chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she was very sick; Felt really bad; Couldn't get up from bed; dizziness; headaches; nausea; slight fever; Couldn't get up from bed, couldn't do things, she was feeling very tired.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she was very sick), FEELING ABNORMAL (Felt really bad), FEELING OF RELAXATION (Couldn't get up from bed), DIZZINESS (dizziness) and HEADACHE (headaches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL and VITAMINS NOS for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced ILLNESS (she was very sick), FEELING ABNORMAL (Felt really bad), FEELING OF RELAXATION (Couldn't get up from bed), DIZZINESS (dizziness), HEADACHE (headaches), NAUSEA (nausea), PYREXIA (slight fever) and FATIGUE (Couldn't get up from bed, couldn't do things, she was feeling very tired.). At the time of the report, ILLNESS (she was very sick), FEELING ABNORMAL (Felt really bad), FEELING OF RELAXATION (Couldn't get up from bed), DIZZINESS (dizziness), HEADACHE (headaches), NAUSEA (nausea), PYREXIA (slight fever) and FATIGUE (Couldn't get up from bed, couldn't do things, she was feeling very tired.) outcome was unknown.            Patient reported using Tylenol for reported adverse reactions.   This case was linked to MOD21-074495, US-MODERNATX, INC.-MOD-2021-075133 (E2B Linked Report).; Sender's Comments:  MOD21-074495: US-MODERNATX, INC.-MOD-2021-075133:
I was walking and experienced extreme shortness of breath, and rapid heart rate. I went to the emergency room and was tested for COVID-19 and it came back negative. I had a chest X-ray and a CT scan done as well. The CT-scan confirmed blood clots in the lungs. The doctor prescribed me ELIQUIS, which is a blood thinner. I stayed on that for 3 months. I had a blood test done to see if it was caused by genetics, but that came back negative. The doctors think the birth control I was taking may have caused it so they switched it to norethindrone.
02/02/2021 my legs ached all night, and on 02/16/2021 cold sore that had been gone for years suddenly reappeared, but it did go away after 2 weeks on medication.
About 5 minutes after receiving 2nd dose of Pfizer Covid-19 vaccine, patient began to feel dizzy and faint. Patient remained seated and cold compresses were applied. Patient began to feel better within 10 minutes.
Woke up 8-4-12 with swollen face, lips no shortness of breath went to ER.
This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. Concurrent conditions, medical history and historical drugs were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD injection, lot # N008826, expiration date 12-SEP-2018, for prophylaxis (strength, dose, route and anatomical location not reported), which was inappropriately stored. The reporter stated that the vaccine had been under temperatures from -14 °C to -10 °C for 360 hours, without a previous temperature excursion. The sterile diluent (MERCK STERILE DILUENT) used for reconstitution of the dose of PROQUAD was properly stored. No adverse effects reported. This call was made because of a digital data logger. This is one of several reports coming from the same source.; Sender's Comments: US-009507513-1712USA014470: US-009507513-1712USA014471: US-009507513-1712USA014472: US-009507513-1712USA013124: US-009507513-1712USA014469:
An hr and a half after shot experienced severe shakes. Went to ER. Had extremely high fever.
I developed chills, body aches, stuffy nose, and headache while sleeping Thursday night/Friday morning.  Friday morning I woke up with nausea.  These symptoms continued most of Friday, but were relieved by alternating Tylenol and Ibuprofen.  By Friday evening, I had only a mild headache, which continued until Sunday. Arm soreness and itching for 3 days.  Muscle twitching of eyelid was also noticed over the weekend.
Right thigh where Hib & Hep-B vaccines were given, became very red and hive-like. Area of redness approx. 6cm. Instructed mom to apply cold compresses and directions for oral Benadryl was given per doctor. Probable reaction to Hep-B. Samples of Elocon given per doctor.
Client was given Pneumovax and flu to left del. She was joking and laughing in the clinic room. Walked out and in to the hall with her employer and was laughing and joking with him. He reports she doubled over in pain, got her a chair to sit in she was bright red, screaming loudly, c/o pain to lower back, abdomen and knees. became SOB she was placed on O2 and given EPI 1:1000 and Benadryl 50mg. EMS called.
sneezing, swollen, red eyelids, audible breathing, runny nose onset 25min p/vax;given DPH 25mg po @ 1255PM;
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medication were provided.   This case was linked to MOD-2021-395985 (Patient Link).
Seasonal flu shot. I now have sore throat, congested nose, sneezing, headache. My husband also got the shot a day later than me and has the same symptoms. I write in case this years shot has more side effects than usual. I have no allergies so this reaction is unusual for me.
Patient had vaccines 6/10/09. Had High fever (TMAX 104.1) (6/11/09), given TYLENOL/MORIN; No vomiting, no seizures. Also with runny nose, mild cough, - on ZYRTEC.
This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022 15:19) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022 15:19) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Jan-2022 at 3:19 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022 at 3:19 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022 15:19). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022 15:19). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022 15:19) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022 15:19) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Vaccine administration time was reported as 15:19:33. The patient received booster Moderna vaccine past its 30 day of expiry date. No treatment information was provided.
Sedation, Myalgia, Arthralgia, NauseaVomiting, Pain/swelling @ injection site; Swollen lymph nodes Narrative:
Around 30 patients received vaccine more than 12 hours after 1st puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Around 30 patients received vaccine more than 12 hours after 1st puncture) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Around 30 patients received vaccine more than 12 hours after 1st puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Around 30 patients received vaccine more than 12 hours after 1st puncture) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Pain; Did not have strength to get up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and ASTHENIA (Did not have strength to get up) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Pain) and ASTHENIA (Did not have strength to get up). At the time of the report, PAIN (Pain) and ASTHENIA (Did not have strength to get up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment medications provided by the reporter.
Coughing up a little bit of blood. It?s not much but enough to worry me.
The first thing I noticed was slight chills and I checked my temperature and had a fever of 102. I had a metal taste in my mouth. I have also been way more winded than usual. I come from the living room to the bedroom and I am breathing really heard. It's affected my brain as well. I have had brain fog. I have hit a wall mentally. I have had to lighten my load a lot. My anxiety has spiked as well.  I have had a chronic cough after OCVID-19 as well. I have been taking N-Acetyl Cysteine for 5 days and it hasn't helped yet.
Approx 12 hours after 2 month vaccines had temp of 102.5. At ER, fever work up done including WBC 22k, spinal tap. ROCEPHIN given. All cultures negative.
pt vax on 10JUN05 was reported to have had a sz on 11JUN95 @ 1230AM; pt was taken to ER @ that time;
Adult  was given Pfizer Covid Vaccine for the 5-11 age group 0.3 cc without dilution.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult female patient who received SHINGRIX. On 13th April 2018, the patient received the 1st dose of SHINGRIX. On 13th April 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness. In April 2018. the patient experienced injection site swelling, injection site erythema and injection site warmth. In April 2018, the outcome of the tiredness was recovered/resolved. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the tiredness, injection site swelling, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's husband. The age at vaccination was not reported. On Friday, the patient received SHINGRIX on an unknown arm. It was reported that the vaccine almost knocked the patient out. She was tired and slept most of the day on Saturday but the tiredness resolved after one day. Less than a week after receiving SHINGRIX, the patient's injection site was raised, red, and warm to the touch. The reporter did not want to provide additional details on the patient's experienced and stated that she would call back later on the date of reporting with further details.
Information has been received from a physician concerning a 14 year old male who on 14-JAN-1997 and 14-FEB-2000 was vaccinated with the first and second doses of MMR II (LOT # reported). On 16-NOV-2009 the patient experienced mumps. On 28-DEC-2009, the patient was diagnosed with mumps. The patient had fever (102 F) and had a parotitis on the left side. The patient's outcome was unknown, this case was non-serious. This is one of several reports from the same source. Follow-up information was received from the physician indication that on 18-JAN-2010 (previously reported as 16-NOV-2009) the patient experienced mumps and mumps was diagnosed on 20-JAN-2010. The patient had swelling under left ear. It was unknown if the patient got orchitis. Additional information has been requested.
loss of sleep; sore arm around injection; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (loss of sleep) and VACCINATION SITE PAIN (sore arm around injection) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm around injection). On 18-Apr-2021, the patient experienced INSOMNIA (loss of sleep). At the time of the report, INSOMNIA (loss of sleep) and VACCINATION SITE PAIN (sore arm around injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided by the reporter no treatment information was provided by the reporter.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 08-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
This spontaneous report was received from a nurse and refers to a four unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unspecified dates, the patients were administered an improperly stored doses of PROQUAD (albumin status: recombinant human albumin, rHA) injection (lot # M044018 with expiration date at 01-MAY-2018; doses, routes of administration and anatomical locations were not reported), for prophylaxis. On an unknown date, the administered doses of vaccine were exposed to a temperature of 6 degrees Fahrenheit (F) for 4 minutes. There was also reported a previous temperature excursion including exposure to a temperature of 12 degrees Fahrenheit (F) for 3 minutes (date unspecified). Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA013693:
I have developed hives on both arms that itch; I have developed hives on both arms that itch; This is a spontaneous report from a contactable consumer (patient reported herself). A 48-year-old non-pregnant female patient received first dose of BNT162B2 (COVID 19, Formulation: Solution for injection) via an unspecified route of administration on 12Feb2021 02:00 PM at single dose for Covid-19 immunization. The patient's medical history included multiple sclerosis (MS) and allergic to COPAXONE (known allergies: Copaxone). Concomitant medications were not reported. Other medications in two weeks was reported none. Facility type vaccine: Workplace clinic. Covid was not tested prior or post vaccination. On 13Feb2021 06:00 PM, the patient developed hives on both arms that itch. The patient did not receive any treatment in response to the events. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Bed ridden, Fever, chills, sweats, extensive body aches, headache clusters, no energy or appetite. I woke up and did tele-health because I thought it was Corona.
pt recv vax 8/31/89 & 5/13/98 pt sought medical attention & a lab eval revealed a lack of seroconversion for rubella;
Information was received from a doctor of pharmacy who reported on a male patient. On 20-SEP-2012, the patient received PNEUMOVAX23, 0.5 ml and AFLURIA, 0.5 ml. Both were mixed in the same syringe and given as one injection, intramuscularly. The AFLURIA, lot# P59107, exp. Date of 30-JUN-2013, was supplied as a prefilled syringe and the dose of PNEUMOVAX23, lot# 0709AE, exp. Date of 04-JAN-2014 was drawn up into the AFLURIA prefilled syringe and added to the AFLURIA vaccine. No adverse effect was reported. Follow-up information has been received from the doctor of pharmacy provided a new information about the responsible physician, the person, who administered the vaccines to the patient and the patient at the age of 60 year old. On 20-SEP-2012 at 07:00 PM, the patient received the first dose of PNEUMOVAX (Lot #: 0709AB), first and AFLURIA (lot#P59107). The pharmacist reported that the patient claimed to have felt that the vaccines worked fine and re-administration wasn't necessary after the muscle soreness at injection site (approximately on 20-SEP-2012)-no adverse events reported. It was reported that the patient did not seek medical attention. Additional information is not expected.
pt became pale, shallow breathing, legs below knees-turned blue, including feet;paramedics summoned from home;transported to ER tx-released same day;
No adverse reaction. Patient was given a Moderna vaccine and they are under 18 years old.
This case was initially reported by a consumer and confirmed by a pediatrician and described the occurrence of Guillain Barre Syndrome in her 13 year old daughter who received Engerix-B. This case has been reported directly to VAERS. On 10/12/00, the pt received the first dose of Engerix-B, lot ENG3332A9. On the same day, the pt received an injection of TD. Eight days post-immunization. On 10/20/00, the pt experienced Guillain Barre Syndrome with partial paralysis which was considered life-threatening. The pt was seen at a physician's office and subsequently hospitalized. On an unspecified date, the events resolved. The immunization series was delayed. The immunization series was restarted on 5/11/04 with Recombivax without inicident. The physician considered the events to be possibly related to vaccination with Engerix-B. The mother stated "Please understand, Guillain Barre Syndrome's (sic) cause is unknown. There is no definite way to prove that it came from vaccine. There is evidence that some patients who have had the disease had a vaccine relatively soon to having the disease. My daughter had a vaccine, but also had a sinus/virus infection." The pediatrician reported that the sinus/virus infection symptoms onset on 10/4/00. Report subsequently received via Mfr. (Note: the pediatrician also submitted a report to VAERS.) Comment: Guillain Barre Syndrome was assessed as medically serious by MFR.
pt recv vax & devel symmetrical polyarthropathy;lab eval nl ESR, negative RA, ANA of 1:80 & sl anemia;
After receiving flu vaccine pt became vasovagal. Placed in chair, head to knees, water tolerated PO. Became diaphoretic, pale, O2 non rebreather applied, LOC approx 5 sec, EMS called, B/P taken, pulse taken, fingerstick done. Removed from health unit by EMS, stable v/s wnl per EMS.
COVID(+) WITH SYMPTOMS COUGH, BODY ACHES LOW GRADE FEVER Narrative:
DTaP given RU arm on 11/6/02 inflammation on 11/7. Called nurse line seen erythema, edema over deltoid. 11/8 almost gone 11/11.
Received quadrivalent influenza vaccine 10-23-15. C/o itching at the site starting at 6 pm that night. C/o tenderness at the site, redness larger than 50 cent size nad headache started at about 6 pm the same night. No difficulty breathing. Dr notified advised ibuprofen 600 mg for headache/ice pack to use on arm.
A little over a week after the vaccine my throat got super sore in which a cough developed.  I had a low grade fever for 1 day which prompted me to go to the urgent care.  A COVID test was performed and was negative and I was prescribed a cough med to help with the symptoms
Dose 1: chills Narrative: Dose 1: chills  Other Relevant History:
I noticed an increase in my non a fib arrhythmias, I didn't have any changes in medication or prescribed any new medications.
(+) slightly red/raised rash; (+) tender at injection site. Pt declined appt and insisted she wasn't worried just called office to let us know (patient is a RN). Denied itching, pain, fever, or anaphylactic sx. Advised pt to use ice compresses 3-4 times daily on site and take MOTRIN prn. Pt has emphysema and is on many meds so believes sx related to that. Advised her that it has been documented that 10% have this same reaction to the pneumonia vaccine.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 07-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 suspension ten 0.5ml single-dose vial (SDV) (lot # M005714, expiration date 03-OCT-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 112 hours with the highest recorded temperature of 12 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Pt exp dizziness beginning night following flu vax, & continuing to the present; pt has hx of vertigo, MD did not think the dizziness was caused by flu vax; MD noted pt had chronic dizziness for yrs, which is aggravated by any meds;
pt recvd vax; found dead next am in foster home;no fever,local rxn or oth sxs following vax;autopsy results pending;