chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 20 year old female who on an unspecified date was vaccinated with the second dose of Gardasil. Subsequently, the patient developed a red, slightly raised area around the injection site. It was reported that the patient improved after two days are was doing fine. Additional information has been requested. This is one of two reports from the same source.
pt recv vax & exp a failure to seroconvert;the reporter did not have nay further info regarding the pt since reported someone else's pt;
no additional AE; improperly stored administered vaccines; This spontaneous report was received from a nurse and refers a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-NOV-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), dose: 0.5 milliliter, lot# S021326, expiry date: 05-JAN-2021 (dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -10.8 degrees Celsius for 1 hour 30 minutes. There were previous excursions related: -12.3 degrees Celsius for 1 hour and -10.3 degrees Celsius for 10 hours and 30 minutes. Data logger was involved. No adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA003543:
25 doses of expired Moderna Covid-19 vaccine were administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patient) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medication were provided.  The vial was initially stored in the refrigerator on 29 Apr 2022 and 04 May 2022. The vial  does not undergo any temperature excursions.
Pt developed swelling & redness on 6/11/08 after receiving meningococcal vaccine.  Mother states swelling and redness is decreasing today 6/12/08.
I was warned of mild flu-like symptoms, however, by 9 p.m. on 10/15/19, I began suffering severe body aches (my eyelids hurt and I had difficulty even reading) and nausea.  I felt EVEN worse on 10/16/19 with my fever beginning approximately 2:50 p.m. at 99 degrees which advanced to 102 by 4 p.m.   I contacted my primary care physician, and spoke with his nurse she advised that if I continued to worsen to go to an urgent care.  Thankfully, my temperature was normal by daybreak, however, I continue to feel exhausted with some MILD flu-like symptoms.  I did have the flu vaccine approximately 7 hours prior to the Shingrix.  I was not told by anyone that both vaccines taken in the same 24 hour period could be detrimental.  I am a Medical Technologist, but no longer work in the field and had no idea what could happen until I became very ill.   I am unsure as the safety of taking the second Shingrix vaccine.  Please make sure this vaccine is much safer!
At approximately 1130, RN  assisted patient to anti-gravity chair. RN reported patient started leaning on her when they were walking to the anti-gravity chair. RN and EMT assisted patient into anti-gravity chair. RN  assessed patient. Patient was diaphoretic and pale. Patient stated she was "nervous about getting the vaccine". Patient reported previous episodes of fainting due to menstrual cramps. Patient denied itchiness, rashes, hives, difficulty swallowing, and difficulty breathing. At 1133, EMT assessed patient vital signs: blood pressure 105/65 mmHg and pulse 51 beats/minute. Patient reported eating in the morning. RN utilized breathing techniques with patient. At 1138, EMT  assessed patient vital signs: blood pressure 124/76 mmHg and pulse 51 beats/minute. Patient stated she was "feeling better". At 1141, EMT  reassessed patient vital signs: blood pressure 115/61 mmHg and pulse 55 beats/minute. At 1146, EMT reassessed patient vital signs: blood pressure 98/62 mmHg and pulse 61 beats/minute. Patient stated she felt "normal". Patient offered chips. Patient ate chips. At 1156, EMT  reassessed patient vital signs: blood pressure 109/63 mmHg and pulse 63 beats/minute. Patient stated she felt "fine" and "normal". RN educated patient on signs/symptoms of when to seek emergency care, to follow up with primary care provider and to sign up on v-safe. Patient called grandmother to drive patient home. Patient waited for grandmother to arrive at facility. At 1215, patient left facility with unlabored respirations and steady gait.
Chills; Headache; Coughing; Tiredness; Nasal congested; Feels like her sinus were blocked; Body ache; feeling sick; Sneezing; This is a spontaneous report from a contactable nurse (patient, front line health care worker). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EH9899) via an unspecified route of administration in the left arm on 28Dec2020 (at 10:30 or 11:00 AM) at single dose for COVID-19 immunization. Medical history included hypertension, diabetes, and stroke, all reported as family history (her parent). There were no concomitant medications. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no additional vaccines administered on same date of the Pfizer suspect. The patient did not have prior vaccinations within 4 weeks. The patient had body ache (reported as medically significant) on 01Jan2021 with outcome of recovering, had been sick for a week/ very ill on 28Dec2020 with outcome of unknown, sneezing on 28Dec2020 with outcome of not recovered, chills on 01Jan2021 with outcome of unknown, headache on 01Jan2021 with outcome of recovering, coughing on 01Jan2021 with outcome of not recovered, tiredness on 01Jan2021 with outcome of unknown,  nasal congested on 01Jan2021 with outcome of not recovered, feels like her sinus were blocked on 01Jan2021 with outcome of unknown. Treatment was received for the events. Reported she had a lot of sickness, by evening that day (28Dec2020) she got sneezing and feeling sick. Then the next day was the same, then the third day. She became very ill with chills, body ache, headache, coughing, and tiredness on 01Jan2021 (also reported as 3 days later vaccination). And she had no fever, but stated she had been sick for a week. Added the headache and body ache were a little better but still she felt so congested. Clarified she had nasal congested that feels like her sinus were blocked. She treated herself with acetaminophen, once daily 500 mg by mouth starting 01Jan2021. Added the body ache pain was still on the back of her chest but her legs and arms were better. She used steam inhalation for the congestion. She was not scheduled for the next dose yet, she was just waiting. The patient was wondering if she should do a test for COVID 19. Mentioned she had been healthy all through this year and digging in the COVID 19 all the time but then after the vaccine she got so sick. This was the first day she could get up and did anything. Advised caller to consult her HCP.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the body ache. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
moderate diarrhea  and intestinal discomfort. more than 4-5 prolonged bowel events in a 24hr period fully recovered 24 hours later
Exactly 24 hours from receiving the vaccine I experienced profound fatigue and aches.  I was actually paddle boarding and was unable to paddle back to the dock.  Went directly to bed and for 30 hours had all body aches (even in my groin!) and extreme fatigue.  I kept myself hydrated and took some ibuprofen which eased the aches.  I contacted my PCP @ 1 PM on 26th and she suggested I maintain what I've been doing and rest.  By noon on 28th I was fine!
Moderna COVID-19 Vaccine EUA  Slight redness with some itching and small dime-sized bruise appeared at injection site about 6 days after first dose. More pronounced red "ring" type rash (circular but not perfectly so) with bruise in center at injection site appeared about 11 days after first dose (no itching, pain, or swelling).
2-3 days later pt devel itching, pain & cellulitis of lt arm;
VOMITING  AFTER GETTING THE COVID VACCINE; NAUSEA  AFTER GETTING THE COVID VACCINE; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was 59.1 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient was treated with macitentan (tablet, oral, batch number: ZM021B0101 expiry: 30-NOV-2023) 10 mg, frequency, and therapy dates were not reported for primary pulmonary hypertension. The patient initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included treprostinil sodium.  On 21- MAR-2021, the patient was admitted to loyola hospital due to nausea and vomiting after getting the Covid vaccine and still hospitalized.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The outcome of the nausea after getting the Covid vaccine and vomiting after getting the Covid vaccine was not reported..  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210349126- Covid-19 vaccine ad26.cov2.s-Vomiting. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210349126- Covid-19 vaccine ad26.cov2.s-nausea. This event is labeled and is therefore considered potentially related. 20210349126-macitentan-nausea and vomiting. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Right before bed, my arm started really hurting.  The next day, I could barely lift my left arm to put my clothes on.  I felt really fatigued and developed a low grade temperature.  Day 2 and 3, still have a low grade temperature.  My arm is feeling a little better each day.
This spontaneous report was received from a pediatrician via company representative referring to unspecified number of patients of unknown ages and genders. The patient's concurrent and historical conditions were not reported. On unknown dates the patients were vaccinated with the second dose of GARDASIL 9 (lot number, expiration date, dose and route were not reported). The reporting physician stated that the patients received the first dose on unknown dates and then did not come back to office for the second dose, but returned one year later and received the second dose of GARDASIL 9, they received dosing outside recommended schedule (inappropriate schedule of drug administration). No adverse effects were reported. No product quality complain was involved. Additional information has been requested.
swelling of the fingers; itchiness on her palm; This is a spontaneous report received from a contactable physician. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot# unknown), via an unspecified route of administration on 18Apr2021 (at the age of 45-years) as single dose for COVID-19 immunization. Medical history included multiple sclerosis (was a high-risk patient), hypertension, anaphylactic reaction (allergic to Cephalosporins and Steroids) all events are ongoing. Concomitant medication included diovan, immunoglobulins. The patient previously took benadryl for hypersensitivity. Patient took 50 Mg of Benadryl before her first dose. On 18Apr2021 (7-hours of the vaccine), the patient had swelling on her fingers, itchiness on her palm. Patient then took 25mg of Benadryl and took a nap for about 4 hours, when she woke up the swelling and itching were completely gone. The patient received the unspecified treatment for events. The seriousness for event was reported as non-serious by physician. The outcome of the events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Daily Headache: (one per day every day since being vaccinated)  80% upon awakening; 15% 2 hours after awakening; 5% afternoon;
Upper lip swelling night after he received flu vaccine. Moc gave BENADRYL, swelling went away, then came back. No facial swelling, shortness of breath or difficulty swallowing or rash. Moc thinks possible egg allergy.
Within 24 hours left leg with 10 cm edematous and red, hot area, tender to touch.  Prescribed rocephin 1000mg, Keflex 2 teaspoons twice a day for 10 days, Benadryl.
I started feeling sick on February 21, 2023, but I thought I just had a cold. I had an appointment on February 26, 2023, and was tested for COVID-19 and it was positive. I quarantined for an additional six days. I lost my sense of smell and had soft stools. I had a runny nose and congestion. I had a very mild case. I had open heart surgery, so this COVID-19 slowed my progression down a little. I still don't have a great sense of taste.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown ages and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients received an improperly stored dose of GARDASIL (lot # K010215, expiration date 05-MAY-2017; dose unknown) intramuscularly. No adverse effect was reported. The vaccines were stored under the temperature 1.9 Celsius degree for 6 minutes. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
cyst under the left and right armpit; bad headache; fever of 102.8; nauseated for several days; little sore in the muscles and bones; Lymphadenopathy; This spontaneous case was reported by a consumer and describes the occurrence of CYST (cyst under the left and right armpit), HEADACHE (bad headache), PYREXIA (fever of 102.8), NAUSEA (nauseated for several days) and ARTHRALGIA (little sore in the muscles and bones) in a 56-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 information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced LYMPHADENOPATHY (Lymphadenopathy). On an unknown date, the patient experienced CYST (cyst under the left and right armpit), HEADACHE (bad headache), PYREXIA (fever of 102.8), NAUSEA (nauseated for several days) and ARTHRALGIA (little sore in the muscles and bones). At the time of the report, CYST (cyst under the left and right armpit), HEADACHE (bad headache), PYREXIA (fever of 102.8), NAUSEA (nauseated for several days), ARTHRALGIA (little sore in the muscles and bones) and LYMPHADENOPATHY (Lymphadenopathy) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-102307 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Event information is updated.
vulvar aphthous ulcers Symptoms started 3 days after vaccine shot. 2 ulcers appeared.   Not going to seek treatment  Similar reaction occured as a child as a result of virus infection
This case was reported by a consumer and described the occurrence of torticollis in a 2-month-old female subject who was vaccinated with Pediarix for prophylaxis. Concurrent vaccination included Haemophilus influenzae type b vaccine (manufacturer unspecified), hepatitis B vaccine recombinant (manufacturer unspecified), inactivated poliomyelitis virus vaccine (manufacturer unspecified) and pneumococcal vaccine (manufacturer unspecified) all given on 2 July 2007, 11 September 2007 and 14 November 2007 with the exception of Haemophilus influenzae type b vaccine which was not given on 14 November 2007. Concurrent medications included Fluoride started sometime between the 2nd and 3rd doses of Pediarix and multivitamin. On 2 July 2007, the subject received the 1st Pediarix vaccination (0.5 ml) at two months of age. Seven days later, on 9 July 2007, the subject experienced torticollis and an episode of vomiting (vomiting at 15:30). The subject was taken to the emergency room and was reportedly hospitalized. She was sent home with a strained neck. Vomiting resolved 9 July 2007 and torticollis was resolved by 11 July 2007. On 11 September 2007, in the morning, the 4 month old subject received 2nd dose of Pediarix (0.5 ml). Seven days later, on 18 September 2007, in the morning, the subject experienced torticollis and vomiting again. The subject was treated with Pedialyte. The events reportedly lasted "hours" and then resolved. Third dose of Pediarix was received by the 6 moth old subject on 14 November 2007 (0.5 ml). Seven days later, on 21 November 2007, the subject developed torticollis in the morning and vomiting. The subject vomited once on the 21st in the afternoon and started again on the 22nd. Vomiting on the 22nd lasted 6 hours and then resolved. Torticollis was unresolved at the time of reporting. The reporter thought that the pertussis may have caused the torticollis, which may have been causing the vomiting. The subject was also reportedly leaning towards the right and favored the right side. On 297 November 2007 a physician reported that the reported events jeopardized the subject or required intervention (disabling was unknown). The doses of Pediarix administered were reportedly 0.5 ml. The events of torticollis were described as a head tilt to the right and vomiting was said to be projectile. The physician reported that all events were possibly related to treatment with Pediarix. The events of torticollis and vomiting continued intermittently for about 48 hours, according to the physicians report, following the 2nd dose of Pediarix and then resolved spontaneously. The physician stated that the same reaction was experienced by the subject exactly seven days after the 4 and 6 month vaccines.
Redness at injection site (by patient description), swelling, temp to 103 F, no itching, no wheeze.
RA swollen at site of shot. Hot to touch. Pt states no pain. Duration Friday 5/31/02 to Monday 6/3/02 (still slightly swollen).
This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 27-SEP-2017, the patient was vaccinated with improperly stored doses of VARIVAX lot # N012131, expiration date 17-APR-2019 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit and 17 degrees Fahrenheit for 3 hours and 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007766.
Pt exp erythema lt cellulitis 25 x 15 cm in region where inject was administered; 3 days earlier;
Excruciating muscle pain; This is a spontaneous report from a contactable consumer or other non hcp. An 84-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: 610247; Expiration Date: Aug2022), dose 2 via an unspecified route of administration, in Arm Right on 11Feb2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. 5 days after vaccination, the patient experienced Excruciating muscle pain in right thigh. Her daughter-in-law had Pfizer COVID-19 Vaccine and had the same symptoms of excruciating muscle pain for two weeks. The patient took acetaminophen 250mg, aspirin (two pills q5hours), caffeine: 85mg. The outcome of the event was unknown.   No follow-up attempts are possible, and no information is required.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021208189 same drug/event, different patients.
No reaction to first dose.  Second dose no immediate reaction. 3 days after 2nd shot swelling in the both wrists, at the time I thought it was tendentious.   4-5 Days after, stuffy nose and cold symptoms. 7 days, asthma symptoms began to get worse.  Day 9-12 asthma attacks became severe leading to lung congestion, heavy mucus production and intense wheezing and coughing attacks.  Treatment during the attacks was FloVent 110 2 puff 12 hours apart.  As attacks grew worse, use of Ventolin rescue inhaler had to be used to control severe bronchial constriction and build up of thin mucus causing breathing congestion and more coughing.  The coughing and difficulty breathing meant using the Ventolin every hours.  The