chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had high pitched cry could not console. Lasted for 9hrs. Afebrile, no redness or swelling at sight of Immunizations. Per follow-up: Mother stated high pitch, uncontrolable, crying for approx 7 hrs. Low grade temp unconsoleable on 8/19/05 took child to emergency room approx 2130 at medical center, received vaccine on 8/18/05.
Pt presents w/ redness to eye, "spots" to eye area 20 mins after vaccination.  No visual disturbances.  No respiratory issues.  No swelling.  NKDA, No PMH or medications.  BP 114/74, HR 81, RR 18
Information has been received from a nurse referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L038018 with expiration date of 13-SEP-2017, lot# reported as L044694 with expiration date of 04-FEB-2018, lot # reported as L023387 with expiration date of 22-JUN-2017, dose, strength and route unknown). The RECOMBIVAX HB was stored at 9.9 Celsius degree for 1 hour and 23 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Developed progressive lower extremity weakness/numbness requiring intubation 6/30 for respiratory failure. EMG/MRI consistent with GUILLAIN-BARRE Syndrome. Remains intubated in ICU with flaccid paralysis and paresthesias.  8/10/09 PCP medical records received DOS 5/26/09 to 6/9/09. Gardasil administered.  8/17/2009 Received hospital medical records of 6/28-7/30/2009. FINAL DX: Guillain-Barre syndrome; respiratory failure s/p extubation; ventilator assoc acinetobacter & staph aureus pneumonia  Records reveal patient experienced acute onset of progressive ascending LE weakness, areflexia & paresthesia, difficulty swallowing.  Admitted to PICU, LP done & intubated.  Developed neuropathic pain, fever w/(+) resp c/s.  Neuro, Pulm, ID consult done.  Tx w/IVIG w/o improvement, tx w/plasmapheresis x 8, multiple IV antibiotics, tube feedings.  Continued to worsen.   Gradually improved, extubated to RA & diet advanced.  Transferred to inpatient rehab on continued IV antibiotics.  10/16/09 ICD-9 Codes received: 781.2 Abnormality of gait, 357.0 Ac infectious polyneuritis, 518.81 Acute respiratory failure, 997.31 Ventilator assoc pneumonia, 041.85 Infection-gram neg nec, 041.11 MSSA, 599.0 Urin tract Infection NOS, 345.90 Epilepsy NOS-Not intract.
My son was sick when he got his vaccines. He was only 2 months old. He had a fever when they gave it to him, they were only going to do one and somehow she thought it be a good idea to do three more. This was at his two month old well check up, but I was also bringing him there because he had a horrible cough and was sick. So after the vaccines he just got sicker and sicker throwing up fever Sunday 03/17/2019 I ended up at Hospital Emergency Room and they did nothing for him. They kept us there for 5 hrs and gave him ZOFRAN and another shot an antibiotic shot for Sepsis. They ran blood work, it wasn't the flu. They did an X-ray it wasn't pneumonia. The Dr ordered an IV but since the hospital didn't have small enough needles didn't do anything for him; didn't send us to somewhere to treat my baby. He was dry heaving choking on his foam and saliva, it was awful my baby died the next morning when I got up they told me he would be fine this is so wrong.
Syncope- Pt fainted in seated position. Responded to light tapping on cheeks shortly after. Pt was given a cup of water and began to feel better. Pt was advised to have someone pick her up. She left the pharmacy with a friend at 245pm (over half hour later). Pt states she was feeling fine and was advised to seek medical attention if fainting and/or swelling of lips/tongue/throat were to occur. Pt was also advised to have friend stay with her for rest of the day, so that someone was watching over her. Pt confirmed that she understood instructions provided as stated above.
This spontaneous report was received from a pharmacist, referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown dates, the patients were vaccinated with multiple improperly stored doses of ZOSTAVAX (strength, dose, frequency and administration route were not reported) lot number M038351, expiration date 06-DEC-2017, for prophylaxis. Concomitant therapies included a properly stored sterile diluent (unknown lot number and expiration date) used for reconstitution. On an unspecified date, the vaccines were exposure to a temperature excursion; the data logger registered a temperature range between 15°Fahrenheit (F) and 46°F during a time frame of 27 hours. There was a previous temperature excursion. No adverse effects were reported. Upon receipt of follow-up information it was determined that this case is now valid because of patient identifiers. Follow-up information has been received from a pharmacist on 11-MAY-2018. On 05-OCT-2017, two patients were vaccinated with ZOSTAVAX (dose, units, frequency, route not reported), lot # M03851, expiration date: 06-DEC-2017, with temperature excursion.
Patient came to Pharmacy today stating he had noticed a bruise at the injection site with soreness starting about Saturday or Sunday (6/9 - 6/10). He also stated he had some tingling in left hand. Have not been get note to report to MD. No treatment other than patient taken a generic TYLENOL pm at night.
received the 2nd vaccination of Moderna on 2/12 930a on 2/13 at 11a started to feeol diczzy - try to make it the bed but able to do so ended up part on bed and part on floor - unable to move - could hear things around me - the tv was on - I could feel the sweat drops coming off my face - (it felt like I was "locked in" - term used when coma pts can hear but able to move - I could feel the chills down my back - this lasted about 1/2 hr then started to be able to feel myself coming around - the whole time I kept telling myself to take slow deep breaths- the entire episode lasted about 1 1/2 -2hr - felt low energy after that - following morning felt back to normal
One hour after vaccination, patient states she developed a severe macropapular rash throughout the majority of her body, from her forehead to her calves.  Photographs also seemed to reveal urticaria.   She went to the urgent care and was treated with IV Benadryl and steroids.  She was also prescribed oral Benadryl and corticosteroids.   The rash and hives persisted throughout the ensuing 30 hours and was only mildly ameliorated with the meds.  She presented to our ED at 2 AM on 8/4/2021 (31 hours post vaccination) and a physical examination revealed severe macropapular rash and hives throughout her forehead and stretching down to her thighs.   Patient reported severe discomfort, itching and soreness.  We treated her with 50 mg IV diphenhydramine, 125 mg IV methylprednisolone and 20 mg IV famotidine.   The condition improved over the next three hours and she was discharged with instructions to continue taking the urgent care medications from the previous day and to return to the ED if symptoms worsened or failed to resolve.
4-5 hrs - headache/mild 8 hours fever/chills/body aches/muscle weakness/fatique 12 hours - worse headache, (blinding) neck pain/nausea 48 hours - symptoms begin to lessen, mild headache. Took Ibuprofen/pain killers.
99.4 F temperature 20 hours post dose; General fatigue; local soreness; This is a spontaneous report from a contactable consumer.  A 27-years-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number EL3247, via an unspecified route of administration, in the left arm, on 19Jan2021 at  13:45 (at the age of 27 years old) as a  single dose for COVID-19 immunization. The vaccination was administered in a workplace clinic. There was no medical history and no concomitant medications were reported.  The patient was not tested for COVID-19 prior to vaccination. There was no other vaccination given in 4 weeks. On 20Jan2021 at 10:00, the patient experienced a temperature of 99.4 F 20 hours post dose, general fatigue and local soreness. There was no treatment for the events. The clinical outcome of the temperature, general fatigue and local soreness was recovering. The patient was not tested for COVID-19 post-vaccination.
Red, hard, warm 3" circle around injections site (R) thigh. Dx. cellulitis. Tx with KEFLEX.
mom called 6DEC93 to report that pt devel rash on face, chills, & vomiting-started 5DEC93; mom states pt has not been well since receiving vax;
Myalgia Very notable throat gland swelling and same side ear pain within 1 hour of vaccine; body aches, weakness later the same day; weakness persisted for about 48 hours and then all symptoms resolved Narrative:
PATIENT FAINTED SHORTLY AFTER RECEIVING THE VACCINE. HE LOOKED PALE AND SWEATY. COMPLAINED FROM NUMBNESS OF HIS CHIN, AND HIS EXTREMITIES. FELT SICK TO HIS STOMACH TOO.
Presented on 9/17/02 with induration and pain and a depression in the right arm at site of yellow fever injection-on the lateral lower deltoid. She was treated by a dermatologist with Advil and heat to the arm.
This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. Since 05-MAY-2014, unspecified number of patients received PROQUAD (Merck) which was improperly exposed to temperatures above 5F. No known adverse effects. No product complaint was reported for PROQUAD (Merck). This case is linked to 1411USA001655, 1411USA004432, 1411USA004433, 1411USA004434, 1411USA004435, 1411USA004437, 1411USA004438, 1411USA00439, 1411USA004440, 1411USA004441 and 1411USA004442 (same reporter link). Additional information has been requested.
High Grade Fever, Body Aches, Sleeplessness, Cold Sweats, Hot Sweats lack of any appetitie
Tiredness; Injection site pain; Arm pain; fever at 99.4 F; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Dec2021 12:45 (Lot number: FK5618) at the age of 6 years as dose 1, 0.2 ml, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 06Dec2021 21:00, outcome "unknown", described as "Tiredness"; VACCINATION SITE PAIN (non-serious) with onset 06Dec2021 21:00, outcome "unknown", described as "Injection site pain"; PAIN IN EXTREMITY (non-serious) with onset 06Dec2021 21:00, outcome "unknown", described as "Arm pain"; PYREXIA (non-serious) with onset 06Dec2021 21:00, outcome "unknown", described as "fever at 99.4 F". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional info: Patient took other vaccine on same date (06Dec2021) on Left shoulder. Facility where the most recent COVID-19 vaccine was administered: Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Patient describes pain, swelling, nausea, and dizziness beginning about two hours after injection. Induration, warmth and erythema are noted on entire upper left arm.
PATIENT REPORTED RASH, BLURRED VISION, MAJOR MIGRAINE, AND FACIAL SWELLING.  REPORTED TO WALK-IN CLINIC WHO RECOMMENDED AN ER VISIT FOR EVALUATION/MANAGEMENT OF SEVERE MIGRAINE.  IN THE ER, SHE WAS TREATED WITH PROCHLORPERAZINE, BENADRYL, AND TORADOL.  HEADACHE RESOLVED AND PATIENT WAS DISCHARGED HOME.
Generalized rash 6-8 hrs after shots. Fever. Had been ill with febrile illness, but was better, when he got shots. Seen ER, where he received ROCEPHIN and BENADRYL.
Within 4 hours of receiving the immunizations, patient experienced a rash on her left arm in the spot the immunizations were given. Patient went to urgent care and was prescribed triamcinolone acetonide 0.1% cream on 7/5/19
Patient received the FLUZONE quad vaccine. She immediately had a reaction such as a bruise and swelling and warm to touch.
Hallucinations, nausea, vomiting, passed out, BP fluctuations, dizzy
Left arm swelling and red, sore 2 day after shot. Worsened over 5 days Pt was treated w/ KEFLEX.
Soreness first couple of days at sight, got worse, still has limited motion at shoulder due to pain as of 40 days after injection.
No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a certified medical assistant (C.M.A.) referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 10-JUN-2021, the patient was vaccinated with one of following incorrectly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were not reported) for prophylaxis: lot # T024283 has been verified to be a valid lot number, expiration date reported as 14-JUL-2022, but upon internal validation established as 15-JUL-2022; lot # T032930 has been verified to be a valid lot number, expiration date reported as 27-SEP-2022, but upon internal validation established as 28-SEP-2022 (incorrect product storage). The vaccine underwent a temperature excursion as it was stored at 47.2 Fahrenheit (F) (above 46 F) for 52 minutes, recorded by digital data logger. There was no previous temperature excursion. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
Patient's mother called pharmacy & said that pt was "almost unresponsive," vomiting, & "lost hearing." Pt went to the ER where mother said she was told she had "a mild reaction to the vaccine".
This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, pain and swelling. On an unknown date, the outcome of the erythema, pain and swelling were unchanged. The reporter considered the erythema, pain and swelling to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced redness, swelling and pain after receiving SHINGRIX. The reporter called to find out appropriate treatment for this event(s). The patient has denied permission to contact their physician. The reporter was in hurry and provided limited information about this case.
Extreme pain on right arm felt like it was dislocated. Had nausea from pain.  Tylenol did not help slept through Saturday, Sunday was able to move arm only from wrist to elbow, Monday had more movement on Wednesday was back to normal.
This spontaneous report was received from a Licensed Practical Nurse refers to a 4 year old male patient. The patient previously received one dose of measles virus vaccine live (Enders-Edmonston) mumps virus vaccine live (Jeryl Lynn) rubella virus vaccine live (Wistar RA 27/3) (M-M-R), one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 25-JUL-2018 the patient was vaccinated with PROQUAD from lot R003292 dose 1, subcutaneous in the right deltoid for prophylaxis. On the same day, the patient was also vaccinated with KINRIX from lot 95FR9 dose 1, intramuscular in the left deltoid for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The medical assistant was not sure which sterile diluent (manufacturer unknown) lot numbers were used.  The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the several reports linked via same reporter link.; Sender's Comments: US-009507513-1807USA007589:
Dose # 2 Moderna COVID 19 Vaccine. Fever 100.7, chills, nausea, body aches lasting 36 hours
36-year-old female with history adult onset diabetes onset approximately 5 years ago presents with complaint of anterior chest pain which has occurred almost daily since early November at which time she took her first Covid vaccine.  She states typically she has 3-5 episodes per day but since 4 days ago has had many episodes.  Patient has been seen and evaluated by cardiology, and has had previous nuclear stress test which by history was normal.  States over the past few days has had 10-12 episodes of pain and typically relieved with nitroglycerin.  She describes the discomfort as heaviness and sharp with average duration 5 to 10 minutes with associated shortness of breath, nausea, and palpitations.  No provocation factors.  Patient also gives history of having cough productive of scant clear sputum along with fever and nasal congestion since Monday or Tuesday.  Chest pain is worse with cough.  Patient's son was diagnosed with Covid infection on Monday. No hx DVT/PE. Fam Hx Long QT syndrome.  Last normal menstrual  December 15
Within 5 minutes of receiving the Tdap immunization, patient had passed out on the floor and started seizureing. She convulsed for approximately 45 seconds. Her pupils were dilated and she seemed to be in a shock-like state staring off at nothing. After a few minutes, she was able to walk with assistance to a room where she could lay down. After 15 minutes, she felt much better but had pain and soreness in neck and in arm where the shot was administered. Blood pressure, pupils, heart rate were checked twice by Dr, then by nurse and I was told everything was ok. Neck and arm were very sore for 3 days. She was given Advil every 4-6 hours.
This is a spontaneous report from a contactable nurse received via the non-clinical study program. A 24-year-old male patient of unspecified ethnicity received PREVNAR single dose via an unspecified route of administration on an unspecified date in 2008 at 24 (units not provided). Relevant medical history included germ cell cancer from an unknown date to 1996 (patient has been cancer free since 1996). Relevant concomitant medications were not reported. The patient experienced off-label use when he received PREVNAR at the age of 24 (units not provided) and asthma on an unspecified date. The outcome of the events was unknown. Patient was now 31 years of age and the oncologist recommended a booster of PREVNAR 13 which the patient received on an unspecified date and experienced no adverse events.  Follow-up (08Oct2014): New information reported from the same contactable nurse includes: Patient information (age) and subsequent information regarding booster dose of PREVNAR 13. Follow-up (09NOV2014): Follow-up attempts completed. No further information expected.
+ covid 7/21/2022;  admitted 7/23/22 altered mental status, had  mild confusion after AAA repair 7/6/22 but worsened the last few days prior to admission .  covid infusion? 7/22.     Pneumonia.  given roephin, azithromycin, decadron and later vancomycin and zosyn.  CT showed indeterminate age infarct  & chronic small vessel ischemic disease tPA not recommended, had carotid artery disease.  Statins held due to transaminitis.  transfered to ICU d/t acute resp failure s/p cardiac arrest apparently on 7/25/22 and he had ROSC, placed on ventilator, levophed.  AKI, AGMA,    did not improve and expired 7/30/22
Upper arm is swollen, hot, sore, red, and itchy.  Symptoms did not appear until nine days after shot.
Localized hives along with a typical local reaction to Tdap 15 Aug 2016 in the setting of a URI. The question of hives raises the concern for anaphylaxis. Was this anaphylaxis? Not likely. Anaphylaxis to tetanus containing vaccines is extremely rare. Her reaction does not fit the definition of a generalized reaction, however, an abundance of caution is used in healthcare, and proceeding in a cautious way with further Tdap/Td immunizations is recommended.
Mother reported a grapefruit-sized site reaction.  Reported she had the same reaction last year.  Resolved.
08/18/2005 patient presents to clinic with swelling and redness in left deltoid.  Pruritus, no fever, no history of asthma, no pain, denies any history of localized reaction from other vaccines (had both IPV and DTAP in the past).  Swelling, Erythema, on left outer arm.  Swelling measures 16cm x 13 1/2cm, no acute distress, lungs clear to auscultation, temperature 98.3 degrees, Heart: regular rhythm and rate, active/alert.  Range of motion within normal limits.  Strength bilateral arms 4+/4.  Referred to primary care doctor.
Left deltoid warm to touch, pink circular area at injection site,  slightly tender and "itchy".
This spontaneous report as received from a certified medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with an unspecified amount of doses, with unspecified lot number/unspecified expiration date of PNEUMOVAX 23 that underwent temperature excursions starting on 01-NOV-2016 for prophylaxis (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature was 47 degree Fahrenheit-77 degree Fahrenheit and time frame was 2 hours 10 minutes. Call was due to digital data logger and there was no temperature excursion before. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA006335: US-009507513-1707USA006922: US-009507513-1707USA006921:
Patient presented to the local District Health Department to receive a Pfizer Bi-Valent booster vaccine. Patient was inadvertently administered a Pfizer Mono-Valent vaccine.