chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started menstruating one week following the first dose of my vaccine.; This is a spontaneous report from a contactable consumer (Patient). A 40-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0186) via an unspecified route of administration, administered in Arm Right on 17May2021 (at the age of 40-years-old and not pregnant at the time of vaccination) at 12:45 PM as 1st dose, single dose for COVID-19 immunisation. The patient's medical history included Subglottic stenosis, start and stop date not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received birth control medications within 2 weeks of vaccination with no drug name. Relevant past drug history was reported as None known. On 26May2021 at 06:30, the patient had started menstruating one week following the first dose of my vaccine. She was taking her birth control correctly and had no physical symptoms leading up to the breakthrough bleeding. Patient was not on prolonged hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for event caused. The outcome of event at the time of last observation was Recovering/Resolving.
Woke up to weak right side of face. From right eye to the side of mouth and chin, couldn't hold water in mouth. Sagging right eye and right side of lip. Headache, pain on right side of shoulder and achy muscles.
Pt started having pain in his right arm, shooting pain that would travel to his neck, has had it since 11/4, not going away.
Approx 10 min after administration of vaccine, PT reported feeling dizzy and nausea. PT stated last meal ~24 hrs ago, dehydrated with no fluid intake this date. PT's vital signs obtained and normal. PT provided meal and oral hydration. PT noted improvement but stated she was unable to continue working and needed to go home and rest; stating, "I'll be fine tomorrow. I just need some rest."
Strange popping in my neck while doing simple head movements such as drinking out of a cup of other device to hold liquid. Almost like as if there were air bubbles in my C-joints of the vertebra. I can't say that it's painful but after a days worth of it my neck feels a little bit sore int hat area. I've never ever had this issue before, that's why its alarming and why I wonder if it's connected with the Vax?
Extreme cutaneous vasculitis on my lower limbs; This spontaneous case was reported by a consumer and describes the occurrence of CUTANEOUS VASCULITIS (Extreme cutaneous vasculitis on my lower limbs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced CUTANEOUS VASCULITIS (Extreme cutaneous vasculitis on my lower limbs) (seriousness criterion medically significant). At the time of the report, CUTANEOUS VASCULITIS (Extreme cutaneous vasculitis on my lower limbs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided.  Patient experienced extreme cutaneous vasculitis on lower limb and received 5 dose treatment of steroids and antibiotics over 6 months period without any improvement success.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced serious (medically significant) unexpected event of Cutaneous vasculitis (reported as Extreme cutaneous vasculitis on my lower limbs), approximately 5 months after receiving second dose of mRNA-1273 vaccine. The patient received 5 dose treatment of steroids and antibiotics (both unspecified) over 6 months period without any improvement success. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced serious (medically significant) unexpected event of Cutaneous vasculitis (reported as Extreme cutaneous vasculitis on my lower limbs), approximately 5 months after receiving second dose of mRNA-1273 vaccine. The patient received 5 dose treatment of steroids and antibiotics (both unspecified) over 6 months period without any improvement success. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Large red rash with white raised bumps, covering entire body. Fever of 101 degrees.
Shortness of breath within a week of receiving the vaccine. Awoken at night gasping for air several nights in a row. Night of ER admission; 9/3/21, due to shortness of breath with left arm weakness, chest discomfort from left side of chest heading up to left neck and brain,  blood pressure 174/107, left leg with pitting edema +1
Vaccinated arm immediately turned red, running the length of my arm. That night, I could not lift my arm laterally X 4 days. On day 8, the injection site area [2 inches X 4 inches] became red, inflamed and hot to the touch which resolved 5 days later [12 days after injection]. Currently, my arm still aches at the injection site.
Left upper arm is hot, swollen to elbow, painful and red. Temp 99 degrees. Called doctor. Advised to apply ice and take Tylenol.
Red rash on injection site. Warm to the touch. Itching. Treatments BENADRYL hydrocortisone cream.
Headache, myalgia, arthralgia, fatigue, injection site soreness/swelling.
pt recvd vax @ 2mos of age; following day, very sleepy & difficult to awake, according to parent;not eating much;MD visit same evening-pt is fine; recovered;
Swollen lymph nodes for 4 days. Very painful to move arm. Disappeared on day 5
Patient experienced chest pain and tightness at night same day of shot. Symptoms lasted about 1 hour and then gone.
Presented to ED one day after immunization with fever 40.4, increased fussiness, decreased activity, edema, pain - BP 100/32 - Treated with N S bolus, antibiotics - Admitted to hospital x 3 days, treated with morphine and antibiotics - Resolved.   10/6/08 MR received for DOS 9/12-15/2008 with D/C DX:  Sickle Cell Disease HgbSS.  Inflammatory Reaction.  Pt presented 1 day after Pneumovax with fever, leg pain and swelling and refusal to walk.  PE (+) for mild icterus, dry lips, tachypnea, and swelling/warmth of L thigh/knee.  Tx with abx and pain meds.
Administer expired vaccine to patient after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. The vial did not undergo any temperature excursions. No treatment medication was reported.    Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information.
Fever 102.7; severe myalgia/arthralgia; severe myalgia/arthralgia; sore throat; profuse sweating; Headache; swollen lymph nodes; This is a spontaneous report from a contactable nurse reporting for self.  A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 2, via an unspecified route of administration on 22Jan2021 16:30 (at the age of 37 years old) as a single dose in left arm for COVID-19 immunization.  The patient was not pregnant at the time of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included dyslipidemia, hypothyroid, bipolar type 2,and sleep apnea. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products.  Concomitant medications included atorvastatin, lamotrigine, and levothyroxine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 1, as a single dose on an unspecified date for COVID-19 immunization. On 23Jan2021 01:00, the patient experienced fever102.7, severe myalgia/arthralgia, sore throat,headache, profuse sweating, and swollen lymph nodes. As treatment for the events, the patient received acetaminophen and ibuprofen. No hospitalization was required. The events were reported as non-serious. The clinical outcome of the events fever102.7, severe myalgia/arthralgia, sore throat, headache, profuse sweating, and swollen lymph nodes was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
approx 15 mins post vax, mom notified PHN of 2 raised, red hives on pt face; MD notified; pt given DPH; 320PM by 335 rash resolved;
Allergic reaction; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FOOD ALLERGY (Allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergic to Food dyes).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced FOOD ALLERGY (Allergic reaction) (seriousness criterion hospitalization). At the time of the report, FOOD ALLERGY (Allergic reaction) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Nurse is currently in the emergency room due to an allergic reaction presumed to be due to food dyes and unrelated to Moderna first dose and says this reaction has happened many times before. Asking if she can still get the second dose of Moderna vaccine which is scheduled tomorrow due to this allergic reaction. Nurse requested information in writing to email provided. Adverse Event reaction occurred after dose 1 Safety consent not granted. Healthcare provider unknown No concomitant drug information was provided. Treatment included  IV decadron and oral steroids.  Very limited information regarding this events has been provided at this time. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Company assessed the events to be unlikely related to company product.
This spontaneous report as received from a pharmacist refers to an 82 years old female patient with poor metabolizer of drugs and medical history of polio. On unspecified date, the patient started therapy with statin (unspecified) (dose, route an indication not provided). No concomitant medications were reported. The pharmacist reported that on unspecified date, a patient developed muscle pains while taking an unknown statin. The pharmacist did not know the name or manufacturer of the statin and had no details of the adverse experience. The outcome of muscle pain was unknown. The relatedness for muscle pain was unknown for statin (unspecified). Follow-up information has been received from the pharmacist who stated that even though the patient was on a statin therapy (unspecified), the patient also received a dose of ZOSTAVAX (lot#, dose and route not reported) in December 2012 and complained of muscle pain couple days later. At the time of reporting, the outcome of muscle pain was unknown. The relatedness for muscle pain was unknown for ZOSTAVAX and statin (unspecified). Additional information is not expected.
Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.        Concomitant medication were not reported. Treatment medication were not reported.   This case was linked to MOD-2021-294383, MOD-2021-294516 (Patient Link).
1st dose 1-3 years ago, 2nd not yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who did not receive Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patients did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after not receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 1-3 years ago, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-APR-2023 Pharmacist called to inform that some patients from the facility had received the 1st dose of Shingrix but didn't finish the series of time. According to pharmacist, the time from 1st to 2nd dose was around 1-3 years in different patients. The reporter did not consent to follow-up. HCP was not willing to provide information regarding patients, or adverse event information in general. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Baby received 1st immunization. Mother advised of possible reactions. Baby cried continuously for 5 hours, following IZ. Mom called and was advised to see PMD, immediately. Did not have transportation. Public Health Nurse and Immunization Coordinator went to home. Baby examined and appeared active, alert and in no distress. Temperature normal. Breast feeding.
Nausea and vomiting and feeling dizzy began 1 hr after the vaccine.
Redness, swelling, warm around injection site. Nausea, diarrhea, headache and fatigue.
Pt arrived for MMR and Varicella vaccines. MMRV and Varicella were given.  Dr. informed who then informed family.  No known reactions.
Patient is a 57-year-old male currently in rehab facility with past medical history of heroin dependence, mood disorder, nephrolithiasis, history of 20 foot fall 5/21/2021 from fire escape to concrete floor with polytrauma , burst fracture L1 and L2 vertebral bodies, right lateral malleolar fracture, open right calcaneal fracture, sacrococcygeal fracture and left avulsion fracture of tibia, admitted to hospital, patient status post posterior fusion T11-L4, incision and drainage of right calcaneal wound and pinning, I&D left leg abscess, patient has resultant neurogenic bladder and neurogenic bowel post fall and has been self catheterizing, patient was initially discharged to current and rehab on 5/29/2021 and patient was discharged to rehab facility on 6/15/2021, presented to Medical Center emergency room with 3-day history of palpitation and shortness of breath, 2-day history of hematuria,, work-up in the emergency room at Medical Center included CTA of the chest which showed bilateral pulmonary embolism, CT scan of the abdomen pelvis showed multiple bilateral nonobstructive renal stones, bladder stones, fracture of L1-L2 vertebrae with postoperative changes, fracture of coccyx.  Patient started on IV heparin, patient received 2 L of IV fluids and patient was also given Rocephin and cefuroxime initially hospital was contacted for transfer apparently they did not have any beds and patient was transferred to Hospital.  When seen patient noted to be alert awake oriented x3 patient has a indwelling Foley catheter with gross hematuria, patient is on heparin drip, patient is complaining of pain lower back, numbness left foot.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (dose unspecified, oral, lot # L000569 with expiration date of 13-JUL-2016, lot # K019372 with expiration date of 13-JUL-2016, lot # L000434 with expiration date of 10-JUL-2016). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Almost fell down; lightheadedness, dizziness; head pressure; cold hands and feet; runny nose; This is a spontaneous report from a contactable consumer (patient herself) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date, as 2nd dose, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that after the second dose "the 4th", the patient almost fell down, experienced head pressure, cold hands and feet. The patient also experienced adverse events such as lightheadedness, dizziness and runny nose after her 2nd dose. The patient took paracetamol (TYLENOL). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
constant headache/ it was like on and off and now it is a steady headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: NORVASC taken for cardiovascular disorder. The following information was reported: HEADACHE (non-serious) with onset Oct2023, outcome "not recovered", described as "constant headache/ it was like on and off and now it is a steady headache". Therapeutic measures were taken as a result of headache. Additional information: NDC number of Comirnaty: 00069-2362-10. Patient would like to know if he should visit a doctor after experiencing headaches following the vaccination of Comirnaty 2023-2024 formula for 12 years and older. The headache started out slowly and just became a constant headache. He had an mRNA COVID shot about 2 and a half weeks prior. He was having a headache that, it just started like 4 days prior, and it was like on and off and became a steady headache. He started taking ibuprofen (MOTRIN) and then he stopped and he went and he got bare aspirin that thin out his blood because he was reading on here about blood clots and he was hoping that isn't it.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Covid vaccine given sat at room temperature for 7 days. Called patient on 12/6/2021 to notify her to come back for a repeat dose. She came back in for a repeat dose on 12/6/2021 same lot number and same injection site. She did state her first vaccine (one that sat at room temperature for 7 days) caused soreness of arm and swelling under arm. I called patient today 12/13/2021 to ask how she was doing. She stated swelling under arm is gone. She had no issues with the 2nd shot given on 12/6/2021.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications are reported   Reporter did not allow further contact
Information has been received anonymously concerning a female who was vaccinated with GARDASIL. Subsequently the patient experienced an adverse event. Caller disconnected before any further information could be obtained. The patient sought unspecified medical attention. No further information is available.
No adverse reaction in office after receiving a 2nd dose of Pediatric Pfizer COVID-19 (5-11) vaccine in office on the same day. Parent was contacted the next day to follow up on child's status but no answer.
This report describes the occurrence of uncontrollable crying in a 2-month-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  This report was received from the subject's mother and has not been verified by a physician or other healthcare professional.  The subject reportedly had no medical history, concurrent conditions, or concomitant medications.  On 12/20/2002, the subject received an injection of Infanrix (lot DTPA574A2).  On the same date, he reportedly received an injection of combination Haemophilus influenzae type b conjugate/hepatitis B vaccine (Comvax).  The mother stated that at an unspecified time post-immunization, on 12/20/2002, "My child had a severe reaction, uncontrollable crying for three hours."  The subject's pediatrician reportedly recommended paracetamol (Tylenol) which "significantly" helped.  As of 012/30/2002, the event had reportedly resolved.
Information has been received from a physician assistant referring to a 21 year old female patient with cinnamon bark allergy. The patient had no pertinent medical history. On 21-AUG-2014 the patient was vaccinated with the first dose of GARDASIL (0.5ml, lot# and expiration date were not provided) intramuscularly. The third dose of GARDASIL (0.5ml, lot# K011492, expiration date 22-JUN-2016) was received on 05-MAR-2015, which was confirmed not GARDASIL 9. There was no concomitant medication. On 06-MAR-2015, the patient experienced palpitations, light-headedness, upper and lower extremity heaviness, weakness, and paresthesia. Neurological exam on an unknown date in 2015 was normal and unspecified laboratory testing was normal. The patient was prescribed oral iron and vitamin D supplementation. The paresthesia had resolved on an unknown date in 2015, but other symptoms were ongoing. The patient sought medical attention through office visit. At the time of report, the causality was unknown. Additional information has been requested.
Seven days after injection, itching and swelling at injection site. A red patch about the diameter of a baseball. No pain. Throbbing and itching.  Took one Benadryl. No change in symptoms.
This 5 year old pt, same day post vax, became pale and developed a shaking episode. Medical attention was sought. She recovered the same day.