chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her symptoms were so bad that it kept her awake and couldn't sleep at all; aching so badly; could not get warm; possible fever; feel woozy, dizzy; extremely cold that fluctuates to extreme hot spells; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feel woozy, dizzy), FEELING OF BODY TEMPERATURE CHANGE (extremely cold that fluctuates to extreme hot spells), INSOMNIA (her symptoms were so bad that it kept her awake and couldn't sleep at all), PAIN (aching so badly) and NASOPHARYNGITIS (could not get warm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (feel woozy, dizzy), FEELING OF BODY TEMPERATURE CHANGE (extremely cold that fluctuates to extreme hot spells), NASOPHARYNGITIS (could not get warm) and PYREXIA (possible fever). On 13-Mar-2021, the patient experienced INSOMNIA (her symptoms were so bad that it kept her awake and couldn't sleep at all) and PAIN (aching so badly). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 13-Mar-2021 for Ache, at an unspecified dose and frequency. At the time of the report, DIZZINESS (feel woozy, dizzy), FEELING OF BODY TEMPERATURE CHANGE (extremely cold that fluctuates to extreme hot spells), INSOMNIA (her symptoms were so bad that it kept her awake and couldn't sleep at all), PAIN (aching so badly), NASOPHARYNGITIS (could not get warm) and PYREXIA (possible fever) had not resolved.            Concomitant medications were not provided.
Dizziness Narrative:  Nausea, light headed  Other Relevant History:
Abdominal pain; Difficulty of breathing; Muscle pain; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Difficulty of breathing) and MYALGIA (Muscle pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Anxiety, Asthma, Allergy to antibiotic (septra ), Seafood allergy and Penicillin allergy.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Difficulty of breathing) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form, qid. At the time of the report, ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Difficulty of breathing) and MYALGIA (Muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included currently patient is taking medication for high blood pressure and anxiety.  Treatment information included taking inhaler.  Action taken with mRNA-1273 in response to the events was not Applicable.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles and product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter declined to provide demographics or details for the report. The reporter was patient's wife. In 2018, after receiving 1st dose of SHINGRIX the patient experienced shingles outbreak. The reporter reported that the patient missed 6 months window for the second dose of SHINGRIX due to pharmacy not having in stock, which led product suplly issue. The patient had denied permission to contact their physician. No further details were provided.
Six hours after the injection the opposite arm had extreme pain in the biceps and could not be used. The patient reports she was concerned that the muscle had ripped off the bone. This lasted two days, and for the next four days the pain and movement gradually improved but there was still limited mobility and pain one week later.  It generalized to the right anterior shoulder girdle. it should be noted that the right biceps had already been problematic due to a general aching  Of have several weeks duration.
Pt recvd Engerix-B & 24 hrs p/dose had abdominal cramping for 2 hrs;
Mother contacted office on 10/14/2002 stating patient was seen over weekend at the local E.D. because of increased swelling and erythema at injection site.
This spontaneous report as received from a medical assistant refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, multiple unspecified patients were administered improperly stored ROTATEQ orally, lot # L008034 exp. 05-AUG-2016 (dose was not provided). There was no adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Headache; Muscle ache; fever; This is a spontaneous report from a contactable consumer, the patient. A 54-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 30Mar2021 at 11:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have allergies to medications, food, or other products. The patient did not receive concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On an unknown date in 2021, the patient experienced headache, muscle ache and fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of events headache, muscle ache and fever were recovering at the time of reporting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
running nose; fever; This is a spontaneous report from a contactable consumer (parent). A 13-years-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration on 10Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the caller stated that patient is due for her second dose today but yesterday she developed a fever and running nose and called the pediatrician and they recommended she wait to receive the second dose and wanted to know how can reschedule this. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
swollen lymph nodes; dizziness; nausea; fever; This is a spontaneous report from a contactable consumer (Patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. Patient stated that four or five days later, she had some glands that swelled behind her ear and on her head. She also had fever, and nausea and she had to go to the doctor. Patient stated that the doctor injected her with two very strong antibiotics. She stated that it continued, and two days later, she went to see the same doctor again, because she was getting more glands, and the doctor sent her to the emergency room. At hospital, the staff did a CT, and they told her that she had some swollen nodules (swollen lymph nodes), and they changed her antibiotics. Patient reported that they are still swollen, they are less, but she is also still dizzy and nauseous (medically significant). Patient is wondering if this could be a side effect of the vaccine. Patient states that she was due on Monday for her second dose, and she was wondering about if she should still get it. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  No further information is expected
Woke up the next morning  with an extremely bad headache/migraine.  Light sensitive to my eyes.  I had to take ibuprofen and acetaminophen around the clock, and I went back to bed and slept until 1pm that day.  Headache remained dull the rest of the day, but I began feeling better.  My left arm was also very sore and second day past vaccine now have armpit soreness/pain.  Took ibuprofen again today for that.
3-18-09 3:40p seen for erythema 3.5 cm X 3.5 cm & sore.  Right Axilla tenderness.  R upper arm started 3-17-09 with pain in Axilla & progressed to injection site area.
Patient believes she has shingles. Noted red bumps/vesicles on legs and chest 2 days after receiving vaccine. Not diagnosed by doctor but a nurse at the facility she works at told her it was shingles
It started the afternoon of 02/19/2021 neck pain and dizziness, it continued through the night with chest pains and rapid heart rate, I could not go to sleep because my heart rate was so fast, the chest pains would wake me up every time I went to fall asleep. By morning the chest pains and rapid heart rate went away, The next day 02/20/2021 body aches, chills, fever, fatigue and later on in the day I had dizziness, that went on through Sunday and I was better by Monday.  I called my family doctor on Monday when the office reopened.  The told me to go to the ER if it happens again.  At that point the symptoms had subsided so there was no point to go in.
Tinnitus. Loud ringing in ears started 9 hours after vaccination. It has not fully subsided yet.
expired MENACTRA was administered to a patient with no reported adverse event; Initial information received on 17-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call canter.  This case involves a 17 years old male patient who experienced expired menactra was administered to a patient with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 17-JUN-2022, the patient received a 0.5 ml (total) dose of suspect meningococcal a-c-y-w135 (d conj) vaccine lot U6952AA, expiry date: 09-Jun-2022 (strength, formulation, frequency: unknown) via intramuscular route in the left deltoid as Immunization.  On 17-JUN-2022 the patient developed a non-serious event expired menactra was administered to a patient with no reported adverse event (expired product administered) (latency same day) following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired product administered).  At time of reporting, the outcome was Unknown for the event expired product administered.   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 the guidelines. 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.
Pt. presented to EC with mental status changes on 04/07/21; discharged home on 04/08/21.
Indigestion; Hiatal hernia; Weakness; Inflammation; Heart attack; Reflux gastritis; Headache; Fever; Sleep disturbance; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SPIRONOLACTONE, LISINOPRIL, TICAGRELOR (BRILINTA), ATORVASTATIN and METOPROLOL SUCCINATE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced SLEEP DISORDER (Sleep disturbance), HEADACHE (Headache) and PYREXIA (Fever). On 09-May-2021, the patient experienced REFLUX GASTRITIS (Reflux gastritis). On 19-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced DYSPEPSIA (Indigestion), HIATUS HERNIA (Hiatal hernia), ASTHENIA (Weakness) and INFLAMMATION (Inflammation). The patient was treated with MAGNESIUM OXIDE HEAVY, SODIUM BICARBONATE (ANTACID C) at a dose of 1 dosage form; NITROGLYCERIN at a dose of 1 dosage form and Surgery (Stent insertion) for Myocardial infarction. At the time of the report, MYOCARDIAL INFARCTION (Heart attack), SLEEP DISORDER (Sleep disturbance), DYSPEPSIA (Indigestion), HIATUS HERNIA (Hiatal hernia), ASTHENIA (Weakness), INFLAMMATION (Inflammation), REFLUX GASTRITIS (Reflux gastritis), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Electrocardiogram: abnormal (abnormal) abnormal. In 2021, Endoscopy: abnormal (abnormal) abnormal.         Treatment information included proton pump inhibitor. 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-108529, BE-MODERNATX, INC.-MOD-2021-108559 (E2B Linked Report). This case was linked to MOD-2021-213971 (Patient Link).; 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. US-MODERNATX, INC.-MOD-2021-108529:(crosslink) BE-MODERNATX, INC.-MOD-2021-108559:(crosslink)
screaming x 8 hrs nonstop per mom hx; t103; swelling of leg; mom reported event 16NOV93;
EXTREME LETHARGY; INTERMITTENT FATIGUE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. The patient experienced nausea and vomiting when treated with sulfamethoxazole/trimethoprim, and itching and swelling when treated with neomycin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced extreme lethargy. On 12-APR-2021, the subject experienced intermittent fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme lethargy, and the outcome of intermittent fatigue was not reported. This report was non-serious.
started feeling headache; tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (started feeling headache) and FATIGUE (tiredness) 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 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Dec-2021, the patient experienced HEADACHE (started feeling headache) and FATIGUE (tiredness). At the time of the report, HEADACHE (started feeling headache) and FATIGUE (tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
hives, rash, itchiness. over entire body. Severe at times. Responds to allergy medication such as benadryl and Zyrtec. Ongoing symptoms as of 1/7/22 for booster shot given 11/16/21
A mild rash has appeared about 4.5 inches below injection site on my upper left arm. Strangely, the rash is rectangular in shape, about 4 inches long by 1 inch wide. The rash itched only once, is not painful, and is very warm to the touch. I have not treated the rash, as it has not been bothersome.
lightheaded; muscles shaky; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737) via an unspecified route of administration, in the left arm on 03Apr2021 at 12:45 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included bisoprolol fumarate (ZEBETA), escitalopram oxalate (LEXAPRO), atorvastatin calcium (LIPITOR), buspirone hydrochloride (BUSPAR) and hydrochlorothiazide (MANUFACTURER UNKNOWN), all for unknown indications  from unknown dates. The patient previously received epinephrine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 03Apr2021 at 12:45, five seconds after vaccination, the patient felt lightheaded, muscles were shaky and nauseous. Felt this intensely for two hours and then it lessened but still felt sick. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of the events of lightheaded, tremor muscle and nausea were recovered with sequelae on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Rash on right thigh, sensitve to the touch, with water filled blisters. Achy joints and pain associated with rash.
constipation; patient seems to be in a dense fog; patient does not remember speaking to the caller on two occasions during the morning which is; caller concerned that the vaccine has affected the patient's cognition; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (patient seems to be in a dense fog), MEMORY IMPAIRMENT (patient does not remember speaking to the caller on two occasions during the morning which is), COGNITIVE DISORDER (caller concerned that the vaccine has affected the patient's cognition) and CONSTIPATION (constipation) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included Surgery (geo blastoma with a mass the size of an avocado that was removed from his brain.) and Surgery (gamma knife surgery) in December 2020.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 25-Mar-2021, the patient experienced FEELING ABNORMAL (patient seems to be in a dense fog), MEMORY IMPAIRMENT (patient does not remember speaking to the caller on two occasions during the morning which is) and COGNITIVE DISORDER (caller concerned that the vaccine has affected the patient's cognition). On an unknown date, the patient experienced CONSTIPATION (constipation). At the time of the report, FEELING ABNORMAL (patient seems to be in a dense fog), MEMORY IMPAIRMENT (patient does not remember speaking to the caller on two occasions during the morning which is), COGNITIVE DISORDER (caller concerned that the vaccine has affected the patient's cognition) and CONSTIPATION (constipation) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-062435, US-MODERNATX, INC.-MOD-2021-057891 (Linked Report).; Sender's Comments:  MOD21-062435:MOD-2021-057891 - 1st dose of vaccine. US-MODERNATX, INC.-MOD-2021-057891:MOD-2021-057927 - 2nd dose of vaccine.
itching at injection site in the right arm/she got it the injection site was itching and now has spread down her arm and back; now has spread down her arm and back; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6207), via an unspecified route of administration, administered in right arm on 17Mar2021 at 09:00 (at the age of 20 years) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were none. On 17Mar2021 09:00 (right after she got the vaccine) patient stated injection site was itching and the itching had spread down her arm and back, did not know if she should be concerned. The patient had not yet recovered from the events.  No follow-up attempts are possible. No further information is expected.
raised, red, itchy, & hot circular area of about 4 inch diameter around the pneumovax injection site that was still present 6 days after vaccination
pt recvd vax;devel edema, erythema, & pruritus at inject site;
Dizzy, Hot, pt 33 weeks pregnant bp  111/67 pulse 75 o2 sats 100% monitored by EMS pt advised see ob/gyn for next vaccine pt released by ems.
Body pains, fever, chills redness/and hardness on the left arm at the injection site and all over the left arm.
This spontaneous report was received from a certified medical assistant refers to unspecified number of patients of unknown demographics. On an unknown date the patients may have been vaccinated with VARIVAX (Merck) (lot#, expiration date and route not reported) which reached a high temperature of 28 Celsius (C). No adverse effects have been reported. This is one of the several reports from the same source. Additional information has been requested.
Terrible chills, fever of 101, extreme fatigue, significant joint pain, splitting headache and nausea and inability to sleep peacefully for 36 hours
Patient began having Covid-19 symptoms on 1/16/22 and tested positive on 1/21/22. Symptoms included fever >100.4, Muscle aches, Sore Throat and Fatigue. Patient died on 3/1/22