chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2020, the patient received the 1st dose of Shingrix. On 27th July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 28th July 2020, the patient experienced fever. Shingrix was continued with no change. On an unknown date, the outcome of the pain in arm and fever were unknown.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. After receiving Shinrix, the patient experianced arm pain and fever. The reporter was consented to follow up. This case was linked with case US2020144254, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020144254:same reporter
Immediately after vaccines developed fevers, 2 days after vaccines had 30 min Tonic-clonic seizure. Since then has continued to have monthly GTC seizures.
Extreme joint pain in hips, knees, hands, wrists, ankle and neck. Pain rated 10/10.
Mom states that patient c/o fatigue, arm pain at injection site, mild dizziness about 12hours after injection. Early AM following day patient c/o not being able to lift arm and extreme pain. Pt arm was warm to touch, red and pt states she could not move arm and it hurts bad enough that pt was crying.
Pr received H1N1 shot in left deltoid (IM) at about 11:35 AM on 2/3/10. Later that night left hand began to swell and turn red, became painful. Pt went to clinic on 2/4 to receive an RX for CEPHALEXIN. Diagnosed with skin infection. Also presented on 2/5/10 to see doctor for dizziness had hemoglobin checked.
Had a hard time sleeping, woke up  very early Sunday morning with pain at injection point.  Took tylenol.  Developed joint aches and pains during the day and was extremely tired.  On Monday woke up with swelling around the eyes and face was noticeably red.  Eventually took Benadryl at 11:30 am.  By 2:30 pm had to take a nap (very unusual for me).  Rash continued to spread to my chest.  Called the doctor at 5 pm.  He told me to take more Benadryl, which I did at 6 pm.   Still feel ichy with red rash on face and chest as I write this at 10 pm.
Patient reports diarrhea starting the morning following vaccination and continuing now for 5 days. She has been on a BRAT diet and her PCP offer testing a stool sample. Her insurance will not pay for stool sample test unless diarrhea lasts 7+ days and she plans to follow up if needed. She also reports a headache and cough starting today.
The patient and Technician administering the vaccine notices it was hard to inject the vaccine into the deltoid. There was more than normal resistance in the elderly mans small deltoid. Almost one month later the patient is still complaining of pain in his shoulder. He mentioned that his physical therapist suggested that he may have recieved the vaccine in a tendon instead of a muscle. He is considering having a steriod shot in the area to help alleviate the pain.
Next day, suffered a stroke, hospitalized for 6 days for tests, 12 days in rehabilitation,  physical, occupational, and memory.  6 weeks outpatient doing the same.  Psychology test to determine memory.  Diagnosed with mild dementia.  Also a partial cortoid artery blockage 39%.  walking is hesitant.
`5 minutes after injection, pt c/o throat "strangeness". No itching, rash, hives, chest sx. No clear GI sx.   OP clear Lungs clear Skin clear   Pt improving. DCed home with instructions to call PCP soon and especially before next injection
blood clots in her lungs; blood clots in her lungs; Pfizer Covid 19 vaccine booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Nov2021 (two weeks ago since 10Dec2021) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PULMONARY EMBOLISM (medically significant), PULMONARY THROMBOSIS (medically significant), outcome "unknown" and all described as "blood clots in her lungs"; IMMUNISATION (medically significant), outcome "unknown", described as "Pfizer Covid 19 vaccine booster". The event "blood clots in her lungs" and "blood clots in her lungs" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of pulmonary embolism, pulmonary thrombosis with Eliquis blood thinner. Clinical course: The patient stated that they just got the booster and she has blood clots in her lungs; stated that they just got out of the ER last night.   The lot number for bnt162b2 was not provided and will be requested during follow up.
MISSED TO TAKE FOURTH DOSE OF VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case report (PVX2019-1886) was received from a consumer on 22-Jul-2019. It described a 33-year-old male consumer who "missed to take fourth dose of Vivotif according to schedule" (PT: Product dose omission), while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took first three doses of Vivotif according to schedule, but forgot to take the fourth dose on 21-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome was unknown.  Company's Comment: The causality of the event "missed to take fourth dose of Vivotif according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take fourth dose of Vivotif according to schedule" was considered as not applicable.
Urticaria, scalp and body, hives, and dermatographia. Treated with 7 day tapered treatment of Prednisone. Today is day 5 of steroid treatment, dermatographia persists, and mild itching.
48 hours after vaccine given-fever, headache, pain and swelling at inj. site. 72 hours-arm still swollen. Pt feeling better. 4th day-fever and headache gone. 5th day-Pt seen by another RN who noted that an area about 4cm in diameter at inj. site that is swollen, warm and red. No streaking. Pt reports.
Information has been received from a registered nurse concerning an approximate 13-year-old female who on 20-JUL-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
June 17, 2021 I received the Shingrix vaccine.  By mid-afternoon (2:30-3:00) My left arm (injection arm) was really hurting.  I was forcing myself to keep it in motion.  My husband was having the same issues.  We both spent a miserable afternoon and night barely sleeping.  It took several of days for the extreme soreness to SLOWLY begin to diminish to a more livable level.  After about two weeks, I began to believe it would get better but it took fully two months for all the soreness to go away.    To put the level of pain I experienced in perspective, I had massive rotator cuff repair on my right shoulder two years ago, complete with two sets of screws/pins, six weeks immobilized and another six weeks of therapy three times a week.  The pain I experienced from the Shingrix shot and the length of time it took to get back to normal made my rotator cuff surgery and recovery seem like a walk in the park.    People need to be informed about the REAL potential side effects of this shot and allowed to make an informed decision.  Not just a simple "you may have some soreness in your arm"!
Trouble sleeping; Sore arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Trouble sleeping), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE SWELLING (Swollen arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE SWELLING (Swollen arm). On 18-Jan-2021, the patient experienced INSOMNIA (Trouble sleeping). On 19-Jan-2021, INSOMNIA (Trouble sleeping), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE SWELLING (Swollen arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Flacid arm several hours after shot. Had not shown much improvement 60 days after original vaccine shot.
Had PPV in (R)ight arm 9/17. States arm still tender. No redness. Also has rash on both lower legs.
Patient's mother was called 19 hour after immunization given. She said child's injection site was slightly sore without swelling or discoloration.
Typical left arm ache and weakness starting at time of vaccination. Severe aches, nausea, and weakness starting 7.5 hours later, with more severe symptoms developing throughout the night. Was unable to sleep, with severe chills, nausea, and aches continuing until 3:30am the next day (now).  Took adult dose of Tylenol  at 8pm when symptoms arises, to no effect. Took a half dose of Tylenol and 400mg of ibuprofen at 3am with some effect. Drank water throughout the night.
After  first covid vaccine 3/26/21   Moderna i'm  having light Headache  After second vaccine 4/ 23/21 that first 3 days i'm having a wrose headach  i have to caalout from work because my headache   i'm haviing  wrose headache everyday  May  5/20/21  i go to the Urgent care  because my left side Knee pain just came that day when im at wrok  after work i go to the urgent care doctor saw me he send me to the ER  because he said my left side weaker then right side i go to ER that day they did CT scan and MRI they diganoses me brain aneurysm  my letf sida weaker then right side and doctor just 4 week a ago they digoanoses me vertigo . i cant take this headach  no more it is bad this happen to me bec covid vaccine.
difficulty breathing -shortness of breath - chills - not aware of what I was saying to my wife - often repeating myself - sleeping in a different bedroom I laid there wondering why my wife and son weren't coming in to say goodbye to me -I felt I was at deaths' door  obviously felt a little better the next day with full recovery the next day
Immediately after injection, the patient developed a red rash about 2-3 inches in diameter surrounding injection site. She described it as being painful but denied any shortness of breath or systemic symptoms. I observed her for a few more minutes and she asked to leave. She said she was feeling ok and was going to go home and take some Tylenol.
This spontaneous report as received from a registered pharmacist refers to a 75 year old female patient with no known drug reactions/allergies and pertinent medical history.  On 03-FEB-2013 the patient was vaccinated with a dose of live ZOSTAVAX (lot # H018092).  On 04-FEB-2013, 2 days after onset of therapy the patient developed an injection site reaction at the site where live ZOSTAVAX was administered. The injection site reaction was described as a red area about 2 inches in diameter at the injection site without itching and not warm to the touch. No lab diagnostics studies were performed. At the time of reporting, the outcome was reported as not recovered/not resolved. The patient sought medical attention by contacting the pharmacist. The relationship between the event and live ZOSTAVAX was not reported. Additional information is not expected.
Pt vacc.DTP/OPV developed obtundancy, nonresponsiveness, personality change, high pitched cry, decreased muscle tone, refused to bottle feed, lt sided seizure;9 hrs of illness, repeated 1 hr later 65 min seizure 68hrs /p vac. Given IV Meds.
Aches, profuse sweating, fever, chills, no appetite. No resolution after 4 days. Ambulance called after 3 days w/ recommendation to be taken, but refused.
Fatigue lasting 6 days, swelling in the joint of my left thumb. As of 2/1/2021, the swelling has not diminished.
cried cont for about 10hr (2PM-12PM)-APAP & Motrin given w/o effect napped x 1-2hr from 12PM-1PM;
On 2/24 patient started with breathing problems - till her body was shaking. She got hives (slight) on the arm where the shot was given. As of today she still has pain in her arm, she can hardly move her hand.
Within a week of COVID-19 vaccine I had an outbreak of shingles in my left eye.
Around 1pm the day after my shot, I started experiencing nerve pain down my left arm. That disapated by around 7pm, at which my left axillary lymph nodes began to swell and become extremely tender. As of 8pm 2 days after my shot, I have firm, hard lump that is about the size of half a tennis ball.
Felt Flu like symptoms 12 hours after the injection.  March 8 then had a fever and severe headache.  Continued to have a sore throat and fever and headache all day.  March 9 felt exhausted.   April 5 tested positive for COVID 19 felt sore throat, cough, severe headache, fever, shortness of breath, exhaustion, body aches.   April 6 lost taste and smell April 7  veing popped out on right calf went to hospital and got a sonogram of vein in right leg.  April 8 started feeling fizzing all over skin
Pt. receive a Zostavax vaccination on 3/15/2014. Pt. stated he had a rash at the injection site and on left side of his abdomen. He did not mention when the reaction occurred however he did state that he saw his primary care physician and his doctor state, "That's good." He also stated the rash is gone.
patient developed hives on her left arm which continue to right arm and both feet.   Stated her throat was tight and lung sounds coarse.  Pulse oximetry range 91-98%.  Given 50 mg of diphenhydramine.  Became hypotensive when standing up.  First response team called and taken to the ED for further observation.
he has red rash at injection site of 3inch in size; he has red rash at injection site of 3inch in size; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (he has red rash at injection site of 3inch in size) and VACCINATION SITE ERYTHEMA (he has red rash at injection site of 3inch in size) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Chemotherapy.   On 20-Apr-2021, 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 20-Apr-2021, the patient experienced VACCINATION SITE RASH (he has red rash at injection site of 3inch in size) and VACCINATION SITE ERYTHEMA (he has red rash at injection site of 3inch in size). At the time of the report, VACCINATION SITE RASH (he has red rash at injection site of 3inch in size) and VACCINATION SITE ERYTHEMA (he has red rash at injection site of 3inch in size) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This case refers to 70th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that  the temperature was not monitored on 24-Oct-2017 and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event and reporter's comment: Amended narrative accordingly.
I received my first vaccine dose on 4/15/20 and my second dose on 5/6/21. I've been on birthcontrol pill for the past 8 years which successfully stopped my horrific endometriosis pain...until now. In June (one month after second dose) I started to experience bad pelvic pain/endometriosis pain again. The following September I experienced breakthrough bleeding despite skipping the sugar pills since 2018. Followed by more cramps. In November I received my booster shot and I am once again experiencing endometriosis pain despite taking my birthcontrol pill. It seems like the cramps appear extra strong right after the covid shots. I was painfree in July, August, October, and November.
04-07-2021 exhausted, shivers at night. Next 4 nights, exhausted, pain in right, right groin, right hip  ongoing still.
Pt very tired in evening after shots.  About 48 hours later after acting normally, mother found pt laying on floor with eyes open not responding to sound.  Pt very limp mother held for approximately 2 min when she started to become responsive afterwards hands very shaky.  PT after drank and then went to ED.  Has acted normal since.
This spontaneous report as received from a consumer via Clinic refers to a currently 67 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-MAR-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
1) Sudden Blurring of vision, lasting more than one month (still occurring), 2) partial loss of hearing in both ears, 3) nerve sensitivity when moving body and when objects (seats, walls, bed) touch skin, feeling like shooting pain on contact. 4) loss of muscle strength, and extremely sharp pain (like spear stabbing) when using muscles (see symptom #3 above). 5) fatigue and spontaneously falling asleep, even when standing or doing dishes. 6) toe nails deformity within weeks of shot, curling and turning sideways. 7) uncontrollable leg adema, severe with water leaking out of legs.
Fatigue/ feel Excessive tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (Fatigue/ feel Excessive tiredness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L208A) for COVID-19 vaccination.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis.    The patient's past medical history included Asthma since an unknown date and Rheumatoid arthritis. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-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 started TOFACITINIB CITRATE (XELJANZ XR) (unknown route) dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue/ feel Excessive tiredness). At the time of the report, FATIGUE (Fatigue/ feel Excessive tiredness) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  No treatment details were reported.
he has missed two days of work now; having abdominal pain; pain on palpation; This is a spontaneous report received from a contactable Nurse (Patient's mother). A 20 year old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter wants to know if there is any compensation for people who have gotten the COVID-19 vaccine and experienced side effects. She states that he has missed two days of work now, he is a college student, and has a high insurance deductible. Her son got the vaccine on Friday and since Saturday he has been having abdominal pain, and pain on palpation. She wants to know if anyone else has reported these symptoms at this point. She states that she has reached out to her son's doctors. She states that she filled out a safety report online this morning. Caller states that she is trying to get a hold of his doctor by they have been busy. She states she is just going to take care of him now and see what today brings. Caller was given information: Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include: injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell, swollen lymph nodes (lymphadenopathy), non-severe allergic reactions such as rash, itching, hives, or swelling of the face, severe allergic reactions, diarrhea, vomiting, arm pain. These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 Vaccine is still being studied in clinical trials.1.The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Fever greater then 100 F, runny nose, body aches, severe cough.