chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in with her mother who had experienced a reaction to the vaccine when she got her first shot. Her Nurse advised her to wait 30 minutes in case she also had a reaction. Patient received her vaccine around 8:45 and around 9:15 the patient told the Nurse that she was experiencing itching all over. The nurse called the Pharmacist, and she advised to give her the injectable antihistamine. The patients vitals were checked several times and they were normal. The only reaction the patient was experiencing was itching and feeling hot. At first, the patient did not want to get the antihistamine shot because it would make her drowsy but her mom advised her to since she started having redness/bumps on the arm that she received the shot in. Patient was given the shot around 9:30 and asked to stay longer for further observation. Around 9:45 the patient complained of having blurred vision and dizziness. The Nurse suspected that it was from the antihistamine shot and we had the patient lie down. The patients vitals were checked again and they were normal. Patient left with her mother around 10:00. We advised her not to return to work while drowsy. The Nurse documented the reaction in patients chart.
Patient did not report any adverse event on that FLUVIRIN was administered instead of FLUARIX.
Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Two days after Tdap administration, the patient contacted our nurse advise line with the following complaints:  "Has a bubble that has formed over her clavicle near her throat that is growing.  The site is sore and sensitive to touch.  Arm is sore and hard to move.  Body aches, headaches.  Welt is 4 inches long."  Nurse documented a reported fever up to 100.5 degrees and that bubble/lump is a few inches away from the injection site of Tdap.  Patient instructed to go to ED or urgent care. Patient was seen by physician on 4/1/23.  That visit documented vitals as BP 128/86, HR 108, Temp 36.9C, RR=18, Wt=215 pounds, SpO2=97%, BMI=37.49.  Physical Exam = slight redness on left side of lower neck laterally at the upper chest.  No abscess; left upper arm pain redness warmth to touch where Tdap administered.  No red streaking, no drainage.  Medication Decision Making = Reaction to Tdap immunization with possible secondary cellulitis of the left upper arm and left side of neck.  Treatment = patient received one dose of Ceftriaxone 1gm injectable IM in clinic, and a prescription for clindamycin 300mg capsules, 1 capsule by mouth 3 times daily for 7 days.   Follow-up visit with PCP on 4/4/23 documented improvement in systemic symptoms and redness, but persistent lymphadenopathy.  Sent for imaging. Ultrasound from 4/18/23 showed "mildly morphologically abnormal features including hypoechoic foci projecting within the hilar nodal component.  Heterogenous lymph node.  Most likely reactive but Radiology recommending repeat imaging in 6-8 weeks. Patient called 4/18/23.  Provided noted that supraclavicular nodes remain enlarged and tender.  Profound fatigue.  Will send patient to hematology for consult.  Now suspecting not cellulitis, but a reactive lymph node following immunization.
11/08/2006 evening area around injection sites became blotchy, red, raised, (hives like about size of dime) covered left upper arm 2.3 of way toward elbow, inner and outer aspect of upper arm left. Benadryl 25 mg PO Q 6 hours. 11/13/06 per mom resolved except tiny bump size of pencil eraser.
This is a spontaneous report from a Pfizer sponsored Program, by a contactable consumer (patient).  A female patient of an unspecified age, race and ethnicity received PREVNAR 13, via an unspecified route of administration, at single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, two weeks after the vaccination, the patient had skin out breaks on her legs. On an unspecified date, one month after the vaccination, the patient was taken by ambulance to hospital with very low blood pressure and chest X-ray showed pneumonia. Clinical outcome of the events was unknown at time of this report. No follow-up attempts possible. No further information expected. Information about batch/lot number cannot be obtained.
pt recv vax;devel flat,red achy rash over entire body;given antihistamine & sx resolved w/in 1/2 hr;
FOR THREE DAYS FOLLOWING IMMUNIZATION, DONOR EXPERIENCED THE FOLLOWING SYMPTOMS: SORENESS, HEADACHE, DIAPHORESIS, FATIGUE.
First Dose: Fever/Second Dose: Fever; This is a spontaneous report from a contactable consumer or other non-HCP, who reported for her mother.  A female of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as a dose 1, single and the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was Not reported) via an unspecified route of administration on an unspecified date as a dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced first dose: fever/second dose: fever. Caller called to report adverse events for herself and mentioned her mother adverse event below during questions for the supplemental form. The reporter stated her mother had a hard time with the vaccine, she had a fever both times but she did not have the arm thing. Declined to complete a safety report for her mother. The clinical outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Itching developed at day 6. By Day 8, patch of erythema  measuring 3x3 inches.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. In November 2015 (during that time frame of 05-NOV-2015 through 15-NOV-2015), the patients were vaccinated with improperly stored doses of M-M-R II (lot # K016153, expiry date 24-SEP-2016; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
High fever, sore throat, cold symptoms, body aches. Lasting 1+ week.
Diarrhea started in the afternoon the day after the first dose. Bowel movements have been loose continuously and  mild cramping at times. Diet/medications/vitamins have not changed. Tried adding yogurt to diet for good bacteria in the gut. It may helped for the day, but then stools are loose again.
Refractory idiopathic thrombocytopenia purpura requiring multiple hospital admissions and put patient therapy by hematologist.
October 20, 2022 - TIA - weakness on the left side of the body, went to ER, was admitted for 24 hours  November 2, 2022 - TIA - weakness on the left side of the body, went to ER, was admitted for over 24 hours November 7, 2022 - STROKE - weakness on the left side of the body, facial droop, slurred speech, was given tPA  - ICU for 3 days
patient reported that she developed a headache,that radiate to the neck on 02/28/2021 @0200. patient reported that she took tylenol but didnt help. patient reported no allergies.
Case number PHEH2014US025009 is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 34 years old male patient. Past medical history and concomitant medications were not reported. The temperature excursion of FLUVIRIN (batch number: 145701) began around 16 Oct 2014 and the patient received the vaccine intramuscularly at a dose of 0.5 ml on 22 Oct 2014. It was reported that the vaccine administered was at 49 F 12 times over a period of 34 days. There were 12 separate temperatures excursions lasting 30 minutes each in which the temperature was 46 to 49 F during each of those excursions. No adverse events were reported following the maladministration.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 18-JAN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot number M031568, expiration date 24-DEC-2017 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius (C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082.
About an hour after receiving injection he started having a severe headache, nausea, numbness in arms and legs. He was pale, his temperature at 3:00 was 95.1 oral. He began vomiting about 5 hours after injection and continued with the headache throughout the night. We gave him Vitamin C 2000mg, Magnesium and Omega 3 at 8:00pm that night and again at 7:00am on 10/13/17.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about March 2016, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about September 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
upset stomach; fatigue; chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), FATIGUE (fatigue), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX on 04-Dec-2020. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) from 14-Feb-2021 to 14-Feb-2021 for Shingles.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), FATIGUE (fatigue), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), FATIGUE (fatigue), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Follow up received and contains no new information
This spontaneous report as received from a clinical medical assistant refers to an unspecified patients of unknown age and gender. THere was no medical history, drug reaction/allergies and concomitant medication provided. On 20-MAY-2015, the unspecified patients were vaccinated with an improperly stored doses of ROTATEQ (route oral, dose, lot # and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient noted edema extending from injection site right deltoid to right axilla, sore and uncomfortable PM date received.
Got shingles 3 weeks after Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 2-AUG-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The reporter stated that patient got shingles 3 weeks after Shingrix and took antiviral meds helped tremendously. The follow-up would not possible as no contact details were available.
Erythema extending from the site of the injection, developing 2 days after the injection was given.  Felt to be consistent with a cellulitis and treated with antibiotics.
Mild injection site reaction of pain; Mild injection site reaction of pain and redness; This case was reported by a nurse and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hypothyroidism. Concurrent medical conditions included penicillin allergy. Concomitant products included levothyroxine sodium (Synthroid).   On 22nd January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were as follows: It was reported that 51 years female patient recived the shingrix vaccine on 22nd January,2020 in left deltoid, and experienced some reaction at the injection site that is injection site pain and injection site redness both abated 3-4 days post injection. It was reported that patient was using Synthroid 50mcg dose concomitantly. Patient had hyperthyroid in past, and currently she has PCN allergy. This case has been linked with US2020AMR193708 this case. The reporter consented to follow up.  Note: The Synthroid's daily dose of 50mcg was removed from the structured fields to allow the e VAERS PADER report to be ack.
Chest pain, Hypotension, bilateral lower extremeties continuously shaking  Examined at ER, returned to facility 11/8/23
Per PA note (1-11-22) 1) COVID-19 (ICD-10: U07.1) Would like to obtain CXR to rule out possible causes of her chest pain. Consider costochondritis/rib strain from coughing. Consider doing medrol pak for inflammation.   May need to be evaluated in person here or UC if not improving; consider EKG.    Symptomatic therapy suggested: push fluids, rest, gargle warm salt water, use vaporizer or mist prn, use Mucinex, tylenol, ibuprofen prn and apply heat to sinuses prn.  Lack of antibiotic effectiveness discussed with her at this time, consider pending CXR results.   - Email to patient, 1-11/22 from PA  Hi (Privacy),   Your chest xray did not show any infection. I would like to see you in clinic if you are not feeling better so we can listen to your lungs and heart.   If you cannot make an appointment with me and are feeling worse, I would like you to be seen at urgent care or the emergency department.   PA-C
Bells Palsy, facial paralysis on right side of face, 2 weeks after second shot
Face felt numb; Red face; Felt like novocaine; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Face felt numb), ERYTHEMA (Red face) and HYPOAESTHESIA (Felt like novocaine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced HYPOAESTHESIA (Face felt numb), ERYTHEMA (Red face) and HYPOAESTHESIA (Felt like novocaine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at a dose of 2 dosage form. On 29-Mar-2021, ERYTHEMA (Red face) had resolved. At the time of the report, HYPOAESTHESIA (Face felt numb) and HYPOAESTHESIA (Felt like novocaine) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.
reports that her vaccine reaction has not resolved. worsening change in sense of smell, reports phantom nasty smell causing nausea, loss of appetite, is now taking zofran in a routine basis, and being followed by ENT and Nutritionist due to only eating e Narrative: employee states she is seeing pcp, ent, nutritionist, and pcp for her adverse reaction
15 year old patient given a Moderna dose (0.5 cc) instead of a Pfizer dose.
Based on clinical data, reporting predictable reaction of rash (2-3 inches x 1 to 1 1/2 inches) at spot of injection. No other adverse event reported.
Patient died within 12 hours after vaccination. Sudden death without prodrome. Only complaints after administration were soreness at the vaccine site. Autopsy performed and no obvious evidence vaccine played a role. Dilated cardiomyopathy at examination. No evidence of anaphylaxis, or pulmonary emboli.
At the time of the vaccine, I had typical symptoms of fatigue and arm soreness. A few weeks later about mid April, I was getting a hoarse voice. I am a teacher and was attributing to that. The hoarseness became more frequent and my throat became sore and painful and difficult to speak. I have a past history of silent reflux. My sore throat and hoarseness did not improvement and I consulted with a telehealth doctor on 6/26/2021. I was prescribed Pepcid 20mg twice a day. The Pepcid seems to be helping. I am drinking a lot of honey and tea. I do have an appt with ENT on 7/13/2021.
Extreme migraine headache.  Blood pressure spiked very high.  Nausea.
Left side of my face was tingling, felt like bugs were crawling, lasted for about 4 days, the following day it went from my face to the entire right side of my body, it felt like it was numb as if my right side was falling asleep. The days after it went from my right side of the body to my left side and it was really hard to move my left arm in the morning because it was asleep, it took me about 2 hours to get my arm to feel somewhat normal to where I could use it without feeling the tingly feeling. It was very scary
No adverse effect reported; PROQUAD that underwent a temperature excursion were administered to an unspecified number of patients; This spontaneous report as received from a medical assistant refers to a 16-months-old female patient.  Information about medical histories, concurrent conditions and concomitant therapies was unknown.  On 20-NOV-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (one dose, lot # S024054 which is invalid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), expiration date: 01-DEC-2020; route and strength were unknown) that underwent a temperature excursion were administered to the patient for prophylaxis.  Temperature excursion was reported as range -0.52 Celsius degrees(C) for time frame 10 hours and 34 minutes. There was no previous temperature excursion. A digital data logger was involved. No adverse effects were reported.   This is one of the three reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA013604: US-009507513-2005USA009271:
Pt. experienced chills later that night on 7/26/19 (L) arm painful, red and swollen. pt seen in office for reaction given Dexamethasone IM
lt am edematous x 2 size-w/in 24hrs was cool, numb, lost feeling & pain hurt like the devil;tx DPH w/relief-swelling x 72hrs-dec during that time;
Approximately one month after receiving booster shot, started to experience debilitating bilateral Tinnitus which has lasted 24/7, 7days a week. I have had Tinnitus intermittently for approximately 40 years. I have never before experienced such debilitating symptoms until after receiving the COVID 19 booster shot.
Nausea and vomiting started on 7/24 (about 36 hr after vaccine).  Vomiting was relatively severe - 6-8 times during the day and night.  On 7/25, I noticed on my home heart monitor that my heart rate had markedly increased (from my normal ~40 bpm [I?m a runner] to ~130 bpm, and my blood pressure had dropped (from my normal ~120/70 to ~100/50).  On 7/26, I went to a  Urgent Care facility, and an EKG done there showed a distinct pattern of atrial flutter.  I was sent to an emergency room in an ambulance, and was successfully treated by an ablation procedure (on my right atrium) on 7/27.  I went home on 7/28, initiated anti-coagulant treatment with Eliquis,  and have had no further problems.
Adverse event: Mild fever, body aches and fatigue 24 hrs after 2nd dose. Treatment: Ibuprofen and acetaminophen every 4 hrs . Outcome: reduced signs and symptoms.  Adverse event: swollen L lymph nodes for  one week (ended 2/4/2021)Treatment: Ibuprofen every 8-16 hrs . Outcome: reduced signs and symptoms.