chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the Engerix recalled lot; received the Engerix recalled lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in an unspecified number of patient who received HBV (Engerix B) (batch number CP23D, expiry date 31st December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error 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: Age at vaccination were not applicable. A medical assistant reported that unknown amount of patients may have received the Engerix recalled product.  The vaccine was recalled on 22nd October 2021. No symptoms reported. The health care professional (HCP) received the recall letter and the lot number was showing up in their system but at the time of this report, he had not looked into how many patients might have received the vaccine.  No further details available at this time. The HCP did not have the administration dates available at the time of report. The reporter consented to follow up via email.
A non-serious unlabeled spontaneous case of impetigo with redness and irritation under the nose has been received from a physician for a five-year old male, subsequent to receiving FLUMIST. The patient received one dose of FLUMIST nasally for flu vaccination on 26-Sep-2008. The reporting physician stated the patient developed irritation and redness under his nose several hours after FLUMIST administration. The patient went to his primary care physician on 02-Oct-2008 with a crusting red area under his nose that appears to be impetigo. The patient was treated with MUPIROCIN CALCIUM and CEFALEXIN. The events were considered resolved on 09-Jan-2009. The reporting physician indicated he is doubtful if FLUMIST caused the impetigo. Follow up received on the 21-Oct-2008 includes treatment for the impetigo and no outcome for the event. Follow up received on 12-Jan-2009 includes outcome of the events, patient's name and date of birth. Follow up received on 16-Jan-2009 includes general vaccine information and patient's address and county of the physician's office. The reporter also confirmed the information received on 12-Jan-2009.
Immediate Tingling in lips and hands and tongue, numbing of half face, tinnitus
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 at 09:00 as dose number unknown,single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Overweight" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient did not receive other medication in two weeks. Paxlovid (anti-viral) treatment started on 28Jul2022 and stopped on 01Aug2022. It's been two days after ending isolation. She have mild sore throat, nausea, vomiting and diarrhea. She did not receive treatment for AE and it was unknown if patient recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Dizziness, Headache, Diarrhea,  EXTREME FATIGUE Narrative: She was seen by provider in the Medical Center
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 23rd March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd March 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 25th March 2019, the patient experienced shivering and panic attack. On 25th March 2019 05:30, the patient experienced cold sweat. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the shivering was recovered/resolved and the outcome of the panic attack and cold sweat were unknown. It was unknown if the reporter considered the pain in arm, shivering, panic attack and cold sweat to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the left arm. The patient's arm became sore on Saturday and it was still sore at the time of reporting but was resolving. 2 days after receiving SHINGRIX vaccination, on the day of reporting, the patient woke up at 5:30am in the morning with cold sweats. The patient got up and dried himself off and went back to bed at which time he started shivering involuntarily. The patient said it almost felt like he was having a panic attack. The shivering lasted for 15 to 30 minutes and then resolved. The patient did not consent to follow-up.
redness; swollen; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA and PERIPHERAL SWELLING in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ERYTHEMA and PERIPHERAL SWELLING. The patient was treated with TYLENOL for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ERYTHEMA and PERIPHERAL SWELLING outcome was unknown.
1st injection of Moderna resulted in Covid Arm.  The arm where the injection was given was swollen, hot to the touch, and red.  The area extended around the injection site and down my elbow. I have photographs of this.  2nd injection of Moderna:  22 hours after injection, I began to chill.  This was followed by severe aching in my neck and along my spine.  My temperature started to elevate.  At 1 p.m. (26 hrs. after injection) my temp was 100.2.  It peaked at 101.8 thirty hours after injection. I took Tylenol (650 mg) every 4 hours, and used ice packs on my neck and back.  The side effects got better approximately 36 hours after injection, but the body aches, chills, and a fever of 99.4 continued for a total of 7 days.  I was also extremely tired.  I had to cancel several appointments that week because of low energy and because the places I was planning to go take your temp when you enter the building, and I knew I had a fever.  (My sister experienced the same side effects, but they only lasted 24 hours. ) I have no idea why my response to the 2nd vaccine lasted exactly one week.  The worst of it was the day after the injection - serious side effects which lasted 12 hours - but I just couldn't shake the chills, body aches, and fever for the following 6 days.  I contacted my physician via email on a daily basis, but he couldn't really give me an answer, or do anything for me.  The only response he gave me was that I have a very highly developed immune system (I never get flus or flu shots), so the vaccine might have overloaded my immune system.  This injection was my first injection in 50 years.  I was on the couch for one week after receiving it.  Nothing in my life has evoked this response - not even major surgery.   I would not look forward to having another Covid vaccine injection in the future.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 25-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # L040459, expiration date 06-APR-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 27.7 degrees Fahrenheit for 10 hours and also at a temperature of 31.3 degrees Fahrenheit for 11.5 hours. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
< 5 mins. after TDAP is given pt started feeling weak, nauseous, skin cold, blurry vision, looking pale. Had patient lay down immediately on the floor on his back, knees bent. Patient also had syncopal episode before during blood drawn.
pt recvd vax & exp an unspecified rxn;no further details were provided;
More than 36 days, and has not received 2nd dose; shortness of breath a week after vaccine; some light headedness right after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath a week after vaccine), DIZZINESS (some light headedness right after the vaccine) and PRODUCT DOSE OMISSION ISSUE (More than 36 days, and has not received 2nd dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DYSPNOEA (shortness of breath a week after vaccine) and DIZZINESS (some light headedness right after the vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days, and has not received 2nd dose). At the time of the report, DYSPNOEA (shortness of breath a week after vaccine), DIZZINESS (some light headedness right after the vaccine) and PRODUCT DOSE OMISSION ISSUE (More than 36 days, and has not received 2nd dose) had resolved.            No concomitant medications were provided by reporter. No treatment medications were provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Causality assessment for Product dose omission issue is Not applicable
Patient waited normal 15 minutes seated in area for monitoring after injection.  Patient stated she experienced numbness/tingling in left leg and swelling.  Stated no pain or heat from area, just similar to leg falling asleep.  Nurse measured vitals.  Pulse 72, blood pressure 157/82.  Patient did not want any Benadryl (just in case).  No issues breathing, only leg issue.  Patient was on her work shift.  Tried walking around to see if it eased.  Left facility later (unknown if symptoms improved).
Redness, swelling, hot to touch, itchy but not until 10 days later.
Initial report received on 03 December 2007 from a health care professional.  A 25-year-old female patient had received a right deltoid injection of ADACEL, lot number C2842AA, on 03 December 2007.  The patient took a pregnancy test on the same day which was positive.  Date of last menstrual period was 03 November 2007, and the estimated date of delivery was reported as "10 August 2007."  Current medications were none.  There was no adverse event reported.  Follow-up information received on 23 June 2008 from a physician.  The ADACEL had been administered intramuscularly on 03 December 2007.  The patient had received no previous doses of ADACEL and there was no illness at the time of vaccination.  The physician confirmed that the date of the last menstrual period was 03 November 2007 and the estimated date of delivery was corrected to 11 August 2008.  The patient's prenatal testing included an ultrasound on 24 March 2008, which was normal.  The current pregnancy had no complications.  The patient's past obstetric history included one live full-term birth with no congenital anomalies.  The physician confirmed that there was no adverse event.  Follow-up information was received from a health care professional on 06 October 2008.  Based on new information, which indicates the patient developed gestational diabetes mellitus (onset date not reported), the case has been upgraded to serious.  Treatment with metformin was initiated on 16 June 2008.  On 23 July 2008, gestation week 37 2/7, the pregnancy ended with a vaginal delivery of a live female infant (weight 7 pounds, 11 ounces; length 21 inches).  There were no complications of labor and/or delivery.  The infant had no congenital anomalies.  Apgar scores were 9 at one minute and 10 at five minutes.
It was reported that a 32 year old female pt received a TD Adult vaccination on 01/26/2001 at 10am. Reportedly by 6pm that evening the pt developed 2cm of redness now with induration from >10cm redness. Redness started on Friday and minimal redness now. Treatment of Benadryl per oral prescribed every six hours as needed. Reportedly the pt recovered from this experience. Frm follow up # 1 correspondence received on 03 APr 2001, no further information was provided. See reports U2001-00435, U2001-00436, U2001-00447 through U2001-00454 and U2001-00456 through U2001-00461, same reporter.
fatigue; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and MYALGIA (arm soreness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Lupus syndrome, Fibromyalgia and Gastrointestinal symptom NOS.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced FATIGUE (fatigue) and MYALGIA (arm soreness). On 21-Apr-2021, FATIGUE (fatigue) had resolved. At the time of the report, MYALGIA (arm soreness) outcome was unknown.            The concomitant medications information was not reported. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD21-060565 (E2B Linked Report). This case was linked to MOD-2021-054664 (Patient Link).; Sender's Comments:  MOD21-060565:
Pt 1  of 9 from total from total of 191 who completed series of 3 Hep B vax and failed to achieve immunity. Pt did not seroconvert.
More than 35 days since the first dose without taking a second dose/Got a dose of the Johnson&Johnson vaccine/patient received mixed series; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (More than 35 days since the first dose without taking a second dose/Got a dose of the Johnson&Johnson vaccine/patient received mixed series) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 for COVID-19 vaccination.    No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient received dose of COVID-19 VACCINE NRVV AD26 (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (More than 35 days since the first dose without taking a second dose/Got a dose of the Johnson&Johnson vaccine/patient received mixed series). On 16-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (More than 35 days since the first dose without taking a second dose/Got a dose of the Johnson&Johnson vaccine/patient received mixed series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment information was not reported. The patient second dose of Johnson&johnson vaccine on 16-Sep-2021.
Within minutes of getting the  Janssen covid-19 vaccine, patient began to feel dizzy/light headed and warm. Patient lost consciousness a few times over 10 minutes stretch monitored pt. for 30 additional minutes
Immediately, within 2 hours of the vaccination, I developed a severe headache, join pain (knees, elbows, mostly legs and lower extremities) which evolved into intense, burning abdominal pain.  My blood pressure rose to 160; however, there was no fever, cough or shortness of breath.  This condition lasted until the 7am on the morning of February 8th, but pains returned that evening (Monday 2/8) through Tuesday morning.  Symptoms subsided during the day on Tuesday, yet on Tuesday evening (2/9, approximately 48 hours after the injection), severe symptoms returned, similar to the initial evening.  I visited my Primary Physician on Wednesday afternoon (2/10) for a consult.
2 min post vax pt devel 6 cm area of hives @ the inject site.
pt was apprehensive to receiving vax;mom states approx 5min p/vax pt started jerking, blurred vision, dec hearing & pale;returned to hlth ctr;BP 100/60, cool compressses;APAP for fever;
Cramps in joints; red patches/spots at joints. Blotches on feet, legs and thighs. Itching on back.
This spontaneous report as received from a consumer refers to a female patient (consumer's daughter) of unknown age. On an unspecified date the patient was vaccinated with "chickenpox vaccine" (manufacturer unknown). On an unknown date the patient got the shingles from the chickenpox vaccine. No treatment information was reported. The outcome of shingles is unknown. Reporter disconnected without providing further information. Additional information is not expected.
COVID like symptoms already I have fever; have like COVID like symptoms already I have fever and stuff; I have fever; This is a spontaneous report from a contactable consumer (patient reported for self). A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection, Batch/Lot number and Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced covid like symptoms already and had fever. This was considered as drug ineffective. It was reported that patient had second appointment like today (unspecified day) like for the second dose but cant make it because she had covid like symptoms already and had fever. The patient hung up the call abruptly before retrieving. Hence further probing could not be done and limited information available over the call. At the time of this report, the outcome of events was unknown.  No follow up attempts are needed. No further information is expected.
Patient said she had fever and muscle aches/soreness.  She followed up with urgent care but the said this reaction was normal.  Advised patient to take ibuprofen, when I followed up later she was feeling a lot better
This spontaneous report as received from a registered nurse refers to a patient of unknown gender and age. The nurse reported that first and second doses of GARDASIL were almost 2 years apart. The patient was vaccinated with dose 1 GARDASIL (route, dose and lot # not reported) on 19-AUG-2010. On 09-AUG-2012, the patient was vaccinated with dose 2 GARDASIL (route, dose and lot # not reported). No adverse effects were reported. Additional information has been requested.
Patient passed out about 15 minutes after receiving the vaccine. She stated that she had not eaten since breakfast and is the reason she felt lightheaded. Staff provided water and a snack for the patient and sat with her until she felt ready to stand up.
10 hours after receiving the second dose, I have muscle aches, headache, fever, runny nose.
Client became unresponsive, had stiffening of head, neck and body with some jerking movements, lasted approx 15-30 seconds.
On previous visits i was told that i needed to get this shot since i was pregnant and the whooping cough was deadly in infants, i declined several times. On this particular date i felt pressured because i was so close to my due date (Jan 29) and i gave in and got it. My arm was very sore for a couple of days, and on December 11th  i began to have no taste buds. The very next day my jaw started to hurt really bad like a toothache. Few days later the right side of my face was in pain and i couldn't hear very well either. Then the next morning my eye was very watery and i couldn't fully close my eyelid. So i finally went to the hospital December 19th , 2018 and was diagnosed with Bell's Palsy.
Patient's mother reports between 1 and 2 hours after leaving clinic on Friday 5/14/2010 patient developed headache > backache > arm and leg pain> generalized body pain> cramping of hands.  Crying with pain and fingers on hands curled up.  Unable to straighten fingers on own for ~5- 10 minutes.  Mother able to straighten fingers passively.  Given Motrin and symptoms completely resolved 20 minutes after taking.   Slept more than usual over weekend including a 4 hour nap on Sunday.
Projectile vomiting for 4 days. Diarrhea. Extreme Swelling at Injection Site. Fever of 103 to 105. Lethargy. Difficulty Sleeping.
Severe hives that persisted for 5 months, red, raised, severely itchy skin.
Pt was lightheaded, w/ nausea, w/o any pain or vomiting. Patient transferred to gurney Assessment done and vitals checked. Patient stated that he had not had a good breakfast in the morning BP 94/60, pulse 62, 02 sat 98%. Advised him to drink sips of water, and snacks were given. He was observed for an extra 20 minutes. Patient felt better after 15 minutes BP 118/70, pulse 64. Advised patients father to consult with PCP before second dose. Advised to drink more fluid and keep hydrated. patient left for home with father without any symptoms of being lightheaded or nauseated
Hives and rash on face, neck, and back presenting 2.5 hours after injection. Benedryl given and gone by morning (~10 hour duration)
Pain at site of injection, beginning in the evening, first noticed around 8:30 pm. Upon going to bed, noted a slight headache. Upon waking around 5:30 am, noted general achiness over my body, slight headache continuing. Around 6:00 am, took Tylenol for the headache and body pain, by 11:00 am headache has gone, body achiness has largely subsided.
Onset of cold. On the third day, I began coughing. The cough has been persistent and is still present today, although less conspicuous.
fever, headache,, muscle aches, no appetite, chills, migraine,lost portion of smell
Ongoing side effect day 3 now after third dose.  Severe non-stop cough, nasal and chest congestions, lots of mucus production,  severe headache,  fever, fatigue, not able to sleep. Lost sense of taste and appetite, muscle weakness.