chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately after receiving the DTaP vaccine in his left thigh, the patient cried for three seconds and then stop breathing. His eyes were wide open and staring. The nurse gently shook the patient to try to get hime to stary breathing. there was no responds. the nurse then breathed into the patient's mouth 1-2 times and he began breathing and crying. He was ok after that.
face was still red; swollen; feeling weak; Tired; Severe allergic reaction; Difficulty swallowing; A spontaneous report was received from a healthcare professional concerning herself, a 28 year old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a severe allergic reaction,  difficulty swallowing, face was still red, swollen, felt  week and tired.  The patient's medical history included anxiety and allergy to latex. Concomitant product use was not provided by the reporter.   On 12-Jan-2021, 15 minutes prior to the onset of the symptoms, the patient received one of two planned doses of mRNA-1273 (026L20A) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   12-Jan-2021, after receiving the vaccine, the patient experienced a severe allergic reaction which made her face puffy, red, and covered with hives.  She took 50 mg of diphenhydramine.  She was also having trouble pronouncing words because her tongue was swelling and she couldn't swallow water, so she used epinephrine  and go to the emergency room.  On 14 Jan 2021 she felt weak and tired.   On 13 Jan 2021follow up information was received and per source document/call -  In addition one day later, on 13Jan2021 around 5:30 pm, patient reported that she went to the bathroom and noticed that her "face was still red" and "swollen" and had a "little bit of difficulty swallowing" and took another unknown dose of Benadryl and felt better.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events,severe allergic reaction, difficulty swallowing, face was still red, swollen and felt weak and tired was not reported.; Reporter's Comments: This case concerns a 28 year old female with medical history of anxiety and allergy to latex who experienced serious medically significant unlisted event of severe allergic reaction described as her face puffy, red, covered with hives, tongue swelling and difficulty swallowing within 15 minutes after the first dose of the study medication administration (LOT:026L20A). Patient also experienced additional reported events of non-serious listed events of "face was still red" and "feeling tired" and non-serious unlisted events of "face swollen", had a "little bit of difficulty swallowing", and "feeling weak". Patient was treated for the severe allergic reaction with initially Benadryl 50 mg and then with epinephrine pen and was sent to ER. Based on the temporal association between the use of the product and the start date of the events within 15 minutes of receiving the vaccine, a causal relationship cannot be excluded and the event of severe allergic reaction is possibly related to vaccine. Additional reported events of non-serious listed events of "face was still red" and "feeling tired" and non-serious unlisted events of "face swollen", had a "little bit of difficulty swallowing" and "feeling weak" are possibly related to vaccine.
Headache; Flush red face; Flush red face; Low fever; Swollen lymph nodes under arm on right and left side; Low energy; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the right arm on 10Sep2021 at 16:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and known allergies to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received unspecified concomitant medications. On 10Sep2021 at 21:00, the patient experienced headache, flush red face, low fever, swollen lymph nodes under arm on right and left side and low energy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, flush red face, low fever, swollen lymph nodes under arm on right and left side and low energy was not resolved at the time of this report.
This spontaneous report as received from a pharmacist via a company representative refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with ZOSTAVAX injection. The pharmacist reported that he was "seeing generally more injection site reactions than he thought he would" after ZOSTAVAX administration. The outcome of the events and the relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received vaccines on 2/13/03 and had swelling, redness and warmth noted to left arm. On 2/14/03, was taken to ER. On 2/15/03, dx'd with cellulitis. Mom stated that child developed bacterial infection (result of puncture sites) and was given Rocephin injection and PO antibiotics. Mom states no redness, swelling or warmth now; crisis resolved.
Redness and swelling to injection sites = cellulitis.  Treated with Omnicef.
Pt inadvertently received an intradermal injection of Tetanus Toxoid Adsorbed, Purogenated and subsequently developed a 2.5 X 2.5 cm granuloma at the injection site.
Fever for 2 days now, total body pain, red welt below the injection site, tiredness
Sore arm directly after the shot, lasted 3 days. Exactly 1 week after shot, developed itching and swelling at injection site (4/5).  Still there 5 days later, today, 4/9.  Looked up symptoms and discovered it's called  Covid Arm or Moderna Arm, and is not uncommon. Feeling fatigued 4/8 and 4/9.
Right after the shot had a severe headache, chills, dizzy, lightheaded, arm was very sore, bones was hurting extremely, couldn't eat,  was always cold and she was always tired.
Pt stated he got a rash located on his calves, forearms and back and feels itchy all over. No other symptoms. Spoke to his physician and he told him to take an antihistamine.
She is feeling weak because she has pain all over her body; She is feeling weak because she has pain all over her body; getting hot and cold, fever like she was feeling hot and then cold, hot and cold both back and forth; getting hot and cold, fever like she was feeling hot and then cold, hot and cold both back and forth; This is a spontaneous report from contactable consumer (patient daughter) reported for her mother. A female patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207, Expiry Date: unknown, Solution for injection), via an unspecified route of administration on 19Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. Historical vaccine included bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunisation. Consumer stated, yesterday on 19Mar2021 her mother got her second shot for the vaccine and today 20Mar2021 she was feeling weak because she has pain all over her body, she was getting hot and cold, fever like she was feeling hot and then cold, hot and cold both back and forth." Reporter confirmed the vaccine as Pfizer Covid 19 vaccine. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
i had fatigue, mild fever, chills, heart palpitation, congestion, headaches, & nausea
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever and sickness. On an unknown date, the outcome of the influenza-like symptoms, fever and sickness were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever and sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter asked should we take the second shot of SHINGRIX vaccine if we are sick with flu like symptoms and running fever.
The patient reached out to our onsite RN on 22MAR21 to report injection site pain, redness and swelling (left deltoid).
12/26/2020 "got vaccine on Wed then started on Thursday was feeling run down, had a temp 101.8 feeling SOB with some assoc chest painwith deep breaths has a cough no loss of smell or taste"  12/29/2020"pt developped sxs with fever and cough with the first covid vaccine she still has some sxs sometimes feels heavy chest, she has a pulse ox at home now the pulse ox reads 96-97% with tachycardia (she has chronic tachy with normal TSH) she is feeling a little better than yesterday but still has sxs "
Watched for approximately 15 minutes after vaccination and then as he did not develop any symptoms he left.  He notes he was not until approximately 1.75 hours after vaccination that he began to develop a runny nose and aching primarily in his arm.  He felt this might be normal but then soon after developed a hot itchy tight feeling in his throat with ongoing rhinorrhea, mild tightness in breathing and soreness in his left arm. He has had similar reactions with Remicade in the past and they became severe and that is why he is no longer using Remicade.
Birth weight 4451 grams at 41 weeks of gestation/large for gestational age; Foetal exposure during pregnancy; This is a serious spontaneous case, initially received from other health professional on 18-Jun-2019, concerning a male neonate patient.   The patient's mother was 21-year-old with no previous pregnancies. The patient's mother did not have any history of offspring with major congenital malformation. Also, had no maternal or paternal history with major congenital malformations. The current conditions of the patient's mother included Rhesus antibodies (Anti-D screening) positive and Rhesus antibodies (Rh D) negative. The concomitant medications of the patient's mother included Rhogam (anti-D Immunoglobulin) for Anti-D screening Positive and prenatal vitamins (minerals Nos; vitamins Nos) as a supplement. The pregnancy status of the patient's mother was collected, and no pregnancy complications were noted.  The last menstrual period (LMP) date of the patient's mother was 28-Aug-2018. The type of pregnancy was singleton. The patient's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   On 07-Nov-2018, at gestational age of 10-weeks, the foetus was exposed to Afluria Quadrivalent [Influenza Vaccine, route of administration: transplacental, batch number: YF42609, dose, anatomical location and expiry date: not reported] (explicitly coded as foetal exposure during pregnancy) for an unknown indication. On the same day, the patient's mother underwent ultrasound test, and no major congenital malformation was noted.  On 26-Dec-2018, the prenatal tests of the patient's mother included sequential 2 test and inheritest core test done, and no major congenital malformation was noted. On 07-Jan-2019, 2 months after vaccination, the patient's mother developed anaemia and was treated with Iron [dose: 325 mg, frequency: daily (qd), route of administration: oral, start date: 07-Jan-2019 to ongoing].  The corrected estimated date of delivery of the patient's mother was reported as 02-Jun-2019 and estimated date of delivery was reported as 04-Jun-2019.   On 09-Jun-2019, at gestational age of 41 weeks, the mother gave a live birth to a male neonate by vacuum assisted vaginal delivery method. The characteristics of the neonate included birth weight: 4451 grams (coded as large for gestational age), head circumference: no data, body length: no data and appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute, 9 at five minutes and no data for ten minutes). No major congenital malformations were identified at birth.  This case is cross-linked to the case: 201903638 (mother case).; Reporter's Comments: A male neonate patient with exposure to Afluria QIV during 10th week of gestation had birth weight of  large for gestational age (4451grams at 41 weeks). Considering the no known biological mechanism the company assessed the event as not related to suspect vaccine. Other risk factors can be considered as post term pregnancy and male fetus.
Reported *sudden* onset of severe pain/pressure (like being hit or "having large bruise sensation") over large swath of L anterior chest and shoulder (L arm shot). Sudden onset, 7/10 pain. Stated anterior chest vein turned "bright blue" and reported sudden onset left arm coldness.  Per pt. report: urgent care doctor noted mild anterior chest lymphadenopathy, warmth around injection site, treated with Keflex.  On 2/13, questionable trace swelling L anterior chest.  Minimal lymph nodes supra and sub-clavicular (questionable, <.5cm)  Still c/o significant dull pain 2/13.
Patient was found deceased by her son 2 days following vaccination. Coroner stated heart attack was the likely cause of death. However, a autopsy was not performed before the body was cremated.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route of administration were not provided) lot# N017700 and expiration date: 09-JUN-2019. The VARIVAX was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccine was stored in between 15 degrees Fahrenheit (F) to 46 F for 1 hour and 9 minutes. Previous temperatures excursions were in between 6 F 14 F for 76 minutes and in between 15 F to 46 F for 1 hour and 23 minutes. The digital data logger was involved in recording the temperature excursion.; Sender's Comments: US-009507513-1711USA002012:
rash steroid and non steroid ointments, shampoo and inflammation medication for scalp
PER MOTHER, PATIENT DEVELOPED A HIGH FEVER AND VOMITING "A FEW HOURS" AFTER HEP A VACCINATION ON 7/31/18. FEVER AND VOMITING CONTINUED THROUGH THE NIGHT. ON 8/1/18 THE PATIENT WENT TO ER, HAD BLOODWORK AND RADIOLOGY TESTING THEN WAS RELEASED TO HOME. PATIENT CONTINUED TO HAVE STOMACH CRAMPING AND VOMITING LAST NIGHT AND TODAY.
No adverse event; some dose leaked out of the syringe; some dose leaked out of the syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of SYRINGE ISSUE (some dose leaked out of the syringe), UNDERDOSE (some dose leaked out of the syringe) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Nov-2022, the patient experienced SYRINGE ISSUE (some dose leaked out of the syringe) and UNDERDOSE (some dose leaked out of the syringe). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, SYRINGE ISSUE (some dose leaked out of the syringe), UNDERDOSE (some dose leaked out of the syringe) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for SYRINGE ISSUE (some dose leaked out of the syringe) and UNDERDOSE (some dose leaked out of the syringe).    No concomitant medications were reported. The pharmacist stated that they were trying to administer Moderna bivalent 0.5 ml, but some dose leaked out of the syringe.  No treatment information was provided.
"Says started with rash over forearms tuesday, right forearm itchy now resolving; received 2nd round of covid vaccine yesterday. Skin is locally warm and itch like a sun burn warm; no history of atopy; blanching rash, only outer aspects of elbows rash. Received moderna vaccine yesterday given 7.30 am; showed up with rash 1 pm. Says current meds taken for more than 5 months. Says skin seems more warm, burn than itch; left worse; feels right is getting better. Says will take tylenol for now for discomfort, she will also report as possible vaccine adverse event to her vaccine provider. No fever or joint pains. No other concerns at this time."
I received the vaccine on day 5 of my period.  I take no hormones of any kind and my periods are regularly 5-7 days in length. My period began on 4/6. Instead of beginning to wane, my period started to get extremely heavy and I started passing clots again about 24hr after the injection. On the night of 4/12 I passed an unusually large clot, roughly the size of a hockey puck and felt very faint and weak. I continued to bleed quite heavily until this morning (4/19), for a total of 14 days. I called my obgyn on Tuesday of last week to report the excessive bleeding and that my cervical lymph nodes had become so swollen that it was bothersome to swallow. My Dr said to go to ER if I experienced typical blood clot/PE symptoms and had received no guidance about the effects of this vaccine on menstruation.  I have had mild headaches, sore throat, mild fevers and fatigue as well since the injection
2x2cm erythematous raised patch that is blanchable and warm to the touch; hard to tell if it is tender as patient is crying throughout the exam.
ATRIAL FIBRILLATION; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included: left sided stroke 2 years ago, and colon resection in 2002/2004, and concurrent conditions included: neurofibromatosis nf1, and other pre-existing medical conditions included: The patient did not have any known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (The dose number in series 1) (suspension for injection, route of admin not reported and batch number: LO3A21A expiry: unknown) dose was not reported, 1 total, administered on 04-MAY-2021, to left arm for prophylactic vaccination. Concomitant medications included atorvastatin, clopidogrel, Flonaze (fluticasone propionate), hydrochlorothiazide, Levothyroxin (levothyroxine sodium), Ativan (lorazepam), Meclizine (meclozine), metoprolol, nortriptyline, and omeprazole for drug used for unknown indication.  On an unspecified date, she stated of being unaware about her heart problems. On 22-NOV-2021, she underwent Colonoscopy and fast heart rate was noted which was further diagnosed with atrial fibrillation. Laboratory data included: Colonoscopy (NR: not provided) atrial fibrillation. She also further stated that, she did not took metoprolol on the morning of the procedure and was administered the dose during the time of the colonoscopy. She has a cardiologist appointment on 13-DEC-2021, and was ordered to undergo holter monitor testing on 20-DEC-2021 and TEE (transesophageal echocardiogram) on 12-JAN-2022. She was not prescribed any medications by the cardiologist.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of atrial fibrillation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211240438-JANSSEN COVID-19 VACCINE Ad26.COV2.S- atrial fibrillation .This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient is fully vaccinated.  COVID + at ED visit.  Her symptoms include: shortness of breath, occasional cough, nausea, loose stools, body aches, fevers and chills. Positive for chest pain, congestion.  She took Tylenol at home earlier for her temperature which was about 101. CXR: no acute process. Zofran ODT ordered. Dsicharged home.
Pt received 1st dose of Pfizer vaccine at Convention Center vaccination site  and about 10 minutes after receiving the vaccine she began to complain of dizziness, scratchy throat and mild tongue swelling. Pt reports that she has multiple allergies (especially tree nuts). BP 138/80. EMS on scene. Pt was administered 25 mg IM Benadryl and EMS transported pt to Hospital ED.
Patient came to pharmacy two months after getting the vaccine and complained that a week earlier, she went to a doctor due to pain in her right shoulder.  She said she had no pain for weeks after the vaccine, but then when pain started, they felt it was the vaccine.
Abrupt cascade of symptoms at 11:15pm after 3pm injection:  Muscle soreness, sudden migraine (no warning, unlike most migraines), fever 100.5 degrees F, lethargy.  Migraine addressed partially successfully with Treximet 2x.  Tylenol 1x for ache.  All others gone within one day.  Quite abrupt declination of symptoms as well.
PATIENT WAS GIVEN THE WRONG TYPE OF PFIZER COVID-19 VACCINE. PATIENT WAS SUPPOSED TO GET PFIZER 5-11 ORANGE CAP.
Chills, fatigue, headache, muscle and joint pain,  nausea, a fast heartbeat, dizziness and weakness.
No additional adverse effect reported; patient was administered a dose of improperly stored ROTATEQ; This spontaneous report was received from a physician refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.   On 24-JUN-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # S005875, expiration date 30-NOV-2020 (exact dose was not reported), orally, for prophylaxis. The data logger registered that the vaccine was stored at the temperature below 36 (F), reported also as 34.8 (F) for 25 minutes. There was previous temperature excursion below 36 (F) which was 34.5 (F) for 1 hour and 24 minutes. No additional adverse effect was reported.
Very sore and achy right arm - more than usual. Redness, swelling hot welt area about an inch below the injection site. Area went from top of arm to fully below arm about 2in x 5in in size. This lasted 4-5 days.
Patient received Pfizer-BioNTech adult COVID-19 vaccine, but should have received the pediatric vaccine. RN adjusted dose from 0.3mL to 0.2mL prior to administering the adult dose. Patient's father notified of the error and per guidelines. Patient's father advised to monitor for adverse events. Guidelines do not recommend repeat dose at this time.
Bilateral Axilla, dominant on vaccinated arm rash, itch Redness, Swelling