chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2/28 1 day after receiving INJ. Typhoid (TYPHIM-VI) and Hepatitis A (HAVERIX) dose #1 client developed low grade fever, body aches, chills, lightheadedness, HA. 3/1/18 she felt tight chested and experienced wheezing and cough and difficulty breathing.
Was administered an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Sep-2021, the patient received third 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) (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 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Large hives in the area of ??the vaccine and near the clavicle on the right side.
This spontaneous report has been received from a medical assistant, concerning to patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 06-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N002720 and expiration date 12-MAY-2019 (dose, frequency, route of administration were not provided) for prophylaxis. No adverse event was reported. The vaccine was stored at a temperature of 78° Fahrenheit or warmer, time frame of 26 hours; no previous temperature excursion was reported and digital data logger was not involved. No product quality complaint (PQC) was involved. Additional information has been requested.
Low fever - 100 Chills Fatigue Nausea Headache Soreness at injection site
Congestion; Fatigue; Cough; Loss of taste and smell; Loss of taste and smell; Aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP)via COVID-19 Adverse Event Self-Reporting. The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 11:15 (Lot number: ER8731) at the age of 27 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot number: EW0150, administration time: 06:15 AM, vaccine location: Left arm), administration date: 07Apr2021, when the patient was 27 years old, for COVID-19 Immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset 01Nov2021, outcome "recovering", described as "Congestion"; FATIGUE (non-serious) with onset 01Nov2021, outcome "recovering", described as "Fatigue"; COUGH (non-serious) with onset 01Nov2021, outcome "recovering", described as "Cough"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 01Nov2021, outcome "recovering" and all described as "Loss of taste and smell"; PAIN (non-serious) with onset 01Nov2021, outcome "recovering", described as "Aches". The events "congestion", "fatigue", "cough", "loss of taste and smell", "loss of taste and smell" and "aches" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nasal congestion, fatigue, cough, ageusia, anosmia, pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Info has been received from a CMA concerning a healthy 11 year old male pt with no allergies, who on 3/27/98 was vaccinated with a dose of varicella virus vaccine live. On 11/16/05, the pt developed 20-30 lesions, fever (103.2F) and headache. He was treated with Tylenol and supportive care. There was no product quality complaint reported. There was no other info available regarding the adverse event or the pt's outcome. Additional info has been requested.
Breakthrough case admission after 3 vaccines Moderna 3/7/21 Lot# 030A21A;  Moderna 4/5/21 Lot# 06B21A;  Moderna 12/6/21 Lot# 013F21A
injection site rash; red rash  at the injection site; warm  rash at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2022, the patient received the 1st dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced injection site rash, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site rash, injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, injection site erythema and injection site warmth to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the Shingrix on Monday.  On the day of reporting, he/she still had a warm, red, rash at the injection site.  The reported wanted to know was this normal. Additional Supportive Information: The follow up would not possible as no contact details were available.
malaise, headache, right earache, left arm pain (same side as vaccination), vomiting x 1.
Fever & Nausea Vomiting Narrative: fever of 99.9 and N/V.
The employee returned to work the day after her vaccination with facial swelling. She stated that she woke up around 7am and noticed the swelling. The employee arrived at work at 11am today. The employee was given 25mg BENADRYL by medical staff at 1105.
If symptoms prior to 5/1/12, I didn't think uncommon 5/1/12 pain with (R) shoulder movement, increased shoulder pain lying down - gradually worsened - 5/14/12: unable to use arm to turn steering wheel of car - tried ice, heat, MOTRIN with no relief. Saw orthopedic surgeon, x ray (+) bursitis, shoulder injected with XYLOCAINE & CELESTONE - ROM exercises given. MD stated possibility shoulder cuff was punctured with immunization since high deltoid injection.
Information has been received from a registered nurse concerning a 43 year old female employee who on 01-DEC-2008 was vaccinated with the first dose of VARIVAX (Lot# 661658/1135X). On 03-DEC-2008 the patient developed swelling and erythema at the injection site. The patient sought medical attention at the employee health. At the time of reporting (04-DEC-2008) the outcome of the patient was unknown. The nurse requested a lot a search of VARIVAX. A standard lot check investigation was performed. All in-process quality checks for the lot number investigation was performed. The testing performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several cases from the same source. Additional information has been requested.
Headache, fever, diarrhea, nausea/vomiting o/g x3 months
Case number PHEH2015US020590, is an initial spontaneous report received from a nurse on 13 Oct 2015. This report refers to a 52 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with an expired dose of FLUVIRIN (batch number: 1412701) intramuscularly at a dose of 0.5 ml on 08 Oct 2015. No adverse event was reported following this maladministration (expired vaccine used).
Information was received from a certified medical assistant concerning multiple unspecified patients, who on unknown dates, were vaccinated with ROTATEQ that were exposed to temperatures outside of recommended condition. No adverse events were reported. No further information was provided. This is one of four reports from the same reporter. Additional information has been requested.
Slight fever 8 days later, pebble under skin at vaccine site on LUE, posterior side then redness appeared at day 9 about nickel size then, increase to today's size 3.5cm x 2cm with induration.
This is a non serious spontaneous case from a nurse of a medication error. The reporter causality was not provided to Flumist. A nurse reported a series of medication errors. The nurse misunderstood the dosing instructions for FluMist and administered a double dose of vaccine to seven pt's . Prior to the administration of the vaccine she removed the dose divider clip thereby giving 0.50ml per nostril versus the prescribed dose of 0.25 ml per nostril. On 26Oct04, at 10:00 in the morning, the reporter gave a double dose of FluMist to a 34 year old female pt whose medical history was not reported. The reporter stated the pt had no adverse events. No further information is available.
This spontaneous report as received from a pharmacist refers to a 70 year old female patient with medical history of one knee replacement. ON 01-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J006155, expiration date 30-AUG-2014, 0.65 ml, subcutaneously) on arm. The patient's relevant concomitant medication and past drug history were unknown. In November 2013, the patient got a tiny bruise at the injection site. On 02-NOV-2013 the patient experienced soreness in her shoulder joint and in the knee that she did not have the replacement. The soreness was so bad that she could hardly move her knee or shoulder. It was unknown if there was relevant lab data. As of 03-NOV-2013, it was unknown if she would receive ZOSTAVAX again and she had not recovered from the events. Additional information has been requested.
Developed lymphadenopathy in clavicular lymph nodes with sweeping of left side of neck post vaccine  day 4. One week post vaccine developed itching and 2-3 inch welt at injection site. At this time neither have resolved.
Patient came to pharmacy at 10:15 AM today to show her arm. About 3" below injection site there is a raised (about 1/4") circular area about size of baseball that is red. She said she just noticed it in shower this A.M. She took Fexofenadine as usual.
PER PT:  IT STARTED ABOUT 2 DAYS AFTER INJECTION AS WELT, HARD KNOT, SENSITIVE TO TOUCH, HURT TO MOVE ARM.  NOW THOSE SYMPTOMS HAVE SUBSIDED BUT IT ITCHES RANDOMLY AND LOOKS LIKE THE SKIN IS PEELING (LIKE AFTER A SUNBURN).
Patient received SHINGRIX vaccine in (L) deltoid on 4/15/19 at approximately 10:30 am. Flu-like symptoms started less than 12 hrs. later at approx. 8 pm: chills, body aches, HA, loss of appetite, fatigue lasting until 4/17/19. Rash started on 4/16/19 in the morning with increasing swelling and pain since. Now measuring 12cm x 12cm rash.
lump in her arm; redness; hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump in her arm), ERYTHEMA (redness) and VACCINATION SITE WARMTH (hot to the touch) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE MASS (lump in her arm), ERYTHEMA (redness) and VACCINATION SITE WARMTH (hot to the touch). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (lump in her arm), ERYTHEMA (redness) and VACCINATION SITE WARMTH (hot to the touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient used Lexapro and second concomitant which name was not clear.
I had my first Pfizer dose on 4/11/21 and my second dose on May 2, 2021.  On June 14, 2021, I went to the ER because I was having trouble breathing, back pain, and side pain. After being admitted they performed a scan of my chest cavity and determined I had a pulmonary embolism resulting from a blood clot. They immediately put me on a blood thinner and I was discharged on June 16, 2021 and continued taking blood thinners for six months. The insurance company refused to pay for any more of the blood thinners and my doctor had me stop taking them.
To begin with the second day in I had chilled fever and was very tired and it kind of stayed for two weeks. My left ear was blocked and was having pain in the ear. The doctor said I did not have any infection.
itching head, face, and body itching; I am a little bit sensitive; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching head, face, and body itching) and SENSITIVE SKIN (I am a little bit sensitive) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PRURITUS (itching head, face, and body itching) and SENSITIVE SKIN (I am a little bit sensitive). At the time of the report, PRURITUS (itching head, face, and body itching) and SENSITIVE SKIN (I am a little bit sensitive) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient take blood pressure pill in Concomitant medication. No Treatment Medication was provided by Reporter.
My side effects from the 2nd dose started the next day. They were the same symptoms as first dose with fatigue, chills, body aches and a low grade fever. I was out of work for a week. I wasn't able to do anything. In August 2021 I tested positive for covid. Since getting covid it felt like my head was being squeezed in a vise, and I have been experiencing fever, chills, dizziness, loss of smell and taste, and brain fog. Sometimes it feels like I can do something but then when I actually do it I don't feel very well. I am still currently not doing well since getting covid.
Severe pain in arm where shot was administered. It is difficult to sleep on my side and have difficulty with simple tasks such as putting on my coat.
I am male 36 years old.  On May 5th 2021 around 8:20am, I received the Johnson & Johnson Vaccine at Pharmacy.  Within several hours that Same day I experienced soreness spread from the poke sight on my arm that spread outward to my entire body. Muscle soreness and joint pain. Physical fatigue and mental fog. Lately I've still been experiencing Muscle cramping without antagonizing with exercise. Also Lately I've been developing hives that come and go. My chiropractor has witnessed entire large muscle groups especially through my back, raised and inflamed.
Three weeks after receiving the vaccine, I felt very anxious and nervous as if I were high on caffeine. This anxious and nervousness along with trembling of hands continues. A month ago I started experiencing high blood pressure and erratic heart rhythm. I went to the ER at local Hospital.
FEVER; LOW ENERGY; EXTREME FATIGUE; SLEEPLESS; SEVERE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 )expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced severe headache. On 15-MAR-2021, the subject experienced sleepless. On 16-MAR-2021, the subject experienced extreme fatigue. On 21-MAR-2021, the subject experienced low energy. On 23-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from sleepless on 16-MAR-2021, was recovering from severe headache, and fever, and had not recovered from extreme fatigue, and low energy. The reporter considered related  causality between covid-19 vaccine ad26.cov2.s and sleepless ,severe headache, fever ,extreme fatigue, and low energy and company causality between covid-19 vaccine ad26.cov2.s and sleepless ,severe headache, fever ,extreme fatigue, and low energy was possible. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Cellulitis (R) upper arm. Started on KEFLEX - 25x 10 1/2 cm Follow-up in 2 days
Information has been received from a 25 year old female with no known drug reactions/allergies who on an unknown date was vaccinated with the first dose of GARDASIL.  This is part of a pregnancy registry.  On 17-MAY-2007, the patient was vaccinated with a second dose of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified).  3 months later, on approximately 17-AUG-2008, the patient returned for the third dose and a urine test was positive for pregnancy.  On an unspecified date, the patient was hospitalized and delivered a female infant one month early on 19-APR-2008 via Cesarean section due to breech presentation.  The infant is healthy.  Additional information has been requested.
immun given 15JUN93; pt devel fever @ 130AM on 17JUN93 to 105; 130PM 17JUN93 temp down to 99.7 R: pt also has BOm & has been taking Suprax;
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Patient's pertinent medical history and drug reaction were not reported. On 28-JAN-2016 the patient was vaccinated with a second dose of  RECOMBIVAX HB lot # L026037, expiration date on 17-JAN-2018 (dose, frequency, route of administration and anatomical location were not provided), which was later than the recommended dosing schedule (inappropriate schedule of drug administration) (Date of first dose was not provided). No adverse reaction was reported. Product quality complaint was not filled.  Additional information has been requested.
Headache nonstop, sinus congestion shooting pains, brain fog, fatigue, muscle aches,  joints hurt, tinnitus, brain burn, photosensitive, dizzy.  Was making progress getting over long COVID.  Vaccine brought back all symptoms.  Second vaccine on 4/16/2021 made it worse.  Symptoms have not abated to date 3/28/2023 still unable to work.  No treatments have helped.  No OVC medications help and prescription Amitriptyline, Pravastatin, Plavix, Maraviroc, Antihistamines, Prednisolone, Fluvoxamine, Nambumentone,
Arm sore for the following 3 weeks. Not able to move arm laterally or above horizontal to the ground. It has been 3 weeks and 1 day, and it is slowly improving, but still painful. Doctor's appt at 2 weeks indicated no infection. No action taken by Dr other than use of OTC pain medications.
tiredness; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) in a 68-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills). At the time of the report, FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medications were reported. The patient reported that he had regular symptoms tiredness, fever, chills, those kind of things. Treatment information was unknown.   This case was linked to MOD-2022-543630, MOD-2022-543627 (Patient Link).
The shot felt painful as it was administered. Her arm has been very sore every since. No physical swelling is present.
Storage unit temperature excursion, vaccines deemed non viable by manufacturer contacting patients for re-vaccination.
pt recvd vax & approx 4 days later, exp serum-like sickness & was hospitalized; pt was treated w/IV steroids & discharged from the hospital p/3 days;
SEVERE BACK PAIN; SEVERE MUSCLE PAIN IN LEGS; TINGLING OF LEGS; NUMBNESS IN LEGS; DIFFICULTY IN WALKING/LIMPING; This spontaneous report received from a pharmacist concerned a 50 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-Jun-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-APR-2021, the subject experienced severe back pain. On 20-APR-2021, the subject experienced severe muscle pain in legs. On 20-APR-2021, the subject experienced tingling of legs. On 20-APR-2021, the subject experienced numbness in legs. On 20-APR-2021, the subject experienced difficulty in walking/limping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe back pain, severe muscle pain in legs, tingling of legs, difficulty in walking/limping, and numbness in legs. This report was non-serious.
1 day p/vax pt devel an inj site rxn characterized by pain,inflammation & edema;pt treated w/ibuprofen & applications of ice;this is 1 of 2 pt of this facility, out of 53 vaccinees, to have an adverse exp p/vax;
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the new pneumonia shot brought back feelings of the illness the patient had after taking the shot, on an unknown date, last year (2016). Patient also reported that for 3 days she ran a fever and felt as though she had a bad case of the flu on an unknown date. Patient added she was not aware of the effect it could have on the lungs. Had she known prior to having the shot, she probably would not have had the vaccine. Outcome of the events was unknown. No follow up attempts are possible. No further information is expected.