chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt given immunizations. Pt was mistakenly given DTaP, Hib, IPV (Pentacel) instead of DTaP, Hep B, IPV combined Vaccine. Pt also given separate HIB (PedvaxHIB) at the time of injections. Mistake caught after entering information into immunization registry. MD notified, observed pt, and spoke with Mom. Hep B vaccination ordered and given. Pt tolerated well with no adverse reactions. Mom given VIS, AVS, and immunization registry form.
I went to get the flu vaccine and when i got it i thought i had picked up the regular dose flu vaccine and when i went to chart it the scanner would not pick up the bar so i checked it and saw that i had given the high dose. I immediately went in and told the patient and the doctor and she was fine with no harm would come to her. Dr. said she is just extra protected.
More than 35 days since patient received his first vaccine/Can patient receive 2nd dose? after 54 days is now been 3 month since the first dose; More than 35 days since patient received his first vaccine,is now been 3 month since the first dose; 17 and a half year old received the first dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and a half year old received the first dose of the Moderna Covid-19 vaccine), PRODUCT DOSE OMISSION ISSUE (More than 35 days since patient received his first vaccine/Can patient receive 2nd dose? after 54 days is now been 3 month since the first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since patient received his first vaccine,is now been 3 month since the first dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and a half year old received the first dose of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days since patient received his first vaccine/Can patient receive 2nd dose? after 54 days is now been 3 month since the first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since patient received his first vaccine,is now been 3 month since the first dose). On 03-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and a half year old received the first dose of the Moderna Covid-19 vaccine) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days since patient received his first vaccine/Can patient receive 2nd dose? after 54 days is now been 3 month since the first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since patient received his first vaccine,is now been 3 month since the first dose) outcome was unknown.        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.    Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Significant Follow up appended On 14-Jul-2021: Non significant follow up
As per Emergency Room Report dated 03/09/06: Baby was found unresponsive in her crib by her mother @ 3:15pm. Vomitous around her mouth, last seen alive @ 2:30pm when dad turned patient on back. ALS was done at scene, patient was in asystole and transported to emergency room.
RIGHT UPPER ARM RED, SWOLLEN HOT TO THE TOUCH (2X2 1/2").  LEFT OUTER ARM RED (3/4X 3/4") AREA.
Irregular period -I had my second shot 4/29 and had a normal period 5/7 but started spotting 5/29 for two weeks. I was supposed to have the next one 6/6 but it was a week late.
Patient has not gotten second vaccine by day 35 from date of first dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not gotten second vaccine by day 35 from date of first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not gotten second vaccine by day 35 from date of first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not gotten second vaccine by day 35 from date of first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot #: Unknown) with no associated AEs.
pt recv vax 31UAG98 & fever to 103 every other day until 13SEP;decreased activity-decreased eating;lt thigh was swollen @ inj site;no redness +pain, +limping;better now;unusual gait seem to be r/t leg length discrepancy or tibial torsion;
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 01-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles (herpes zoster). On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingle was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
After the fist shot-extreme fatigue kicked. I hurt to move. No food or water, I had nausea. Could not move much  for 3 days 7/15/2021 at 5PM
P:  Vaccine reaction HPI- patient received her vaccine at 930.  At 9:50 she c/o feeling hot and itchy.  No dyspnea, no angioedema sx, no nausea O 950:  bp 126/80, p 79, o2 sat 98% No distress,  Alert/oriented, slightly anxious appearing Wearing heavy sweatshirt over 2 additional layers, typically wears this sweatshirt for warmth when outside.   HEENT:  Face is flushed/red, no urticaria/hives.  No diaphoresis Mouth:  Lips pink, no edema, Pharynx: no redness,  Left tonsil 4+ and right tonsil 2+ this is pts baseline and she is scheduled for tonsillectomy in 2 weeks.  No angioedema Lungs: clear,  No wheezing, no stridor anterior and posterior lung fields CV: rrr Skin:  Left arm, some mild redness to area surrounding injection site. patient was observed scratching/rubbing the area a few times during her observation Patient encouraged to remove her heavy outer sweatshirt, given water Given 25 mg of benadryl- patient refused to take 50mg dose.  After sitting with observation for another 20 minutes, she was no longer flushed, or feeling warm.  Stated she was much better.  A:  Localized reaction to Covid vaccine-  Warm feeling most likely related to being overheated vs stress reaction to vaccine vs mild hypersensitivity response P:  Discussed red flag sx to seek treatment for- dyspnea, sensation of obstructed breathing, facial swelling, itchy throat, nausea- will discuss second dose after observation for ongoing sx.
Information has been received from a physician concerning a 7 year old pt who on 05/14/1998 was vaccinated with a dose of varicella virus vaccine live. On 11/03/2004 the pt experienced a chicken pox breakthrough case., with less than 40 lesions. The pt was given supportive care and has recovered. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Patient stopped into store on 9-4-15 and informed me that 12 hours after receiving HIGH DOSE flu shot she developed an upset stomach, aching bones, & diarrhea. She is fine now.
I had a severe sore throat.  Following that, I had a low grade fever, listlessness, a welt on my arm where I had the injection.  It is now 2 days later, and I'm still not back to normal, feeling weak, tired, though better.  The sore throat is gone.
The medical assistant gave a pediatric patient a hepatitis A vaccine instead of of the HPV 0.5 ml vaccine that the provider ordered. The medical assistant will triple check the order to make sure he is giving the correct vaccine and comparing the vaccine bottle in hand with the order to assure he have the correct vaccine that was order.
This spontaneous report was received from a medical assistant refers to a patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient's were vaccinated with improperly stored ROTATEQ lot # K023535 (expiry date: 22-MAY-2016) at an unknown dosage. The temperature of the vaccine was 33.8 F and time frame was 96 hours. There was no data logger. No adverse reactions were reported. No further information was provided. This is one of the two reports received from the same reporter. Additional information has been requested.
Knuckles in my left hand became swollen like someone who has had rheumatoid arthritis for years. My knuckles have never swollen before. It?s been 2 weeks and they are still swollen with large knots on the first joint near the tip of my pointer, middle and pinky fingers.  My right hand is not affected at all.
Warm, red, tender area measuring 11x11 cm. Left deltoid area whose DTaP was given on 8/31/04.
Information has been received from a 71 year old female consumer with no pertinent medical history or allergies who on 26-FEB-2008 was vaccinated with a 0.65mL dose of zoster vaccine live (Oka/Merck). There was no concomitant medication. On 27-FEB-2008, the patient experienced redness, swelling, and warmth in a two inch circle around the injection site. No medical attention was sought. No lab studies were performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information is not expected.
Patient 90 days overdue for 2nd dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient 90 days overdue for 2nd dose of the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient 90 days overdue for 2nd dose of the Moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient 90 days overdue for 2nd dose of the Moderna vaccine) outcome was unknown. Not Provided      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.   Concomitant medication information was not reported. Treatment information as not reported.
Shortness of breath within 5 minutes and pale. Oxygen at 2l/min given. On room air at 1426. Patient is feeling well .
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On 04-Mar-2021, DIARRHOEA (Diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Patient presented to pharmacy today (11/22) to inquire about next Shingrix vaccine. Patient stated they developed a truncal rash a few days after receiving immunizations accompanied by burning pain. The rash lasted a couple of days per patients. Patient did not receive any treatment.
Case number PHEH2014US003968, is an initial spontaneous report from a pharmacist received on 24 FEB 2014 and a follow up report from the pharmacist received on 01 APR 2014. This report refers to a 16-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with one dose of FLUCELVAX 2013/2014 (batch number: 004011A and expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly in the left deltoid on 08 JAN 2014 at 8:30 PM.  No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Follow up report from the pharmacist received on 01 APR 2014. FLUCELVAX vaccination site, time and patient initials were updated.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 01 APR 2014. The BPI labeling of the event"inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. The healthcare worker stated that on 09-JUN-2011 the patient was vaccinated with GARDASIL, intramuscular injection, dose 1, (strength, dose, anatomical location, lot number and expiration date were not reported). On 05-JAN-2012 the patient was vaccinated with GARDASIL, intramuscular injection, dose 2, (strength, dose, anatomical location, lot number and expiration date were not reported) and on 26-NOV-2014 the patient was vaccinated with GARDASIL, intramuscular injection, dose 3, (strength, dose, anatomical location, lot number and expiration date were not reported). No adverse effects were reported. No further information was provided. Additional information is not expected, because the reporter not consent additional follow up.
pt vax hepta B. pt ex low grade fever, malaise, backache, fatigue, and abdo cramping which persisted for 3-4 days. aft recv 2nd vax, pt devel fever <103degF, severe abdo spasms, & backache. pt hosp.
Patient had episodes of jumping even when not startled. Looked like a motor reflex, EEG - N seen by neurology.
Initial information received on 13-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp from Other manufacturer Novartis under the reference number-PHEH2018US015045. This case involves a 57 years old female patient who experienced allergy to tetanus toxoid, while she received vaccine TETANUS TOXOID. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route. The patient developed a non-serious allergy to tetanus toxoid (allergy to vaccine) following the administration of TETANUS TOXOID. (Other relevant tests included No lab test.) Final diagnosis was allergy to tetanus toxoid. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergy to tetanus toxoid.
This case was reported by a nurse via sales rep and described the occurrence of passed out in a 16-year-old male patient who received BEXSERO. Concomitant products included MENACTRA. On an unknown date, the patient received BEXSERO. On an unknown date, immediately after receiving BEXSERO, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to BEXSERO. Additional details were provided as follows: The patient passed out almost immediately after receiving the BEXSERO. No hospitalization or intervention was required. The patient also received MENACTRA.
Feritine was found to be more than 40000 mcg/l/Extreme hyperferritinemia; Hypertriglyceridemia to 2285 mg/dl; Hepatocellular injury with deranged liver function tests; This is a literature case initially retrieved on 07-Oct-2019, concerning a 65-year-old, male patient.   A 65-year-old man presented to clinic with daily nausea, vomiting and diarrhea in the setting of 15 lbs weight loss, ferritin level more than 1000 mcg/L, cytopenias and mild liver function test (LFT) abnormalities. There was no lymphadenopathy on exam. Hemochromatosis DNA testing was negative. Magnetic Resonance Imaging of brain, Computed Tomography of chest, abdomen, pelvis, and upper and lower endoscopies were non-contributory. The patient had an unknown illness causing non-specific constitutional symptoms and derangement of acute phase reactants (APRs).  During this work-up, seasonal influenza trivalent adjuvant vaccine was given [influenza virus vaccine polyvalent; dose, batch number, route of administration, anatomical location and expiry date: not reported] for an unknown indication.  Less than 24 hours later, a routine ferritin was found to be more than 40,000 mcg/L, along with deranged LFTs and hypertriglyceridemia to 2285 mg/dL without cytopenia. Due to concern for rapidly escalating unknown illness, patient was admitted to hospital for monitoring and expedited work up. Tests including, but not limited to, blood culture, hepatitis panel, human immunodeficiency virus, acetaminophen level, stool culture, C. difficile polymerase chain reaction (PCR) as well as soluble CD25 returned negative. Liver biopsy showed hepatocellular injury but no hemophagocytosis. Bone marrow biopsy was also without hemophagocytosis and otherwise normocellular.   Hyperferritinemia and abnormal LFTs remained persistent for 3 to 4 days before spontaneous downtrend without antibiotics or immunosuppressive therapy (recovered).   The outcome for the event of 'hypertriglyceridaemia' was not provided.  The reporter's comment is as follows: Laboratory, imaging and pathology work up was non-contributory, and there was a close temporal relationship between vaccine administration and onset of hyperferritinemia', while the causality assessment for the other two events was not reported.; Sender's Comments: The patient experienced hyperferritinaemia, hypertriglyceridaemia and hepatocellular injury 24 h after vaccination with the suspect product seasonal influenza trivalent adjuvant vaccine. Chronology is suggestive. Medical history of unknown illness may have contributed to development of the events. No concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
chest pressure and difficulty breathing in chest, thought at first due to asthma progressed over 24 hours to stabbing constant chest pain below sternum, constant stabbing chest pain worse with walking or minimal exertion since 8-11-21, not relieved by asthma medications, ice, heat or various NSAID or tylenol, pain persist with no clear diagnosis
Vaccine given 1/13; symptoms began 1/21-burning and intermittent blurry eyes/double vision, drooping left eyelid, drooping left side of mouth, fatigue; went to ER on 1/22, blood work, EKG, MRI normal, ER MD didn't know the cause but if symptions persisted, go to internal medicine MD; symptoms improved but saw Dr. on 1/28. She referred me to a neurologist. By 1/31, most of my symptoms had cleared. On 2/4, neurologist exam showed weakness in facial muscles, diagnosed condition as viral Bell's Palsy. Following medical exams, I read CDC report which referenced Bell's Palsy in Unsolicited Adverse Events section. Am sending this report
Excruciating pain in my muscles; Excruciating pain on the front of my chest; Excruciating pain down my back near my scapula; Excruciating pain down my back near my scapula; Muscle twitching it's like someone has stabbed put a knife in my muscle and twisting; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on 19Feb2020 at single dose for immunisation. Medical history was none. Concomitant medication included bimatoprost (LUMIGAN). On an unspecified date, the patient experienced excruciating pain in his muscles, excruciating pain on the front of his chest, excruciating pain down his back near his scapula and muscle twitching that it was like someone had stabbed put a knife in his muscle and twisting. On an unspecified date, the patient underwent lab tests and procedures which included blood test and physical examination with unknown results. Therapeutic measure was taken as a result of excruciating pain in his muscles which included ibuprofen 800 mg every day. Clinical outcome of events was unknown.