chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving immunizations, family was waiting their 15 minutes in the lobby area when child's grandmother walked into the clinic and informed PHN and PHN that child had spit-up. PHN assisted child by removing the small amount of clear mucous, < 1 ounce, from the child's face with a paper towel. 10:45 am: PHN completed assessment of child VS: Apical HR 88, RR 36, Temp 97.2, BP 90/70. Lung sounds clear bilaterally, good aeration. No redness, swelling, or hives at or around injection site. No respiratory distress or generalized hives. Child was alert and responded to verbal commands during assessment. Child rested and was reading a book. No further episodes of spitting-up . Reviewed S/S of severe allergic reaction (swelling of the face, mouth or throat; difficulty breathing and generalized hives) and response with parent prior to releasing family at 11:15am. Child left walking with father and grandmother in no apparent distress.
PATIENT CALLED AFTER SECOND DOSE STATING HEADACHES THE FIRST 2 DAYS, THEN SPORADIC.  OF IMPORTANT NOTE WAS THAT PATIENT STATED SHE FELT TONGUE WAS SWELLING PREVENTING HER FROM SWALLOWING.  PATIENT DID NOT CONTACT US UNTIL A WEEK LATER.  PATIENT DID NOT GO IN TO DOCTOR OFFICE.  NONE OF HER SYMPTOMS WAS OBSERVED BY ANY MEDICAL PERSONNEL.
This spontaneous report as received from a nurse practitioner via company representative refers to a female patient of unknown age. In May 2012 the patient was vaccinated with influenza virus vaccine (manufacturer unknown) and experienced supraclavicular nodes (case number 1405USA013174). In May 2013 the patient was vaccinated with FLUMIST and experienced supraclavicular nodes again. On an unknown date the patient was vaccinated with GARDASIL first dose (route, lot and expiration date not reported) for prevention of HPV and experienced the same adverse event, supraclavicular nodes. At the time of the report the outcome of developed supraclavicular nodes was unknown. The patient sought medical attention. This is one of two reports from the same reporter. (1405USA013174). Additional information has been requested.
DUE TO ERROR AT INTAKE PATIENT RECEIEVED 3RD DOSE OF COVID VACCINE (MODERNA)
Pt had sz while in store on 7SEP91; ambulance took pt to ER; Had periodic jerking of muscles, rolling upward of eyes, & limpness w/passing out for 1/2 hour; Parents report as a febrile seizure;
patient started to feel very nauseous and had stomach cramps, went home early and took some OTC related medications to relieve symptoms
Pain w/L lifting or rotating my left arm, reaching arm across front or stretching back. Waking up in the nights when moving arm unintentionally, tired, lack of concentration.
Started out aches all over, headache, fatigue, loss of appetite, depression, anxiety, extreme weakness, couldn't move, nausea, couldn't eat, dizziness.  Still have weird headache and nausea that hasn't gone away.
LOCALIZED REACTION ON ARM THAT VACCINATION WAS GIVEN (RED, RAISED, WARM TO THE TOUCH, ITCHY AREAS) AND A GENERAL FEELING OF MALAISE STARTED WITHIN 18 HOURS OF INJECTION. SHE WILL USE COLD COMPRESSES AND BENADRYL TO RELIEVE THE ITCH AND IBUPROFEN TO RELIEVE THE GENERAL ILL FEELING. NO FEVER.
burning; pain; trouble below the skin; This case was reported by a consumer via interactive digital media and described the occurrence of burning skin in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced burning skin, pain and skin discomfort. On an unknown date, the outcome of the burning skin, pain and skin discomfort were recovered/resolved.   It was unknown if the reporter considered the burning skin, pain and skin discomfort to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that, after vaccination with Shingles shot had trouble below the skin at times, burning and pain. GSk note- since the narrative was not clear if the events occurred after single dose or after each dose, only one case processed for both doses.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR029148:same reporter
Massive infection in intestinal wall. Had to get ct scan, colonoscopy and meds. Still continue to have abdominal pain to date.
Was immunized for shingles around May 28, 2008. Within 7 days broke out with shingles across my stomach and around to my back. Bad back rash followed. Eventually redness disappeared but I have had an itchy back every day for two+ years. This summer in July I had a breakout on upper right back of about 5 inches in diameter of very small spots that really itched. Consulted a physician who prescribed topical cortisone. No effect on the itching. I have spoken with at least one other person who had the same breakout and continual itch on back.
Exactly 7 days from vaccine left arm was swollen with a red itchy spot. The next morning I developed hives on the left side of my back and upper arms. Then it spread to my upper legs. 5 days later I still have a few spots on my legs but the back and arms have basically cleared up. Can still see a few red spots but not raised or itchy. I have taken benadryl morning and night.
Blood sugar over 200, Temp 100.4, Double vision, Sweating for 2 days after shot, pulse ox dropped to 82.
Red spot at area of injection. Fever, chest congestion. He appears increase of pain from post herpetic neuralgia.
Rec. shingles vaccine 5:30 PM on 6-21-07. On 6-23 Blood pr. fell to 100-43. On same night, blood pr went to 213-103. No prev Blood pr problem, weakness in left arm.
At the injection site I have the first time around I just had some soreness; This is a spontaneous report from a contactable consumer (patient). This is one of two reports with first dose details. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), first dose via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included that suffered from allergies on a regular basis from an unknown date and unknown if ongoing. Concomitant medication(s) included loratadine, pseudoephedrine sulfate (CLARITIN-D); diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. The patient experienced at the injection site which patient had the first time around, just had some soreness on an unspecified date. Clinical outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (patient received fourth booster 1 day after expiration date) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 058A222A) for COVID-19 immunization. No preexisting condition or allergy 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 administered expired product (patient received fourth booster 1 day after expiration date). At the time of the report, administered expired product (patient received fourth booster 1 day after expiration date) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. No other side effect reported.
11/3/2021 JANSSEN SECOND J96.00 ACUTE RESPIRATORY FAILURE
immediate arm pain; Severe sinus headache; Tired; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 13:30 (Lot number: EN6205) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: PROBIOTICS. Past drug history included: Morphine for Drug Allergies: morphine; Clarithromycin for Drug Allergies: Clarithromycin. Vaccination history included: Bnt162b2 (lot number EL9266, le, administration date 10Mar2021, administration time 02:30 PM, vaccine location Left arm]), administration date: 10Mar2021, for COVID-19 immunisation, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Mar2021, outcome "recovered", described as "immediate arm pain"; SINUS HEADACHE (non-serious) with onset 10Mar2021, outcome "recovered", described as "Severe sinus headache"; FATIGUE (non-serious) with onset 10Mar2021, outcome "recovered" (11Mar2021), described as "Tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, sinus headache, fatigue.  Additional information: The patient did not have COVID 19 prior vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021500107 same patient and reporter, different dose and event
Patient was sitting in a chair and  Told his mother he felt like he was  going to pass out. At that point he  lost consciousness and started  shaking. By the time staff reached  patient, he came to. 911 was called.  He stated he had not eaten. He asked for a candy  bar and water. After he had eaten that, an ambulance  Arrived, checked his vitals, and parents opted to Called mother several hours later. She states he is  doing fine. 8-11-21- called PCP doctor  he will  document patient's reaction.
No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, 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 17-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date).    Case contains information regarding patient 1 of 2 reported.  Concomitant products were not reported.  It was reported that it was unknown whether patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine.  Treatment medications were not reported.
Chills, body aches on Friday then Wednesday evening arm swelled and had 6 cm red, hot bump at injection site.
This spontaneous report as received from a nurse practitioner refers to a 14 years old female patient, who was vaccinated with the first dose of GARDASIL (lot # not reported), 0.5 ml, intramuscularly, on 23-MAR-2009 the second dose in June 2010 (lot # not reported), and the last dose in August 2011 (lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that in May 2012 the patient had joint pain in her right hip and left shoulder. At the time of the report the patient's outcome was unknown. The patient sought medical attention - "Went to pediatric rheumatologist told to take a non-steroidal anti-inflammatory". Additional information has been requested.
pt recv vax 27NOV96 & 2DEC96 pt exp a raised, indurated, papular, warm to touch rash 3cm x approx 4cm in area @ each inj site;there was no fever or malaise;no tx was given; vax series discontinued
Immediately after given the shot my lymph nodes began to swell. I am having difficulty swallowing, eating, speaking, and my salivary glands are creating an enormous amount of spit. I am in a great deal of pain and fatigue. I have taken ibuprofen but it only helps for a couple of hours. It is day 5 since the shot and it does not seem to be going away. If symptoms persist I will not take the second dose of covid.
No adverse event reported at this time- Patient given COVID 19 vaccine 10 days apart from tetanus vaccine instead of the recommended 14 days. Called, studies failed to identify whether there have been interactions with other vaccines at this time.
The patient had pain to her left upper arm and shoulder since approximately 2 hrs post administration.  The patient was seen by DR on 12/27/00 and was placed on EC Naprosyn.  The patient was diagnosed with arm soreness.
Noted patient came in today for COVID-19 vaccine to Health Center as well as a Health Clinic.
pt recvd vax & 2 hrs p/vax c/o nausea, pain in arm, t101, abdo pain;
Morning after receiving vaccine has huge white blister on lower lip, inside cheek and very sore spot on tongue. Also, very very tired, little movement, no energy. Tuesday, patient called MD office, and was told to go to emergency room. Patient went to Hospital and was there 5-6 hours. The MD who saw her said it looked like she had bitter herself. She had not recollection of doing that and said so. They gave her a prescription, but at her pharmacy they told her she should use something else. She went back to the MD office that originally administered the vaccine on that Friday and saw an NP. The NP verified that the blisters were still in her mouth, and have her an antihistamine. The NP also documented this reaction in her medical record. Notes: Patient states she had similar results 2 years ago after receiving this vaccine. Her memory has been affected by numerous brain surgeries, so she did not remember this type of reaction until she had already gotten the vaccine and the reaction started again. Patient felt bullied into receiving the vaccine and is upset that her previous reaction was not listed in her medical record.
Immediate swelling of tongue. Within 4 minutes of receiving shot.     Slight nauseaness.    Tongue returned to normal approx three hours later.
I was having chest pain going across my left shoulder and up side of my neck, I also had dizziness, I went to the ER around 08:30PM on 12/30/2021 I was told that their was some type of inflammation on my chest, I was given medicine at the hospital that helped me and I was release from the hospital. I went back to the same hospital on 01/07/2022 at 3:30AM because I was having chest pain and they said I needed blood work, Chest X-Ray and EKG which the bloodwork came back positive for the blood clots and since that came back positive they ran CT scan and that came back clear. I have an appointment on 01/17/2022 with Primary care for a follow and talk more about the blood clots and what to do moving forward.
9:30: reports nausea; 9:45 started vomiting, continued to vomit; VS: HR:103, BP: 130/82, O2sat: 100%;  9:55 transferred to ED for further evaluation
This spontaneous report as received from a physician via company representatives and an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown, which was stored at -6.66 Celsius Degrees for 408 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Patient had complained of pain in her R arm with pain radiating from shoulder to hand the morning of 1/28/09.  This pain is still present > 1 week after vaccination.  Mother gave IBUPROFEN which helps but not completely.  Mother will call pediatrics Dept @ the end of 2 wks.  if pain has not resolved.
SYMPTOMS STARTED ON THE 27TH-28TH OF SEPTEMBER  -  NUMBNESS AND WEAKNESS OF BILATERAL LOWER EXTREMITIES, ATAXIA, NUMBNESS OF PALMS AND FINGERS BILAT  ,
No patients experienced symptoms; unspecified patients may have been administered improperly stored doses of PEDVAX HIB, GARDASIL 9, RECOMBIVAX HB and ROTATEQ; This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On unknown dates, the patients were vaccinated with improperly stored doses of the following vaccines: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # R036178 with expiration date on 09-OCT-2021, and lot # R027329 with expiration date on 12-JUL-2021; HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # S026372 and expiration date on 01-APR-2022, and lot # R029507 with expiration date on 10-JUL-2021; Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot # R031056 with expiration date on 04-JUN-2021, and lot # R031055 with expiration date on 04-JUN-2021; and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # 1660685 with expiration date on 21-MAR-2021, and lot # S005875 with expiration date on 30-NOV-2020, (strength, dosing details were not reported) via unknown route, all vaccines for prophylaxis.  It was reported that the vaccines were exposed to a temperature of 47.6-degree Fahrenheit for 41 minutes and 31.9-degree Fahrenheit for 6 hours and 58 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved. No symptoms were reported.  This is a non-valid case due to the lack of patient's identifiers.  Follow-up information was received on 03-MAR-2020 from a nurse supervisor.  The nurse referred to an 8-months-old female patient (previously considered non-valid).   On 17-JAN-2020, the patient was vaccinated with improperly stored Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength not reported) lot # R031056 with expiration date on 04-JUN-2021 for prophylaxis (product storage error).  The reporter confirmed that there had been no reports of adverse event following the administration of the vaccinations. She also reported that no patients received the Merck vaccination Hemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB). Additional information has been requested.  This is one of the several reports by the same reporter.; Sender's Comments:  US-009507513-2003USA001374: US-009507513-2003USA001375: US-009507513-2003USA001376: US-009507513-2003USA001377: US-009507513-2003USA001379: US-009507513-2001USA006732:
Pt was seen on 3/31/11 at 3:15 pm - child woke up with rash. Rash started on abd - has spread to the arms, back, cheek, legs and neck. Sx of rash - itching - redness - appearance - erythematous macular rash with small white wheals in the center over most of the body excluding face (although cheeks are flushed). No rash noted on the palms or plantar surfaces of the hands and feet.
resp s/s x 2 wk; paroxysmal coughing x 3 days; adm to hosp 19JUN95 placed on Oxygen; pos IFA for pertussis; vax failure;
administered first dose from vial punctured over 24 hours before; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered first dose from vial punctured over 24 hours before) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered first dose from vial punctured over 24 hours before). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (administered first dose from vial punctured over 24 hours before) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Treatment information was not reported.
Very tired for first 2 days on the third day development of an itchy rash on lower abdomen
Pt developed pain over Lt arm, hot totouch, no fever or chills.  Erythema and warmth over the L upper arm/deltoid triceps area 8cm by 3cm.  Cellulitis.  Rx Keflex 500mg QID x7days.
Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: ARM NUMB AND TINGLING FROM SITE OF INJ TO FINGERTIPS-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Approximately 7 hours after immunization, I experienced a change in orientation.  I did not remember getting a vaccination, day of week, month, color of my car, president.  However, I knew my name, birthdate, people who were with me at the time of the event.  I experienced no speech or mobility impairment.  I was able to walk with no difficulty in my gate.  My grasp was strong and equal.  No facial muscle weakness was noted.   45 minutes later I had total recall of the day's activities. I am not a smoker, no consumption of alcohol or illegal drugs.  Called primary care physician on 3/5/21 at approximately 4:30 pm.  Primary physician was not available, spoke to a nurse.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX vaccine (received years before the reporting date). In August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, 14 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to doctor. The patient received the vaccine on the right arm. He developed shingles 2 weeks after receiving SHINGRIX. The patient had denied permission to contact their physician.