chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up around 1:00 am with the shakes and freezing and then had to run to the bathroom with diarrhea which happened about 5 times during the night.  I also had a horrible headache, backache, and my joints ached.  This lasted until I took Aleve at around 7:00 am.  I finally fell asleep about 8:00 am and slept for about 4 hours.  I felt better when I awoke but was still really tired for about 12 more hours.  I have had stomach issues since, diarrhea for at least 10 days and then still bloated and cramping.
Patient reports receiving Pfizer vaccine 5/21/2021 and insomnia since receiving vaccine and feeling "electricity" throughout body.  Per patient, went to urgent care on 5/24/21 in PM, had normal vital signs, and was given hydroxyzine and Flexeril and was able to sleep for 2 hours overnight, but it was not a restful sleep. When I spoke with patient on the phone, patient was agitated, and had pressured speech, and appeared to be in pain. I prescribed Lunesta 3 mg and told patient if unable to sleep, to go to Emergency Department for further evaluation.
SkinRash, fever, arm pain, axillary swelling and erythema over left breast area. Rash over perineum, and neck area.  Improving s/p RX with prednisone. Narrative:
swelling on the injection site; Muscle pain; arm pain; Joint pain; Redness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 27Sep2021 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single), administration date: 16Aug2021, when the patient was 72 years old, for covid 19 immunization, reaction(s): "no side effects". The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 27Sep2021, outcome "unknown", described as "swelling on the injection site"; MYALGIA (non-serious) with onset 27Sep2021, outcome "unknown", described as "Muscle pain"; PAIN IN EXTREMITY (non-serious) with onset 27Sep2021, outcome "unknown", described as "arm pain"; ARTHRALGIA (non-serious) with onset 27Sep2021, outcome "unknown", described as "Joint pain"; ERYTHEMA (non-serious) with onset 27Sep2021, outcome "unknown", described as "Redness". Therapeutic measures were taken as a result of vaccination site swelling, myalgia, pain in extremity, arthralgia, erythema.  Additional information: Consumer stated, "That I get any medication afterwards. No, I did not get no medication just the injection (Further Clarification Unknown)."  Follow-up attempts completed. No further information is expected.
Developed COVID-19; Elevated platelet counts (300 to 530); Trouble sleeping; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT INCREASED (Elevated platelet counts (300 to 530)) and COVID-19 (Developed COVID-19) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1232366) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) for an unknown indication.    Concurrent medical conditions included Dry skin. Concomitant products included OMEPRAZOLE, DIAZEPAM and HYDROXYZINE for an unknown indication.   In June 2021, the patient RUXOLITINIB PHOSPHATE (JAKAFI) (unknown route) dosage was changed to 1 dosage form. On 02-Jul-2021, RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) dosage was changed to 5 milligram twice a day. On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 5 milligram once a day. In July 2021, the patient experienced PLATELET COUNT INCREASED (Elevated platelet counts (300 to 530)) (seriousness criterion hospitalization). On 18-Jul-2021, the patient experienced COVID-19 (Developed COVID-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced INSOMNIA (Trouble sleeping). The patient was hospitalized on sometime in July 2021 due to PLATELET COUNT INCREASED. At the time of the report, PLATELET COUNT INCREASED (Elevated platelet counts (300 to 530)), COVID-19 (Developed COVID-19) and INSOMNIA (Trouble sleeping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Platelet count: 530 (High) High. On an unknown date, Platelet count: 300 (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient visited the emergency room 3 time due to elevated platelet count. No treatment information was provided.  Company Comment: 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. Concomitant medication RUXOLITINIB was considered as cosuspect.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 and mRNA-1273 is assessed as not applicable.; 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. Concomitant medication RUXOLITINIB was considered as cosuspect.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 and mRNA-1273 is assessed as not applicable.
mild arm soreness; This is a spontaneous report from a contactable physician (patient) via Pfizer sales representative. A male patient of an unspecified age received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced mild arm soreness on an unspecified date (a day or two after vaccine). The outcome of event was recovered on unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received on 15-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a family practice as recommended for routine adult health maintenance and for the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster the very virus the ZOSTAVAX is intended to prevent. On or about 01-JUL-2015, the patient was treated at a family practice for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Feeling tired after the vaccine; This is a spontaneous report from a contactable consumer (Patient). A 34-year-old male patient received (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 23Dec2020 09:00 at single dose for covid-19 immunization (Front line health care worker). Vaccine location was left arm and it was the first dose. He was scheduled to get the second dose in Jan2021. The COVID-19 vaccine was administered at Hospital. Medical history included attention deficit hyperactivity disorder (ADHD). Concomitant medication included ongoing methylphenidate hydrochloride (CONCERTA) for ADHD taking for five years. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was feeling tired after the vaccine on 23Dec2020, Stated he just got the vaccine and he was now just really tired, not sick or anything and he was at work. He was considering going home from work and they told him he had to call Pfizer. Reported he received the COVID 19 vaccine today at work at the at 0900 23Dec2020 in the left arm. About 20 minutes after the injection he started to feel tired and like he wanted to go home from work. His feeling was staying the same. The outcome of the event was not recovered.
Projectile vomiting, lethargic, pulling legs to chest while crying, bloody jelly-like stool
This spontaneous report was received from a licensed practical nurse, and concerns to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 17-FEB-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) by subcutaneous route. lot # L024255 with expiration date 01-JUL-2017. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Breakthrough case admission after 3 vaccines Moderna 3/30/21 Lot# 018B21A;  Moderna 4/27/21 Lot# 043B21A;  Moderna 12/21/21 lot# 068H21A
BLOATING; CRAMPS; CHILLS; FEVER; HEADACHE; LOSS OF APPETITE; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non alcohol, and non smoker, and other pre-existing medical conditions included the patient has no abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 07/MAY/2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included vitamins nos. On MAY-2021, the subject experienced abdominal pain. On MAY-2021, the subject experienced loss of appetite. On 07-MAY-2021, the subject experienced chills. On 07-MAY-2021, the subject experienced fever. On 07-MAY-2021, the subject experienced headache. On 08-MAY-2021, the subject experienced cramps. On 08-MAY-2021, the subject experienced bloating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache, and had not recovered from abdominal pain, cramps, loss of appetite, and bloating. This report was non-serious.
This spontaneous report was received from a pharmacist refers to a 65 year old female patient. The patient had drug reactions/allergies to penicillin, cephalosporin, doxycycline (diarrhea reaction), tetracycline, LEVAQUIN (caused sleepiness), FOSAMAX (with unspecified reaction), codeine and NAPROSYN. The pharmacist reported that the patient developed red bumps and swelling at the injection site of a PNEUMOVAX23 (lot# unspecified) (dose, route and location unspecified, could not be ruled out). The patient received the Pneumococcal vaccination at her physician's office (name of physician unspecified) within the last two days approximately 10-SEP-2013. The patient had sought medical attention via contacted the pharmacist. No lab diagnostic study was performed. At the time of report, the outcome of the event was recovering. This is one of several reports received from the same patient. Additional information is not expected.
Approximately 15 minutes after injection; patient complained that his eyes feel "puffy/full and he says he feels warm."  No other symptoms. After 5-6 minutes he says he felt back to normal and left.
Chills; Ache; Slight fever/I had slight fever 99.7; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 01Feb2021 17:00 (reported as 5 PM) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the vaccine last night at 5 PM on 01Feb2021 and woke up on 02Feb2021 (morning) at 5 AM with chills, ache with no fever at that time but as the morning ahead, patient had slight fever 99.7. Patient read in the paper that those are very common side effects. Outcome of the events was unknown.
At the moment the vaccine was administered to the left arm (deltoid) the liquid was expelled from the patient's injection site. The syringe used was 3ml BD Integra 25Gx1.  I contacted rep and they are going to contact CDC for recommendations, in case the patient needs to repeat the dose.
since 10 days after vaccine, patient has had evening fevers (5 weeks at this time).  initially she had a sore throat with the fevers but this has resolved.  The cause of the fevers, despite extensive evaluation, remains unknown.
Information has been received from a nurse concerning a 10 year old male patient with hypersensitivity (dog hair and carpet), seasonal allergies and a history of hyperlipidaemia who on 17-AUG-2009 was vaccinated SQ with the second 0.5 ml dose of VARIVAX (Merck) (lot number 664507/0689Y).  There was no concomitant medication.  On 18-AUG-2009 the patient developed a red raised area about 2.5 to 3 inches in size at the injection site.  Unspecified medical attention was sought.  There were no lab studies performed.  At the time of the report, the patient had not recovered.  This is one of several reports from the same source.  Additional information has been requested.
Patient developed headache, myalgias, increased temperature, and fatigue 5 days after receiving influenza vaccine injection. See by physician 2 days after onset of symptoms and he will treat with acetaminophen and follow patient (Physician doubted that symptoms were due to influenza vaccine). No further information available.
Fever (101 degrees); chills; dizziness; extreme fatigue; headache; body aches; pain, swelling, redness and itching at injection site; red, lacy rash on torso - all symptoms began within 20 hours of vaccine and subsided gradually by 48 hours after vaccine - no treatment other than rest
2 big circles where the shot went in. It was kind of red; This is a spontaneous report from a contactable consumer (patient) via Pfizer RxPathways and from a Pfizer sponsored program COVAX US support.  A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), on Feb2021 at single dose in arm for covid-19 immunisation; celecoxib (CELEBREX 100 mg), via an unspecified route of administration from an unspecified date to an unspecified date, at 100 mg unknown frequency for an unspecified indication. The patient medical history and concomitant medications were not reported. Previously the patient took celecoxib and experienced chest hurt. On an unspecified date in Mar2021, the patient experienced 2 big circles where the shot went in, around injection site and both circles were a different color; it was kind of red, now it was kind of brown and the outside of it was kind of light pink. The outcome of the event was unknown.No follow-up attempts are needed; information about lot/batch number cannot be obtained.
fever 100 for 36hr p/vax 101 12hr p/vax @ one reading loose stools & vomiting x 24hr;pt called MD;reports MD did not want to see pt unless condition worsened;
Unknown which shots went into which thigh and which one was an oral drink. We are currently going through the symptoms and can post more later.
On Tuesday 11/1 I was tested for the flu and COVID-19, it's also not bronchitis or pneumonia but it's some kind of viral infection. Sore throat, headache, clogged ears, nasal congestion, shallow breathing, very fatigued and coughing that got worse and worse. These have been my symptoms and have been fairly severe. Today is day 8 and I'm on 3 different medications, I'm slowly improving but it's definitely still there. I had COVID-19 this past May. The symptoms weren't bad, I thought I had allergies. I had a scratchy throat and a slight temperature. What I have now is ten times worse than when I had COVID-19.
Information has been received from a medical assistant referring to an unspecified number of patients who were 13 years old and older. The patients' concomitant therapy, concurrent condition and medical history were unknown. On an unknown date, the patients were vaccinated with an unspecified number of doses of PROQUAD (dose, frequency and route were unknown, lot # N012489, expiration date:17-OCT-2017) for prophylaxis(drug administered to patient of inappropriate age). No adverse effects reported.
Sore throat; Cold; Fever of about a 100 degree; Discharge that begin to happen that night; This is a spontaneous report from a contactable consumer (patient). A 39-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179), dose 1 via an unspecified route of administration, administered in Arm Left on 18May2021 11:30 (at the age of 39-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 19May2021, beginning Wednesday afternoon, the patient experienced sore throat, more or less had cold, fever of about a 100 degree, discharge that begin to happen that night. The patient would prefer just to report because the patient was sick right now and I don't feel like having to repeat. The patient did not receive any treatment. Outcome of the event was unknown. Information on Lot/Batch number was available. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: The pt felt lightheaded and passed out for a few seconds.  His father was with him and caught him and laid him on the ground.  I contacted my nurses who stayed with the pt and monitored him for more than 30 mins.  The pt was awake but felt light headed, had low blood pressure and blood sugar.  The pt was given water and crackers.  My DM was also here and called the paramedics who took him to the hospital.
Smallpox vaccine administered 21Nov05. Initial read 28Nov05 was normal reaction. Returned today 29Nov05, now with approximately 2 inch diameter area on Rt Deltoid, localized swelling, warmth, pain. Decreased Shoulder ROM secondary to pain. Pt c/o Chills. Treatment with OTC Tylenol at present and continue to observe site. F/U PRN.
Developed urticaria rash over entire body about 1 hour post vaccination. Resolved with one dose of BENADRYL.
Initial and follow-up information has been received from a registered nurse and an administering healthcare professional concerning a 11 year old female patient with allergy induced asthma who on 27-DEC-2011 at 12:14 was vaccinated with the third dose of GARDASIL, (lot number 670050/1229AA), I.M. right deltoid (dose not reported) at private doctor's office/hospital. The immunization with GARDASIL was reported due to out of temperature range, fridge temperature fell below 32 degrees F (it was also reported as 30 degrees F) over 16 day period. It was reported that no adverse reaction occurred. This is one of several reports received from the same source. No further information is available.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-JUL-2017, the patient was vaccinated in error with a dose of VARIVAX injection, by subcutaneous route (strength, dose, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Caller mentions that she already had Covid and already took the vaccine; Caller mentions that she already had Covid and already took the vaccine; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller mentions that she already had Covid and already took the vaccine". Clinical course: Transferring agent stated that the caller was a nurse calling for her neighbor. The caller stated that her neighbor was 67 years old. The caller stated that the Pfizer Covid 19 Vaccine was not available and asked if it was out of stock. Transferring agent stated that the caller mentioned that the caller already had Covid and already took the vaccine. Caller came onto the line and immediately asked if the transferring agent was from overseas. Caller stated that the transferring agent talked too fast, if she talked any faster, she could be a recording. Caller did not verified or clarified about the statement provided by the transferring agent about the caller, herself, having already had Covid and already taken the vaccines. This report was concerning the caller herself. Then attempting to clarify information from the transferring agent the caller became upset, stated she did not need to do any reports. Caller remained upset. Stated that for her own self, she was already vaccinated, and double booster dosed and didnot provide the name of the vaccines she was referring to. The caller never verified which vaccines she herself received, or the statement from the transferring agent about how the caller mentioning that the caller already has had Covid and already took the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the events  drug ineffective and COVID 19 and the suspect drug  BNT162b2
This spontaneous report was received from a nurse refers to a 1-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 27-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis. The lot of M-M-R II were reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.