chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever close to 105; Got full Body rash; blood platelets and blood counts all dropped; blood platelets and blood counts all dropped; Drentched in sweat; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 17:15 (Lot number: ff2587) at the age of 18 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing); "Anaphylaxis to shellfish, peanuts" (unspecified if ongoing), notes: known allergies: yes Anaphylaxis to shellfish, peanuts and treenuts; "allergies: yes Anaphylaxis to shellfish, peanuts and treenuts" (unspecified if ongoing), notes: known allergies: yes Anaphylaxis to shellfish, peanuts and treenuts; "allergies: yes Anaphylaxis to shellfish, peanuts and treenuts" (unspecified if ongoing), notes: known allergies: yes Anaphylaxis to shellfish, peanuts and treenuts. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Product: Covid 19, Brand: Pfizer, lot number: fc3183, Vaccine Administration Time: 05:15 PM, Location of injection: Left arm), administration date: 20Aug2021, when the patient was 18 years old, for Covid-19 immunization. The following information was reported: PYREXIA (medically significant) with onset 22Sep2021 20:00, outcome "recovered", described as "Fever close to 105"; RASH (non-serious) with onset 22Sep2021 20:00, outcome "recovered", described as "Got full Body rash"; PLATELET COUNT DECREASED (non-serious), FULL BLOOD COUNT DECREASED (non-serious) all with onset 22Sep2021 20:00, outcome "recovered" and all described as "blood platelets and blood counts all dropped"; HYPERHIDROSIS (non-serious) with onset 22Sep2021 20:00, outcome "recovered", described as "Drentched in sweat"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 10Sep2021 17:15, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The events "fever close to 105", "got full body rash", "blood platelets and blood counts all dropped", "blood platelets and blood counts all dropped", "drentched in sweat" and "inappropriate schedule of vaccine administered" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (22Sep2021) close to 105; full blood count: (22Sep2021) dropped, notes: My blood platelets and blood counts all dropped; platelet count: (22Sep2021) dropped, notes: My blood platelets and blood counts all dropped; sars-cov-2 test: (24Sep2021) negative, notes: Blood test; (24Sep2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of pyrexia, rash, platelet count decreased, full blood count decreased, hyperhidrosis.  Clinical course- No other vaccine in four weeks. No COVID prior to vaccination reported. COVID was tested post vaccination. Treatment: Benadryl.  No follow-up attempts are possible. No further information is expected.
Feeling Hot & Cold; Joint pain; sore body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Feeling Hot & Cold), ARTHRALGIA (Joint pain) and MYALGIA (sore body) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 010A21A and 015L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feeling Hot & Cold), ARTHRALGIA (Joint pain) and MYALGIA (sore body). On 21-Nov-2021, FEELING OF BODY TEMPERATURE CHANGE (Feeling Hot & Cold) had resolved. At the time of the report, ARTHRALGIA (Joint pain) had not resolved and MYALGIA (sore body) was resolving.            Patient is suffering from Heart Condition, it is under control with medicines and is not affected by vaccine. No treatment information was provided by the reporter. No Concomitant medicines were reported.  Company comment- This case concerns a 68 year old female with no reported medical history , who experienced Non-serious , unexpected event of feeling of body temperature change and non-serious , expected events of arthralgia and myalgia which occurred on the day after vaccination with the 3rd dose ( booster dose) of mRNA-1273 vaccine ( moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the events occurred on the 3rd dose and no additional doses will be given and also the outcome of the events not resolved. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-402750 (Patient Link).; Sender's Comments: This case concerns a 68 year old female with no reported medical history , who experienced Non-serious , unexpected event of feeling of body temperature change and non-serious , expected events of arthralgia and myalgia which occurred on the day after vaccination with the 3rd dose ( booster dose) of mRNA-1273 vaccine ( moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the events occurred on the 3rd dose and no additional doses will be given and also the outcome of the events not resolved. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves Child patient (age and gender was not reported) who received a dose of vaccine FLUZONE HIGH DOSE (lot number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was reported that gave a FLUZONE HIGH DOSE to a 3rd grade. It was unknown if the patient had any 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 Directive 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.
Extreme pain with swelling of left upper arm at injection site. Pain and swelling continues down arm to hand. Started 1/20/2021 and continues to worsen. Pain unbearable.
Headache, Arthralgia, Fever, chills, fatigue, injection site arm pain Narrative:
Fever since immunizations performed, T-max 103 degrees in office. Pt with nearly inconsolable screaming greater than or equal to 12 hours (described as a painful cry). Tachypnea, tachycardia. Admitted for 24 hour observation.
Pt became light headed following immunization, fainted, had some seizures posturing lasting= 3 seconds, Then raised up head and asked "what had happened?", O2 by mask was applied @ B-10 / mea, Client offered O.J and cheese. BP taken q 5 mins ranging from 108/60 to 90/60. Left HD @ 11:58 am with mother
Patient (5yo male) was given DPT booster and polio vaccinations in left arm at same appointment.  Later that day patient complained that stomach hurt and that he didn't feel good.  Was lethargic.  This resolved.  The next day (09/10/2011), patient again complained that he didn't feel good and ramped up to lethargy.  This cleared up after a while.  Later that night (7PM, 09/09/2011) saw that patient had a large 2 inch welt on left arm at site of vaccination.  This was hard and red.  This welt subsided after a couple of days.
This is a pleasant 70 y.o. female who presented with allergic reaction to COVID-19 shot.  This was her first shot.  She got the shot and within 10 to 15 minutes noticed that her face was red a little bit of swelling in her eyes her throat felt "funny" and she had some chest tightness.  No difficulty swallowing no sensation of throat closing no wheezing or shortness of breath no abdominal pain nausea vomiting diarrhea or skin rashes.  First responder was called and patient was taken to the ER.
By next morning-could not hardly move arm started with blotches in area of injection. Then fever. Second day doctor visit with shot of antibiotic and blood wk. That night Emergency room swelling spreading. Admitted for IV-antibiotics-two days.
Localized itching, edema and itching bilaterally in arm pits and upper arms.
Information has been received from a physician concerning a patient with no known allergies or pertinent medical history, who on 19-MAR-2007 was vaccinated SC with a second 0.5mL dose of varicella virus vaccine live (Oka/Merck) (Lot# 656079/1306F). Concomitant therapy included amoxicillin. On 22-MAR-2007, the patient had an injection site that was red and tender to touch after vaccination. Unspecified medical attention was sought. No labs were performed. Subsequently, the patient recovered. There was no product quality complaint. No further information was provided. Additional information has been requested. This is one of several reports from the same source.
Patient became pale and clammy, then fainted.  Nurse and assistants lowered patient onto floor and elevated feet, applied cold cloth to forehead and back of neck, directed fan towards patient.  Nurse monitored blood pressure and pulse every 5 minutes.  Patient fully recovered within 20 minutes.  Patient's father drove patient home.
Initial health care professional report received on 11 Feb 2010: This patient who had already received Sanofi H1N1 vaccine on 26 Oct 2009, received FLUVIRIN second dose (batch number 102133P1) 0.25 ml, intramuscular on 30 Nov 2009. On 30 Nov 2009, the patient (18 month old) received 0.25 ml of Novartis H1N1 as second dose. No other adverse event was reported.
2 1/2 hrs p/vax pt eyes rolling, jerking, tongue movements lasting estimated 10 mins; then was quiet but fine;
Starting at 3:00 pm on 7/11 right upper arm started hurting. By early evening I developed chills, body ache, dry mouth & lips, fever, some shooting ear pain (left side), which seemed strange).  Early morning on  7/12 I started to feel better. A red area around the shot area is still visible which is 2 x 3 inches.
RIght arm was achy; Red rash; Headache significantly worsened; Fatigue; Swollen part on right arm at injection site; Round soft ball size red spot; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (RIght arm was achy), RASH ERYTHEMATOUS (Red rash), HEADACHE (Headache significantly worsened), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Swollen part on right arm at injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine in 2010 and Shingles on 13-Jan-2021. Concurrent medical conditions included Ragweed allergy, Dust allergy (Allergy to dust mites), Grass allergy, Allergy to plants (Trees), Allergy to animal (Dog allergy), Allergy to animal (Cat allergy), Allergy to animals (Horse allergy), Allergy to molds, Allergy to animal (shrimp), Allergy to animal (crab), Seafood allergy (salmon), Peanut allergy, Allergy (Unknown allergy caused red swollen rash covering arms and neck) since March 2008 and Allergy (Unknown allergy caused red swollen rash covering arms and neck) since July 2008. Concomitant products included AMITRIPTYLINE for Migraine, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and BUDESONIDE (NASOCORT) for Multiple allergies, FLUOCINOLONE ACETONIDE for Multiple allergies and Dry skin, VITAMIN C [ASCORBIC ACID] and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 09-Jun-2021, the patient experienced PAIN IN EXTREMITY (RIght arm was achy), RASH ERYTHEMATOUS (Red rash), HEADACHE (Headache significantly worsened), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swollen part on right arm at injection site), VACCINATION SITE ERYTHEMA (Round soft ball size red spot), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) (oral) ongoing since an unknown date for Adverse event, at a dose of UNK UNK, prn. At the time of the report, PAIN IN EXTREMITY (RIght arm was achy), HEADACHE (Headache significantly worsened), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swollen part on right arm at injection site), VACCINATION SITE ERYTHEMA (Round soft ball size red spot), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown and RASH ERYTHEMATOUS (Red rash) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jun-2021, Body temperature: 101.4 (High) 101.4 °F, 98.8 (normal) 98.8 °F, 99.4 (High) 99.4 °F and 101.4 (High) 101.4 °F.         This case was linked to MOD-2021-116613 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2021: Follow up information received on 01-AUG-2021 - lab data, unknown allergic reactions and treatment medication were added.
This case was reported by a healthcare professional and described the occurrence of injection site blisters in a female subject of unspecified age who was vaccinated with ENGERIX B. Concurrent medication included NORVASC, Hormone replacement therapy and Antibiotics. On the morning of 13 May 2008, the subject received 2nd dose of ENGERIX B (1 cc, unknown, left arm). On 14 May 2008 at 7:00 a.m., approximately one day injection site blisters. The subject presented to a physician's office for an evaluation and the nurse treated her by covering the vesicles with gauze and a bandage to prevent breakage. The nurse stated that the subject did not have flu-like symptoms or fever, just the local reaction. In addition, the nurse stated that she did not know if she would administer the 3rd dose of ENGERIX B to the subject due to this event. At the time of reporting, the event was resolved. Follow-up information was received on 02 June 2008 via a nurse, who indicated that this case was reported to a Regulatory Agency (VAERS ID # was unspecified). The subject was a 51 year-old female who was reported to be recovering from an ear infection at the time of vaccination with ENGERIX B. The subject's medical history included allergies to Penicillin and pollen. The nurse reported that the injection site blisters had "dried up" and were improved as of 19 May 2008. The nurse stated that the event was considered to be related to vaccination with ENGERIX B per her facility medical director, but indicated that the event was not serious. In addition, the healthcare professional reported that the event could have been associated with the subject's medical history/concurrent illness of recovering from an ear infection. The immunization series with ENGERIX B was discontinued.
5 1/2" by 2" size, red, warm, swollen area on right thigh, began 36-48 hours post vax; no fever and acting well. Local reaction.
"Moderna COVID-19 Vaccine ."  - About 30 minutes after the shot, in addition to having a sore arm, all of the pain that I usually get on my arm from the pinched ulnar nerve on my elbow got really intense without me having triggered any movements that could have aggravated it. The pain extended through all of it - from my elbow through both my little finger and ring finger, and I could barely move my arm without it making it hurt more. The intense pain slowly went away within the next 3 hours.  - About an hour later I was really exhausted.  -Around 4pm, I was extremely tired, had a really fast heartbeat, and I was having difficulty breathing (similar to when I have asthma). The fast heart rate and the breathing difficulties went away around 6/6:30pm. The fatigue went away the next day.
knot on the arm - right arm; nauseous; fever - 102; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (knot on the arm - right arm), NAUSEA (nauseous), PYREXIA (fever - 102) and HEADACHE (headache) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included VITAMIN for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (knot on the arm - right arm), NAUSEA (nauseous), PYREXIA (fever - 102) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 10-Feb-2021, PAIN IN EXTREMITY (knot on the arm - right arm), NAUSEA (nauseous), PYREXIA (fever - 102) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medication include a low dose hypertension medication.
about a half hour after the vaccine was given my mouth and tongue were numb for about an hour then it went away but came back for another hour or so and went away again and stayed gone.
Shingles; This case was reported by a nurse via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-Nov-2022 Reporter's comment: The patient contracted shingles, the day after received Shingrix vaccine. The reporter agrees to follow up from GlaxoSmithKline. Additional supportive information: This was one of the 2 case reported by the same reporter. This case has been linked to the case US2022AMR160148 reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR160148:Same Reporter
side effects after getting the booster dose and these were worse than the 1st and 2nd doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after getting the booster dose and these were worse than the 1st and 2nd doses) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after getting the booster dose and these were worse than the 1st and 2nd doses). At the time of the report, VACCINATION COMPLICATION (side effects after getting the booster dose and these were worse than the 1st and 2nd doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.   This case was linked to MOD-2021-404967, MOD-2021-426874 (Patient Link).
Site of injection was swollen, red, itchy and hot. Started on 08/23/2010 7:00 PM. On 08/24/2010 7:30 AM face was swollen. Later at about 10:30 AM arm was hurting all the way to index finger. The site of injection was Triple the size. Face felt like it was burning. AT 12:00 PM took Zyrtec. AT 3:00 PM I was having difficulty breathing, very dizzy, took Benadryl. At 3:45 PM I was worse with difficulty breathing. Was taken to Emergency. In emergency I started to get a strong head ache and body ache.
stomach issues; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issues) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach issues). At the time of the report, ABDOMINAL DISCOMFORT (stomach issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Difficulty breathing, coughing attacks, wheezing, congestion, runny nose; required medication (pulmicort, albuterol) every 3-4 hours daily for 10 tens to open up airway.  Note: he has never needed medication continuously for more than 4 days
patient then saw a physician for arm pain; Initial information received on 12-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 61 years old female patient who experienced patient then saw a physician for arm pain (pain in extremity), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE once (lot UJ463AA and expiration date 19-Mar-2021) via unknown route in unknown administration site,for prophylactic vaccination.  On an unknown date (latency unknown), it was reported that, the patient received a flu shot with Flublok in her left arm.  There maybe was a little knot there after the vaccine.  The nurse caller stated she is assuming it continued.  The patient then saw a physician for arm pain (pain in extremity).  The physician told her it was most likely an adverse event due to the flu shot.  The patient then had an MRI for the arm pain.  The Magnetic resonance imaging (MRI) came back normal.  The arm pain continues.  The nurse stated that the patient says she is going to pursue this.       No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment..  Outcome of the event was Not Resolved at the time of reporting.