chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm pain; vaccine exposure during pregnancy; Initial information received on 22-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.   This case involves Adult female patient who had arm pain (pain in extremity) after receiving INFLUENZA VACCINE (exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The reported events occurred at unknown gestation period.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's previous pregnancy/ies were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious arm pain (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was an actual medication error due to vaccine exposure during pregnancy (same day latency).  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was reported "Okay to be honest (tbh) I don not usually get my flu shot, but I got it this year bc my doc said it was highly recommended for pregnant women. So I got it. And here comes the arm pain lol."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported events.   Additionally, at time of reporting, the outcome of the pregnancy was unknown.  There will be no information on the batch number for this case.
Swelling of left deltoid a few hours after vaccination. Swelling significantly over entire deltoid/shoulder/upper arm by 24 hours post vaccination.
The day following getting my second shot, I broke out with a pimply rash on arms, legs, and back. It was very itchy.  I had a severe headache. I was very Tired.  I was Nauseated for 3 days.   I did not seek treatment.  I slept for 2 days. My headache went away on day 3.  My rash is almost gone on day 5.  My stomach ache went away on day 3.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was COVID 19
After the vaccine was given, it was discovered that the high dose vaccine was administered not the preservative free vaccine that was registered.
This spontaneous report as received from an 81 year old male consumer refers to himself. The patient's medical history included colon bleeding after using aspirin 4 years ago. Current condition includes "blood pressure". On an unknown date in July 2013 the patient was vaccinated with ZOSTAVAX (dose, units, route, lot # unknown). Concomitant therapies included unspecified "blood pressure" drug. On the next day after receiving ZOSTAVAX, the patient felt pain and soreness in the injection arm. The pain had continued, and progressed into the patient's shoulder about 3 months ago. The patient went to health care professional (HCP) to seek medical attention. The patient's HCP prescribed unspecified pain reliever pills that only relieve some of the pain "but not all of it." The patient stated that this pain was constant and getting worse. The patient said he "can't use" the affected arm. No lab test was performed. Outcome of "can't use the affected arm" was unknown. Additional information has been requested.
Day of shot, DTAP leg was slightly red. Tuesday mother did not notice anything. Wednesday AM mother noticed right leg swollen, red, and sore. She had her doctor look at it and he said the pt had a local reaction. Leg now back to normal-no residual symptoms.
01/17/22 presents to ED for "Elevated blood pressures". PMHx of "HTN, HLD, CKD stage 3, prior stroke, dementia, RA on prednisone, hypothyroidism, recent admission for UGIB"
I had very mild fever 100.0 and I had chills. I have muscle weakness.
pt recv vax & devel rigors, fever, chills, nausea, & malaise;pt was recovered as of the date of this report;this is one of three pt from this site to report adverse rxn;
Received call from mother on 5/5/04. States 5/4 in am child right arm had small bruise, was pinkish red but not swollen. Later in the evening on 5/4/04, mother rechecked arm. Right arm had "fist" sized redness, swollen, tender to touch. Child had no fever, no drainage, no red streaks, and no decreased range of motion. Mother took child to ECU for evaluation. ECU stated arm was "infected" and placed child on Cephalexin. On 5/5 mother states redness and swelling are decreasing.
Noted vertigo with change in head or body position.  Increased when head was tilted back or especially when first lying down, the room would spin for a few seconds and then it would stop.  If I tilted my head back, I could not keep it back long enough to see if it would resolve without feeling sick or feeling like I would fall.  Although I feel like the vertigo has resolved, I still don't feel like myself, stiff neck, chilling, lack of energy.
Pins and needles feeling in my feet, legs, hands and arms. Started out off and on, but is now almost constant. It's been 13 days since I  was vaccinated and is not going away yet. Very prevalent shaky, buzzy type feeling. I am concerned about getting the second vaccine. Do I still get it? It is scheduled for Apr 1st. Hopefully this will have subsided by then. If not, and I don't get the second dose, am I still protected against Covid?
pt recv vax & devel a rash @ the site of Acel-Immune administration;
Facial swelling and redness around left ear.  Sent to urgent care facility per supervisor. Supervisor stated symptoms improved.
bilateral facial paralysis, Treatment: Immune Globulin - 5 infusions, steroid, anti-viral; recovering; 6 days
Suspected vsccnation failure; Shingles on May 7; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 11th April 2021, the patient received COVID-19 VACCINE. On 7th May 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingrix 4 years ago from the date of reporting. Less than 2 months after receiving Covid-19 vaccine, the patient got shingles. It was unknown if the reporter considered the shingles to be related to Covid-19 vaccine. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation of shingles was not provided. This case had been linked with case US2021AMR266507, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR266507:same patient - 2nd outbreak
Swelling; Redness on all of arm to elbow; Tenderness; Headache.
Patient reports allergic reaction on the arm where the vaccine was administered, first PFIZER dose. Refers intense itching. There is redness from the area to the wrist. Patient walks to to the paramedics and vitals are taken. Pressure 150/90, saturation 96%, pulse 87. We offer "BENADRYL" 25mg oral. At 10:10 am we monitor her vitals. Pressure 140/90, pulse 67, saturation 98%. Doctor is consulted, and recommends drinking a "SPRITE" to the patient since she is feeling nauseous. At 11:04am vitals are taken pressure  140/80, pulse 67, saturation 99%. Doctor is consulted again and orders to monitor vitals every 15 to 30 minutes. Patient refers feeling good and looks alert. At 11:43am we monitor vital signs for the last time, pressure 120/90, pulse 73, Saturation 99%. Doctor recommends visiting her cardiologist as soon as possible.
Arm below vaccination site red and swollen, painful. 2.7 cm more swollen than unaffected side.
6hr p/vax pt exp ringing in ears w/sore throat;during the noc devel muscle contraction (uncontrollable) of legs/feet & hands lasting 4-5hr;awoke w/thick tongue, unable to talk, cont ringing, felt like throat closing;
Pt recv vax on 8/17/98; on 8/30/98 pt exp sparse, red, papular rash on face & upper trunk; pt imp in 3-4 day
Patient presented to the ED for altered mental status and was subsequently hospitalized for Hemorrhagic cerebrovascular accident within 6 weeks of receiving COVID vaccination.
malaise; left clavicular lymph node enlargement; tingling; left arm soreness; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ophthalmic herpes zoster (2017).   On 2nd August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 2nd August 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, enlargement of lymph nodes and tingling of extremity. On an unknown date, the patient experienced malaise. On an unknown date, the outcome of the pain in arm, malaise and enlargement of lymph nodes were recovered/resolved and the outcome of the tingling of extremity was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, malaise, enlargement of lymph nodes and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The physician reported that patient received Shingrix in left deltoid. The patient experienced left arm soreness, malaise, left clavicular lymph node enlargement, and left sided tingling down the body radiating to left upper extremity.  Adverse event was filed.  Number and website for GlaxoSmithKline medical information given for future reference and warm transfer provided. The reporter consented to follow up.
developed sigmoid diverticulitis on 3/16/2021. Seen in ER. Improved on outpatient antibiotics.
Patient started to have a reaction the  day after the vaccine was administered. She started to notice she was feeling "funny". Then on Thursday she noticed her tongue was swollen.  Over the next day she had swelling in eyes, face, tongue, and she was unable to breathe.  Patient went to the hospital where she was admitted and given benadryl+steroids.
Second dose on 14Jan2021. Caller reports that her mother was just diagnosed with Covid; Second dose on 14Jan2021. Caller reports that her mother was just diagnosed with Covid; This is a spontaneous report from a contactable consumer (Daughter). Follow-up received on 05Mar2021 was processed together with initial information.  A 78-years-old female patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration on 14Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation . The patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 21Dec2020 as SINGLE DOSE for covid-19 immunisation. Medical history included , lung disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient experienced second dose on 14Jan2021, caller reported that her mother was just diagnosed with covid on an unspecified date. It was  reported that her mother always had bad lung issues.  The outcome of event was unknown.  Information on the lot/batch number has been requested.
Given 3/19/2001 - seen in office 3/21/01 R thigh red, swollen, lump local reaction only - walking on leg ok no infection noted.
Vaccines for impending travel: Hepatitis A #1 of 2, Influenza 2011-12, Polio IPV, Typhoid TYPHIM VI, Yellow Fever.
Flu vaccine given 10/30/07 - for HCW. 11/1/07 reported "reaction" to shot. Injection site red 2 1/2 x 1 1/2 inches, swelling and tender area larger. Appears well otherwise. No other similar reactions.
Within minutes of receiving the shot my left ear started to turn red, hot and tingly. This is similar to how I react to shellfish which I have severely allergic to. The redness and hives then spread from the left cheek over my nose to the right side of my face and down my neck. I was then taken to an ambulance and treated by an EMT. I was advised to either be given an antihistamine cocktail via IV or be released and take it at home. I chose to go home since I was driving myself and knew that the drugs would make be very tired and impossible to drive safely. I took the dose as soon as I returned home and then 6 hours later took a second dose as the hives were still appearing on my face. The next day, April 2, I woke without symptoms.
Information has received from an office manager (also reported as administrator) referring to a female patient of unknown age. On 09-JAN-2012, the patient was vaccinated with a first dose of VARIVAX (Merck) (lot#, expire date were unspecified, 0.5 ml) subcutaneously. On 27-APR-2015 the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # J005253, expiration date 26-APR-2015; second dose, 0.5 ml) subcutaneously. No adverse effects were reported. This is one of several cases reported from the same reproter. Additional information has been requested.
Report from a consumer who experienced swelling and bleeding at an influenza injection site eight months after starting Enbrel.
Fever 101.1, aching joints, shortness of breath that I still have week later, loss of taste,
sore arm that she couldn't lift above her head for a day or so; This is a spontaneous report from a contactable consumer reported for a patient. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller mentioned that someone he knew had their first dose of the vaccine and had no side effects other than a sore arm that she couldn't lift above her head for a day or so on an unspecified date. The outcome of the event was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
pt recv vax 1JUL97 & exp malaise, myalgia, pharyngitis, headache;
Pt recvd 3 doses of Engrix-B & it was determined that pt was a non-responder;
Patient reports since receiving the vaccine he has had "occasional Stabbing, shooting pains" in his neck- between his shoulder blades. He reports "it is getting better now".
I started my period the day after my 2nd vaccination shot and I did not stop my period Until I had to have a hysterectomy on September 20th 2021. the doctors tried multiple medications to get the bleeding to stop and nothing work.  I had normal periods up to that point.
Information has been received from a physician concerning her son who on an unspecified date was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently the patient developed a fever and rash. It is unspecified if the patient recovered or if medical attention was sought. There was no product quality complaint involved. The patient's brother (WAES# 0607USA03670) had similar experience following vaccination with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). No further information is available.
1st dose at 7-years old; A nurse reported that a 7 year old patient was administered Vaxelis; This non-serious spontaneous safety report with reference# 02268150 and interaction# 02268145 was received by a partner on 14-OCT-2022 from a Nurse and forwarded on 14-OCT-2022.  Due to the nature of the event, the causality between Vaxelis and the reported events of "A nurse reported that a 7 year old patient was administered Vaxelis", was not applicable.  Off label use classification added as 1st dose at 7-years old.  Further information is expected.
pt recv vax & became feverish & fussy that afternoon (5-6 hr later) but still feeding;to ER 30JUL98 w/severe resp distress, grunting, cyanosis, drawing in of chest, semi-comatose shock, afeb;intubated;WBC 49.2, segs polys 33%,lymph 61%;
Pt recvd DTP/HIB/OPV on 18JUN & 19JUN 12 hrs later pt had 10 mins generalized tonic/clonic sz assoc w/t101; 2nd sz (1 1/2 min) occurred 3 hrs later @ approx 6AM;
Localized swelling, redness left thigh. Where shots were given & itchiness.
PATIENT/EMPLOYEE GIVEN VARICELLA VACCINE ON 1-23-06 AND DEVELOPED ERYTHEMA & INFLAMMATION AT THE SITE OF INJECTION ON 1-24-06. RE-EVALUATED IN EMPLOYEE HEALTH ON 1-26-06 AND HAD APPROX. 15CM X 8CM AREA OF ERYTHEMA & INFLAMMATION WITH PAIN AND ITCHING. NO RESPIRATORY S/S OR RASH. EMPLOYEE SENT TO OCCUPATIONAL HEALTH MD AND RX FOR KEFLEX AND BENADRYL WAS PROVIDED.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 17 years old female patient with none drug reactions or allergies and none pertinent medical history. The patient's history of previous pregnancies and live births was not known. On 24-JAN-2012, the patient was vaccinated with the first dose of GARDASIL, intramuscularly (lot number reported as H011350, expiration date 21-FEB-2015) (dose not reported). No other co-suspects were reported. There was no concomitant medications. The patient was then administered her second dose of GARDASIL, intramuscularly (lot number reported as H011350, expiration date 21-FEB-2015) (dose not reported0 that day on 03-jAN-2013 and subsequently found out later in the day that she was pregnant. the second dose of GARDASIL and urine pregnancy test were conducted at the health department. At the time of the report the patient was in a six weeks pregnancy. Her estimated LMP was on 22-NOV-2012 and an EDD will be on 29-AUG-2013. Initial exposure to GARDASIL was at 6 week. The patient was exposed to GARDASIL during trimester 1. Additional information has been requested.
I was in extreme Pain.  Everywhere I have ever had an injury previously was in horrid pain for at least 4 days then it has changed to chronic.  My scar tissue on my head was and still is inflamed.   I have numbness from my knees to my ankles and my ankles are weak. my joints and my neck are soar, I am very tired and can hardly do a good job at work because of it. I have minor heart palpitations,.
DVT, Antiphosilipid syndrome, lupus anticoagulant, heart failure, iritis, nerve problems
sore arm; hand swell at injection site; couple of bouts of vertigo; ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Apr2021 11:00 (Lot number: ER8732) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ulcerative colitis", start date: 2005 (ongoing), notes: Blood infusion 4 points.; "Osteoporosis", start date: 2019 (ongoing); "Heart block", start date: 2019 (unspecified if ongoing), notes: Test: Hospital, start date: 2019, Results: Chest X-ray and EKG, Comments: Heart block. Concomitant medication(s) included: MERCAPTOPURINE taken for colitis ulcerative, start date: Nov2005 (ongoing); ALENDRONATE taken for osteoporosis, start date: Dec2019 (ongoing). Vaccination history included: Flu shot; Pneumonia shot (Pneumonia shot both kinds starting 2017), administration date: 2017. The following information was reported: VERTIGO (non-serious) with onset 2021, outcome "unknown", described as "couple of bouts of vertigo"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "ill"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "hand swell at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo, illness.  Additional information:Prior to vaccination, patient  was not diagnosed with COVID-19.Since the vaccination, patient has  been tested for COVID-19.Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
Covid arm: red, swollen circular area on arm at area of injection. Hot to touch, sore. This was 2 days after vaccine. Third day after vaccine (today) less sore, still red, swollen, very itchy, hot to touch. Small 1/2 inch white circle around actual injection site. Icing the area, taking benydryl. Not sure how long it will last.
Arm is really sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient had the shingles in 2008 after having breast cancer), breast cancer, stress and nerve pain. Previously administered products included Shingles vaccine (The patient took the shingles shot in 2009).   In July 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date:21-JUL-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The shingles was worse than going through breast cancer.  The patient was told he/she needed the new shot but put it off because he/she would have to pay dollar 120.00 per shot. The patient stated that, which had to have two shots 2-6 months apart.  The patient broke his/her back in January and had been going through a lot of stress, he/she was sure that, he/she had the shingles again.  The same place on his/her back as before but he/she did not get the blisters this time but the nerve pain was horrible.  The patient stated that, it was terrible even without the blisters.  The patient further stated that, it seemed like his/her shingles were lasted about 5-6 weeks.  The patient just went a got the new shot 3 days ago.  The patient hoped the second shot would not make his/her arm as sore as this one did. The patient stated that his/her arm was really sore from the shot but he/she hope to never have shingles again. Additional Supportive Information: The follow up would not possible as no contact details were available.
76 YO M C/O LEFT SIDE RING AND LITTLE FINGER HAS GONE NUMB AFTER COVID 19 SHOT (PFIZER) WHILE WAITING IN THE OBSERVATION AREA. PT HAS NO OTHER C/OOR SX. NUMBNESS IS IMPROVING AFTER MOVING ARM AROUND. DENIES ALL SX RELATIVE TO ALLERGIC/ANAPHYLACTIC REACTIONS.FOUND ABOVE PT SITTING A/O X4, NO DISTRESS, CX - GOOD RESP EFFORT, WITHOUT C/O. EXTREM - GOOD PMS X4 WITH EXCEPTION OF LITTLE AND RING FINGER OFLEFT HAND. R/O TEMPORARY NUMBNESS OF RING AND LITTLE FINGER OF LEFT HAND SECONDARY TO ULNAR NERVE COMPRESSION. EXAM, T&R WITH INSTRUCTIONS TO FOLLOW UP IF NUMBNESS DOESNT GO AWAY.