chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a consumer and refers to a 11-year-old female patient. The patient's concurrent conditions included attention deficit/hyperactivity disorder (ADHD). The patient did not have any drug reactions or allergies. On 12-AUG-2016, the patient was vaccinated with GARDASIL 9 injection dose 1 (dosage, frequency, route of administration, lot validation and expiration date were not provided) for prophylaxis. Subsequently, she received the second dose of GARDASIL 9 on an unspecified date. Concomitant therapies included ADHD medicine (unspecified). The mother reported that at some point after receiving her first dose of GARDASIL 9, her daughter "started to experience issues of falling down (date and time not specified)". The mother reported that her daughter sought medical attention and was diagnosed with epilepsy on 18-SEP-2016. The mother also reported that her daughter was subsequently been put on 6 different unspecified epilepsy medications that have made the condition worse. The mother also reported that her daughter had also developed blood pressure issues as well as kidney issues. The patient received treatment for the events. On an unspecified date, electroencephalogram, magnetic resonance imaging, capillary agglutination test scan, 3 rounds of blood work were performed (results not provided). The outcome of epilepsy, renal disorder, blood pressure fluctuation and fall was reported as not resolved at the time of the report. The action taken was not applicable. The causality between the events and the suspect vaccine was not provided. Upon internal review, epilepsy and epilepsy aggravation were considered to be medically significant.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Apr-2021 at 3:49 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 3:49 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 74.69 for dose administered on 29-Apr-2021. No concomitant medications were reported. Batch number 007C21A underwent temperature excursion on 29-Apr-2021 with temperature 33 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 19-Apr-2021 and beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 29-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion for 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. No treatment medications were reported. This case was linked to MOD-2022-566976 (Patient Link).
10/30/2016 Eye was twitching and taste of drink was less. 10/31/2016 Next Morning at 8:15 AM full Bell's Palsy on right side of her face. Extreme face and leg pain Hard to walk. 11/01/2016 Hard to breathe and cloudy thinking. 11/02/16 Right leg partial paralysis extreme pain in Right leg arm and face. Hard to walk. She has been to the hospital twice and the Dr's twice she has a follow up appointment in a few days. She has missed 4+ days of school.
Information has been received from a registered nurse concerning a female who on 19-JAN-2007 was vaccinated with Zostavax. On 23-JAN-2007, the patient experienced shingles on her buttocks. Unspecified medical attention was sought. No additional information to report. There was no product quality complaint involved.
PT. WAS DIAGNOSED WITH COVID-19 AND SUCCUMBED TO THE ILLNESS.
had #1 vaccine (pfizer) on 28 December  2020 and #2 on 19 January 2021.  mammogram on 02 February 2021 was performed.  Mastitis symptoms began on 17 February; 19 February diagnosed with Bactrim DS started BID; admitted on 21 February and received Rocephin X1 and Vancomycin X2.  went home on Keflex QID dosing.  completed antibiotics, and mastitis has resolved.  26 February contacted PCP and they recommended reporting.  Called CDC and they said to report
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates, these patients were vaccinated with improperly stored doses of ROTATEQ (lot # L028645, expiry date 25-MAY-2017) (strength, dosing details, anatomical location were unknown). The vaccine had been stored at 8.1 degree Celsius for 15 minutes, and also at 8.3 degree Celsius for 15 minutes. The temperature excursion was detected by a data logger. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Patient called at approximately 12 noon today 04/13/17 to report rash on torso, back legs and "a little on cheeks" starting several hours after vaccine given. She was treated with Hydrocortisone cream, told to see PCP.
Patient states that he has sharp pain in his right arm and is unable to raise his arm without pain. He says these symptoms subsided a little on the second day but he is afraid that some nerve damage has happened, He states that the vaccines were given on very high location on his arm very close to his shoulder and that's why he's concerned about nerve damage. He was recommended to contact his PCP to be evaluated.
dizzy, woozy; second dose really messed her over; face was slightly swollen; diarrhea; constipation; headache; chills; knees hurt; aches/muscle aches/pains; nausea; arm hurt/right arm felt as if she had gotten the shot in that side; disorientation; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (disorientation), DIZZINESS (dizzy, woozy), FEELING ABNORMAL (second dose really messed her over), SWELLING FACE (face was slightly swollen) and DIARRHOEA (diarrhea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced DISORIENTATION (disorientation) and VACCINATION SITE PAIN (arm hurt/right arm felt as if she had gotten the shot in that side). On 02-Apr-2021, the patient experienced DIZZINESS (dizzy, woozy), FEELING ABNORMAL (second dose really messed her over), SWELLING FACE (face was slightly swollen), DIARRHOEA (diarrhea), CONSTIPATION (constipation), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (knees hurt), MYALGIA (aches/muscle aches/pains) and NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) at an unspecified dose and frequency; MENTHOL, METHYL SALICYLATE (BEN GAY) at an unspecified dose and frequency and CAFFEINE, ETHENZAMIDE, PHENAZONE (HEADACHE POWDER) at an unspecified dose and frequency. At the time of the report, DISORIENTATION (disorientation), DIZZINESS (dizzy, woozy), FEELING ABNORMAL (second dose really messed her over), SWELLING FACE (face was slightly swollen), DIARRHOEA (diarrhea), CONSTIPATION (constipation), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (knees hurt), MYALGIA (aches/muscle aches/pains), NAUSEA (nausea) and VACCINATION SITE PAIN (arm hurt/right arm felt as if she had gotten the shot in that side) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Itchiness, Pain, Warmth, Tenderness, 12x6 cm red/rash area surrounding injection site, muscle pain throughout tricep.
G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/16/2023 RIGHT FACIAL NERVE DISORDER G47.33 OBSTRUCTIVE SLEEP APNEA 4/7/2022 RIGHT FACIAL NERVE DISORDER G51.0 RIGHT FACIAL PALSY 4/28/2023 RIGHT FACIAL NERVE DISORDER R29.810 RIGHT FACIAL MUSCLE WEAKNESS 4/16/2023 RIGHT FACIAL NERVE DISORDER G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/16/2023 RIGHT MASTOIDITIS G47.33 OBSTRUCTIVE SLEEP APNEA 4/7/2022 RIGHT MASTOIDITIS G51.0 RIGHT FACIAL PALSY 4/28/2023 RIGHT MASTOIDITIS R29.810 RIGHT FACIAL MUSCLE WEAKNESS 4/16/2023 RIGHT MASTOIDITIS
This spontaneous report as received from a nurse refers to multiple patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # N008823, expiry date: 26-MAY-2018) (route: subcutaneous) reconstituted with sterile water diluent. The vaccine was stored at a temperature of 0 to 1°C (1.2 C) for 34 minutes. There was no previous temperature excursion. The call was because of the data logger. No adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA007422: US-009507513-1708USA007198: US-009507513-1708USA007441: US-009507513-1708USA007438.
got upset; pulse faster than normal; Nervous; Worried; This is a spontaneous report from a non-contactable consumer (patient). An 80-year-old patient of an unspecified gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: Unknown), via an unspecified route of administration on 2021 at a single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medication included rosuvastatin calcium (CRESTOR) and unspecified blood pressure medication (the patient takes 40 mg and then with that, the doctor gave patient, it started with Hydro something and that kind of eliminate the salts from your body when you urinate a little bit more). The patient has hypertension and got upset and had a pulse faster than normal. The patient pulled over the vehicle and drive through and 'drive a mile' but then in about 10 minutes it started again but it seems like a 'fall down' and the patient got real nervous and patient was still nervous. The patient is 80 years old. The patient said he/she did not know he/she got home and the patient took a Benadryl as treatment.  The patient got home, nervous and can breath all right, just nervous. The patient mentioned being in good health and everything and was just worried about himself/herself. The outcome of the event pulse faster than normal was recovering; nervous was not recovered; outcome for all other events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Hives after second dose. Started the morning after the second shot. One week later they are getting worse and persisting. From the bottom of my feet, trunk, legs, and back.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with VITAMINS NOS at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported    This case was linked to MOD21-082154, US-MODERNATX, INC.-MOD-2021-090569, US-MODERNATX, INC.-MOD-2021-090584 (E2B Linked Report). This case was linked to MOD-2021-090554 (Patient Link).; Sender's Comments:  MOD21-082154: US-MODERNATX, INC.-MOD-2021-090569:Wife dose 1 case US-MODERNATX, INC.-MOD-2021-090584:wife dose 1 case
Since becoming fully vaccinated, I've had two viral infections or episodes physically triggered. One was an upper respiratory illness which was mistreated with antibiotics as a bacterial infection. This latest viral episode manifests itself with fever blisters on my upper lip, fatigue, stomach pain, body aches, dehydration. It could've been triggered by excessive sun exposure, but fever blisters are not reoccurring whatsoever for me. Both of these incidences are atypical for my body. I suspect either I'm temporarily & mildly immunocompromised. Or I'm experiencing a hyper immune system that is overreacting to the presence of dormant viruses. It's in "fighting mode."
patient's watch was reading HR in the 150s, on exam, pulse was 64.  No other symptoms.  Denies SOB
Everyday I have migraine; I have tingling like all over the body; Not persisting, Comes and go.; I have nausea almost everyday; I can not really eat because like I am nauseous all the time; I have body ache all the time; it feels like flu; I have body ache all the time; it feels like flu; I already started being sick and I have not been stopped being sick since then; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FC3181), dose 1 intramuscular, administered in Arm Left (Upper left arm) on 09Aug2021 as dose 1, single for covid-19 immunisation. Medical history included hypothyroidism, iron deficiency anemia. The patient's concomitant medications were not reported. The patient stated she had migraine from basically every day. She took the vaccine on 09Aug2021 (first shot). It's migraine every day. She had tingling like all over the body, its not persisting it come and go tinkling. She had nausea almost every day also she have body ache all the time, it felt like flu. Yesterday she went to the hospital and they were tell her that she didn't have Covid but did diagnose with her having adverse event with vaccine. It was like two days after that not even it was the day after she got it on the 9th and on the 10th (Confirmed as Start date of adverse event as 10Aug2021). She already started being sick and she has not been stopped being sick since then. Reminder for 1st and 2nd shot and then the date that is for 2nd shot. She stated, yesterday since she had flu or Covid. She went to the urgent care. No she didn't have that with me, they gave her a PCR test and a rapid test and then they gave her a flu test and strep throat test that was it. The patient stated, treatment of Adverse Event was Excedrin Migraine (as Treatment). Yeah its actual name is Excedrin Migraine. It has different variant she was actually using the migraine one. She stated "That's Excedrin that's it, that's all I have using it, Yeah that's it that's all I have been doing and then I cannot really eat because like I am nauseous all the time, I don't take anything for that." When probed for using Excedrin on daily basis for migraine, Consumer stated, "Yes every day." The patient mentioned that she was not diagnosed with Covid but with adverse events of Covid-19 vaccine. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
shipment was received late and one dose was given to a patient, no AE; shipment was received late and one dose was given to a patient, no AE; Initial information received on 03-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 31 years old male patient who was vaccinated with a 0.5 mL dose of suspect vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number: UJ313AA and expiry date 30-Jun-2020) via intramuscular route in the right arm on 02-Jan-2020, which was not stored properly.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not reported.  It is a case of actual medication error due to incorrect product storage and product shipment delay.  It was reported that the shipment was received late and one dose was given on 02jan2020 to a patient during a regular clinic visit. (Shipment date was 30-Dec-2019 but received on 02-Jan-2020).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
has the red arm; severe anterior nosebleed that went on for an hour and the half; had body aches; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (severe anterior nosebleed that went on for an hour and the half), FATIGUE (tiredness), VACCINATION SITE ERYTHEMA (has the red arm) and MYALGIA (had body aches) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B514 and 027421A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (tiredness). On 06-Apr-2021, the patient experienced MYALGIA (had body aches). On 24-Apr-2021, the patient experienced EPISTAXIS (severe anterior nosebleed that went on for an hour and the half). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (has the red arm). The patient was treated with PARACETAMOL (TYLENOL) 06-Apr-2021 at a dose of 1 dosage form twice a day. At the time of the report, EPISTAXIS (severe anterior nosebleed that went on for an hour and the half), FATIGUE (tiredness), VACCINATION SITE ERYTHEMA (has the red arm) and MYALGIA (had body aches) outcome was unknown.            Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Updated the Description as reported in the event Epistaxis Severe posterior nosebleed that went on for an hour and the half to Severe anterior nosebleed that went on for an hour and the half
Chills at night, then the next day body aches, low grade fever, headache, fatigue, jaw/neck pain, ear ache
PATIENT RECEIVED VACCINNE THAT IS NOT YET APPROVED FOR HER AGE GROUP. NO KNOWN SIDE EFFECTS.
Information has been received from a consumer concerning her 13 year old daughter with allergy to sulfa who on 06-AUG-2008 or 08-AUG-2008 received the first dose of GARDASIL vaccine injection, (lot# not provided). There was no concomitant medication. About ten days after receiving the vaccine, the patient started to lose her hair above the to right ear. At first the physician thought it was ring worm and had given her medication, name was unspecified. Since the spot did not get better, the patient saw a dermatologist. the dermatologist did a scraping of the spot and the patient was then diagnosed with alopecia. The consumer also reported that her daughter had a sore in her vaginal are. the patient's sore in vaginal area and alopecia persisted. Additional information has been requested.
late Engerix-B third dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   Previously administered products included Engerix-B (received 1st dose on 14th August 2019, batch number 54A32 and expiry date 12th November 2021) and Engerix-B (received 2nd dose on 17th September 2019, batch number 53P39).   On 17th June 2021, the patient received the 3rd dose of Engerix B and hepatitis B vaccine pre-filled syringe device. On 17th June 2021, unknown after receiving Engerix B and hepatitis B vaccine pre-filled syringe device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was 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 pharmacist reported that the late Engerix-B third dose was given to the patient, which led to lengthening of vaccinations schedule. The reporter consented to follow up. No information about lot number from Engerix-B third dose at the moment of the call.
Couldn't breathe,  entire body was in pain. Runny nose, cough,cold sweats, chills, blurred vision, evacuation,  sore throat, dry mouth, gasping for air,
This spontaneous report as received from a registered nurse refers to a patient who was vaccinated oral with ROTATEQ (lot # (669476/1529Z, 03-SEP-2012) on 08-OCT-2012. It is not known which dose in the ROTATEQ vaccination series this is. No adverse effect reported. Additional information has been requested.
Felt like lump in throat, swelling of throat and difficult to breath.  Treatment: Benadryl
Four months subsequent to receiving the third dose of Lymerix, the pt presented with monoarticular knee synovitis. His serology at the time revealed antibodies to 93, 66, 41, 31, 30, 28 and 21 kDa antigens on IgG and 93 and 41 on IgM. The authors stated that since it was difficult for clinicians to differentiate either between either vaccine induced arthritis or Lyme arthritis in a pt, the pt was treated with a full course of doxycycline therapy. Four months later the pt was asymptomatic. It was commented by the authors that this was likely a delayed vax induced arthritis. The events of the knee synovitis and arthritis do not meet ICH serious criteria, but are being submitted as an expedite report by special FDA request.