chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lymphadenitis; Swollen lymph nodes in arm pit; This case was reported by a pharmacist via call center representative and described the occurrence of lymphadenitis in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number TB2PK, expiry date 5th October 2021) for prophylaxis.   On 5th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced lymphadenitis and axillary lymph nodes enlarged. On an unknown date, the outcome of the lymphadenitis and axillary lymph nodes enlarged were unknown.   It was unknown if the reporter considered the lymphadenitis and axillary lymph nodes enlarged to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient developed swollen lymph nodes in arm pit.  At the time of reporting the patient had lymphadenitits. The reporter consent to follow up.
Information has been received from a pharmacist concerning her daughter with seasonal allergies and a facial tick that has worsened over the past year who between May and June 2007 was vaccinated 0.5ml, IM with a dose of GARDASIL. In May 2008 the patient was vaccinated 0.5ml, IM with a 2nd dose of GARDASIL. There was no concomitant medication. In spring 2008, the patient began developing chest pain and shortness of breath. It first occurred after running a 400 meter race at a track meet. On an unspecified date, the patient had an Echocardiogram and Electrocardiogram and the results were inconclusive. On an unspecified date, the patient had the echocardiogram repeated and believed the results showed "some type of mitral valve or injection fraction problems. "The patient outcome was not reported. The patient sought unspecified medical attention during an office visit. Additional information has been requested.
Rash - primarily on extremities, started within 24 hours of vaccine, has persisted until evaluated 1-7-11.
Sore shot arms; TIRED; achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore shot arms), FATIGUE (TIRED) and MYALGIA (achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore shot arms), FATIGUE (TIRED) and MYALGIA (achy). At the time of the report, PAIN IN EXTREMITY (Sore shot arms), FATIGUE (TIRED) and MYALGIA (achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-043696 (Patient Link).
injection site soreness; A spontaneous report was received from a consumer concerning a 80-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events a little bit of soreness at the injection site.  The patient's medical history was not provided. Concomitant medications were not reported.  On 5 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown)via unknown route to the left arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event(s) a little bit of soreness at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), a little bit of soreness at the injection site was unknown..
Information has been received from a physician concerning a 70 yr old female family friend who on 22Aug05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 23Aug03, the pt's arm was swollen almost to her elbow. The physician said, it looked like angioedema. No treatment was needed. At the time of this report, the pt was recovering. It was noted that the reporting physician was a family friend and the pt was vaccinated at another doctor's office. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 02-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The sum of hours in excursion was 64 hours and the lowest recorded temperature reported was 33 Fahrenheit (F) (0.555555556 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Four days later and I still have very swollen painful deltoid and underarm/lymphnode.... very swollen breast tissue and left scapular area.
tiny scabby spot on part of the rash / entire rash has been scabby; rash on abdomen approx 3/4 inch wide, 3 inches long, about 3 inches above navel; This case was reported by a consumer and described the occurrence of rash in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number FY5H2, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 22nd December 2020, the patient received the 2nd dose of Shingrix. On 23rd December 2020, 1 days after receiving Shingrix, the patient experienced rash. On 27th December 2020, the patient experienced scab. On an unknown date, the outcome of the rash and scab were not recovered/not resolved.   It was unknown if the reporter considered the rash and scab to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received 1st dose of Shingrix on 8th October 2020 and had no adverse reaction. After 2nd dose patient had a rash on abdomen approximately 3/4 inch wide, 3 inches long, about 3 inches above navel. Rash was smooth as rest of skin, no itching or pain. The patient had a tiny scabby spot on part of the rash. Ever since 28th December 2020, the entire rash had been scabby. Still had no itching or pain. The patient was concerned that this might affect her ability to obtain the Covid vaccine. The reporter wanted to know if this kind of adverse reaction to the Shingrix vaccine was something she should be concerned about when she would be able to get the Covid vaccine.  The patient was in the high risk group, due to age and underlying medical conditions.
chills; nausea; Local Erythema; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nausea) and INJECTION SITE ERYTHEMA (Local Erythema) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination.     The patient's past medical history included Vomiting, Stomach cramps and Wheezing. Concurrent medical conditions included Crohns disease aggravated since July 2012, Allergy to molds, Drug allergy (Allergic to Demerol induced vomiting and pass out), Allergic reaction to antibiotics (Allergic to Augmentin) and Asthma. Concomitant products included MESALAZINE (LIALDA) for Crohn's, ESTRADIOL (VAGIFEM) from 2018 to an unknown date for Dryness of eyes, LANSOPRAZOLE (PREVACID) from 2000 to an unknown date for Reflux esophagitis, L-THYROXINE [LEVOTHYROXINE] for Thyroid disorder.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, 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 CHILLS (chills), NAUSEA (nausea) and INJECTION SITE ERYTHEMA (Local Erythema). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 27-Feb-2021 to 03-Mar-2021 at an unspecified dose and frequency and BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) 28-Feb-2001 at an unspecified dose and frequency. On 04-Mar-2021, CHILLS (chills), NAUSEA (nausea) and INJECTION SITE ERYTHEMA (Local Erythema) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-028875 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Non-Significant Follow-up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Later at night following the vaccine experienced fever-like symptoms and chills and pain in arm. 2 days later experienced a grand mal seizure while driving and had multi-vehicle car accident and was taken to hospital. Have never blacked out while driving before and it had been several months since I had experienced a partial seizure.
56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Patient reported having  hives over most parts of the body after 1 hour of receiving the vaccine.  It lasted for up to 3 days.  Patient took diphenhydramin OTC tablets and applied Benadryl cream to the reactions sites.
Patient reported itching at the injection site within a few minutes of the injection. At that time she had no other symptoms.  A few minutes later she reported generalized itching and nausea. She did not have a visible rash. She continued to deny any shortness of breath, trouble swallowing, or swelling of the tongue or throat. She stated that her current symptoms (itching and nausea) were similar to those she had experienced with past serious allergic reactions and agreed to receive epi. Epi was administered via epi pen at 12:36 PM, EMS was called at 12:37 PM. A few minutes after epi was given, she still did not have a visible rash but began gagging and appeared to struggle on inspiration. Although patient had a glazed expression she was still able to focus her eyes and respond yes when asked if she could breath. She did not vomit but still reported feeling nauseous. EMS arrived at 12:48 and transported her to the ED. Per review of ED records she received an additional dose of epi in route to the hospital. Per hospital report, she received diphenhydramine, methylprednisolone IM, and ondansetron. She was monitored for 4 hours and discharged in stable condition.
kept her up throbbing; pretty significant muscle pain; Initial information received on 26-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 23 years old female patient who experienced muscle pain (myalgia) and throbbing (Pain), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6657LA and expiry date: 30-Jun-2019) via intramuscular route in the left deltoid.  On an unknown date, patient experienced a non-serious pretty significant muscle pain (myalgia). It looks to be a perfect injection site in the right spot in the muscle. Nurse said she palpitated her injection site and there was nothing there and no redness. It looks to be a perfect injection site in the right spot in the muscle. It was reported that, it kept her up throbbing (Pain). At first, she had as expected, just typical soreness and she did not think anything of it and It seems to be worsening a bit. She never had this type of reaction before specifically to the flu. She had pain when trying to take off a shirt, when lift her arm up past her shoulder line, and when lying in bed (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No lab data was reported.  Final diagnosis was myalgia.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as Unknown for myalgia and throbbing.
Within a few hours of receiving the vaccine I began feeling ill. Symptoms included nausea, headache, fatigue, general aches and pains. As time has passed, these symptoms have intensified. My symptoms now include chronic headache accompanied by random shooting pains on the left side of my head, constant nausea, severe food intolerances, chronic fatigue, muscle/bone/joint aches, periodic muscle tremors, short fainting spells, anxieties, depression, and insomnia. Since receiving the yellow fever vaccine I have also been diagnosed with thyroid problems and now take Synthroid daily. I can trace a drastic decline in my health to the time of the vaccine.
arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Sep2021 (Lot number: 30130A) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Sep2021, outcome "recovered" (11Sep2021), described as "arm pain".  Additional information: The patient stated she was very, very upset because it has been 5 months. She has had arm pain from the injection and the doctor said they can't get it out. She does not know who else to turn to. The patient stated the pain started the day they gave her the injection. With the first injection, it lasted maybe 2 days at the most. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Sick; worst reaction; Initial information received on 30-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media.  This case involves Adult and unknown gender patient who was sick and worst reaction while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, frequency, formulation, lot number and expiry date was unknown) in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date the patient developed a non-serious event "sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date the patient developed a non-serious event "worst reaction" (adverse reaction) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported" Last flu shot I got gave me the worst reaction I ever had, sick for 5 days, never had one since and never had the flu again."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (worst reaction, Sick).  At time of reporting, the outcome was Unknown for the event worst reaction and was Unknown for the event sick.
NAUSEOUS; ARM SORE AT INJECTION SITE; BRUISING OF ARM/BLUE AND BLACK AROUND INJECTION SITE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, administered on 16-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On NOV-2021, the patient experienced bruising of arm/blue and black around injection site. On 16-NOV-2021, the patient experienced arm sore at injection site. On 17-NOV-2021, the patient experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nauseous, arm sore at injection site, and bruising of arm/blue and black around injection site. This report was non-serious.
This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 39-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 14Jan2021 16:15 at a single dose on left arm for COVID-19 immunization. Medical history included GERD, sciatica, allergies, asthma, allergies to some foods (non anaphylactic). Concomitant medication included curcuma longa (TURMERIC [CURCUMA LONGA]), metaxalone, mometasone furoate (NASONEX), famotidine. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 26Dec2020 01:00 PM at a single dose on left arm for COVID-19 immunization. About 8 hours after the shot, on 15Jan2021 01:30 AM, patient woke up very cold, checked temp it was 95.9. Remained that way though the night (96F), could not sleep much b/c of chills. In the AM, temp gradually increased back to baseline 97.9. She doesn't think it was thermometer malfunction bc sx (symptoms) correlated with the temperature and she took the value repeated times. No treatment received for the events. The outcome of the events was recovered on 15Jan2021. The patient was not pregnant. Facility type vaccine was Workplace clinic. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot number reported as: M034691, expiration date on 04-NOV-2018 (Strength, dose number, route and anatomical location were not provided). No adverse effects were reported. It was stated that the vaccine was exposed to a temperature of 6°F (Fahrenheit degrees) to 14°F (10 °F) with a time frame of 4 hours. It was stated that the temperature excursion was noticed due to a data logger. No previous excursions were reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided. Sender's Comments: US-009507513-1705USA004121.
Adverse events: Severe migraine that was sensitive to sound and light, Body ache and pain from head to heels of feet. Primary soreness was in low back/hips. Brain fog - hard to concentrate at a single tasks. Lack of appetite. Treatment: Water intake, hot bath, cold compress, sleep in dark room, around 9pm took acetaminophen (waited due to mixed directions on whether or not to take pain reliever with covid shot). Outcome: migraine finally went away and next morning all adverse symptoms were gone.
severe reaction to the flu vaccine/flu vaccine caused the allergic reaction; arms swelled up, hot to the touch; arms swelled up, hot to the touch; breathing issues; medically fragile; Initial information regarding an unsolicited valid serious case received from a Consumer/non-hcp (healthcare professional) via Information (Reference number- 00609408) and transmitted on 20-May-2021  This case involves a 12 years old male patient who experienced severe reaction to the flu vaccine/flu vaccine caused the allergic reaction (hypersensitivity), arms swelled up (peripheral swelling), hot to the touch (skin warm), breathing issues (dyspnoea) and medically fragile (asthenia), while receiving vaccine INFLUENZA VACCINE.  The patient's medical history included a genetic abnormality.   The patient's past medical treatment(s), past vaccination(s), concomitant medication and family history were not provided.  On an unknown date in year 2009, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in year 2009, the patient developed a serious severe reaction to the flu vaccine (hypersensitivity), arms swelled up (peripheral swelling), hot to the touch (skin warm), breathing issues (dyspnoea) and medically fragile (asthenia), (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for these events.  Laboratory data was not reported.  The reported stated that they received a letter  confirming that the flu vaccine caused the allergic reaction. At this time, the caller would like to know if it is safe for patient (now 24 years of age) to receive the Covid-19 vaccine.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the patient was recovered from all the events on an unknown date.  Batch number has been requested for suspect product for this case.; Sender's Comments: This case concerns a 12 years old male patient who experienced hypersensitivity, peripheral swelling, skin warm, dyspnoea and asthenia, after vaccination with INFLUENZA VACCINE. The time to onset is unknown. The patient's medical history included genetic abnormality. The patient's concomitant medication, medical condition at time of vaccination and other lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Had vaccine 7-10-15. Developed itchy red rash on feet and legs on 7-10-15 evening / 7-11-15 day. Spread to back and arms by 7-13-15. Took to pediatrician and was diagnosed per guardian with allergies to new soap and given allergy medicine (liquid).