chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Morning of 4/8 at 0615, patient was in shower, started feeling pressure on top of head, was struggling to use arms, trouble using legs, unable to stand well.  Wife noticed slurred speech, drooping left side of face.  Called 911.  Was taken ED and transferred to another Hospital.  Was found to be having ischemic Stroke.
allergic reaction/acute allergic reaction; hives on the majority of her body/the hives were gone within an hour; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:30 at the age of 23 years old (Lot Number: EP7533) as 1st dose, single for covid-19 immunisation. Medical history included problem with allergies/ hives. There was no concomitant medication. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Administered Vaccines administered on same date with the Pfizer vaccine considered as suspect. No Prior Vaccinations (within 4 weeks). The caller stated she had an allergic reaction to the first dose of the vaccine and in the Emergency Room was given famotidine, epinephrine, and Benadryl. No Investigation Assessment. The patient was calling about the Covid 19 vaccine. She got her first dose a couple weeks ago and she did have an allergic reaction (10Apr2021). The day after she received the Covid 19 vaccine she ended up going to the hospital and she received some other injections. She was asking if she was able to get her second dose today, 30Apr2021. She was given Sodium Chloride, Epinephrine, Famotidine, and Benadryl. She was not admitted to the hospital. She was discharged from the emergency department. The emergency room doctor said she had an acute allergic reaction. She had hives on the majority of her body. The hives started the day after the vaccine on 10Apr2021. She went to the emergency department at around 2:00AM on 11Apr2021. The hives started the night of the 10Apr2021 but in a couple hours the hives got bad quickly and that's when she went to the emergency department. The medicine she was given in the emergency room worked and the hives were gone within an hour. She reported she did have a problem with allergies as she had had the hives before. Her doctor was not positive what causes her hives. She did have to get allergy tested. She had no drug allergies that she knows of. The outcome of the event "hives on the majority of her body/the hives were gone within an hour" was recovered on 11Apr2021, of the other event was was unknown.  No follow-up attempts are completed. No further information is expected.
I have a history of prior anaphylaxis in 2009 when I received (separate arms, same date and time) the 2009 seasonal flu vaccine and the 2009 H1N1 vaccine. Both were from multi-dose vials and providers I established care with following the reaction believed I likely had a reaction to a preservative. I?ve received single-dose flu vaccines with no issues since then. When I received the Moderna covid vaccine on 1/8/21 I had some right-sided throat swelling about 15 minutes after injection. It did not worsen and I was monitored for 1 hour after shot time. I went home and the feeling in my throat resolved after about 4-5 hours with no medication or intervention needed. I did not have any other symptoms until 3pm on 1/9/21. Started with mild abdominal pain, an hour and a half later I had chills, headache, fatigue and fever around 100.8F. No medication taken. The fever resolved within about 6-7 hours. On Sunday 1/10/21 the abdominal pain worsened and was a constant pain around umbilical region that felt as if it radiated outward, LLQ slightly worse. It was severe, directly affected normal daily functions. I could not walk, move, eat or drink room-temp water without pain increasing.  Walking 20ft at one point even caused me to crumble to the floor and cry, had to stay there for 5 minutes before even attempting to get back to the couch. No diarrhea, no vomiting, no fever, no nausea. I did have loss of appetite. The pain continued through the night and was constant. I could not find a comfortable position to lay in and tossed and turned most of the night. At 0430 on 1/11/21 I got up out of bed to pee, abdominal pain was so bad it kept me awake for about an hour after. Pain finally started to improve and I was able to sleep from 0530-0930. When I woke up on 1/11/21 around 0930 my abdominal pain was very mild and continued to improve as the day went on. Currently (1600 on 1/11/21) my abdomen feels about 90% better, I have no other symptoms. The symptoms, specifically the fever and abdominal pain, caused me to miss 2 days of work (Sunday 1/10/21 and Monday 1/11/21).
Local erythema area on (L) upper forearm 5x6" circular area where pt. received vaccine (TD tetanus) on 6-25 - Tx with 10mg IM DEXAMETHASONE on 7-1-08 and BENADRYL 25 mg po Q4-6 hrs. No urticaria, edema, difficulty breathing
also like Covid over again; also like Covid over again; Tired; Weak; Lots of muscle pain aching; Aching; had a reaction after taking when took deep breath taking my chest; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had an adverse reaction and people told patient the first shot usually don't. Patient was like very tired, weak, lots of muscle pain, aching and patient also like Covid over again you know and it last for three or four days. Patient's question was should patient surely get a second shot or should leave. Because patient heard people have been getting pretty sick after the second shot and patient didn't know. Patient had a reaction after taking when took deep breath taking chest. Patient mean it is now since subsided. It has been a week now or 7 days or 6 days, but patient had 4 days back the reactions from. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
error resulting in administration of expired vaccine; Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 20-Aug-2021, PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Patient couldn't describe symptoms but was hot and sweating, she said a little lightheaded. I gave her TYLENOL, cold water and a cold rag for her forehead. She remained seated for approximately 10 to 15 minutes.
Information has been received from a health professional concerning a 17 year old female who on 04-DEC-2006 in the PM was vaccinated with a second dose of Gardasil (lot # 653735/0688F), in the left deltoid. There was no concomitant therapy. On 04-DEC-2006 the patient experienced "pain, hot, sweating, dizzy, nauseated." On 14-SEP-2006 the patient was vaccinated with a first dose of Gardasil (yeast). Additional information has been requested.
Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) in a 54-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.   The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
Rash appeared approx. 45 min. hr after shot. Called nurse who administered it and left message on her cell phone.  Never returned my call. Rash started on both arms then spread to neck and back and went away after an hour.  Next morning started dizziness, sweating and extreme fatigue with vomiting.  Had to use 2 1/2 days of my vacation/sick time till able to return to work.
pt recv vax 4DEC96 & by 11PM same day t100.9, irritable;5DEC96 during the noc T101.9 & 103.9 A;10PM T104.9-105.9R, ;6DEC96 T103A;7DEC96 T102A, cough, cold sx;8DEC96 T102 A, crying, cold sx;
Red indurated 1cm raised rash x 2 spots near VARIVAX injection site. Occurred 3 days status post shot. Fever to 102 deg. and >100 blanching measles 8 days after vaccination  No scabbing, rash faded over time.
I have felt horrible since receiving the second dose of Moderna. I felt profoundly fatigued, sore all over, and nauseated for 18 or so hours. Since then I have been feeling nauseated after I eat. I cannot eat like I normally do and it has been almost five days. If this persists through the weekend I will visit my doctor next week.
Hurts to move the arm  after 3rd shot; Left arm Injection site hurting after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hurts to move the arm  after 3rd shot) and VACCINATION SITE PAIN (Left arm Injection site hurting after 3rd shot) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 026L20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced PAIN (Hurts to move the arm  after 3rd shot) and VACCINATION SITE PAIN (Left arm Injection site hurting after 3rd shot). At the time of the report, PAIN (Hurts to move the arm  after 3rd shot) and VACCINATION SITE PAIN (Left arm Injection site hurting after 3rd shot) had not resolved.            No concomitant medication was reported.   The treatment information was unknown.
She said she was weak after the vaccine. Onsite EMS was requested.bp 127/87 hr 88 99% O2 on room air.  They were able to find a specific cause and she refused additional workup
Nausea, lightheadedness, left arm ache. previous reaction (unknown) to a Tdap 8/7/14 and a local site reaction to Td 12/29/10.
In bed with a fever; Chills; Tiredness; felt sick for two days; This is a spontaneous report from a contactable Nurse (Mother). A male patient of an unspecified age received BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date caller was reporting on herself, she mentioned her son got the Pfizer covid vaccine and for two days he was in bed with a fever and chills and everything. She states he had tiredness, fever, chills and felt sick for two days. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
My bloid pressure increased significantly and has not gone back to normal.  I have always had #s on thr lowest end of normal and now they are consistently at the higher end of normal.  While they are still technically normal, they are very much abnormal for me.
My son had a fever then became unresponsive, fixed gaze to the left, dilated pupils, posturing, tremors, shallow breathing and had blueing of the lips and fingers. the whole episode lasted approximitley 4-5 min.
9PM 25OCT rt arm knot, swollen @ site of inj cleared w/in 24hrs;26OCT95 during noc last through following day nausea, diarrhea, vomiting, clammy sweats, chills;another 2 days a/felt well
Patient felt stingy sharp pain on the vaccinated shoulder. Nurse put an ice pack on patient's shoulder. Patient felt better and left in stable condition.
Breakthrough Covid Infection; Breakthrough Covid Infection; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE; Lot Number: EP6955), intramuscular, in left arm on 24Mar2021 as dose 2, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE; Lot Number: EL3248), intramuscular, in left arm on 03Mar2021 as dose 1, single, both at the age of 55-years-old, for COVID-19 immunization. The patient had no medical history or no known, allergies. Concomitant medications included citalopram, omeprazole and levothyroxine. Prior to vaccination, the patient was not diagnosed with COVID-19. No other vaccine was given in four weeks. The patient experienced breakthrough covid infection on 05Oct2021. The patient underwent lab tests and procedures which included nasal swab test: positive on 05Oct2021. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received Regeneron Antibody Infusion as treatment for the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
vaccine reconstituted with a non-supplied liquid diluent.; vaccine reconstituted with a non-supplied liquid diluent.; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The nurse reported that patient was administered a Hiberix vaccine reconstituted with a non-supplied liquid diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow- up.
pt called & stated was hospitalized the day p/vax w/pneumonia;wanted MD ofc to pay hosp bill because was near death when went in the hosp
NAUSEA, VOMITING, SEVERE HEADACHE A COUPLE HOURS AFTER THE VACCINES WERE GIVEN- PARENT BROUGHT HER TO A LOCAL ER(The Hospital) WHERE SHE RECEIVED IV FLUIDS, AND MEDICATION FOR HER HEADACHE PER THE MOTHER. WE HAVE REQUESTED THESE RECORDS FROM THE HOSPITAL SO AT THIS TIME ALL WE KNOW IS FROM THE MOTHER. PATIENT WAS RELEASED A FEW HOURS LATER, PARENT STATES SHE HAS BEEN DOING WELL SINCE.
10-15 min dizziness - nausea- heart racing - red flushed, lightheaded. Contacted EMS. Had her sit down - breath deeply, slowly. Complaint light headed, dizzy. EMS arrived and took over.
pt recvd Hep B vax on 21JAN92; pt exp soreness @ inject site; On 25JAN92 lab eval revealed a pos test for pregnancy;
Pt was not old enough to receive the booster shot. His dr had sent him to the site to get the 3 dose of Pfizer. His mother later stated that he was immunocompromised. Pt did not have any adverse reactions
No additional AE; HBP reporting that PROQUAD was administered after it experienced a supported temperature excursion. No side effects reported from HBP.         ?    Names of vaccines involved (including lot/exp): PROQUAD, Lot: W036940, Expiration: 4/15/2024; This spontaneous report was received from a healthcare business professional and referred to a patient of unknown age or gender. The patient's medical history, concurrent conditions and drug reaction/allergies were not reported. Concomitant medication included sterile diluent 0.5 milliliter.   On 12-JUL-2023, the patient received vaccination with second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #W036940, expiration date: 19-MAY-2024, administered for prophylaxis (strength and route of administration were not provided) after it experienced a supported temperature excursion (Product storage error). The storage temperature of the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was -8.6 degrees Celsius for a time frame of 51 minutes. There was previous temperature excursion, the storage temperature of the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was -11.5 degrees Celsius for a time frame of 1 hour and 16 minutes. No side effects reported. No additional adverse event.
While injecting ZOSTAVAX (approximately 1/3 of dose), patients arm began swelling at the site (looked like a mosquito bite) and concurrently became red at the site & surrounding it. I stopped & withdrew the syringe; eventually discarded the remainder of the dose. I had the other RPh on duty view the reaction as well. Pt was instructed to take BENADRYL.
This spontaneous report as received from a Licensed Vocational Nurse (LVN) refers to a 13 year old female patient with no known drug reactions/allergies. On an unknown date the patient was vaccinated with GARDASIL lot # H017698 dose 2 (site and dose not specified). The patient had not eaten before being administered the vaccine. Concomitant  therapies included diphtheria toxoid (+) pertussis whole cell vaccine (+) tetanus toxoid (manufacturer unknown), influenza virus vaccine (manufacturer unknown) and tuberculin purified protein derivative (PPD). On 28-JUN-2013 the patient fainted after receiving GARDASIL. After falling, the patient developed a little scratch on her face or head area. The patient was given oxygen, elevated her legs and provided a sugar popcicle. No lab diagnostic tests were performed. The event occurred during an office visit. The outcome of the events was unknown. The causal relationship was not reported. Additional information has been requested.
This spontaneous report as received from a medical assitant, refers to a currently 5 months old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored ROTATEQ per oral, (which had a lot # of N030366 and an expiration date of 13-MAR-2019; however, dosage number was not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA006354:
Gave Pfizer monovalent 5y-11y vaccine to this 4 year old.  Tolerated well, monitored for 15 minutes after dose given
Breakthrough COVID infection. Symptoms of fatigue, dizziness, with mild cough and shortness of breath on exertion. Unsure when symptoms started. Positive test collected 10/27/2022.
During patient observation time, pt. stated                she could not wait any longer to use restroom, urge became strong. When exiting restroom pt. was flushed (red) in face and hands, became weak,  tachycardic, and blood pressure became elevated. Pt. was  still able to communicate verbally. Also, experienced chills.  EMS called and transported pt. out.
On the day after the 2nd dose, I had a fever of 100.4 for the entire day.
24 hours after vaccine has very red, indurated area on arm 4x5 inches. Achy, not painful, no systemic signs.
1" x 1" warm, reddened area on left thigh in area where Varicella vaccination was received.
It started with a sore throat, no fever, it felt like a cold was coming on, stuffy nose, strange cough, felt lightheaded. It's unlike any cough I've ever heard but not like a bronchial cough I've had in the past. I tested once right away when my husband tested positive but it came back negative, a week later my symptoms showed up so I tested again and it was positive. I called my primary care physician the nurse practitioner called back and said they felt I did not need the PAXLOVID. I feel better now.
6 days after vaccine urticaria, migrating measles like rash covering from scalp to toes. No palmar or plantar rash. Benadryl oral and topical application with ice packs  and ice baths.  Symptoms continuing  24 days post vaccination. Face and neck and arm are improving.  Neck lymph nodes are palpable day 9-21. Currently resolved.
Pt recv vax on 11/5/98; on 11/6/98 pt exp a cold
Sore arm, head-aches, flu-like symptoms, eye swelling, cheek selling, sever ear lobe itching
approx 4 days p/vax pt began w/1-2  spells of tonic/clonic movements of extremities; ea spell lasting 1 min; spells occurred daily until late February; now  1 wk w/o spells occurring;
After getting this shot the next day I had severe pain in my ankles, back head neck all joints. Had to go to the ER the pain was so severe.
Information has been received from a registered nurse concerning a 13 year old female patient who on 17-AUG-2010 was vaccinated with the first dose of GARDASIL (lot number:667165/1167Z) (expiration date, dose and site of administration not reported). On 08-NOV-2010, the patient was vaccinated with the second dose of GARDASIL (lot number: 667165/1167Z) (expiration date, dose and site of administration not reported). On 06-JUN-2011, the patient was vaccinated with the third dose of GARDASIL (lot number: 667165/1167Z) (expiration date, dose and site of administration not reported). On 06-JUN-2011, the patient experienced clamminess, lightheadedness and upset stomach. This was not a problem for the previous two doses. It was unknown if the patient sought medical attention. No treatment was given for the adverse event. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Patient or his brother  received adult bivalent covid vaccine in error.  Mother aware.  Spoke with mother 10-10-2022 and neither child has had any side effects over the weekend.  No treatment.