chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and PRURITUS (itching) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 025B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: VARICELLA ZOSTER VACCINE in 2020.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). On 03-Apr-2021, the patient experienced PRURITUS (itching). At the time of the report, HERPES ZOSTER (Shingles) and PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided Treatment medication  includes  Benadryl   This case was linked to US-MODERNATX, INC.-MOD-2021-069802 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069802:CROSS LINKED WITH DOSE 2
Fever 100 degrees.  Large raised, red, hot, & very sore at site of injection, (4 inch circle with white ring around swelling).  Painful arm sore to shoulder & elbow areas.  Very sore for 6 days-rc'd meds to relieve itching.  Used ice bags 2 days.  6/30/08-still has 2"-3" area-red & warm.  Flu-like symptoms 1 wk.
Information has been received from a physician concerning a 17 year old female patient who on 27-Feb-2009 was vaccinated with the first dose of GARDASIL IM 0.5ml. On 01-Mar-2009 the patient developed a facial rash. There was no concomitant medication. On approximately 22-Mar-2009, after 2-3 weeks the rash resolved without treatment. The patient mentioned this adverse reaction on 13-May-2009, when she came to the office for her second dose of GARDASIL. No further information provided at the time of reporting. Follow up information has been received from another health professional reported that the 17 year old female patient was vaccinated with the second dose  of GARDASIL (lot#: 661046/0546X) with an expiration of 01-Dec-2010 on 13-May-2009 and it was the only vaccine she received that day. It was confirmed that the patient recovered. No additional information is expected.
No adverse event, but both Pediatrix and Pentacel where given at the same time. (Pentacel given instead of HIB).
Information has been received from a licensed practical nurse concerning a 75 year old male with no pertinent medical history, drug reactions or allergies who on 12-NOV-2007, at 12:15, was vaccinated subcutaneously into the left arm with a first dose of Zostavax (Oka/Merck) (Lot #658398/1087U).  There was no concomitant medication.  On 15-DEC-2007 the patient "may have developed shingles".  He started with one spot, then a rash around the spot.  The patient experienced pain when laying down at night.  The pain radiated around to the abdominal side.  Unspecified medical attention was sought.  There was no product quality complaint.  At the time of reporting the patient had not yet recovered.  Follow up information was received from a nurse who reports that a 75 year old male verbalized that on 15 DEC 2007 "he started to get a rash, which was painful at times and took ADVIL.  The rash started at the tailbone area and radiated to the lower right quadrant of HBD and hip".  The final outcome was not reported at this time.  Additional information is not expected.
Aug 3 vaccine. Friday Aug. Broke out with welts, quarter size welts all over body. Head to toe. Took her to prompt care. Dr. stated hives caused from vaccines. Pediaprobe (antihistamine) rx given. 2 weeks after broke out again and taken to own Dr.  Dr. states as a result of vaccines. Mother denies child being introduced to new foods, soaps, surroundings. Mother states this has happened 3x's since child has been vaccinated.
Ache, chills,  and atypical right sided chest pain.  Started 1 day after shot and 12 days later pt. came to hospital with chest pain.
Information has been received from a registered nurse referring to a 5 year old female patient. The patient's medical history was not reported. On 04-MAY-2015 the patient was vaccinated with improperly stored PROQUAD (Merck) injection lot # K020749, exp 30-APR-2015, 0.5 ml, subcutaneously in the right vastus lateralis. No adverse effects reported at this time. No concomitant medication was reported. Action taken and outcome were not provided. This is one of several reports from the same source. Additional information has been requested.
Heart is beating fast for approx the past week.  Wake up between 4-5 a.m. and can?t go back to sleep. On day of shot only had mild symptoms.
First what happened I had swollen lymph node under my arm and then couple days later I got a rash that was red, itchy, warm to touch and swollen. I compare it to spider bites that I have an allergic reaction to. I spoke to a doctor over the phone from the clinic. They recommended Tylenol.
SEVERE HEADACHE, MILD DIZZINESS, RUNNY NOSE , EAR ACHE, STOMACH ACHE, COLDS,COUGH
fatigue; This is a spontaneous report from a contactable nurse(patient) via a sales representative.  A patient of unspecified age and gender received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization .  The patient medical history and concomitant medications were not reported. Patient previously first dose BNT162B2 for COVID-19 immunization and experienced headache and arm pain.  The patient experienced fatigue after use of product, it was reported that it "laid me out for one day" described as fatigue as well.  Outcome was unknown.    Information on the lot/batch number has been requested.
pt to receive 5-11 y/o  bivalent pfizer booster formulation of the covid vaccine but incorrectly received the 6mons-4 years pfizer formulation instead.  No side effect reported in the event.
Child received vaccine at 3:46 pm. Approx 3:49 pm he had a vasovagal response and had a brief seizure lasting less than 15 seconds. He was unresponsive during this time, pale, and diaphoretic. His mother held his head, and I elevated his feet. He was alert and oriented immediately after seizure, and threw up x1. He was then placed on the floor in lying position with legs elevated on a chair as he was hypotensive. 88/38. He was talkative while on the floor and remained alert and oriented. He was clammy, and still slightly pale but blood pressure was better 98/62. Pulse rate and respirations remained WNL the entire time. About 7 minutes later the child wanted to drink something so Gatorade was offered, and he drank about 8 oz with no nausea nor vomitting. He was sitting at this time. BP was 98/62. Then about 10 minutes later he wanted to sit in a chair. His BP remained stable and color improved slightly.  BP 102/78  Mother declined EMS 3 times and stated she would drive child to the ER as it was only a couple of miles down the road, and husband was coming to help her. Child left in wheelchair around 4:25 pm. BP was 100/68. Heart rate and respirations remained WNL the entire time.   Addendum-mother called me back later that night to let me know that the ER testing was all normal. EKG and Vital signs (not sure of other testing). She did say that pt has same vagal response to the IV start with a seizure as well. She stated it was the exact thing that happened after vaccination. The ER physician stated this was indeed a vasovagal response to a stressful situation, and he referred child to pediatrician for more evaluation.
Pain in arm of shot; Whole body chills; Headache; Fever; Third/booster dose of BNT162b2; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administration date 30Nov2021 (Lot number: unknown) at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication included: SUMATRIPTAN taken for Migraine. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL3247; Anatomical site: unspecified; Route of administration: unspecified), administration date: 25Feb2021, when the patient was 49 years old, for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE; Lot number: EL3247; Anatomical site: unspecified; Route of administration: unspecified), administration date: 18Mar2021, when the patient was 49 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "Third/booster dose of BNT162b2"; PAIN IN EXTREMITY (non-serious) with onset 30Nov2021 at 16:00, outcome "not recovered", described as "Pain in arm of shot"; CHILLS (non-serious) with onset 30Nov2021 at 16:00, outcome "not recovered", described as "Whole body chills"; HEADACHE (non-serious) with onset 30Nov2021 at 16:00, outcome "not recovered", described as "Headache"; PYREXIA (non-serious) with onset 30Nov2021 at 16:00, outcome "not recovered", described as "Fever". Therapeutic measures were taken as a result of pain in extremity, chills, headache and pyrexia. Additional Information: The patient had no known allergies. 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. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures included treatment with TYLENOL and ADVIL.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Fever (99-101.5) from 2AM day 5/8 till 9 PM 5/8 so far.  Swelling and pain at left base of neck on collarbone, lymph nodes.
1st time flu shot receiver slight erythema and swelling of forearms bilaterally. Pt had other ABX allergies, but not to aminoglycoside
Information has been received from a registered pharmacist, also the patient, via a company representative, concerning herself. The pharmacist reported that during her second dose of Gardasil (yeast), she experienced a tremendous amount of stinging. She also noted that the second day after vaccination she was still very sore. Additional information has been requested.
Pt vaccinated with DTP/OPV possible febrile seizure, temp to 104.
Left arm sore at point of vaccination. Swelling, tenderness, and pain in under left arm lymph nodes. Left teeth very sensitive to cold drinks. During night (3 AM 12/12/03) when awakened to go to bathroom, lost balance, all faculties quit, legs folded. I fell into wall, then regained equilibrium and returned to bed. After in bed, tried to sit up and reach for drink of water; could not. Tried to sit up. Could not. Called 911 and taken to emergency center. 3 episodes after returning home. Discharge Summary received on 1/25/2005 arachnoid cyst and ischemic changes.
Erythematous rash within 24-36 hours of administration. Two episodes of facial angioedema with 24-48 hours of administration. Dx was compounded by simultaneous use of lisinopril.
No adverse symptoms reported; The patient received an improperly stored dose of ROTATEQ on 3/3/20; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, drug allergies or reactions, and concomitant therapies were not reported.  On 03-MAR-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, administered orally (PO) (strength, dose and vaccination scheme were not reported; lot number was 1660112, expiration date was on 18-OCT-2020) as prophylaxis (incorrect product storage). No adverse symptoms were reported.  The suspect rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was exposed to a highest temperature above 47 degrees Fahrenheit (°F) (52.1 °F) for a time frame of 15 minutes. There was a previous temperature excursion, at a highest temperature above 47 °F (55 °F) for 21 minutes. In addition, a digital data logger was involved.
Patient developed prickly tongue and itchy throat two hours after vaccination.  Patient developed an upper body rash on core, arms and face 7-8 hours after vaccination.  Patient took Benadryl and prickly tongue and itchy throat went away but still has upper body rash.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/27/2021, 4/6/2021, and 11/30/2021. Presented to Emergency Department for altered mental status and hypoxia. Per nursing home, patient tested positive for COVID on 1/9/2022. Admitted for COVID-19 pneumonia w/acute hypoxic respiratory failure, osteomyelitis, AKI, and septic shock. Treated with supplemental oxygen, pressors, vitamin C, steroids, antibiotics, and zinc. Continued to decompensate requiring higher doses of oxygen and pressor support with multi-organ failure. Expired on 1/13/2022.
Information has been received from a physician's assistant (PA) concerning an infant who was vaccinated with the first dose of Rotateq after 13 weeks of age.  It was unknown if medication attention was sought.  Additional information has been requested.
Lasting Severe Joint pain to date 2 months after.    12 hours after: high fever,  eye pain, blurred vision, unable to walk 10 hours,  skin sensitivity, bad headache,  nausea
Flu vaccine (L) deltoid - redness, induration at time of injection already resolved when patient returned to clinic for another visit. Tdap (R) deltoid - skin colored bumpy, non-itchy rash around injection site. Pt made us aware on 1/20/16.
feeling sick; diarrhea; not able to sleep all night; rash; redness; Chills; feeling nauseated; Vomiting all night; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), DIARRHOEA (diarrhea), INSOMNIA (not able to sleep all night), INJECTION SITE RASH (rash) and INJECTION SITE ERYTHEMA (redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included INSULIN for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced MALAISE (feeling sick), DIARRHOEA (diarrhea), INSOMNIA (not able to sleep all night), INJECTION SITE RASH (rash), INJECTION SITE ERYTHEMA (redness), CHILLS (Chills), NAUSEA (feeling nauseated) and VOMITING (Vomiting all night). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) (oral) on 22-Jan-2021 for Vomiting, at an unspecified dose and frequency. At the time of the report, MALAISE (feeling sick), DIARRHOEA (diarrhea), INSOMNIA (not able to sleep all night), INJECTION SITE RASH (rash), INJECTION SITE ERYTHEMA (redness), CHILLS (Chills), NAUSEA (feeling nauseated) and VOMITING (Vomiting all night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       In addition to four insulin shots patient reported using a lot of other medications concomitantly (not specif   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Event outcome updated. patient said she followed up with her HCP, she has underlying conditions which caused adverse events she is fine now and declined further follow ups.
I have been on birth control with a regular period for over 5 years. I continuously take it so that I do not bleed each month. I have been spotting and cramping while on birth control on and off since getting the first does of my vaccine. This is completely abnormal, and nothing has changed (ie. diet, exercise, things that could cause stress) that could cause this irregularity. I do not know 1000% it was the vaccine, but it seems to be the only thing that could possibly make sense. I just thought I would bring this to attention, incase others were experiencing the same issue.
Intense HSV1 outbreak beginning two days after second dose of Moderna vaccine. Symptoms lasted for about a week. Acyclovir 800mg twice a day for 5 days was taken for symptoms.
Employee stated she had pain and weakness in her left arm that traveled to underneath her left arm and then to her chest.
Shoulder injury related to vaccine administration.  subacromial bursitis. Left shoulder joint. Description: after 2nd dose of Pfizer, Left arm was very sore at injection site, but it was just sore like after getting a tetanus shot but higher pain and quite swollen.  The soreness and swelling subsided over approx a week.  But then the pain at the injection site came back.  It was marked and constant by the beginning of April 2021.  The pain at the injection site continued, at various levels (significant but usually mild), for many months.  Finally, in November, I sought medical care.  This was to see if there was any concern about my reaction, and whether I should get the booster and if so, which brand and in what arm.  My primary care physician referred me to a specialist (sports medicine).  He performed an ultrasound and provided the diagnosis. He injected the shoulder with Kenalog.  The Kenalog  helped some, but the injection site is still sore to this day (almost 12 months since receiving my second Pfizer dose).  Note: my first dose was Pfizer in the left arm on Feb 15 2021, after which my injection site and shoulder felt fine.  My second Pfizer dose was in the left arm March 8 2021, after which the reported pain developed and persists.  I received a Moderna booster in my Right Arm in November 2021; my right arm is fine at this time .
Mother of patient was notified by school of child's (L) arm w/ redness and swelling came to office for evaluation.
I am suffering from the tinnitus, which i got right after the Moderna vaccine (July 17 2021), My both ears are ringing ever since then,  I never had such kind of ear problem ever.
This spontaneous report was received from a physician assistant and refers to a 10 week old female patient. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 30-OCT-1997, the patient was vaccinated with the first dose of RECOMBIVAX HB injection (lot#, expiration date, dose, anatomical location and route of administration were not reported). On 08-JAN-1998 (more than one month after the first dose), the patient was vaccinated with the second dose of RECOMBIVAX HB injection (lot#, expiration date, dose, anatomical location and route of administration were not reported). On 08-JUL-1998, the patient was vaccinated with the third dose of RECOMBIVAX HB injection (lot#, expiration date, dose, anatomical location and route of administration were not reported. On 25-SEP-2015, the patient had titers drawn for hepatitis B immunity and the titers came back as negative. No treatment was given. The outcome of the event was unknown. The relatedness between the event and RECOMIVAX HB was not reported. Additional information has been requested.
Information has been received from a health professional concerning a 12-year-old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, on 01-FEB-2007, the patient experienced chickenpox. It was also noted that the patient's brother developed chickenpox after vaccination with varicella virus vaccine live (Oka/Merck) (Lot # 0702USA03440). Additional information has been requested.
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case is linked to cases 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298593, 2018SA298573, 2018SA297575, 2018SA298622, 2018SA298644, 2018SA298649, 2018SA298611, 2018SA298692, 2018SA298695 and 2018SA298701 (same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a 5 ml dose of FLUZONE HIGH DOSE which was previously frozen, (lot U1995AB and Exp. Date 20 Jun 2018) via intramuscular route in the arm (either right or left) during the period lasting 01Oct2018 to 08Oct2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage and overdose. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 82-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included drug allergy. On 2nd July 2018, the patient received the 1st dose of SHINGRIX. On 2nd July 2018, less than a day after receiving SHINGRIX, the patient experienced pruritus and nausea. On 4th July 2018, the outcome of the pruritus and nausea were recovered/resolved. It was unknown if the reporter considered the pruritus and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm around 2:00 or 3:00 pm. The patient reported that around dinner time that evening, she felt nauseous and then the joints on both hands, feet, and elbows became itchy. By Wednesday, all symptoms had resolved. The patient gave consent to follow up. The patient gave permission for her physician to be contacted and provided details of the same. Unable to obtain additional information. For tolerance to 2nd dose, refer case US2018GSK213571.
Information has been received from a medical assistant concerning a 2 month old patient who on 12-SEP-2008 was vaccinated with the first oral dose of ROTATEQ but spit up a few minutes later. No problems reported. No product quality complaint involved. Additional information is not expected.
Erythema multiforme- started 5/2/09. Thought to be hives- nuclear by E multiforme on 5/4/09. BENADRYL tried w/o relief.
extreme fatigue, fever of 100.5, headache, dizziness, nausea, teeth and jaw ache, lack of appetite, lethargy on 04/09 lasting for 24 hours. On 4/11 I developed an open sore on the right side of the roof of my mouth and a sore throat. On 4/12 I developed an itchy sore on on the right side of my external anus and also on the right side of my inner cheek. On 4/13 my right lower gums swelled and I developed a sore on my tongue. On 4/14 I began to notice a tender nodule on my right foot on the pad between 2nd and 3rd toes. Today (4/15) the nodule is larger and is painful to walk on.
Mouth and tongue blisters - also bottom lip skin peeling off - occurred within 1st 24 hrs. Also chills no fever - slept a lot.
PATIENT HAD DIZZINESS WHILE STILL IN OFFICE, FELL OVER AND HIT FACE ON DOORWAY.
complaint of chest pain - sharp, stabbing type of pain at the sternum which radiated outwards with movements and deep breaths.  Currently on day 3 of pain - has lessened at this point compared to days 1 and 2