chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Broke out in a sweat  felt sick and had to lay down....took a Bendryl    tablet around 5 p  ....when I  woke up in am had headache  took a tylenol
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On an unknown date, an unspecified patient was vaccinated with an improperly stored dose of VARIVAX (lot #M006722 with expiration date 08-FEB-2018, 1 dose, route unknown). No adverse effects were reported. On 02-AUG-2016, multiple unspecified patients were administered improperly stored doses of VARIVAX (lot # M006722 with expiration date 08-FEB_2018, lot # M009765 with expiration date 23-FEB-2018, lot # L031069 with 18-AUG-2017, lot L039092 with expiration date 06-OCT-2017, lot #M004330 with expiration date 26-JAN-2018; dose and route were not reported). The lot numbers listed were improperly stored at 16.3 degree Fahrenheit (F) for 4.5 hours and then back in range. There was no previous excursion and data logger was not involved. No adverse effects were reported. At the time of the report, the nurse could not confirm which lot numbers were administered. This is one of several reports received from the same reporter. Additional information has been requested.
her doctor told her to wait 90 days; COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) and OFF LABEL USE (her doctor told her to wait 90 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive). On an unknown date, the patient experienced OFF LABEL USE (her doctor told her to wait 90 days). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) outcome was unknown and OFF LABEL USE (her doctor told her to wait 90 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, SARS-CoV-2 test positive: covid positive Pt tested positive for COVID, 8 days after first vaccine..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs and treatment medications were reported.
left arm hurt; injection site irritated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm hurt) and VACCINATION SITE IRRITATION (injection site irritated) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm hurt) and VACCINATION SITE IRRITATION (injection site irritated). On 20-Mar-2021, VACCINATION SITE IRRITATION (injection site irritated) had resolved. On 21-Mar-2021, PAIN IN EXTREMITY (left arm hurt) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
This non serious case was received on 02 February 2009 from a health care professional. A three month old female patient received the following vaccinations on the morning of 31 January 2009: an initial dose injection of ActHib lot number UF594AA (Sanofi Pasteur SA lot number D0070-1) intramuscularly in the right leg an initial dose of Tripedia (lot number U2398B) intramuscularly in the left leg. On the morning of 02 February 2009 the patient presented to the doctor's office with hives described as flat on both wrists and trunk. The patient did not have any other complaints. Follow up information was resolved on February 2009 from a health care professional. The patient's parents were instructed to contact an allergist if the patient's hives continued. The patient recovered from the event. No treatment was necessary. Follow-up information received on 11 March 2009 from a nurse. Per the reporter, they have no additional information at this time. No further information is expected.
extreme fatigue like really bad; headache; achiness across my shoulder and neck basically the whole area; extremely exhausted for 4 days; achiness across my shoulder and neck basically the whole area; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue like really bad), HEADACHE (headache), ARTHRALGIA (achiness across my shoulder and neck basically the whole area), FATIGUE (extremely exhausted for 4 days) and NECK PAIN (achiness across my shoulder and neck basically the whole area) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (extreme fatigue like really bad), HEADACHE (headache), ARTHRALGIA (achiness across my shoulder and neck basically the whole area), FATIGUE (extremely exhausted for 4 days) and NECK PAIN (achiness across my shoulder and neck basically the whole area). At the time of the report, FATIGUE (extreme fatigue like really bad), HEADACHE (headache), ARTHRALGIA (achiness across my shoulder and neck basically the whole area), FATIGUE (extremely exhausted for 4 days) and NECK PAIN (achiness across my shoulder and neck basically the whole area) outcome was unknown. Not Provided      This case was linked to MOD-2021-083418 (Patient Link).; Sender's Comments:  Mother case- dose 2
On 2/12/21 a mom presented with her two young adult male children for a Covid-19 vaccination appointment.  She was told her that unfortunately were not eligible for the vaccine because they were under the age of 65.  Upon further discussion we determined that in fact the children did qualify for the vaccine because they reside in a congregate long term care facility.  Both were given the first dose of Moderna vaccine on that day to complete their appointment.  It was not until after the vaccine was administered that we realized that one of the boys was 17 years old.  Moderna vaccine is only approved for patients 18 years and older.  On 3/15/21 the patient returned and was given the second dose of vaccine in order to complete the series.  No adverse events have been reported from the first or second dose.
Resident received Moderna Bivalent dose instead of initial Moderna dose.  This was her first dose in her series.
Myalgia, NauseaVomiting, Chills, Fatigue Narrative:
Hives; whelps; redness at site, viewed today 11/17/16, 6 days after vaccination. Patient has had rxn since 11/11/16. Our pharmacy gave her famotidine 10 mg and hydrocortisone 1% crm to take home.
tech pulled incorrect imz from fridge;  I did not check identity of imz.  I injected 0.3ml of undiluted covid covalent children's vaccine instead of 0.3ml of adult vaccine.  I called pfizer.  got lucky.  0.3ml of undiluted child bivdalent vaccine is same dose as 0.3ml of adult  bivalent covid vaccine
This spontaneous report was received from Registered Nurse regarding to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regimen unknown. It was reported that the vaccine was exposed to a temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to precious temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reports received form the same reporter. Additional information had been requested.
UrticariaPruritus Reported lip numbness c/ injection, reported to monitor no action. Employee left and called staff and reported hives on upper and lower lips, lips warm to touch Narrative:  Reported lip numbness c/ injection, reported to monitor no action taken. Employee left after 15mins. Employee reported hives on upper and lower lips, lips warm to touch ( text message) no action taken
The next day after my vaccination I became unbalance and felt like I was dragging my right foot. The pain was in the right leg around the angle and went up my leg I felt I was dragging it and the next day was no better and I called the pharmacist and they advised me to call my doctor. I called my doctor and they are sending me for a Doppler Sonogram to make sure that it is not a blood clot. I go tomorrow for the ultrasound.
The morning after the vaccine, I had soreness and mild fatigue. The soreness and stiffness was greatest in the arm of injection, and was less intense but present in my upper back and neck. This soreness and stiffness lasted the whole day after the vaccine but was becoming milder, until day 2 after the vaccine when it had completely resolved. No medications were required.  Day 1 after vaccine I also had a bright red, flat, rash that appeared as very close small circles near the injection site (where the bandage was placed) but not on the actual vaccine site. No itching, spreading of rash, or other symptoms. This resolved day 2. I have no known allergies to bandages at this time. No medications were required.
No issues until 10/23/18. Starting on 10/23 left arm/shoulder began hurting badly to the point of being unable to move arm without severe pain.
Numbness and pain in entire right arm, right side of head; Pain in entire right arm,; Pain right side of head,; Severe exhaustion for 3 days post vaccination; This is a spontaneous report from a contactable consumer. A 39-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Apr2021(at the age of 39-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was unknown weather the patient had received any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced numbness and pain at entire right arm, right side of head, and severe exhaustion for three days post vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events numbness and pain in entire right arm, right side of head, and severe exhaustion for three days post vaccination was recovered on unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT WAS ADMITTED TO ICU ON 5-11-2021. CHIEF COMPLAINT BEING BLOOD CLOTS.
Drop in heart rate, light-headed at about noon on June 30 and then drop in heart rate and anxiety and sleeplessness on Jul
erythema shoulder to elbow, posterior aspect lt arm; onset approx 24 hrs p/recvd vax;
Delayed onset of very sore and itchy area at injection site. Started a week after I received the vaccine. Injection site is swollen, hot, hard, painful, and itchy.
This report is concerning an approx. 6 week old male who in 7/98, was vaccinated with a dose of Hep-B vaccine recombinant (yeast). Concomitant therapy included a dose of Hib conjugate vaccine, a dose of poliovirus vaccine (IPOL) and a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. He reportedly, developed injection site reactions characterized by hard lumps, redness and warmth. He later, experienced a "high fever". His mother notified the physician. The pt became irritable and inconsolable. He experienced high pitch screaming for several hours and arching of his back. The pt became chronically constipated, needing help to pass hard, clay-like lumps which often made him bleed. Shortly following his immunizations, he experienced a series of "vague seizure activity". His entire body would twitch and he would seem unresponsive. The physician was notified. He experienced a few more episodes and recovered. It was reported that the pt's experiences of seizures are considered an "Important Medical Event". This was originally reported by the pt's mother. No further information is available.
Patient said that she felt sick while in observation. She ended up dizzy, shaky, and a fast heart rate.  We got her to get a drink and lay down for a bit. Her initial bp was 143/107 with a heart rate of 108.  After resting for some time,  she felt back to normal.
2/13/21- Pt reports severe adverse side effects that may be related to the vaccine that started on 2/8/21 at 8 am. Went to work 2/8 but had to call out for the rest of the week. Complaints of excruciating headache, lower back pain and cramps, and bilateral calf pain so severe she could not sleep for 5 days.  The pain was so bad she couldn't walk because she felt a Jolt or shock of pain go through her body. Took Tylenol but after 4 hrs the pain would return. 99 to 100 fever via a temporal thermometer. Reports feeling better today 2/13/21 Leg pain resolved but mild back pain and slight headache. Had a rapid COVID test 2/9/21 at Urgent Care , PCR with her DR 2/10/21 which was negative. Advised not to get the 2nd shot due to severe headache, severe back pain, severe constant leg pain which also  she describes as Jolting pain that she could not walk very well due to the pain. Has appt with Dr. Friday 2/19/21. Teacher reports no known exposure to a person with covid.  Denies any past back or spinal cord or sciatica pain. No recent lifting or working out at a gym. Reported to VAERS 2/13/21 Registered Nurse
Same day post vax, the pt experienced fever of 102-104, erythema of face and neck, and hives.
Headache; Fatigue; Achy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue) and PAIN (Achy) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and PAIN (Achy). At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue) and PAIN (Achy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
A tin taste after having vaccine. Went to doctors. The tin taste I have when I eat food of any kind. Still get that horrible taste.
Patient received 2nd dose of Pfizer COVID-19 vaccine on 4/12021 at Park. She developed itching and tingling of her hand. She was evaluated  and given Pepcid 20 mg x1. She was observed for 30 min and sent home.
Severe Tinnitus that has been continuous. Several doctors appointments, hearing test, flushing of the ears. I've had to increase my blood pressure medication. Due to lack of sleep, now taking Nortriptyline. The many doctors have said there is NO cure.
Headache has continue and got much worse last night, left side of head and eyes hurting this morning; fever; chills; nausea; felt like he couldn't move; a sore arm; Headache has continue and got much worse last night, left side of head and eyes hurting this morning; This is a spontaneous report received from a contactable consumer (Calling on behalf of her son) reported for a 32-year-old male patient that received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 22Apr2021 (Lot Number: EW0162) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previous took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 31Mar2021 (at age of 32 years old, Lot Number: EP7533) as a single dose for covid-19 immunization. The patient developed headache, fever, chills nausea, felt like he couldn't move, and a sore arm on Apr2021. Fever ended on Saturday (24Apr2021). Headache had continue and got much worse last night, left side of head and eyes hurting this morning (26Apr2021). He took two Advil this morning. The reporter asked how long will it last, if any info on severity, if Left side of the head- is that more of a migraine and what about eye pain. The outcome of event was "Fever" was recovered on 24Apr2021, outcome of "Headache aggravated" was not recovered and other events was unknown.  No follow-up attempts are needed. No further information is expected.
She has sore arms; Body aches; Inappropriate schedule of product administration; This is a spontaneous report from a contactable consumer. An adult female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 08Jan2021 as a single dose in the left arm for COVID-19 vaccination.  Medical history and concomitant medications were not reported. Historical vaccination information included receiving the first dose of  BNT162B2 on 17Dec2020 for COVID-19 vaccination. On an unspecified date, the patient experienced sore arms and body aches. It was unknown if the patient received treatment for the events. The clinical outcome of sore arms and body aches, and inappropriate schedule of product administration was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
fatigue; no appetite; nauseous; chills; headache; Sore arm; My pulse was over 100 again resting but went back normal by late morning; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 16Feb2021, for COVID-19 immunisation, reaction(s): "Slight sore arm", "headache", "total fatigue", "loss of appetite", "pulse went up 139". The following information was reported: FATIGUE (non-serious) with onset 10Mar2021, outcome "unknown", described as "fatigue"; DECREASED APPETITE (non-serious) with onset 10Mar2021, outcome "unknown", described as "no appetite"; NAUSEA (non-serious) with onset 10Mar2021, outcome "unknown", described as "nauseous"; CHILLS (non-serious) with onset 09Mar2021, outcome "not recovered", described as "chills"; PULSE ABNORMAL (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "My pulse was over 100 again resting but went back normal by late morning"; HEADACHE (non-serious) with onset 09Mar2021, outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 09Mar2021, outcome "unknown", described as "Sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Onset latency for the events fatigue, decreased appetite and nausea was 01 day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Administered 1ml to five patients; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Administered 1ml to five patients) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (Administered 1ml to five patients). On 30-Mar-2021, ACCIDENTAL OVERDOSE (Administered 1ml to five patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This report refers to a case of accidental overdose for mRNA-1273 with no associated AEs.
Constant diarrhea along with other common vaccine side effects for over a week.; This is a spontaneous report from a contactable nurse, the patient. A 58-Year-old non-pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 10Mar2021 at 17:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The medical history includes diabetes, obesity, arthritis, hypertension, high cholesterol, chronic pain. Concomitant medication includes metformin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), nifedipine (MANUFACTURER UNKNOWN), novolog (MANUFACTURER UNKNOWN), lantus (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date. The patient had allergies to Shellfish, iodine, mangoes, latex, dental lidocaine, flagyl, Diflucan. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient has not tested positive for COVID-19 since vaccination. On 10Mar2021 at 17:30, the patient experienced Constant diarrhoea along with other common vaccine side effects for over a week. The clinical outcome of the event diarrhoea was not recovered at the time of report.   No follow-up attempts are needed. No follow-up information is expected.
Patient had verbalized he was afraid of needles as the pharmacist was administeringt the vaccinations. He had also mentioned that he has never had a flu shot prior to this. He was getting both vaccines because his wife is currently pregnant with their second child. After the vaccinations the patient stood up but the pharmacist recommended he sat down for a while just in case he "felt woozy". Patient agreed as he was already starting to feel woozy. Patient became pale, unconsious, and soiled his pants. He arose after about a minute and unsure of what happened. He remained seated on the chair throughout.
patient received 3 doses of moderna  dates 01/06/21, 02/04/21, and 03/04/21 all at pharmacy store
After administering  vaccine to the patient, she complained  about feeling lightheaded  and it seemed like  she was fainting for a couple of seconds with some shaky movement.   I supported her to prevent her from falling , and within about a minute  patient seemed ok.