chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician assistant via a company representative refers to a handful of patients of unknown ages and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (lot#, expiration date and route not reported). On an unknown date the patients experienced developed shingles. The physician assistant was not able to confirm the exact number or identities of the patients involved. It was unspecified whether laboratory diagnostic studies were performed for the event. The patients sought unspecified medical attention. The outcome of the event was unknown. Causality was not reported. Additional information is not expected.
Patient received two immunizations on same arm.  Patient complained of redness and swelling of injection site; patient experienced  fever, chills and tiredness , but these symptoms have subsided.
Headache, Myalgia, Arthralgia, NauseaVomiting, pain, redness, wollen left arm and swollen glands, sore throat, fatigue Narrative:
11mar2021 - fatigue was immediate 3-4 several weeks I had flare and double vision constant and stomach issues.  Doctor - 21May201. Increased my methotrexate - 4 pills now 6  & mestinone 60 milligram twice a day . Groin pain which was crystals in mid May201 and this has never happened before.
Fever started 6.25h after injection and quickly rose to at least 103.2 by 9.75h after injection; patient subsequently tool acetaminophen 650mg and went to bed. Temperature at 08:00 4/7/21 (20h after injection) remained 101.4 and persisted.  Grade 3 fever was accompanied by significant chills but no over rigors. Also, mild (grade 0-1) (L) deltoid pain only with contraction began approx 22 hrs after injection.
Within 24 hours of immunization, 4-5 episodes of lower lip quivering and blank stare. Episodes lasted 20 seconds. No fever.
About  15 hours after getting booster shot began having high fever 102, chills, sweats, mild nausea, tachycardia and body aches.  Also unable to sleep even before severe symptoms started, despite feeling tired. Quite significant as I had not had  anything to this level with 1st or 2nd COVID  vaccines. I am a health care worker in a hospital. My second COVID  vaccine was 1/11/2021. Only injection site pain, fatigue and sleep problem with second dose. It is now 24 hours later. I took acetaminophen to try to break the fever. Feeling a bit better?no more fever but do have body aches,  mild dehydration (tachycardia), dizziness and fatigue.
I was feverish, foggy, and had chills at time. I went to the Dr. for my regular Dr. checkup in April for my thyroid and the nodule in my thyroid changed in appearance.
Few minutes after vaccine, pt stated dizzy, lightheaded, blurred vision and was pale - placed cool rag on patients neck and monitored blood pressure. pt began felling better after a few minutes.  BP/HR reading #1 90/68BP 84 HR 2:44pm #2 111/78BP 85 HR 2:52pm #3 112/76 BP 83 HR 3:00 Offered to call 911 for EMTs to check patient out, Pt stated felt better after staying for total of approx 30 minutes and left with spouse. Called pt several hours later and pt stated felt fine and no more adverse effects.
This spontaneous report as received from a Licensed Practical Nurse refers to a couple of patient of unknown age and gender, who approximately in January 2014, reported as about a month ago, were unable to received doses of ROTATEQ vial due to ROTATEQ with "particular matters" - it was reported that ROTATEQ had particulates inside, no information on lot# number, expiry date. No adverse effect reported. Additional information has been requested.
Patient is 12 years of age and was given the first dose of the Moderna vaccine which is not yet approved for persons under the age of 18 yrs.
Angioedema of right tongue prompting ICU admission. Treated with high dose steroids, Benadryl, epinephrine, FFP, TXA, Pepcid, and protonix with symptom resolution within 24 hours and discharge to home
Pink rash 3" x 2.5" around injection site appeared ~48 hours after injection.  Hot around injection site ~48 hours after.  Muscle pain on touch after two days (reducing since injection)
Fever, chills, headaches, body aches for two days after injection. Headaches returning 10 days afterwards leading to tinnitus and vertigo. 10 weeks later, nonstop tinnitus, headaches and dizziness.
Around 8:00 pm on 12/23/2020, I began to experience headache, fatigue, soreness at injection of site, and nausea. Over the next hour, the headache and nausea intensified dramatically, and at around 9:00 pm, I vomited.
Patient had acute erythema and induration occur at injection site. Area was 6.5cm in diameter at 48 hrs. also she developed systemic body aches.
Patient states bruising (about quarter-size with varying shades of dark purple) on 10/19/2016 around injection site (right deltoid) and numbness in right wrist/forearm on 10/22/2016. RN recommended she make an appointment with primary care provider to obtain follow-up.
Information has been received from a physician concerning a 12 month old white female patient with no known drug allergies who on 10/13/2004 at 10:00AM was vaccinated was vaccinated with a first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, in the arm.  There was no concomitant medication or illness at the time of vaccination.  On 10/13/2004 at 10:05AM the patient inconsolable crying with local rash over site of injection which lasted 30-45 minutes.  The patient's experience was also described as cried uncontrollably for 30 minutes, and developed a red swelling and rash around injection site.  There was observation but no treatment.  It was reported that the patient calmed down and was doing well.  The patient recovered on 10/13/2004.  It was reported that the office manager said that this must be a bad batch of MMR and should be removed.  The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory.  The lot complies with the standards of the center for biologics evaluation and research and was released.  It was also reported that another patient had an adverse event.  No additional information is expected.
Information has been received from a physician concerning a female pt who on 6/16/06 was vaccinated with a dose of MMR II/Varicella vaccine (lot 652678/1135R). Subsequently, on 6/28/06, the pt developed a breakthrough case of chicken pox. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
After receiving second shot (6/7/21),  in October I began noticing an immune response that has being going on until now and still is. Lymph nodes swollen, running nose, fatigue, joint and muscle pain.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 23rd May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported an adverse event via click to chat. The age at vaccination was not reported. The age at vaccination was not applicable for 2nd dose report. The healthcare professional reported, the patient that received SHINGRIX vaccine then contracted shingles at the end of July. The patient was now due for her 2nd dose of SHINGRIX. Till the date of this report, the patient had not received the 2nd dose of SHINGRIX, which led to incomplete course of vaccination. The reporter wanted to know whether the 2nd dose was advisable to be given when the patient had shingles 4 months ago. Later, chat disconnected. It was unable to clarify if healthcare professional would like follow up.  When asked for patient and product identifiers, the healthcare professional stated, that he was not working on the day of reporting. Would be working on following day and could furnish that information. The patient wanted to know if she could receive her 2nd vaccination.
The patient developed an urticarial rash on her face, trunk and extremities and shortness of breath. The patient was treated with Benadryl.
Consumer answered "Yes" when asked if they had received the Moderna COVID-19 and experienced a side effect; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Consumer answered "Yes" when asked if they had received the Moderna COVID-19 and experienced a side effect) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (Consumer answered "Yes" when asked if they had received the Moderna COVID-19 and experienced a side effect). At the time of the report, UNEVALUABLE EVENT (Consumer answered "Yes" when if they had received the Moderna COVID-19 and experienced a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
pt had sz of 5 mins duration 8 days pst vax; pt had been well & asymptomatic prior to sx; pt had not had any fever or other sx since recvd vax; pt evaluated for sz in ER: according to mom ER MD felt sz was post-react to vax;
Drowsy; Flu like symptoms; Warm body; Fatigue; Body Aches; Headache on the Right Side of Head, Headache in the mid section of Head; Mild Sore Injection Site (After 2nd dose); Mild Numbness on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (Mild Numbness on the Injection Site), SOMNOLENCE (Drowsy), INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING HOT (Warm body) and FATIGUE (Fatigue) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PARAESTHESIA (Mild Numbness on the Injection Site) and VACCINATION SITE PAIN (Mild Sore Injection Site (After 2nd dose)). On 31-Mar-2021, the patient experienced SOMNOLENCE (Drowsy), INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING HOT (Warm body), FATIGUE (Fatigue), MYALGIA (Body Aches) and HEADACHE (Headache on the Right Side of Head, Headache in the mid section of Head). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 31-Mar-2021, VACCINATION SITE PARAESTHESIA (Mild Numbness on the Injection Site) and VACCINATION SITE PAIN (Mild Sore Injection Site (After 2nd dose)) had resolved. At the time of the report, SOMNOLENCE (Drowsy), INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING HOT (Warm body), FATIGUE (Fatigue), MYALGIA (Body Aches) and HEADACHE (Headache on the Right Side of Head, Headache in the mid section of Head) outcome was unknown.            Concomitant medications were not provided.
Right calf pain 5 minutes after administration of Pfizer vaccine, found to have a right lower extremity DVT after ER workup
pt states about 5 minutes after vax her arm was sore and her heart was racing, then she got light headed feeling like she was going to pass out.  Her BP was 180/100 and heart rate was in the thirties.  Pt was then transported to the ER by the staff that administered vax.  Pt had EKG and blood work.  Pt was given IV fluid sand released from ER after everything returned to normal.
Fever; nausea; fatigue for 24 hours; headache (week); This is a spontaneous report from a contactable consumer, the patient. A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm Right on 15Feb2021 11:00 (at the age of 46-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm left on 18Jan2021 10:30 (at the age of 46-years-old) as a single dose for covid-19 immunization. The patient had allergies with codeine. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Feb2021 18:00, the patient experienced fever, nausea, fatigue for 24 hours, headache (week). The patient did not receive any treatment. Outcome of the event was recovered, at the time of this report.  Information about lot/batch number have been requested. Follow-up attempts completed. No further information expected.
In the spring of 2000, the  pt experienced left arm pain, which was considered to be non-cardiac in origin. In approximately 4/00, the pt began to experience episodes of intermittent chest pain and dyspnea sometimes with dizziness. The pt was diagnosed with non-cardiac chest pain, clinically insignificant coronary artery disease, and normal left ventricular wall motion. Two-three weeks following the catheterization, the pt had two or three episodes of syncope. A holter monitor was placed on 8/3/00. Analysis of the recording revealed rare supraventricular events scattered throughout the study. The pt was to see a Lyme disease specialist in 8/00. As of 1/31/01 the outcome of these events was unknown.
The patient states bruising & swelling started Wednesday, July 18, 2018. She came back into pharmacy Thursday, July 19th, with a bruise about the size of a baseball at suspected injected site & swelling with redness slightly below bruise. I recommended patient to be seen by family physician. Pt was seen Thursday,  July 19th. She diagnosed her with possible cellulitis secondary to vaccination. Dr's office recommended pt to use ice & take TYLENOL. They also gave pt a script for KEFLEX to start taking if it does not improve over weekend.
Lymph node swelling left side of neck. +2 left anterior cervical node that is tender to palpation, no induration or heat. Patient also had a positive PPD. Referred to the health department for a chest x-ray to insure the positive node is not from TB infection. Patient is asymptomatic.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An 82-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "dementia" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; ASPIRINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient received Paxlovid orally from 17Aug2022 to 22Aug2022 for COVID 19 Treatment. Patient experienced acute kidney injury on 22Aug2022, after 5 day course of Paxlovid, Scr = 3.0 on presentation to hospital, treatment included treatment: IV fluids and bicarb, patient was resolving as of 24Aug2022 (AER 202201089918).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist referring to a 19 year old male patient. The patient had no pertinent medical history as well as no drug reactions or allergies. On an unknown date, as a child, the patient was vaccinated with 2 doses of MMR II (anatomical route of vaccination, lot number and expiration date were not provided). The patient was not taking any concomitant medication. On an unknown date, the patient's titers for measles, mumps and rubella were drawn, as he will be entering college this fall and the results came back low (measles antibody negative, rubella antibody negative and mumps antibody test negative). Furthermore, no treatment was provided for the adverse event and no product quality issue was involved. At the time of the report, the outcome of measles antibody negative, rubella antibody negative and mumps antibody test negative was unknown. Additionally, the reporter did not provide for a causality between the adverse events and vaccination with MMR II. Additional information has been requested.
After the patient got the first dose of covid shot, patient started to feel light headed and sweating.  Patient also stated that he started can't see thing or heard thing. But after he drink some water and sitting down waiting for ambulant he was feeling ok. EMT came and checked him out and he was ok
First, hives across breasts and headache (same day as shot). Next day I had fever, chills, nausea, headache, extreme tiredness, total body aching, pain at injection site, my  lips swelled and went numb, I was in and out of awake state and was rushed back to hospital. Given benedryl and pepcid in IV form and monitored. Took 2 doses of benedryl after I was home until symptoms cleared up. Could not get vaccine info details from hospital when I called 7/30/19; they said they were too busy.
Severe pain at HSV2 outbreak site on posterior leg.  Blister started following morning. Recurrent outbreak never painful in past. Pain persisted for 4 weeks at site and on other leg.  Ischial tuberosity and hamstrings. Some intermittent pain remains.  42 days from start
Severe sore throat, chills, cough, severe mucus, aches, headache, fatigue 11/4/2017 for about a week. Milder symptoms about 1/20/2018 for about a week: main complaint is severe sore throat for about a week. Been ill again starting 3/7/2018 and continue to be ill today: main complaint is bad cough.
a bit of cough; The caller got her first dose on 18Mar2021 and then on the 19Mar2021 she was diagnosed with covid; This is a spontaneous report from a Pfizer-sponsored program. A 50-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6208; Expiry Date: Unknown), via an unspecified route of administration at left arm on 18Mar2021 as single dose for COVID-19 immunization. Patient's medical history and concomitant medication were not reported. The patient stated that her first dose of the vaccine on 18Mar2021 and tested positive for covid and wanted to know if it's okay to take second dose of the covid vaccine. The patient got her first dose on 18Mar2021 and then on the 19Mar2021 she was diagnosed with covid. The patient still had a bit of a cough and her second dose was supposed to be on Friday 09Apr2021.The patient's covid symptoms started on 19Mar2021. Product complaint was reported. The patient underwent lab test and procedure which included COVID-19 virus test was positive. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Pt recv vax on 3/30/98; on the same day pt exp welts&itchiness from shoulder, upper trunk&upper extremities.Pt tx=Benadryl every 6 hrs prn-alleviated welts.
I felt tired and run down after shot.  two weeks later, on 5/4, a friend died and I could feel myself slipping into depression biochemical, but that day I started having all the covid symptoms except for the fever.  I CAN NOT BREATHE.  It feels like a contact panic attack.  Smothering, pressure.  Its way worse when I lay down.  Insane muscle aches, especially on left side. diarrhea, loss of smell, loss of taste and want for food, insomnia, insane tiredness - up for 1 hour, sleep for 4.  some cough - feel need to cough.
Failure per Pfizer / covid test result=Positive; Failure per Pfizer / covid test result=Positive; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 15:45 (Lot number: Fd7218) at the age of 49 years as dose 3 (booster), single, administered in arm left, administration date 16Apr2021 15:45 (Lot number: Ep6955) at the age of 48 years as dose 2, single and administered in arm left, administration date 26Mar2021 16:00 (Lot number: Ep6955) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Steroids Allergy" (unspecified if ongoing), notes: Steroids. The patient's concomitant medications were not reported. No other vaccine was administered in four-weeks. Past drug history included: Aspirin, reaction(s): "Allergy". The following information was reported: IMMUNISATION (medically significant) with onset 16Dec2021 15:45, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021 12:30, outcome "not recovered" and all described as "Failure per Pfizer / covid test result=Positive". The event "failure per pfizer / covid test result=positive" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: covid test type post vaccination=Nasal Swab, covid test name post vaccination=Binax.
Approx 1 1/2 inch by 1 1/2 inch erythematous warm, tender lesion to (R) arm at injection site.