chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Local itching & swelling to injection site, 1 day post vaccination. Client visited clinic with concerns. Client was instructed by RN to continue antiinflammatories and to seek medical follow-up if swelling does not subside by next day. Client stated that she initially applied alcohol based perfume to cool skin. Instructions given not to place alcohol or perfume to affected area. Client stated understanding.
Employee started to have an itchy/tingling mouth about 10 minutes following vaccine administration. She was given diphenhydramine, which helped alleviate the symptoms. As the day went on she developed hives on her neck, chest, back, arms and hands. She continued to take Benadryl every 4-6 hours and all symptoms were gone within 24 hours after vaccination.
Patient asked for a flu shot and was given a flu shot.  At the end of the conversation she said, " I don't know why this is necessary?"  I asked her why a flu shot would not be and she said, "No, I wanted a COVID shot."  Patient stated she had a flu shot at another Pharmacy.  Informed patient of the misunderstanding and no adverse side effects have been reported.
It was reported a occurrence of elevated liver enzymes in a pt who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis. There were no known allergies.  On 1/16/03, the pt rec'd an injection of Twinrix; the number of previous injections of Twinrix was not specified. On the same day, the subject also rec'd typhoid vaccine (manufacturer unknown) and yellow fever vaccine (YF-Vax, Aventis Pasteur). On 1/22/03 6 days post immunization, the subject developed elevated liver enzyme (NOS), jaundice, lethargy, and dark urine. The pt was seen by his physician. As of 2/6/03, the events had improved. The reporter considered the events to be possibly related to Twinrix administration. The jaundice in this report is considered GSK medically serious.  Follow-up information received on 5/14/2003 states: On ? January 2003, concentrations of alkaline phosphate, total and direct bilirubin, asparte amniotransferase, ?alanin aminotransferase were found to be increased. Please see laboratory data section. The physician made a diagnosis of chemical hepatitis.  The physcian considered made diagnosis of chemical hepatitis.  The physician considered the chemical hepatitis to be related to Twinrix administration. The chemical hepatitis resolved on 27 March 2003.  Hepatitis is considered medically serious (OMIC).
Dose of Moderna was possibly drawn from a vial that was previously punctured a few days before, but had been refrigerated in between.
Large area of redness and swelling concentrated in the upper half of the left upper arm (especially the deltoid area), but involving the entire arm.
soreness followed by inc discomfort over first few days w/persistence over months;dx brachial plexitis;
both of his arms are itchy; A little bit red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (both of his arms are itchy) and VACCINATION SITE ERYTHEMA (A little bit red) in a 72-year-old male 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (both of his arms are itchy) and VACCINATION SITE ERYTHEMA (A little bit red). At the time of the report, PRURITUS (both of his arms are itchy) and VACCINATION SITE ERYTHEMA (A little bit red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included an unspecified cholesterol medicine.  Treatment medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received on 09JUL2021,  updates reporters contact information.
Information has been received from a registered pharmacist concerning her 18 year old daughter, who on an unknown date, was vaccinated with several doses of GARDASIL. The pharmacist reported that the patient experienced symptoms similar to mono after the vaccine. She had swollen lymph nodes after each dose and she felt achy and feverish for several days. The patient's outcome was unknown. No further information is available.
Body hurting; Headache; Chills; Fever of 99.0 Fahrenheit; This is a spontaneous report from a contactable consumer. A 29-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported) via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medication were not reported. On an unspecified date in 2021, patient had body hurting, headache, chills and fever of 99.0 Fahrenheit. The outcome of all events was unknown.  Information on lot/batch number has been requested.
This spontaneous report was received from a nurse concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On 18-FEB-2016, the patient was vaccinated with an expired dose of ROTATEQ (Lot # K004795, expiration date: 11-FEB-2016), oral. No adverse effect was reported. Additional information has been requested.
Patient recieved smallpox vaccine that was reconstituted with sterile water instead of 50% glycerin, and 0.25% phenol in Sterile Water. Patient does not have any adverse reaction site looks within normal limits.
PATIENT EXPERIENCED REDNESS AND ITCHING AT INJECTION SITE, INCLUDING A RED AREA THE SIZE OF A QUARTER.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, since 01-MAR-2015, the patients were vaccinated with improperly stored doses of VAQTA, (dosing details not reported). No adverse effects were reported. The vaccine was exposed to high temperature of 10.3 degree Celsius for a cumulative time frame of 731 hours from 24-NOV-2015 through 26-OCT-2016. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse reaction notified. The zoster vaccine expired 12/12/17 and was given on 12/14/17.
disruption of menstrual cycle. I've had a regular cycle my entire life. The only time I have been late is when pregnant. I am not pregnant now and over 23 days late. My sister also was very regular and had a disruption in her cycle. The only change in my medical history is getting the Pfizer vaccine.
Swelling in the left and right ankles.  The left ankle has the most swelling. The swelling occurs intermittently and has not been associated with any activity. When it is mildly painful, I lay down and raise my legs. I have not had any previous history with my ankles swelling prior to July 2021. Also, about three weeks after the vaccine I had severe pain in my right elbow and right shoulder.  The pain resolved in about 4 to 5 weeks.
12 days after injection a slightly raised, slightly warm, circular red ring/rash appeared around the injection site (about three inches in diameter).  It was mildly itchy, which was adequately addressed by a low dose of Benadryl and a topical antihistamine.
It's painful and it goes up into my shoulder; Rash at the injection site; Rash is so itchy; Its painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (It's painful and it goes up into my shoulder), INJECTION SITE RASH (Rash at the injection site), INJECTION SITE PRURITUS (Rash is so itchy) and INJECTION SITE PAIN (Its painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN (It's painful and it goes up into my shoulder), INJECTION SITE RASH (Rash at the injection site), INJECTION SITE PRURITUS (Rash is so itchy) and INJECTION SITE PAIN (Its painful). At the time of the report, PAIN (It's painful and it goes up into my shoulder), INJECTION SITE RASH (Rash at the injection site), INJECTION SITE PRURITUS (Rash is so itchy) and INJECTION SITE PAIN (Its painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
05/01/2022, I started experiencing random all over body pain. I tried several different anti-inflammatory medications.  Pain became increasingly worse in October 2022.  My primary care physician ran blood tests in October and I was found to have markers for Mixed Connective Tissue Disease. It comes and goes and I have flare ups. I started a course of steroids this morning.  I have been referred to a Rheumatologist, who I will see in March.
Migraine type headache; Sleep disturbance; Vomiting; Shoulder pain; Body ache; Headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine type headache), SLEEP DISORDER (Sleep disturbance), HEADACHE (Headache), PYREXIA (fever) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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, 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 experienced MIGRAINE (Migraine type headache), SLEEP DISORDER (Sleep disturbance), HEADACHE (Headache), PYREXIA (fever), VOMITING (Vomiting), ARTHRALGIA (Shoulder pain) and MYALGIA (Body ache). At the time of the report, MIGRAINE (Migraine type headache), SLEEP DISORDER (Sleep disturbance), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown, PYREXIA (fever) and MYALGIA (Body ache) had resolved and ARTHRALGIA (Shoulder pain) had not resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.
This spontaneous report was received from an office manager and refers to a 4 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 18-OCT-2016, the patient was vaccinated with the first improperly stored dose of  VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Immediate redness of arm surrounding the injection site.  Redness/blotchiness spread from arm across entire chest.  Legs felt heavy and weak.  Heart racing. Face red and may have been slightly swollen as well, as noted by medical staff.
Patient vomited for 48 hours after the vaccine was given.  Patient had low grade fever (not documented).  Also received other vaccines that day.  Vomiting began about two hours after vaccine was given.  Mom refused second dose at 4 monts of age.
This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 62-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles (over 50 times prior to getting the Shingles vaccine after the 1st dose) and foot surgery. On 1st October 2018, the patient received the 1st dose of SHINGRIX. On 7th January 2019, the patient received the 2nd dose of SHINGRIX. In October 2018, 21 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles. On 24th February 2019, the patient experienced headache. On 25th February 2019, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and vesicle. On an unknown date, the outcome of the vaccination failure, shingles, headache, shingles and vesicle were unknown. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure, headache, shingles and vesicle to be related to SHINGRIX. Additional details were reported as follows: The reporter did not have batch number or expiry date for the suspect vaccine doses. The patient stated she had broke out in a shingles rash about 3 weeks later receiving 1st of SHINGRIX vaccine. The patient stated the rash occurred on her sacral area on the right side. The patient stated it always shows up in the same spot. The patient also mentioned that she had to have foot surgery after the 1st dose but did not gave any further information. The patient stated twice she did have the shingles rash on the sacral area on the left side. The patient stated yesterday on 24th February 2019 she developed a headache and today on 25th February 2019 a new vesicle appeared on the sacral area on the right side again. The reporter consented to follow up. This case was considered as suspected vaccination failure laboratory confirmation for shingles was not provided at the time of reporting.
Shot it settled in his spine and caused pain making it hard to walk; Shot it settled in his spine and caused pain making it hard to walk; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Shot it settled in his spine and caused pain making it hard to walk) and GAIT DISTURBANCE (Shot it settled in his spine and caused pain making it hard to walk) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (Shot it settled in his spine and caused pain making it hard to walk) and GAIT DISTURBANCE (Shot it settled in his spine and caused pain making it hard to walk). At the time of the report, PAIN (Shot it settled in his spine and caused pain making it hard to walk) and GAIT DISTURBANCE (Shot it settled in his spine and caused pain making it hard to walk) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
pt recv vax; 4 hr later, exp dizziness, nausea, fatigue and HA; tx w/ Advil; sx subsided next day;
sore throat 10/28/2011 - 12/10/2011 pain in muscles & joints, arms, legs  10/20/2011 - 12/21/2011  EXTREME PAIN IN SAME 10/30/2011 -11/28/2011 methocarbamol & meloxicam
Fever of 102.5-103.5 for 24+ hrs. Fever began 7 am 3/1/2018 (day after vaccination) and continued until 9 am 3/2/2018 the following morning. Patient was awake for a combined total of a maximum of 3 hrs during this time.
pt broke out in hives 24hrs p/vax;still on Amoxicillin for OM;
Around 9:55 pm on 2/27/2021 client took Afrin nasal spray for nasal congestion. About 5 minutes later (10:00 pm) client states he went into anaphylactic shock. The ambulance was called by his wife. Per client, her received infusions of epi and Benadryl from ambulance staff. Client was taken to Hospital for further treatment. He was subsequently transferred to Heart Hospital for overnight observation due to possible heart issues. Note: Client has take Afrin nasal spray for over 30 years and has never had a reaction.
THE EVENT WAS ANAPHYLASTIC RHATION (DIFFICULTY SWALLOWING COMPLETELY NULL, DID NOT SWALLOW) NUMB HANDS AND FEET. DISCOMFORT IN THE THROAT. INFLAMED AXILLARY NODULES. TREATMENT OF SOLOMEDROL SERUMS, BENADRYL SERUM. THEN BENADRYL PO EVERY SIX HOURS.
Severe headache located at the back of the head that started 10 mins after administration and lasted approximately 3 weeks. Tylenol and Ibuprofen did NOT improve symptoms. Still getting occasional headaches in the same location. Never had headaches like this before.
States that evening (1/3/19) she had severe pain and swelling in her Right shoulder. Pain continues, decr ROM, unable to raise her arm high enough to put her coat on. Woke drenched in sweat the first night. She understands this could have been from getting the vaccine. Dr talked to her in detail. Couldn't lift her arm for a few days. Now can lift her arm to chest level. Pain is more in shoulder then arm.
Experienced greater head pain; This case was reported by a consumer via call center representative and described the occurrence of headache in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles a year ago on 6th January 2021, which left her with nerve pain on the left side of her head), nerve pain (on the left side of her head) and headache. Concomitant products included pregabalin.   On 1st February 2022, the patient received the 1st dose of Shingrix. On 2nd February 2022, 1 days after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced greater head pain than she had previously. This head pain was unresolved. No further information reported. The reporter consented to follow-up.
patient received flu shot instead of shingles shot (patient has already received a flu shot on 10/20/2021); after receiving the flu shot we realized patient had requested the shingles not flu; patient then proceeded to ask to still get the shingles shot. followed up with patient the next day and she was doing fine
Client reports getting the high dose Flu vaccine about (4) weeks ago. The day after she experienced left arm pain & then the area of the injection became somewhat swollen & hot to touch. Developed a fever as well (? not taken). Arm remains tender to touch & she is in PT to resolve problem. Does have hx of tendon problem for same area.
I received the injection about 2 pm and within the next hour, I started to feel "odd" and a little cold. I was out running errands, so I decided to go home. As soon as I arrived home, I went to bed with the chills. By 7 pm my temperature was 102 and by 9 pm it was 104. The fever continued all through Weds Nov 6, running about 102 and I stayed in bed all day, drinking fluids, but no appetite. Sometime during that next night I woke up covered in sweat and the fever was gone. I spent Thursday Nov 7 feeling weak and wobbly and stayed home all day. Friday, Nov 8,  was the first day I felt like myself.
immunocompromised; general malaise; feeling bad; Initial information was received on 10-Oct-2023 regarding an unsolicited valid serious case received from a consumer/non-health-care professional.  This case is linked to case 2023SA310485.  This case involves 66 years old female patient who experienced immunocompromised, general malaise and feeling bad after receiving influenza quadrivalent recombinant vaccine [Flublok QIV].  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 0.5 ml of suspect influenza quadrivalent recombinant vaccine (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for Immunization. The information on batch number was requested.  On an unknown date the patient developed immunocompromised (immunodeficiency), general malaise and feeling bad (feeling abnormal) (unknown latency) following the administration of influenza quadrivalent recombinant vaccine.  Reportedly "See inquiry 01795947 Consumer states that she had a bad reaction to a non-Sanofi influenza vaccine 3 years ago. See inquiry 01796949. But she has taken FLUBLOK "for many years" without any "bad side effects". She states that she has experienced general malaise and feeling bad after receiving FLUBLOK, but it wasn't a problem, compared to the experience she had a few years ago with the other vaccine. Consumer has questions about comparison of the different flu vaccines and which one she should take. MIS discussed comparison and referred to HCP."  Action taken with QUADRIVALENT RECOMBINANT influenza vaccine (Flublok QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the events (general malaise, feeling bad, immunocompromised).  At time of reporting, the outcome was Unknown for the event general malaise, feeling bad and immunocompromised.  Seriousness criteria : Medically significant for immunocompromised.; Sender's Comments: Sanofi Company Comment dated 13-Oct-2023 : This case involves 66-year-old female patient who experienced immunocompromised after receiving influenza quadrivalent recombinant vaccine [Flublok QIV].Further information regarding Past medical history, concurrent condition, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Mild throat closing, tongue swelling, chills, sweats, and nausea all overnight. Self resolving. Pt did not seek medical attention.
pt recv vax 30OCT96 & 3JAN98 pt devel a clinical illness dx to be chickenpox;
pt recvd vax 8AUG95 &  devel a vesicular rash;10 days later 6SEP95 pt devel a low grade temp of 99 & abd pain;pt did not devel any lesions or chicken pox;pt's sibling who were not vaxed devel chickenpox;