chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Vaccine Breakthrough Case  Moderna Dose 1 4/1/21 (lot not listed in database) Moderna Dose 2 4/29/21 (lot not listed in database) COVID Positive 8/27/21  8/27/21: Patient is a 93 year old male who presented to ED with his daughter with complaints of shortness of breath. Patient lives at home with his disabled son, his daughter checks on him daily. She visited him today and found him in bed vomiting. She checked his pulse ox and stated she was unable to get him above 80%. He does not wear supplemental oxygen at baseline. He has a past medical history significant for coronary artery disease status post stenting, severe aortic stenosis, congestive heart failure, hypertension, paroxysmal atrial fibrillation not on anticoagulation, hyperlipidemia, abdominal aortic aneurysm, history of MI history, history of prostate cancer, anemia, chronic hematuria, cognitive impairment, former tobacco user and chronic pain. On Tuesday of this week the patient did sustain a fall while home alone, daughter is unsure how the fall occurred or if the patient hit his head. He was seen by his PCP, on Wednesday. Outpatient CT head was ordered but has not been done yet. He does have bruising to his left elbow. There was also some suspicion for aspiration pneumonia and patient started on Levaquin x7 days.  On arrival to ER patient was febrile 101.6 and hypoxic on room air at 82%.  3 L nasal cannula was applied with improvement oxygenation saturations to 96%.  Laboratory findings were significant for CKD G3a creatinine 1.39. ProBNP 2899. Troponin 0.05.  Pancytopenia WBC 3.85 and RBC 3.63.  Thrombocytopenia platelets 109. Urinalysis showed large hematuria.  Chest x-ray was unremarkable.  Vancomycin and Zosyn were initiated in ED.  IV fluid hydration was given with NS 0.9% 500 mL bolus.  Patient was seen and examined in ED with his daughter at bedside. Patient states he feels better with oxygen on and is less nauseated. Denies chest pain. Has not been eating and drinking normally. Has had generalized weakness. Daughter feels his confusion has progressively worsened, was going to f/u with neurology on outpatient basis. He does have CHF but is only taking his lasix prn. Endorses constipation. On opioids for chronic pain related to an accident several years ago. No recent fevers. Pt has been fully Covid-19 vaccinated.  9/7/21: Patient is a 93-year-old male presented on 08/27/2020 chief complaint of shortness of breath.  His symptoms were initially thought to be secondary to aspiration pneumonia.  However, he tested positive for COVID-19.  He was treated for both with steroids, antibiotics, and vitamins.  Patient spent several days in the hospital pending placement as it was difficult to find a skilled nursing facility that would take him with his COVID-19 positive status.  On 09/07/2021, he was deemed COVID recovered and was discharged to a residential facility.  Of note, the patient was requiring O2 at 2 liters/minute via nasal cannula to adequate saturations at time of discharge.  He also had elevated blood pressures in the hospital and will need follow-up for hypertension management.
Symptoms started within 0ne minute s/p vaccine- started numbness tongue/throat/ mouth, the palms, feet, lower legs and developed intense severe burning in center of chest. no improvement after 45- left .  Call PMD  from home told to take Benadryl.  -told to get medical attention if not improvement. Went  to  urgent  care a couple hours later because no improvement.- told to go back to hospital.  Went to hospital waited 7 hours to be seen. They did ECG and blood work and neuro checks- discharged told to follow up with PMD.  Burning and numb kept intensifying  and had right groin pain (last a couple hours), tourniquet feeling in spine and head, difficulty walking. saw PMD next day given Lexpro- no improvement. Symptoms continued to intensify and she went Hospital 9/30/21 - Provider said he seen this reaction from the vaccine and gave her Normal saline, Solumedrol, CT head, ECG and blood work. Discharge home with prednisone.  symptoms decreased  by a good amount.  Better but still having numbness in feet, lower leg , spine, ,back of head, biceps and hands since vaccine.
About 3 inches below injection site, a red spot in a rectangular shape approximately two inches long with the feeling of a knot below the skin
I  got extremely hot with sweating, I got a massive headache that started at the base of my neck that effected my vision. I was dizzy, BP was high over 140, temperature increased. I had some tingling in my upper extremeties. I had really bad GI pains, I had itching and a light rash.  I had to go to the ED  where I received a cocktail.
Started with symptoms sale day after receiving vaccine: fever max 102, vomiting, congestion, HA, fatigue. Was on Abx. for OM at time of appt. Seen for the above symptoms on day 5 of illness.
Patient reported to pharmacy next day with redness around the injection site approximately 3 inches in diameter. Told patient to monitor the area and if it got any larger or no  improvement to seek medical attention. Patient was seen that evening at after hours care where the site had spread to the whole upper arm with itching, swelling and redness. Prescriber treated pt for possible cellulitis and allergic reaction with antibiotic and steroid dose pack.
Cellulitis developed > 1 week from injection. Patient given course of BACTRIM DS x 7 days.
Emesis one hr /p injection then pain lt side of face, shoulder & back pain on lt neck flexion.
Patient experienced soreness, swelling, redness, and itching along with a rash surrounding the injection site. The rash is still visible 6 days after administration.
palms are red and swollen; palms are red and swollen; she woke up at 1am because she could not stop scratching her hands; rash inside of her elbows and knees/ patches of rash everywhere; not just a rash but hives in her scalp, head, ears, earlobes, armpits and bellow and underneath; rash/ hives terribly itchy; lips swollen and look like she had Botox but she does not do that; pain in the muscle where she got the shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (not just a rash but hives in her scalp, head, ears, earlobes, armpits and bellow and underneath), PRURITUS (rash/ hives terribly itchy), LIP SWELLING (lips swollen and look like she had Botox but she does not do that), ERYTHEMA (palms are red and swollen) and SWELLING (palms are red and swollen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, DULOXETINE, NORTRIPTYLINE and VITAMINS NOS for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced MYALGIA (pain in the muscle where she got the shot). On 16-Feb-2021, the patient experienced URTICARIA (not just a rash but hives in her scalp, head, ears, earlobes, armpits and bellow and underneath), PRURITUS (rash/ hives terribly itchy) and LIP SWELLING (lips swollen and look like she had Botox but she does not do that). On 17-Feb-2021, the patient experienced ERYTHEMA (palms are red and swollen), SWELLING (palms are red and swollen), PRURITUS (she woke up at 1am because she could not stop scratching her hands) and RASH (rash inside of her elbows and knees/ patches of rash everywhere). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. On 12-Feb-2021, MYALGIA (pain in the muscle where she got the shot) had resolved. At the time of the report, URTICARIA (not just a rash but hives in her scalp, head, ears, earlobes, armpits and bellow and underneath), PRURITUS (rash/ hives terribly itchy), LIP SWELLING (lips swollen and look like she had Botox but she does not do that), ERYTHEMA (palms are red and swollen), SWELLING (palms are red and swollen), PRURITUS (she woke up at 1am because she could not stop scratching her hands) and RASH (rash inside of her elbows and knees/ patches of rash everywhere) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Patient vaccinated on 2/11/21 and then tested positive for COVID-19 on 8/30/21
Vial administered was stored outside recommended temperature. First puncture was 6/23/21 @ 250p
I had a sore arm for about a day. In 12/2022, I developed a cyst on my right side of my neck. It became abscessed and I had it drained in 02/2023. As of today, it has healed.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, site of administration and lot number not reported). On an unknown date, a year after the vaccination, the patient developed a mild case of shingles. The outcome of the event was unknown. The relationship between the event and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Arthralgia, Rash, UrticariaPruritus, red and swollen site, itchiness and stiffness Narrative: sore and swelling to L arm site on day 1 and day 2 of vaccine; 1 week after noted redness, swelling more than previously, itchiness to  injection site, headache and stiffness to L shoulder
Shakiness, nausea,  extreme fatigue starting 4/20.  chills, fever 101+ sweats added 2/25.
Patient reports having arm pain/soreness when reaching up or putting her coat on, or when laying on that arm in bed.  She states that is started within a few days to within a week of receiving the immunization. She has been taking Extra Strength Tylenol to help with the pain.
The following day while driving I blacked out for a second then had several severe sets of dizziness then a major headache that did not go away for days. Then I had a less painful headache but pressure in the ears that lasted 3 months. I thought maybe I had a mini stroke. I did not know it was the vaccine till I had the next vaccine PREVNAR 13 in 2018. Pressure in the ears and headaches started the next morning. I have been dealing with the head issues since then. I have been to the hopital, Ear, nose and throat doctor, neurologist and regular doctor. Each several times with no relief.
Tingling fingers (both hands), tingling toes (both feet), tingling back & outside of both legs, tingling top of thighs both legs. Also Burning fingers, burning top of both feet  Also Wrist weakness. Also Shooting pain in legs. Occasional pressure both ears. Trouble walking and lifting things Severity varies day by day.
Fever, headache, nausea and brain fog. Suppressed energy, mood and stamina. Depression. I am a cyclist and before this vaccine I was extremely healthy. After my second shot the above listed symptoms were magnified 10 fold plus muscular burning and aching. I missed 6 days of work and to this day I am suffering a huge drop in energy, mood and stamina. I feel foolish for taking this vaccine. Shame on you all.
Soreness; headaches; muscle aches; chills; Fatigue; fever; Hot flashes; This spontaneous case was reported by a patient and describes the occurrence of HOT FLUSH (Hot flashes), PAIN (Soreness), HEADACHE (headaches), MYALGIA (muscle aches) and CHILLS (chills) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 18-May-2021, the patient experienced HOT FLUSH (Hot flashes), HEADACHE (headaches), MYALGIA (muscle aches), CHILLS (chills), FATIGUE (Fatigue) and PYREXIA (fever). On an unknown date, the patient experienced PAIN (Soreness). At the time of the report, HOT FLUSH (Hot flashes), PAIN (Soreness), HEADACHE (headaches), MYALGIA (muscle aches), CHILLS (chills) and FATIGUE (Fatigue) outcome was unknown.            No relevant concomitant medication and treatment information was provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.    This case was linked to MOD-2021-162062 (Patient Link).
Information has been received from an MA concerning a non-smoking female pt with no allergies and a history of cataract surgery and hysterectomy who on 3/9/00 was vaccinated with pneumococcal vaccine 23 polyvalent. Shortly following vaccination, the pt's arm, where she received the injection, swelled and turned red. On 3/10/00, the pt presented to a walk-in clinic. The pt was not admitted to the hospital but was evaluated at the walk-in clinic and treated with Rocephin and instructed to take Benadryl. That night, the pt took 1 dose of Benadryl and on the following morning, she presented to the clinic again because her arm was worse. A WBC count was normal. The pt was referred to the ER for evaluation. A physical exam showed an afebrile, well developed, well nourished female and all review of systems were negative except for a redness of the left upper arm down almost to the elbow. There was no induration or tenderness and the area was slightly warm to touch. The medical records indicated that the impression was an: "allergic reaction to pneumococcal vaccine 23 polyvalent." The pt was prescribed prednisone 40mg per day for 4 days, 20mg per day for 4 days and 10mg per day for 4 days. She was advised to follow-up with the walk-in clinic or her physician within 2 to 8 days. On 4/2/01, the MA noted that the pt was "fine". It was also noted that the pt had never received pneumococcal vaccine 23 polyvalent before. Upon internal review, it was determined that the pt's allergic reaction was an "Other Important Medical Event". Additional information is not expected. The reporter also provided information regarding the experience of the pt's husband, following the same vaccine vaccination; (see WAES 01031442).
Early period Feb,  Early and extremely light period March, late by a week period April ( multiple negative pregnancy tests)
Information has been received from a RN concerning 5 yr old female twin with asthma who on 26Jul99 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. The RN reported that the pt SC developed about 10-20 varicella lesions. The lesions were reported to be all different, some were crusted, some were vesicular and some looked like bug bites. Unspecified medical attention was sought. The pt was noted to be afebrile. The pt also developed a cough, but the physician thought it was due to her asthma. The pt was treated with pain medicine (unspecified) and an unspecified asthma medication. No product quality complaint involved. The physician also reported that the pt's twin sister also developed varicella after being vaccinated with varicella virus vaccine live (WAES0406USA01530). Additional information has been requested.
Pain in right arm, under arm, elbow, upper back; Pain in right arm, under arm, elbow, upper back; Pain in right arm, under arm, elbow, upper back; Pain in right arm, under arm, elbow, upper back; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: 9266) via an unspecified route of administration in the left arm on 23Feb2021 at 10:30 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported.  The patient had known allergies to some blood pressure medicines. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified blood pressure medication from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: 1686) via an unspecified route of administration in the left arm on 02Feb2021 at 11:00, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021, the patient experienced pain in right arm, under arm, elbow and upper back. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with chiropractor. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in right arm, under arm, elbow and upper back was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Instant hive reaction post vaccine administration. Pt given 4.5 ml oral diphenhydramine.
This case was reported by a nurse via call representative and described the occurrence of redness in a 4-year-old female patient who received KINRIX (batch number 3425B, expiry date 17th April 2018). Concomitant products included MMRV. On 2nd December 2016, the patient received KINRIX (intramuscular) 0.5 ml. In December 2016, less than a week after receiving KINRIX, the patient experienced redness and swelling arm. On an unknown date, the outcome of the redness and swelling arm were unknown. The reporter considered the redness and swelling arm to be probably related to KINRIX. Additional details were provided as follows: This case was previously reported to health department. At 11.45 hours, the patient received a dose of KINRIX on her right arm. On the same day, the patient concomitantly received MMRV (non-GSK) vaccine on her left arm. The batch number reported for MMRV was M026879 with expiry date as 27th November 2017. The patient's parent had called the physician's office over the weekend before reporting date to report that the patient had a red and swollen right arm. The physician was also notified about this situation. Further details were unable to obtain. The reporter's call was transferred to Medical Information (MI). The reporter also reported similar adverse events for 4 other children (see cases US2016180181, US2016180183, US2016180270 and US2016180271) that received the same lot of KINRIX vaccine.
there are millions of needles in her eye and her left eye is almost completely swollen; left ear feels like there is stinging in it; Shingles; This spontaneous report was received from a 68 years old female pt. The pt was vaccinated with zoster vaccine live (ZOSTAVAX) one dose injection on 28-AUG-2012. Lo t# and route were unspecified. Concomitant medication included lisinopril.  On 02-SEP-2012 the pt experienced shingles. On 04-SEP-2012, the pt developed a rash all over the left side of her face. On 05-SEP-2012, the reactions became much worse. The patient said it felt like "there were millions of needles in her eye" and her left eye was almost completely swollen. In addition, her "left ear felt like there was stinging in it". On 06-SEP-2012, the patient went to her physician and was prescribed medications. They were: acyclovir, gabapentin, and hydrocodon acetaminophen 7.5-325m. The patient still had shingles and was not recovered yet. No lab diagnostic study was performed.    Follow up information has been received from a lawyer on 21-OCT-2019, referring to the female pt, around August 2012 (also reported as "28-AUG-2012") was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route of vaccination, lot # and expiration date were not provided) for its intended purpose: the prevention of shingles. Shortly after being vaccinated with zoster vaccine live (ZOSTAVAX) the pt suffered shingles. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Furthermore, the pt had suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages. At the time of the report, the outcome of herpes zoster was considered to be not recovered. The lawyer considered Herpes Zoster to be related to vaccination with zoster vaccine live (ZOSTAVAX).
At 0720, patient received her vaccine. She reported shortly after that she was not feeling too well. She was asked to lie down on the bed, help was called and her vitals were taken. Her vitals were as follows: HR 97 BP 156/93 and SPO 100%. While her vitals were taken, she was asked to describe how she felt. Her vitals were taken again at 0730: HR 110 BP 165/110 and SPO 100%. Help came and another set of vitals were taken at 0735: HR 101 BP 152/86 and SPO 100%. Patient was transferred to ED
Flu vaccines intended for ID, intradermal use and those 18-64y.o., administered to those greater than 65 y.o., without consideration of ID versus IM.
10-23-08 Employee called center to report she had a swollen left arm which she had received a flu shot in on 10/20/08.  Employee stated left arm was red & swollen and she was unable to lift arm.  Also neck was sore.  Employee advised to seek medical attention.
BPV Vertigo on both sides, Dizzy spells, spinning, Vomiting, Nausea loss of balance, Nystagmus dehydration
Pt 18w2d.  Headache x3 days - located on right sided of forehead and wraps around to ear. Described as pulsating, throbbing and pressure. Unrelieved by Tylenol. Vertigo and dizziness.   Fever, Nausea and vomiting. Facial rash.
Client was given Pentacel instead of ActHIB and when the error was discovered, manager was notified and parents were contacted.
Pt fainted after giving flu shot while sitting but did not fall. BP reading was 130/90 & HR was 80- we called emergency services, they checked his BP & vital signs & seemed to be OK & took him to hospital.
Pt. had a second Monovalent vaccine administered on the same day that the CDC decided that Monovalent vaccines were no longer authorized. I was contacted by the local vaccine department and advised that we needed to file a VAERS report as this is being considered a vaccine administration error.
pt recvd vax & had headache; chills; fever; arm swollen; hot to touch; ached in arm;  tx w/APAP q 4 hrs til sx subsided;
This case was reported by a consumer via call center representative and described the occurrence of generalized muscle aches in a 54-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included Shingrix with an associated reaction of myalgia (received 1st dose on an unspecified date for tolerance see case US2018GSK162339). On 27th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced generalized muscle aches, influenza-like symptoms, fatigue, injection site pain and shivering. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the generalized muscle aches, influenza-like symptoms, fatigue, injection site pain and shivering were unchanged. It was unknown if the reporter considered the generalized muscle aches, influenza-like symptoms, fatigue, injection site pain and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient received the SHINGRIX vaccine before the day of reporting. The patient was experiencing muscle ache all over the body, pain at the injection site, shivering, fatigue, and flu like symptoms. The patient gave permission to contact her health care provider. No further details were provided.