chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Thrombosis; Palpitations; chest Discomfort; Oedema peripheral; Diarrhoea; Dyspnoea; weight Increased; Oxygen Saturation Decreased; Dermatitis Contact; This is a spontaneous report received from the Regulatory Authority. The regulatory authority report number is 18848208.   A contactable consumer reported for 41-year-old female patient received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation; macitentan (OPSUMIT), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; and treprostinil sodium (REMODULIN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history was not reported. Concomitant medication included sildenafil citrate. The patient experienced palpitations, chest discomfort, thrombosis, oedema peripheral, diarrhoea, dyspnoea, weight increased, oxygen saturation decreased, dermatitis contact in Jan2021. The patient was admitted for the events. The action taken in response to the events for treprostinil and macitentan was unknown. Outcome of the events was unknown. The case was reported as serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (19Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
had dystonia or dystonic reactions; Initial information was received on 22-Jun-2021 regarding an unsolicited valid serious case from a physician (GMI Inquiry number: 00652151).  This case involves a five-month-old (unknown gender) patient who experienced dystonia or dystonic reactions (dystonia) after receiving HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious dystonia or dystonic reactions (dystonia) (unknown latency) following the administration of HIB (PRP/T) VACCINE. This event was assessed as medically significant.  The HCP stated that they ran labs on the patient and there were no inflammatory markers detected. The HCP informed that, the patient's mother was very cautious and didn't want her child to receive more than 1 vaccine in the visit. HIB (PRP/T) VACCINE [ACT-HIB] was the only vaccine administered during this visit. The HCP asked for clarification on how often these cases are reported out of 10,000 and to confirm that there were no reports associated with dystonia and ActHib in patients without inflammatory conditions.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the event outcome was unknown.  Information on batch number is requested.; Sender's Comments: This case involves a five-month-old (unknown gender) patient who experienced dystonia (unknown latency) after vaccination with ACT-HIB. The time to onset was unknown. The patient's laboratory tests showed no inflammatory markers. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Information has been received from a nurse concerning an 18 year old white female student (145 lbs., 64 in.) who on 15-MAR-2007 was vaccinated with Gardasil (Lot #654702/0011U).  On 15-MAR-2007 the patient experienced feeling dizzy after the injection.  The patient had not eaten all day.  The patient's outcome was not reported.  No further information is available.
Information has  been received from a nurse concerning an around 14 or 15 year old female patient who a few month ago, on an unspecified date was vaccinated with a second dose of GARDASIL (Lot # unknown). The nurse reported that after the patient received the second dose of GARDASIL started experiencing syncope episodes that persisted for a few months. According to the nurse, the patient was still experiencing dizziness and lightheadedness. The outcome of the syncopes is unclear. At the time of the report, the patient had not recovered from dizziness and lightheadedness. The patient sought unspecified medical attention. This is one of several reports received from the same source. No further information is available.
I started feeling body aches; slight fever; pain in the arm at the vaccine point.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Oct2021 06:30 (Lot number: FF2590) as dose 3 (booster dose), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR; BENICAR; INVOKAMET. Past drug history included: Ampicillin. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Right), administration date: 19Apr2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Right), administration date: 29Mar2021, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 20Oct2021 17:00, outcome "recovering", described as "I started feeling body aches"; PYREXIA (non-serious) with onset 20Oct2021 17:00, outcome "recovering", described as "slight fever"; VACCINATION SITE PAIN (non-serious) with onset 20Oct2021 17:00, outcome "recovering", described as "pain in the arm at the vaccine point.". Therapeutic measures were not taken as a result of pain, pyrexia, vaccination site pain.  Additional information: Patient didnt have COVID prior vaccination and not tested for COVID after vaccination. Patient signed privacy policy consent and didnt receive any vaccine in other four weeks.  No follow-up attempts are possible. No further information is expected.
Muscle aches and pains as if he had the flu. The symptoms quickly subsided. Went to see his primary physician. Now feeling better.
Very heavy/sustained menstruation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 03May2021 as dose 2, single (Lot number: EL3247, Expiration Date: May2021) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Headaches/Cramps" (ongoing); "Headaches/Cramps" (ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN] oral taken for muscle spasms, headache (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical location: Left arm, Batch/Lot number: EL3247, Expiry date: 00May2021), administration date: 12Apr2021, for COVID-19 Immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 2021, outcome "unknown", described as "Very heavy/sustained menstruation". Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional information: The patient had very heavy/sustained menstruation for a period of approximate 2 months started in Jun-Jul2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201375441 same patient and product, different dose and event;
Constipation; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONSTIPATION (Constipation). At the time of the report, CONSTIPATION (Constipation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Parent reports temperature of 107F, post vax. Denies other neurological symptoms. Seen today for exam. Temperature 99.4F. Vaccines not given at this site.
That evening (10/28/03) broke out in erythematous rash all over body.  Denied any tongue swelling or difficulty breathing.  Required IV steroids and Atarax at ER.  Is on a prescription for steroids orally (tapering dose.  Currently with minimal rash left 10/30/03.  report made by her PMD.
Information has been received through the pregnancy registry from a physician concerning a 26 year old pt with a second dose of varicella virus vaccine live. On approximately 9/23/02, hte pt found out she was 7 weeks pregnant. On 9/27/02, the pt's boyfriend reported that the pt was in the hospital because she was "very sick, cannot stop vomiting and her ulcer hurts" and that a few days ago he noticed she had the chickenpox. On 9/27/02 the physician saw the pt in the hospital and reported that she was hospitalized with hyperemesis that she was experiencing with her pregnancy. The physician also reported that the pt was in isolation for a chickenpox rash, but that she did not have any lesions on her. The physician has requested clarification from the internal medicine physician regarding the pt's chickenpox. The reporting physician was waiting to see if the pt had an increase in her IgM and IgG and has requested a perinatal consult. Additional info has been requested. A 15-day follow up report received 9/17/2003 adds: Follow-up info was received frmo a registered nurse. On 05/09/2003, the pt delivered a male infant via vaginal delivery and as far as the reporting nurse knew, the infant was fine (the reporter stated, "(they) are not the pediatrician"). Additional info has been requested.
8//31/2022. AM PATIENTS GOT MONOVALENT BOOSTERS AT CLINIC. WE WERE ALERTED LATER IN DAY TO NOT DO MONOVALENT AND USE THE BIVALENT MODERNA ONCE AVAILALBE. ALERTED STAFF. DISCARDED MONOVALENT VACCINE AND AWAITING BIVALENT TO ADMINISTER.  LOT 083822A. EXP 9/10/2022
After the flu shot in (L) deltoid, felt pain in (L) forearm, and hard sharp, shooting in nature, denies any weakness or numbness. No rash or allergic reaction, denies CP/SOB/dizzy.
Patient stated that about 24 hours later she has developed a red swollen area that is warm to the touch.  She states her arm is sore.  She does not have a fever.
DEATH; ADVERSE REACTION; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse reaction and death. On an unspecified date, the patient died from adverse reaction to vaccine. The reporter reported "My friend's ex wife just dropped dead shortly after an adverse reaction to vaccine. She was forced yo get it or lose her job. Now her 20 yr old daughter has no parents. Covid VAX is a death sentence for those age 30-50. Do not get it." It was unknown if autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of adverse reaction was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20220910829-covid-19 vaccine ad26.cov2.s -Death, Adverse reaction. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: ADVERSE REACTION TO VACCINE
Some itching during stay started 10 minutes after observation period started. kept 45 min. improved after went home. Declined need for ED visit.
I woke up Saturday morning with a red area encircling the injection site. No itching, may have been slightly raised, hard to tell. Still there on Monday, slightly larger, with the edges a more pronounced red color than the center now.
While covering for my colleague during lunch, I accepted care of the pediatric patients. I grabbed the pediatric Pfizer vaccines and Moderna booster vaccines from a different station and brought them to my station. The Moderna booster vaccine bin was sitting inside the pediatric Pfizer bin. When I went to administer the pediatric Pfizer vaccine to the patient I accidentally grabbed a Moderna booster vaccine by mistake since the bin was sitting on top of the other. The patient accidentally received a Moderna booster vaccine.
That night of the vaccine I had high blood pressure, didn't sleep, had a fever, felt nauseous, body was trembling, severe headache felt in the middle of my brain. Beginning in June I started having chest pains in the middle of my sleep (documented in email to doctor who reports it coud be from inflammation).  Back pain began in July then worsened to where I was waking in the middle of the night with severe spasms not allowing me to sleep. Xrays were completed in August revealing degeneration which I believe to be caused from inflammation (myleitits) derived from the vaccine. Previous hip xrays do not reveal degeneration of my spine prior to the vaccine.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patient's medical history or concurrent condition were not provided. Heathcare worker reported that unspecified doses of improperly stored GARDASIL (lot#, dose/dose number, route, duration were unspecified) were administered to the unspecified patients on unspecified dates. No concomitant therapy was provided. No adverse effects reported. This was one of several reports that received from the same reporter. Additional information has been requested.
This case was reported by a nurse via other manufacturer and described the occurrence of injection site erythema in a patient who received DTaP. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to DTaP vaccine. No additional information available at the time of reporting.
p/vax pt seen in ER c/o fever; chills;dizziness; mild tachycardia & cough; MD impression probable viral illness;tx: IV hydration & tylenol PRN;a questionable systemic react to 4th vax
Pt. received Flu vaccine. Sat for 10 minutes and when she got up to leave she fell forward due to fainting, she had a small laceration to forehead. Dr. sutured wound.
Redness and swelling of upper arm to elbow with excoriated blister vs abrasion at shot site.
PATIENT REPORTED SIGNS AND SYMPTOMS OF BELLS PALSY. PATIENT WENT TO THE ER WITHIN 1 HOUR OF SX. PATIENT WAS GIVEN AN ANTIVIRAL MEDICATION CALLED  VALTREX.   Patient  says due his diabetes they did not prescribe corticosteroids.
neck stiffness; rigors; Severe myalgias; nausea; Pfizer Booster dose administered and experienced events; Pfizer Booster dose administered and experienced events; This is a spontaneous report from a contactable Physician (patient) reported for herself.  A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration, administered in arm left on 29Sep2021 14:15 (Batch/Lot Number: FF8841) (age at vaccination 26-year-old) as Dose 3 (BOOSTER), single for covid-19 immunisation at Hospital; influenza vaccine (INFLUENZA), via an unspecified route of administration at right arm on 29Sep2021 (Batch/Lot number was not reported), at dose number unknown, single for an unspecified indication. The patient had no known allergies. The patient medical history included attention deficit hyperactivity disorder and asthma from an unknown date and unknown if ongoing. The patient received historical vaccine of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as dose 1 single and dose 2 single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications included Allegra, acetaminophen, bupropion within 2 weeks of vaccination taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had received Pfizer booster on 29Sep2021, experienced events (Off label use, extra dose administered) ; severe myalgias, neck stiffness, nausea and rigors on 30Sep2021 at 03:30 am. Events were reported as non-significant. The patient did not received any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I got 2 phizer vaccines. The first was in August and the 2nd 3 weeks later in early September.
He came home with a heartburn; This is a spontaneous report from a contactable consumer (patient's son). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine earlier in the morning (unspecified date). He came home with a heartburn and took his esophagus medication for it. By 3:00 pm he still had a heartburn and took another dose of his medication. The patient was asking if there were any reports of heartburn as a side effect. Outcome of the event was unknown.  Information about batch/lot number has been requested.
A burning, tingling sensation went up my right arm, across my chest and down my right arm. It lasted about 40 mins and my bp rose to 160/92. After 40 mins, it went away and my bp returned to 125/72. About an hour later it happened again from my stomach up to my throat lasting about 5 mins.
Shingrix vaccine was delivered to immunocompetent patient under the age of 50. Prescription was entered into computer system by technician and checked by pharmacist and neither caught the patient age. Patient stated she had had shingles in the past and her doctor advised her to get the vaccine early. Pharmacy will hold off on administering second dose of vaccine until patient is 50 years old.
pt says she felt very strange like she was having some type of reaction and like something was wrong with her.  She wants to sleep all the time and stay asleep.  She says she has never been so tired and she is scared to even drive.  She reported this to her pharmacist.  She cant keep her balance and has never been so tired in her entire life, saying she could sleep night and day if she could and has felt bad since the day she took the vax.  She also has some brain fog.  She had to put her husband in a Rehab because he needs her care and she was not able to take care of him since she was so sick.  (she wanted me to take note of these numbers)
This spontaneous report as received from a nurse refers to an approximately 61 year old female patient with hypothyroid and Bactrim allergy. On an unknown date the patient experienced a generalized rash to an unspecified formulation of Bactrim. On an unknown date in October 2013 the patient was vaccinated with ZOSTAVAX 9lot number and expiry date not reported) (dosing regimen and frequency unknown) subcutaneously (also reported as routine vaccination). Concomitant therapies included Levothyroxine sodium (manufacturer unknown). On October 2013 the patient experienced knot at the right arm injections site which was warm and reddened. There were no lab diagnostic studies performed. The knot at the right arm injection site which was warm and reddened improved each day and resolved on an unspecified date. The outcome of knot at the right arm injections site which was warm and reddened was reported as recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. Additional information has been requested.
rahs - irregular shaped wheals,  pruritic in nature - hives resolved by 4/14 w/ use of Benadryl
This spontaneous report as received from a pharmacist refers to a 62 year old female patient with codeine allergy. On 10-OCT-2013, the patient was vaccinated with ZOSTAVAX lot # J004267, expiration date: 12-JUL-2014, subcutaneously. (dose not reported). Concomitant medications included "unspecified number of medications". On 11-OCT-2013, patient experienced silver dollar size rash around injection site which was painful, swollen, warm to touch and tender. The patient called pharmacy. No treatment was given for the events. No laboratory diagnostics studies performed. The outcome the events was reported as recovering. Additional information has been requested.
Patient stated she developed clots during hospital admission with the complaint of chest pain. Patient stated at hospital admission, they discovered blood clot in her right leg and right lung. Patient was treated with oxygen and medication. Patient was inpatient for two nights and sent home lovenox injections for one week and continuing with Eliquis. Patient is currently on Eliquis for unknown duration. Patient will see cardiologist in three weeks and reevaluate.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with improperly stored RECOMBIVAX HB (lot#, dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.