chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Post vaccine no major issues.  Had three or four little  bite appearing itchy areas on trunk.  Applied Cortisone cream, with no relief.  On day four, more appeared and progressed rapidly to entire trunk, arms, face and legs.  and throat felt tight.  Urgent Care Center gave me two injections: Methylprednisolone Sodium Succinate, and Diphenhydramine.  Was observed for 40 minutes.  Whelps and rash had not resolved, so doctor had me begin taking Benadryl 50mg every 6 hours x 24 hours.  Rash began to resolve approximately 10 hours afte treatment initiation.  Continuing to resolve.
patient was given products that were exposed to highest temperature excursion at 49 fahrenheit and for 45 minutes/ No AE; Initial information received on 12-May-2021 regarding an unsolicited valid  non-serious case received from a other health care professional via Agency.  This case is linked to case 2021SA178936 (consumer case).  This case involves an unknown age female patient who was given INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] pre-filled syringe lot number: UJ562AA expiration date: 30-Jun-2021, lot number: UJ507AA expiration date: 30-Jun-2021, lot number: UJ471AA expiration date: 30-Jun-2021, lot number: UT7073KA expiration date: 30-Jun-2021, lot number: UT7115KA expiration date: 30-Jun-2021, INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE] lot number: UJ507AA expiration date: 30-Jun-2021, DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number: U676AA expiration date: 31-Jul-2022, lot number: U6900AA expiration date: 18-Nov-2022, lot number: U6927AA expiration date: 28-Jan-2023, MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number: U6827BB expiration date: 18-Feb-2022, lot number: U6827BA expiration date: 18-Feb-2022, IPV (VERO) [IPOL] MULTI DOSE VIAL lot number: T1D482N expiration date: 25-Jul-2022, DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot number: C5688AA expiration date: 26-Nov-2021  and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] lot number: UJ529A expiration date: 22-Jul-2022 for prophylactic vaccination and was tested with TUBERCULIN TEST [TUBERSOL] lot number: C5804AA expiration date: 03-Feb-2023 for tuberculin test via an unknown route and administration site that was exposed to highest temperature excursion at 49 Fahrenheit and for 45 minutes (Product storage error).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error due to incorrect product storage (latency: same day).  Description: Clinical coordinator called to report stability information of vaccines exposed to temperature excursion. On 09-Apr-2021, the highest temperature was at 49 Fahrenheit and the excursion lasted 45 minutes. On 23-Apr-2021, the highest temperature was at 48.7 Fahrenheit and the excursion lasted 30 minutes. Reason for excursion is that the fridge was not closed correctly, it did not shut all the way. Product used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recvd vax & 3 months & 1 day p/vax exp arthralgia;
2 DAYS AFTER VACCINE - FLU-LIKE S/S THAT RESOLVED SPONATNEOUSLY. IN THE FOLLOWING 2 WEEKS SHE DEVELOPED INTERMITTENT PETECHIAE AND LARGE, PAINLESS ATRAUMATIC BRUISES THROUGHOUT HER BODY. PT ALSO C/O FATIGUE, FEELING COLD AND MILD SOB, BUT SHE ATTRIBUTED THIS TO NORMAL CIRCUMSTANCES. DENIES TRAUMA, HA, DIZZINESS, CHEST PAIN, BLURRY VISION, OR BLEEDING AND HAS NO HX OF EASY BRUISING OR CLOTTING DISORDERS IN HER PMH OR FMH.
RECEIVED LESS THAN 0.5 ML  OF VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (suspension for injection, route of administration, and batch number were not reported) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination (dose number in series 1). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: 11-APR-2022) dose was not reported, 1 total administered on left arm on 01-DEC-2021 for prophylactic vaccination (dose number in series 2).  No concomitant medications were reported.  On 01-DEC-2021, the patient experienced received less than 0.5 ml of the vaccine as a booster dose (vaccine underdose) and off label use (dose number in series 2). As per the report, "the health care professional (HCP) withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5 ml but the caller mentioned that the math (she arrived at that by dividing 2.5 ml by 5 doses) did prove that they received approximately around 0.3 ml". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5 ml of vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210588, 20211210610, 20211209775, 20211210159, 20211210409, 20211210733, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211210662, 20211209679, 20211209740, 20211210670, 20211210824, 20211210350, 20211209912, 20211210141, 20211210585, 20211210107, 20211209921, 20211210180 and 20211210385.
Patient was inadvertently given 1 year shots at 9 month check up. She developed a low grade temp, fussy and tired, not eating as much as usual. She had no local reaction from where vaccines were given. Provider discussed at length with mother of patient that these vaccines were given early and that this should not cause any long term problems.
Eyes reddish, skin had whelps, & fine bumps on trunk, the whelps on neck area & pt was scratching neck; BP 100/60 lt arm; temp 98 by mouth; DPH given;
On 06/10/2000, the patient developed breakthrough chickenpox that consisted of approximately 30 lesions and a low grade fever. The patient sought unspecified medical attention. A nurse indicated that she had been noticing a lot of chickenpox in the area, although exposure of the patient to varicella was unknown. No further information is available.
This spontaneous report as received from a consumer refers to a female patient of unknown age. In 2003, the patient was vaccinated with VARIVAX for prophylaxis. In 2003 the patient experienced herpes zoster. The outcome of herpes zoster was reported as recovered/resolved. Additional information is not expected.
Vaccine administered 12/24/03. 12/25/03, patient developed skin rash and swelling. ER gave IM Benadryl. Patient returned to this provided 12/26/03 with low grade temp at 100.4 and cellulitis. Patient required IV antibiotics on 21 occasions and oral antibiotics currently. No overnight hospitalization.
fever; This is a spontaneous report from a Pfizer-sponsored program a contactable consumer reported for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. On an unspecified date, after the vaccination the patient experienced fever. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Brief febrile convulsion within 12 hours of receiving Dtap, Hib, Prevnar, and Flu vaccine. 1/29/07  Received medical records from provider which included ER record.  Seen in ER on 1/10/07 for mouth twitching, eye twitching & rolling back lasting for approx 1 min & followed by a period of quietness.  Had cold/cough for few days prior to receiving vax & was running a fever of unknown value.  Temp in ER was 101.  Tx w/antipyretic & d/c to f/u by PCP next day.  At PCP office, 1/11 & no further fever or seizure activity noted. LABS: WBC 16.7. FINAL DX: Febrile seizure.
Pt appears to have acquired shingles after the vaccine over the right leg L4/5 dermatomes. Mild pain, no pruritis, lesions are vesicular.
Headache (lasted one week; not normal for patient to have headaches); fever (100.5 degrees starting 24 hours after, lowered to 99.5 degrees by 48 hours after, and remained at 99.3-ish (average) for a week); fatigue; arm soreness; This is a spontaneous report received from a contactable consumer, the patient. A 33-years-old non-pregnant female patient received  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 06Mar2021 at 15:30 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history was not provided. Concomitant medications included etonogestrel/ethinyl estradiol  (NUVARING), cetirizine (MANUFACTURER UNKNOWN), calcium citrate(CITRACAL), multivitamin (MANUFACTURER UNKNOWN), fiber (MANUFACTURER UNKNOWN) all from unknown dates for unknown indication. Allergies to medications, food, or other products was reported with antibiotic ointment, seasonal allergies. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Mar2021 the patient experienced headache, fever (100.5 degrees starting 24 hours after, lowered to 99.5 degrees by 48 hours after, and remained at 99.3-ish (average) for a week), fatigue and arm soreness. The patient did not receive any treatment for events. The clinical outcome of headache, fever, fatigue and arm soreness was recovered.   No follow-up attempts are needed; information about lot/batch number is requested.
Nurse reconstituted Pediatric Pfizer with 1.8 ml diluent then administered to a 17 year old leading to a very low  dose.
Extreme muscle pain down to the wrist with eventual non mobility of my arm. Symptoms still exist over a week later but have improved about 95%. I have not sought treatment due to improvement.
Patient said  she developed humming sound in her ears after getting the shot. She said the sound got better after few days but it still happens some days
back pain,says a spot in back hurts when she is on her feet all day; collarbone pain she is eperiencing; could not raise left arm, felt like "it was pummeled with sledge hammer"; low grade fever last night 99 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain,says a spot in back hurts when she is on her feet all day), BONE PAIN (collarbone pain she is eperiencing), PAIN IN EXTREMITY (could not raise left arm, felt like "it was pummeled with sledge hammer") and PYREXIA (low grade fever last night 99 degrees F) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C211A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Broken collarbone (when she was 14 years old) and COVID-19 on 23-Jun-2021. Concomitant products included FAMOTIDINE and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back pain,says a spot in back hurts when she is on her feet all day), BONE PAIN (collarbone pain she is eperiencing), PAIN IN EXTREMITY (could not raise left arm, felt like "it was pummeled with sledge hammer") and PYREXIA (low grade fever last night 99 degrees F). The patient was treated with PARACETAMOL (TYLENOL) for Back pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (back pain,says a spot in back hurts when she is on her feet all day), BONE PAIN (collarbone pain she is eperiencing), PAIN IN EXTREMITY (could not raise left arm, felt like "it was pummeled with sledge hammer") and PYREXIA (low grade fever last night 99 degrees F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 degrees f (High) 99 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Case number PHEH2014US024304 is an initial spontaneous report from a nurse received on 02DEC2014 and with a follow-up from a nurse received on 21JAN2015. This report refers to a 45 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) into left deltoid intramuscularly at a dose of 0.5 ml on 05NOV2014. The nurse reported that FLUVIRIN 2014/2015 was stored at 49F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up from a nurse received on 21JAN2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 6 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had medical history of atopy: anaphylaxis, allergic rhinitis, reactive airway disease and 'other (TIV)'. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, between 60 to less than 90 minutes after 5 test doses vaccine, the patient experienced anaphylaxis. The symptoms included erythema (throat), generalized pruritus and rash and cough. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with epinephrine and oral antihistamine. The outcome was reported as recovered. Reporter's comments: The attributed trigger was vaccine.
chorioamnionitis/amniotic cavity infection; vaccine exposure during pregnancy; Initial unsolicited literature report received from a healthcare professional on 18 June 2015.   This case is linked to: 2015SA090249, 2015SA090258, 2015SA090259, 2015SA090257, 2015SA090261, 2015SA090262. (Same literature, reporter and event)   This case involves 2 female patients who experienced chorioamnionitis/amniotic cavity infection (amniotic cavity infection), after they received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and INFLUENZA VACCINE. while they were pregnant.  Data regarding this pregnancy were received prospectively.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  It was no reported if patients had previous pregnancy.  On an unknown date, the patients each received a dose DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer) and INFLUENZA VACCINE (produced by unknown manufacturer) (batch number, frequency, dosing details and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patients developed a serious amniotic cavity infection/chorioamnionitis (amniotic cavity infection), (unknown latency) following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and INFLUENZA VACCINE. This event was assessed as medically significant.  Pregnancy exposure timing was unknown.  It was also a case of vaccine exposure during pregnancy (latency same day).  Laboratory investigations and corrective treatments were not reported.   The outcome of the pregnancy is unknown.  At time of reporting, the patients were recovering from the event amniotic cavity infection.  Follow up information received on 19-Apr-2021 regarding an unsolicited valid serious case received from the other health care professional.  The outcome for event amniotic cavity infection was updated from unknown to recovering.  Report type was updated to Unsolicited non-literature  Seriousness for event exposure during pregnancy updated (serious to non serious) and listedness updated.; Sender's Comments: This case concerns a 2 female patients who experienced amniotic cavity infection and exposure during pregnancy, after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (unknown manufacturer) and INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. The patient's medical history, concomitant medication, medical condition at time of vaccination and other lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of an individual vaccine cannot be assessed. US-SA-2015SA090249:CLUSTER US-SA-2015SA090257:CLUSTER US-SA-2015SA090258:CLUSTER US-SA-2015SA090259:CLUSTER US-SA-2015SA090261:CLUSTER US-SA-2015SA090262:CLUSTER
Patient received MENACTRA and VARIVAX on 8/12/09, at 12 year check-up. Had no problems after getting shots in office. Seen at ER 8/26/09 for seizure, lasted 30 seconds. Patient was at school, had rapid eye movement? unresponsive episode.
Patient woke with itching and burning on arm shot was given in, rash noted from elbow up. Patient went to Urgent Care with diagnosis of shingles and given a prescription for an anti-viral medication. Painful at sight of rash.
Fatigue headache muscle pain nausea and lymph nodes under my right arm and I'm still sore and have headache I can't really hold up my right hand.
Immediately and shortly after injection pt. had pain in her left arm. She had trouble moving her arm and had been to the ER three times and received treatment with cold and warm packs, ibuprofen, antibiotics and Benadryl.
Severe arm pain and full paralysis from  left shoulder to fingers in left arm from about 9:00pm Friday 05/07/21 to about 7:30am Saturday when pain reduced about 15% and paralysis reduced about 20%. Paralysis and pain were about 80% gone and 100% gone by around 5:00pm Saturday 05/08/21. New symptoms showed all at once around 4:50pm Sunday 05/09/21. Symptoms came on without warning: Sever arthritis in right foot, fibromylagia pain in upper and mid back, acid reflux attack mild. Severe arthritis continues currently making it too painful to walk. Fibro pain still modrate in upper back and shoulders. I had no symptoms of anything for 4 months prior up to two days after the vaccine!
Patient experienced redness/swelling that spread down arm where vaccine was administered. Patient received a prescription for Naproxen on 11/11/2015.
I HAD A TOTAL KNEE REPLACMENT ON JAN 5TH. I WAS HOSPITALIZED AND GOT OUT THE NEXT DAY. SINCE THEN I'VE BEEN PASSING CLOTS OF BLOOD FROM MY NOSE AND STREAMS OF BLOOD COMING DOWN MY NOSE. IT'S REDUCED AND VERY LIGHT NOW BUT STILL HAPPENING, FOR ABOUT 3 WEEKS I WAS PASSING CLOTS OF BLOOD FROM BOTH NOSTRILS. DOCTORS COULDN'T FIGURE IT OUT BECAUSE THEY NEVER PLACED ANYTHING IN MY NOSE. I'M TAKING 1 BABY ASPRIN TWICE A DAY FOR BLOOD THINNER. THEY SAID IT'S SO RARE AND ODD THAT THE ASPRIN WOULD CAUSE THIS. DOCTORS DON'T KNOW WHAT COULD HAVE CAUSED THIS.
Around 6 minutes post-vaccination, at 11:35, patient stated feeling a warm sensation radiating down both legs. After 10 minutes, around 11:45 the sensation had completely gone away. Patient reported no pain, dizziness, or nausea. Patient monitored for an additional 15 minutes, with no additional symptoms.
the 2nd day after felt cold like symptoms. Did have chills for 2 days, myalgias. no fevers .the for 5 days has had constant decreased sensation in bilateral toes and slightly progressing ascending paresthesia- tingling. NO weakness, NO areflexia.
hearing loss; neuropathy; shingles; Information has been received from a lawyer, concerning a case in litigation and refers to patient of an unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. In or around March 2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered hearing loss, neuropathy and shingles. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the Company's product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality was related.   The reporter considered the events of hearing loss, neuropathy and shingles were considered to be disabling. Upon internal review, the events of hearing loss and neuropathy were determined to be medically significant.
Information has been received from a physician, concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and frequency were not reported) (Lot # and expiration date were not reported). Physician reported that on the same day the patient was also vaccinated with a dose of PREVNAR. There were no adverse effects. Additional information has been requested.
Two days following the vaccine, the pt developed a blotchy rash on his face, lips, and body. He sought unspecified medical attention and the rash faded without treatment. Two days after receiving the second dose of Hep B vaccine, the pt developed the same rash. No further information is available.