chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from female consumer of unknown age referring on herself. The patient had a medical history of herpes zoster approximately in May 2011. On 11-MAR-2013, the patient was vaccinated with ZOSTAVAX (route, strength and dose unknown). There was no concomitant medication reported. Approximately in February 2014, after she received the vaccination with ZOSTAVAX, the patient experienced shingles again. It was also reported that on November 2015, the patient had experienced shingles again. The outcome of shingles developed in February 2014 was considered as recovered. The outcome of shingles developed in November 2015 was unknown. The relatedness between the events and ZOSTAVAX was unknown. The seriousness assessment was not provided. Additional information is not expected as no contact information was provided.
Patient called pharmacy & reported a red area & swelling. Went to see doctor & he said it was an infection from injection site.
broke out in hives; Initial information received on 27-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to 2019SA333485.  This case involves a 34 years old female patient who broke out in hives (urticaria), while she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious event broke out in hives (urticaria) 1 week following the administration of INFLUENZA VACCINE.  (Other relevant tests included no laboratory data.)  Final diagnosis was hives.   It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for hives.  Information on the batch number was requested.
It was reported that a pt (3 of 5) received a Fluzone SV 'oo - "01 vaccination. Reportedly sometime after the vaccination the pt developed a local reaction of redness and warmth. No specifics provided, further information is requested.
Initial report received from healthcare professional on 18 February 2014. A 52-year-old female patient, who has no medical history with no illness at the time of vaccination and concomitant medications were not reported, had received intramuscular dose of ADACEL (batch number and dose number were not reported) in left deltoid on 14 February 2014. It was reported that on 14 February 2014, by the evening after receiving ADACEL, the patient experienced rash on left shoulder that was red, raised but not itchy. The next morning, the patient had sores in her mouth that were painful and had low grade temperature. The corrective treatment was not reported and laboratory investigations were not performed. At the time of this report, the outcome was not recovered. Documents held by sender: none
Parent of patient went to ER with c/o warmth with swelling and tenderness to touch to the left thigh.
Got only half dose of vaccine; A spontaneous report was received from a consumer concerning a 52-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and got only half dose of vaccine/ underdose.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 11 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 032M20A) in the left non dominant arm for prophylaxis of COVID-19 infection.   On an unknown date, it was reported that her vaccine administrator told her that she received only half dose of vaccine, So she had to repeat the dose again. Also she noticed some of the vaccine running down her arms from injection site. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event, got only half dose of vaccine was considered as resolved.; Reporter's Comments: This report refers to a case of  Underdose for mRNA-1273, lot # 032M20A with no associated AEs.
No adverse reactions from the first shot, second shot my arm ached quite a bit for a few days. after a few weeks my body started have unusual aches and pains, i began having abdominal distress and tiredness.  still ongoing and gaining in intensity.
Patient received both vaccine doses in early 2020.  On 9/8/2021 patient presented with symptoms of COVID-19 and a GI bleed.  Patient was eventually intubated during hospital admission more for bleeding issues than respiratory issues.  Patient needed multiple trips to IR to fix bleeding.  Patient was ultimately transferred on 9/28/2021 from our facility to another hospital. Patient has been waiting for liver transplant for awhile and because of continued bleeding transferred to a higher level of care for hepatobiliary surgery.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies reported. On an unknown date, the patients were vaccinated with an improperly stored doses of M-M-R II recombinant human albumin status (lot# L030162, expiration date 11-AUG-2017; lot# L005290 expiration date 17-FEB-2017; dose, anatomical location and route of administration were not reported). No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Tachycarida, blotchy face, clearing throat, felt "strange" gave 0.3 mg Epi, 50 mg PO bendadryl
severe headache; myalgia; severe pain; This is a spontaneous report from a contactable physician. This physician reported similar events for four patients. This is the second of four cases. A 19-year-old patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA) ,(lot/batch# CM8296), via an unspecified route of administration, on 12Aug2020, at single dose, for immunisation. Medical history and concomitant medications were none. The patient experienced severe headache, myalgia and severe pain all in Aug2020 with outcome of unknown.    No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020335485 Same reporter/event, different patient
About 4 hours after vaccine became flushed and soaked in sweat. Anxious and uneasy feeling. BP elevated. Was taken to ER. Told reaction to flu shot.
received two, influzenza vaccine Fluzone High-Dose Quadrivalent vaccine doses because of confusing packaging with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who received two, influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] doses because of confusing packaging with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.   On an unknown date, the patient received two doses of suspect  influenza quadrival A-B high dose HV vaccine (lot number, strength, dose, expiry date not reported) via intramuscular route in unknown administration site as prophylactic vaccination because of confusing packaging with no reported adverse event (extra dose administered) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
After shot dizzy  and light headed; Had shot Tuesday Friday night left side jaw pain and teeth misaligned due to jaw not closing due to pain and swelling.
BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 24 year old female. The patient's weight was 135 pounds, and height was 66 inches. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included no known drug allergies, drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever on 09-APR-2021, and the outcome of headache was not reported. This report was non-serious.
Initial report received 14 August 2007 from a health care professional. A 31-year-old female patient had received a prophylactic injection of Fluzone on 26 December 2006 during her second trimester of pregnancy. The patient's date of conception had been reported as 25 August 2006 with an estimated delivery date of 18 May 2007. Exposures reported during pregnancy included alcohol, passive smoke, caffeine, and mold "in office". During her third trimester, beginning on 12 February 2007, she experienced a cough which lasted seven days, ending on 18 February 2007. Then, beginning 08 March 2007, she experienced a temperature of 100 degrees Fahrenheit, and "bronchitis/cold" symptoms. Her temperature returned to normal the following day but her bronchitis/cold symptoms persisted until 04 May 2007. She had been prescribed "antibiotics NCS" from 01 April 2007 until 30 April 2007 and Z-PAKs from 15 April 2007 to 04 May 2007. An ultrasound performed 02 May 2007 revealed "low amniotic fluid" and a non-stress test performed on 08 May 2007 had normal results. The patient had a c-section after diagnosis of oligohydramnics on 18 May 2007, her AFI was 2. The baby had cyanosis at birth which resolved within 2 hours. Shortly after birth the baby started having difficulties breathing and was diagnosed with pulmonary hypertension and intubated for 24 hours and the pulmonary hypertension resolved. Oxygen was administered another 24 hours and on 20 May 2007, the baby was breathing normally. The baby had been prescribed antibiotics for one week and all laboratory results were normal, negative for infection. The baby had been monitored for five additional days and had been released on 26 May 2007. This case was originally reported as non-serious, however, it was upgraded to serious by manufacturer. This case is linked to the baby's case 2007-02795 (pulmonary hypertension, jaundice).
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "80 YO female with PMH of drug induced parkinsons, depression, hypertension, breast cancer who presented to the ED for chief complaint of "cant swallow." Reports this started "a few days ago", was progressive but rapidly so. Cannot state if she has had similar prior. She answers my questions in vague ways including "a while ago...you could say that...perhaps."    Patient was septic and positive for acute respiratory failure with hypoxia likely secondary to aspiration gram negative pneumonia and COVID leading to admission.  Given oxygen support, fluid resuscitation, and Rocephin leading to improvement of both progressing to normal oxygen saturation on room air and completing full course Rocephin.  Concern for stroke according to speech delay found on exam.  MRI head negative.  Speech therapy cleared patient for thick nectar, which improved to general diet.  Significant rise in troponins also found leading to diagnosis of NSTEMI.  Cardiology was referred recommending medical management with aspirin, atorvastatin 40, metoprolol tartrate 25 mg twice daily and lisinopril 40 mg daily.   Patient showed decreased appetite and flat affect consistent with major depressive disorder.  Patient had decreased appetite and body mass index of 15.  Patient and husband spoke with medicine team, stating patient would tolerate oral intake well and does not need a G-tube placed.  PT/OT met with patient recommending skilled nursing facility treatment.  Patient states she is willing to work with them.  Case Management secured placement for ongoing treatment.   Patient also reported acute near urinary retention with bladder scan greater than 300 x 2 requiring straight catheterization.  Foley catheter placed.  Flomax started.  Patient instructed to continue Foley care while at SNF and to have a voiding trial 5 days s/p discharge"
Information was received 28-JUN-2017 via a phone call from a nurse. The nurse reported that a 2-6 month old infant of unknown gender was given a dose of ROTATEQ for vaccination on an unknown date. The lot number and expiration date were not provided. Relevant lab data, medical history, medication history and concomitant medications were unknown. The mother of the infant gave the infant formula immediately after receiving ROTATEQ and the baby vomited.  As of 28-JUN-2017 it was unknown if the baby was to be re-vaccinated.  No further information was provided. The outcome of vomiting is unknown. Additional information was requested.
immed post vax pt became very pale & weak, dizzy;pt remained somnolent for 6hr p/vax;low grade fever;pt vomited x2;eval in ofc 6 hr p/vax;lethargic, pale but arousable & coherent;BP 90/30, T95.4, P90-100
Case number PHEH2015US019327, is an initial spontaneous report received from a health care professional on 24 Sep 2015. This report refers to a 16-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M14097, expiry date: 31 Dec 2015) on 14 Jul 2015 which was stored on incorrect temperature of 34.0 degrees Fahrenheit and 50.2 degree Fahrenheit at 48-120 hours. No adverse event was reported following this maladministration (incorrect storage of drug). Follow-up information received on 25 November 2015: Previously administered products included MENVEO which was well tolerated. The patient's details (height and weight) were provided. The MENVEO batch number was changed to M14070. The vaccine was administered intramuscularly on the left deltoid.
I got the first shot on 1/30/21 and the second shot on 2/20/21 and then on 2/21/21 I woke up and couldn't hear.
Pt recvd vax on 22OCT92 devel a pos blood culture for Haemophilus influenza, type f; addtl info has been requested;;
Left leg: 6cm redness, warmth, tender, relatively firm to touch.  Right leg: 2cm redness, warmth, tender, slightly firm to touch.
Local reaction at injection site.  This happens every year.  His entire upper arm becomes very hot and remains this way for approximately four days.  There is NO respiratory/anaphylactic reaction.
This spontaneous report as received from a registered nurse refers to a 71-year-old male patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 14-DEC-2015, the patient was vaccinated intramuscularly with one dose of PNEUMOVAX 23 (dose: 0.5ml, route of administration: left deltoid, lot # K010466, expiration date: 23-MAR-2016) which was stored improperly. There were no adverse effects reported. Additional information is not expected as the reporter did not want to be contacted.
Information was received from a pharmacist via a company representative regarding a 61 year old female patient. "Last week," the patient was vaccinated with ZOSTAVAX (dosage and route of administration not provided) immediately after the injection, the patient experienced swelling at the injection site. The outcome of swelling at the injection site was reported as recovered on an unspecified date. Additional information has been requested.
A pt with unk medical history, had received a dose of Fluzone SV 2006-2007 USP, lot number U2273AA on an unspecified date. The route and site of administration was not reported. The day after receiving the vaccination, the pt appeared to have a severe hypersensitivity to the vaccination of pruritic allergic reaction that progressed, and actually required short hospitalization and treatment with systemic corticosteroids, etc. Diagnostic performed were not reported. Per the reporter, there were no other causes that could be determined for this, and therefore the assumption was that it was indeed due to the influenza vaccine.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 18-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The vaccine had three temperature excursions one of 328 hours with a lowest recorded temperature of 29 Fahrenheit (F) (-1.666666667 Celsius (C)), the other one of 264 hours with a lowest recorded temperature of 33 F (0.555555556 C) and the third one of 64 hours with a highest recorded temperature of 48 F (8.888888889 C). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning about his 60 year old wife who on 08-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number not reported). The wife reported no relevant medical history or past drug history. Concomitant medication also included cinnamon. In April 2011 after receiving the ZOSTAVAX (Merck) the physician stated that his wife experienced burning, itching and pain bilaterally around the waist line which was accompanied by a red rash no vesicles. On 09-APR-2011 and 10-APR-2011, the rash was treated with an unknown topical steroid. There was no relevant laboratory data. As of 10-APR-2011, the physician's wife continued to experience burning, itching and pain bilaterally around the waist line which was accompanied by a red rash no vesicles. Additional information has been requested.
I am a moderate diabetic but after the injection I have had a considerable increase in fasting and postprandial blood glucose reaching 330.; This is a spontaneous report received from a contactable Health care Professional. A 81-year-old male Patient received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/batch number and Expiration date: UNKNOWN ), via an unspecified route of administration in left arm on 27Mar2021 15:00 as a single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included Metformin 850mg, gliclazide 60 mg, detusitol. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19.   On 28-MAR-2021 at 08:00, the patient stated, I'm diabetic, moderate, but after the injection I've been presenting high fasting and postprandial blood sugar level, reaching to 330. Patient was treated with Glicazide (dose increased). Seriousness of the event was not reported. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
product storage error; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (product storage error) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. The vaccine was placed in refrigerator on 18 Oct 2021. The vaccine did not go any temperature excursion and does not experience adverse event. No treatment information was provided.
pt saw PCP on 1/13/22 with sx of sore throat, decrease in appetite, fever, chills, sinus problems cough, SOB, nausea and vomiting; states has fallen twice in last few days due to vertigo; denies hitting head or LOC; strep test came back positive; COVID test done but results not ready at visit time; given Amoxicillin; COVID test did turn out to be positive; pt expired at home per death certificate; death certificate and med records submitted to VAERS per their request
July 21st (months after the dose) was diagnosed with Bell's Palsy, had the usual symptoms of nerve damage, right side of face, eye would not close. Given antiviral and steroid at the ER, told it would take up to 3 months to return back to normal. I would say that I am 98% recovered, just having lingering ear issues and not able to blow nose correctly because of the nerve. Did not see other medical staff, as the symptoms were well-explained by ER doctor and they resolved as.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported by reporter.  No treatment reported.   This case was linked to MOD-2021-395985 (Patient Link).
Allergic reaction - hives on arms, face and neck, eyes burning, and some difficulty breathing.