chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A little tired; Started menstruating 14 days before; High flow early in the period; Exhausted; Fever; Unusual back ache; Hips really hurt; Quadriceps really hurt; Mild pain around inject site; Normal recovering bruise; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0510), via an unspecified route of administration in the left arm on 31Mar2021 at 13:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included a basal metabolic index of 30.0, normal blood pressure, cholesterol and pulse. The patient also reported that she was previously anaemic. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced seasonal pollen allergies and had no other allergies. Concomitant medications included a generic brand multivitamin (MANUFACTURER UNKNOWN) two times per day, iron (IRON) (ir supplement) both taken from an unknown date for unknown indications, and paragard (INTRAUTERINE DEVICE) since just over four years. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6207), via an unspecified route of administration in the left arm on 09Mar2021 at 14:00 as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Apr2021 at 16:30, the patient experienced an unusual back ache, hips and quadriceps that really hurt, very mild pain around inject site, a normal recovering bruise. On 01Apr2021 at 20:00, the patient reported that she was exhausted and developed a fever that was more than 4-degree Fahrenheit above her normal body temperature. The patient reported that she slept for 12 hours. On 02Apr2021, the patient was a little tired but reported that the aches and fever had subsided. On 02Apr2021, the patient suddenly started menstruating that afternoon, about 14 days before the expected start (started early) and had a high flow early in the period. The patient reported that since she was on the IUD from just over 4 years, she had 26-31 days between her cycles and the early period and high flow caught her off guard. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures included intake of NSAIDS (unspecified) for back ache, hips and quadriceps that really hurt, pain around inject site and fever. The patient did not receive any treatment for the events inject site bruise, exhausted, irregular period, heavy flow and felt tired. The clinical outcome of the events unusual back ache, hips really hurt, quadriceps really hurt, pain around inject site, inject site bruise, exhausted, fever, felt tired, menstruating 14 days before and high flow early in the period were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Feeling so sick right now, I can't even think straight; Feeling so sick right now, I can't even think straight; Full body chills; Fever of 102; Feel bad; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on 09Aug2021 16:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Then evening started to have really bad adverse effects, had full body chills, a fever of 102, on 17Aug2021, feeling so sick right now, patient could not even think straight and Feel bad. The patient underwent lab tests and procedures which included body temperature: 102 degree centigrade on 17Aug2021. The patient was suggested to reach out to nearest Physician in case of emergency room in case of any medical emergency. The outcome of the event feel bad was unknown and other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Dose 3: Pfizer Monovalent 12+: 01/15/2022- lot # not provided. Patient is a 52 year old female with history of CKD IV on IHD, Wounds secondary to calciphylaxis, DM 11, GERD, HTN who presents from rehab facility due to hypotension and AMS onset earlier this day. Patient has had long course since last July resulting ultimately resulting in CKD HD due to obstructive uropathy requiring chronic foley changed every month by nursing staff, multiple wounds due to calciphylaxis which became acutely infected previously who presented today again for AMS. Patient found to have lactic acidosis in addition to profound hypotension requiring vasopressor support. Currently undergoing fluid resuscitation and septic work up. She will be started on broad spectrum antibiotics and admitted to the MICU.  Patient became unresponsive and hypotensive maxed on levo and vaso overnight. Patient was intubated for hypoxia and an arterial line was placed. Patient on levo 0.05, vaso 0.08, and epi gtt started. Patient found to have HCO3 of 7 and pH 6.9, given 2 amps of bicarb and started on bicarb gtt. Lactic acid 13.1 this AM. Leukocytosis worse this AM. H/H down to 6.7, one unit of PRBC ordered. Mild transaminitis this AM. Pupils now fixed and dilated. While assessing the patient, she lost a pulse and was PEA, given two amps of bicarb, 2 of epi, and 1 of calcium given and ROSC achieved. Patient was made a DNR and went asystole.
Chills, hot flash, achy and weak about 18 hours Sore arm for 10 days Itchy red splotch below shot site started 5 days after and lasted 5-7 days
Patient was admitted  3/19 with 3 days of fever and determined to have atypical Kawasaki disease and received one dose of IVIG on 3/21. He developed SVT on 3/20 that did not break with adenosine. He was then transferred to the CICU for esmolol therapy.  His SVT broke and he was transitioned to propanolol without recurrence of SVT. He had 2 normal echocardiograms, no evidence of coronary dilation. He has tolerated high dose aspirin initiation with GI prophylaxis without event. He has returned to normal activity
57mm X 53mm erythematous area to posterior right tricep. Area TTP. Tightness in throat, 24 hours, post vax.
p/vax pt dx w/ITP 11/12/99 hosp & treated;MD told pt mom that he has seen ITP p/vax & should file report;tx w/ IVIG
He started wheezing and was unable to breath normal. We took him to the doctor, and they told us his oxygen level was low. They gave him a nebulizer with steroids. They asked us to come back the next day and his oxygen level was better, but he was still breathing heavy. Then they put him on two antibiotics, azithromycin and amoxicillin for 7 days. This kept going on, so we made an appointment with his PCP. He just had us continue the same treatment. He got better around 5/6/23.
One month later developed bilateral muscle inflammation and pain in legs, this resolved several weeks later. No labs done. Developed insomnia and irritability in following month, three months later (november) diagnosed with hyperthyroidism with tachycardia. Now this  month confirmed diagnosis of new onset Graves Disease  Thyroid stimulating IG level 3.38.  Had prior history of thyrotoxicosis 10 years prior after a viral illness. Spontaneously resolved after 9 months.
Patient developed severely swollen glands in neck at approximately 10 days after MMR shot. Developed fever 18 days after MMR shot, followed by outbreak of measles rash, starting at the head and continuing downward over the body. This was accompanied with an extra sensitivity to bright light and overall joint stiffnes that persisted for 5-6 days.
This spontaneous report as received from a medical assistant refers to a 12 month old male patient. On 31-MAR-2014 the patient was vaccinated with PROQUAD, 0.5 ml, subcutaneous. On 08-APR-2014 (reported as 8 days after vaccination) the patient experienced chickenpox, which was diagnosed on 11-APR-2014 when the patient sought medical attention and was seen by a physician. The patient was treated for the event, he was advised to take ZYRTEC for itching and ibuprofen (manufacturer unknown) for fevers. Lab diagnostics were not performed. The outcome of chickenpox is unknown. Additional information has been requested.
Pt recvd vax 12MAR & rash began 13 & 14MAR sl raised & red;
10NOV93 recvd vax;  11NOV93 very sore throat, bad h/a, stuffy post nasal drip;
103 degree fever, body aches, shivering, headache for 5 days.  Tylenol 325mg q6h.
Pt has a PMH of CAD and atrial fibrillation. He was transferred from an outlying facility after experiencing frequent syncopal episodes over the last 2 weeks. Pt was found to be V. tach. The pt did have a cough with sputum production and was found to be COVID positive the day after admission.
2" raised, red, itchy patch at site of injection, symptoms improved by 11/20 but not completely resolved.
Headache, Diarrhea, NauseaVomiting, CHILLS AND FATIGUE Narrative:
Paint and induration at injection site.  Pain extends upper arm and back (shoulder).  Induration 10cm circle around injection site.  Afebrile.  Tyco #3 by mouth for pain.
This spontaneous report received from a nurse and physician referred to a currently 23 year old female patient. The patient's current condition included allergy to sulfa drugs. Concomitant medications were not reported. On 14-AUG-2007, the patient received the first dose of GARDASIL 0.5 ml intramuscularly (lot#0188U, unspecified expiration date), on 17-OCT-2007, the patient received the 2nd dose of GARDASIL (confirmed lot#0927U, unspecified expiration date) and on 09-FEB-2008, the patient recieved the 3rd dose of GARDASIL (lot#1487U, unspecified expiration date). The nurse stated the patient was seen in the office on 21-NOV-2016 for an annual exam and it was determined then that she had a previous ascus Pap Smear result that was HPV positive. The physician reported that after completion of GARDASIL, the patient had a "Pap Smear" performed that was ascus hpv positive. The patient had another pap smear on another unspecified date after vaccination that showed low grade squamous intraepithelial lesion (SIL). The patient did not receive treatment for the events. At the time of this report, outcome of the events was unknown and causality assessment for the events was not reported.  Additional information has been requested.
Moderna COVID-19 Vaccine EUA:  7 days after receiving the first dose of Moderna's COVID vaccine my arm became itchy, red and swollen around the area where the vaccine was administered.  It is a raised, red circular area on my arm about 2.5 inches long and wide.  Currently treating with hydrocortisone on my own.
Pfizer-BioNTech COVID-19 Vaccine EUA. Received vaccine at 6:00 p.m. on 12/28/20. States initially had a metallic taste in mouth after receiving vaccine, however felt fine until she woke up the next morning at 08:00  on 12/29/20 with headache, body aches and dizziness. Describes the dizziness as "lightheaded, in a fog, vision seemed a little blurry like a fog around everything". States began experiencing diarrhea at noon, then at 2:00 p.m. she began to experience chills and "racing heart". States she thought the racing heart was due to anxiety. States she rested, took Immodium & drank fluids. Did not require medical care. States when she woke up on 12/30/20 her heart was no longer racing, and headache & dizziness were improved. States today 12/31/20 she feels completely fine.
Information has been received from a registered nurse regarding a 67 year old female who was vaccinated with a dose of GARDASIL. It was reported that the patient erroneously received a dose of ADACEL in the office. No adverse symptoms reported. No further information provided. Additional information requested.
first dose in 2019, second in 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th September 2019).   On 19th January 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 19th January 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter called on behalf of the patient. The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The reporter gave a consent to follow-up with himself for follow-up. The reporter did not have lot or expiry date for the second dose of Shingrix.
This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A male patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration from an unspecified date for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fatigue and headache on an unspecified date after receiving. Patient was out of school for 3 days. Outcome of event was unknown. No follow-up attempts are possible. No further information is expected.
Pt. received second dose of Moderna Covid 19 EUA vaccine at 3:15pm. At 3:31, pt stated she felt lightheaded/dizzy and could "taste the vaccine", which was making her anxious.   Vitals @  3:22 139/86, HR79, Resp 36, O2 97, temp 97.3.  Patient given water.   Vitals @3:37 119/81, HR80 O2 98.  Patient reported feeling better, and taste was gone.   Vitals @ 3:42 120/84 HR78 O2 98, resp 32. Patient then released with instructions to contact MD/ER should any symptoms recur.  Patient expressed understanding.
today a vaccine was administered and it expired on August 11th; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (today a vaccine was administered and it expired on August 11th) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (today a vaccine was administered and it expired on August 11th). On 18-Aug-2021, EXPIRED PRODUCT ADMINISTERED (today a vaccine was administered and it expired on August 11th) had 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.   No relevant concomitant medications were reported. No treatment information was provided.
Patient reports that upon rising in the morning she has no control over her right side of body.  She fell on 10/21/20 and went to ER.  Upon arrival at ER patient could walk fine and received no treatment.  She states that she experiences the same lacking of functioning of right side every morning upon awaking.  After she is up for a couple hours she functions normally and has no lingering effects.
Migraine with aura beginning 12 hours after vaccine administration. Continued weekly migraines and photosensitivity for more than 6 months. Treated with topomax, maxalt, and Botox.
Tightness in chest; body aches; headaches; mild nausea; This is a spontaneous report from a contactable consumer (reported for herself). A 50-year-old non pregnant female patient received second dose of BNT162B2 (Pfizer COVID 19 vaccine lot number: unknown) via an unspecified route of administration on right arm, as single dose on 23Feb2021, for covid-19 immunization. Medical history included Waldenstrom Macroglobuanemia. She did not have any known allergies. Concomitant medications were not reported. The patient received first dose of BNT162B2 (Pfizer COVID 19 vaccine lot number: unknown) via an unspecified route of administration on left arm, at a single dose on an unspecified date in Feb2021 01:45 PM, for covid-19 immunization. On 24Feb2021 06:00 AM, the patient experienced tightness in chest, body aches, headaches and mild nausea. The patient did not receive any treatment for the events. She was not diagnosed with COVID-19 prior to vaccination, neither was she tested for COVID-19 since the vaccination. The outcome of the events of tightness in chest, body aches, headaches and mild nausea was not recovered.  Information on the lot/batch number has been requested
Patient experienced redness and swelling at the injection site which was noticed approximately 48 hours after injection. She described the size of the redness as being the size of a lemon. The inflamed area is itchy and warm to the touch. The patient is also experiencing some minor muscle soreness on that arm. She has not sought out medical help nor tried any treatments to alleviate symptoms. She described the symptoms as not that bothersome and will monitor them moving forward.
One day after immunization, she began to feel soreness in arms, became weak, body ache: joint and muscle pain. She ran a fever. Her wrists, knees and shoulder also affected. Each day she felt worse until she was put on prednisone and ASA, which is helping.
Info has been received from a health professional concerning an 8 year old male pt with no allergies and no pertinent medical history, who on 9/3/98 was vaccinated once, SC with a 0.5 mL dose of varicella virus vaccine live. On 1/5/06, the pt developed chicken pox which was confirmed by a physician. At the time of this report, the pt currently has chicken pox and is not recovered. There were no lab studies performed. There was no product quality complaint reported. Additional info has been requested.
The area was red and itchy and swollen for about a week; The area was red and itchy and swollen for about a week -; itchy and sensitive to touch; the site of the shot got very pink; a tiny bit of redness; headache; tired; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (a tiny bit of redness), VACCINATION SITE PRURITUS (itchy and sensitive to touch), HEADACHE (headache), FATIGUE (tired) and VACCINATION SITE ERYTHEMA (the site of the shot got very pink) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Pollen allergy (Mild to moderate.) and Allergy to molds (Mild to moderate). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LORATADINE (CLARITIN [LORATADINE]), SPIRONOLACTONE, HYDROCHLOROTHIAZIDE, FAMOTIDINE, FLUVOXAMINE MALEATE, GABAPENTIN, MIRABEGRON (MYRBETRIQ), OLOPATADINE HYDROCHLORIDE (PATADAY) and OLOPATADINE HYDROCHLORIDE (PATANASE) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced ERYTHEMA (a tiny bit of redness), HEADACHE (headache) and FATIGUE (tired). On 30-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchy and sensitive to touch) and VACCINATION SITE ERYTHEMA (the site of the shot got very pink). On an unknown date, the patient experienced SWELLING (The area was red and itchy and swollen for about a week -) and PRURITUS (The area was red and itchy and swollen for about a week). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; CORTISONE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 25-Jan-2021, HEADACHE (headache) had resolved. On 26-Jan-2021, ERYTHEMA (a tiny bit of redness) had resolved. On 30-Jan-2021, FATIGUE (tired) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchy and sensitive to touch), VACCINATION SITE ERYTHEMA (the site of the shot got very pink), SWELLING (The area was red and itchy and swollen for about a week -) and PRURITUS (The area was red and itchy and swollen for about a week) outcome was unknown.        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.   This case was linked to MOD-2021-260913 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant follow up appended.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 28-DEC-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Redness and itching at the injection site with swelling and hard lump approximately 2 by 3 inches.
Tested COVID positive- symptoms include chills, muscle aches, and nausea/vomiting.
significant local rxn of hard, indurated knot w/local redness & tenderness, n/v & flu-like sx;last prev dose 12-13yr;
Patient began developing itchy, small lesions on skin 2-4 days after she received the HPV vaccine.  New spots continued to appear over the past 10-12 days after the original spots. Patient states she has not been outdoors at all in that time frame or around any poison ivy, poison oak, or any other contact allergens. Patient didn't have cough, shortness of breath, tongue or lip swelling. Patient's rash is mainly on her neck and face, but she has some scattered lesions on her trunk and genitalia. Patient has numerous small MP/maculobullous lesions, and some hive-like.
Had only very mild tinnitus in the right ear prior to the vaccine and now I have severe tinnitus in the right ear.
This spontaneous report as received from a physician via company representative refers to approximately 9 week old male infant patient. No information provided regarding medical history and concurrent conditions. On 27-MAR-2014 the patient was vaccinated with VAQTA(dose, route, lot# not reported). No concomitant medications reported. The physician reported that the VAQTA was administered too early to an infant. No adverse events are being reported. Little patients details were given. The patient sought medical attention. The patient present status were reported as recovered. The vaccine was re introduced. The patient was not hospitalized due to experience. No death. Intervention to prevent serious criteria was not required. Product quality compliant was not involved. Additional information has been requested.
Patient into clinic 1/28/13 to receive Typhoid vaccine. Reports continued episodes of dizziness & nausea since receiving Yellow Fever 1/25/13. Dizziness happens with rising and decreases as day progresses. Dizziness only affects the left side of patient's body. Nausea is continuous throughout the day. Reports muffled Left ear at this time.  No medications or Treatment given at this time. Advised patient to follow up with PMD for muffled left ear. Does not report pain or fever.  Patient's vital signs are WNL, afebrile, injection site is WNL.