chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose of shingrix in 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. 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 Information: GSK Receipt Date:06-APR-2022 Additional Supportive Information:The patient did not receive the second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The case had been linked to US2022061071, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061071:Same reporter
Pregnancy; Delivered Healthy Infant; Initial Report Received on 23-Apr-2020 and 27-Apr-2020  A Pharmacist reported a retrospective pregnancy outcome to the pregnancy registry.  The Pharmacist reported that a pregnant female was vaccinated with HEPLISAV-B on 06-Feb-2019 (Lot # 933093).  40.5 weeks of gestation, the female delivered a healthy infant.   On 07-Aug-2019, the female received another vaccination with HEPLISAV-B (Lot # 933840).    The reporter noted that this pregnancy report had previously been reported to VAERs about a week after exposure last year.    No additional information was provided.  Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
flare of her psoriasis/ flare up in her psoriasis/ the patient stated her psoriasis it was mainly on the palms of her hands, but also under her arms, scalp, neck and hair line; This is a spontaneous report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from regulatory authority (manufacturer control number: US-AMGEN-USASL2021156413), license party for etanercept (ENBREL).  A 61-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unknown route of administration on an unspecified date in Sep2021 (at the age of 61-year-old) as dose number unknown (booster), single for covid-19 immunization and also received influenza vaccine (FLU VACCINE VII) via an unspecified route of administration on an unspecified date in Sep2021 (Batch/Lot number was not reported) at unspecified dose for influenza. Patient's relevant medical history included ongoing psoriatic arthritis and ongoing plaque psoriasis. The patient's concomitant medications were not reported. On an unspecified date in 2021, patient had a flare of her psoriasis symptoms and experienced flare of her psoriasis/flare up in her psoriasis. The patient stated her psoriasis it was mainly on the palms of her hands, but also under her arms, scalp, neck and hair line. The patient did use an unspecified steroid cream for a couple of days as treatment. Outcome of the event was unknown.  Regulatory authority comment: This individual case report does not change the safety profile of the product.  No follow-up attempts are possible. No further information is expected.
Swollen lymph nodes of the right arm with itching and redness began on 12/24/20. No treatment.  Swelling is improving, itching and redness remains unchanged.
Pityriasis Rosea; skin irritation; Face became swollen; Ankles became swollen; Psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PITYRIASIS ROSEA (Pityriasis Rosea), PSORIASIS (Psoriasis), SKIN IRRITATION (skin irritation), SWELLING FACE (Face became swollen) and JOINT SWELLING (Ankles became swollen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21-1A, 006M20-1A and 030L20-1A) for COVID-19 vaccination.    Co-suspect product included non-company product PREDNISONE for Itchy skin.    Previously administered products included for Flu: Seasonal IM Flu vaccine (On or around 15-Oct-2021 the patient received Seasonal IM Flu vaccine) in October 2021. Past adverse reactions to the above products included No adverse event with Seasonal IM Flu vaccine. Concurrent medical conditions included Vitiligo (Diagnosed with Vitiligo 40 years ago. Autoimmune disease) and Allergy to insect sting (Allergy to bee stings).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient started PREDNISONE (Oral) at an unspecified dose. On 28-Feb-2022, the patient experienced PSORIASIS (Psoriasis). On an unknown date, the patient experienced PITYRIASIS ROSEA (Pityriasis Rosea), SKIN IRRITATION (skin irritation), SWELLING FACE (Face became swollen) and JOINT SWELLING (Ankles became swollen). The patient was treated with BETAMETHASONE (topical) for Itchy skin, at an unspecified dose and frequency and FLUOCINOLONE ACETONIDE (topical) for Psoriasis, at an unspecified dose and frequency. At the time of the report, PITYRIASIS ROSEA (Pityriasis Rosea), PSORIASIS (Psoriasis) and SKIN IRRITATION (skin irritation) had not resolved and SWELLING FACE (Face became swollen) and JOINT SWELLING (Ankles became swollen) had resolved.            No concomitant medications were reported.  It was reported that it was difficult to read lot number on the vaccination card. It was reported that the treatment drug prednisone was prescribed for 21 days to the patient. Patient stated that the prednisone and betamethasone cream helped with the skin itching but the prednisone had caused her face and ankles to become swollen. It was also reported that the swollen face and swollen ankle caused by prednisone had not caused the patient to seek medical care, had not occurred in the past, this events had resolved on an unknown date, no death was caused and the symptoms were resolved. Patient had stated that she had never had psoriasis or skin rash in the past. She was diagnosed with vitiligo 40 years ago and stated it is an autoimmune disease.
Case received 2 Covid-19 vaccines (per local Immunization Registry) in March and April 2021, and was hospitalized for Covid in July 2021 with confirmed breakthrough disease.
patient was vaccinated with Pentacel that had been diluted with a diluent made by Merck; Initial information received on 02-Apr-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a three months old female patient who received a 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5) /HIB(PRP/T) VACCINE [PENTACEL] lot UJ065AA, expiration date: 16-Oct-2020 via intramuscular route in the left thigh on 26-Mar-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.   It was an actual medication error due to inappropriate reconstitution technique. Pentacel that had been diluted with a diluent made by Merck.  It was unknown whether patient experienced any adverse event following vaccination.  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.  List of documents held by sender: none.
I have loud ringing in my right ear, and what appears to be some level of hearing loss. This started 28 days after my first Moderna shot, and just hours before I had my 2nd shot. I have never experienced this and come to hear that it is a relatively common adverse reaction people are having to the Covid-19 vaccination. What do we do now?
Hives on right arm with pain and itching on arm and left hand. Body cold with sweats with heavy breathing.
tired; achy; chills; stiff neck; can not turn her head; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no problem after receiving the first dose of the COVID-19 vaccine; and felt a little tired and achy, with chills after the second dose. The patient also has a terribly stiff neck and can not turn her head. The outcome of events was unknown.  Information on the Lot/Batch Number has been requested.
On 10-31-07 I received a call from pt's mother wondering if child's symptoms could be from shots given the day before. Child had a severe headache the evening of 10-30-07 child told mother she didn't felt good after shots were given. Child told mother after mom got off from work. The am of 10-31-07 child was pale, had a headache and stomach ache. Child also stated both arms hurt. Child took an ibuprofen and went to sleep. Mom checked on child throughout morning and child had sweat beads on forehead and would not stay awake very well. Mother took child up to the clinic to be evaluated. Upon returning home child went back to bed and slept. When I called mom stated clinic P.A. told her the effects were from the vaccine. Child had no fever but was very pale. Told to keep child home and let her body rest. At 3 pm I called home and pt answered stating she felt better but had just gotten up from a nap. Told I would check in the next day. Called mom on 11-1-07, and she told reporter that child seemed to feel better after 4 pm on 10-31-07. Child did go to school on 11-1-07.
I had sore throat and it developed on Saturday, November 12th and I was negative. On the 13 still nothing & once I tested again on the 14th, I was than positive. I was also very fatigue & a slight runny nose.
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003208: US-009507513-2104USA003209:
ON 04/07/08, THE 2 MONTH IMMUNIZATIONS OF PEDIARIX, PREVNAR, ACT HIB AND ROTATEQ WERE ADMINISTERED TO THIS PATIENT AT HER CURRENT AGE OF 3 1/2 MONTHS. THERE WERE NO ADVERSE EFFECTS NOTED WHILE IN THE OFFICE.  THERE WERE NO PHONE CALLS FROM PARENTS REPORTING PROBLEMS AFTER LEAVING THE OFFICE.  MEDICAL EXAMINER CALLED THIS MORNING (04/11/08) TO MAKE DR. AWARE THAT PATIENT HAD BEEN FOUND UNRESPONSIVE ON MORNING OF 4/11/08.  RESCUE SQUAD WAS UNABLE TO RESCUSITATE THE INFANT.  CASE IS BEING INVESTIGATED BY COUNTY SHERIFF'S OFFICE AND IS MEDICAL EXAMINER'S CASE. AUTOPSY WILL BE DONE. AT PRESENT THE PRESUMED DIAGNOSIS IS SUDDEN INFANT DEATH SYNDROME.  6/27/08 Autopsy states COD as sudden unexplained infant death assoc w/prior sibling death, non-standard bedding & prematurity.  Autopsy states no evidence of trauma, disease or congenital anomaly.
Right arm numbness which became worse and then involved numbness from neck down.  Patient was unable to move extremities.  Patient was diagnosed with Guillain Barre syndrome.  IVIG therapy was started.
At 36hrs the swollen of that same area(left armpit - lymph node area)increased a little bit and the pain ismild-moderate.; at 24hrs felt pain (pressure like) in thearmpit (same as shoot - left shoulder)- lymph node area; start to feel flu likesyndrome; at 24hrs felt little bit of fever; muscle ache; Mild pain right after shot and increased to moderate within 12hrs; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: ER2613) via an unspecified route of administration in the left arm on 27Mar2021 at 14:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included ascorbic acid vitamin C (MANUFACTURER UNKNOWN), glocosamine (MANUFACTURER UNKNOWN) and condoitrin supplements (MANUFACTURER UNKNOWN) from unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204) via an unspecified route of administration in the right arm on 06Mar2021 at 16:00 as a single dose for COVID-19 immunisation. Prior to vaccination patient not diagnosed with covid-19. The patient had not tested for COVID-19 since having the vaccine. On 28Mar2021 at 08:00 the patient experienced mild pain right after shot and increased to moderate within 12hrs. At 24hrs, on 28Mar2021 at 14:00, the patient felt pain (pressure like) in the armpit (same as shoot - left shoulder) - lymph node area also felt a little bit of fever and muscle aches similar to when somebody start to feel flu like syndrome. That fever and muscle discomfort resolved within two hours. At 36hrs, on 29Mar2021, the swollen of that same area (left armpit - lymph node area) increased a little bit and the pain was mild-moderate. The patient received paracetamol (PANADOL) as a therapeutic measure for the event Pyrexia. The clinical outcome of the events pain, lymph node pain, influenza and lymphadenopathy were resolving and pyrexia and myalgia was resolved after 2hrs, at 16:00 on 28Mar2021 at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.    No follow-up attempts are needed. No further information is expected.
tired; Severe, heavy chills; A little sluggish/Sluggish; Mild arm pain; Could not stop shaking; tenderness; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (A little sluggish/Sluggish), PAIN IN EXTREMITY (Mild arm pain), TREMOR (Could not stop shaking), TENDERNESS (tenderness) and PYREXIA (Feverish) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced SLUGGISHNESS (A little sluggish/Sluggish), PAIN IN EXTREMITY (Mild arm pain), TREMOR (Could not stop shaking), TENDERNESS (tenderness), PYREXIA (Feverish) and CHILLS (Severe, heavy chills). On 25-Apr-2021, the patient experienced FATIGUE (tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 25-Apr-2021, SLUGGISHNESS (A little sluggish/Sluggish), PAIN IN EXTREMITY (Mild arm pain), TREMOR (Could not stop shaking), TENDERNESS (tenderness), PYREXIA (Feverish) and CHILLS (Severe, heavy chills) had resolved. At the time of the report, FATIGUE (tired) outcome was unknown.            No concomitant product reported by reporter.   This case was linked to MOD-2021-403962, MOD-2021-403962 (Patient Link).
4/1/21 Pt arrives to clinic for 2nd Moderna covid vaccinations. Pt states "my face isn't right" Pt takes off mask. O: R sided facial drooping; R Lip sided lips-unable to make smile; R eyelid drooping. Pt went to MD on 3/14; MD provided ABX and informed pt related to "stress" s/p #1 bells palsy- related to covid vaccination. Pt admits to h/p bells palsey x1 > 5 yrs.
Information has been received from a medical assistant concerning a patient who in January 2009, was vaccinated with a dose of PNEUMOVAX (659922/1667U). In January 2009 the patient went to ER for possible cellulitis in the injection site arm but was not admitted. As of 23-JAN-2009 the outcome of the patient was unknown. This is one of 2 reports from the same source. Additional information has been requested.
Nausea, vomiting, diarrhea approximately 40 hours after vaccine administration. Mild soreness at vaccine site.
Information has been received from a nurse practitioner (N.P.) concerning a 23 year old female with diabetes mellitus who on 20-MAY-2008 was vaccinated with the first dose of GARDASIL (lot # 0152X) and on 21-JUL-2008 was vaccinated with the second dose of GARDASIL (lot # 0250X). Concomitant therapy included ORTHO-CYCLEN, LANTUS, NOVOLOG, montelukast sodium (MSD), finasteride (manufacturer unknown), SIMVASTATIN (manufacturer unknown), XYZAL and minoxidil. The patient experienced dizziness after receiving the first dose (recovered) and also the second dose. The patient was recently hospitalized for ketoacidosis. Medical attention was sought via calling the nurse. At the time of this report, the outcome was unknown for the second episode of dizziness and ketoacidosis. No product quality complaint was involved. The temporal relationship to GARDASIL was unspecified by the N.P.. Additional information has been requested.
14 days after vaccine patient developed prgoressively worsening lip, buccal and lingual ulcerations c/w either aphthous stomatitis or Stevens-Johnson syndrome
Caller states she cant focus/She just can't focus; this is horrible/I have a hard time focusing; I'm like you know fogged; I just want to sleep/I have been sleeping all weekend that was horrible; I have some headache; I just don't feel right this is terrible; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in the arm on 18Dec2020 at single dose for covid-19 immunization. Medical history included seizure. Concomitant medication included celecoxib (CELEXA), levothyroxine sodium (SYNTHROID), phenobarbitone [PHENOBARBITAL] for seizure. The patient stated that she could not focus, this was horrible and had a hard time focusing on 18Dec2020, the patient also stated that "like you know fogged" on 18Dec2020, the patient just wanted to sleep and she had been sleeping all weekend that was horrible on an unspecified date in Dec2020, the patient had some headache on an unspecified date Dec2020, she just took some Ibuprofen for the headache, the patient just didn't feel right this was terrible on an unspecified date in Dec2020. The outcome of 'could not focus' was not recovered and the outcome of the other events was unknown.
Slurring his words; Difficulty breathing; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (Slurring his words), DYSPNOEA (Difficulty breathing) and HEADACHE (Bad headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Blood pressure. Concomitant products included METOPROLOL for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DYSARTHRIA (Slurring his words), DYSPNOEA (Difficulty breathing) and HEADACHE (Bad headache). On 01-Mar-2021, DYSARTHRIA (Slurring his words), DYSPNOEA (Difficulty breathing) and HEADACHE (Bad headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product also included cholesterol medications, blood pressure medication and nebulizer.  Treatment medication included rescue inhaler.
Patient reports usual reactions six hours after vaccine (body aches, chills, fever of 103). These resolved after 48 hours with the aid of ibuprofen and Tylenol.  On Saturday, April 17,2021; she was awakened with a piercing headache on the top of the right side of her head and radiating to her right eye. She was seen in the ED at Hospital on 04/28/2021 for the headache that would not subside. She was seen again on 05/04/2021 for fainting with the headache. The ED physician has asked for a VAERS report since the headache has not resolved and is worsening.
Initially, after receiving my 2nd COVID shot, I was fine. A week later I shaved my underarms. The following morning I woke up with a rash under both arms. Thinking it was from shaving I was not real concerned about it. However, the rash began to spread. It traveled from my underarms around to my back, halfway down my left and right sides, to my breasts, and my stomach. I started to become concerned as this was the first time I ever got a rash from shaving my underarms, let alone it spreading around my upper body. I researched the vaccine for side effects and discovered that a rash is one of them. My rash has raised, reddened pustules that itch, bleed and resulted in some discoloration of the skin.