chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed stomach ache and headache at 1 pm on 12/2/21 at school.  Mom picked him up and while driving home, he had a seizure (right hand posturing, body turned to left, emesis and turned blue, he gasped)this lasted 4-5 minutes.  Emergency was called and in the ambulance, he had a second witnessed tonic clonic seizure with eyes deviated.  He was given 2.5 mg of Versed IM  He was taken to hospital.  Temp was noted to be 103.8 rectally.  Child quickly back to baseline and was discharged to home that afternoon.  He has remained well this week.  Neurology followup planned 12/14/21
Patient is a nontoxic-appearing 54-year-old female with a history of lung cancer on chemotherapy this usually regulatory with stable vital signs complaining of generalized fatigue body aches nausea and vomiting.  She is Covid positive.  She was recently admitted to this facility and discharged 4 days ago.  She was doing somewhat better throughout the week and then today she started declining.  States she is having body aches as well as generalized fatigue nausea and vomiting.  She last took a dose of Zofran approximately 2 hours prior to arrival.  Denies any shortness of breath however does have a persistent cough.  No hemoptysis.  She did receive her Covid vaccinations as well as monoclonal antibody treatment Associated Symptoms: cough, fatigue, nausea, URI symptoms, vomiting, weakness
About an hour after receiving my first dose I began to have a headache. Since Friday I have taken tyenol and ibuprofen with no relief from what is now a migraine. Friday evening I started experiencing nose bleeds that have continued sporadically over the weekend.
Pt experienced dizziness, lightheadedness, and headache after receiving covid vaccine. Headache improved after pt took ibuprofen, but lightheadedness worsened when ambulating, leading to ED visit. No treatment given in ED, pt's symptoms self-resolved after 40 minutes.
on 01/08/2021 got a bruise and redness around the injection site, redness went away on 01/11/2021. The redness came back on 01/15/2021 and a fever of 99.4 and the site was very itchy.  The redness went away on 01/17/2021
Became pregnant 12/17/20 and miscarried at gestational age of 6 weeks.  Received first vaccine dose on 12/31/20 Received second dose on 1/19/21 Began to miscarry on 1/30/21
Patient had a large red, raised area to her Right deltoid. It measured 5in x 2in was red and hot, 5 days after vaccine was administered. Patient also swelling to the right side of her body and underarm.
This spontaneous report was received from a physician assistant refers to a 64 years old female patient with no pertinent medical history and allergy to sulfa who in October 2011, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number 671452/1124AA, Exp. Date: 12-OCT-2012). No other co-suspects were reported. No concomitant medications were reported. The physician assistant stated that on 04-SEP-2012, the patient developed shingles even though she had been given ZOSTAVAX in the past. Acyclovir was given as a treatment for the existence. No lab diagnostics studies were performed. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for the patient developed shingles was unknown for ZOSTAVAX. Additional information has been requested.
the pain as radiating to the shoulder blade, and down the arm to the elbow, and the pinky finger; the arm was stiff and difficult to move; the arm was stiff and difficult to move; headache; experienced arm pain, rated at 8/10 in her left upper arm, where the vaccine was administered/ arm pain, was reduced to a 6/10; body temperature rose from a baseline of 96. D degrees Fahrenheit to 99.1 degrees Fahrenheit; This is a spontaneous report from a contactable nurse received by Pfizer from Merck and Co., Inc. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot/batch number and expiration date not reported), via an unspecified route of administration in the upper left arm on 25Nov2019 16:00 as single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that about 4 p.m. on 25Nov2019, and subsequently experienced arm pain, rated at 8/10 in her left upper arm, where the vaccine was administered. Nurse reported that the patient described the pain as radiating to the shoulder blade, and down the arm to the elbow, and the pinky finger. Nurse reported that the pain began about 4 hours post vaccination. Nurse also reported that the patient's body temperature rose from a baseline of 96.5 degrees Fahrenheit to 99.1 degrees Fahrenheit, approximately 8 hours after receipt of the vaccine. Nurse reported that the following morning, the patient awoke with a severe headache, but that the arm pain, was reduced to a 6/10, but that the arm was stiff and difficult to move. Nurse reported that the patient is treating herself with 1000 mg of TYLENOL every 6 hours as well as 50 mg of BENADRYL every six hours. The outcome of the event experienced arm pain, rated at 8/10 in her left upper arm, where the vaccine was administered/ arm pain, was reduced to a 6/10 was recovering; while the rest of the events are unknown.   No follow-up attempts are possible. No further information is expected.
Patient was diagnosed on 10/11/2012 with Guillain Barre Syndrome.
04/30/2022 I have a history of sigmoid diverticulitis and I started getting a lot more of left lower abdominal quadrant pain. I went to the ER at the Hospital. My white blood cell count was 11,200. They did a CT of my abdomen which showed sigmoid diverticulitis. They ordered Cipro 500 mg, twice a day for 7 days.. They also started on Flagel 500Mg three times a day for 7 days. I am still having issues. I went to an APN 05/05/2022 because I was still in a lot of pain in my left lower quadrant of my abdomen. She extended my cipro and Flagel to 14 days. She rechecked my bloodwork and my while blood cell count had dropped. My CRP was 1.82 which is high. They never checked that previously in the ER. I feel miserable.
This spontaneous report as received from a registered nurse refers to a 26 year old female patient. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (route and lot # not reported). The nurse reported that on an unknown date, the patient experienced redness and swelling at the injection site. The outcome of redness at the injection site and swelling at the injection site was unknown. This is one of two reports concerning the same patient. Additional information has been requested.
Patient developed blood clots in her legs, heart, and lungs within 48 hours after receiving her second dose of the Moderna vaccine. She was subsequently treated with Eliquis (apixaban).
Acute wheezing and hoarse cry and cyanotic lips - briefly, restarted spontaneously.
inflamed upper lip, she didn't do anything but wait, resolved after 16-20 hours
Disrupted menstrual cycle (missed 2 cycles with mild spotting in between and irregular cycle persisting for 10 months following). Extreme fatigue, disruptive to life. Decrease in physical abilities from regular active lifestyle that included running to struggling with mobility around house due to severity of fatigue. Breathlessness/shortness of breath. Abnormal heart rhythms, tachycardia and bigeminy. Chest pressure and pain. Menstrual cycle was eventually normalized but fatigue, heart rhythm abnormalities and fatigue still persist to present.
was administered the PENTACEL that expired 3 weeks ago; Initial information was received on 12-Jul-2021 regarding an unsolicited valid non-serious case from a other health professional (Agency Inquiry number: 00677892).  This case involves a 15 month old female patient who received the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that expired 3 weeks ago (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 12-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number: UJ349AAA, expiry date: 22-Jun-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination (expired product administered) (latency: 1 day).  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  It was reported that "Nurse reports that a patient was administered the PENTACEL that expired 3 weeks ago, should they revaccinate the 15 month old? They were confused with the date."  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
24 hrs post vax, 1 of 4 pt's exp h/a, swelling & pain @ inject site, inability to move arm, fever of 101-103 for 3 days, & a cough; tx APAP & pain & fever;
Since shots yesterday-pt. increased N/V and dizziness. Mother reports child has vomited and has severe headache.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 07-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml) (lot # L036245, expiration date 09-FEB-201). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion for three times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer) (R/F) for the first and second time were 48, 34 and $; 16, 29 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer)(R/F) For the third time were 24. 49, and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a medical assistant concerning a female with no past medical history and no known drug allergies who on 05/19/1998 was vaccinated with the first dose of varicella vaccine SC in the left arm. There was no illness at the time of vaccination. On 08/04/2001, the pt was presented to the physician's office and was found to have chicken pox. There were many vesicular lesions, however less than 50. The lesions were described as "some large 1cm in diameter," mostly on the trunk, and a few located on her face, scalp, limbs and palms. It was also noted that the pt also had two lesions on the soft palate. The pt was given Benadryl for relief of itch as well as Zyrtec. It was also reported that the pt had mild headaches but no fever. The pt was seen again in the office on 08/10/2001 and the rash was nearly gone except for the lesions on her palm which was still blistering. Follow-up reported that the blisters healed and dried within one week. No further info is expected.
expired dose of Pentacel administered with no reported adverse event; Initial information received on 23-Jul-2021 regarding an unsolicited valid non-serious case from an other health professional and physician via Global Media information (under reference 00694720).  This case is linked to cases 2021SA247614 and 2021SA247618 (Cluster).  This case involved a 4 months old male patient who received an expired dose of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE  [PENTACEL] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) and PNEUMOCOCCAL VACCINE 13V [Lot number and expiration date were not reported] for prophylactic vaccination.  On 19-Jul-2021, the patient received a dose of suspect PENTACEL (lot UJ342AAA and expiration date: 22-JUN-2021) via intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported that "patient Information patient age lees than one year enter as 2 month, 4month, etc. Many pediatric vaccines need month for age. Dose 0.25 mL to 2 mL for vaccines or 0.1 mL for TB (Tuberculosis) skin test-0.5ML, Strength standard for Fluzone HD-STANDARD. Pregnancy-not applicable, Last menstrual period, due date, AE (adverse event) symptoms or no AE, If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food drug administration) requirement". It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
She is 39 weeks and 1 day gestational. This is her first pregnancy. She was having left sided facial numbness, right arm numbness, paralysis of left face. NIH of 2. MRI showed no stroke. Was discharged home.   She later had the baby with a birth weight 3.23 kg.
This spontaneous report was received from a pharmacist and refers to a 25 year old female patient. There was no information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications provided. On 11-APR-2017,  the patient was vaccinated with the first dose of M-M-R II (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. On 23-APR-2017, 13 days after onset of therapy, the patient developed a rash all over her body. The patient sought medical attention by contacting her pharmacist. It was reported that treatment was not given for the patient's event of rash. The outcome of rash was reported as not recovered/not resolved. The relatedness between the event of rash and  M-M-R II was not reported. Additional information has been requested.
A little hard at injection site; A little itchy at injection site; A little sore where the injection site was; little red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (A little hard at injection site), INJECTION SITE PRURITUS (A little itchy at injection site), INJECTION SITE PAIN (A little sore where the injection site was) and INJECTION SITE ERYTHEMA (little red at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced INJECTION SITE INDURATION (A little hard at injection site), INJECTION SITE PRURITUS (A little itchy at injection site), INJECTION SITE PAIN (A little sore where the injection site was) and INJECTION SITE ERYTHEMA (little red at injection site). At the time of the report, INJECTION SITE INDURATION (A little hard at injection site), INJECTION SITE PRURITUS (A little itchy at injection site), INJECTION SITE PAIN (A little sore where the injection site was) and INJECTION SITE ERYTHEMA (little red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that it was a little red where the injection site occurred, it was little itchy where the injection site occurred, and  it was little hard where the injection site occurred.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: TCR Received: patient she says she is all good and doesn't want frutherfollow up.
Left arm swelling from injection site (deltoid) to elbow. Also pain and redness. Started same day ended after two days. Arm was itchy afterwards for two more days.
I had a miscarriage within 2 weeks of receiving the second dose. I was likely was "pregnant" at the time of vaccine, dose 2.  1st miscarriage was 5/12/21 (4.5 weeks pregnant) 2nd miscarriage was 7/16/21 (8 weeks pregnant)
Information has been received from 2 nurses concerning a 17 year old female with a history of fainting who on 30-DEC-2008 was vaccinated with the first dose of GARDASIL. The patient fainted within an hour after receiving the vaccine. The patient fainted 3 times. The patient recovered that same day and went home. Lot# was not available. Follow-up information was received from a registered nurse (RN) concerning the 17 year old female patient who came to office and was vaccinated intramusculary in the left deltoid with the first dose of GARDISIL (6650555/0279X) on 30-DEC-2008. There was no illness at the time of vaccination. Subsquently the patient experienced a syncopal episode (less than 15 seconds), and it occured twice more. The patient was able to walk out of the office finally after aproximately 1.5 hours. BP: 114/72 mmHg (standing level) 104/60 mmHg; o2 sat, 98%. The patient recovered on 10-DEC-2008. No relevant diagnostic tests or laboratory tests were performed. The patient sought medical attention by visiting the nurse and physician's office. No further information was available.
2 days ago, received Td 03/23/2005. 1 day later, felt right deltoid area painful and hot. Today more swollen and red. Right deltoid has area of 2x2cm  edema and erythema. No RX.
Cellulitis; Shingles; Itchy rash on the neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 07-Apr-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 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (Itchy rash on the neck). On 18-Apr-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant) and HERPES ZOSTER (Shingles). At the time of the report, CELLULITIS (Cellulitis), HERPES ZOSTER (Shingles) and RASH PRURITIC (Itchy rash on the neck) outcome was unknown.            No concomitant medications are reported. Treatment medications includes; Tx: Neosporin, Valtrex and Keflex Action taken with mRNA-1273 in response to the event was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient had a reaction to receiving the Moderna Bivalent at 1403. PT remained in waiting area under direct observation by Imms staff for 15 minutes post vaccination, the patient stated he was hot in the face and very itchy around the throat. Peds provider consulted on patient S/SX.  PT in no acute respiratory distress.  PT stated flush feeling in face and itching around the throat decreased after 15 minutes, but not resolved.  PT remained in waiting area for another 15 minutes of monitoring as care was coordinated with ED for patient to be transferred where additional treatment/monitoring was performed.  PT transferred via ambulatory measures to ED with MA as escort at 1435 14NOV
Pt received scheduled shingles vaccination on 6/6. Waited 15 min after felt fine. About 1-2 hrs later started to feel tingling about 4 days later pt cont MD felt bumps on chin. MD diag shingles on right side. Pt on VALTREX 1 gm tid.
Arm is swollen; This is a spontaneous report from Pfizer sponsored program. A consumer reported that a female patient (daughter) of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that his daughter got her shot, arm was swollen on unspecified date. Outcome of the event was unknown.   Information about lot/batch number cannot be obtained. No further information expected.
approximately two minutes after administration of vaccination patient had sat down in waiting area and became lethargic/dizzy/blurred vision. She had passed out with face pale and lips turning blue, minimally responsive. Called 911 and while awaiting for ambulance patient had recovered from all symptoms with the exception of "spotted visions." Observed patient for over an hour while a family member came and upon the time of departure there was resolution of all adverse events.
This spontaneous report was received from a physician and refers to multiple patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the patients were vaccinated with VAQTA (lot# M017982, expiration date: 13-SEP-2017, dose and route of administration were not provided) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Began with body aches, feet felt cold to the touch but rest of my body was warm with a 100 degree temp.  I got up to walk around and was hit with a migraine headache (have never had one before) which included nausea, light hurt my eyes, vision was impaired with what seemed like fog in the room and humming in my ears, felt as if I was going to faint (I did not).  I took 2 Advil liquigels and sat down on the floor.  After about 20 minutes the migraine began to ease off to just a headache.  For the next 24 hours I had low grade temp, headache, a heaviness in the frontal area of my head, minor body aches, injection arm was sore from the shoulder to just above the elbow.  Continued one Advil every 6 hours up until 8pm 4/22/21.  Today I have no headache, no body aches, but my thinking skills are  a little fuzzy.  The arm where I received the injection has the injection site plus 2 other areas on the same upper arm that are red raised and itchy.
Fever 104, took him to ER and was admitted for liver enzymes being in the 300'S.
24 hours after the patient received ZOSTAVAX at our pharmacy, the patient experience redness across her chest, some disorientation, and a small, closed-rash under her breast. Patient was seen by her PCPA on 8/17 and it was unable to determine if this reaction was associated with the immunization received.
Patient experienced an outbreak of hives all over her body 8-10 hours after receiving vaccine.
pt recv vax MAR96 & ELISA testing revealed a lack of seroconversion;