chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was considered medically important for the event of developmental coordination disorder (OMIC). Information regarding Prevnar was received from a physician regarding a 12 month old male patient who exhibited a developmental coordination disorder on 2/18/05. At 9 months of age, the patient received his fourth dose on 11/16/04. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 11/16/04. Dose regimen was 1 dose (IM). Concomitant therapy included Hepatitis B vaccine and influenza virus vaccine. A physician reported that on 11/16/04 during the patient's 9 month office visit, the patient inadvertently given what was thought to be a third dose of Prevnar. This dose was actually the patient's fourth dose, and was administered in accordance to an incorrect immunization data entry on the patient's chart. At this visit, the patient's Denver assessment and appearance were noted as fine. The only questionable note in the chart was that the patient was only sometimes pulling to stand. On 2/18/05, the patient received a fifth dose of Prevnar. The physician noted at this time that the patient was not standing or taking steps and subsequently classified the patient's gross motor skills as floppy. The child's fine motor skills were assessed as good. The patient was referred to the hospital where his gross motor skills were also assessed as floppy. An appointment has been scheduled with a neurologist in April. No additional information was available at the time of this report.
Initial report was received on 21 July 2011 from a consumer, who is also the patient's parent. A 14 year-old male who was "two or three years-old" at the time of vaccination had received an injection of DTP (manufacturer, lot number, route, site and date of administration not reported) and with in a few minutes turned red and had difficulty breathing. The patient was treated in the physician's office. Treatments were not reported. According to the reporter, "it was so many years ago she had no other information to provide. She refused contact information for the patient's past or present health care professional  and wishes no further contact regarding this report. No further information was available at the time of the report. The patient's outcome was not reported. Document held by sender: none.
Recipient began feeling warm and getting lightheaded after being vaccinated. Recipient and mom verbalized he had not eaten all day. The recipient laid down with feet up and was given water. Recipient started feeling better. Recipient was kept for 30 minutes to monitor and verbalized felt much better. RN's advised mom to get recipient food and encouraged fluid intake. No further issues or concerns to report.
This spontaneous report was received from a 69 years old female patient concerning herself. The patient's medical history included shingles and allergy to anti-cholesterol drugs. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX on 06-OCT-2012. No other co-suspects were reported. Concomitant medications included: DETROL. On 07-OCT-2012 the patient developed itching on the ear after receiving ZOSTAVAX. The itching worsened and on 10-OCT-2012 the back of her ear was "crusty" and she had developed a red circle on her throat. The patient was diagnosed with shingles on 10-OCT-2012. The patient sought medical attention. The patient was told by her physician to use CLARITIN, isopropyl alcohol, IVY DRY and an unspecified anti-itch cream as treatment. No laboratory tests were performed. The outcome of shingles was reported as not recovered/not resolved. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Ulnar neuropathy symptoms such as tingling and mild swelling of the left arm radiating to fingers
Pain at injection site; Fever; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date received 1st dose of 0.5 mg/ml.).   On 15th June 2022, the patient received the 2nd dose of Shingrix .5 mg/ml. On 15th June 2022, immediately after receiving Shingrix, the patient experienced injection site pain, fever and tiredness. On an unknown date, the outcome of the injection site pain, fever and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever and tiredness to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The caller was the husband of the patient. The reporter stated that the patient got her second Shingrix vaccine on left arm and was experiencing pain at the injection site, fever, and tiredness. The reporter stated that the pain started almost immediately, and the fever and tiredness started about 8 hours later. The patient was still experiencing these symptoms at the time of reporting. The reporter was unsure when patient got her first vaccine, but that it was in the appropriate time frame. The reporter did not have any further information about the vaccines such as lot or expiration. The reporter did not consent to follow-up.
About 10 days after my third Covid-19 Moderna vaccine (booster shot), I developed hives all over my body. The hives present as itchy red welts that last for about 20-30 minutes before dissipating, but the hives recur in different spots on my body shortly after.  I have had hives for a week so far.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 22-OCT-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Swollen lymph nodes near left side clavicle. The size is a grape in size, occurred 1.5 days after vaccine.
PT WENT TO ER AFTER INJECTION AFTER 2 DAYS DUE TO SHORTNESS OF BREATH. HOSPITAL FOUND INFLAMATION AROUND THE HEART (SIMILAR TO CONGESTIVE HEART FAILURE), CLOTTING, ARRYTHMIA.
Area of about 6" x 6" is red, swollen and hot to the touch.
Case number PHEH2016US023735, is an initial spontaneous report received from a medical assistant on 14 Sep 2016. This report refers to an 17 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with one single dose of FLUVIRIN (batch number: 1514801 and expiry date: May 2016) at a dose of 0.5 ml, intramuscularly on 13 Sep 2016. On 13 Sep 2016, 8 patients have received expired FLUVIRIN vaccine from last year over several days. No adverse event was reported following this medication error (expired product administered). The case was assessed as non-serious by the medical assistant.
Ever since, I have had significant changes to my menses.  They are much less predictable, both in duration, heaviness, and regularity.    Although they seem to happen much more frequently, they are not as heavy as usual and also I no longer have the kind of significant PMS symptoms and menstrual pain I have had my entire life.  I don't consider this a bad thing, however, especially because I'm not intending to have any more children.
Sx: Freezing, skin sensitive, nausea, no vomiting and pain, dizzziness. Tx: ADVIL for symptoms relief.
Patient presents with hypertensive crisis, pain in left knee, elbow and fingers and toes. Dry mouth. Vomit is colored green. Oliguria.
This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm right on 02Jun2021 around 2:00 to 3:00 pm (Batch/Lot number was not reported) as single dose at the age of 70-year-old for COVID-19 immunization. Medical history included lot of medical conditions, recovering from broken leg, blood pressure high treated before with Lisinopril and then with a new drug just prescribed, dissociative identity disorder, depression, anxiety, acid reflux, pain, neuralgia, had ulcerative colitis in the past (treated with medication). Family medical history included her mother had diarrhea very badly. Concomitant medication(s) included ziprasidone hydrochloride (GEODON, capsule) orally, twice a day, taken for dissociative identity disorder, start and stop date were not reported; tramadol (manufacturer unknown,  tab) 50 mg, twice a day, orally, taken for pain relief, start and stop date were not reported; hydroxyzine (manufacturer unknown) 25mg taken for nerve pain, start and stop date were not reported; clonazepam (manufacturer unknown, tablet) 1 mg, orally, taken for neuralgia, start and stop date were not reported. The patient previously received, lisinopril for hypertension. Vaccine history included BNT162B2 on 23Feb2021 for covid-19 immunization. No other vaccine administered together with BNT162B2.  In Jun2021 the patient experienced this is much worse than ulcerative colitis (medically significant) with outcome of unknown, diarrhoea (non-serious) with outcome of not recovered, she cannot eat anything without getting sick (non-serious) with outcome of unknown, she was very sick with diarrhea (non-serious) with outcome of unknown, she received BNT162B2 2st dose on 23Feb2021 and 2nd dose on 02Jun2021 (non-serious) with outcome of unknown. The course of events was as follows: She got the COVID019 vaccine on 02Jun2021 afternoon and she had diarrhea repetitive diarrhea ever since its uncontrolled diarrhea she had to wear diaper and on 04Jun2021 she had to wash her clothes several times and she lied on bed for a while she had to wash that cloth as well she was very sick with diarrhea and she was reading diarrhea can be result of the vaccine she cannot eat anything without getting sick and she did not know what to do. Treatment received in response to event diarrhoea: Pepto-Bismol during the day time, 2 Pepto-Bismol every 30 minutes; 262 mgs. Information on the lot/batch number has been requested.
Adult patient was given pediatric doses of havrix and engerix b; Adult patient was given pediatric doses of havrix and engerix b; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in an adult female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix pediatric) for prophylaxis and hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric, Engerix B Pre-Filled Syringe Device, Havrix pediatric and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric, Engerix B Pre-Filled Syringe Device, Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product 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 details were reported as follows: The age at vaccination was not reported. The reporter reported a medication error occurred as an adult patient was given pediatric doses of Havrix and Engerix B which led to adult use of child product and accidental underdose.  The reporter asked how to move forward.  The reporter consented to follow up.
Next day low grade fever and a headache.  Two days after, my right arm was itchy, sore and red.   Was prescribed Clobetasol for something else but was told by Dr. to use on arm and it cleared it right up.
4 days after receiving vaccine he began having a red rash on his face and shoulders. On day 8 after receiving the shot he broke out with hives and a red rash on legs then began a temperature. Rash, hives, and temp continued for 4 more days. First began treating with Benadryl for the hives and Motrin for his temperature. His temperature fluctuated between 101.5F- 99F. After 4 days with little improvement, the doctor prescribed Hydroxide liquid and after 2 days symptoms improved.
Varicella- Information has been received from a registered nurse concerning a 5 year old female patient who in 1995 was vaccinated with varicella virus vaccine live.  On 01 Jun 2000 the physician's office was notified by the patient's mother that she has developed approximately 20 varicella lesions.  Unspecified medical attention was sought.  Additional information has been requested.
Pt recvd vax & exp fever, sweats, achinesss, elevated liver function tests & SMA12 abnormalities; pt did not go to ER & was not hospitalized; dx w/bactrim induced hepatitis; also exp inc BP;
flu; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect Influenza Vaccine (strength, formulation, route, dose, frequency: unknown) produced by unknown manufacturer lot number not reported in unknown administration site.  On an unknown date the patient developed a non-serious "flu (influenza)" (unknown latency) following the administration of Influenza Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  Outcome: unknown
Within 15 minutes of the injection, the individual became aphasia and stroke like symptoms. She was taken to the ER where she was later diagnosed with a cerebral hemorrhage and passed away.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 71 years old with past medical history of IBS, Iron Deficiency Anemia, Hyperlipidemia, Hypothyroidism, Coronary Arteriosclerosis, Hematuria, Obesity, Benign Hypertension, Foot Pain, Mood Disorder. Per last few days Patient was having food nutrition through G-tube. Also had BIPAP mask full time with oxygen through g-tube, also within past few days he was losing weight. Patient last visit to ER notes developed sob and swallowing difficulties in 6.2020. He was unable to eat and peg tube was placed in Sept 2020. For the ALS treatment patient was getting Radicava via PICC line to slow progression of ALS. He continued IV treatment and was admitted to hospital from 4/8 to 4/15 for pneumonia and SOB. Patient was enrolled for a home and functional assessment, remote monitoring, and care coordination. Cause of death of patient is noted as progression of ALS. Patient was deceased on 5/16/2021.
pt recv vax; resp arrest; pallor, lethargy; aspiration pneumonia; tx ventilator;noted pale, eyes rolled up while laying on side; resp difficulty; to er;
Turned hair colors.  Hair was originally white and hair has turned black in the back of her head and new hair growing in the front. Aches in hip, shoulders, elbows and knees.  Lasted about 2 weeks.
PULMONARY EMBOLISM IN BOTH LUNGS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose was administered on unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date (within a month after vaccination), the patient had pulmonary embolism in both lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism in both my lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210859993-covid-19 vaccine ad26.cov2.s-Pulmonary embolism in both my lungs. This event(s) is considered unassessable. The event(s) 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(s).
It started with my neck, I went to the chiropractor in January because of the pain in my neck. In June I started having pain in my right hip and then transferred to the left. It was all over my body within three weeks. I went to physical therapy and it didn't do anything. I demanded to  see specialist, Rheumatologist. I was then diagnosed with an auto immune disease, Polymyalgia Rheumatica on 9/14.
Narrative:  Patient tested positive on 12/27/2021 and hospitalized despite one time J&J vaccine on 05/14/2021, no booster received to date. COVID-19 symptom of dry cough began 8-9 days prior to admission for syncope. No monoclonal antibody treated utilized.
Site: Bruising at Injection Site-Mild, Systemic: Bell's Palsy-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: complianed about facial numbness of tongue cheek and eye swelling on one side. I, the pharmacist on duty advised the patient to seek medicall attention asap. he has not seen a doctor yet? but did complain of neurologocal deficiets
DEVELOPED HIVE AT SITE WITHIN 5 MIN. SINCE HAS DEV. SYSTEMIC HIVES SCATTERED ALL OVER BODY AND HEAD. PARENT ADMINISTERED BENADRYL AT HOME. SCRIPT CALLED FOR ZYRTEC.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Apr2023 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anti-synthetase Syndrome" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Oct2023) Negative; (23Oct2023) Possitive. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 09Oct2023 to 13Oct2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
feeling lots of malaise; dizziness; short of breath; lots of sleep; headache; fever; lots of chills; lots of tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling lots of malaise), DIZZINESS (dizziness), DYSPNOEA (short of breath), HYPERSOMNIA (lots of sleep) and HEADACHE (headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MALAISE (feeling lots of malaise), DIZZINESS (dizziness), DYSPNOEA (short of breath), HYPERSOMNIA (lots of sleep), HEADACHE (headache), PYREXIA (fever), CHILLS (lots of chills) and FATIGUE (lots of tiredness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, MALAISE (feeling lots of malaise), DIZZINESS (dizziness), DYSPNOEA (short of breath), HYPERSOMNIA (lots of sleep), HEADACHE (headache), PYREXIA (fever), CHILLS (lots of chills) and FATIGUE (lots of tiredness) outcome was unknown. Not Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Covid Arm: Itchy, hot, red welty rash appeared about 36 hours after the shot. It was treated with Benedryl, Motrin, and Tylenol which helped the rash subside. It appeared again the following day and then once more the day after that. The same treatment was applied. The rash stopped appearing 5 days after the injection.
first dose of the vaccine on 02Apr2021 and then tested positive for COVID-19 on 06Apr2021; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old female patient received the first dose bnt162b2 (Pfizer, Lot Number: ER8733) via intramuscular on 02Apr2021 16:00 as single dose in arm right for covid-19 immunisation at the age of 49-year-old. There was no medical history and concomitant medication. No previous immunizations with the Pfizer vaccine considered as suspect and no additional vaccines administered on the same date. The patient got her first dose of the vaccine on 02Apr2021 and then tested positive for COVID-19 on 06Apr2021. The outcome of the event is unknown. The patient underwent sars-cov-2 test: positive on 06Apr2021. The event didn't require visit to Emergency Room and Physician Office. The patient was out of isolation and has no symptoms and to ask was it okay for her to get her second dose of the vaccine on 23Apr2021.   No follow-up attempts are possible. No further information is expected.
A lump approx 3cm on lt anterior thigh;non-tender;the area is the same temp as the other par of the body;bruised;