chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortness of breath; Felt like when patient had COVID19 Virus; Knot at injection site; Fever; Chills; Injected arm was very sore; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (Shortness of breath), COVID-19 (Felt like when patient had COVID19 Virus), VACCINATION SITE REACTION (Knot at injection site), PYREXIA (Fever) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive in January 2021.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE REACTION (Knot at injection site), PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PAIN (Injected arm was very sore). On 16-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath) and COVID-19 (Felt like when patient had COVID19 Virus). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), COVID-19 (Felt like when patient had COVID19 Virus), VACCINATION SITE REACTION (Knot at injection site), PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PAIN (Injected arm was very sore) outcome was unknown.        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.   concomitant products used for Hypertension ,Hyperlipidemia and Thyroid however the product information was not provided.
Patient's arm became red and itchy at injection site. Patient's caregiver thinks it was given to close to inside of arm and not in deltoid so it would have been more of a SQ injection vs an IM in deltoid.
This spontaneous report as received from a Licensed Practical Nurse refers to a 9 months old patient. The patient was vaccinated with VAQTA (route, dose and lot # were unknown) rather than RECOMBIVAX HB on 07-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. No product confusion, just an administration error. The outcome of event was unknown. Additional information has been requested.
- triggered menstruation 1 week early - menstruation was prolonged by 4-5 days - fever/ myalgia/ axillary lymph node pain for 24 hours, exactly 24 hours after the first shot
4 hrs after shots with crying inconsolably. Gasping for breath-parent reported apneic spell and shaking episodes she felt hot to touch and had body rash. Pt assessed at ER, tx with IV fluids, admit for obs.
Patient received twinrix vaccine on 07/28/2005 and called the clinic to report that she was experiencing a headache and an increase in rash symptoms and some welts that were itchy.  She had received the first twinrix vaccine on 06/30/2005 along with being given one gram of zithromax at the clinic visit that day.  She states she started to get a rash the evening of the 30th.  On 07/28/2005 she was seen at the clinic for rash symptoms and was told to use an OTC hydrocortisone cream.  She reportedly has broken out in a rash after drinking wine before and states the rash increases when out in the sun.  Patient received twinrix dose number 2 after seeing the doctor and she phoned in to the clinic the next day to report increased symptoms noted above regarding the rash.  She was advised to report to the local emergency room for possible treatment.  She had reported an increase in the headache also.  Patient at that time felt symptoms were due to the twinrix vaccine and not the zithromax that was given previously.
This spontaneous report (local reference number:US12-047886) as received from a physician refers to a male patient of unknown age. On 04-SEP-2012, the patient received an unspecified flu vaccine (lot # and manufacturer unknown) and on 06-SEP-2012 the patient received the first instillation of his second treatment with TICE BCG (lot # unknown). No concomitant medications were reported. Approximately on an unknown date in September 2012, the patient experienced flu like symptoms and decreased appetite within one week after he received. The patient had no fever. The physician asked if there were any interactions with flu vaccine and TICE BCG live. It was unknown if the patient had sought medical attention. No treatment information was reported. The outcome of flu like symptoms and decreased appetite was unknown. Additional information has been requested.
2-3 days after pt received vaccine she developed bilateral lower extremity, flat rash which originally was on the dorsum of both feet and legs. It spread proximally to above the ankles. She has bilateral swelling and pain. Was biopsied and was diagnosed with IGa vasculitits
urticarial rxn @ the site of the inj;looked like hives, very pruritic, non-tender w/erythema;occurred w/in 8-10hr of vax;tx w/DPH but kept growing in size over 2-3 days;treated by allergist w/steroids w/relief by 16OCT95;
rash on her arms and legs; redness spread down to her elbow; injection site started to turn birght red; arm on injection site swelled a bit; felt warm; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site started to turn birght red), VACCINATION SITE SWELLING (arm on injection site swelled a bit), VACCINATION SITE WARMTH (felt warm), ERYTHEMA (Redness) and RASH (rash on her arms and legs) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site started to turn birght red), VACCINATION SITE SWELLING (arm on injection site swelled a bit), VACCINATION SITE WARMTH (felt warm) and ERYTHEMA (Redness). On 06-Feb-2021, the patient experienced ERYTHEMA (redness spread down to her elbow). On 07-Feb-2021, the patient experienced RASH (rash on her arms and legs). On 08-Feb-2021, VACCINATION SITE SWELLING (arm on injection site swelled a bit) and VACCINATION SITE WARMTH (felt warm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (injection site started to turn birght red), ERYTHEMA (Redness), RASH (rash on her arms and legs) and ERYTHEMA (redness spread down to her elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Reporter did not allow further contact
Currently 32 weeks pregnant, delivery date of March 14,2021. The next morning I had a sore arm  that lasted 2 days. A couple days of fatigue. I had on episode of vomiting, I believe it was the 12/31 or 1/1/.
Local rash (5-10 cm), pain at injection site x 4 days, Fever and chills x 36 hours, muscle aches x 36 hours, nausea, headache
(L) Arm Pain with Movement. Tx: Moist Heat, ADVIL and ALEVE for 5 days
Swollen lymph nodes; painful lymph nodes; chills; fever; body aches; headache; fatigue; pain redness and itching at injectionsite; itching at injection site; pain redness and itching at injectionsite; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Apr2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and spinal arthritis with radiculopathy. 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. Concomitant medications included cyclobenzaprine (MANUFACTURER UNKNOWN) and brimonidine tartrate (ALPHAGAN); both from an unknown date, for an indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Mar2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 (also reported at 00:00), the patient experienced swollen lymph nodes, painful lymph nodes, chills, fever, body aches, headache, fatigue, pain redness and itching at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph nodes, painful lymph nodes, chills, fever, body aches, headache, fatigue, pain redness and itching at injection site was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Described that an itchy rash which started after dinner, in the evening,  in the bicep and waistband area.  The rash continued to spread to most of the rest of his body by the next day (Tuesday, 11/02/10).
Patient's second pregnancy, 35 weeks and 3 days. History of fibroids and IUGR last pregnancy. Estimated due date February 18, 2021. No signs or symptoms experienced until Growth ultrasound performed on 1/21/21, Monthly growth ultrasounds performed after 20 weeks gestation due to pregnancy history. Ultrasound on 1/21/21 showed fetus weight estimated 6 pounds, and new umbilical varix which was not seen on any previous ultrasounds.  Patient was sent to triage at delivery hospital, and cesarean section was performed 1/22/21 due to high risk of still birth related to umbilical varix.
The patient was given the 12 and older dose. The 12 and older covid vaccine was administered with the consent of the parent prior to her 12th Birthday.  The patient stayed in the office 15 minutes post injection. The patient's mother stated she did not have any signs or symptoms of any adverse reaction to the covid vaccine.
CHILD HAD IRRITABILITY, SWELLING OF LEFT EXTREMITY HIP DEC ROM AND SWELLING OF LEFT KNEE
About a week after vaccination, a 3 inch square of redness appeared on upper arm. This gradually spread covering about two-thirds of the way down my upper arm. As it spread the redness lightened in color. It was warm to the touch and itched a bit intermittently, but was not sore. It lasted about a week and is now gone. No treatment was given or sought.
Narrative COVID infection following COVID vaccine series 04/13, Pfizer,  dose #1 05/04, Pfizer, dose #2 09/10 COVID-19 ANTIGEN (BINAX): not detected 12/24 COVID swab, result: detected 12/22 pt cc: cough, diarrhea, exposure: unknown 12/24 SARS-COV-2 Variant Sequencing: pending 12/24  pt admit ED cc: intermittent fevers and chills dx: COVID 19 nasopharyngitis LOS: 1  day
Post-menopausal (15 years) heavy bleeding & clotting. Vaginal ultrasound showed mass in uterus
PERIPHERAL NEUROPATHY 4/15/2023 ELEVATED TROPONIN I ACUTE NON ST ELEVATION MI 4/11/2023 ELEVATED TROPONIN I PERIPHERAL NEUROPATHY 4/15/2023 HTN (HYPERTENSION) ACUTE NON ST ELEVATION MI 4/11/2023 HTN (HYPERTENSION)
Pt rec'd immunizations on 8/23/11. (L) arm swelling reported to triage RN on 8/24/11 1630. 8/29/11 Swelling improved.
Sore Arm Stuffed Nose Headache Sneezing Sore throat
Three hours after receiving the 2nd dose, right arm begin to ache. Felt ache down the arm into the hand and fingers. Body aches and chills through out the night ache across the shoulders, neck and up toward the base of the neck and lower back. Next day symptoms were slightly worse I developed a slight headache became very listless had to go to bed. Friday night, the injection site arm developed a red rash that was warm to the touch.
pt recv vax 12MAY95 & 1APR97 devel approx ten pox lesions;a visit to MD was required;pt recovered from sx by 7APR97 or 8APR97;
itch at injection site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itch at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE from 15-Jun-2013 to an unknown date for Blood pressure management.   On 01-Mar-2021 at 11:22 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 12-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at injection site). On 20-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itch at injection site). At the time of the report, INJECTION SITE PRURITUS (itch at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) outcome was unknown.            Treatment information include cold compress.  Action taken with mRNA-1273 in response to the event was not applicable.     This case was linked to MOD-2021-037442 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Batch number is updated
Initial and follow-up information has been received from a licensed practical nurse concerning a 13 month old male patient with no drug allergies or medical history who on 13-JUL-2009 was vaccinated with a dose of VARIVAX (Merck) (lot# 664468/0684Y). Secondary suspect vaccination administered on the same day included MMR II (MSD) (duration and dose not reported). On 22-JUL-2009 evening, the patient developed a full blown case of chickenpox. The child was covered in more than 75 lesions and had a fever. The patient was seen in the office on 23-JUL-2009 but no medication prescribed. Only "symptomatic treatment" recommended. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. Follow-up information has been received from a licensed vocational nurse concerning a 13 month old (also reported as 14 month old) male patient with Atopic Dermatitis at time of vaccination and no pre-existing allergies or medical history who on 13-JUL-2009 was vaccinated with a first dose of VARIVAX (Merck) SQ into the right arm at 11:20am. Secondary suspect vaccinations administered on the same day at 11:20 AM included the first dose of MMR II (MSD, lot#663165/1640X) SQ into the left arm and the first dose of VAQTA (MSD, lot#663683/1715X) IM into the right leg. Other concomitant vaccination on the same day at 11:20 AM included the fourth dose of PREVNAR (Lederle, lot#D63486) IM in the left leg. Subsequently, during the night time on 22-JUL-2009, the patient developed a rash. The patient had an ill appearing, non toxic, moderate amount of varicella exanthema on his trunk, which was greater than 75. On 23-Jul-2009 the patient visited the doctor's office. No lab diagnostic tests were performed. At the time of the report, the patient recovered on an unspecified date. This is one of several reports from the same source. Additional information is not expected.
After receiving influenza vaccine (IM) on 11/25/14 patient developed a few days of fever, gum swelling, and mouth blisters. Resolved within one week. No previous adverse reaction to flu shot given in 2010.
Chronic muscle or nerve pain for over 2 weeks. Cant lift or move arm backwards.  Cant sleep at night or even put a shirt on .
HPV vaccine for fingers warts (peringual);   This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 32 year old female patient. The patient's pertinent medical history included therapy with liquid nitrogen, salicylic acid, candida albicans, sinecatechins ointment and curettage. The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for fingers warts (peringual) (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   The patient's immune status was reported as none. The patient was followed up for treatment for 9 months. There was no resolution of patient's condition.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.  Follow-up information was received via telephone call on 02-APR-2020.  A request was made for patient identifiers, events experienced and causal relationships.; Sender's Comments:  US-009507513-1912USA001729:
On 7/19/01, pt had swollen left thigh with rash approximately 10 cm x 8 cm. There were no complaints of pain. Pt given Benadryl for rash and heat packs.
Rapid heart rate that woke me up. I couldn't lay flat and had to be upright. This reaction happened the following night as well but was less severe. I took an aspirin prior to bed the second day.
SkinRash, Rash & UrticariaPruritus Employee had allergic hives on forehead, head, trunk. Needed to go home to recover in order to take 50 mg benadry.
pain after the vaccine and then lost range of motion; pain after the vaccine and then lost range of motion; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jul2021 (Lot number: EW0202) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arrythmia" (unspecified if ongoing); "low IGG" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: ZOLOFT. No other vaccine in four weeks. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot Number: ER8733), administration date: 31Mar2021, when the patient was 51 years old, for Covid-19 immunization, reaction(s): "covid". The following information was reported: PAIN (disability), JOINT RANGE OF MOTION DECREASED (disability) all with onset 31Jul2021, outcome "not recovered" and all described as "pain after the vaccine and then lost range of motion"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Jul2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". Clinical course was reported as follows. She had pain after the vaccine and then lost range of motion. After it didn't go away and got worse. She went to a doctor and physical therapy. She had covid in Feb2021 and that is why she waited longer in between my 2 vaccines because she got very sick after her 1st vaccine and doctor told her to wait a bit for the 2nd. She has had a MRI, 2 cortisone injections and physical therapy and can't do things like put on a bra or jacket or do small things around my home or wash my hair. The event "pain after the vaccine and then lost range of motion" and "pain after the vaccine and then lost range of motion" resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment for events included physical therapy, 2 cortisone shots and MRI. The patient underwent the following laboratory tests and procedures: PRL Covid 19: (17Dec2021) negative, notes: Nasal Swab; MRI: (unspecified date) unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101841484 similar report from same reporter
Throat pain/sore throat/woke up at 3 am with throat killing her; Congestion; Nauseous; Fever; Chills; Body ache; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Throat pain/sore throat/woke up at 3 am with throat killing her), NASAL CONGESTION (Congestion), NAUSEA (Nauseous), PYREXIA (Fever) and CHILLS (Chills) 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, the patient experienced OROPHARYNGEAL PAIN (Throat pain/sore throat/woke up at 3 am with throat killing her), NASAL CONGESTION (Congestion), NAUSEA (Nauseous), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body ache) and ARTHRALGIA (Joint pain). At the time of the report, OROPHARYNGEAL PAIN (Throat pain/sore throat/woke up at 3 am with throat killing her), NASAL CONGESTION (Congestion), NAUSEA (Nauseous), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body ache) and ARTHRALGIA (Joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: abnormal (abnormal) She had an antibody test and it showed she had great high numbers of antibodies.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that the patient had hearing issues.  No concomitant medications were reported.  No treatment information were reported.   This case was linked to MOD-2021-392244 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up received contains new events (fever, chills, body aches, joint pain, sore throat, congestion, nausea) On 24-Nov-2021: Follow up received contain no new information.
This spontaneous report as received from a medical assistant refers to a 16 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 16-JUN-2014 the patient was vaccinated with second dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # J009788, expiry date: 17-MAR-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.