chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red; Swollen; Itchy; Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red), SWELLING (Swollen), PRURITUS (Itchy), CHILLS (Chills) and PYREXIA (Fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). On 20-Feb-2021, the patient experienced ERYTHEMA (Red), SWELLING (Swollen) and PRURITUS (Itchy). At the time of the report, ERYTHEMA (Red), SWELLING (Swollen), PRURITUS (Itchy), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Reporter contact details were updated.
Unknown amount of vaccine leaked out side of syringe due to a faulty syringe (needle not secure on barrel in manufacturing process), and unknown amount into patient. Will have to read minister vaccine.
The pt experienced an erythematous slightly indurated area measuring 9" x 6 1/2".
Narrative:  78 yo male male died at home in home hospice on 10/5/2021. Pt has been enrolled in hospice care due to HF and declining renal function. Pt had received covid vaccines on 3/11/2021 & 2/10/2021. This death is not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
TIRED; ITCHY; SCRATCH; TIGHTNESS IN CHEST; RASH; FATIGUE; BODY ACHES; This spontaneous report received from a patient concerned a female of unspecified age.The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk, expiry: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  On 21-MAR-2021, the subject experienced body aches. On 21-MAR-2021, the subject experienced fatigue. On 22-MAR-2021, the subject experienced itchy. On 22-MAR-2021, the subject experienced scratch. On 22-MAR-2021, the subject experienced tightness in chest. On 22-MAR-2021, the subject experienced rash. On an unspecified date, the subject experienced tired. Treatment medications (dates unspecified) included: fexofenadine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fatigue, had not recovered from rash, itchy, and scratch, and the outcome of tightness in chest and tired was not reported. This report was non-serious.
0930 vaccine, and at 1030am (1 hour after vaccine injection) pt experienced red, hot rash from left deltoid injection site up to her neck.  Pt states that she took Benadryl at 1230 and  this rash and redness is now resolved.
slept unbelievably long period of time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EL1283) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "cancer survivor Cancer in 2021", start date: 2021 (unspecified if ongoing), notes: Comments: cancer survivor Cancer in 2021. The patient's concomitant medications were not reported. The following information was reported: HYPERSOMNIA (non-serious) with onset 26Feb2021, outcome "unknown", described as "slept unbelievably long period of time". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient took first shot in Mar2021. At that point, had unbelievable sleep reaction. Did not have any other problems, other than she slept unbelievably long period of time. Went ahead and reported that to Pfizer. On 26Feb2021 when that first reaction happened. Most people have reaction to second and she had reaction to first.
Patient had a very restless night. He awoke at 4am with fever (checked by ear thermometer) of 102. I gave Tylenol. Swollen leg, unable to walk on leg until Sunday. Finally stopped limping on Monday.
Patient received vaccine at 10:39am. Vaccine administration was routine, nothing noted. Patient returned to waiting area for observation. Approximately 1049am, patient started making retching sound. Vomited in small trash can in waiting area. I went out to the waiting area to check on the patient. She stated that she got very sweaty and then vomited but feels better after vomiting. She denies any shortness of breath/trouble breathing or any other symptom. I asked if she wanted a cup of water or ice pack. She requested water and a new mask and denied an ice pack. The patient states she could have had a panic attack.  I requested that she continue to stay for observation.  I checked in with the patient at 1059am and she stated she felt better.  I requested again to stay for additional observation.  At 1110am I asked the patient again how she was feeling. She stated she was feeling better. Over 30 minutes passed since vaccination, patient denied SOB or other symptoms. At 1110am, pt left waiting area.
Information has been received from a health professional concerning a 55 year old male pt with multiple medical conditions, cardiac problems and a history of multiple pneumonias. The most recent case of pneumonia occurred in March 2002 and the pt was treated with azithromycin. The WBC was normal. On approximately 04/05/2002 the pt was vaccinated at 15:00 with a first dose of pneumococcal vaccine. On approximately 04/08/2002, approximately 3hrs post vaccination the pt developed sweats, fever, chills, total body joint aches, "redness" and injection site hive "that was the size of a first." He presented to the ER and the ER personnel "called it cellulitis." The pt may have been treated with Keflex. He was hospitalized for two days. The attending physician felt that the pt had not developed cellulitis. The pt's sweats, and fever (resolving within 36hrs) resolved the same night that they first occurred. The pt's joint pain resolved within 24 hrs, and redness resolved within 48 hrs. By day 2 or 3, the size of the hive at the injection site reduced to half it's former size. The pt was discharged from the hospital at that time. The recovery status for the chills was not specified. Additional info has been requested.
pt recv vax; 4-5 days p/ vax, exp ha, malaise, night sweats and fatigue; sx continue
cold; This is a spontaneous report from a contactable consumer (reported for herself). A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On inbound call, patient stated she was taking her Pfizer second vaccine on Sunday and she had cold, asked if she would be able to take the second vaccine. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Felt a ball to the throat. B/P 155/88, HR 87, O2Sat 98%, T 97. 12:42pm Patient left Park stating that he feels better.
given nasal flu vaccine - had nose pain, felling of needing to sneeze, later medial face discomfort left greater than right, no runny nose, no cough, some headache bilat temples and some throat clearing.  Exam 10/6 reveals erythema and edema of nasal mucosa left > right.  treated with nasal steroid spray
Information has been received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown dates, between 02-AUG-2015 and 31-AUG-2015, the patients were vaccinated with GARDASIL (dose, strength and route were not provided) that was improperly stored. Co-suspect or concomitant therapies were not reported. No adverse effects were reported. The lot number reported for GARDASIL were: L012190 with expiration date on 13-APR-2017, K006960 with expiration date on 19-FEB-2017 and K023432 with expiration date on 18-JUN-2016. Follow up information has been received from the certified medical assistant on 06-OCT-2015. It was reported that, two doses of improperly stored GARDASIL, were administered to two patients. This case was concerning a 11 year old patient of unknown gender. On 19-AUG-2015, the patient was vaccinated with a dose of GARDASIL (lot # L012190, expiry date: 13-APR-2017) (dose, strength and route were not provided) which experienced 46.9 degrees Fahrenheit for 20 minutes before administered. The patient was safe with the vaccines given. This is one of several reports from the same source. Additional information. Patient's information, therapy information and narrative were updated.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and in May2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (01Aug2022) Positive, notes: I tested again and was positive on August 01 2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Adverse event: Started process on 21Jul2022 completed process 5 days later wore a mask for 5 days. Day 6 after completing Paxlovid patient started having the same symptoms headache sore congestion achy body so he tested again and was positive on 01Aug2022. The patient did not received any other medications within 2 weeks prior to vaccination and the patient did not have any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial and follow-up information has been received from a nurse practitioner concerning a 19 year old female with no pertinent medical history who on 09-JAN-2007 was vaccinated in the hip area with a first dose of Gardasil.  On an unspecified date the patient was vaccinated in the hip area with a second dose of Gardasil.  On approximately 12-JUL-2007 the patient was vaccinated intramuscularly in the arm with 0.5 ml third dose of Gardasil (658094/0524U).  There were no concomitant medication.  On approximately 12-JUL-2007 the patient developed, "tenderness and swelling that formed a hard knot at the injection site".  On 10-AUG-2007 the nurse reported that that patient still had the "knot" in her arm, swelling, and pain.  The patient had been on steroids but there was still no improvement.  There were no laboratory or diagnostic tests performed.  At the time of the report the patient had recovered.  Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose Number: 2, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose Number: 3 (Booster), Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Clinical course: COVID 19 Treatment (brand: Paxlovid), Treatment start date: 26May2022 and stop date: 31May2022. The patient received other medication in 2weeks. The patient had no known allergies. The patient experienced on 03Jun2022. She tested negative for two days after completing paxlovid treatment. However, on day 3 She had sore throat, tiredness and headache and sob with cough. She tested positive again on home rapid antigen test. She had paxlovid rebound infection. The outcome of event was not recovered. The patient was not received treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Shot on 9/10. Tired 9/11 and 12-migraine-aches and pains. ER on 9/14-shots. ER on 9/16-I.V.-ER on 9/21-I.V.
The patient called to say that her arm has been very sore after receiving her flu vaccine yesterday. She said she barely slept last night due to the pain, and that it hurt too badly to lift her arm today.
Myalgia, Angina, Chest pressure, feeling flushed and body aches  Narrative:
She got her vaccine, that same night after sleeping she woke up and had full body aches, headaches and similar to when you have the flu.   Anybody that touched her lightly felt like a punch/pain.  Headaches, feverish.  Her eyes felt like they were swollen and felt hot and watery.  She took some Tylenol for the body aches.  She called her doctor who told her to take the same thing that she was already taking.   She felt horrible for the first 24 hours and the next day it wasn't as bad, and then by the third day she was feeling back to the same as she did the first day and called off of work.   She had respiratory issues, her doctor gave her steroids and was on breathing treatments for 3 weeks.  She felt as if she was not getting enough air into her lungs which is why she was on the steroids.   The vaccine gave her brain fog as well, and is still off work due to the forgetfulness and the brain fog.    She was very emotional and crying a lot.  Bout of crying and feeling like overwhelmed easily.  Not being herself, and taking her a long time to do simple tasks that she was able to do without problems before.    Pharmacy told her to not take the 2nd vaccine.  Her doctor also told her not to get it.    When she first started with the brain fog she was stuttering, could not finish her sentences or choose the right words while she was speaking.
Administration error: parent presented requesting Moderna for dose #2, forgetting they had originally gotten Pfizer for dose #1.
Started with normal side effects; fatigue, fever, achy. Progressed to severe headache and hives on most of body. These lasted for several days improvement on 2/30/21
Approx 45 minutes post vaccination Pt reported "funny" taste" in mouth, itching at injection site, generalized itching, tongue swelling, chest tightness. Treated in the Emergency dept with Benadryl, Solu-Medrol. Sent home on decreasing doses of steroids.
Right sides axillary lymphadenopathy; This is a spontaneous report received from a contactable reporter (other healthcare professional). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in right arm, administration date 26Nov2021 at 21:00 (Batch/Lot number: UNKNOWN) at the age of 34 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 28Nov2021 at 09:00, outcome "unknown", described as "Right sides axillary lymphadenopathy". Therapeutic measures were not taken as a result of lymphadenopathy.   Additional Information: The patient had no known allergies. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Narrative: Patient is 87 yo male with a past medical history of aortic stenosis s/p TAVR, CAD s/p stent to RCA 2014, Afib, HTN, and neurocognitive disorder who presented to Emergency Department on 8/9/2021 for worsening SOB in setting of COVID infection. Patient recently evaluated in ED 5 days prior for "not feeling up to par" and "fatigue" and found to be COVID positive despite being fully vaccinated with COVID Pfizer vaccine. At that time he refused monoclonal antibody treatment and was discharged home with no medications for COVID. On 8/9/2021, at the 2nd ER visit, the patient was hypoxic requiring 2L O2 and Afib RVR with rates in 140s. Patient also with new hypotension with BP 86/63. Patient initially admitted to floor and started treatment for COVID PNA with antibiotics, steroids and remdesivir. Transferred to the ICU 8/11/21 for afib with RVR. Heart rate was difficult to control with rate control medications, so after discussions with family decision made to start on amiodarone and heparin infusions. He reverted to NSR after starting amiodarone but continued to require supplemental O2. He was intermittently agitated and required dexmedetomidine infusion. Patient's mental status did not improve during admission. He remained confused, eventually unable to communicate with staff or family, and stopped eating. Palliative care consulted and family made decision to transition to comfort care. On the evening of 8/21, patient had no respirations with asystole on telemetry monitor. Exam with no chest rise, no heart sounds and no carotid pulse after 1 min. Pupils fixed and dilated. Time of death 21:58.
Left arm with several inch diameter; itchy erythematous, indurated area at site of TDaP and MENACTRA vaccines. BENADRYL and icepack helped. Improved within a day or two.
Patient reports a "couple hours" after receiving vaccination she noted that her whole right arm hurt. Patient reports that she did not sleep well that night due to the pain. Patient reports next day she notice that her arm was swollen from injection sight to elbow, it was also red and warm to the touch.  Patient reports as the day went on the pain lessened and is now gone. Patient called clinic today 1/5/17 to notify of reaction. Pain is now gone, swelling and redness have started to fade.
Fatigue; Headache; Myalgia; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 753RM, expiry date 3rd December 2021) and (batch number 7RK7K, expiry date 26th November 2021) for prophylaxis.   On 12th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. In November 2019, less than a week after receiving Shingrix, the patient experienced fatigue, headache and myalgia. On an unknown date, the outcome of the fatigue, headache and myalgia were unknown.   It was unknown if the reporter considered the fatigue, headache and myalgia to be related to Shingrix.  Additional details were provided as follows: The healthcare professional (HCP) stated any information on 2nd dose reactions, would they be worst than the 1st dose a patient experienced of typical side effects of headache, fatigue and myalgia from 1st dose. The pharmacist asked any information on 2nd dose reactions of Shingrix. The adverse event (AE) collected. The reporter did not consent to follow-up.
Case received from a healthcare professional in the USA on 26-OCT-2005 via the MIS/VIS under the reference number 05-0576. A 46-year-old female with a medical history not reported had received a dose of FLUZONE, batch number U1762AA in the left deltoid on 17-OCT-2005 and 1 day later, i.e. on 18-OCT-2005, she developed a red, swollen arm, swollen lymph nodes, painful neck and low grade fever. The patient did not present with any illness at time of vaccination and received her last dose of influenza vaccine in 2003. Her symptoms were not resolved at the time of the report. The patient required a doctor visit. Further details were requested. Follow-up information received on 13-FEB-2006. Per the reporter, there is no additional information at this time. Additional information is not expected.
Left arm cold-internally, blurry vision, upset stomach/ nausea, pain under right arm into pectoral muscles. Pt had not eaten at all and at 1:15 reported these developments. Instructed to eat something and lie down.
105 temp for 4 days.  Rash all over the body, sore legs to touch, extreme screaming for 2 days.  Foul odor from mouth, lazy eye (on left eye).
sz started w/in 2-3 days of vax; no high fever; many sz per day (6-14) started Phenobarbitol w/in 1 wk; inc dosage p/3 wks but no improvement; unable to track object visually p/sz; had strabismus; vision problems dx cerebral palsy;
Flushed hot cheeks; dizziness; eye discomfort; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Apr2021 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication included bcp (MANUFACTURER UNKNOWN) from unknown date for an unknown indication. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 the patient experienced flushed hot cheeks, dizziness, and eye discomfort. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the events flushed hot cheeks, dizziness, and eye discomfort were recovered on unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient experienced sweating/chills, followed by increased shaking and agitation overnight. Overnight he experienced excessively high blood pressure (230/110+) eventually requiring heart surgery and stent placement.