chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported arm pain that occurred during administration and lasted for a week before they decided to seek medical care from the ER on two occasions concerning this pain. The patient reported that the ER diagnosed it as bursitis. The patient also went to their PCP Dr. to seek treatment for the adverse event. According to the patient, he referred the patient to a neurologist and orthopedic specialists to rule out potential causes of the pain.
diarhea; Dizzy Spells; flu-like symptoms; increased heart rate, 106 bpm; Feeling weak; increased respiratory rate; injection site pain; injection site firmness; Injection Site Swelling; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included pneumococcal immunization.   On 10th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th September 2019, 12 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, heart rate increased, feelings of weakness, respiratory rate increased, injection site pain, injection site induration and injection site swelling. On 11th September 2019, the patient experienced diarrhea and dizzy spells. The patient was treated with antihistamine (Anti Histamine). On an unknown date, the outcome of the influenza-like symptoms, heart rate increased, respiratory rate increased and diarrhea were resolved with sequelae and the outcome of the feelings of weakness, injection site pain, injection site induration, injection site swelling and dizzy spells were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, heart rate increased, feelings of weakness, respiratory rate increased, injection site pain, injection site induration, injection site swelling, diarrhea and dizzy spells to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient stated that 12 hours later vaccination experienced flu like symptoms, increased heart rate, feeling weak, increased respirator rate, and injection site pain, swelling and firmness. The patient stated that after 24 hours of vaccination experienced diarrhea and dizzy spells. At the time of reporting all events resolved except feeling weak, injection site pain, injection site induration and injection site swelling. The patient stated that he went to healthcare professional regarding the events experienced and was told to take over the counter anti histamines. The healthcare professional told to avoid future pneumonia and all vaccines. The patient consented to follow up.
Patient states pharmacist told her to stay in store for 20 minutes. She works at local hospital so she went to work. Felt "funny" and BP was high, started IV steroids in clinic b/c of rash. She passed out and went to ED. Given meds to lower BP and released. Next day had terrible headache. Back to Dr. and diagnosed with meningitis. Sick for 6 weeks.
Headache: onset: 3/10/09-present. OTC MOTRIN taken for symptoms. Lower back pain: onset:3/10/09 x 1day. Fever: onset:3/10/09 x 1day Reported by mo. of pt. temp unknown. Left arm pain: onset: 3/10/09-present.
Patient had already received his vaccines on 3/27/23.  Then received an additional dose on 7/24/23.
Covid-19 symptoms for 5 days after injection. Could hardly walk because of joint inflammation and pain. Fever, cough with thick sputum. Headache and soar throat. In May I began to have digestive problems followed by heart issues in June through January of 22. Still have unrelenting joint inflammation and pain in shoulders, toes, fingers, wrists, knees, and hips along with neck and at times, teeth and jaw.
48 hours after administration of PCV 13 only vaccine given pt parent report red hard swollen tender area at site of vaccination. After clinical eval Dx cellulitis.
Shingles; Neuralgia affecting the nerves of your torso; This spontaneous report was received from a consumer via Agency referring to a patient of unknown age and gender. Patient's concurrent conditions, historical condition and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency, lot#, expiration date and anatomical location were not provided) for prophylaxis.   On an unknown date in 2018 ( three years ago), after taking the zoster vaccine live (ZOSTAVAX), the patient had shingles manifested by Rash one evening and it was gone in next morning and had neuralgia affecting the nerves of your torso which was very painful. On an unknown date, Patient took new vaccine to prevent another outbreak and the patient stated that, would recommend the vaccine, 15% of people who get the shingles develop neuralgia ! why is that not mentioned?  The outcome of the events was unknown.   The reporter did not provide the causality assessment between zoster vaccine live (ZOSTAVAX), shingles and neuralgia.
Pt developed Afib at 2AM on 1/23.  Started on amiodarone and Xarelto
Fluzone Vaccine administered Left deltoid. The next day, patient had pain, swelling, and itch below the injection site which increased the following day. Pt came to MD on 10/25/10 and parent claims it has improved slightly.  Site below injection site reddened, warm to touch, blanching and NT.  Patient's parents instructed to apply cool compresses, and return to clinic if no improvement in 2-3 days.
Muscle aches, headache, and chills for the first 48 hours. After 48 hours, these symptoms ended but rash appeared.
Pt arrives with fatigue and malaise. Pt reports that his wife lives in a nursing home and he has had a COVID exposure there. Pt was admitted with acute hypoxic respiratory failure and COVID-19.
Small amount of redness at injection site ~1cm 12hrs Later, then 16 hrs  after injection, 5mm x 5mm area of redness, warmth and mildly tender
1st dose on 10Sep2020 and 2nd dose on 06Oct2020.; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 6th October 2020, the patient received the 2nd dose of Shingrix. On 6th October 2020, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 1st dose of Shingrix on 10th September 2020. The health care professional stated that, the patient received 2nd dose of Shingrix early than the recommended time interval, which led to shortening of vaccination schedule. The reporter did not have lot number and expiration date information at the time of the call. The reporter consented to follow up.
mom called via phone states child recv vax 3MAR99 & on 4MAR99 rt thigh was swollen, red, warm & tender to touch & mom states remains swollen, red, feverish, shot area bigger than a fifty cent piece as of this date;mom giving child APAP;
I TOOK THE SHOT MONDAY 11/17/08 AT ABOUT 11:23AM WHEN I GO HOME I FELT REAL TIRED AND WEAK. A COUPLE OF HOURS LATER I HAD HEADACHES, CHILLS AND FEVER ALL I DID WAS REST AND SLEEP IN ALL DAY.I WAS NOT ABLE TO GO IN TO WORK THAT DAY. THE NEXT DAY TUESDAY 11/18 I STILL FELT THE SAME BUT STILL WENT IN TO WORK. THAT NIGHT ABOUT MIDNIGHT I FELT REAL ITCHY I HAD ACHES ALL OVER MY BODY. ON MY ARMS, HANDS, LEGS AND STOMACH THIS WENT ON AND OFF FOR ABOUT FOUR DAYS. IT WAS WORST IN THE EVENING AND AT NIGHT I WAS NOT ABLE TO SLEEP DUE TOT HE ITCHINESS UNTIL I WENT BACK IN TO MINUTE. THE REAL NICE NURSE THAT WAS THERE THAT DAY TOLD ME TO TAKE ZYRTEX AND USE AN OATMEAL SCRUB TO TRY AND STOP THE ITCHING. I DID NOT GO IN TO WORK FOR THE REST OF THE WEEK DUE TO HOW I FEELING. THE HEADACHES, CHILLS TIREDNESS, WEAK AND THE WORST THE ITCHINESS. I STARTED FEELING BETTER FORM THOSE SYMPTOMS AFTER I TOOK THE ZYRTEX.
This spontaneous report was received from a registered pharmacist concerning a 72 years old female patient with no medical history or drug reactions/allergies who on 21-AUG-2012 was vaccinated with a dose of ZOSTAVAX (dose and route not provided) (lot # 0242AE, expiration date on 01-APR-2013). There was no concomitant medication. On an unknown date in approximately August 2012 "few days after receiving ZOSTAVAX", the patient developed a large rash at the injection site and shortness of breath. No treatment was given for the event and no laboratory tests were performed. The patient sought medical attention in pharmacy. At the time of the report, the patient had not recovered from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
immed p/vax pt was noted to be unresponsive, pale, limp & in stuporous state;general air given became responsive to stimuli approx 5-10sec then became nauseous & vomited x 1;
Mon October 3 I started what seemed to be cold symptoms (head ache, body aches, cough). Antigen test negative. Thurs Oct 7 went to doctor. Flu test and antigen test negative and PCR was positive for COVID. Started Paxlovid October 8.
30 minutes post vax, the pt complained of site redness, swelling and itching. The area was 3cm x 2 1/2cm that was warm and elevated. No systemic symptoms. Lung are clear. Treated with Benadryl.
accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; This is 1 of 30 cases reported from this site; No adverse effects noted;
Fainted twice; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted twice) 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 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 SYNCOPE (Fainted twice) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainted twice) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided.  No treatment information was provided.  It was reported that, the patient took Moderna vaccine the previous day and at present morning fainted twice.  Company Comment : Very limited information regarding this case. However, based on the current available information from the case narrative and temporal association between the use of the product connected to the event, a causal relationship cannot be excluded.     Reporter did not allow further contact; Sender's Comments: Very limited information regarding this case. However, based on the current available information from the case narrative and temporal association between the use of the product connected to the event, a causal relationship cannot be excluded.
101 FEVER; HEADACHE; MUSCLE ACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced 101 fever, headache, and muscle aches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 101 fever, headache and muscle aches was not reported. This report was non-serious.
This case was considered medically important. Information regarding Dryvax was received from a literature source regarding a 54-year-old female patient who on unspecified dates received a dose and experienced progressive vaccinia. In December of 1970, the patient experienced progressive vaccinia. The virus was thought to have been isolated from a single skin crusted lesion, but the source may have been as many as four lesions. Patient was treated with vaccinia immune globulin. The outcome was not provided. The authors commented that it was not known if the patient was vaccinated or became infected following contact with a vaccinated individual. The immune status of the individual is not known, thus the underlying basis for the clinical findings is not clear. Furthermore, became virus was isolated from only one of a few lesions it is not known how the sequence of VACV-DUKE would compare to virus isolated from other lesions. Virus culture (results: VACV-DUKE vaccinia virus) was done in 1970. No additional information was available at the time of this report. See attached literature article.
Swelling - covered with bright red welt over vaccination site. Apprx 6" in diameter tender to the touch, itching.
Pt recvd 3 doses of Engerix-B on 16JUL90, 20AUG90, & 16JAN91 & was found to be a non-responder;
Myalgia, Fever, Diarrhea, swelling of left arm and neck; fever; diarrhea;  fatigue; body aches; night sweats Narrative:  OTC Tylenol as needed; Pepto-Bismol  Other Relevant History:
Was  admitted to hospital on January 24th for unexplained weakness and dizziness - I noticed she was slurring her speech starting around the 20th of January.  Hospital could not determine cause and she was released into nursing facility on the 28th.  Did not recover.  Received her second dose of Pfizer Covid vaccine at nursing home on Feb 4th.   Starting having symptoms of slurred speech and became more weak.  Labs on Feb 6th indicated very low hemaglobin levels and was admitted to the hospital on Feb 6th for transfusion.  She is requiring transfusions of blood and iron.  Possible ITP?
Case number PHEH2014US003680 is an initial spontaneous report received from a pharmacist on 20 Feb 2014. This report refers to a 17-year-old patient of unknown gender. The patient's medical history and concomitant medications were not reported. This patient under the age of 18 years might have vaccinated with 0.5 ml of FLUCELVAX (batch number: unknown) intramuscularly on unknown date in Nov 2013. No adverse event was reported following this medication error. No further information was provided. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 20 Feb 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug use in unapproved population".
Felt rush towards his nose and mouth right after he had the injection Then developed metallic taste in his mouth and altered sense of smell since then
Has reported history of anaphylaxis to aspirin. Symptoms have started to resolve at this time with use of acetaminophen
Myocarditis - Chest pain, heart palpitations, shortness of breath, blood pressure increased to 160/105, pulse increased to 115-120.
Patient with history of seizure activity presented with seizure-like activity approximately 5 hours after vaccination. Patient appeared disoriented and postictal following the episode. Episode lasted approximately 2 minutes. Patient was hyperventilating, and alert but not oriented during the postictal phase. Patient bit his tongue during the episode, but did not have significant bleeding. Patient was evaluated by EMS, and refused transport against medical advise. Neuro-exam by on-site medical provider revealed sluggish reflexes, and minor dystaxia. Patient was picked up from work by his wife, with instructions to follow up with previously established Neurology provider.
Started with chills and body aches, then high fever 103.  All lasted for 3 days. Then fever went to 100 and chest started getting congested along with sinus headache.  Minor stomach pain and nausea were also present.  5th day fever went to 99.7.  On 6th day just feeling chest congestion, sinus pain, dizziness and all over icky.
This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 10-FEB-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
mom came to WIC window asking for help;looked in waiting room pt was lying in floor;lt hand was jerking;when got to pt's side was trying to sit up but seemed disoriented @ that time;
Started with body aches mostly in the upper back, shoulders, and neck one day after the vaccine.  The symptoms started to clear the   day after they began.  However, the following day his neck was very stiff and painful.  This symptom has persisted since then almost 3 weeks following his booster shot.
Headaches started about 12 hours after first shot and now - 7 weeks later they have not stopped.
Swelling and redness in toes, painful above and below nail bed. Resulted in drying and scarring of skin on two toes.
The patient was incorrectly given the second dose in the Pfizer BioNTech series earlier then the recommended time frame of 21 days/17 days at 16 days. The patient did not receive any additional dose per the cdc instructions.
1-20-21: fever (temp unknown), fatigue, lethargy, flu-like symptoms including aches and pains and continued on for days. On 1-22-21 fever was 102.7F. Cellulitis at site of infection noticed on arm a few days later. Went to walk-in clinic on Saturday 1/23/21 and received a prescription for doxycycline (unsure of dose- take twice daily for 7 days).
LEFT ARM WHERE IMMUNIZATIONS OF DTAP, AND IVP WERE ADMINISTERED BECAME RED WARM AND SORE TO TOUCH. VERY EDEMATOUS APPRO 6IN IN DIAMETER.
Nose bleed a few hours after injection; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 01Apr2021 at 08:30(at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient has no allergies to medications, food, or other products. Concomitant medications included duloxetine hydrochloride (CYMBALTA), gabapentin (MANUFACTURER UNKNOWN) and lisdexamfetamine mesylate (VYVANSE) all since an unknown date taken for unknown indication. 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 vaccination. On 01Apr2021 at 16:30 a few hours after injection the patient experienced nose bleed. The patient did not receive any treatment for the event. 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 event nose bleed was recovered on 01Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
ER 11/15 FOR ACUTE ABDOMINAL PAIN DX ACUTE PANCOLITIS. ER TO ADMIT 11/23 ACUTE PE AND DVT.
High fever-104 degrees. Withdrawn. Loss of appetite (48hrs.). Loss ov verbal communication. Loss of eye contact. Lethargy. Labored breathing. Injection site swelling.
diarrhea; vomiting; dose 1: 04MAR2021, Moderna; dose 2: 08APR2021, Moderna; dose 3: 31OCT2021, Moderna; dose 4: 06MAY2022, Moderna; dose 5: yesterday (25Oct2022), Pfizer Covid 19 Vaccine Bivalent; don't have a lot of appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 10:30 as dose 5 (booster), single (Lot number: GH9697) at the age of 72 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: coviD-19 vaccine moderna (Dose: 01, Lot number: unknown), administration date: 04Mar2021, when the patient was 70-year-old, for COVID-19 immunization; coviD-19 vaccine moderna (Dose: 02, Lot number: unknown), administration date: 08Apr2021, when the patient was 70-year-old, for COVID-19 immunization; coviD-19 vaccine moderna (Dose: 03, Lot number: unknown), administration date: 31Oct2021, when the patient was 71-year-old, for COVID-19 immunization; coviD-19 vaccine moderna (Dose: 04, Lot number: unknown), administration date: 06May2022, when the patient was 71-year-old, for COVID-19 immunization. The following information was reported: DECREASED APPETITE (non-serious) with onset 25Oct2022, outcome "unknown", described as "don't have a lot of appetite"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 25Oct2022 at 10:30, outcome "unknown", described as "dose 1: 04MAR2021, Moderna; dose 2: 08APR2021, Moderna; dose 3: 31OCT2021, Moderna; dose 4: 06MAY2022, Moderna; dose 5: yesterday (25Oct2022), Pfizer Covid 19 Vaccine Bivalent"; DIARRHOEA (non-serious) with onset 25Oct2022 at 22:30, outcome "recovered" (26Oct2022), described as "diarrhea"; VOMITING (non-serious) with onset 25Oct2022 at 22:30, outcome "recovered" (26Oct2022). Therapeutic measures were taken as a result of diarrhoea, vomiting.  Additional information: Caller stated the she received the shot at 10:30 a.m. and about 12 hours later she had diarrhea that lasted about 2-4 hours and a couple hours after that started she vomited her entire evening meal. Caller stated she did not have a reaction to her previous vaccines, but the others were Moderna. Treatment: Drank soda and put a pillow on her belly. The patient did not received any prior vaccinations within 4 weeks.
Feel like I have arthritis in my neck, shoulders, low back, hips, hands, a week and a half out!; Feel like I have arthritis in my neck, shoulders, low back, hips, hands, a week and a half out!; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: FA7484), via an unspecified route of administration, administered in left arm on 30Jul2021 19:45 (at the age of 42-year-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Patient was not pregnant at the Time of Vaccination. Patient had not been tested for COVID-19 since the vaccination. Patient had no other vaccine in four weeks. Medical history included High cholesterol, high blood pressure, depression, Anxiety, hyperthyroidism and COVID-19 prior vaccination. Patient had no known allergies. Concomitant medication(s) in two weeks included vilazodone hydrochloride (VIIBRYD); rosuvastatin calcium (CRESTOR); losartan potassium (LOSARTIN); levothyroxine sodium (LEVOTHYROXIN), cholecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. On 05Aug2021 12:00, patient experienced arthritis in my neck, shoulders, low back, hips, hands, a week and a half out. Patient did not receive any treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.