chrisvoncsefalvay/vaers-outcomes huggingface dataset:
elevated body temperatures; severe local reaction of the injected arm  that was red; severe local reaction of the injected arm  that was hurt; severe local reaction of the injected arm  that was swollen; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox twice, once as a child and again at the age of 51). Previously administered products included Zostavax (had Zostavax at age 60) and Shingrix with an associated reaction of erythema (On an unknown date, received first dose, for tolerance refer US2023AMR136194).   On 25-SEP-2023, the patient received the 2nd dose of Shingrix (left arm). In SEP-2023, an unknown time after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: severe local reaction of the injected arm that was red), pain in arm (Verbatim: severe local reaction of the injected arm that was hurt) and swelling arm (Verbatim: severe local reaction of the injected arm that was swollen). On 26-SEP-2023, the patient experienced fever (Verbatim: elevated body temperatures). The patient was treated with non-drug therapy (Ice Pack (No Medication)) and benadryl (nos) (Benadryl). Rechallenge with Shingrix was positive. The outcome of the fever was not resolved and the outcome of the erythema of extremities, pain in arm and swelling arm were resolving.   It was unknown if the reporter considered the fever, erythema of extremities, pain in arm and swelling arm to be related to Shingrix.   It was unknown if the company considered the fever, erythema of extremities, pain in arm and swelling arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR136194   Additional Information: GSK Receipt Date: 29-SEP-2023 The reporter stated that she received the second dose of Shingrix and since Tuesday, she had been experiencing elevated body temperatures between 99.6 to 99.8 degrees Fahrenheit and sometimes 100 degrees Fahrenheit. The patient also stated she had a severe local reaction of the injected arm that was red, swollen and hurt. The patient iced the arm and took Benadryl to alleviate symptoms. As of the day of reporting, the events with the arm had improved. The patient stated that she had a similar local reaction to the first dose of Shingrix (injected arm that was red, swollen and hurt), but was not as severe as the second dose. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR136194:Same patient, second dose
Chills; arm was so red; arm swelled up; arm was so itchy; Very bad diarrhea; Nausea; very achy; Chills; diarrhea all morning, noon and night (ongoing; occasionally),; couldn't eat; Fever; severe headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of the second episode of CHILLS (Chills), FEEDING DISORDER (couldn't eat), ERYTHEMA (arm was so red), DIARRHOEA (diarrhea all morning, noon and night (ongoing; occasionally),) and DIARRHOEA (Very bad diarrhea) in a 72-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 Hip discomfort. Concurrent medical conditions included Arthritis (in both knees and hip).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced the first episode of NAUSEA (Nausea). On 24-Mar-2021, the patient experienced FEEDING DISORDER (couldn't eat), DIARRHOEA (diarrhea all morning, noon and night (ongoing; occasionally),), PAIN (very achy), the first episode of CHILLS (Chills), HEADACHE (severe headache) and PYREXIA (Fever). On 18-Apr-2021, the patient experienced the second episode of NAUSEA (Nausea). On 19-Apr-2021, the patient experienced DIARRHOEA (Very bad diarrhea). On an unknown date, the patient experienced the second episode of CHILLS (Chills), ERYTHEMA (arm was so red), PERIPHERAL SWELLING (arm swelled up) and PRURITUS (arm was so itchy). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea, at an unspecified dose and frequency. On 24-Mar-2021, HEADACHE (severe headache) and PYREXIA (Fever) had resolved. At the time of the report, last episode of CHILLS (Chills) and DIARRHOEA (Very bad diarrhea) had not resolved, FEEDING DISORDER (couldn't eat), ERYTHEMA (arm was so red), DIARRHOEA (diarrhea all morning, noon and night (ongoing; occasionally),), PAIN (very achy) and the last episode of NAUSEA (Nausea) outcome was unknown and PERIPHERAL SWELLING (arm swelled up) and PRURITUS (arm was so itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       relevant concomitant products usage were not reported by the reporter. Treatment details not included.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19/APR/2021Updated reporter details; Other relevant history  arthritis; Updated Product tab  anatomical location of vaccine information; Treatment drug  Imodium for diarrhea;Added in Events tab  diarrhea (very bad diarrhea); nausea; chills;Updated in Event tab - event outcome  peripheral swelling (arm swelled up) to recovered/resolved; Pruritus (arm was so itchy) to recovered/resolved;Updated event assessment; product event details
Sore left arm; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore left arm) and FATIGUE (Tiredness) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 047B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BENAZEPRIL and IRON for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced MYALGIA (Sore left arm) and FATIGUE (Tiredness). At the time of the report, MYALGIA (Sore left arm) and FATIGUE (Tiredness) outcome was unknown.            Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Vomiting x1, severe headache, fever 101 deg, fatigue. From 0400 on 11/14/21. Symptoms gone upon awakening morning of 11/15/21 at 0645.
swelling rt upper arm deltoid area site of DT vax; erythema area 1x1 inc indurated;
Approximately 5 minutes after receiving the vaccine patient began to feel very weak and drained and sleepy.  Arms felt weak.  Pain in the back of the neck.  At 3:05pm, BP 155/88   HR=66   Temp 98.4F  O2=95%  Glucose=160.  Patient reports taking Tylenol prior to receiving the vaccine.  At 3:10pm, BP=148/95  HR=68, O2=95%.  Patient was released from clinic at 3:17pm.  Patient reports having similar symptoms following 1st dose of Pfizer Covid-19 vaccine occurring 1 hour after receiving the dose.  Patient reports being very sleepy and fatigued.  Fatigue lasted for 3 days.  Per patient, symptoms resolved with Tylenol and rest.
Pt called that she had shingrix and flu vaccines on the same day but on the arm with the shingrix is red and swollen and she had some nausea earlier today. Rec. pt to take some Aleeve and ice the area and will check check with her later on. Rec. also if needed pt can go see her doctor or go to the urgent care. A few hours later called to check on the patient but patient did not answer.
OUTSIDE OF GUIDELINESS THIRD PARTY STAFF ADMINISTERED FULL DOSE DOSE (0.5ML) OF MODERNA VACCINE INSTEAD OF BOOSTER DOSE (0.25ML)
11 days after booster shot, spontaneous itchy hives in scalp, torso. 12 days after booster, spontaneous itchy hives moved to lower legs, torso, scalp.  13 days after booster (today), spontaneous itchy hives moved to arms, scalp. and lower legs.  Benadryl and zyrtec temporarily relieve hives and itchiness.
Fever, chills, sore arm; swollen lymphnoid in arm pit; severe headache; body weakness and fatigue
(R) arm became red, hot and inflamed from PEDIARIX vaccine. Pt never had a reaction to individual vaccines given in past.
Body aches and fatigue for 12 hours. Injection site soreness for 3 days.
Fatigue, chills, sweating on Saturday 2/13, dull headache in the afternoon of 2/14, dull headache in the morning of 2/15
Patient (my son) had a tonic-clonic seizure 2 days after shots. No fever, no other symptoms. Seizure lasted close to 1 min; slept 4 hours afterwards. 2 seizures 3-23-17. 1 seizure 4-13-17.
About 1.5 hours after vaccine administration mother checked on baby who was sleeping.  Mother said baby not breathing and was blue around mouth.  Was listless but by time got to hospital was breathing OK
temp to 106R 3hrs p/vax; cont throughout the day;vomited 1 time 27MAR95;limp & lifeless;temp to 103 R through out the next day 28MAR95; t100R 29MAR95;
Fever, chills, pounding heart, unusually extreme fatigue, naseau, extreme weakness, dizziness, headaches, general malaise.
Approx. 4-09-09 I started getting a 'burning - itchy' feeling on right (back) thigh - it was painful - itchy for about 9 days - (and red) it was now gone.
No unusual side effects the day after my fist dose on 1/31/21  (just felt "crummy" and achy for a day).  BUT five days later I woke up with dizziness...a feeling of "disequilibrium", being "off-balance" and extreme exhaustion which lasted for five days (after three days saw a doctor who thought the two symptom might be a delayed reaction to the vaccine but of course no way to tell).  Also, my right elbow (the side where I was vaccinated) has been very sore since a week after the first dose. I have had some arthritis in other joints but never the elbow.       The dizziness is a lot better now (but not completely gone). Tiredness somewhat improved, elbow still quite sore. Here's my issue...I'm due for the 2nd shot on 2/21/21 and am concerned about going into it if these symptoms are still persisting.  I would prefer to have the 2nd shot in my left arm but had three lymph nodes removed on that side in 2006 (when I had breast cancer on the left).    Is it safe to request to have the next shot on the left arm?  Should I try to re-schedule until my dizziness and joint pains from the first shot are gone? (Note: it's extremely hard to get an appt. for the Covid vaccines in my town. I don't know if an exception for me can be made by the provider.)  I am worried the second dose will only exacerbate the symptoms and who knows how long they will persist. I'm normally an active,  healthy 70 year old, 5'2", 152 lbs.
This spontaneous report was received from a physician via a company representative referring to a female patient of unknown age. Information about concurrent condition, concomitant mediation and medical history was not provided. In October 2016 ("within the last month"), the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, frequency, route, lot # and expiration date were not reported). After being administered, the patient experienced syncope. At the time of this report, the outcome of the event was unknown. The causality between the events and GARDASIL 9 was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recv vax on 10/10/97; 3 hr post vax pt exp local rxn of red, warmth, tender & induration; {12 hr post vax pt exp fever, chills, cough, runny nose, diarrhea &vomiting} x 24 hr
I received my first Moderna COVID-19 booster on 10/24/2021. On 5/18/2022, my daughter tested positive, so I tested myself, and I also tested positive. As a result, I was out of work for 6 days. I contacted my doctor to see if I was eligible to receive PAXLOVID, but I wasn't, so she just advised me to rest and follow the general protocol set forth by the CDC. On 5/18/2022 and 5/19/2022, I was so fatigued that I couldn't get out of bed, and I also had a low-grade fever, a cough, body aches, and a headache. On 5/20/2022, I felt a little better and was able to sit up in bed and eat a little. On 5/21/2022, I felt well enough to work a jigsaw puzzle with my daughter and eat at the table, but I was still extremely fatigued. On 5/22/2022, I felt weaker, and it was as if I had expended too much energy the day before. I also felt fatigued and had a headache and some body aches. I took some OTC cold and flu medicine, but since it didn't help, I stopped taking it. I also had a severe cough during my illness, and the nurse at the facility where I work suggested that I take MUCINEX to loosen the phlegm. I took it from 5/19/2022 until 5/24/2022, but it didn't do much good. On 5/23/2022 and 5/24/2022, I felt much better, so I started moving around more, but I felt fatigued again by the early evening. On 5/25/2022, I returned to work. I was able to work, but I had minor coughing and fatigue by the early evening. The coughing lasted at least until June 2022, plus I had brain fog, which may have lasted as late as September 2022. I also continued to feel fatigued and had less stamina through June 2022. I went to an amusement park on 6/7/2022, and there were times in which I would sometimes have to sit and rest on a bench while my husband took the kids to the rides. I would like to add that we were notified on 5/16/2022 that my daughter had been a close contact to someone with COVID-19 on 5/13/2022. We tested on 5/17/2022, and the results were negative. When we tested again on 5/18/2022, they were positive.  I feel that I've recovered from the effects of COVID-19 for the most part, but I still occasionally headaches, and I wasn't prone to headaches before I got COVID-19. Whenever I now have headaches, I always test myself to make sure that I haven't it contracted it again.
Urticaria starting on the face -spread to the rest of the body-no other symptoms  No itching.  Lasting 3 days-seen today still with rash-waxes and wanes.
Significant swelling, erythema of left upper arm involving the deltoid area.  Down to anterubical tossal.  Area warm to touch and painful.
Information has been received from a consumer who was the father of the patient, reported that "his son was supposed to receive PNEUMOVAX 23 (MSD) but instead received MMR II. No further AE information provided. It's unknown if the patient has sought any medical attention. Consumer didn't want to provide his information or his son's physician's information. Legal Issue Involved-AE sent to Legal. No further information is available.
Day One:  Immediate fatigue and headache; loss of appetite; pain at injection site  Day Two:  Elevated heart rate (woke up with heart rate of 119 bpm).  Average resting heart rate:  88bpm.  Diarrhea.  Day Three:  Nausea, fatigue, stomach upset, loss of appetite, chills
Within 96 hours of receiving multiple vaccinations (DTaP, Hib, PCV7) our son was feverish, lethargic, and in obvious discomfort (e.g., prolonged crying and moaning). He refused to eat owing to painful, angry lesions on his tongue, palate and throat. When we took him to the E.R., we were told he had Coxackie Virus, and were told to keep him hydrated and to treat his discomfort with an OTC pain reliever.
Swollen intraclavicular lymph node on right side after first vaccine in right arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 16:45 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 05Apr2021, outcome "recovering", described as "Swollen intraclavicular lymph node on right side after first vaccine in right arm.". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information The reason was unknown for Lot: Not available/provided to reporter at the time of report completion. The hospital was the Facility type.The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not have any AE(s) following prior vaccinations. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client's mother reported at 2:00 am 2-19-16 client woke up reporting pain in Lt deltoid area, numbness from shoulder to fingers on Lt arm. Client was also pale. Client taken to ER. Advised to ice area and not lift. Mother reports after 24 hrs client had occasional numbness in Lt arm 32 hrs client had full recovery denied tenderness or soreness.
Patient woke up the morning of 6/25/21 with a rash on both of her hands. Throughout the day, the rash did spread to her upper thighs and lower legs. The rash continued to spread to her feet. The rash was bilateral on her body, and appearance was similar to a viral rash. She did complain of her body being sore and achy as well. The rash did not itch. We gave her ibuprofen and antihistamine during the day which seemed to help with comfort. The next morning (6/26), patient woke up and the rash was almost gone. She still had a little bit of the rash on her calves and feet. By the end of the day and next day, the rash was gone.
PATIENT RECEIVED FLUMIST SEASONAL AND H1N1 BOTH LAST TUESDAY (11/2/09) SINCE THEN HAS HAD HEADACHE, NAUSEA, AND DIARRHEA. FEELS TERRIBLE THIS MORNING 11/9.  CALLED PATIENT 12/2 FOR FOLLOW-UP.  SHE SAID THAT LATER ON THE DAY OF THE INJECTION, SHE HAD AN UNUSUALLY BAD HEADACHE, LIGHTHEADEDNESS AND FAINTING FEELING.  SYMPTOMS LASTED ALMOST A WEEK.  CALLED DOCTOR.  DOCTOR TOLD HER THAT A LOT OF PEOPLE WERE  HAVING REACTIONS-MOSTLY OLDER FOLKS.  DAUGHTER HAD SAME COMBINATION SAME DAY WITH NO ILL EFFECTS.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Localized edema and ecchymosis (mild) over posterior aspect of right upper arm. Pt assessed 3 days following vaccine administration. Patient treated with NSAID and antiemetic, advised to follow up if symptoms worsen.
injection shoulder stiffness; could not lift injection arm; injection shoulder tenderness; injection shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (injection shoulder stiffness), MOBILITY DECREASED (could not lift injection arm), VACCINATION SITE PAIN (injection shoulder tenderness) and ARTHRALGIA (injection shoulder pain) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 209L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (injection shoulder stiffness), MOBILITY DECREASED (could not lift injection arm), VACCINATION SITE PAIN (injection shoulder tenderness) and ARTHRALGIA (injection shoulder pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (injection shoulder stiffness), MOBILITY DECREASED (could not lift injection arm), VACCINATION SITE PAIN (injection shoulder tenderness) and ARTHRALGIA (injection shoulder pain) outcome was unknown.            No concomitant medication was reported. The treatment information was unknown.  Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-056518 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056518:Cross-Linked with patient case
Information has been received from a doctor of pharmacy concerning a 75 year old retired white female pt with no allergies and no pat medical hx who on 28OCT2003 at 15:00 was vaccinated IM in the deltoid with a dose of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccination. On 28OCT2003 at 22:00, the pt developed a severe local reaction. The reaction went all the way down the arm and was described as "cellulitis-like". The reporter stated the swelling in the left arm and redness went to cellulitis. Medical attention was sough, but lab tests were not performed. The pt was being treated with antibiotics and was "recovering with sequalea" at the time of the report. A product quality complaint was not involved. The reporter also mentioned a second patient who had a local post vaccination with dose of pneumococcal vaccine 23 polyvalent. Additional info has been requested.
I had chills, a fever and I had to take Tylenol. I experienced pain in my back and chest, that moved to my shoulder and jaw. I felt like I was hit by a truck. I went to ER. At the ER, they did some testing. They made me stay longer than 3 hours to monitor me. After the test results came back, they told me that I had low platelets, but the tests were not showing any bad results. I did have to follow-up for my gallbladder.
Patient reporting joint soreness and muscle stiffness of entire body. Patient has been using Aspirin/Tylenol with little relief for past week.
Chest pain and "heart skipping a beat" No fever. No other symptoms.  Pain is reproducible with pressure over sternum. Symptoms resolved completely after ibuprofen was given.
Fine afterwards, jumped off a small block at daycare on November 6 and hasn't been able to walk since. The only consistent is that he always grabs the thigh where the shot was given. Xrays and blood work done and nothing came back. He now has full range of motion in his leg and hip but still won't put pressure on left leg to walk. We are now going on week 3. No fevers. Told it was toxic synovitis and to treat with ibuprofen.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II for prophylaxis. Other suspect therapies included sterile diluent (MRK) for prophylaxis. On an unknown date, 6 days after onset of therapy the patient experienced urticaria and pruritus. The outcome of urticaria and pruritus was unknown.
Information has been received from an office site manager (healthcare administrator HCA), concerning a 38 year old male patient with diabetes. On 14-MAR-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and frequency were not reported) (Lot #:H020684. Expiration date: 17-APR-2014). On the same date, the patient experienced high fever, and allergic reaction of a rash and redness in the right forearm location, and was admitted to the hospital on 16-MAR-2013. On 25-MAR-2013, the patient was discharged from hospital. On 26-MAR-2013, the patient was fully recovered from all of the events. Additional information has been requested.