chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; sinus infection; being sick; Initial information received on 14-Dec-2021 regarding an unsolicited valid non-serious case received from a non-healthcare professional (under reference: US-SA-SAC20211222000712).  This case involves a 77 years old female patient who experienced headache, sinus infection and being sick when received vaccine INFLUENZA VACCINE.  The patient's medical history included pulmonary arterial hypertension.  The patient's past vaccination and family history were not provided.  Concomitant medications included AMBRISENTAN (LETAIRIS), TADALAFIL (ADCIRCA) and WARFARIN.  In October 2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  In 2021 the patient developed a non-serious headache, sinus infection (sinusitis), being sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "On an unreported date, the patient experienced event of was off Tyvaso for a little while but has since restarted (therapy interrupted)."  Laboratory details were not reported.   The patient was treated with TREPROSTINIL SODIUM (TYVASO) for pulmonary arterial hypertension.  At the time of reporting, the outcome was unknown for all the events.  There will be no information available on the batch number for this case.
Patient is a 46 years old, well nourished, well developed female. Presents at the clinic today for pruritic rash on face and neck x 5 days. Reports that rash started at nighttime the same day that she received the covid booster vaccine. Reports that the rash stated around her nose and mouth (where mask is) and spread under her chin and down her neck. Denies angioedema. Reports that rash worse at night, exacerbated by wearing mask. Reports no issues after last 2 doses of covid vaccine. Reports trying antibiotic cream from a different location with little relief. Reports history of sensitive skin but denies hx of dermatitis and facial rashes. Pt is awake, alert, cooperative, & in no acute distress.
Vulvar aphthous ulcers; Vulvar aphthous ulcers; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 19-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 19 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: VULVAL ULCERATION (non-serious), APHTHOUS ULCER (non-serious), outcome "recovering" and all described as "Vulvar aphthous ulcers". The event "vulvar aphthous ulcers" and "vulvar aphthous ulcers" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of vulval ulceration, aphthous ulcer.  Additional information: Patient received treatment using steroid cream. The patient was not tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 08-SEP-2015, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 336 hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius). the vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Left arm pain 8/10 (with 10 being the most painful) started at the injection site radiating  to the left shoulder on Saturday 10/5/19, increasing on Sunday 10/6/19  to 10/10 pain level. Pain occurs with every movement. Also, loss of range of motion with each attempt to move arm forward, backward, or upward . Can't lay on left side when sleeping; and pain continues as described to this day.
Swollen lymph node right side of neck and under left arm. Covid arm. Low grade fever. Congestion x 5 weeks following vaccine.
On 12/09/2021 around 5:00pm I got a headache, chills and a fever. which lessened in severity by 11:00pm. On 12/10/2021 I developed congestion and cough which diminished by 12/13/2021.ON 12/12/2021 when I awoke in the morning I lost my sense of smell which has not returned at this time 12/13/2021 8:00pm . I also developed  Diarrhea which still persist today.  I can taste some food but it must be strong in flavor. I had no adverse reactions to the first and second  shots. My mane concern is my lack of smell
Hives noticed about 6 hr. after shots.  Pediapred prescribed for 7 days bid.  Also Benadryl 1 tsp. every 4-6 hr., & Zyrtec 1 tsp. daily for itching.  The patient is a 1-year-old female came in yesterday and had her 1 year immunizations.  Last night at her bath time dad noticed a couple of red spots.  This morning when she woke up she was covered with hives.  She has been scratching at them a little bit.  She has not had a fever and she has otherwise seemed fine.  Erythema multiforme secondary to one of the vaccines she received yesterday most likely, which include MMR, varicella, hepatitis A, and Prevnar, which is less likely because that was her third dose.  She will be placed on Pediapred 30 mg initially, 10 mg tonight at bedtime, then 20 mg b.i.d. for 2 days, 10 mg b.i.d. for 2 days, then 5 mg b.i.d. for 2 days.  Also it is recommended that she get some Benadryl today, 1 teaspoon every 4-6 hours and they also could try Zyrtec 1 teaspoon daily until her itching is diminished.  They will return with increasing symptoms or as needed.  She should not receive any of the above vaccines again.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose12/19/20 2nd dose01/08/21 Diagnosed covid positive:08/23/21 Symptom onset:08/21/21 Exposure: Symptoms:fever, cough, muscle aches.
This was vaccine #2 About 11 hours after the vaccination: chills that lasted 16 hours followed immediagely by sweating for 9 hours. 24 hours after vaccine extremely painful backache along with headache. Headache lasted 2 days after onset, backache lasted for 3 days after onset. Felt like my brain was in a "fog", much decreased processing capacity, 36 hours after vaccine lasting 3 days.  48 hours after vaccine, stomach ache, lack of appetite for 3 days. Felt back to normal 7 days after vaccine
5 hours after receiving Fluzone HD 2010-11 PFS (SAN) I had back pain, chills & shivering, cough, general body discomfort particularly in lymph nodes, mild fever, muscle aches.  These symptoms reached a peak at 02:00 AM 01/26/2011 and then began to subside noticeably.
No adverse effect reported.; one dose of expired VARIVAX (M033905 7/20/2018) that was administered to one patient on 3/20/2019; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition and medical history was not provided.   On 20-MAR-2019, the patient was vaccinated with one dose of expired varicella virus vaccine live (oka/merck)(VARIVAX) (lot # M033905, expiration date  20-JUL-2018, subcutaneous; dose detail and anatomical location were not reported) for prophylaxis. The sterile diluent that was used to reconstitute the varicella virus vaccine live (oka/merck)(VARIVAX) was not expired. No adverse effect was reported.
patient reported itching, swollen and heat.  when contacted the following day, the symptoms had subsided considerably.
Hives all over torso, front and back - less than 2 days after 2nd dose
Headache, Myalgia, Fever, injection site pain/swelling, chills Narrative: Employee reports injection site pain/discomfort and swelling, as well as fever, chills, headaches, and body aches. Reports took Advil (ibuprofen) for symptom relief.
Patient came back to facility about 1 hour after receiving the flu shot. She complained of feeling lightheaded, nausea, and clammy skin Pharmacy protocol says a this point to monitor for worsening or improving condition. At about 12:30, she start complaining of tingling in her right upper lip and numbness in her tongue. I had my technician call 911 and I monitored her until EMS arrived. She refused an Epipen, which is advised in pharmacy protocol. EMS arrived within 5 minutes and took over the situation. They took her vitals, etc and ultimately advised her to further monitor and take benadryl. I called the patient at 7PM and the symptoms had disappeared after taking the benadryl.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. Since 12-FEB-2014 the patients were vaccinated with PROQUAD (Merck) which was administered subcutaneously and underwent supported temperature excursions on unknown date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Entire left arm, all the way from shoulder to the fingers swelled up to 1.5 times the normal size. The left index figure and thumb started tingling and became numb. The pain is present in the front and back of the left shoulder as well. Saw a Dr and she told me to take 4 x 200mg Motrin every 6hrs for next 4-5 days. She also gave Tylenol 3. The pain was so acute that I asked my doctor to just chop off my arm. I couldn't sleep, I couldn't stand, sit or lay down. It hurt all the time. Lost all strength in the left hand and arm.  Motrin and Tylenol didn't help with the pain. The swelling went down quite a bit in 3 days. Motrin caused a flare up of Crohn's.   Saw another Dr 5 days later. She prescribed gebapentin, flexrel, norco, toradol, etc. It's now been almost 20 days since the injection. The pain has subsided but not completely gone. I am still unable to do much work and it hurts just to sit! I still have pain and still do not have my strength back. I am still unable to go back to work.
unable to lift his arm; excruciating pain; This spontaneous report was received from a 67-year-old male patient. The patient's concurrent conditions included high blood pressure, unspecified urinary condition and allergy to sulfa drugs. Concomitant medications included unspecified blood pressure medication and unspecified urinary medication  On 01-APR-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscularly, in deltoid muscle for pneumonia prevention (dose, lot # and expiration date were not reported). On the same day, hours after getting pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) administered, the patient was unable to lift his arm and experienced excruciating pain. No treatment was given for the events, no lab diagnostics were performed. The patient did not seek medical attention.  At the time of the report, the patient did not recover from the events. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.
Arthralgia, CoughWheeze, Rash, SHORTNESS OF BREATH Narrative:
On 2/23/03, pt noticed red bumps over whole body (arms, legs, bottom of feet, back, etc). Pt went to ER where he had a slight temperature 99F. He stated he was dizzy, had nausea with no concentration and pain in left arm. Pt was given Motrin and Atarax, also placed on quarters for 24 hours and relocated from tents to a dorm. Pt was told to return to the ER the next day. Pt was experiencing symptoms, the same as the previous day. Pt was given IV's, pictures were taken of red bumps and the pt was told to remain at home (dorm room) on quarters. Pt returned to ER today for evaluation. Pt states he feels better today but still has pain in left arm. Pt told to return again to ER tomorrow. Pt is still on quarters at this time. Generalized vaccinia.
Complaints of redness and swelling, pain and warmth in legs 2 weeks after vaccine.
Started experiencing onset urological symptoms of a UTI which include burning, itching, swelling, and bleeding about 3 hours after receiving the vaccine.   I?ve never had problems of this nature before until I got the Moderna vaccine.  For treatment I use OTC yeast infection ointments and inserts.  At this time, too much friction is causing the symptoms to worsen so it hurts to move.  It also hurts to urinate.
Complained of severe deltoid pain where the vaccine was given, also low grade fever, and full body muscle aches. Lasted for about 24 hours after onset. Patient feels much better today 2 days post vaccination.
PATIENT SATES THAT BY EARLY EVENING OF INJECTION SHE WAS VERY WARM TO TOUCH HER ARM WAS WARM TO TOUCH, RED AND THROBBING.  DID NOT REST WELL THROUGH THE NIGHT AND FELT SHE MIGHT HAVE HAD LOW GRADE FEVER. LEFT ARM WAS INCREASED WARMTH AT SITE WITH 4 INCH BY 8 INCH AREA OF REDNESS.  AREA CONTINUED TO THROB WHERE FLU WAS GIVEN.   PRIVATE DOCTOR TREATED FOR CELLULITIS WITH DOXYCYCLINE 10/20/2009.  PT APPLIED COOL COMPRESSES 10/29/2009 BUT DID NOT IMPROVE.
SEVERAL HOURS AFTER PT LEFT CLINC HE COMPLAINED ABOUT PAIN UNDER THE ARM THE NIGHT HE RECEIVED VACCINE. PARENT DIDNT NOT SEE REDNESS OR SWELLING IN THE AREA.
On May 28, 2021 started mild joint pain until 2nd shot on June 15 had high fever, fatigue, dizzy, muscle aches for 2 days and headache for two weeks and moderate joint pain. My pain continue till the 3 week mark after that no symptoms but lost some hair while having my second shot.  Also, possible weight gain from 1st shot.
has actively had a shingles outbreak for over 3 years; did not help with her pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included gabapentin.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for herself. The age at vaccination was not reported. The patient had received Gabapentin as conmed. The patient received a dose of Shingrix in 2019 and dose did not help with her pain (lack of effect). The patient has actively had a shingles outbreak for over 3 years and Health care professional advised the patient to got her 1st dose. No additional information was provided by the reporter. The reporter did not consented to follow-up.
12 hours after receiving first dose of Moderna COVID-19 vaccine, felt symptoms of arm and shoulder soreness and skin warm to touch around injection site.  Also felt slight fever and body aches and pounding headache for the next 24 hours starting that midnight.  Took acetaminophen extra strength and found relief of symptoms. 1-2 days later, however, experiencing swelling/tenderness in axillary/armpit area. Yet to subside. May ask a healthcare professional about it.
Headache, Myalgia, Arthralgia, Fever,  EXTREME TIREDNESS, INJECTION SITE PAIN, SWOLLEN GLANDS Narrative:
Left upper arm, 3-4 inches in diameter, warm to touch, red, swollen "itches'
On day 10- noticed 10 pale pink, non-raised macules on central abdomen only. (Below the skin only). Denies itching/burning. Not spreading- is fading with no additional macules. Denies fever or other illness except "sinus congestion" which is common for this client.   Denies any new foods, soaps, clothes. Client did begin pediatric office observation on day 6/7 post vaccination.
Diarrhea; Hives; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), URTICARIA (Hives) and FATIGUE (Fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Codeine).    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced DIARRHOEA (Diarrhea), URTICARIA (Hives) and FATIGUE (Fatigue). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), URTICARIA (Hives) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. No lab data provided.
The vaccine expiration was incorrect, and the patient received an expired dose of Pfizer COVID-19 vaccine.
Extreme soreness at injection site began 12/23/2020 when I woke up and continue through today  Fever and chills began about 4:30 pm on 12/23/2020. Fever was 101.4  Took Motrin 800 mg and went to sleep at 9:00 pm . When I woke at 7:00 am 12/24/2020 the fever had broken. Tired easily 12/24/2020 and 12/25/2020 but feeling much better. Arm is still a bit sore and injection site is itchy but much improved over 12/23/2020.
About 3 hours after the shot, I experienced severe painful PVCs that then turned into a tachycardia of over 180 bpm while I was driving.
I was having trouble breathing, I was given a Albuterol and nebulizer and another drug and they gave me a 5 day prednisone, I followed up with my primary dr who told me to keep using my Albuterol inhaler as needed and gave me a prescription for cetirizine. I have been taking 2 Zyrtec in the morning and Benadryl at night and I have been using my inhaler. It seems to be helping but sometimes I still have tightness in my chest. And sometimes it feels painful in my upper chest area. Today I had an appt with a specialist, he suggested I had an EKG but I do not know the results for that test yet. They also did a chest x-ray on the first day and my lung were clear.
PATIENT REPORTS HAVING SEVERE LOCAL REDNESS AND RASH ON FACE ONLY THE DAY AFTER VACCINTION W FOR COVID AND SHINGLES. PATIENT WENT TO FAMILY MD AND RECIVIED NO TREATMENT THE I AM AWARE OF SPECIFICALLY FOR REACTION. MD DID PRESCRIBE MEDROL DOSE PAK ON 11/22/2022 FROM MD
Pain at site of injection; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the arm left on 02Apr2021 at 10:00(at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. On 02Apr2021, the patient experienced Pain at site of injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the vaccination site pain was unknown.  No follow-up attempts are needed. No further information is expected.
I got the first dose of the Moderna COVID-19 vaccine at 3pm 1/13/21. I was fine for the 30 minutes after, not even sore at the injection site.  Around 6pm, my muscles started aching, but not painful enough to be concerned.  At 3am 1/14/21, I woke up in pain in every muscle. Enough to wake me, but not terrible.  At 7am, I noticed a pinpoint pain in my armpit, and my muscles still ached.  At 9:30am, I took ibuprofen to attempt to curb the pain a bit.  Around 10am, it got so painful I was limping, and having trouble bending down or reaching above shoulder height.  At 11:30am, I noticed the pinpoint pain in my armpit had gotten worse, and there is a hard, approximately quarter-sized round lump in this spot. Very painful.  At 2:30, I went to move my shirt sleeve and the pain at the injection site was so intense I screamed when I touched it.  This pain continued until 1/16/21 when I woke up feeling entirely normal.  Since 1/16/2021, my hands have been randomly stiffening, either completely stretched out and dropping anything in them, or closing tight enough to leave fingernail marks on my palms. I will also reach to grab things and my hands will sometimes bend into odd shapes, instead of what I intended for them to do. This began at 1-2 times a day, and is becoming more often. It is now up to 2-4 times daily.
Debilitating pain mostly on the right side of body from hip to foot, inside of knees on both legs, left shin, front and back of left leg; Shooting pain is similar to sciatica; Pain caused to quit walking and doing exercises; Sometimes the pain wakes up at night; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 20Feb2021 at 10:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and iodine allergy (internal). 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 COVID vaccine. Concomitant medication included hydrochlorothiazide/losartan potassium (MANUFACTURER UNKNOWN) "100'' for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the left arm on 24Jan2021 at 10:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. The patient previously received oxycodone/aspirin (PERCODAN), lorsartan potassium (MANUFACTURER UNKNOWN), ketotifen fumarate (ZADITOR EYE DROPS) and amlodipine (MANUFACTURER UNKNOWN) and experienced drug allergy. On an unknown date in Mar2021, the patient experienced debilitating pain mostly on the right side of body from hip to foot, inside of knees on both legs, left shin, front and back of left leg. Sometimes, shooting pain was similar to sciatica which caused to quit walking and doing exercises. Walking up and down stairs was painful and it bothered the patient mostly at night when lying in bed. Sometimes, the pain woke her up at night. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result adverse events and included unspecified treatment which was ongoing. The clinical outcome of the events debilitating pain mostly on the right side of body from hip to foot, inside of knees on both legs, left shin, front and back of left leg, shooting pain was similar to sciatica and pain caused to quit walking and doing exercises and sometimes the pain wakes her up at night were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
A week after I received the vaccine, I developed a knot on the injection site that is fairly large, sore and warm to the touch.