chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was brought into outside hospital with weakness as well as coronavirus symptoms.  Patient had positive home coronavirus test which was confirmed as positive outside hospital.  Initial laboratory evaluation showed a blood glucose of 48. Due to this an IV was established and patient was started on D10.  Due to her hypoglycemia as well as disordered eating the decision was made to transfer the patient to the  hospital service for further evaluation management of care.  Medical Level of Care is being upgraded from Observation on 1/24/22 to Inpatient because she has a current diagnosis of dehydration, with poor ability to keep hydrated at home. Anorexia with hyperglycemia as well as coronavirus positive.
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves patient who experienced the allergic reaction and welt, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Nov-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported via unknown route in unknown administration site). On an unknown date, the patient developed a non-serious the arm suspected allergic reaction (hypersensitivity) and the patient had a 1 inch welp that grew to about 4 or 5 fingers and is currently about 6 inches on the arm (urticaria) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included No lab data.) Final diagnosis was welt and allergic reaction. It was not reported if the patient received a corrective treatment. On an unknown date, the patient outcome was reported as unknown for all the events. List of document held by sender: None.
pt recv vax 24OCT95 & w/in 12-24 hrs devel an inj site rxn characterized as red,raised,warm & 3 inches circumference;
This spontaneous report was received from a physician concerning a 68 years old female patient. The patient had no concurrent conditions. The patient's drug reactions included allergy to penicillin and cephalexin(KEFLEX). On 26-APR-2017, the patient was vaccinated with a dose of PNEUMOVAX23, lot # N003993, expiration date 20-OCT-2018, for prophylaxis (dose number, route and anatomical location of administration was unknown). There were no concomitant medications. On 28-APR-2017, the patient came to the physician's office with a complaint of "redness and swelling to the injection site and the entire arm". The patient received treatment with triamcinolone acetonide (KENALOG) injection, doxycycline 100 mg twice daily, and methylprednisolone (MEDROL) dose pack. Afterwards, the patient stopped taking methylprednisolone (MEDROL) dose pack on an unknown date because of unspecified "side effects". No laboratory diagnostics were performed. On 01-MAY-2017, the physician spoke with the patient, and she stated that the "redness and swelling resolved". At the time of reporting, the outcome of the unspecified "side effects" was unknown. The causality assessment between the events and PNEUMOVAX23 was not provided. Additional information has been requested.
Severe chills, low grade fever, headache, body aches, sore arm at injection site
Couldn't walk, tiredness, muscle pain, fever, vomiting, elevated heart rate.
Arm swollen & fever about 102, diarrhea. 5 days later symptoms subsided. Pt came in 1 1/2 weeks later to report symptoms.
pt recv vax 22JUL96 & on 1DEC97 pt exp mult lesions on arms, back, face & ankles;2DEC97 pt was seen by MD who dx chickenpox;
Began feeling itchy all over.  No rash or hives just itchy. It happened about an hour after my injection and lasted for maybe four hours.
SMALL KNOT IN ARM AT FIRST THEN SPEADED TO LARGER AREA OVER TIME. HAS REDNESS AND SWELLING OVER A 2.007 SQ METERS. DR PRESCRIBED KEFLEX AND BENADRYL.
Patient informed that she went to store with her sister 3-4 hrs after she recieved her first COVID vaccine. She said she felt lightheaded and nauseous and attempted to sit down.  She reported that she felt "off" and that it was like she was "under water and her ears were clogged" shortly before she had the episode. Her sister who was with her reported that she fell to the floor with her hands/arms postured toward her chest, and could be audibly heard "frothing from her mouth" as per sister's report s he still had her mask on. Sister informed that she stopped breathing during this time for an unknown period of time, and was sweating a lot with body "tightness." After the episode, Patient reported that she felt ok other than a very bad headache. 911 was called during the episode for transport to the hospital.
Information has been received from a physician via medical records concerning an 18 week female with secondhand tobacco smoke exposure and a history of feeding problem in newborn, diaper rash and oral candidiasis (WAES # 0806USA03719) who on 19-AUG-2008 and 23-OCT-2008 was vaccinated orally with the first and second doses, respectively, of ROTATEQ (Lot # 660425/0278X). On 19-AUG-2008, the child also received ACTHIB (Lot #C57536), PREVNAR (Lot #C57536) and PEDIARIXF (Lot #AC21B143AA). It was reported that on 19-AUG-2008, the patient's body temperature was 99 F. She was placed on therapy with acetaminophen 80 mg/0.8 ml (12-17 pounds) drops, 0.8 ml, orally, every 4 to 6 hours for one day (as needed for fever). On 23-OCT-2008, the child was taken to the office for routine health check, complaining of nasal congestion with maximum temperature of 99.5 F. Per her Great Aunt, she had had upper respiratory symptoms for several days with nasal congestion. It was reported that the child had otolaryngeal symptoms of pulling at the ears, nasal discharge, nasal passage blockage and excessive drooling. She strained to stool, but stools were soft and sometimes runny. Physical examination showed the patient temperature was 98.5 F, nasal discharge was clear and mucoid, nasal mucosa was normal. The patient was diagnosed with acute upper respiratory infection and was placed on therapy with Acetaminophen 80 mg/0.8 ml (12-17 pounds) drops, 0.8 ml, orally, every 4 to 6 hours for one day (as needed for fever). On 29-OCT-2008 the child was taken to the office again, complaining of drainage from both ears. The discharge from the ears had existed for 2 days. It was reported that the child had no fever (body temperature 98.8 F) and gastrointestinal symptoms. Physical examination showed abnormalities purulent discharge in canals B. There was no nasal discharge seen. The child was diagnosed with acute suppurative otitis media B and was placed on therapy with Amoxicillin, 400 mg/5 ml powder for reconstitution, 4 ml, orally, twice a day for 10 days and Floxin, otic 0.3 % solution, 5 gtt in each affected ear, twice a day for 10 days. The outcome of the patient was not reported. Additional information has been requested.
Leg turned a little red immediately after shots were given, area gradually enlarged.  By 1/15/09 (2 days after shots) the area covered her left thigh + has hot, swollen + painful to touch.  Seen by me & started on 10 day course of KEFLUX.
the patient is past due for dose two of Shingrix.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th July 2020, batch number- 5TH3L, expiry 19 November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). 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 reporter consented to follow up.
Patient, who was staff member, passed out about 10 minutes after vaccination. Was administered oxygen and given water. Blood pressure was a little elevated. Oxygen saturation was normal. Refused  to go to hospital. Was observed for 30 minutes then allowed to go home.
On 5/25/23 pt. seen in reported local reaction to vaccine. Pt seen in office on 5/25 by MD. MD reported at site of vaccine-- swelling, hard, red, tight, perhaps some SOB, no wheezing, no cough, no fevers, felt hives internally. MD recommended OTC antihistamine with icing for swelling, referred to allergy for evaluation. Allergy PA noted that local reaction was most likely due to the Prevnar 20 vaccine and that pt. can continue icing.
Pentacel was given without the Acthib portion, no AE; Initial information received on 21-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a nine months old male patient who received third 0.5 ml dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UG015AA and Exp. Date 26-Oct-2020 (Acthib Lot: UG015AA Exp. 26-Oct-2020 and Dtap Ipv Lot: U6218AA Exp. 26-Oct-2020) via intramuscular route in the right thigh, on 14-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE for Immunisation.  It was an actual medication error case due to inappropriate reconstitution technique.  It was reported that Pentacel was given without the Acthib portion. Dtap-Ivp was administered on august 14 2019 to patient,however the Acthib portion was never mixed or administered to the patient.  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 holder's 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.  List of documents held by sender: none.
Patient reported: difficulty breathing, headache, fatigue, lethargy, and left side chest/rib pain when breathing.
11 weeks and received her fluarix vaccine; This prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccine exposure during pregnancy in a 37-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number PD237, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season. On 29th September 2021, the patient started Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2021-2022 season at week 14 of the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was lost to follow up.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient self-reported this case. The NDC number was provided as 5816088752. The patient reported that the she was pregnant and received Fluarix vaccine yesterday, which led to exposure during pregnancy. The last menstruation period and due date was unknown. No additional information was provided. The reporter did not consent to follow up as FU NO - Permission Denied, hence the outcome of pregnancy was considered as lost to follow up.
3/16/21 Extreme tiredness, shortness of breath upon mild exertion, both symptoms continue to present 7/6/21 Diagnosed mild pulmonary hypertension, left ventricle hypertrophy, small pericardial effusion, trace aortic and mitral valve regurgitation
Awakened w/hives ons soles of feet, legs, arms, & face irritable, fatigue, & itchiness; also c/o local rxn @ inject site swelling; Also recvd DPH;
Itchy rash developed along facial hair line on day 1, and continued to expand over next two days resulting in rash across chest from shoulder to shoulder, and all along facial hair line, uppermost forehead, and back of neck at hairline.
Mass above left collarbone extending into neck larger than a golf ball. Red, tender and warm. painful to touch or move. Started Saturday morning.
29Jul2022-Started experiencing pain in right shoulder blade.  Had experienced some itching in that area also a few days before but had attributed that to a slight sunburn I got in middle of June.  Pain worsened over next several days and on 03July2022, I broke out in a small rash of blisters about the size of a 50 cent piece.  Sent picture to my son, who is a physician and was told it looked like shingles.  He referred me to ships doctor who diagnosed me with Shingles and gave me acyclovir 800mg to take qid until pack of 35 tablets was gone.  Upon returning home on 09July2022, I still was in pain and was seen by my primary physician on 11Jul2022.  I was given gabapentin 100mg to take until pain was better.  Pain is currently resolving, but I still have some episodes of significant pain.  I travelled again during week 15July2022 and 22Jul2022.  Several people on my tour appeared sick at the end of the trip so I tested myself and my husband, by PCR test and were negative.  However Sunday, 24Jul2022, I woke up feeling like I had a sinus infection.  I did a rapid test and was positive (very faint line) so I repeated to make sure.  My husband did not have symptoms then but felt worse as day went on so he tested positive that afternoon.  He also received 4th dose of Moderna on the same day I did at the same pharmacy and with same lot number.  We both tested negative by PCR on 29Jul2022 and 30Jul2022.  However he tested positive and I tested negative on a rapid test on30Jul2022.  We have just tested negative on rapid test on 03Aug2022 and neither of us have symptoms.
tested positive on rapid test for covid after bivalent booster; tested positive on rapid test for covid after bivalent booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive on rapid test for covid after bivalent booster". Events took place after use of product. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Small rash all body with no SOB or wheezing pulse OX 100% BENADRYL PO every six months.
transient lower extremity weakness; This case was reported by a consumer and described the occurrence of lower extremities weakness of in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. In April 2020, 2 weeks after receiving Shingrix, the patient experienced lower extremities weakness of. On an unknown date, the outcome of the lower extremities weakness of was resolved with sequelae.   It was unknown if the reporter considered the lower extremities weakness of to be related to Shingrix.  Additional details were provided as follows: The reporter was inquiring because an acquaintance experienced this symptom two weeks out from the second inject of Shingrix. The event occurred around April 2020. The weakness was transient. The reporter asked if there were any reports of transient lower extremity weakness with Shingrix. The reporter personally did not believe if there was a correlation but wanted to see if it had been reported during trials and follow up. The patient was concerned now only because of the possibility of taking the COVID vaccine. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021003169:same reporter
Immediatly after ROTATEQ was given pt. had red blotches appear on her trunk, chest, and lower ext.   No s/s resp distress, n/v, and pt. remained happy without behavior change.
My left deltoid region started to get really sore and tender. The next day, I had about an inch of swelling coming up off my deltoid region. The pain was limiting and I could not lift my arm over my head due to pain. It has been improving over the last three days and the swelling is gone.
Hives to back of bilateral knees, phoned nurse friend who told her to take Benadryl.  By Monday she had recovered.
4 cm diameter circular erythema at the injection site, axillary lymphadenopathy on the vaccine side, scapular and neck pain on the same side as vaccine injection.
Mother of patient called into clinic stating she took patient to ER for leg swelling. patient was treated for cellulitis around injection site.
expired dose was given to patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 47-year-old male patient who received HAV (Havrix) (batch number J99R4, expiry date 20th May 2022) for prophylaxis.   On 24th May 2022, the patient received Havrix. On 24th May 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: The health care professional reported expired dose was given to patient. The reporter consented to follow up. The Vaccine Administration Facility was the same as primary reporter. Additional Supportive Information: The patient received Havrix which was already expired which led to expired vaccine used.
Narrative:  Hospitalization, COVID positive and fully vaccinated upon admission, admitted for shortness of breath with a later COVID19 pneumonia diagnosis
Sclera pink both eyes started 30JUN91;Center aspect of each sclera bright pink x 3 days per MD, not related to vax;
Two months after my booster everything started to rise my BMP. My kidney function, my kidneys are not working like they were. I have had to be put on blood pressure medicine my BUN, creatine, and my injection fraction or EGFR have risen. I am currently in stage three kidney failure.
Mom stated pt became queasy and began vomiting continued intermittently throughout the night. On 5/18/00 complaint of aching of stomach and head. Unable to eat. 5/19/00 feeling 50-50 but improved.
It has come to my knowledge that the nurse vaccinated a child under 12 years old.  Patient presented a rash after vaccinated. No other known event.
9-5-07 Generalized maculopapular rash 24 hrs after Pediarix, HIB, Prevnar, Polio; temp (98.3 temporal). Will check 9-6-07.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06May2022 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR taken for depression. The patient received other medications and antidepressant within 2 weeks after vaccination. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jul2022) Rebound covid, notes: Rebound covid post paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 14Jul2022 to 19Jul2022 as treatment for Covid-19.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As per limited available information the causality of the event drug ineffective and covid -19 can not be ruled out.it will be reassessed once more information received.
After receiving HPV, patient felt lightheaded and was seeing white. Per DO, pt said she was seeing white and purple. Placed in Trendelenburg position and color improved. States she had some tingling in her arms after last HPV injection. Blood pressure taken (100/60 supine) was given some apple juice. BP rechecked and again 100/60 and feeling fine. Discharged home.
About 8 days after COVID booster shot patient reported  full body hives.   Patient also reports he  got redness that started on scalp and then migrated to another location. Rash usually lasts 24h then moves.  Patient tried Zyrtec and Benadryl 50mg qhs.  Prednisone 40mg prescribed on 10/15/2021 for 5 days.
administered expired Pentacel because the expiration date on the box was confusing, with no reported adverse event; Initial information was received on 07-Jul-2021 regarding an unsolicited valid non-serious case from other health professional in the (GMI Inquiry number: 00672437).  This case involves a four-month-old female patient who experienced administration of expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Suspension For Injection) because the expiration date on the box was confusing (expired product administered).  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation and ROTAVIRUS VACCINE for Immunisation.  On 02-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number: UJ350AAA, expiry date: 22-Jun-2021] via an intramuscular route at left thigh for prophylactic vaccination.  Description: The caller reported that two patients were administered expired Pentacel because the expiration date on the box was "confusing". The caller wanted to know what they need to do now, for those patients.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.; Sender's Comments:  SAD20210707001286: