chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a doctors office manager via a company representative refers to an approximately 7 year old (reported as 7 or 8 years) male patient. On 26-JUL-2010, the patient was vaccinated with first dose of M-M-R II, (lot number, expiration date and route not reported). On 30-NOV-2012, the patient was given 0.5 ml (milliliters), second dose of M-M-R II, (lot number reported as 0233AE, expiration date and route not reported). The patient was given (Merck) VARIVAX concomitantly each time, (first dose was given on 26-JUL-2010, (lot number, expiration date and route not reported) and second dose on 30-NOV-2012, with lot number H011962, expiration date and route not reported). The patient received ACTHIB, which was administered on 22-SEP-2009, 23-NOV-2009 and on 26-JAN-2010. No adverse event was reported. The patient sought unspecified medical attention. Additional information has been requested.
Presented to ED with headache, hematuria, and petechiae.  Found to be thrombocytopenic with platelet count of 7,000.  Urinalysis positive for blood. MRI/MRV/MRA head negative for bleeding or other abnormalities. Hgb 11, platelet 7,000, AST 90, ALT 76, total bilirubin 7.9, other labs within normal limits.  Admitted for IVIG treatment for presumed ITP on 1/9. Platelet count not yet improved 1/10.
Information has been received from a physician concerning a female between 15 and 16 year old who was vaccinated with a 0.5 ml dose of HPV vaccine (yeast).  After receiving the vaccine, the patient fainted.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
pt recv 2 doses of vax MAY96 & JUL96 & 13AUG97 pt exp negative titer;
Received the multi dose flu vaccine (QUAD) on Nov 3 subsequently developed a swelling at the site which progressed.
first dose/on December 20th 2019/ second dose has not been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 20th December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The Vaers details were reported for 1st dose of Shingrix. The reporter did not consent to follow up.
This spontaneous report as received from a physician via a company representative refers to a 15 year old female patient. The patient had a history of fainting, syncope, after blood draws or other vaccinations. On 29-AUG-2013 the patient was vaccinated with an unspecified dose of GARDASIL, (lot #, expiration date, dose and route not reported) for vaccination. On 29-AUG-2013 the patient was also vaccinated with TD vaccines. Post vaccination the patient fainted while still in the physician's office on 29-AUG-2013. EMS were called to the doctor office at that time, but the patient refused to go to the emergency room. The outcome of the event was unknown. The patient had sought medical attention in office. Additional information has been requested.
Information has been received from a consumer concerning her 41 year old daughter with a history of cancer who on 16-OCT-2005 was vaccinated intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine (Lot 650453/0791P).  Concomitant therapy included an unspecified cancer therapy.  It was reported that on 16-OCT-2005 the patient's arm had swelled and that she had red welts covering her arm near the injection site.  The patient's mother also reported that her arm" hurts very much" near the injection site.  Medical attention was not sought.  At the time of the report, the patient had not recovered. Additional information is not expected.
Numbness of the whole left side. If I'm holding something in that hand i drop. I have pain in the arm that make me feel like I'm having pains in my chest,
C/O dizziness and generalized "tingly" feeling approx. 15 minutes post vaccination.  Person reports issues with anxiety currently and in past.  Received diphenhydramine 25mg PO.  Initial B/P 139/92, HR 80bpm.  Sxs resolved quickly.  Repeat B/P at 14:15 hours at 121/93.  D/C'd at 14:16 with resolution of sxs.
Narrative:  According to nursing note, Spoke with patient and reports receiving J&J vaccine approximately 3 weeks ago. Patient states she initially experienced fatigue and rash/hives on her body with the exception of her face or genitalia. Patient has attempted OTC Benadryl with minimal effects; switching to Allegra then topical cortisone with no relief. Patient reports no open lesions, but continues to experience urticaria with pruritic sensations. Patient is requesting for a  medication to address the dermatological response." treated with oral predpak.
One day post vax, the pt started itching which lasted most of the day. It itched like dry skin, the pt used lotion. The next day, the pt woke up with itching with hives on the buttocks, sides and back, abdomen and top of legs and waist line. Ears were hot and swollen. Took Benadryl. Hives lightened. Was taken to the ER.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature increased: 102 (High) 102. On 13-Jan-2021, Body temperature increased: 103 (High) 103. On 15-Jan-2021, Body temperature increased: 103.1 (High) 103.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product  and the start date of the event, a causal relationship cannot be excluded.
Moderna vaccine more than 12 hours after the vaccine was removed from the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine more than 12 hours after the vaccine was removed from the refrigerator) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021 at 4:22 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine more than 12 hours after the vaccine was removed from the refrigerator). On 01-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine more than 12 hours after the vaccine was removed from the refrigerator) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.   Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Patient demographics and anatomical location updated.
RUNNY NOSE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced runny nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from runny nose. This report was non-serious.
Patient complained of tongue and jaw feeling "numb and tingly". Vital signs stable. Numbness resolved but throat feels slightly swollen. No wheezing, or difficulty breathing, speaking in full sentences. Doctor onsite consulted. Patient observed for additional 30 minutes. Symptoms resolved. Discharged from clinic with doctor's approval.
6-6-07 Child seen for routine well-child PE/immunization approximately 6:00 PM temp 101.4 (ax), decrease with acetaminophen (tactile), 6-7-07 approx 1:00 AM child shaking, did not appear to respond, ambulance called and taken to hospital. Temp 104 (ax) blood drawn, attempt at urine by cath. unsuccessful - told febrile seizure and sent home. 6-8-07 Child sent for follow-up bagged for urine, seemed fine and was afebrile.
METALLIC TASTE IN MOUTH, SWEATS, HOT TO TOUCH SKIN, BURNING IN CHEST, SLIGHT DIZZINESS WHEN THERE WAS A MOVEMENT, (LATER THAT AFTERNOON), PAIN IN LEGS, SHOT SITE REALLY SORE
Pt had vasovagal reaction followed by transient tonic-clonic limb movements, eyes rolling back and lasted for 1.5 minutes.
Case reference number B1005904A was reported in a literature article and refers to a subject of undetermined gender who was born between 2004 and 2008 and was diagnosed with a seizure between 93 and 730 days of life. This diagnosis occurred within seven days of receiving an unspecified rotavirus vaccination on an undetermined date (manufacturer, batch number, route and dose unknown). The subject received this first vaccination on a delayed schedule as it should have been given at two months of age. No further information regarding the subject's medical, family history or concurrent medication has been provided. A subject of undetermined gender and born between 2004 and 2008 was diagnosed with a seizure either in an emergency department or in a hospital between 93 and 730 days of life. This diagnosis occurred within seven days of receiving an unspecified rotavirus vaccination on an undetermined date (manufacturer, batch number, route and dose unknown). No further information has been provided regarding any symptoms displayed by the subject or any clinical examinations or investigations performed; but the authors report that the event was classified using the ICD-9CM codes for "seizure". Diagnosis was seizure. Treatment and outcome of the event were unspecified. Author's conclusion: "For children who received their first vaccination on a delayed schedule between 93 and 730 days of life, the incident rate ratios for seizures were generally elevated but not significant." This was one of 3 cases reported in the same article.
Information has been received from a physician concerning a 2-year-old patient with no pertinent medical history or allergies who at one year of age was vaccinated with her first 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # unknown). There was no concomitant medication. On an unspecified date the patient experienced "a shingles rash". Medical attention was sought via an office visit. No diagnostic labs were performed. On an unspecified date the patient recovered. A product quality complaint was not involved. No further information is available.
Diarrhea; Leg hurts; Back hurts; Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Leg hurts), BACK PAIN (Back hurts), PAIN (Aches) and CHILLS (Chills) in an 119-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Leg hurts), BACK PAIN (Back hurts), PAIN (Aches) and CHILLS (Chills). At the time of the report, DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Leg hurts), BACK PAIN (Back hurts), PAIN (Aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Followup received on 21-JUL-2021, Fax Number Updated
Initial unsolicited report received from a consumer (patient's grandmother) on 26-Jul-2015. A patient (age and gender not provided), whose medical history and concomitant medications were not reported had received a dose of Meningococcal vaccine (batch number, expiry date, dose details, route and site of administration were not provided) on an unspecified date. On an unspecified date post-vaccination, the patient developed meningitis symptoms and was hospitalized (date was not specified). Laboratory investigations and corrective treatment were not provided. At the time of this report, the outcome of the event was not reported. Documents held by sender: none.
Numbness in feet; Stomach pain; Bloated feeling; Feeling abnormal/did not feel right; Abnormal touch sensation/ hard to touch; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), ABDOMINAL DISTENSION (Bloated feeling), FEELING ABNORMAL (Feeling abnormal/did not feel right), PARAESTHESIA (Abnormal touch sensation/ hard to touch) and HYPOAESTHESIA (Numbness in feet) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In April 2022, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), ABDOMINAL DISTENSION (Bloated feeling), FEELING ABNORMAL (Feeling abnormal/did not feel right) and PARAESTHESIA (Abnormal touch sensation/ hard to touch). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in feet). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), PARAESTHESIA (Abnormal touch sensation/ hard to touch) and HYPOAESTHESIA (Numbness in feet) had not resolved and ABDOMINAL DISTENSION (Bloated feeling) and FEELING ABNORMAL (Feeling abnormal/did not feel right) outcome was unknown.            Concomitant drugs were not reported. Patient said her feet had been numb ever since, might be something else, Patient had a lot going on. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment details were not reported. Causality for Rinvoq(upadacitinib): The reporter causality for the events of stomach pain and numb feet with rinvoq(upadacitinib) was no reasonable possibility. the reporter causality for the events of felt bloated, did not feel right and hard to touch was not provided.
Rash; Pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash) and VACCINATION SITE PAIN (Pain at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced RASH (Rash) and VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, RASH (Rash) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.   This case was linked to MOD-2021-024194 (Patient Link).
Within 4 hours I developed a covid rash and severe arm pain at the injection sight; Within 4 hours I developed a covid rash and severe arm pain at the injection sight; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 21-years-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FF8891), via an unspecified route of administration, administered in Arm Left on 08Oct2021 16:45 (age at vaccination was 21 years) as dose 1, single for COVID-19 immunization. The patient's medical history included food allergy (Egg white) from an unknown date and unknown if ongoing. The patient received birth control medications within 2 weeks of vaccination. The patient receive flu shot within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient previously took Flu shots via an unspecified route of administration in arm on 09Sep2021 for immunization. On 08Oct2021 at 20:00 (within 4 hours) patient developed a covid rash and severe arm pain at the injection sight. Patient didn't received treatment for the events. Device Date: 11Oct2021. The clinical outcome of the events was recovering.   No follow-up attempts possible. No further information expected.
22OCT began having diff breathing, pvt MD out of office went to hosp ER given 4 or 5 shots, 2 breathing tx & 02;also recv CXR & EGG;given rx for prelone syrup;
Patient admitted to hospital and was found to be asymptomatically positive during admission.   Moderna 2/15/21, 3/24/21, 12/8/21
arm pain; Arm tenderness that last half day; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Arm tenderness that last half day) and PAIN IN EXTREMITY (arm pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced TENDERNESS (Arm tenderness that last half day). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, TENDERNESS (Arm tenderness that last half day) and PAIN IN EXTREMITY (arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Concomitant medications were not provided. The Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Event Onset Date, 1st and 2nd dose date and event updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
4 1/2 hrs p/vax very fussy, pale, acted as if in pain, vomited;seem to settle down p/that;episode lasted about 1 1/22hrs then fell asleep;slept all noc;
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (administered past the BUD date Nov 1, 2021) and product storage error (stored Moderna vaccine in refrigerator, administered past the BUD date) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011F21A) for immunization. No medical history reported. On Feb 13, 2022, patient received the  first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 13, 2022, patient administered expired product (administered past the BUD date Nov 1, 2021). On an unknown date, patient experienced product storage error (stored Moderna vaccine in refrigerator, administered past the BUD date). At the time of the report, administered expired product (administered past the BUD date Nov 1, 2021) and product storage error (stored Moderna vaccine in refrigerator, administered past the BUD date) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
After the first shot I had tinnitus or ringing in my left ear for approximately two weeks.  After the second shot i developed a fever of 101 for 24 hours, severe headache and body aches and again tinnitus only in my left ear.  I am four days post second dose and still have left ear tinnitus.  I have not gone to my primary care doctor about this yet but plan to if the symptoms do not go away within two weeks.
The day of the shot, felt little to no symptoms until developing a slight headache in the evening (around 6:30PM). Fell asleep early at 9PM. Had elevated temp overnight (99.7 at 3am) and chills, woke up with extreme headache that did not resolve until about 4:30PM following day. A few days later on Saturday, developed pain in lower left abdominal area ? felt like cramping or gas. Continued for the next 5 days on and off and is ongoing. Period is not expected for another 10 days and these are unusual symptoms. If pains continue, will seek medical advice.
dizziness & numbness of face & cheeks w/thickening of tongue & throat p/4th dose in series;
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity . The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had never got covid in the past. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown; expiry: unknown) dose was not reported, 1 total administered on 04-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested.No concomitant medications were reported. On 28-JUN-2021,after 24 days after vaccination, the patient had antibody test done and the result found to be negative screen.Patient did not have antibodies in blood against covid-19(suspected immunological vaccine failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210666886-COVID-19 VACCINE AD26.COV2.S-suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.