness, swelling and itching at site of flu vaccine  9/26/19-The size of the red skin has increased by 1.5 fingers approx. It?s bigger in the bottom part. The top it is still intact. Same place mark. Patient says it hurts and that it?s uncomfortable.  She is scratching/ touching it.  9/26/19-blotchy pink 3 inch irregular rash at site of immunization  deltoid region.  Slight  induration right at site of shot-rest is soft and there is no tenderness and moving arm freely.
From initial information received on 26/Oct/2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 31-year-old female patient inadvertently received a 0.1 ml dose of TD ADS adult, lot number U0922AA, administered intra-dermally in the forearm on 24/Oct/2003. Two days later, the patient developed redness, induration and discoloration at the injection site. The patient's recovery status is currently unknown.
Pt states that after receiving 5th Anthrax vaccine within 24 hour he started experiencing muscle twitching in the whole left arm. The pt states that the twitching lasted about 10 minutes on 5 different occasions.
one side of his face was paralyzed/ had bell's palsy; A spontaneous report was received from a consumer concerning an 85-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and one side of his face was paralyzed (Bell's palsy).   The patient's medical history as not reported. Concomitant use was not reported.   On 08-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 11-Feb -2021, three days after receiving vaccine, one side of his face was paralyzed. They called the nurse line and was unsure if he was having a stroke. They were instructed that he needed to go the emergency room and to call 911. After several hours in emergency department, the healthcare professionals said he had Bell's Palsy. He was given antiviral medication, prednisone, and eye drops as a treatment.   Action taken with mrna-1273 in response to the event was not reported.    The outcome of event was not reported.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, and excluding any other etiology, a causal relationship with the event cannot be excluded.
BURNING SENSATION; ARM PAIN; This spontaneous report received from a consumer concerned a 63 year old male. 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: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced burning sensation. On 04-MAY-2021, the subject experienced arm pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain, and burning sensation. This report was non-serious.
Patient got 0.5mL of Moderna (batch/lot# 012H21B) as a second dose of the vaccine. Patient should have gotten a 0.25mL booster.
fever  of 101.9 within 9 hours of vaccine administration requiring a visit to an emergency room
Pt rec'd 2nd Anthrax shot on Thursday 11/14/02. Pt stated she felt dizzy after receiving shot. The next day on Friday woke up with body aches and headaches with slight fever. Pt did attend work on Friday. Then pt laid in bed all day, Saturday and Sunday and then went to hospital Sunday evening at 09:30 PM. Doctor at ER stated for her to file VAERS report since she had not eaten in the alley.  2 symptoms could be side effect of Anthrax shot. Doctor told pt she could receive next shot. Pt given Donnatol at ER. Pt is on quarters for 48 hours. Pt's symptoms include stomach cramp, diarrhea, dizziness, fever + pt states she had no eaten since Thursday. Fluids were given at ER. No physical side effects such as redness swelling at injection site of shot.
Patient received vaccine from an outside source  I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 4/25/2021 GERD (GASTROESOPHAGEAL REFLUX DISEASE) I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/25/2021 GERD (GASTROESOPHAGEAL REFLUX DISEASE) J96.00 ACUTE RESPIRATORY FAILURE 4/25/2021 GERD (GASTROESOPHAGEAL REFLUX DISEASE)
Swelling on arm 3 inch in diameter, with fever to skin, itchy, welt , red and almost purple at injection sight. has gotten larger as time has passed.
Per parent pt became covered in large 1/2 dollar sized red rash all over body approximately 2-3 hours after vaccine administration. No fever. ? itching, less by following morning. Resolved completely by day 2. No treatment.
Red irritation around injection site about a week after the shot. Hot and sensitive to touch and a little itchy. Irritation intensified over the next few days.
A few minutes after receiving the immunizations, he developed generalized flushing, left abdominal pain with paresthesias and a sense that something bad was happening. No dyspnea. Gave epi and transferred to Urgent Care. Referring to Allergy.
Pt began noticing swellling @ inject site lt deltoid w/in 48 hrs p/vax; swelling has not subsided & pt c/o h/a x 2 days, pain lt shoulder radiating into back; noted erythema 60mm w/induration & 30 mm center w/induration; hot to touch;
hives onset the next morning with itching; treated today with steroids/zyrtec/pepci