chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash began on left leg on 01/14/21; rash progressively spread to entire both legs and left neck; became very itchy and nothing over-the-counter (topical or oral) helped or reversed symptoms; rash continued for over 5 weeks; also experienced dull, around-the-clock headache during this time;  On the morning of 02/21/21 awoke to petechial rash on bilateral eyelids, cheeks, left and right neck; went to urgent care; placed on steroids- Steroid IM injection given on 02/21/21, Medrol Dose pack started on 02/22/21- all symptoms resolved quickly with steroid dosing
rash consistent with cutaneous lupus erythematosus; rash consistent with cutaneous lupus erythematosus; This is a spontaneous report from a contactable physician.    A 65-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 10Mar2021 (Batch/Lot number was not reported) (Age at Vaccination: 65-years-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included hypertension. Historical vaccine included first dose of bnt162b2 Intramuscular administered in Arm Left on 16Feb2021 (age at Vaccination: 65-years-old) for COVID-19 immunization. No Covid prior vaccination. No known allergies. Concomitant medications included Metoprolol, atorvastatin and Tamsulosin. The patient experienced rash consistent with cutaneous lupus erythematosus on 01Apr2021. AE resulted in Doctor or other healthcare professional office/clinic visit. AE treatment included topical corticosteroids. The outcome of the events was recovering. The events were reported as non-serious. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event cutaneous lupus erythematosus and suspect drug BNT162B2 cannot be excluded.   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.
Acute onset thunderclap headache which had never been experienced previously.  I have 17 events in 14 days treated with IM Tordol and Promethazine  Headaches were 10/10 pain scale and included profuse vomitting, disorientation, blurred speech and vision.
No additional AE reported; patient was administered an expired dose of VAQTA.; This spontaneous report as received from a registered nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 10-NOV-2021, a patient was administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S001832 has been verified to be a valid lot number, expiration date reported as 12-MAY-2021, but upon internal validation established as 12-MAY-2020; dose, strength and route were unknown by reporter) for prophylaxis (expired product administered). The reporter confirmed the suspect vaccine experienced no temperature excursions. The reporter was provided the not supported disclaimer based on the information in the post expiry memo. No additional AE reported.
Patient called 3/15/07. Patient states the morning after she received her 2nd dose of Gardasil, when she woke up her face and neck was red and cheeks were puffy and also itchy. Patient did state she was in the sun x 45 minutes after she left our office- was using a new sunblock x 4days. Patient states swelling and redness was gone by the next day. No treatment. Information has been received from a registered nurse concerning a 19 year old female with no illness at the time of vaccination, allergy to ibuprofen, and seasonal allergies who on an unspecified date was vaccinated with a first dose of GARDASIL. On 12-MAR-2007, the patient was vaccinated with a second dose of GARDASIL (lot # 6555619/1427F). 0.5 ml IM in the right deltoid at 10:30 AM. Concomitant therapy included unspecified therapies. On 13-MAR-2007, in the early morning, the patient experienced redness of her neck and cheeks, face was little puffym, and itchy almost like sunburn after receiving the second dose of GARDASIL. Medical attention was sought. At the time of reporting, the outcome was unknown. No further information was available at the time of reporting. Additional information was received from the registered nurse. The patient had called on 15-MAR-2007 to report that the morning after she received the second dose of vaccine, when she woke up, her face and neck were red and her cheeks were pufy and also itchy. The patient was in the sun for 45 minutes after she left the office. She was using a new sunblock for four days. The patient reported the swellinf and redness were gone by the next day, No treatment. At the time of reporting, the patient had recovered. No additional information is expected.
Morning after the 2nd vaccine, I felt nauseous after eating breakfast, went to the kitchen sink to puke, passed out, and woke up on the floor in a puddle of vomit and with 2 broken teeth.
Burns; Very painful; Rash from head to toe that itches; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash from head to toe that itches), BURNING SENSATION (Burns) and PAIN (Very painful) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (Rash from head to toe that itches). On an unknown date, the patient experienced BURNING SENSATION (Burns) and PAIN (Very painful). At the time of the report, RASH PRURITIC (Rash from head to toe that itches), BURNING SENSATION (Burns) and PAIN (Very painful) had not resolved.            No concomitant product use was provided by the reporter. No treatment medication was provided.
The pt experienced a red, swollen warm indurated area around the vaccination site to the right deltoid.
SICK; VOMITING; FEVER; CHILLS; MUSCLE ACHES; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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 not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced sick. On 2021, the subject experienced vomiting. On 2021, the subject experienced fever. On 2021, the subject experienced chills. On 2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, sick, vomiting and muscle aches was not reported. This report was non-serious.
Fever 100 08/29.  Red, blister looking pustule on belly and one between 3rd and 4th finger left hand.  6-8 tiny red papules in various stages on abdomen right thigh, 2 on left arm, 1 on right arm, post neck.  First spot noticed 08/30/2003.  Patient parent informed to keep clean and dry, give Benadryl, Tylenol, call progress.
This case was reported by a physician and described the occurrence of bilateral leg swelling in a four month old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 18Nov03, the pt received the second dose of Infanrix injected into the right thigh. The same day the pt received Haemophilus influenzae type b conjugate vaccine, poliomyelitis virus vaccine (IPOL), and 7-valent pneumococcal conjugate vaccine (Prevnar). The sites for the administration of the concurrent vaccinations were not specified. On an unspecified time post-immunization, on 18Nov03, the pt experienced redness and swelling of both legs and inconsolable crying. The events resolved on 20Nov03. The immunization series with Infanrix was discontinued. The physician considered the events were probably related to vaccination with Infanrix.
This spontaneous report was received from a doctor of pharmacy concerning a 54 year old female with no pertinent medical history and no drug reactions or allergies. On 09-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as J001005 and 24-APR-2014 respectively, dose and route unspecified). There was no concomitant therapy. Approximately on 11-JUL-2013, about two days after administration of ZOSTAVAX, the patient experienced redness at the injection site that measured about 3 inches. The patient did not seek any medical attention. She was treated with BENADRYL and cortisone. No lab tests were performed. Approximately on an unknown date in 2013, the patient was recovered from redness at the injection site that measured about 3 inches. The relatedness for redness at the injection site that measured about 3 inches was unknown for ZOSTAVAX. Additional information has been requested.
Caused a lump, redness, soreness on lower abdomen. Appearance 3 days after vaccine, blood sugar and blood pressure went up. Puffiness around eyes and redness. Extreme tiredness. Still red around eyes and on lower stomach. Follow up on 11/13/2003: "Patient describes symptoms starting 09/29/2003.  Reports increased blood pressure, blood sugar increased and eyes red and swollen.  Also reports bumps on skin one on lower abdomen one on back of neck.  These resolved on own.  Seen by nurse practitioner 10/20/2003 diagnosis of left eye stye.  Patient has hypertension and Otitis Media.  Still with eye problems."
received INFANRIX instead of BOOSTRIX; adult received dose of INFANRIX; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 30-year-old male patient who received DTPa (Infanrix) (batch number ak443, expiry date 16th September 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd June 2022, the patient received Infanrix .5 ml and Infanrix Pre-Filled Syringe Device. On 3rd June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comments: The health care professional reported that the patient received wrong vaccine. The patient was an adult who received Infanrix instead of Boostrix. The reporter consented to follow up. Additional Supportive Information: The health care professional reported that a patient received Infanrix vaccine instead of Boostrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration. The case US2022092462 was identified as duplicate of this case. The case US2022092462 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
During the night after the first dose of the vaccine I got a fever and headache. I had chest pressure I have had congestion and breathing problems for six months since I got the first dose. I am constantly experiencing drainage and congestion which I had never had before. The pain was on the left side under my breast. As the day progressed the chest pain got worse. My fever fluctuated between 101-103 for seven days. I had severe headaches and body aches that whole time. By the tenth day I still had the headache and the fever and body aches had improved. The first three months after the first dose of my vaccine I had more severe Migraines which were so bad that I was nauseated and required a prescription for Imitrex. It helped alleviate the pain. I was medication every other day for five months. My Migraines used to be only once a month and they were controlled Ibuprofen. The pressure on my chest was sharp pains that radiated out from the left side. It has been six months and my Migraines are still persistent three times weekly. The chest pressure has improved but I am still very congested. I got the second dose of the vaccine and there was no change in my symptoms.
Routine immunizations administered 5/29/01. Onset of elevated temperature (>104F), weakness, shaking and complaint of eyes hurting on 5/30/01.
My next period was only 2 days early, however it has lasted 8 days now. I have never had a period continue this many days; my period started 7 days early with many clots (also abnormal for me).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 (Lot number: FA7485) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUOXETINE. Past drug history included: No. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FA7485, Location of injection: Arm Left), administration date: 06Aug2021, for COVID-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 04Sep2021, outcome "not recovered", described as "My next period was only 2 days early, however it has lasted 8 days now. I have never had a period continue this many days"; MENSTRUAL DISORDER (non-serious) with onset 04Sep2021, outcome "not recovered", described as "my period started 7 days early with many clots (also abnormal for me).". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder, menstrual disorder.  Additional information: Patient have had regular periods for years. However, following her 2ND dose of the vaccine, her period started 7 days early with many clots (also abnormal for me). The period lasted only 3 days. Typically, her periods last 5 days. Patient's next period was only 2 days early, however it has lasted 8 days now. Patient never had a period continued these many days. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Facility where the most recent COVID-19 vaccine was administered was Clinic facility.  No follow-up attempts are possible. No further information is expected.
I61.9 - ICH (intracerebral hemorrhage) (CMS/HCC)
PCR confirmed Monkeypox; Case reference number US-BN-2022-004669, is a spontaneous case report initially received from a healthcare professional via Agency (reference number: USBAV22-1943) on 11-Nov-2022 and concerns a patient of unknown gender or age.  The patient medical history included human immunodeficiency virus (HIV) with CD-4 lymphocytes, at 915 (units not provided).  The patient's concomitant medication was not provided.  On unspecified date, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at unknown dose, route of administration and anatomical location, for indication reported as to decrease the incidence of monkeypox.  On unspecified date, reported as two weeks after Jynneos vaccination, a polymerase chain reaction (PCR) test confirmed the patient had monkeypox.   At the time of this report, outcome of event monkeypox was unknown.  The reporter assessed the event monkeypox as non-serious and related to Jynneos vaccination.   Additional information received from the physician via Agency on 11-Nov-2022: New information included seriousness and causality assessment for event monkeypox.  Additional information received from Bavarian Nordic on 14-Nov-2022 included the local BN case ID.  This case is linked with US-BN-2022-004662, US-BN-2022-004663, US-BN-2022-004664, US-BN-2022-004665, US-BN-2022-004666, US-BN-2022-004667, US-BN-2022-004668 (same reporter).; Reporter's Comments: A patient of unknown demographics received two doses of Jynneos, applied on unknown dates for monkeypox prevention. Two weeks after vaccination, the patient developed the serious (medically significant) event of monkeypox, confirmed via PCR test. Monkeypox is unlisted per the CCDS V1 and PI for Jynneos. Medical history included HIV, with CD4 lymphocytes level currently at 915. Considering that Jynneos is a non-replicating vaccine which does not contain the monkeypox, and that the event occurred two weeks after vaccination, the event is assessed as not related to Jynneos. As with any other vaccine, vaccination with Jynneos may not result in protection in all cases.; Sender's Comments: A patient of unknown demographics received two doses of Jynneos, applied on unknown dates for monkeypox prevention. Two weeks after vaccination, the patient developed the serious (medically significant) event of monkeypox, confirmed via PCR test. Monkeypox is unlisted per the CCDS V1 and PI for Jynneos. Medical history included HIV, with CD4 lymphocytes level currently at 915. Considering that Jynneos is a non-replicating vaccine which does not contain the monkeypox, and that the event occurred two weeks after vaccination, the event is assessed as not related to Jynneos. As with any other vaccine, vaccination with Jynneos may not result in protection in all cases.
chills and vomiting; vomiting; This is a spontaneous report from a contactable consumer (patient's mother). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in 2021 as unknown dose, single for COVID-19 immunization in pharmacy. Medical history included ongoing diabetes for about 5-10 years and had a callus on his big toe referring to diabetic ulcer. The patient's concomitant medications were not reported. The patient experienced two episodes of chills and vomiting in Apr2021. The first episode was in Apr2021 (3-4 weeks ago and about 2 weeks after the shot) while the second episode in May2021 (on that past weekend). The outcome of these events was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
sudden onset unilateral tinnitus to the side of the vaccine administration (left).; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperlipidemia. The patient had no known allergies.  Concomitant medications 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. On 26Mar2021, the patient experienced a sudden onset unilateral tinnitus to the side of the vaccine administration on the left side. The patient denied any associated hearing loss, otalgia, otorrhea, prior tinnitus, or history of loud noise exposure. He stated that it was present after the first shot and then mildly improved, and then significantly worsened after the second shot. The patient further described the tinnitus as high pitched buzzing, non pulsatile and he had no issues on the right side. This event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of tinnitus and included treatment with prednisone (60mg) for 5 days and the patient underwent MRI brain scan with internal auditory canal (IACs) which was normal, audiogram was essentially normal with mild left high frequency sensory neural hearing loss. The clinical outcome of the event tinnitus was not recovered at the time of this report.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended Start date and stop date of vaccine were removed, reporter information, and anatomical location.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Turned very red, back pain-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose number unknown, single (Lot number: TE3590) and on 15Apr2022 as dose number unknown, single (Lot number: FJ4989) at the age of 68 years for covid-19 immunization. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing). The patient took other medication in 2weeks. Past drug history included: Codeine, reaction(s): "known allergies Codeine", notes: known allergies Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures of Paxlovid  were taken from 08Jun2022 to 13Jun2022 as a result of drug ineffective, covid-19.
Dizziness next day couldn?t walk without hanging on to something, very bad tinnitus in both ears snd persistent cough 3 weeks after 2nd Moderna shot Hasn?t gone away. Tried antibiotics and nasal spray  with no success