chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LLQ abdominal pain. N/V. visit to local ER on 7-21-10 for increased abdominal stress.
Patient noted to have  new rash antecubital fossa, back of neck, behind knees, erythematous, hive like on back of neck starting approx 20 min after receiving vaccine.  Given benadryl and watched for additional 15 minutes after the benadryl without changes.  However, review of our clinic policy showed ER recommendation so sent to ER for extended monitoring which was normal.
Child Given vaccine that may have had temperature excursion (Data Logger Failure) with Stable Fridge temps Before & After. DOH determined the vaccine to Be At Risk & Advised Reporting & Revaccination Child Had No ill Effects thus FAR
CHILLS; FEVER; LITTLE WEAKNESS FOR A DAY; This spontaneous report received from a patient via a company representative 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, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.    No concomitant medications were reported.  On an unspecified date, the patient experienced chills, fever, and little weakness for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and little weakness for a day. This report was non-serious.
pt recv vax 11AM;APAP given started prior to vax few hrs later t104 R, irritable;seen in MD office 530PM-alert, active, t101.5R;
Fever,chills, burning sensation all over body, joint pains, trouble walking, malaise.
Very late diagnosing as shingles; Headache at work after vaccine; then got more severe along with leg very sensitive and burning feeling; then got more severe along with leg very sensitive and burning feeling; severe stomach pain; This is a spontaneous report from a contactable other HCP (patient). A 61-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 28Jan2021 09:00 (at 61 years old), single dose for covid-19 immunisation. Medical history included concussion, endometriosis, all from an unknown date. Concomitant medications included estradiol; progesterone. No  other vaccine in four weeks. On 28Jan2021 09:00, patient experienced Headache at work after vaccine , then got more severe along with leg very sensitive and burning feeling, better then 5 nights very severe stomach pain-Dr appt and ER to get sonogram, CT-Very late diagnosing as shingles. The outcome of the events was not recovered. Treatment of adverse events was CT, Sonogram. No covid prior vaccination. Not covid tested post vaccination.  No Known allergies.  Information about lot/ batch number has been requested; Sender's Comments: Based on known disease pathophysiology, the event herpes zoster is assessed as not related to suspect vaccine BNT162B2.
During injection for patient, the vein jumped and patient got anxious and moved arm, I removed the injection when I already injected half dose to avoid breaking the needle. Right after that, I changed new needle and completed the dose with another injection next to it IM - 1 dose with 2 injections on the same arm. Patient got fainting when he stood up after the injection. He described that he could not hear well and quiet surrounding around him, and he did not see well. I asked him to sit down at the consultation room for another 15 minutes. I brought patient water cups to drink because he said he is thirsty.
FAST HEARTRATE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered to left arm on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced fast heartrate. On 03-APR-2021, the subject experienced nausea. Laboratory data included: Heart rate (NR: not provided) Increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fast heartrate, and nausea. This report was non-serious.
pt recvd vax;pt groaned,eyes rolled back,almost passed out,ammonia adm & pt came rt back;pt said head hurt;to er;apap & advil given;13mar95,pt was c/o deafness in both ears;advised to take to MD if cont;
Breakthrough case admission after three vaccines Moderna 2/6/21 Lot# 007M20A;  Moderna 3/7/21 Lot# 023M20A;  Moderna 11/24/21 Lot# 058F21A
15 minutes post administration patient experienced localized urticaria and mild edema on the right eye/orbital area. Patient had no SOB or breathing issues.
Pt states approximately two weeks after vacination she experienced vertigo.  Was placed on Valium and unable to walk for 4 days.  PMD thought it was an inner ear infection.  Patient has developed an irregular heartbeat, PVCs.
s/sx-low grade fever, malaise, body aches, headache  tx-sleep
Nausea,  headache, muscle aches, severe lethargy, each time I received the vaccine (first then the booster) my menstrual cycle started. Symptoms began about 6 hours post vaccine and lasted about 48 hours
At 9am on 1/14/21, Patient was unable to speak and unable to move her arms. After an undetermined period of time (likely less than 5 minutes), she was able to call me (her daughter).  She could hardly move her mouth but she was able to tell me that she needed help. I arrived about 20 minutes later.  She had full movement at that time and was able to speak.  Her BP was 140/73, HR 60. She was tired but scared to go to sleep around 5pm so we went to the local ER.  Her labs, EKG, and MRI were all normal for her age. Today (1/15/21) at 10:30am, she experience the same thing but only in her face.  She was able to move her arms but not able to talk.  I was with her and could tell that she was fully conscious and aware, just couldn't move.  It happened again but not as severely after she ate lunch around 12pm.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients were vaccinated with M-M-R II (dose, route and lot # not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a 73 year old retired male with hyperlipidaemia, no known drug allergies, and no illness at the time of being vaccinated who on 23-OCT-2006 was vaccinated with Pneumovax 23 (lot # 651404/0325F exp. 11-MAY-2007) 0.5 ml IM into the left deltoid. Concomitant therapy included LIPITOR and ezetimibe (MSD). On 24-OCT-2006, the patient experienced fever of 100 degrees Fahrenheit, chills, and redness, tenderness, and warmth at the injection site of the left deltoid. On 24-OCT-2006, the patient sought medical attention and was examined. The physician prescribed KEFLEX, and MEDROL. The patient self-medicated with BENADRYL previous to seeking medical attention. The outcome of the events was unspecified. No further information was available at the time of reporting. Information was received from the registered nurse who requested a lot number check because several patients had a reaction to this Pneumovax 23 vaccine lot number. Additional information was received from a physician. The onset date of the events was reported as 23-OCT-2006 (previously reported as 24-OCT-2006). Laboratory diagnostic tests performed included liver function tests and cell blood count (CBC) which were within normal limits (WNL). The patient recovered after 27-OCT-2006. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of agency and was released by the regulatory agency. Additional information has been requested.
Pt received the vaccine around 1200 PM. Around 1400 pt lost consciousness and became unresponsive and hypotensive with systolic BP at 90 per EMS. Pt was unconscious and unresponsive for approximately 10-15 minutes. Pt regained consciousness spontaneously and her BP slowly returned to normal over the next 3 hours.
Patient received flu vaccination at approximately 10:50pm.  At 11pm the patient returned complaining of dizziness and hard of hearing. After assessing patient appeared Pale and was placed in the seated position. Patient began shaking for about 5 seconds. Patient was placed on floor and feet elevated. Color regained and patient was coherent. Paramedics called and patient was taken to the hospital.
Pt developed twitching of right side of body (seizures) and a temperature of 103.
Chills/Fever over 100: 04/08/2021, at 3:20am continued incrementally until 04/09/2021, until 1:30am  Upper left arm, injection site, itchy,  swollen red patches and underarm hurts: 04/09/2021 at 8:00am.  Continues as of this reporting.
It was reported that a male patient recived a Tripedia and a MMR (unspecified) vaccination on 08/09/00 Reportedly somtimes after the vaccination, the patient developed a 24 inch raised area at the injection site. Further information requested. From follow-up correspondence received on 10/10/00, additional patient, responsible physician and vaccine information was proivided. No further information is anticipated for this report. From mailed follow-up correspondence received 06/13/02, it was reported that the patient recovered from this experience. "No further information available regarding thispatient or this case." This case is closed.
11/13/2001 *:00 am-Awakened with a headache, took two Advil tablets 8:30 headache 3:00 pm received the Flu vaccine 3:30 pm took two Tylenol tablets 6:30 pm  while changing clothes had red, very raised blotched areas from armpit and below, nipple line to neckline  7:00 pm took Benedryl 8:30 pm asleep to 11/14/2001 at 7:00 am, without rash.
On Sunday the 2/21/2021, about 3PM I noticed that the area where I received the vaccination  was red, swollen, itching, and sore. I googled search and found it was a rare but real reaction vaccine, called COVID ARM. According to the information I read it occurs between 7-9 days after vaccination. Mine occurred exactly 7 days later. I have been putting Hydrocortisone cream with Aloe in it and on it. Today it is more sore then itching and still red. The Hydrocortisone with Aloe seemed to help.   I have also noticed my eyes have been watering a lot more since receiving the vaccine.
After the 1st shot I have flulike symptoms for 3 days, they started on the Friday after (My shot was on Monday).  After the 2nd shot I had a whelp which was swollen and itchy on my left arm inside close to elbow. It lasted 3 days. I had one day in between, then whelps (2) came on my lower stomach. Both areas were swollen itchy and inflamed. They lasted 5 days. I had one day in between. Then a whelp, swollen, inflamed itchy appeared on my right buttocks, it lasted four days. I had one day in between, then my lip and face. My face was never itchy, but it was swallon. I went to the ER. they gave me steroids (prednisone) and benadryl once the meds were gone (one week supply), another whelp has shown up under my right breast. It is swollen, inflamed and itchy. I have made an appointment with the PCP and a dematologist.
I TAKE ZYRTEC DAILY FOR ALLERGIES AND OUR CAT.  01-14, 7 DAYS AFTER VACCINE, AT INJECTION SITE, ITCHY AND 2 SMALL RED MARKS. IN THE MORNING, IT WAS A RED PATCH ABOUT 1 INCH WIDE AND 2 INCHES LONG.  OVER THE WEEKEND, IT CONTINUED TO GET LARGER.  01-19 I SAW PCP IT WAS ABOUT 4 INCHES WIDE AND 5 INCHES LONG.  SAME DAY MET WITH MEDICAL CENTER'S CORPORATE CARE.  BOTH ADVISED ME TO SEE AN ALLERGIST AND STAY ON THE ZYRTEC.  I HAVE AN APPOINTMENT FOR THE ALLERGIST ON 02-02-21 AND TO SEE IF I'LL BE CLEARED FOR MY SECOND INJECTION DOSE ON 02-04-21
PATIENT FAINTED IN THE STORE.  BROUGHT PATIENT TO IMMUNIZATION ROOM AND HAD HER LIE DOWN ON BACK AND HAVE FEET UP. PATIENT WAS RESPONSIVE AFTER FAINTING, WAS PALE AND STAYED IN THE STORE FOR AN ADDITIONAL 30 MINUTES AFTER FAINTING. MD WAS NOTIFIED OF EVENT.  NURSE STATED THAT ONCE SHE FELT BETTER AFTER FAINTING SHE COULD GO HOME
pt exp vax; pt exp generalized deep muscle/bone pain for approx 1mo; w/ 2nd dose pt exp recurrence of muscle/bone pain for approx 1mo;
Pt recv vax on 8/22/96; on 3/11/99 pt exp red spots on upper body; dx=varicella
tested posited COVID 19 congestion, coughing, sneezing, runny nose, sores under tongue,  exhaustion, nausea and sore throat
3 weeks past 2nd covid shot, patient developed nausea, diarrhea, malaise and significant muscle cramping that seems to rotate through different muscle groups. Also experiencing cramping that feels like cramps from menstruations but patient is post menopausal. She wakes from headaches every morning now. Most severe symptoms were from 3/31-4/3/21. Diarrhea and nausea have resolved, but  headaches and muscle cramping still continue.
finished her 5 days treatment for PAXLOVID / should you re-test for covid /receive 2 doses of the Pfizer vaccine and a booster; finished her 5 days treatment for PAXLOVID / should you re-test for covid /receive 2 doses of the Pfizer vaccine and a booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Addisons" (unspecified if ongoing), notes: "I do have 'Addisons' that is very mild and very rare that I get an episode,. Concomitant medication(s) included: ELIQUIS; METOPROLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "finished her 5 days treatment for PAXLOVID / should you re-test for covid /receive 2 doses of the Pfizer vaccine and a booster". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reporter stated she has finished her 5 days treatment for PAXLOVID and wanted to know how long it stays in your system. She stated she is healthy 80 years old and walk 5 miles a day in her apartment. she stated if you are still coughing should you re-test for covid. She did receive 2 doses of the Pfizer vaccine and a booster, will have to wait for the 2nd booster dose. Reporter answered her question because she did mention that she was coughing so it was an adverse event that you need to file a report on and that's all the information has. Patient stated she just threw the box of Paxlovid away Let me see if I still have the prescription hold on. She just threw the box away. Maybe she shouldn't throw the box away can give the prescription number which will not help.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Period started 6 hours before 1st dose, and since 1st dose at 10am period has become painful, intense cramping, and increased number of blood clots.
Raised rash around injection site 5x5 inches that migrated into axilla.  Rash was streaky - streaks from injection site to axilla.  Moderate to severe pain on arm and axilla.  Temp 102 F.  Eye aches, head ache, malaise, weakness, body/back aches, chills.  Treated with Advil which decreased fever to 100 F.   Temperature lasted 48 hours.  Rash took 7 days to go away.  Malaise and weakness subsided after 3 days.
Information has been received from the mother of a nine year old male with an allergy to insect bites who in 1996 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 28-MAR-2003, the patient's mother believed that her son developed chicken pox "today". No medical attention was sought. On 20-MAY-2003, it was reported that the physician's office did not give the immunization and that they were unaware of any adverse reaction. No further information is available.
Patient has a prior anaphylaxis reaction to Doxycycline. 10minutes after immunization, she developed sweaty palms and lightheadedness. No throat swelling or difficulty breathing. Placed supine, BP 160/100, HR 60-70, O2 97% RA. After a period of monitoring the symptoms improved. No intervention given.
No adverse effects reported by patient to mother.  The error was that the product expired on 09-30-2022 but the administration was 10-02-2022.
Severe, progressive worsening of MECFS/post covid syndrome.  Day 0-4 days standard vaccine side effects  5-9 increasing fatigue  10 + profound fatigue unresolved by rest, difficulty speaking due to fatigue, muscle weakness. No longer able to work on medical leave.  18+ additional neurological symptoms, ataxia
PATIENT RECEIVED COVID19 PFIZER VACCINE AND FLUZONE HD VACCINE. STATES ARM WAS SORE AND HURT FOR THREE MONTHS.
Pt received 2nd dose of Covid vaccine on 1/31/21.  presented to clinic with worsening back pain, chills, fatigue, headache and body aches. and overall complaint of "I feel awful"   tested negative for covid
This spontaneous report as received from an unspecified reporter as part of a marketing research program refers to a 54 year old patient. On 04-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # not reported) intramuscularly. On 04-NOV-2015, the patient experienced burning sensation and stinging at injection site. On the same date, the patient recovered. This is one of several reports received from the same reporter. Additional information is not expected as there is no contact information.
A report was received from a health care professional on 11/21/03 concerning a 53 year old female vaccinee who inadvertently received a sub-optimal dose of Fluvirin intradermally on 11/21/03. On 11/21/03 the vaccinee inadvertently received 0.1ml Fluvirin intradermally instead of PPD vaccination. At the time of reporting the vaccinee did not exhibit any adverse events. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Further information was received from a health care professional indicating that the vaccinee experienced a local reaction which resolved in 3 days without any lasting effects. The reporter has assessed the relationship of the vaccine to the event as probable. No follow up pending, all information received.
shingles at the same time; very tired; so sleepy; arm is hurting and aching a lot, very very sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (so sleepy), PAIN IN EXTREMITY (arm is hurting and aching a lot, very very sore), HERPES ZOSTER (shingles at the same time) and FATIGUE (very tired) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included irritation (On Head) on 27-Jan-2021.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced SOMNOLENCE (so sleepy), PAIN IN EXTREMITY (arm is hurting and aching a lot, very very sore) and FATIGUE (very tired). On an unknown date, the patient experienced HERPES ZOSTER (shingles at the same time). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (so sleepy), PAIN IN EXTREMITY (arm is hurting and aching a lot, very very sore), HERPES ZOSTER (shingles at the same time) and FATIGUE (very tired) outcome was unknown.            No Concomitant medications were provided
pt recvd 2nd dose of vax 27jun95 & devel redness & warmth at inject site;tx w/ acetaminophen & ice;
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced a localized reaction. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Low grade fever, myalgias within 24 hours developed soft pink papular rash on forehead & cheeks with gradual spread down abdomen anterior/posteriorly. Non itchy rash.
ADMINISTERED TD THAT WAS EXPIRED. 12/07 3/3/08 PHONED PT. NO PROBLEMS TO REPORT 1 WK PER PT'S REQUEST.
This spontaneous report as received from a physician refers to a male patient of unknown age who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date the patient experienced a rash and swelling on the arm that was vaccinated. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The relatedness for patient experienced a rash and swelling on the arm that was vaccinated was unknown for PNEUMOVAX 23. Additional information has been requested.