chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 12 months old female patient with allergy to amoxicillin. The reporter stated that the patient exhibits an elevated temperature 'every time' the patient receives an unspecified vaccine. On 19-NOV-2013 the patient was vaccinated with VARIVAX (merck) (lot # J003528, expiration date: 25-MAR-2015) (dose not reported). Concomitant therapies included CLARITIN. The reporter stated that VARIVAX (merck) was administered after the expiration date (verified expiration date for lot # J003528 is 25-MAR-2015). The reporter stated that VARIVAX (merck) had been improperly stored (based on a documented temperature excursion) and was only supported, using extended stability, until 01-NOV-2013. On 20-NOV-2013, reported as '24 hours after receiving VARIVAX (merck)', the patient experienced an elevated temperature. The reporter stated that the patient's temperature rose of 103.9 F and lasted 'on and off' throughout the week after the VARIVAX (merck) was administered. The patient was taken to an unspecified emergency room however the patient was not admitted to the hospital. The outcome of the event was reported as recovered on an unspecified date. The relatedness between VARIVAX (Merck) and the event was not reported. Additional information has been requested.
CHILD FAINTED AND ASSISTED TO RESTING POSITION.  LEGS ELEVATED.  RESTED FOR 1/2 HOUR. FELT TINGLING IN FINGERS WHICH RESOLVED.  JUICE ADMINISTERED.  BP 140/80 AP 62 AND REGULAR, RESPIRATIONS EVEN AND UNLABORED.  MOTHER FED CHILD BREAD. CHILD HAD NOT EATEN ALL DAY.  ALERT, ORIENTED, STATES HE IS FEELING BETTER.  HOME WITH MOTHER AND AUNT.
This spontaneous report was received from a physician via company representative and refers to a 4-month-old patient of unknown gender. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not provided. On an unknown date, the patient was inadvertently vaccinated with PNEUMOVAX 23 injection, lot # R021045 and expiry date 14-APR-2020 (exact dose and anatomical location were not provided) instead of intended PREVNAR 13 for prophylaxis. Physician reported the nurse mistook PNEUMOVAX 23 for PREVNAR 13 because she was not paying close attention and only noticed the label said "pneumococcal vaccine" and thought she was giving PREVNAR 13. No adverse effect reported.
Chills; Headache; Stuffy/runny nose; Tired; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05Apr2021 at 12:30 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood obese. The patient did not receive any 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 four weeks prior to the vaccination. On 07Apr2021, the patient experienced chills, headache, stuffy/runny nose and tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of these events which included treatment with TYLENOL and ADVIL from an unknown date in 2021. The clinical outcome of the events chills, headache, stuffy/runny nose and tired was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Awakened from sleep with fullness in chest, something like acid reflux at about 3:00am, 4-1-22. Fell back to sleep within 15 min. Symptoms gone upon awakening. Same symptoms occurred about 10:00 am, 4-1-22 along with chills.  Fell asleep within 10-15 min.  Slept for 45 min. Awakened without symptoms. Continued to feel better remainder of day. No further symptoms.
Approx 8 days after receiving vaccinations, pt broke out in a rash on abdomen. By day 9 the rash had spread all over the trunk of pt, beginning to spread up the back of her neck and down legs. Rash completely stopped at "bikini area" where diaper covered. Pt. fussy, could not sleep.
Tinnitus spike (already had tinnitus but it has increased) followed by 2 episodes of vertigo
Got sick for 4 days; Initial information received on 16-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional via.   This case involves a (unknown age and gender) patient who got sick for 4 days (illness) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), Concomitant medication(s) and family history were not provided.  The patient had no medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient got sick for 4 days (illness, non-serious) (unknown latency) following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events.  No laboratory data reported.  It was reported "Got mine! sick for 4 days! First time ever! "  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
Itchy rash, local swelling, lip tingling. Used Benadryl to curb effects. Symptoms have pretty much resolved at time of this report. She did note have a possible hypersensitivity reaction 6 years prior to Neosporin (neomycin).
sudden onset of dizziness, diaphoresis and nausea VS 97-78-20,112/68, Blood sugar 113, O2 Sat = 97% room air, S/S subsided after 1 1/2 hours.
Within five minutes after receiving vaccine I felt very anxious and I could feel my heart rate go up. The medical staff came over amd took my vitals and blood pressure went up. My heart rate as in the 150?s amd my blood pressure went up to 154/ I can?t remember the bottom number. My head felt tight in my forehead area and my head felt foggy.  They had me do deep breathing and within 15 minutes I felt normal. So I am not sure if my anxiety took over because was extremely scared prior to getting the vaccine or if it was a combination of anxiety amd a reaction. I am scared to get the second one. They said I will have to sit for an hour after the second one. I left the facility after a half hour and felt fine. The next day I felt chest tightness amd my head felt tight. But again not sure if it is anxiety combined.
This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX HB.  No adverse symptoms reported. At the time of the report the action taken was not reported.  All telephone attempts to obtain follow-up information have been unsuccessful.   Follow up information was provided by the register nurse refers to a 1 day female patient. Current conditions and concomitant medications were not reported. On 20-JUN-2014 at 02:44, the patient was vaccinated with an improperly the first dose of RECOMBIVAX HB (Thimerosal Free) intramuscular, lot number J012520 and expiry date 30-JAN-2016). On 09-JUL-2014 at 10:58 AM, the patient received the RECOMBIVAX HB stored to 0-1 degree of temperature x18 different episodes, according to minimum/maximum. All recorded temperature were within 2-8 degrees. The issue that occurred was that they had a temp of 0-1 degrees on 18 different episodes between May 14th and July 21st, they were not able to identify how long the temps were down because it was not documented accordantly. They knew that when the temps were checked each AM and each PM they were within the normal 2-8 degrees. The vaccine was removed once problem was  identified and was not been used after 21-JUL-2014. This is one of several reports received from the same reporter. Additional information is not expected because all follow up information was received.
Patient reported red bumps "breaking out" over both his lower arms. He states that he is experiencing itching along these areas. He also stated he was having slightly worse breathing due to his COPD. Pt states he is also allergic to benadryl. I advised the patient to reach out to his PCP if his condition worsens.
Patient had a reaction to the Moderna vaccine 5 minutes after administration. Symptoms include cramping of the hands and stomach,  sweating, tingling of the face/injection site and difficulty breathing.
Pt vaccinated w/FLUOGEN developed joint pain, rash arms, tingling in arms, rt shoulder pain, joints of fingers swollen (no pain), neck sore, numbness of fingers, difficulty in moving wrist, narrowing of visual field, fever, headache.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (pain in the injection site) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site pain (pain in the injection site). At the time of the report, vaccination site pain (pain in the injection site) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Left arm hurt immediately after receiving injection on 9/30/21 and continued to get worse thru the day.  Sleeping was very difficult that night. The next day, 10/1/21, the pain increased, there was redness and swelling at the injection site, as well as the lower muscle of the arm, limited movement of the injected arm; tiredness; headache; chills, very little appetite.
Swelling, heat, slight erythema followed by syncope. Treatment with cold compress, resolved in less than 2 weeks.
I woke up feeling like i maybe had a stroke but when i went to urgent care Urgent Care location the diagnosed me with bells palsy, No treatment exists yet. they prescribed me an antibiotic and steroids. my face is paralyzed is the outcome.
complex syncope episode immediately after injection,  patient was pale, twitching. BP low, HR low. VS stable after about 20 minutes, bottle of water, and snacks.
Heart rate went up/Fast heart beat with palpations; Heart rate went up/Fast heart beat with palpations; sudden rush of heat in chest; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection.;Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in left arm on 19Feb2021 at 16:00 (at the age of 69-years-old) as dose 1, single for COVID-19 immunization. Medical history included high blood pressure from an unknown date. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Allergies to medications, food, or other products reported as no. Concomitant medication(s) included metoprolol (METOPROLOL) taken for hypertension, magnesium oxide (MAGNESIUM OXIDE), amlodipine (AMLODINE [AMLODIPINE]), valsartan (VALSARTAN) and hydrochlorothiazide (HTZ) received within 2 weeks of vaccination. The patient experienced heart rate went up/fast heart beat with palpations and sudden rush of heat in chest on 19Feb2021 at 16:00. Facility where the most recent COVID-19 vaccine administered was other. It was reported that, almost 3 weeks now but when patient first took the vaccine patient had rush of warp to you know patient upper body (incomplete sentence), patient heart rate went up significantly and actually patient still having problems with that, with heart rate so, they have called patient for that second vaccine but patient was skeptical about taking it because of the reaction that it did, so in expert opinion should patient take the second dose. Outcome of event patient do not know because, patient do have high blood pressure (Clarified as medical history) too, so patient guess it is same. (Patient was unsure, hence not outcome was left unchecked). No treatment received for the events. The patient underwent lab tests and procedures which included heart rate: increased on 19Feb2021. The outcome of the events were unknown.   No follow-up attempts are needed. No further information is expected.
Admitted for abdominal pain and weakness.  Subsequently found to be COVID-19 positive, >14 post vaccination series
11FEB94 1050 pt fainted p/vax,hit head on floor; nurse lifted head sl attempted to arouse w/ammonia inhalant, pt resumed consciousness p/30 sec;  BP 120/78, RR18, pulse 91;
Eyelids started to swell up/swell up a little bit; Eyes were still a little puffy; My eyelids started to get hives; My lips started tingling; my throat start to tighten; This happened after my first dose that my immune system is just more hypersensitive to my allergies; This is a spontaneous report from a contactable consumer (patient). A 22-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in left arm on 16Mar2021 10:00 (age at vaccination was 22 years) (Batch/Lot number: EL8982) as first dose, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included allergies to pure soy (ie. Soybeans, soy milk), pollen, itchy red eyes and eyelid probably due to mild to moderate pollen allergies. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that before getting the vaccine at 10AM, she woke up with itchy red eyes and eyelid probably due to mild to moderate pollen allergies. On 17May2021 (The next day at 3pm), after patient got the first dose her eyelids started to swell up so she took Benadryl that night. 48 hours after the first dose (17Mar2021 at 15:00), her eyes were still a little puffy so she took 2 Benadryl. At around 6-7pm, eyelids started to get hives and swell up a little bit and about an hour later lips started tingling and felt her throat started to tighten. She immediately took another Benadryl and went to the hospital as the swelling started to subside. Patient was possibly thinking that maybe since that happened after her first dose that her immune system was just more hypersensitive to her allergies. The adverse events required emergency room/department or urgent care and Physician office visit. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Covid test: negative on 18Mar2021. Therapeutic measures were taken as a result of the events with diphenhydramine (BENADRYL) and prednisone (DELTASONE). The outcome of the events was recovering.  Follow up attempts are needed; Additional information has been requested.  Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.
Narrative: Patient with breakthrough covid infection. Janssen vaccine on 3/15/21 and covid positive test on 4/13/21. Treated with monclonal antibodies.
No adverse effect reported; inadvertently administered PROQUAD (Lot#R008205/Exp:9/16/2019), instead of MMR II (Lot#Unknown/Exp:Unknown); inadvertently administered PROQUAD (Lot#R008205/Exp:9/16/2019), instead of MMR II (Lot#Unknown/Exp:Unknown); Information has been received from a medical assistant (also reported as a nurse) referring to a 56 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 31-MAY-2019,  the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R008205, expiration date:16-SEP-2019, therapy type: recombinant Human albumin (rHA), route, strength, dose and frequency were unknown) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(strength, dose, frequency, route, lot#, therapy type and expiration date were unknown) (inappropriate age at vaccine administration and wrong vaccine administered). No adverse effect were reported.
Left thigh reddened and swollen. Treated in ER with Benadryl and PO ATB. Follow up with father 4 days later; leg ok and leaving for vacation.
Patient said he was feeling tingling in his arms and hands both sides.  Then he started feeling nauseous, vomited on site for about 1 minute.  Went to the restroom to clean up.  Came back shivering with goose bumps.  Sat down in an observation chair for about 10 more minutes waiting for a parent to come and drive him home.  Felt better and went home
Symptoms of a Sinus Infection; Did Not Feel Good; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Symptoms of a Sinus Infection) and MALAISE (Did Not Feel Good) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced SINUSITIS (Symptoms of a Sinus Infection) and MALAISE (Did Not Feel Good). On 05-Apr-2021, SINUSITIS (Symptoms of a Sinus Infection) and MALAISE (Did Not Feel Good) had resolved. Not Provided          No relevant concomitant medications were reported. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-037141 (Patient Link).
immediate pain at injection site with injection going in shoulder pain and decreased ROM later with frozen shoulder symptoms PT and acupuncture ordered
Information has been received from a consumer concerning an approximately 5 - 12 year old child who in approximately 1996 - 2003 was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient experienced a mild case of chickenpox. Unspecified medical attention was sought. the patient subsequently recovered. There was no product quality complaint involved. Additional information has been requested.
Patient, had difficulty filling out the form.  Birth date looks like 2004 on the form but might be different.  No adverse events reported from the vaccination.  Patient did not have identification, including insurance to verify.
Initial report received on 28 November 2006, from a health care professional.  A 2.5 year old male patient received on 20 November 2006 Fluzone (lot number 02191BA), intramuscular into the left thigh.  On 20 November 2006, within 2 hours of receiving Fluzone, the patient's right eye began to deviate, so as appear "cross-eyed".  The problem occurred intermediately for 24 hours.  The patient was seen on 28 November 2006; the patient's mother reported that he continued to have occasional right eye deviation "cross-eyed".  No other signs and symptoms reported.  Gait stable, neuro exam (performed).  Not seen by ophthalmologist.  No treatment prescribed.  At the time of this report (28 November 2006), the patient had not recovered.  The patient did not receive Fluzone previously.  A corrective version was created with the same latest received date as the previous version (28 November 2006) for the sole purpose of amending the vaccine given on 20 November 2006 from FLUZONE SV '2006-'2007 USP to FLUZONE No Preservative '2006-'2007.  No new medical information was provided.
About 10-20  minutes after receiving the vaccine, patient she started having a sensation of tongue swelling. Patient was treated with an IM injection of epinephrine and  then transported down to the emergency department. Upon arrival  to the ED, she felt markedly improved with no symptoms other than some mild nausea.  Patient was treated with steroids and ondansetron.
Patient reported she felt light-headed and become very flushed.  Patient then began to feel as if she would faint and laid back on a bench.  As she laid back, witnesses reported that patient began to briefly seize and her eyes rolled back into her head.  Patient quickly returned to normal and walked out of store with help.  It was recommended that patient's mother take her to ED to have her checked out.
Pt came home on 5/31/2000 at approximately 10 pm to her bedroom. At 5am 6/1/2000 pt crawled to mother's room and told her that since 10 pm 5/31/2000 she had complained of back pain, breathing problems, dizziness, thick tongue, fast heart rate and fever. Told mom she needed to use rest room but only dribbled urine. Pt refused to go to ER. Mom gave pt 100 mg Benadryl, 500 mg Aleve on 6/1/2000 at 5am. At 10am pt sleeping at home, mom states pt in no distress.
came in to get vaccine and was very anxious about vaccine before getting it. Did well with vaccine administration. She waited with her husband for the required 15 minutes (timed by a timer). When the timer went off she was feeling fine and left to go back to work. This RN got a call from her work partner at 11:15am stating that they were in route to the ER.  was complaining of a swollen tongue and was having slurred speech. She was evaluated in the ER.  She had symptoms of stupor, swollen tongue, rash to the neck, decreased feeling in arms and legs and elevated HR and BP. She was treated with IV fluids and Solu-medrol and then started feeling much better. Was discharged home with prescriptions for Benadryl, Steriods, and Pepcid.  Talked to her today on the phone and she is feeling much better. Stayed home from work today. Tongue is still not quite down to the normal size yet.
On 9-24-09 fever, chills, body aches and headache started and continued til 9-28-09. Went to urgent care and was given VICODIN for headache and advised to take TYLENOL or MOTRIN for fever.
Patient's lips started to get numb and she said she felt really heavy. She took a Benadryl and felt better and was able to go home about 20 minutes later.
no other AE; Caller is a medical assistant who reports a dose of ROTATEQ which expired on 10Sep2022 was given 22Sep2022. The patient had no symptoms or adverse effects after administration. The ROTATEQ had no temperature excursions. Potency was supported by Post-; This spontaneous report was received from medical assistant and refers to a patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, once, lot number U005994, expiration date: 10-SEP-2022, administered orally for prophylaxis (exact dose, and strength were not provided) (expired product administered). It was reported that there was no temperature excursion. No other adverse event was reported (no adverse event).
Pt. states that after receiving the 3rd Booster of Moderna 11/09/2021, started experiencing experience 11/10/2021 of facial swelling on the right side throughout the neck and behind the ear. Primary visit 11/10/2021 prescribing Anti-Biotics due to " Salivary Gland". Fatigue, muscle aches, and headaches continue along with facial swelling. (Booster Moderna dosage Full Dose given)