chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 05-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Currently 35 weeks pregnant. Have had no known contact with anyone infected with covid and have never tested positive myself. The morning after my vaccine I felt achy with chills and a fever that reached 101 and slightly queasy. I also had uterine cramping and my belly would get hard - similar to Braxton Hicks contractions which I had not had up until that day and have not had since. For treatment, I slept most of the day and drank lots of water. I did not have much of an appetite but was able to eat a little. The following morning I felt much better.
Bleeding sore on roof of mouth  - causing discomfort with swallowing. Started day late afternoon 3rd day post injection.  Bleeding stopped after a few minutes - some minimal blood when irritated post eating. As of today (5th day post injection), soreness in mouth seems to be resolving but discomfor on swallowing persists.
pt feels pain throughout the body;SOB, dry mouth, not able to sleep & when down feel lke was choking;pt has no pain @ the inj site;
One week after my vaccine I felt a lump under my left underarm. I observed for a week and it gradually got bigger. I went to my physician and I had an ultrasound done and it showed I had a swollen lymph node. Three days after that ultrasound I went to the ER with severe abdominal pain and was told I had apendicitis. I then had an appendectomy.
Exposed to poison ivy bad case of poison ivy; This spontaneous case was reported by a patient and describes the occurrence of EXPOSURE TO TOXIC AGENT (Exposed to poison ivy bad case of poison ivy) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jun-2022, the patient experienced EXPOSURE TO TOXIC AGENT (Exposed to poison ivy bad case of poison ivy). The patient was treated with PREDNISONE from 29-Jun-2022 to July 2022 for Exposure to poison ivy, at an unspecified dose and frequency. At the time of the report, EXPOSURE TO TOXIC AGENT (Exposed to poison ivy bad case of poison ivy) was resolving.            No concomitant medication were reported. Patient had bad case of poison ivy on 29Jun2022.
Miscarried on may 13, 2021, exactly 3 weeks later.  I was 6 weeks at the time of miscarriage.  I have one healthy child and no history of miscarriage.
Wheezing and difficulty breathing. 11/5/2009 - loss of vision.  MRI showed mass on optic nerve/chiasm.  Possible demyelination, but all tests are inconclusive because of location of mass.  Still have loss of vision.
This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. On an unknown date (also reported as since 11-MAY-2016) the patient was vaccinated with improperly stored dose of GARDASIL 9. No adverse effect reported. The temperature excursion details included exposure to temperature of 47 Fahrenheit for 8 hours. No previous temperature excursions reported. No additional doses have been administered. This is one of several reports received from the same source. Additional information has been requested.
She has been to the ER twice with severe convulsions muscle pain ringing of ears nausea she was admitted to hospital with spasticity as her discharge reference she continues to struggle with severe joint pain headaches and fatigue.
JULY 23, 2021:STARTED TO GET SHARP LEFT CHEST PAINS, ARMS STARTED TO TINGLE, FATIGUE, BODY ACHES  JULY 24, 2021:SHARP LEFT CHEST PAINS, ARMS STARTED TO TINGLE, FATIGUE, BODY ACHES, HEART PALPILATIONS  JULY 25, 2021:WENT TO MEDCIAL CENETER ER AT 0130 AM FROM WORK FOR  SHARP LEFT CHEST PAINS, ARMS STARTED TO TINGLE, FATIGUE, BODY ACHES, HEART PALPILATIONS DOCTOR STATED ALL TEST CAME BACK GOOD BUT WENT ON TO ASK IF I WAS VACCINATED AND WHICH VACCINATION I RECIEVED.  ADVISED DR THAT I DID GET VACCINATED WITH PFIZER 2 DOSE.  DR WENT ON TO SAY THAT OVER THE PAST 2 WEEKS HE HAD SEEN AN INFLUX OF PATIENTS REPORTING THE SAME SYMPTOMS AND ALL PATIENTS WERE VACCINATED.  SO IT COULD BE A SIDE EFFECT FROM THE VACCINE.  JULY 27, 2021:STILL FEELING VERY SICK (FATIGUE, SHORTNESS OF BREATH, BODY ACHES, SORE JOINTS) WENT TO DR AT FACILITY  JULY 28, 2021-AUGUST 09, 2021:INTERMITTENT SHARP LEFT CHEST PAINS, ARM AND LEGS TINGLE, FATIGUE, BODY ACHES, HOT FLASHES, INTERMITTENT HEART PALPILATIONS, SHORTNESS OF BREATH   AUGUST 09, 2021-PRESENT: STILL EXPERINCING INTERMITTENT SHARP LEFT  CHEST PAIN AND SHORTNESS OF BREATH
Leg ataxia with paresthesia of arms and mouth.  Hospitalized and treated for Guillain Barre Syndrome with 2x IVIG.
inadvertently administered which was deemed unsuitable for use after a temperature excursion, with no adverse event; Initial information received on 24-May-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 7 years old female patient who inadvertently administered which was deemed unsuitable for use after a temperature excursion, with no adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Feb-2022, the patient received a dose of suspect IPV (VERO) Suspension for injection (lot T1D482M, expiry date : 25-Jul-2022; strength,: not reported) via intramuscular route in unknown administration site as prophylactic vaccination.  It was reported that, on 16-FEB-2022 a dose of IPOL was inadvertently administered which was deemed unsuitable for use after a temperature excursion on 02-FEB-2022, with no adverse event (poor quality product administered) (latency: same day) following the administration of IPV (VERO).  Caller reporting the dose was administered on 16-FEB-2022, but only brought to her attention yesterday when the office experienced a second excursion, will call back if additional products were affected. Caller reporting a temperature excursion was reported to them in Feb-2022 and the multi dose vial of IPOL that was unsuitable was not discarded. Caller reporting to her knowledge only one patient was affected but will contact us if she finds additional patients who were administered the product. Caller with question on whether patient needs to be revaccinated.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently administered which was deemed unsuitable for use after a temperature excursion, with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
DID NOT TAKE DOSES ACCORDING TO SCHEDULE; This spontaneous case (PVX2019-1537) was received from a consumer on 10-Jun-2019. It describes a consumer who "did not take doses according to schedule". The consumer was receiving oral Vivotif for an unknown indication.  Case report: The consumer did not take Vivotif doses according to the schedule. The doses were taken on 01-Jun-2019, 04-Jun-2019, 07-Jun-2019, and 09-Jun-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not take doses according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take doses according to schedule" was considered as not applicable.
fever blisters on her mouth; arm is still swollen; arm is still sore; felt like a baseball in her muscle; arm is red; mouth is sore; little ulcers on her tongue and mouth; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of LIP BLISTER (fever blisters on her mouth), PERIPHERAL SWELLING (arm is still swollen), PAIN IN EXTREMITY (arm is still sore), MUSCLE MASS (felt like a baseball in her muscle) and ERYTHEMA (arm is red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced LIP BLISTER (fever blisters on her mouth), PERIPHERAL SWELLING (arm is still swollen), PAIN IN EXTREMITY (arm is still sore), MUSCLE MASS (felt like a baseball in her muscle), ERYTHEMA (arm is red), STOMATITIS (mouth is sore), APHTHOUS ULCER (little ulcers on her tongue and mouth), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, LIP BLISTER (fever blisters on her mouth), PERIPHERAL SWELLING (arm is still swollen), PAIN IN EXTREMITY (arm is still sore), MUSCLE MASS (felt like a baseball in her muscle), ERYTHEMA (arm is red), STOMATITIS (mouth is sore), APHTHOUS ULCER (little ulcers on her tongue and mouth), PYREXIA (fever) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
3:25-21: Noon starting muscle aches, fatigue, nausea and confusion, very thirsty; 4 pm stronger muscle aches, fatigue, stronger nausea, very thirsty and couldn't shake the confusion. 3-26-21: 1 a.m. woke with 102/103 temp. extreme full body aches, extreme fatigue, nausea, very thirsty, confusion and panic (I thought someone was trying to kill me.) heart racing. I had difficulty locating Tylenol, Advil and thermometer. Paced in confusion, began crying.  Took 2 extra-strength Tylenol. 3-26-21 8 a.m. temperature 101, full body aches, nausea, extreme thirst, and confusion, paranoia gone took more extra strength Tylenol.  3 p.m. same symptoms. Took two extra-strength Advil.  10 pm same symptoms took two extra strength Tylenol. 3-27-21: 8 a.m. temperature 100, body aches were not as bed,  These symptoms continued to 3-28-2021.
Shot given 10/2/08. Then within 30 days, 10/22/08, 7 mo. old woke up after nap, had a 103.00 temp. Reached 104.0 4 days later. Had a rash all over body, then diarrhea.
In 4 hours, started getting getting very dizzy, then throwing up, and nauseous by 7:30pm felt Luke on worse six flag ride. Blood pressure went up to 166/106. Called 911. Diagnosed with possible reaction  and developed TIA
Patient received Pfizer COVID vaccine on 3/18/21(lot # ER2613), 4/22/21(lot # ER8735), and 2/1/22 (lot # FJ1614).  Patient recently traveled by airplane and upon return, she begin experiencing  cough, headache, chest congestion, rigors, shortness of breath from 7/4/22 to 7/6/22.  On 7/6/22, patient admitted to our inpatient facility (med/surg unit) with acute respiratory failure with hypoxia secondary to COVID-19 infection, urinary tract infection with probable sepsis, and fungemia. Patient was discharged to a short term rehab facility on 7/12/22.
Patient had syncopal episode 10 min post AVA # 1 and Typhoid. Recalled that he was standing, felt dizzy and diaphoretic prior to passing out. Stated he was 'out' for a couple of seconds. Denies any resp problems, swelling, GI symptoms, skin rashes or itching. Stated when he woke up he was given some water and then was given his smallpox vaccine. No problems since. Stated he did not eat breakfast that morning and that he also took some Tylenlol Cold, daytime which he has taken before without problems. Dizziness Start: 11/19/2007 End: 11/19/2007; Diaphoresis Start: 11/19/2007 End: 11/19/2007; Syncope Start: 11/19/2007 End: 11/19/2007
Patient fully vaccinated. COVID-19+ on 2/15/2022. Presented to the ED on 2/24/2022. Patient is a 45-year-old female who presented to the ED with chest pain and shortness of breath. Patient reported worsening shortness of breath, chest pain and cough. Positive for headaches. She was prescribed Z-Pak and steroids. EKG normal sinus rhythm, no infarction or non-specific ST-T changes. Normal troponin. SL nitroglycerin given. Patient prescribed ibuprofen, Robaxin and Tessalon. Patient stable. Discharged home.
Wednesday evening notice rash on shoulder, throat sore on Thursday, Friday, nausea & vomiting and itchy.
51 yo black female c/o itching and dizziness 15 minutes after receiving her 1st dose of the Pfizer vaccine. Patient stated to staff member she started to itch all over 10 minutes after sitting in the observation area.   Patient was escorted to the triage area where she was evaluated by on-site EMS and NP.  Vital signs and EKG initiated . VS 115/78, 64, 18, 98% O2, EKG (NSR). Benadryl 50mg  and IV fluids started by EMS per NP orders.  Patient has a PMH of Hyperthyroidism. NKDA.  After about 30minutes, patient began to feel better and agreed to call her husband to drive her home.   Patient was advised to see her PCP if conditions worsen.
fatigue and body aches developed about 12 hours after 1st injection which resolved after two days. About 3-4 days after injection had stuffy nose with extreme dryness and sores throughout both nasal passage resulting in epistaxis. It has been over 1 week without resolution of sores despite keep nasal passages moist and running humidifer.
pt recv vax & devel a urticaria rxn (swollen face, etc) & then a a gen varicella rash;
BRUISE IN RIGHT ARM; TIREDNESS; FELT LIKE TONGUE TASTED SALTY; This spontaneous report received from a patient concerned a 64 year old   female. The patient's height, and weight were not reported. The patient's concurrent conditions included: food allergy, pollen allergy, and sensitivity to medicines, and allergy to certain insects. The patient reported she had no drug allergies but  she did not want the Moderna or Pfizer vaccine due to the PEG content.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 30-JUL-2021,  around midnight, the patient felt like tongue tasted salty. On 31-JUL-2021, patient experienced tiredness. On 14-Aug-2021, she had a bruise on the right arm even though injection (dose number in series 1) was in left arm and she was told ( "by someone at J and J") to go to  the emergency room (ER). The hospital did a blood test and all was normal. She was tested for blood clots at hospital but does not remember exactly what was done. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like tongue tasted salty on 07-AUG-2021, bruise in right arm on 18-AUG-2021, and tiredness on 31-JUL-2021. This report was non-serious. This case, involving the same patient is linked to 20211245665 (dose number in series 2).
About 4pm Mon 7/12, started noticing pain on top of shoulder - not necessarily in the muscle. Still there Tue am & migrated down the front into armpit. Also noticed redness where this pain is, and is most prominent as its going down into armpit making it sore when raising arm above head. Skin has been raised on shoulder where redness is. Still there this morning - not worse but not sure if much better. No other reactions observed. Put ice on area Wed AM 7/14. Slept on shoulder for 1st time since vaccine Wed PM. Eventually pain and redness dissipated by end of the day Thursday 7/15.
Rash on face, neck, upper extremities (fine papular erythemic rash). Right eye swollen more than left eye. Treated with oral prednisone/Atarax.
10minuTES AFTER RECIEVING THE  2nd MODERNA VACCINE THE PATENT DevelopeD uTICaRiA on aRMs + TRUNK + BecamE ITCHY. LUNGS Clear no THroaT continued -->
Lump, 1 1/2 inches in diameter not warm/hot/hard to touch no bleeding, pt never had problem with flu shot before.
no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 15-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.
Injection site pain, body aches, leg cramps, shortness of breath, coughing, congestion, headache continuing on day two after vaccine.
Soreness and swelling at injection site. Pain rated at 6/10. Headache, Joint pain (Hips, knees, elbows, sholders. Eyes were red.
Approx 1-2 hr after vax, pt became pale & devel cyanosis of his lips & fingernail beds. Taken to ER for observation, then sent home without tx.
shingles rash; second Shingrix vaccination ten months after first dose was given; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th July 2018.).   On 3rd May 2019, the patient received the 2nd dose of Shingrix. On 3rd May 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient received second Shingrix vaccination ten months after first dose was given, which led to lengthening of vaccination schedule. The patient developed a shingles rash last week. The reporter consented to follow up.
Patient presented to the ER with shortness of breath and chest palpitations approximately. He reports this started approximately 7 days prior to arrival and progressively got worse. Patient was worked up and found to have Afib with RVR and CHF.
On the 18-20 my arm was a little sore but not red. From the 21-23 my arm was back to normal. On the 25 and 26 I had a 3" circular red rash around the injection site. It was sore, itchy, and swollen. On the 27, the redness, itchiness and soreness had grown to most of my upper arm to the elbow. It was swollen and warm to the touch. I iced it, took over the counter benedryl, and used a hydrocordisone over the counter cream for the itch. I have had some mild headaches and mild chills off and on.  On the 28, my arm started looking a little better...smaller, less red, and less sore. But on March 1 and 2, the arm was red, sore, and had grown a little more below elbow. March 3/4 redness lighter, some soreness, itchy.
Pfeizer 3rd Booster shot October 2, 2021:  The inside of my  mouth broke  out in a Herpes rash; on the outside,  my upper lip broke out into 5 clusters of Herpes cold sores;  throat is sore as a result of this breakout.  I applied ice to lips, Lysene ointment, took Lysene tablets, but nothing helped.   Pfeizer 2nd shot February 12, 2021:  outside on my upper lip- the lip turned red and I felt burning as though I was going to get cold sores,  but I applied ice on lips, took Lysene tablets & applied Lysene ointment and NO  cold sores.  But my reaction to 2nd shot was milder than reaction to 3rd shot.
Woke up with a red/pink area (about 2 1/2"x4") on my left shoulder. It was slightly itchy, but mild enough that I mostly forgot about it. It lasted about 2 days and then went away. It was not spotted, just solid pink in that area.
05/07/2001 Shots given, 05/15/2001 Fever, 05/24/2001 Cough shots given, 05/29/2001 Fever 101.7 cough and wheezing, 5/30/2001 Sore throat, wheezing, fever, 06/01/2001 Fever, sore throat, neck and weazing 103, 06/04/2001 Skin rash. On 6/5/01, dx'd with a viral syndrome and exanthem. Had diarrhea and shoddy lymphadema.
swollen and itchy throat; swollen and itchy throat; hives on face and neck area; itchy rash on face and neck area; This is a spontaneous report from a contactable pharmacist. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 01Apr2021(at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as unknown. Concomitant medications were not reported. The patient reported allergies to medications, food or other products as unknown. The patient had not 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. On 01Apr2021 at 13:00, the patient experienced swollen and itchy throat within 15 minutes of receiving the vaccine. The patient was asked to wait 30 minutes for further evaluation. Once the patient left the vaccination site, the patient experienced hives and an itchy rash on face and neck area. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events which included BENADRYL. The clinical outcome of the events swollen and itchy throat, hives and itchy rash on face and neck area was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.