chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Hep A on 2/20/16, broke out in a rash on 2/21/16. Mom gave low dose Benadryl with no improvement. Child was seen in the office on 2/22/16, no treatment recommendation at this time. Advised rash may be present 1-2 weeks and to return to the office if there is no improvement.
Rash on right side; This is a spontaneous report received from a contactable consumer, the patient. A 75-year-old male patient received the 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number; EN6206) via an unspecified route of administration in Left arm on 11Mar2021 at 11:00 am (at the age of 75 years) for COVID-19 Immunization. Concomitant medications included Cholesterol, Blood Pressure, Prostate, Vitamins. Patient's medical history was reported as Cholesterol, Blood Pressure and BPH- Benign prostatic hyperplasia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021 at 08:00 am, the patient experienced rash on right side. The patient did not receive any treatment for the events. The clinical outcomes for rash were not recovering/not resolving. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
Tingliness or numbness throughout the body; Tingliness or numbness throughout the body; This is a spontaneous report received from a contactable pharmacist. A patient of unspecified age and gender received the first dose of BNT162B2 (Pfizer 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 experienced tingliness or numbness throughout the body on an unspecified date. Pharmacist was wondering if any reported reactions to the vaccine that was in patient regarded as tingliness or numbness throughout the body. Outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
12-15-11 Nauseated. Left upper deltoid muscle tender, pink & raised area 11 x 14 cm on 12-19-11. 12-17-11 pt. states had some diarrhea with nausea without any vomiting. 12-19-11 Rx for BACTRIM DS PO x10 days called to pharmacy. Pt. advised per MD to use warm soaks & MOTRIN PRN as directed.
a patient received an expired dose of FLUZONE HIGH-DOSE QUADRIVALENT vaccine/ No AE; Initial information received on 18-Nov-2021 regarding an unsolicited valid non-serious case received from a pharmacist via consumer.  This case involves an unknown age and gender patient who received an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "Patient received expired Fluzone High Dose, when can patient be re-vaccinated with current seasons vaccine. Any timing/ spacing considerations."  At the time of reporting, no adverse event was reported.  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.  There will be no information on the batch number for this case.
foaming from mouth;spasticity of all extremities last 1-2min;had one sz 10DEC97;had 7 sz on 11DEC97;
Flu like symptoms; Generalized aching; Chills; Fever; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Generalized aching), CHILLS (Chills) and PYREXIA (Fever) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB for Plaque psoriasis.    No Medical History information was reported.   On 18-Nov-2020, the patient started RISANKIZUMAB (Subcutaneous) at an unspecified dose. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Generalized aching), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Generalized aching), CHILLS (Chills) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  Concomitant medication not provided.  Treatment information not provided.   This case was linked to MOD-2021-033451 (Patient Link).
Started with severe headache Continued with all over body aches Next day woke up with fever  Even when treated with Tylenol, fever got as high as 102. 4 Within 24 hours I was better but very sluggish and still a little light headed
Subsequent to receiving first and second doses of varicella virus vaccine live, laboratory evaluation revealed a lack of response.
nausea aprox 10 min after injection and the following day, treated with Meclizine. Fatigue several hours after injection through 36 hours after.
It was reported that an 18 year old female pt received a Fluzone (U0926BA) administered in her right deltoid, at 6:25 pm on 11/12/02. Immediately after vaccination the pt stated she felt flushed and dizzy. She was given orange juice and cookies, ammonia inhalent was offered. No rash at injection site was noted, no SOB, and lungs sound clear bilaterally. Reportedly the pt recovered. This case is closed.
Patient phoned this AM reporting that she had developed hives at 1:30 AM on 8-12-17. She received Td in our clinic on 8-11-17 at approximately 2:30 PM. States she woke up feeling itchy and noted hives on arms, in mouth and her head felt "itchy." Said she has had hives in past from medications, but has not had them since January 2017. Her immunization screening form listed allergies to PCN, prednisone, CELEBREX, and NEOSPORIN which are not contraindications for Td. States she took 2 BENADRYL tablets at 1:30am, and then Q6hrs x 2 after that on 8/12/17. Hives then dissipated and she did not take any more BENADRYL. Has not had any further hives since that time.
Within the 7 min of the waiting period the patient felt lightheaded and had some visual disturbances. She came to the pharmacy and sat on the floor and when asked she explained what happened. She was told to lay down with feet elevated and she felt a bit better. She asked for water and she felt better. She laid down for 15 minutes and said she could leave but we asked her to stay seated and see how she feels and then after another 15 minutes she said she is fine and left and after an hour called to let us know she is feeling fine.
an expired dose of the vaccine was administered; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (an expired dose of the vaccine was administered) 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 EXPIRED PRODUCT ADMINISTERED (an expired dose of the vaccine was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (an expired dose of the vaccine was administered) had resolved.            Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.
This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender, who on an unknown date was vaccinated with a third dose of GARDASIL, (dose, route and Lot# not reported) 6 weeks from the dose 2. Additional information has been requested.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed blisters on her back which spread to her face, stomach, chest, legs and feet. Pt was treated with calamine lotion and acetaminophen. Five days post onset the pt recovered. The pt experience was a mild breakthrough case of chickenpox.
High fever ( 101F) 12 hrs after vaccination; Chills; Swollen lymphnodes under vaccinated arm; Aches; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6953) via an unspecified route of administration in the left arm on 01Apr2021 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 02Apr2021 at 02:00, the patient experienced chills, ache and swollen lymph nodes under vaccinated arm and at 02:30,  12 hours after vaccination, the patient experienced high fever(101F). The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 02Apr2021 at 02:30, the patient underwent  body temperature measurement which was 101 Degrees Fahrenheit(F). The clinical outcome of the event high fever  was recovered on 03Apr2021 (lasted 1.5 days) and that of chills, ache and swollen lymph nodes under vaccinated arm was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Pt recvd 3 doses of Engerix-B on 31AUg89, 25SEP89 & 2MAR90; following these titer was neg; pt given a 4th dose of vax 9AUG90; pt seroconverted p/4th dose;
injection site reaction; sore arm   Narrative: Patient is a 75 year old MALE who received the 1st dose of COVID vaccine 3/3/21. Spoke w/pt today RE: adverse reaction related to  the vaccination.------------------------------------------------------------------------ SYMPTOMS: Fever No If yes temp: n/a Fatigue No Myalgia No Arthralgia No Rash/Hives No SOB No Bell's Palsy No Injection Site Reaction Yes Other No If yes describe: sore arm x1 day
Seen in office 36-48 hours after start of symptoms. 4 inch x 4 inch red, blanchable warm lesion to upper right arm. No pain. No itching. Antibiotic will be started. Ibuprofen PRN. BENADRYL PRN will monitor closely.
Violently throwing up for 12 hours; Diarrhea; Chills; Sweats; tight chest; could not get out of bed for 3 days; don't feel myself; feeling achy; no energy; chest hurts; This is a spontaneous report from a contactable consumer (patient herself). A 57-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6206) via an unspecified route of administration in left arm on 08Mar2021 01:45 as dose 1, single (at the age of 57-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19, prior to vaccination. Patient was not tested for COVID-19, post vaccination.  Patient medical history was not reported. Patient had no known allergies. The concomitant medications included reflux medicines, hormones and allergy medicines. On 09Mar2021 at 04:00, patient started violently throwing up for 12 hours, diarrhea, chills, sweats, tight chest, could not get out of bed for 3 days. Even after 6 days from start of events on 09Mar2021 at 04:00, patient still did not feel herself, was still feeling achy, no energy, chest hurted. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient received anti-nausea medicines to help with throwing up. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Shingles; sore arm; This is a spontaneous report from a contactable consumer (patient's daughter). An 88-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (at the age of 88-years-old), administered in Arm Left on 16Mar2021 11:45 (Lot Number: EN6208) as 1st dose, single for COVID-19 immunisation. Medical history included ongoing hypertension about 20 years ago, ongoing arthritis about 20 years, ongoing hypercholesterolaemia about 20 years, pneumonia. Unspecified concomitant medications were taken ("he has been taking the same medications for many years and doesn't find his medications relevant. He isn't taking any new supplements or anything like that"). The patient previously has had the pneumonia vaccine and the flu vaccine with no problems. The patient experienced sore arm on 16Mar2021 and shingles on 02Apr2021. The patient received his first Pfizer Covid 19 vaccine on 16Mar2021. The patient had a sore arm beginning the evening of 16Mar2021 after he received his Covid 19 vaccine. Patient's daughter had asked the patient when his arm wasn't sore anymore and he said 2-3 days after the COVID 19 vaccine. The shingles started on Friday, 02Apr2021 (2.5 weeks after the vaccine) and is showing a sciatic distribution. Caller reports the shingles is worsening. He's getting new patches in his lumbar region, left buttock, left back and upper thigh. He was diagnosed with Shingles on 04Apr2021 by his primary care doctor. He has been prescribed Valtrex today for 7 days (1 gram three times daily) which will put him finishing the Valtrex on 11Apr2021. He has not started taking it. Her father's second Covid 19 vaccine is scheduled for 13Apr2021. She is asking if it's ok that her father take the Valtrex and should he push back getting his second Covid 19 vaccine a week or so. The events did not require a visit to the emergency room or physician office. Therapeutic measures were taken as a result of shingles. The outcome of the event sore arm was recovered on an unspecified date in Mar2021 while for shingles was not recovered. The events were considered as non-serious. No prior vaccinations within 4 weeks, no adverse events following prior vaccinations.
No adverse event.  Patient received 2nd dose Pfizer instead of Moderna. Patient had vaccinated by Moderna first dose.
At 30 minutes post administration I developed a right sided headache. At 45 minutes post injection I developed right sided neck, arm, and back pain. During the night post administration I developed a racing heart which awoke me out of my sleep with associated tight/crushing chest pain. This lasted part of the night while the rest of the night I had severe night sweats and then chills in the morning. During the day I had significant weakness, fatigue, body aches, joint pain of the right hand, and depression. On the evening of 2/8 I had significant right sided back pain.
hot forehead; Pain at injection site; chills; muscle pain; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot forehead), VACCINATION SITE PAIN (Pain at injection site), CHILLS (chills), MYALGIA (muscle pain) and FATIGUE (Fatigue) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (hot forehead), VACCINATION SITE PAIN (Pain at injection site), CHILLS (chills), MYALGIA (muscle pain), FATIGUE (Fatigue) and PYREXIA (Fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FEELING HOT (hot forehead), VACCINATION SITE PAIN (Pain at injection site), CHILLS (chills), MYALGIA (muscle pain), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.            Concomitant product use not provided.   Reporter did not allow further contact
Started with feeling like my muscle was vacant and not there. A few weeks later I got a rash around my around and then I felt pain. So much pain I could not move my arm. I went to ER and they gave me anti-inflammatory which helped a bit during the rest of the summer. In the fall and winter the pain came back and was worse. I started physical therapy in January and still have muscle weakness, and something there but not arm disabling pain. Physical therapist gave me a shot in my joint which made me feel a lot better.
not feeling well; have a fever like a hundred or a little bit over 100; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) and PYREXIA (have a fever like a hundred or a little bit over 100) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well) and PYREXIA (have a fever like a hundred or a little bit over 100). At the time of the report, MALAISE (not feeling well) and PYREXIA (have a fever like a hundred or a little bit over 100) outcome was unknown.
LOSS OF APPETITE; SLIGHT CHILLS; TENDERNESS AT SITE OF INJECTION; FATIGUE; SEVERE MUSCLE ACHE; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight was 117 pounds, and height was 67 inches. The patient's concurrent conditions included: non-alcohol user, non-smoker, allergy to lotion, and allergy to gum. The patient had no history of drug abuse or illicit drug use and no allergy to any medication. The patient experienced drug allergy when treated with dimeticone for drug used for unknown indication.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204B214, and expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the patient experienced loss of appetite. On 29-JUL-2021, the patient experienced slight chills. On 29-JUL-2021, the patient experienced tenderness at site of injection. On 29-JUL-2021, the patient experienced fatigue. On 29-JUL-2021, the patient experienced severe muscle ache. The action taken with covid-19 vaccine was not applicable. The outcome of the tenderness at site of injection, fatigue, severe muscle ache, slight chills and loss of appetite was not reported. This report was non-serious.
This spontaneous report as received from a 31 year old female consumer (reporting on herself), with unspecified digestion problems and none drug reaction allergies. On 05-AUG-2013 the patient was vaccinated with a dose of GARDASIL (Lot # not reported) (dose and route not reported). There was no concomitant therapy. On 05-AUG-2013, 5 min after onset of therapy, the patient experienced loss of memory, loss of vision, numbness, tingling, vomiting and pain. The patient went to the emergency room and no treatment was given for the adverse events. Laboratory diagnostic studies were not performed. The outcome of loss of memory, loss of vision, numbness, tingling, vomiting and pain was reported as not recovered. Upon internal review the loss of vision was considered an other important medical event. Additional information has been requested.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medication was reported.
transit complete loss of hearing of both ears after first shot.  Patient stills has hearing changes that after significantly worse then prior to shot
Intense swelling, itching, and heat of upper arm where vaccine given, spreading to lower arm, had to cut her sleeve to get arm in, got abx and steroids, got better.
The first dose of this vaccine was administered toward back of upper right shoulder. There were no adverse side effects following this. Administered on 8/5/22. Clinic then switched to administration of the vaccine subcutaneously in the bottom of the upper forearm. As a result of this form of administration, swelling at the injection site, redness, itching and some tenderness  resulted approximately 12 hours following administration. Redness has continued to increase as has minor swelling, itching and tenderness. Visually, the reaction at the injection site looks worse this morning, 9/12/22 at 10:00am than it did very early morning as indicated above. There is no fever or severe adverse reactions associated with administration. Adverse reaction is currently localized and increasing slowly at injection site.
This case was reported by a nurse via sales rep and described the occurrence of injection site induration in a 16-year-old male patient who received BEXSERO. In June 2016, the patient received BEXSERO. In June 2016, less than a week after receiving BEXSERO, the patient experienced injection site induration, injection site erythema, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site induration, injection site erythema, injection site warmth and injection site pain were unknown. It was unknown if the reporter considered the injection site induration, injection site erythema, injection site warmth and injection site pain to be related to BEXSERO. Additional details were provided as follows: This case was not previously reported to anyone. The patient received  a dose of BEXSERO vaccine and developed a large area of induration between vaccination date and the date of reporting, approximately 3 to 6 inches. The redness surrounding the induration was a bit larger. The injection site had a hot feeling and was painful. The reported vaccination date was unclear: it could be the 15th June 2016 or 16th June 2016. The Medical Science Liaison (MSL) received the adverse events in the form of an email so, he did not have address of the reporter.