chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SHORTNESS OF BREATH; TERRIBLE PAIN IN NECK ON LEFT SIDE; STIFF NECK IN THE SAME SIDE AS  INJECTION - LEFT SIDE; SUSPECTED SINUS INFECTION; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure abnormal, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced nausea and vomiting when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 10:00 for prophylactic vaccination. Concomitant medications included amlodipine for blood pressure abnormal.  On APR-2021, the subject experienced suspected sinus infection. On 14-APR-2021, the subject experienced terrible pain in neck on left side. On 14-APR-2021, the subject experienced stiff neck in the same side as injection - left side. On 20-APR-2021, treatment medications included: doxycycline. On an unspecified date, the subject experienced shortness of breath. Additional treatment medications (dates unspecified) included: camphor/menthol/methyl salicylate/tocopheryl acetate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiff neck in the same side as injection - left side, had not recovered from terrible pain in neck on left side, and the outcome of suspected sinus infection and shortness of breath was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Gardasil administered 11/27/06, dizziness 11/28/06, severe vertigo 11/29/06, hospitalized 11/29/06-12/01/06.  MR received for ER admit for c/o dizziness, vertigo, and vomiting x2 days beginning within 24 hours of Gardasil vax. PE: WNL and in no distress as long as she holds still. Txd with IV fluids, Valium and Antivert.  D/Cd home on Meclizine after 48 hours. Discharge DX: Acute vertigo, possible adverse reaction to Gardasil vaccine. 02/05/2007 Tag-2 received. No new codes.
Reddened and raised welt at injection site. Growing larger daily. First noticed at the size of a quarter. Not responding to allergy medicine. Itchy, burning.
Received booster on left arm 1/8/2023. Left arm sore and warm remainder of the day. 1/9/2023 felt fatigued. 1/10/2023 felt fine. 1/11/2023 fatigue returned. 1/12/2023 enlarged lymph node right side of neck. 1/14/2023 pain cervical spine radiated to right arm lasted a few days. 1/17/2023 rash under arms down trunk also groin area above buttocks which was itchy. 1/18/2023 pink eye in left eye. 1/21/2023 developed arthralgias in both legs, shoulders, knees and ankles. Sore throat since injection.
In the afternoon on Friday 9/10/21 I began feeling nauseous, having heartburn, and extreme fatigue. On the morning of 9/11/2021 I started having profuse anal bleeding and went to the emergency room where the bleeding continued. My blood pressure dropped to 79/55 and I fainted. I was given a blood transfusion and brought into surgery. The doctor did an EUA and did not find the source of the bleed. I was hospitalized overnight and did a colonoscopy prep and had a colonoscopy the next day. The doctor did not find the source of the bleed. She said it was probably an arteriovenous malformation in the small (cont.)
No additional adverse events reported.; Improperly Stored VARIVAX has been administered to a patient; This spontaneous report was received from a registered nurse referring to a 12 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 26-JAN-2022, the patient was vaccinated with a dose of improperly stored (later found supported) varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route of administration were not reported,  lot # U020238, expiration date was 28-JUN-2023) 0.5 ml for prophylaxis (product storage error).  It was reported that the suspect vaccine was exposed to a temperature of 6 Fahrenheit (F) up to 14 F (13.8 F) for a time frame of 1 hours and 45 minutes and 0 seconds, 14 F up to 46 F (14.4 F) for 0 hours 25 minutes and 0 seconds. There were no previous temperature excursions. No further adverse event (AE) information was provided (no adverse event).
Blood Clot in Lung. It began as night leg cramps in both legs.  There was also intense pain in both feet at night.  I also had muscle spasms (Twitches) up and down my legs and feet.  Eventually both legs swelled from the knees down. I was told that I was not a candidate for a blood clot.  I did not have any of the health issues on the list to be a candidate for blood clots. Had chest pain and shortness of breath. I was hospitalized twice. First at medical center and then again at  bigger hospital.
ADACEL administered at 17:30 hr. Immediately following he was flushed and red in face - feeling dizzy. His hand muscle distorted w/fingers - felt needles in skin - grasped hair. Used ammonia salts under nose to revive him - he did not faint. Breathing was shallow, S.O.B. Told him to breathe - he then said left shoulder & right palm of hand were itchy. Called 911 initially in beginning. Monitored vitals - he was feeling better when paramedics arrived.
Information has been received from a registered pharmacist, concerning a 57 year old male patient with phenothiazine allergy and penicillin allergy. The patient had no pertinent medical history. On 05-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # not reported), subcutaneously for shingles prevention. In AUG-2013, after receiving ZOSTAVAX, the patient experienced a lump the size of an egg at the site of injection on an unspecified day. It was also stated that there was no rash and the injection site was a little red. However, there was no pain associated with the redness. The patient sought medical attention by calling the pharmacist. No treatment was given for the events. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
I tested positive for COVID-19 on 6/29/22. I had a terrible headache first. Then, I realized I was running  fever, fatigued, It felt like my hips were giving out, congestion, and a mild cough. I was prescribed Paxlovid and i took that medication. My severe symptoms lasted for about 3 days, then they lingered for a few more days.
MOTHER CALLED AND SAID THE CHILD HAD BEEN RUNNING A FEVER OF 101 TO 103 AND HAD A THICK WHITE COATING ON TONGUE AND TINY BLISTERS ON END OF TONGUE. MOTHER STATED SHE DID NOT HAVE A DOCTOR, ADVISED TO TAKE CHILD TO EMERGENCY ROOM.
Itchy ever since; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced itchy ever since. The follow-up would not possible, as no contact details were available.
p/vax pt devel an inj site rxn characterized by pain, redness & swelling;
The patient has a history of dementia. He was brought to the ED by EMS on 3/30/23 for sudden onset of weakness that began the day prior. In the ED, he was found to be hypoxic with O2 sats at 88% and so was placed on supplemental O2. A rapid COVID PCR test performed in the ED resulted positive. Ultimately the patient was admitted 3/30/23 - 4/10/23. Discharge diagnoses include acute hypoxic respiratory failure due to COVID-19, COVID-19 pneumonia, severe sepsis met criteria on admission. He was able to be weaned off O2 during his admission. He completed a course of Decadron.
PRESENTED 1/27 WITH DYSPNEA, ORTHOPNEA, CHEST PRESSURE. FOUND TO BE IN NEWLY DIAGNOSED HEART FAILURE WITH EF 30-35%. NO PRIOR ECHO FOR COMPARISON. WORK UP CONSISTENT WITH NON-ISCHEMIC CARDIOMYOPATHY. STARTED ON ASPIRIN, DIURETIC, ANTIHYPERTENSIVES. ALSO DIAGNOSED WITH NEW DIABETES.  DISCHARGED HOME 1/31 AND RETURNED 2/1 WITH LEFT VISUAL FIELD DEFICIT, FOUND TO HAVE RIGHT PCA STROKE AND PUNCTATE LEFT HEMISPHERE STROKES SUGESTIVE OF EMBOLIC ETIOLOGY.
Patient has allergic reaction in the area of the arms and abdomen area. Allergic reaction red Petechiae.
An itchy, slightly swollen red rash (approx. 1.5 inches in diameter) was noticed on my upper arm at the site of the vaccination about 24 hours after being administered.  I applied topical 1% hydrocortisone cream 3 or 4 times a day to reduce the itching.  The rash gradually disappeared after 6 days.
On 9/30/2021, It was hard for me to get out of bed, I was stiff and could not lift up my back. It was severe back pain. It was affecting my fingers and I was having severe back pain. I have history of back pain. I showered and was finally able to stand upright. It has been this way even now. I start with having severe stiff back pain in the mornings. I have had relief with some medicine, occasionally Tylenol and Ibuprofen. I do not feel pain when I am laying in bed. I am having extreme fatigue. I work long hours as I am a doctor. It has slowed me down, and cannot see any many patients, because of my pain.  I am extremely fatigue.  Experiencing severe Bursitis in the right shoulder.
dizziness; vertigo; still very sick, couldn't get out of bed because of how sick it was; no focus on the vision, everything is related to the vision; the symptoms are not intense but they are still here, it gets worst throughout the day; couldn't eat; fell; Nausea; Headache; been to every doctor, 2 ophthalmologist , and neuro ophthalmologists, did not get the second shot because is still dealing with the first shot.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VERTIGO (vertigo), ILLNESS (still very sick, couldn't get out of bed because of how sick it was), VISUAL IMPAIRMENT (no focus on the vision, everything is related to the vision) and CONDITION AGGRAVATED (the symptoms are not intense but they are still here, it gets worst throughout the day) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 DIZZINESS (dizziness), VERTIGO (vertigo), ILLNESS (still very sick, couldn't get out of bed because of how sick it was), VISUAL IMPAIRMENT (no focus on the vision, everything is related to the vision), CONDITION AGGRAVATED (the symptoms are not intense but they are still here, it gets worst throughout the day), DECREASED APPETITE (couldn't eat), FALL (fell), NAUSEA (Nausea), HEADACHE (Headache) and PRODUCT DOSE OMISSION ISSUE (been to every doctor, 2 ophthalmologist , and neuro ophthalmologists, did not get the second shot because is still dealing with the first shot.). The patient was treated with MECLIZINE [MECLOZINE] at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and DIMENHYDRINATE (DRAMAMINE) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), VERTIGO (vertigo), ILLNESS (still very sick, couldn't get out of bed because of how sick it was), VISUAL IMPAIRMENT (no focus on the vision, everything is related to the vision), CONDITION AGGRAVATED (the symptoms are not intense but they are still here, it gets worst throughout the day), DECREASED APPETITE (couldn't eat), FALL (fell), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (been to every doctor, 2 ophthalmologist , and neuro ophthalmologists, did not get the second shot because is still dealing with the first shot.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. None of the treatment medication worked for the patient.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up was received on 24-MAY-2021. Reporter's email address was added. Patient's demography was updated, treatment medication and additional events were included. It contains significant information.
03/09/2021 13:31    patient stated feeling dizzy and light headed after receiving the Janssen Vaccines. Patient noted hyperventilating, clammy and sweaty. BP 57/37, P 52, RR 22, Temp 97.2 F. Patient stated she felt nausea and stated that she did not have a meal all day and only ate an apple. Patient noted pale in color. Patient vomited partially digested apple. Call placed to EMS. At 13:45 pm Fire Dept. arrived. Patient assessed by EMS.  Patient declined to go the hospital . BP 116/89, P 84, R 20. Patient states that she still feels light headed. Patient advised by EMS to seek medical care if she were to get worse. Call placed to patient husband.  Patient's husband on his way will continue to monitor.
sore arm; chills; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 (Batch/Lot number: unknown) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot unknown=False, administration date=15Mar2021, vaccine location=Left arm, dose number=1), administration date: 15Mar2021, when the patient was 44 years old, for COVID-19 IMMUNISATION. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Apr2021, outcome "recovering", described as "sore arm"; CHILLS (non-serious) with onset 05Apr2021, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 05Apr2021, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of pain in extremity, chills, headache.  Additional Information: Lot unknown reason was reported as Not available/provided to reporter at the time of report completion. No other vaccine in four weeks, No treatment received for adverse event. Covid prior vaccination and covid test post vaccination was reported as no. Query included: Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date was the date you became aware of the occurrence of the reported events. If you was the patient in the case, your awareness date would be the date that you became aware you was experiencing the reported events. If you was not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates were calculated based on the first day that a Pfizer colleague became aware of the adverse events. Response was reported as 05Apr. . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
died; Information has been received from a consumer who saw a report on the internet concerning two patients (unspecified ages) who were vaccinated with 3 doses of HPV rL1 6 11 16 18 VLP vaccine (yeast) (dates were not reported). Subsequently the patients died, the cause of death was unknown.   This is one of several reports received from the same source. This is a hearsay report, attempts are being made to obtain identifying information to distinguish individual patients.  Additional information has been requested.  This is an amended report: HCP confirmed has been changed to no for regulatory consumer. Company Causality Assessment: Episode Profile: Medically Confirmed: N
symptoms began at: April 28, 3pm No appetite, lethargy, nauseous, high fever (102 - 103+), sleeping for 16 hrs out of 24 hrs with highly disruptive sleep, interrupted by vomiting, dry heaving, delusional fever dreams, tiredness and low grade fever for another 12 hours No medical tests given No physician called
Pt with eyes open, slumped in chair and was not responsive, breathing and HR still present. Pale and diaphoretic. Slight shaking, color returned to pt face then pt awoke stating " What happened." Pt was given juice and observed for 15 minutes with no other reactions.
Flue like symptoms, right arm hurt and felt very cold, body ached, , felt dizzy like vertigo, had the chills, needed to sleep.   went to bed early around 8 and slept through the night getting up once to go to the bathroom.  Has breakfast just toast the next morning and had to get back into bed and slept 4 more hrs.  Body still aching.  slept with heating pad and iced my arm.  I felt a little better the next day around 2 pm.  I drank lots of fluids and rested the rest of the day.   Next day still felt weak.  3 days later feeling ok. I am worried about my next vaccine due on the 14th of Feb.   Would like to know what to take.  My doctor referred me to you with no instructions......
felt sleepy; This spontaneous case was reported by an other health care professional and describes the occurrence of SOMNOLENCE (felt sleepy) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Lidocaine).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (felt sleepy). At the time of the report, SOMNOLENCE (felt sleepy) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that patient received first and second dose as full dose. The patient had also received 2 boosters of Moderna Covid-19 vaccine (Monovalent).  The adverse event had not caused patient to seek medical care. It was unknown if the patient experienced a similar event in the past. The patient was advised by doctor that they should not take the Moderna Covid-19 vaccine as patient had allergies and hence queried if it was okay to receive Moderna Covid Vaccine, Bivalent. No treatment drug was reported.   This case was linked to MOD-2021-293413 (Patient Link).   Reporter did not allow further contact
Information has been received from a registered nurse concerning a 9 weeks old male patient with no drug reactions or allergies and no pertinent medical history who on 22-DEC-2011, was vaccinated with the first 2 mL (reported as "regular dose") dose of ROTATEQ Lot # 669757/0884AA, exp. date 09-MAR-13) (dose was not reported). There was no concomitant therapy. The nurse reported that on 22-DEC-2011, patient's mother called 4 hours after patient received a dose of ROTATEQ and reported that patient had a "bloody stool". The medical attention was sought by calling physician's office. None lab diagnostic tests were performed. Patient did not received treatment. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
After the vaccine on 10/16/2019 became sore and painful joints that evening with chills, went to bed woke up with a headache, nausea, diarrhea, dizziness, vomiting. Very painful back and shoulder joints.laid in bed for 2 days and took pain and then finally felt better but still nausea. Now my eye has a like floating black dot to the right of my right eye. Never had this before but still not over this week. I received the flu shot ant the prevnar vaccine last year with no side effects.
Patient endorsed severe flu-like/car accident-like symptoms including: stiff neck and butt cheeks, whole body aches, swelling of the chest, and pain in her arm even to soft touch. Visited her doctor after the immunization regarding her symptoms.
Small blisters on hands 3-5 mins after dose was administered.  Gave liquid Benadryl and they were gone in 5 mins.  Called patient 2 hours later at home then he was doing well with no issues.
The patient had flu like symptoms. Extreme sweating and a fever of 100 F. This  was reported by the patient to have  lasted for 6 hours
hives began 28AUg97 on back & moved through body in addition to joint pain;seen by ARNP given pred 6 days dec dose & DPH q 6-8hr;phone call again on 2SEP97 hives cont otherwise fine;
fever of 100.1 the morning of 12/2; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100.1 the morning of 12/2) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced PYREXIA (fever of 100.1 the morning of 12/2). At the time of the report, PYREXIA (fever of 100.1 the morning of 12/2) outcome was unknown. Not Provided.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 02-Dec-2021, Body temperature 100.1 (High).         No concomitant medications were reported.  No treatment information was reported.
23 days after vaccinated right thigh muscle went numb, tingly and cold and still happens if lay on back
c/o soreness, swelling @ inject site, fever, weakness; 0 redness;
Systemic: Dizziness / Lightheadness-Mild, Systemic: Loss Balance-Mild, Additional Details: Patient recieved a moderna bivalent booster at 10:30 am. After the patient was seated and waited for 15 min and about to walk out of the pharmacy, the patient felt dizzy and lost her balance. She fell backwards landing on her back.
Localized redness, swelling, itching, warmth. Cold compress, BENADRYL, MOTRIN.
leg had knot size of golfball & area size of adult fist-was red & feverish cont for nearly a wk;still has hard spot @ site child fussy;
Pt recvd vax 30OCT92 & 3NOV92 exp flu-like sx, dizziness, h/a, muscle achess arms, legs, back & upper back, aching in joints & inc BP; lab eval revealed GGT of 65 & SGPT of 32; No further details were provided;
THE PATIENT SKIN WAS PALE AND COLD, SHE WAS ALSO DIZZY AND EVENTUALLY FAINTED.