chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the first shot, pancreatitis set in then her gallbladder was removed. She had severe stomach pain. Things calmed down then two days after second shot the pain started back up. She was hospitalized for 20 days. Skin had sores all over it and puss was coming out of the sores. Her body swelled up like a balloon. She then had to go to a rehab center to get her strength back to walk and move.
reported as a medication error due to inadvertently given expired product, 30Jun2022 with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA419169(CLUSTER) and 2022SA420010(CLUSTER).  This case involves a 7 years old male patient who experienced reported as a medication error due to inadvertently given expired product, 30jun2022 with no reported adverse event while receiving vaccine influenza quadrival a-b vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect  influenza quadrival a-b vaccine at dose of 0.5 mL 1X  lot UT7378MA, Expiry date: 30-Jun-2022 via intramuscular route in the right deltoid for Immunization.  On 07-Oct-2022 the patient developed a non-serious reported as a medication error due to inadvertently given expired product, 30jun2022 with no reported adverse event (expired product administered) (unknown latency) following the administration of influenza quadrival a-b vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (reported as a medication error due to inadvertently given expired product, 30Jun2022 with no reported adverse event).  At time of reporting, the outcome was Unknown for the event reported as a medication error due to inadvertently given expired product, 30jun2022 with no reported adverse 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.
Diffused urticarial reaction no wheezing or difficulty in breathing per physician patient seen 30 Apr 12.
Patient presented with chills, upset stomach, blurry vision, lightheadedness and the feeling that she would pass out. These symptoms presented less than 2 minutes after receiving her Pfizer vaccine. Her blood pressure was slightly elevated when EMS evaluated patient. The feeling resolved after 15 minutes and the patient went home.
Vaccine may have been store under condition that departed from the manufacturer's recommended specification, so the manufacturer deem vaccine not viable and recommended a repeat dose.
I started getting body aches and then I started getting severe pain in my lower jaw and upper teeth and side of my nose of my left side. It came on very comfortably. Rest of my body aches went away with Tylenol but this pain wasn't going away at all. I went  to my dentist. He said everything was normal. I went to Immediate care on Tuesday to see if I had a nerve issue. They diagnosed me with a facial nerve  pain - in the trigeminal nerve - the lower two branches - gave me steroids and Gabapentin. TMJ joint it would radiate to midline of mouth - when it wasn't the stabbing pain it felt like my mouth was being burned. It was a Medrol dose pack and took 6 days. By the next week the pain was completed gone.
Restless nights, excruciating pain in hip and knees, elevated blood pressure(169/114), right side of face numb, entered the emergency room several times back and forth but no overnight stay
Body aches, chills, headache, redness and swollen at injection site, arm soreness
Systemic: numbness in ear, jaw, and neck on side she recieved the shot-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe
Given varicella on 06/21/04 SQ right arm. Area on 6/22 was described as red and hot to touch. Gave advise over the phone for comfort measure. 6/23 pt and her mom came to HU for us to see area red and edematous, warm to touch and itching about 4" in diameter.  6/23/04 had seen the PMD that day. He felt her reaction was because 1 wk after 1st injection she had mild chickenpox disease, a few blisters etc. That had resolved. He felt local reaction because of reaction to 1st vaccine. He felt she should not have taken 2nd shot. 6/28 PC to pt says area is much improved, looks sort of bruised, no longer red or hot to touch and does not hurt but is visible.
Head hurting really bad; Bad muscle pain all across shoulder and neck; Bad muscle pain all across shoulder and neck; some other joint pain too; This is a spontaneous report from a contactable consumer, regarding the reporter's mother. An 89-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0140; Expiration date: 31Mar2021), via an unspecified route of administration, on 29Dec2020 (at the age of 89-years-old) at a single dose for COVID-19 immunization. Medical history included blood pressure, heart problems, back issues, hip issues, and kidney problems. The patient's concomitant medications were not reported. The patient experienced head hurting really bad, bad muscle pain all across shoulder and neck, and some other joint pain too on an unspecified date. The clinical course was reported as follows: The reporter called regarding their mother, who was vaccinated on 29Dec2020. The patient's head was hurting really bad, which she never has a headache and was having bad muscle pain all across her shoulder and neck. The patient was given paracetamol (TYLENOL ARTHRITIS) 650 mg and heat pad. She was having some other joint pain too and the fever was fine. The patient underwent lab tests and procedures which included lab work: unknown results on an unspecified date. Therapeutic measures were taken as a result of the events as aforementioned. The clinical outcome of head hurting really bad, bad muscle pain all across shoulder and neck, and some other joint pain too was unknown.  The batch/lot number for the vaccine, BNT162B2, was provided, but will be confirmed/requested during follow up.
Development of round bullseye rash on arm of injection, started to develop additional on both arms, shoulders, back, sides. Diagnosed with Erythema Multiforme due to vaccination. On 2/10/22, started taking triamcinolone 0.1% twice daily for seven days, which cleared the original rashes, however small ones are starting in other areas.
pt recv vax 12DEC95 & 4MAY97 pt devel approx 40-50 chickenpox, as well as a fever of 101-102;
Arm swelled 24 hours after injection from shoulder to hand - warm and tense - NO fever. Minimal pain. Same exact thing happened last year to same child. May be sensitive to an ingredient.
Red rash appeared on arm near injection site approximately 2"x 4". Disappeared in approximately 60 hours. Not raised, not itchy. Area was slightly sore as rash was disappearing.
Narrative:  Pt admitted to hospice services 4/7/21 with a diagnosis of COPD, however; pt died within 42 days of covid vaccination
This spontaneous report was received from the patient husband refers to his wife of unknown age. No medical history was reported. On 02-APR-2013, the patient was vaccinated with ZOSTAVAX (lot #, expiry date, dose, route not reported). No concomitant medications were reported. On 02-APR-2013, the patient experienced itching at the injection site for one day. The outcome of itching at the injection site was reported as recovered on 03-APR-2013. This is 1 of 2 assistant received from the same reporter. Additional information is not expected.
6 inch diameter swelling/erythema/warmth around the injection site. Extended further inferiorly than superiorly (dependent). Mild itching. Supportive tx (ice, Tylenol, Benadryl for itch) discussed.
pt recv vax 19DEC95 & 22APR96 pt devel breakthrough chickenpox w/about 25 pox in various places from head to feet;no further info was provided;
currently has covid again; mild case of Covid; mild case of Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  An 88-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (batch/lot number: unknown) for covid-19 immunization; BNT162b2 (BNT162B2), as dose 1, single (batch/lot number: unknown), as dose 2, single (batch/lot number: unknown), as dose 3 (booster), single (batch/lot number: unknown) and as dose 4 (booster), single (batch/lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "RA, fairly mild" (unspecified if ongoing), notes: has been taking Methotrexate and Plaquenil for over 30 years. Concomitant medications included: METHOTREXATE taken for RA; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE] taken for RA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "mild case of Covid"; DISEASE RECURRENCE (medically significant) with onset 2023, outcome "not recovered", described as "currently has covid again". The patient underwent the following laboratory tests and procedures: COVID-19 Test: (Nov2022) positive, notes: mild case of Covid; (2023) positive, notes: covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. Clinical course: The patient informed that in Nov2022, had a mild case of Covid and was prescribed Paxlovid. The patient informed that currently has covid again and was taking Paxlovid again. The patient was self quarantining. The patient wanted to know when to get another booster and how long is the self quarantine.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5/ BNT162B2] has been requested and will be submitted if and when received.
Patient received a booster shot of the Moderna Spikevax 12 years and older.  Which is no longer recommended as booster shot as of August 31, 2022.
Patient received an accidental third dose of Shingrix.  Patient reports no symptoms or side effects.  Patient had thought she had only received one Shingrix shot but had forgotten about a previous shot on 4/2/20018.
Chills and headache beginning 10 pm of the day of injection, followed by fever, nausea, body aches, sinus congestion soon thereafter and extreme fatigue.  Aleve (2 tablets) at 7 am the next morning with little, if any, relief but perhaps prevented it from becoming worse and another at 2:30 am on Monday morning (the second day). Slept, although not always well, for the better part of 32 hours, with less than 3 hours of being awake and up, trying to eat little. Was able to make it through a nine hour shift on Monday, still with no appetite and a bit off (attributed to not being truly rested despite 32 hours in bed).
This is a spontaneous report from a contactable healthcare professional received via a Pfizer sales representative. An 80-year-old female patient received PREVNAR 13, (lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history included anxiety, pace maker, congested heart failure, and high blood pressure. The patient's concomitant medications were not reported. On an unspecified date after the use of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), the 80-year-old female patient experienced a blank stare and almost fainted, trembling, both side of the face felt numb, and blood pressure elevated. Patient does have several comorbidities. The outcome of the events was unknown. Information on the lot/batch number has been requested.
This case was reported by a nurse and described the occurrence of a possible allergic reaction in a 5 year old female pt who received DTAP (Infanrix) for prophylaxis. On an unspecified date, the pt received the 5th dose of Infanrix (Lot # DTPA586B9).  On 03/18/03, at an unspecified time post-immunization, the pt experienced a possible allergic reaction characterized by swelling and redness at the injection site. The pt was seen by the physician, who prescribed Zyrtec and Cefzil. The event resolved on 03/25/03.  The reporter considered the event to be related to vaccination with Infanrix.
PM of shot low grade temp; next AM limp, pale, temp elevated;APAP not keeping t105, vomited, dehydrated by noon; pt taken to ER & am; felt to be rxn to DTP shot;
Slight red rash, like red spots, above the injection site, almost on the shoulder blade; Slight (red) rash, like red spots, above the injection site, almost on the shoulder blade; Blood pressure was a little higher than it normally is; Sore arm; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Blood pressure was a little higher than it normally is), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Slight red rash, like red spots, above the injection site, almost on the shoulder blade) and VACCINATION SITE RASH (Slight (red) rash, like red spots, above the injection site, almost on the shoulder blade) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Hives (If he takes a warm shower, he gets hives occasionally). Concurrent medical conditions included Sensitive skin.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced HYPERTENSION (Blood pressure was a little higher than it normally is), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). On 26-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Slight red rash, like red spots, above the injection site, almost on the shoulder blade) and VACCINATION SITE RASH (Slight (red) rash, like red spots, above the injection site, almost on the shoulder blade). On 25-Jan-2021, FATIGUE (Fatigue) had resolved. On 26-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, HYPERTENSION (Blood pressure was a little higher than it normally is), VACCINATION SITE ERYTHEMA (Slight red rash, like red spots, above the injection site, almost on the shoulder blade) and VACCINATION SITE RASH (Slight (red) rash, like red spots, above the injection site, almost on the shoulder blade) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Blood pressure measurement: 170 (High) Blood pressure at urgent care was 170 160, 160 (High) Blood pressure at urgent care was 170 160 and 180 (High) Blood pressure 180. On 25-Jan-2021, Body temperature: 98 (normal) Body temperature was 98 point something. On 25-Jan-2021, Oxygen saturation: 98 (normal) 98.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Patient visited an urgent care on 25-Jan-2021.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Major narrative update. Adverse event hypertension was entered, and panic attack removed. On 26-Jan-2021: Follow-up call with consumer on 26-Jan-2021 clarified panic attack was response to increased blood pressure. Injection site red rash also reported on this date. On 16-Apr-2021: Hypertension outcome recovered. On 29-Jul-2021: Follow-up received  included no new information.
Developed violent chills within a few hours of taking the vaccine.  I developed a 103.5 fever by about 4:30.  I got into bed and laid down because I was feeling extremely ill.  My chills got progressively worse.  They became so violent that I lost all voluntary control of my body and was unable to stand or manually manipulate objects with my hands.  I believe that I had a seizure.  I lost consciousness during the event and completely blacked out.  I awoke several hours later and am not sure how long I was unconscious.  My fever continued into the next day and I was extremely weak.  Standard life tasks were almost completely impossible for the entirety of the next day.   I developed severe joint pains and body aches.  The joint pain persisted for at least 10 days.
First dose: sleepy; Headache; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Mar2021 (Lot number: EN6202) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid", start date: Dec2020 (unspecified if ongoing), notes: Stated that she had Covid in December and waited 90 days before the inoculation. There were no concomitant medications. The following information was reported: SOMNOLENCE (non-serious) with onset 22Mar2021, outcome "recovered" (25Mar2021), described as "First dose: sleepy"; HEADACHE (non-serious) with onset 22Mar2021, outcome "recovered" (25Mar2021), described as "Headache"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Tired". Therapeutic measures were taken as a result of somnolence, headache, fatigue with analgesics and plenty of fluids.  Additional Information:first dose was received 90 days after having Covid.Other Products were No.No Patient History.Investigation Assessment was No.Stated thathad Covid in December and waited 90 days before the inoculation. Stated that this was before any doses. Stated that she had first dose and had a headache and was tired. Stated that her internist said that she had too many antibodies and that Covid would eventually come back and she should not take the booster shot.Treatment: Stated that she took analgesics went to bed drank plenty of fluids for first dose issues.   No follow-up attempts are possible. No further information is expected
Information has been received from a nurse through the Pregnancy Registry for Gardasil concerning a 27 year old female, with a history of two previous pregnancies (one live birth and one spontaneous abortion), who on 19-FEB-2007 was vaccinated in the right deltoid with her first dose of Gardasil.  On 12-APR-2007, the patient was vaccinated in the left deltoid with her second dose of Gardasil (Lot #656051/0244U).  On 10-OCT-2007 it was reported that the patient had a urine test (date unspecified) which was positive (LMP 14-MAY-2007).  The patient sought unspecified medical attention at an office visit.  Follow-up information received 27-MAR-2008, reports that the patient was on prenatal vitamins (unspecified), and developed pregnancy induced hypertension (not further specified).  The patient had routine diagnostic tests (not further specified).  On 13-FEB-2008, the patient delivered a live, normal, 8 pound, male infant (length not reported).  There were no complications during labor or delivery, no congenital anomalies, or complications.  Additional information has been requested.
Routine vaccination for varicella administered (6/19/2008).  No local reactions.  26 days after vaccination, he developed varicella.  This was a typical illness course, not mild.  Last lesion was crusted over by ten days.  After that, he developed a persistent sandpaper-like maculo papular eruption on the trunk and extremities that lasted another three weeks.  A household contact (cousin) started a mild clinical case of varicella 14 days after the onset of his chickenpox. The cousin had no complications.  There is no family history of immune deficiency in the index patient.  His own immune function tests are all normal.
Fever, achy all over, chills, terrible cough, fluid in lungs lasted for approximately 8 months and diarrhea.
02/27/2021- Impacted ear wax and went to urgent care, my blood pressure was checked and it was 198/84 and was informed to watch the blood pressure. Later that afternoon, it was still high. 02/27/2021- Later on, went to the emergency room, blood pressure was elevated 231/98. Kept me for about 4 hours and was given a prescription for Amlodipine.  02/27/2021- Rash on a both forearms and down the front of both of my legs- given ointment by Dermatologist. Never had a problem with blood pressure before the vaccine.
pt recvd vax & exp allergic react; reporting pharmacist indicated no further details are available & this report is 4th hand info; This case is considered to be invalid;
Can't take the ringing in her ears any more and is getting a little suicidal; Took the Pfizer Covid-19 vaccine and it gave her ringing in the ears; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date, she took the Pfizer COVID-19 vaccine, and it gave her ringing in the ears. She couldn't take the ringing in her ears anymore and was getting a little suicidal. The patient also reported that no doctors could help her and that she needed to speak with someone that can tell her what to do. Outcome of the events was unknown.
Severe headache and mental confusion making it impossible to continue my function as a doctor. Also gait unsteadiness and dizzy
Patient got a havrix expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old female patient who received HAV (Havrix) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 7th January 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th January 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. 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 received a Havrix expired dose, which led to expired vaccine used. The reporter consented to follow up.