chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 33-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA433A, expiry date 31st October 2021) for prophylaxis.   On 15th December 2021, the patient received Menveo. On 15th December 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported  The reporter stated that the patient received an expired dose of MENVEO, which led to expired vaccine used. The reporter consented to follow up. This is one of 6 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021261528:Same reporter US-GLAXOSMITHKLINE-US2021261523:Same reporter US-GLAXOSMITHKLINE-US2021261527:Same reporter US-GLAXOSMITHKLINE-US2021261529:Same reporter US-GLAXOSMITHKLINE-US2021261531:Same reporter
a patient received an extra dose of PROQUAD on 08/14/2020. Child's previous shot record was received at the office on 10/20/2020 where it was discovered the child had received MMR II and VA.RIV AX on 07/23/2018; This spontaneous report was received from a nurse regarding a 6 years old female patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not provided.  On 23-JUL-2018, doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route, lot # and expiration date# and anatomical location were not reported) were administered to the patient. On 17-AUG-2020, an extra dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) 0.5 ml (strength, lot # and expiration date# and anatomical location were not reported) subcutaneously for immunization was administered to the patient (extra dose administered). The outcome of the event was not provided.
Nausea, vomiting, diarrhea lasting 5 days, started 2 days after vaccination.  Elevated liver enzymes - persistent through hospitalization & will be rechecked in follow-up.  Mod-severe dehydration-hosp. 5/29/08->5/31/08.  6/10/08 Reviewed hospital medical records of 5/29-5/31/2008. FINAL DX: Elevated liver enzymes, N/V/D, dehydration, ataxia, bilateral OM. Records reveal patient experienced irritability, N/V/D, lethargy, pale, reduced oral intake, dehydration, decreased UO, balance difficulty x 3 days. Received IVF in ER & improved.  Admitted for observation & liver w/u. Clinically improved during hospitalization but liver enzymes remained elevated at D/C to home w/pcp & lab f/u.
dizziness. Had syncope episode, was snoring and twitching. Very diaphoretic. Less than 1 minute regained consciousness. Patient was assisted to floor on his side. Patient able to answer questions.
This case was reported by a other health professional via call center representative and described the occurrence of pain in chest in a 16-year-old male patient who received HAVRIX (batch number A7HC5, expiry date 13th August 2016). Previously administered products included GARDASIL with an associated reaction of influenza like illness (and a bad virus afterwards) and HAVRIX (1st dose, lot number N434L, expiry date 19 February 2016). Concurrent medical conditions included asthma, attention deficit disorder, diabetes and overweight. Concomitant products included NOVOLOG, ADDERALL, albuterol and LEVEMIR. On 21st August 2014, the patient received the 2nd dose of HAVRIX .5 ml. On 21st August 2014, an unknown time after receiving HAVRIX, the patient experienced drug dose administration interval too short. On 1st September 2014, the patient experienced pain in chest (serious criteria hospitalization and life threatening), heart issue (serious criteria hospitalization) and felt sick. On 5th September 2014, the patient experienced pericarditis (serious criteria hospitalization and GSK medically significant). The patient was treated with steroids nos. On an unknown date, the outcome of the pain in chest, pericarditis and felt sick were recovered/resolved and the outcome of the heart issue and drug dose administration interval too short were unknown. It was not reported if the reporter considered the pain in chest, pericarditis, heart issue and felt sick to be related to HAVRIX. Additional details were provided: The patient received medical attention at Inpatient hospital. The patient had a family medical history of heart problems and the patient's brother has diabetes too.
Batch/lot# FK9894 administered after the beyond-use-date of 7/3/2022. Vaccine picked up on 4/25/2022 and to be used by 7/3/2022. Vaccine administered on 7/14/2022. Awaiting feedback from Pfizer regarding vaccine viability.
This case was reported by a physician via sales rep and described the occurrence of shingles in a 55-year-old male patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). On 26th March 2018, the patient received SHINGRIX. On 28th March 2018, 2 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with VALTREX and gabapentin. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reported considered the shingles to be related to SHINGRIX. Additional details were provided as follows: This case was reported by physician and nurse (medical science liaison). The patient was not immunocompromised or had any other medications indicating he was being treated for an immunosuppressive medical condition. The age at vaccination was not reported but could be 54 or 55 years. Forty eight hours after vaccination, the patient developed shingles. Limited information was provided by the physician. The nurse was following up on case for additional details.
After given 3rd Gardasil shot, my daughter broke out in hives. Hives began on her arm then spread to rest of her body.  Called the doctor first but was informed by the nurse that I should take her to a new doctor.  Called another doctor, but the treatment that was given was not strong enough to combat what was happening to my daughter.  Took her to the emergency room the following day.  Recieved IV meds to combat allergic reaction.  2 days later had to return to the emergency room and another series of IV meds 125 mg were given. Sent home with more prescriptions. Doctor at the emergency stated that she had an allergic reaction to the Gardasil shot and and she still is having problems.
This spontaneous report was received from a other healthcare professional refers to a 16 week old patient of unknown gender. On 18-DEC-2014 the patient was vaccinated with ROTATEQ dose 1, oral (strength, dose and lot # was not reported). No adverse effects reported. Additional information has been requested.
patient was not aware she is pregnant.  Urine pregnancy test performed twice. Test resulted positive both times.  RN did not confirm pregnancy test results were positive. RN inadvertently administered IM injection of HPV 9 valent vaccine.
Post vax, the patient developed a hard area at the injection site and "some penny size" bumps. The bumps were not chicken pox. The patient sought unspecified medical attention. Additional information has been requested.
Mother reports that within 48 hours of receiving vaccines, patient developed eye twitching, described by mother as "hard blinking."  She took patient to an opthamologist, who could not find any disease process to explain the problem.  Mother reports opthamologist felt it was a "nerve problem."
Immediately after vaccination, patient said she was going to pass out and felt light headed. She vomited a little. 911 was called and the EMT stated the patient might have had some vaso-vagal response. Sometimes it makes the patient feel wonky per the Paramedic. Their vitals were within normal range.  The patient declined going to the hospital.
First vaccine - sore arm - for two and 1/2 days. I thought I had an ear infection because I get them frequently. But my  husband and daughter had tested positive for COVID. It felt like an ocean in my ears fluid. Amoxicillin that helped with symptoms. In the last 6-7 months, whenever I take antibiotics I now have to take Fluconazole. I quarantined in my room for 10 days. I was mostly okay but there was two days when I was just exhausted. I didn't have a lot of the major symptoms that others get.
very bad pain in his arm; This spontaneous case was reported by a consumer and describes the occurrence of   in a male 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.     On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.
Extream fatigue and chills unable to continue work. I am on day 3  now at home coming in and out of sleep and freezing cold. Hoping it won't last much longer.
pain over the right medial and lateral elbow.  Diagnosis medial greater than lateral epicondylitis, probable related to work-related activities though.
Lower oxygen level; Appetite lost; Arm hurts; Nauseous; Horrible headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OXYGEN SATURATION DECREASED (Lower oxygen level), DECREASED APPETITE (Appetite lost), MYALGIA (Arm hurts), NAUSEA (Nauseous) and HEADACHE (Horrible headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04IL20A and 04IL20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis, Hypersensitivity, Urticaria, Asthma, Hay fever, Asthma in 2000 and Arthritis in 2000. Concurrent medical conditions included Fatigue extreme since March 2020, Throat tightness, Hearing impaired, Numb lips, Palpitation, Chest tightness, Hemiparesis and Stomach cramps. Concomitant products included CLINDAMYCIN from 2020 to an unknown date for Chest tightness, QVAR from 2012 to an unknown date for Chest tightness and Palpitations, XIIDRA 590 for Dry eye, MAGNESIUM and VITAMIN B2 for Hearing impaired, IBUPROFEN from 1990 to an unknown date for Stomach cramps and Hemiparesis, SYNTHROID, Lansporazole, LISINOPRIL, BREO, FISH OIL, CENTRUM SILVER, BUPROPION, VITAMIN D2 and AZITHROMYCIN (AZASITE) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OXYGEN SATURATION DECREASED (Lower oxygen level), DECREASED APPETITE (Appetite lost), MYALGIA (Arm hurts), NAUSEA (Nauseous), HEADACHE (Horrible headache) and FATIGUE (Fatigue). At the time of the report, OXYGEN SATURATION DECREASED (Lower oxygen level), DECREASED APPETITE (Appetite lost), MYALGIA (Arm hurts), NAUSEA (Nauseous), HEADACHE (Horrible headache) and FATIGUE (Fatigue) outcome was unknown.            No treatment medication information was provided. No concomitant medication information was provided.   This case was linked to MOD-2021-054570 (Patient Link).
Patient reported nausea, BP: 159/115. On Amlodipine, last dose 20:00 12/28. Nausea resolved after 30 minutes of monitoring, no medications given.
Vaccine given at 3:15pm. Pt in observation area, had sudden onset stridor/wheezing and difficulty breathing at 3:28pm.  Pt placed in a wheelchair and taken immediately into hospital ED department, arrived in ED at 3:29pm.  Pt in sinus tach with O2 SAT 83% on RA, placed on O2 without change, intubated successfully x1 at 1550 and placed on 100% FiO2. Orogastric tube and foley catheter placed.  Medications given: Decadron 10mg IV, Benadryl 50mg IV, Pepcid 20mg IV, Epinephrine (0.1%) 0.3ml SQ, Epinephrine IV infusion initiated at 0.05mcg/kg/min, Rocuronium 90mgIV, Etomidate 30mg IV, Racepinephrine (2.25%) 1.5ml inhalation x2, Propofol 5mcg/kg/min IV infusion, NS 0.9% x 1 liter IV, Potassium Chloride 20mEq, Versed 2mg IV.  Pt had own Epipen which was noted by ED MD as being used in ED. Pt admitted to CCU, extubated within 2-3 hours per pt request (per CCU RN) and placed on BiPAP.  BiPAP weaned overnight and patient on room air by morning with SATs in the upper 90's.  Weaning of Epinephrine infusion in progress.  Projected outcome: pt to be discharged tomorrow (1/23/21) from CCU to home (per CCU RN).
HEADACHE AND DIZZINESS IMMEDIATELY AFTER SEVERE RASH ON ARM AS OF 4 DAYS AGO
2cm x 4cm fine mass underneath the skin w/1 x 1 cm redness; no tenderness;
29JAN97 c/o nasal congestion, 30JAN97 99.9 actifed/robitussin x 1wk; Flumadine 3FEB97 x 2wk;flumadine reordered 18FEB97 x 7 days;
Pt arrived to observation complaining of "a little short of breath" and "a little dizzy". VS within normal limits. EMS contacted and pt. cleared by EMS.
Patient reported increased fatigue a few hours after receiving first dose.  Fatigue worsened over the next couple of days and had a couple episodes of vomiting.  Consulted with PCP and advised to monitor over next couple of days.  Symptoms resolved by 1/8.
24 hrs after vaccine,  oxygen level went down in the 80 and passed out.  Recouperated and was fine aftewards. Weakness lasted approx 30 mins. No medical attention needed.
Patient had pain/swelling 3-4 hours after immunization, then went to ED of local hospital at about 9 PM. Patient was treated for an allergic reaction and released at 12:16 AM. Patient was treated with steroid in the hospital followed by oral steroids at home. Patient symptoms have improved with treatment. Will continue to monitor patient.
testing positive for Covid after getting the first Covid shot; testing positive for Covid after getting the first Covid shot; This is a spontaneous report from a non-contactable consumer via a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter wanted to know if his child should get the vaccine after testing positive for Covid after getting the first Covid shot on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a nurse practitioner and refers to a 32 year old female patient. It was reported that the patient had drug reactions/ allergies to LEVAQUIN (experienced tongue swelling after it) and Sulfa (described as hives and itching). The patient's historical condition included delivery (date not reported). No information regarding the patient's concomitant medications was provided. On 09-NOV-2015, the patient was vaccinated with a dose of M-M-R II (lot # reported as K016444 is non-valid, expiration date 10-JUL-2017), 0.5 ml, subcutaneously, therapy reason for use was reported as low titers for rubella postpartum. On the same day, the patient developed tingling in her mouth and tongue swelling after she received the vaccine. When the nurse practitioner learned that the patient was experiencing an allergic reaction that could progress to a life-threatening condition, the patient was immediately administered with BENADRYL. No lab diagnostic studies were performed. No PQC (product quality complaint) was involved. The outcome of the event was reported as recovered on 09-NOV-2015, while the patient was still in the reporter's practice. The patient was then allowed to go home on the same day. The relatedness between the event and M-M-R II was not reported. Upon internal review, the allergic reaction was considered to be medically significant as it required an intervention to prevent worsening to life threatening condition. Additional information has been requested.
This spontaneous report as received from Registered Nurse refers to unspecified number of patients of unknown demography. On an unknown date the patients were vaccinated with improperly stored PEDVAXHIB lot # M006709 (expiry: 12-JUN-2018). No adverse effects were reported. No product quality complaint (PQC) involved. This case is linked to cases 1608USA012662 and 1608USA012663 (same reporter link). Additional information has been requested.
PATIENT RECEIVED VACCINATION AT 6PM 9/10/19. AT 6:30PM PATIENT REPORTED TINGLING IN THE FACE AND BODY-WIDE ITCHING. SHE TOOK 2 BENADRYL AT THIS TIME. AT 8PM SHE REPORTED STILL ITCHING BUT ALSO HAD "THROAT ISSUES" - SHORTLY AFTER THIS SHE LEFT WORK TO GO TO ER. THE NEXT DAY SHE HAD A FOLLOW UP VISIT TO URGENT CARE.
Injection site sore; Headache; Joint pain; Tiredness; Chills; This is a spontaneous report from a contactable consumer (patient).   A 69-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200), via an unspecified route of administration, administered in Arm Right on 25Feb2021 15:00 (at the age of 69-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included diabetes, depression, BP and hormones (as reported). Concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (Lot number: EL9265, Administration time: 10:00 AM, Vaccine location: Right arm) on 04Feb2021. On 25Feb2021 at 16:00 the patient experienced injection site sore, headache, joint pain, tiredness and chills. The patient did not receive treatment for events. The patient did not have COVID prior vaccination and she was no tested post vaccination. The events were not resolved.   No follow-up attempts are possible. No further information is expected.
Soreness & a lump @ inject site; tx w/ ice & APAP; Resolved in several days;
Paitent recieved TDAP and a few minutes later complained that injection site area was itching. Area was red but was not swollen or hot to touch. Provider assessed site and ice applied and Benadryl given.
Fatigue; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.
Rt. arm with redness 4 1/2 cm in ht. x 4 1/4 cm width. Nontender, warm to touch. Redness with blotchy spots noted also. No fever noted. Augmentin 400/5 10 ml PO BIX x 10 days. Ibuprofen 100/5 2-4 tsp (10-40ml Q8 hr). PCN fever or pain.
Pt. was seen soon after vaccine was administered at an urgent care facility for redness, swelling and pain. Since then he has complained of worsening chronic fatigue.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 29-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-363032 (Patient Link).
Redness with swelling and warmth at site of the vaccine ... 1 week after I got it. Is that normal?
Systemic: chest tightness, twitching of arms and legs-Mild; symptoms lasted 1 day
pt recv vax 15JUN95 & 23JUN97 pt exp chickenpox w/less than 50 lesions p/mom hand shingles;pt was seen by MD;pt recovered from exp;
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On 14-APR-2008, 12-MAY-2008 and 08-DEC-2008, the patient was vaccinated with the first, second and third dose, respectively, of GARDASIL (lot# and expirations date were unknown) for prophylaxis. The nurse reported that on 01-FEB-2017, the patient was vaccinated with GARDASIL 9 lot# M034780, expiration date: 15-APR-2019) for prophylaxis. No adverse effects were reported. No product quality complaint was involved.  Additional information has been requested.
This spontaneous's report as received from a Medical Assistant refers to an unspecified amount patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses improperly stored of ROTATEQ oral, lot number K005397 expiry date 29-FEB-2016, and lot number reported as L004453 Expiry date 27-MAY-2016 (dose was not reported). No adverse effects reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
mom called stating pt started screaming off & on during noc of 15FEB93 (high pitch) over a course of 2-3 hrs & slept 20 mins intervals during the noc; pt had dry coughing, runny nose & eyes; not sleeping, virus; vomited;
Information has been received from a Physician Assistant (P.A.) concerning a 24 year old female patient who in January 2007, was vaccinated IM with a dose of Gardasil. In MAR-2007 the patient tested positive for 3 types of Human Papilloma Virus (HPV) that are in the vaccine (types unspecified). The reporter did not think that the patient was tested prior to vaccination so it was unknown whether or not the patient was originally positive or negative for the HPV types. The Polymerase Chain Reaction (PCR) test was taken in March 2007. The outcome of the patient was unknown. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a Physician Assistant Certified (P.AC.) concerning a 24 year old female patient who in January 2007, was vaccinated IM with a dose of GARDASIL. In MAR-2007 the patient tested positive for 3 types of HPV that are in the vaccine (types unspecified). The reporter did not think that the patient was tested prior to vaccination so it was unknown whether or not the patient was originally positive or negative for the HPV types. The PCR test was taken in March 2007. In follow up the PA indicated that patient was tested positive for HPV serum human papillomavirus 6 neutralization test, HPV serum human papillomavirus 11 neutralization test and serum human papillomavirus 18 neutralization test and his concern was that whether the vaccine could cause a false positive PCR test. The outcome of the patient was unknown. Additional information is not expected.
Migraine type headaches.  This isn't the first time I've had these reactions.  Last times that I received the shot & got these reactions they told me not to worry about it.