chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information regarding PREVNAR was received from a pediatrician regarding a 61-day-old male patient who experienced pneumococcal meningitis - drug ineffective and became blind.  The patient received the first dose on 12-Oct-2007.  The patient also received the first doses of DTaP (manufacturer unknown), IPV, ROTATEQ (Merck & Co Inc) and Hib (Sanofi) on 12-Oct-2007.  The second dose of Hep B (manufacturer unknown) was also administered on 12-Oct-2007.  Relevant medical history was not provided.  Concomitant therapy included DTaP, Polio-Vaccine, HIB (Sanofi), ROTATEQ and Hep B.  The patient was admitted to the hospital on 14-Oct-2007 with a fever of 103 degrees C.  Diagnostic tests were performed (see test results), however serotyping was not performed.  The blood culture and culture of cerebral spinal fluid were both positive for Pneumococcus.  The patient was diagnosed as having Pneumococcal meningitis - drug ineffective.  The infant became blind on an unknown date in Oct-2007.  The infant survived but remained blind.  The physician considered PREVNAR to be ineffective in preventing Pneumococcal meningitis, but stated that she realized that only receiving one dose in the series did not confer immunity to the disease.  No further information was available at the time of this report.  On 14-Oct-2007 test results were: body temperature (results: 103 deg. F.); CSF culture (results: positive for Pneumococcus); and blood culture (results: positive for Pneumococcus).  12/2/08 Reviewed hospital medical records of 10/15-10/31/2008. FINAL DX: pneumococcal meningitis, seizures, diabetes insipidus. Records reveal patient experienced fever, irritability, reduced oral intake.  Seen in outlying hospital, admitted to PICU, intubated, tx/IV antibiotics & then transferred for higher level of care. Had seizure en route.  Neuro, endocrine consults done.  Tx w/IV antibiotics, anticonvulsants, DDAVP, tube feeds.  Weaned to RA by 10/22.  Transfused PRBCs.    9/26/08 Reviewed Hospital medical records of 10/14-10/15/2007. FINAL DX: sepsis, presumed pneumococcal; meningitis, probable pneumococcal; leukppenia & bandemia; grunting Records reveal patient experienced fever 103.2.  Tx w/IV antibiotics.  Admitted to ICU overnight, began grunting in AM & became lethargic.  Intubated & transferred to higher level of care. 9/16/08 Reviewed PCP office records of 10/12/07-11/8/07. FINAL DX: Records reveal patient experienced thrush on day of vaccination otherwise in good health.  Tx w/antibiotics.  Next is t/c from parent of fever 103.2.  Referred to hospital.  Admitted w/(+) s. pneumon in CSF & tx IV antibiotics. Transferred 10/15 to higher level of care PICU & d/c to home 11/1/07.  Became less responsive at home & readmitted to hsopital w/swelling of hands/feet.
Information has been received from a certified medical assistant in a physician's office concerning an 18 year old female who on 23-AUG-2007 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). About 24 hours post vaccination the physician treated the patient with ZYRTEC which helped clear up the hives. The patient recently discontinued the use of ZYRTEC and the hives returned. No further information was available. Additional information has been requested.
Administered lot #047B21A, but lot #008C21A (exp: 5/20/2021) was logged on forms. Lot #047B21A expired on 5/13/2021.
ONSET NOTED DURING DAY OF 11/4 RASH FROM HEAD TO TOE UNIFORMLY OVER BODY. NO FEVER.  FUSSY BUT EATING AND DRINKING.  MOM REPORTED RASH IS PETECHIAE-LIKE.   IMPROVED TODAY WITH NO OTHER SYMPTOMS.  PT HAD RECEIVED MMR, VARICELLA, AND HEP A ON 10/21/2009 FOR HIS ONE YEAR VACCINES. PT WAS HEALTHY AT THE TIME OF ALL INJECTIONS.  MOM WAS INSTRUCTED TO PULL CHILD OUT OF DAYCARE TODAY WHEN SHE CALLED TO REPORT THE RASH TO OUR HEALTH DEPT.
pt recvd vax 3JAN95 by former MD in Lousiana; 5JAN95-10JAN95 pt cried inconsolibly; had 24 hr fever on 5JAN95; MD found no reason for crying; seen by MD 10JAN95;
Localized reaction red and swollen size of 50 cent piece. Used cold pack to site and resolved.
Directly after the shot and for the next three days a sore arm was observed.  The day after the shot was administered the patient had a black out event while in a seated position. No high exertion or exercise was occurring before or during the event. While seated and speaking to another individual the patient experienced cold sweats, rapid heart rate, which was immediately followed by a blackout and nausea. The rest of day and the day following, the patient continued to experience nausea and dizziness.
This spontaneous report was received from a physician and refers to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was inadvertently vaccinated with a pediatric dose of VAQTA (dose, route of administration, lot# and expiration date not provided) for prophylaxis. No adverse effects reported.
Stated his skins felt funny some fine rash appearing on face. Woke up on Friday 11/06/09 face with some swelling, redness, rash spread to scattered areas on arms, neck, torso, and back. Called Dr. office they felt it was not a reaction to vaccination and to just watch him. Gave Benadryl 25 mg x2 that day. Saturday morning facial swelling increased he stated his throat felt funny and hot. Facial swelling at this point was probably double if not tripled previous day.  Felt uncomfortable keeping son at home, took him to local ER where he was evaluated and treated. Dr. felt in his opinion it was likely a reaction from vaccination. Son was prescribed steriods and epi pen and to continue with Benadryl. Saturday morning 10 year old son also vaccinated on same day as his brother, developing rash to face, arms, and chest. Sunday facial swelling is improving still red with moderate amount of rash thrughout body. Son c/o itching. Face is starting to develop small scabbed areas from itching. Monday stayed home from school due to itching. Called local health department to inquire about any adverse side effects they stated none had been reported to them. He continues on steriods tapering off daily and Benadryl every 4-6 hrs to help relieve itching. Began using anti-itch cream to rash and triple antibiotic onitment to face.
Back Ache; Cough; Sore throat; Headache; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back Ache), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache) and NAUSEA (Nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced BACK PAIN (Back Ache), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, BACK PAIN (Back Ache), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medication was reported.   Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
This medically confirmed literature report (initial receipt 16-Dec-2013) concerns a 78 year old male patient. The patient had a medical history of similar illness with respiratory issues requiring tracheostomy after an upper respiratory infection when he was 10 years old. The episode that the patient developed during childhood was presumably an episode of Guillain Barre Syndrome (GBS) which developed into chronic demyelinating inflammatory polyneuropathy (CIDP). On an unspecified date, the patient received influenza vaccine shot (manufacturer and batch number not provided). On an unspecified date, few days after the vaccination, the patient complained of five days of generalized weakness. He also experienced difficulty in getting up from a chair and difficulty while lifting his arm. A physical exam showed significant proximal as well as distal muscle weakness in bilateral upper and lower extremities. His sensations were preserved and reflexes were absent. His laboratory work up including electrolytes, TSH (thyroid stimulating hormone), CPK (creatine phosphokinase) and aldolase levels were normal. MRI (magnetic resonance imaging) of the head was unremarkable. An Electromyogram with Nerve Conduction Study showed evidence of CIDP. The patient was promptly started on treatment with corticosteroids. He showed gradual improvement in weakness and was advised to avoid influenza vaccines. Outcome was reported as recovering. Reporter's comment: CIPD can have relapses with triggers. This episode was probably from activation of CIDP triggered by influenza vaccination. The episode during childhood was presumably an episode of GBS which developed into CIDP. Studies have shown only small or no risk of these disorders from influenza vaccine.
Pt received primary series pfizer rather than bivalent. Pt is not reporting any side effects.
days 1-4 most extreme;  very fatigued and no temperature regulation (body burning but cold extremities) day 5-6 kind of Ok but still recovering day 7 fatigue returns days 8-9 right side of body achy esp. in joints.  sensitive to touch inside from knee to ankle on right side.  must keep leg up.  limping along with some fatigue and dizziness, some disruption of regulation of temperature day 10 improving day 11 reaction done
This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 30-JAN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N017698, expiration date 09-JUN-2019 (dose and route were not reported) for prophylaxis. Concomitant therapies included Merck sterile diluent. No adverse effects. The temperature involved was 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 10 minutes. A previous temperature excursion was reported as 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 hours and 50 minutes. A data logger was involved.
Developed swollen upper lip and itchy palate approx 30 minutes after receiving vaccine.
Took 2 Moderna shots and waited 6 month and took a Pfizer shot 2 weeks ago.; Took 2 modarna and waited 6 month and took a Pfizer shot 2 week ago.; Took 2 modarna and waited 6 month; Body Aches; Nauseated; Constipated; Stomach ache; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunization. The patient medical history and concomitant medications were not reported (takes other medication). The patient previously received Moderna covid-19 vaccine (dose 1 and dose 2). On an unspecified date, the patient experienced took 2 modarna and waited 6 month and took a pfizer shot 2 weeks ago in 2021, body aches, nauseated, constipated, stomachache and product was used by the patient. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. .
Shooting pains down all of my limbs. Muscle spasms down my right shoulder and arm. Tingling in fingers. 50% loss of strength in right arm and loss of movement.
Swelling at site next day, increased swelling & redness for 2 days after that. Redness & swelling continued for 5 more days - pt applied ice for 3-4 days.
Patient came for her routine 1 year well check-up. Received her MMR and Var vaccines. 1-2 days later developed 103 fevers x 2-3 days. Mom sought reevaluation at an urgent care center was noted to have macular generalized blanching rash.
SHINGRIX, dose 2. Flu-like symptoms. Body aches, chills, and lightheaded. Patient treating with TYLENOL and bed rest. Prognosis good.
Sweating; Chills with clattering teeth; bad headache; Nausea; This is a spontaneous report from a non-contactable consumer (reporting on behalf of the mother). A female patient of unspecified age (in her mid- 40's) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021, for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 06Jan2021 at 03:00 the patient woke up sweating, having chills with clattering teeth, a bad headache and nausea, no fever. Ibuprofen helped with the headache and she did a bland diet for the following day. Events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Breakthrough case.  Positive for covid on 9/27/2021 via PCR test
flu like, headache, nauseous, hot/cold, fatigue, your arm swollen and aches.
FUSION CERVICAL SPINE; This spontaneous report received from a patient via other manufacturer concerned an adult male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry date was not reported) dose was not reported, 1 total administered on SEP-2021 for covid-19 prophylaxis. Age at time of vaccination 44 years old. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported, expiry: unknown) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported.  On an unspecified date, the patient experienced fusion cervical spine. Laboratory data (dates unspecified) included: Magnetic resonance imaging fused neck and spine, fused neck and spine, and X-ray fused neck and spine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from fusion cervical spine. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220740359-covid-19 vaccine ad26.cov2.s- fusion cervical spine. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
pt received the Pfizer Covid vaccine for first dose in the series. Received Moderna Covid vaccine as second IM injection. no adverse reaction noted during 15 minute observation period.
No additional AE's; The caller states that a medical assistant in her clinic gave a 13-month old child GARDASIL 9 instead of their scheduled PREVNAR 13 dose; The caller states that a medical assistant in her clinic gave a 13-month old child GARDASIL 9 instead of their scheduled PREVNAR 13 dose; This spontaneous report was received from a nurse and refers to a 13-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-NOV-2022, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1775811, expiration date: 07-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided) (Drug use in unapproved age group) instead of their scheduled pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), lot # SM7207 and expiration date: 30-JUN-2024 (Wrong vaccine administered). No additional adverse events were reported.
Pt recv vax on 11/23/98; on same day pt exp fever (104) x 3dy; fussy & irritable x 1 wk; runny nose; conjunctivitis
Strong chills and  uncontrollable shivering, lasting approximately one (1) hour.
Pt states 1 1/2 days post vax, a rash was noted on hips and thighs bilaterally. Pt also experienced hives and itching which resolved in 4-5 days. Rash moved to lateral sides of body then elbows and knees then wrists and ankles. Rash on thighs cleared as the rash progressed or traveled.
Mom returned to clinic around 25 min after the vaccines were given. Child received Kinrix, MMR, Varicella. Mom asked for a nurse, and reported child c/o itchy throat. Child did not appear to be in distress, coughing off/ on, no hives noted, and could not sit still. While doing assessment on child, mom already was talking to 911. Mom stated to nurse had a reaction to MMR as a child - eyes swollen and resolved w/ Benadryl, denies anaphylaxis. Paramedics arrived and took over assessment and interventions. Administered epi to child, went to closest ER. I followed w/ mother @ 1:57 pm and 6:20 pm- and reports PT is stable. Discharged w/ Prednisone per mother.
Presented to ED post fall, xray covered femur fracture.  Post surgery complications included hyponatremia and hypokalemia,
BRUISE AT THE INJECTION SITE; SORE ARM; INJECTION SITE BLEEDING; This spontaneous report received from a pharmacist concerned a 73 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and  expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-APR-2021, the subject experienced injection site bleeding. On an unspecified date, the subject experienced bruise at the injection site, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site bleeding, and the outcome of sore arm and bruise at the injection site was not reported. This report was non-serious.
High fever 102 f. Red spot in the left eye, tiredness, fuzziness, small ski. Bumps
Initial reaction within 1 hr lethargy, drowsiness, which passed. Reports arm swelling approximately 10-12 hrs post receiving. Took Benadryl. Next day still swollen. Took more Benadryl. Third day more swollen, treated at hospital she works at.
She had the itch around her left arm and her whole chest for 2 weeks, swollen left side of her face and the injection area for 1 week. Also muscle weakness for one week with difficult sleeping. She emphasized that the swollen on her left face was very severe.
Patient complaint of throat tightness starting 10-12 minutes after injection. Patient did have a non-productive frequent cough during my time of observation. States history of "being sick for 2-3 days" whenever she gets the flu shot but no symptoms like this.   RRR, CTAB, patient had her albuterol inhaler with her and she self-administered 2 puffs inhaled. BP elevated at 182/120, pulse 114. oxygen saturation maintained over multiple checks above 95%.  BP well controlled at last office visit in October. With patient's persistent throat tightness, elevated pulse and BP, EMSA was called and will be transporting her to hospital for further evaluation and treatment.
This spontaneous report was received from a pharmacist referring to a 65 year old female patient. The patient's medical history included unspecified blood pressure issues. On 18-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot# reported as L015417, expiration date: 01-AUG-2016) 1 vial, subcutaneously (frequency was unspecified). Concurrent medications included unspecified cholesterol medicines. On 18-SEP-2015, after the patient received ZOSTAVAX vaccination, a huge bump appeared from the injection site to the armpit (injection site mass) and she was in pain. No PQC was involved. It was stated that the patient sought for medical attention by calling the doctor. At the time of the report, the outcome of injection site mass and pain was reported as not recovered. The relatedness of ZOSTAVAX with injection site mass and pain was not reported. Additional information is not expected as the reporter did not wish further contact.
Pt recvd 3 doses of Hep B vax, 3rd vax given 30JUL90 & it was determined that pt had a neg/borderline Hep B titer p/3 doses; A booster does given 18OCT90 & a Hep B titer drawn p/4th dose was positive;
Information has been received from a female who was vaccinated with a dose of GARDASIL vaccine (yeast). The patient stated she has experienced fatigue and muscle pain since receiving the vaccination. At the time of the report, the outcome was unknown. Additional information has been requested.
pt recvd vax;had localized pain in lt upper arm;described as 'achy';pt noted that arm pain was still present;inc T;
An unidentified male patient, had received a dose of FLUZONE SV 2009-2010 on an unspecified date. The lot number, route and site of administration was not reported. At an unspecified amount of time later, the patient developed a 7cm by 9cm area that was "purplish" in color, but not raised (site not reported). The patient was also itchy. At the time of this report, the patient was no longer complaining of itching, and the purplish color was ongoing. Documents held by sender: None
Received vaccine approximately noon on 1/12/07. Complained of significant arm soreness that night. Woke with 103 degrees fever 1/13 continued arm pain and extreme fatigue lasted until approximately 3pm 1/14. Treated with rest and Tylenol.
PATIENT FAINTED AFTER RECEIVING FLU VACCINE. PT HAD HISTORY OF FAINTING BEFORE WHEN VACCINE WAS ADMINISTERED.  PATIENT  WAS AWAKE BUT LOOKING PALE.  AFTER 30 MINUTES OF OBSERVATION, PATIENT WAS FEELING BETTER AND WENT HOME WITH HIS SISTER.
About 30 sec after receiving vaccination and blurred vision, anxiety and increased HR then facial itching and some shortness of breath. Took BENADRYL and TYLENOL.
Severe itching, burning on palms of both hands, with mild swelling. Lasted 3 days.  Severe itching and inflammation in genitals, lasted 2 days. Had mild itching and swelling of left eye intermittently for 2 weeks.
She saw blood in stool; A spontaneous report was received from a consumer concerning a female patient (age unspecified) who received Moderna's COVID-19 vaccine (mRNA-1273) and saw blood in her stool.   The patient's medical history included urinary tract infection (UTI) and was prescribed antibiotics. No relevant concomitant medications were reported.  On 11/Feb/2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 14/Feb/2021, the patient experienced the event after dinner, she saw blood in stool. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, saw blood in stool was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
5 inch - orange sized - hardened red area that occurred next day. Itching - no pain.
This spontaneous report was received from a medical assistant via company representative regarding a 2 months old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported.On 05-AUG-2016, the patient received 2 dose of RECOMBIVAX HB 5/0.5 mcrg/ml injection (lot# M000442 and expiry date: 31-MAR-2018). No adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.