chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PRODUCT TEMPERATURE EXCURSION ISSUE; POOR QUALITY PRODUCT ADMINISTERED; This spontaneous report received from a pharmacist concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-MAY-2021, the subject experienced product temperature excursion issue. On 17-MAY-2021, the subject experienced poor quality product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product temperature excursion issue and poor quality product administered was not reported. This report was non-serious.
Itching, redness, swelling at site. 12 hours later whole arm was red itchy and hot.  Took about 5Benadryl all day long.  Lasted about 18 hours .
1222 : C/O HEART RACING, FEELING LIGHTHEADED. P 120 INITIALLY. COLOR OK. BP 180/90, P 96. MOVED TO EXAM ROOM SO PT COULD LIE DOWN. HUSBAND PRESENT. 1227 : BP 172/90, P 88 OXY SAT 98%, RR 16. 1232 : 160/90, P 92, R16. STARTING TO FEEL A LITTLE BETTER. C/O SLIGHT HEADACHE. OFFERED WATER. TOLERATING WATER. NO PROBLEMS SWALLOWING. NO OTHER COMPLAINTS. 1238 : 168/90, P 88 RR, 16.  1245 : 158/88, P 75, RR 16. STATES THIS IS CLOSER TO WHAT HER BLOOD PRESSURE HAS BEEN RUNNING LATELY. FEELING MUCH BETTER. 1251 : BP 140/82, P 80, RR 16, OXY SAT 96%. LEFT WITH HUSBAND.
had an episode of the evening p/vax given witnessed only by mom; describes that pt was crying & then began shaking all over; lost breath turned blue lasting 1-2 mins;  had sz;
L ARM REDNESS; ITCHING; ACHE; CIRCULAR ERYTHEMA APRX 4 CM; LOCALIZED INFLAMMATION; PT ADVISED TO RETURN TO CLINIC TO GO TO ER IF CONDITION WORSENS.
This spontaneous case reported by a consumer, describes the occurrence of urticaria (he had hives and was miserable) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031B21A) for COVID-19 immunization. No medical history reported. On Apr 22, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced urticaria (he had hives and was miserable). The patient treated with Benadryl (diphenhydramine hydrochloride), at an unspecified dose and frequency and Sarna (camphor/menthol), at an unspecified dose and frequency. At the time of the report, urticaria (he had hives and was miserable) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication information provided.
I began itching about 45 mins after the shot, mostly my nose.  Then different areas of my body would itch and when I would scratch it, raised white bumps would appear in a a patch.  While the itching started fairly early, the raised bumpy patch did not appear until 7:30 pm .  The itching and raised bumps have continued off and on for over 2 weeks.
Sore throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 05-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Dec-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). 26-Dec-2021, the patient experienced HEADACHE (Headache). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: negative (Negative) negative.         No concomitant medication information provided. No treatment information provided
pt recvd vax 13MAY94 & 22MAY94 pt devel vomiting, fever, & itchy rash on neck; rash worsened & pt was seen in ER; No further details were provided;
6th day p/vax was given pt had a high temp of 104 & 105 the following day; On the 8th day, MD adm pt to hosp p/noting fullness in soft spot; test insignificant; illness attributed to viral infect;
Initial report received on 16 December 2009 from a health care professional. An 11 year old female patient developed a headache and hives after receiving H1N1 2009 monovalent vaccine-preservative
Information has been received from a physician concerning an adult patient who in 2004 was vaccinated with a first dose of VARIVAX (Merck) (lot # not reported). In 2005 the patient received second dose of VARIVAX (Merck) (lot # not reported). "A recent" varicella titer was "not adequate". It was unknown if the patient sought medical attention. At the time on the report on 28-APR-2010 the patient had not recovered from varicella titer "not adequate". Additional information has been requested.
The patient was found on 2/27/15 unresponsive and was resuscitated; admitted to ICU and remains unresponsive on ventilator with a diagnosis of respiratory failure. CT head/neck/chest are all negative. He initially had thrombocytopenia but now stable. Current CXR with BLL infiltrate and hx fever 101.2. Report received from consulting ID MD questions if r/t adenovirus vaccine.
Wooziness; Lightheadedness; Lightheadedness occurs more when has reading glasses on; Feels "off" when exerting energy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Wooziness), DIZZINESS (Lightheadedness), DIZZINESS (Lightheadedness occurs more when has reading glasses on) and FEELING ABNORMAL (Feels "off" when exerting energy) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced DIZZINESS (Wooziness), DIZZINESS (Lightheadedness), DIZZINESS (Lightheadedness occurs more when has reading glasses on) and FEELING ABNORMAL (Feels "off" when exerting energy). At the time of the report, DIZZINESS (Wooziness), DIZZINESS (Lightheadedness), DIZZINESS (Lightheadedness occurs more when has reading glasses on) and FEELING ABNORMAL (Feels "off" when exerting energy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt broke out in chicken pox rash 5/31/2000, symptomatic treatment.
This spontaneous report was received from a registered nurse referring to an unknown number of patients of unknown age and gender. There was no information about the patient's pertinent medical history, drug reactions or allergies and concurrent conditions provided. On unknown dates, (starting on or after 09-FEB-2017), the patients were vaccinated with improperly stored doses of VARIVAX (dose and route of administration were not reported) lot # M034583, expiration date: 27-JUL-2018 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT), MRK INJ, lot # M.020945, expiration date: 05-DEC-2018, which was reported as properly stored diluent used to reconstitute improperly stored doses of VARIVAX. The temperature for the VARIVAX stored was 15 to 46 degree Fahrenheit with 2 hours time frame. There was no previous temperature excursion reported. Data logger was involved. No adverse effect was reported. Lot # M020945 has been verified to be a valid lot number for sterile diluent and not valid for varicella virus vaccine live (oka/merck). Additional information has been requested.
severe headache not helped with tylenol or ibuprofen. Continued from 9/18-9/28/09
This is a spontaneous report from a contactable medical assistant reporting on behalf of a physician. The medical assistant reported similar events for 2 patients. This is the 1st of 2 reports. A 68-year-old female patient received PREVNAR 13, via an unspecified route of administration, on 08May2017, at 0.5 ml single, for immunisation. Medical history included ongoing hypertension, ongoing hyperlipidaemia, ongoing vitamin d deficiency, ongoing glucose tolerance impaired. Concomitant medication included ongoing CLARITIN, ongoing ZETIA, ongoing calcium, ongoing ZOCOR, ongoing acetylsalicylic acid, ongoing hydrochlorothiazide (HCTZ), ongoing TOPROL, ongoing ibuprofen, ongoing DENAVIR. The patient experienced burning when the medication went in on 08May2017 with outcome of unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017207885 Same reporter/drug/event, different patient.
He started to have itching/rash 2 days after the vaccine and it has been spreading since.
A report was received from a consumer on 12Jan04 concerning a 19 month old male vaccinee who received Fluvirin on 11Dec03. On 11Dec03, the vaccinee received 0.5ml Fluvirin. The vaccinee did not complain of any adverse reaction. Follow up pending.
Report 2001004923-1 describes joint stiffness in a 55 year old male who received Lyme disease vaccine (Lymerix). The patient received his first injection of Lymerix on 11/19/99. He received his second injection of Lymerix on 12/20/99. "Within a few months" of receiving these injections, he began to experience soreness and stiffness in both wrists and the right elbow. He received no treatment for the soreness and stiffness. The stiffness and soreness persisted. The patient received his third injection of Lymerix on 11/17/00. As of 02/05/01, the soreness and stiffness in his wrists and right elbow persisted. The patient stated, "It has continued and seems chronic". The vaccine provider submitted this report directly to VAERS. The adverse event of joint stiffness and joint soreness do not meet ICH serious criteria, but is be submitted as an expedited report by special FDA the 06/28/00 letter.
Pt recvd 3 Hep B vax doses given 1AUG89, 5SEP89, & 22JAN90; 14MAR90 titer=16; 19FEB91 titer was neg; Pt was given a 4th dose of Engerix-B vax on 16APR91; p/4th dose titer=93;
Patient fainted after receiving Pfizer vaccine. Approximately 2-3 min after administration. Patient woke up after 30 seconds and was placed in upright seated position. I then measured the patients blood pressure which was 82/55. Patient was then given salty chips in order to bring blood pressure back up to a normal level. After 5 minutes I re-assessed the patients blood  pressure and it went up to 91/72. Patient was feeling better. I spoke to the patients mother and she stated that the patient routinely faints after receiving any vaccines in the past. I informed the patients mother to seek medical help if her daughter faints again or feels unwell when she gets home.
Pain and swelling (L) arm beginning approx 2 hrs post vaccination. Pain radiating to clavicle area 2-25-16. Warm to touch - 2-25-16. Nausea - beginning 2-24-16 and continuing 2-25-16. Ice applied. TYLENOL and BENADRYL on 2-24-16 and 2-25-16.
Swollen, hard, painful lymph node  on left side of neck. Left clavicle painful to touch and swollen. No redness at site or other symptoms noted.
IRRITABLE; CONFRONTATIONAL; AGGRESSIVE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAR-2021, the subject experienced irritablity. On 28-MAR-2021, the subject experienced confrontational. On 28-MAR-2021, the subject experienced aggression. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the irritablity, confrontational and aggression was not reported. This report was non-serious.
Patient contacted the pharmacy one day after injection (1/12/19) and reported she had headache, chills, shakes, and flu-like symptoms following vaccination. Patient has not returned pharmacy call to complete follow up on outcome.
Patient said she started getting rapid heart rate and rapid breathing about 1 hour after recieving the shots.  She continued to experience these symptoms for several days before ending up in the hospital to be diagnosed with Atrial Fibrillation.  The doctors at the hospital did not think it was due to the vaccines, but she wanted us to report it anyway.  This was the first time she ever had a reaction to any vaccine.
Bursitis secondary to vaccine administration high on shoulder- pain in axilla and anterior joint, decreased active ROM of shoulder.  Symptoms started a few hours after the shot.
The left arm was extremely sore for 2 days. I was fatigued the day after the shot. A week after, I had a red rash and a 2 inch bump where the vaccine was injected on my arm. It felt itchy, swollen and a bit of dull pain.
Site: Pain at Injection Site-Medium, Systemic: blurred vision-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: pt states that she experienced blurred vision 40 minutes after her 1st dose and it lastes for 10 minutes. she stes that she could not see anything in front of her and had to sit and wait it out. later on that day she experienced it again and it has been re-occuring everyu day since. she will follow up with her doctor today 11/29/21. she states that she did not have any prtoblems with her vision and did not have to wear corrective glasses, but now she has to wear readers(2.0)
Mom noticed rash on (R) arm 1 day after shot given. Rash is red and swollen. Only "hurts"when touched.
p/1 series, reports inc temp, szs, limpness;no szs since-developmentally delayed now
The Hep A vaccine was administered on 3/5/08.  On 3/6/08 my child appeared tired, irritable and was less hungry than usual.  On 3/7/08, he awoke at 6am with a fever of 103 and still had a loss of appetite.  I called the doctor's office as I read the CDC reactions listed on the vaccine sheet given by the doctor, noting that high fever and behavior changes were listed. The nurse said,"It's probably just a virus- if it was a reaction it would probably be a low-grade fever.  Give Tylenol or Motrin if he's uncomfortable and since it is a high fever."  Tylenol was given to lower his temp. and to alleviate his suspected body aches as he said, "My legs aren't working right" when walking up the stairs.  He was given a dose of Ibuprofen at 8pm on 3/7/08.   He had a temp. of 102.7 the next morning on 3/8/08, so Tylenol was given.  He still had a loss of appetite but was more active at times; he had been inactive and more tired the previous days. On 3/8/08 he took a four hour nap when it is usually only about 2 hours long. That night he couldn't fall asleep at his usual 8pm bedtime, he was given a dose of Tylenol as he had a temp. of about 101, and he was awake until 11:30pm. On 3/9/08 he didn't feel feverish, he was more hungry and increasingly more active though he still didn't seem to be back to normal. He was pale (except when the fever was high) and quite irritable at times throughout the course of these symptoms.  His behavior seemed different- though when healthy he is prone to occasional tantrums, his upsets during this time seemed to involve more irrational demands.  It was noticed by others as well that he would occasionally appear "blank", but only for short periods of time. As of the morning of 3/10/08, my child seems to be feeling much better both physically and mentally.
Urinary Tract Infection - fever, chills, difficult urination Antibiotics for one week
Pt had syncopal episode after given Gardasil and then influenza (TIV) vaccines. Pt felt lightheaded and then passed out, briefly lost consciousness and hit forehead on wall but caught by father.  Pt quickly regained consciousness and AOx3, no complaints of headache but vomited food x 2 right after.  Pt sat down, drank water. BP 90/51, HR 59.  Nl neuro exam, lungs clear, CV: RRR.  Pt observed for an hour after incident and felt better and no further dizziness.  Gait observed and stable and walked out with father.
Partial, momentary blurry vision (no more than 1 min) on left eye. Blinking subdued the effect. I afterwards recovered from the event.
2 vaccine on February 27. April 27 I had a heart attack then followed by thyroid cancer.
Aft pt. received injections she walked to check out and started feeling lightheaded and nauseous.  Pt was put in a wheelchair & taken to an examine room where pt then had seizure like activity.  Pt had no postictal activity.  Pt was alert, oriented & able to give info to call her mother.  Pt was evaluated by Dr.  911 was called - pt was taken by ambulance to hospital.  Dx: vasovagal syncope.
Pt drinking milk & began choking head tipped back eyes rolled back,sucking noises w/mouth & tongue gurgling sounds from milk from bottle& mucus. Unresponsive,color pink lower extrem cool to touch,barefoot,lasted 2 min.;Responded-sleep-to ER
Pain in her arm; Very hot; Cold one day; Bump on her arm the size of a orange; Bump on the arm the size of a cantaloupe; Hardness in her arm; Muscle pain; Joint pain; Redness in her arm; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her arm), HOT FLUSH (Very hot), NASOPHARYNGITIS (Cold one day), PERIPHERAL SWELLING (Bump on her arm the size of a orange) and MASS EXCISION (Bump on the arm the size of a cantaloupe) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arm), HOT FLUSH (Very hot), NASOPHARYNGITIS (Cold one day), PERIPHERAL SWELLING (Bump on her arm the size of a orange), MASS EXCISION (Bump on the arm the size of a cantaloupe), VACCINATION SITE INDURATION (Hardness in her arm), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), ERYTHEMA (Redness in her arm), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Pain in her arm), HOT FLUSH (Very hot), NASOPHARYNGITIS (Cold one day), PERIPHERAL SWELLING (Bump on her arm the size of a orange), MASS EXCISION (Bump on the arm the size of a cantaloupe), VACCINATION SITE INDURATION (Hardness in her arm), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), ERYTHEMA (Redness in her arm), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Allergy medicine. Treatment medication antibiotics   This case was linked to US-MODERNATX, INC.-MOD-2021-071210, US-MODERNATX, INC.-MOD-2021-086105 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071210:Daughter AE's US-MODERNATX, INC.-MOD-2021-086105:crosslinked
During the night of 15 around 2 still couldn't sleep, having difficulty breathing. Felt tightening around chest tried taking 1 Flexural thought it was muscle issue did nothing tried sitting in chair still couldn't catch breath well told my husband at 6 need to go to ER left shoulder had pain so as a nurse felt I needed to go. Once ER room hooked me up took 4 different doses of nitro to relieve pain did bloodwork and enzymes were normal. I couldn't do stress test on Sunday, so was hospitalized for one day. On Monday had to do stress test and it was fine. At that time no pain but I had problems still catching my breath and was wheezy for a couple of months.
This spontaneous report was received from the medical assistant refers to a 4 year old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to the patient included DILUENT MRK INJ used to reconstitute the (Oka-Merck) PROQUAD was properly stored. On 11-JUN-2018, the patient was vaccinated with improperly stored doses of (Oka-Merck) PROQUAD recombinant Human albumin (rHA) (lot number R001541, expiration date 15-JUL-2019), subcutaneously. The doses of (Oka-Merck) PROQUAD were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1806USA001756.
The patient started feeling ill on 5-20-18. She described a fever, malaise for the day after. Today she has a rash covering the majority of her torso. Her arm is hot. (She is an amputee and only has one.) She states she can see a pencil size red dot about an inch below the injection site. She stated that she begin taking BENADRYL 50mg. After her description, I recommended her seeking medical attention via the emergency room for probable allergic reaction to some component of the SHINGRIX.
Muscle pain in both legs, joint pain in both legs, chills, tight chest (used my inhaler 2x with 2 shots each time (albuterol sulfate, 90mcg)) Took first dose of 2 Ibuprofen (200mg each) at 1am then second dose of 2 Ibuprofen (200mg each) at 5am. All symptoms subsided accept for the chest tightness by 730 am on 2/3/2021. Chest tightness is fine and not of concern currently and treated with inhaler.
Patient received vaccine and was observed for 15 minutes. She received Pfixer EW0185 at 8:32 She left the covid center and was in car and stated that she felt a little SOB and that her left gland felt swollen.  This was 8:55. Took her back to the observation center  9:05 Allegra  9:15 Vitals 180/102  HR 99 Pulse ox 100% resp 20 Gave Allegra at 9am- vis- 150/94 HR 85 Pulse ox 100% Resp 20  Feeling a little better She did let me know that she met with her private allergist this past Thursday 7/15/21 and he told her she could have vaccine.  They also did more testing to foods, environment and medication- results are not all in as of yet 9:30  153/93  HR 75 98% Resp 18 States feeling better - gland not as swollen 9:50- 155/91 states her blood pressure meds were stopped about 6 months ago and she has noticed that it has been going up.  Told her to consult her PCP She is feeling better.  Instructed to take Allegra at home that her allergist prescribed if needed.  Go to ER if she gets SOB or other symptoms get worst.  She will also notify her allergist. Was taken to bathroom by nurse and left with her husband.  Feeling much better.
A vein in my arm ruptured. I went to urgent care the next day because I could raise my right arm without pain. The inside of my arm was black and blue and it was hot to touch. Given antibiotics in case of blood infection. Told was thrombophlebitis.  Arm took weeks to heal. Swelling and bruising spread from my elbow to my arm pit.
Right arm tender, red and swollen at the site of injection, patient stated it looked like an allergic reaction.
per Mom, after the injection, 20 minutes later, he started to become lethargic and was in and out consciousness for about 20 minutes. The parents rushed him to the ER.