chrisvoncsefalvay/vaers-outcomes huggingface dataset:
symptoms of Shingles / shingles; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2021, the patient received the 1st dose of Shingrix. On 27th June 2021, 5 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Addtional details were provided as follows: The age at vaccination was not reported. 5 days after receiving 1st dose of Shingrix, patient began to develop symptoms of Shingles.  On 1st July 2021, patient came to clinic and was diagnosed with shingles. The provider asked if this was a coincidence or if Shingrix could reactivate shingles.
Severe body aches, especially back pain, headaches and fever for 5 days so far.
High fever of 103 degrees; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events high fever of 103 degrees/ pyrexia.  The patient's medical history was not provided. Concomitant medications reported were Tylenol Two tablets for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events high fever of 103 degrees.  Treatment details included 2 tablets of Tylenol.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.   The outcome of events, high fever of 103 degrees was unknown.
This is a spontaneous report from a contactable Nurse communicated to a Pfizer sales representative. A Nurse Practitioner administered PREVNAR 13 to his child daughter, via an unspecified route of administration, on an unspecified date (approximately two years ago) at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  After vaccination the patient was kind of got very withdrawn and she stopped speaking for about a week.  The patient recovered from the events on an unspecified date.  She resumed to her normal activity.
Information has been received from a registered nurse concerning a 5 year old female who on 08JUL2003 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. On approximately 19JUL2003 the patient developed 12 chicken pox and a temperature of 104 degrees. It was noted that the child "was not exposed to anyone with chickenpox". No lab diagnostic studies were performed. Unspecified medical attention was sought. The outcome was reported as not recovered. There was no product quality complaint. The reporter indicated that "doctor would like lot 0599M check". The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Patient received 1st dose of J&J Lot # 1805018, 3/25/2021, Returned to vaccine clinic 6/17/2021 received dose J&J  Lot # 203A21A.  Charted as 1st dose.  Returned 12/11/2021 received another dose J&J lot #211D21A.  charted as booster.  (Received 3 doses of J&J from SCHD from )3/25/2021 to 12/11/2021
Administered flu shot at 9 am. Patient left room with no concerns. Had her wait in the lobby for at least 15 minutes to make sure no reaction. At 9:10am patient reported that she doesn't feel good. Patient stated that she has had flu shot in the past with no issues, and that this happened before while having blood drawn but no other time. Says she ate breakfast this morning. Patient fainted for no more than 5 seconds. Placed wet wash cloth on patient's head and advised to take slow deep breaths - patient reported feeling better. Pharmacist was also present and informed to call patient's mother. Stayed with patient until mother arrived around 9:25 am. Both patient and mother were very appreciative. Offered ER to patient and parent and both declined at this time - patient stating I feel good and if it gets worse will go to ER. Follow-up call placed later in afternoon around 4:30 p.m. and patient stated feeling much better and very appreciative.
Information has been received from a health care worker concerning a female who on 9/25/06 was SC, vaccinated with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (Lot 651400/0618F). The vaccine was given concomitantly with a tetanus shot (manufacturer unk) in the other arm. The pt experienced severe pain in the arm she received the Pneumococcal 23v polysaccharide vaccine, and a welt at the injection site. The pt went to the ER, and was given Demerol, which was considered by the reporter to be an intervention. The pt was not admitted the hospital. At the time of the report, the pt was recovering. The reporter considered the pts severe pain and a welt at the injection site to be other important medical events (OMIC). In follow up it was reported that the pharmacist requested a lot check for Pneumococcal 23v polysaccharide vaccine lot 651400/0618F. The pharmacist wanted to know if there have been other adverse events reports with this vaccine. The pharmacist will await the results of the lot check before vaccinating any more clients with Pneumococcal 23v polysaccharide vaccine that was left over from this lot. A lot check of concern has been requested.
No adverse events. Pt was erroneously administered the bivalent vaccine instead of the monovalent vaccine for the first dose of the primary series. It was not ascertained prior to administration that patient was needed the primary series dose and not the booster.
Redness, Tenderness on entire thigh, crying for greater than 3 hours. Also swelling on leg. Mother administered Motrin at home and applied compress symptoms resolved.
I was at a friend's house and I started to get really itchy from my head all the way to the bottom of my feet. I broke out in hives. I thought I was having an allergic reaction to something I ate but it was not the case. I took Allegra. It did not help. Then I took some Benadryl and it help put me to sleep. The next day I was really itchy and I had a rash. It was horrible, I went to urgent care and they gave me a shot. They give me a medication but I did not take it because I was feeling better. The next day I started having the symptoms again. I went to urgent care They put me on steroids for 60 days. Even with the steroids, 2 days after I got the itchiness again. I decided to go to an allergist and they tested me for everything and everything had come back negative. No allergies to any food or anything. In the meantime, I am on medication for it, I am taking an anti-inflammatory and Zyrtec daily to control the rash and itchiness. Only one time I had trouble breathing. It seems to be for no reason, my body breaks out in complete hives and severe itchiness. We are waiting for lab results to come back. If I do not take the medication, I am completely itchy. It has made it hard to drive, focus, work, because they itchiness is horrible. I received half dose of the booster. I also had my flu vaccine on 10/01/2021.
24 hours after vaccine administration, patient's left lateral mid-thigh has 4 x 5cm area of erythema, induration, warmth and tenderness.
Ear ringing started approximately 5 minutes after shot was given. Has lasted 24 hours thus far.
Information has been received from a RN concerning and unidentifiable pt who in approximately February 2001, was vaccinated with a dose of Comvax. Subsequently the pt developed a small knot under the injection site. It was reported that the knot has not resolved yet. Unspecified medical attention was sought. it was reported that 4 other pts had a similar experience following exposure to Comvax. Additional information has been requested.
Infant received 2 mos vaccines and developed hives approximately 12-14 hrs later. Generalized rash
Arm soreness, extreme fatigue, fever of 100.5 for 12 hours, chills, weakness, night sweats
random popping in the left ear anytime during day or night which started about 30 hours after injection. Tinnitus in both ears 5 days after injection.
Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chickenpox.  Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chickenpox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated patients was a 7 year old patient who on 12MAR1997 was vaccinated with a dose of varicella virus vaccine live. On 13MAR2003, the patient developed chickenpox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other patients that developed chickenpox post vaccination with varicella virus vaccine live were also identified.  Additional information is not expected.
Both shoulders were sore,could hardly lift them; arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore at the injection site) and ARTHRALGIA (Both shoulders were sore,could hardly lift them) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 025B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was sore at the injection site). On 02-Mar-2021, the patient experienced ARTHRALGIA (Both shoulders were sore,could hardly lift them). On 03-Mar-2021, VACCINATION SITE PAIN (arm was sore at the injection site) and ARTHRALGIA (Both shoulders were sore,could hardly lift them) had resolved.            Concomitant product use was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to events were not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-068348 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068348:2nd dose
Shortly after the series of Covid-19 vaccines, I began having severe pain in my knees, then feet, then hands. I went to the doctor for bloodwork on 3/30/21 and tested positive abnormal for Antinuclear Antibodies Direct, Rheumatoid Arthritis Factor, and my ALT and AST were both high. I had never had any positive bloodwork prior to this, nor did I ever have pain or inflammation in my joints.
I received a seasonal influenza vaccine (in the left arm) at the same time and location as #17; I do not know the brand or dosage of the influenza vaccine; later that night, I felt as if I had influenza; I felt hot, but at the same time, I was shivering almost uncontrollably for about one hour while trying to sleep; on the subsequent day (11-27), I had a headache, fatigue and joint pain until late afternoon; I am unable to say with certainty that it was solely due to the influenza vaccine or the shingrix vaccine or a combination of the two; my right arm (location of the shingrix vaccine) was very sore for several days, with a light red rash about a 1" radius around the site of the injection
STILL NOT FEELING WELL AFTER SHE GOT HER J&J VACCINE; This spontaneous report received from a consumer via a company representative concerned a 45 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-JUL-2021, the subject experienced still not feeling well after she got her j&j vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still not feeling well after she got her j&j vaccine. This report was non-serious.
Fussy x 4 hours with continuous crying after vaccines. Resolved with TYLENOL.
This spontaneous report was received from a registered nurse refers to a currently 27 year old male patient. On 03-JUN-2014 the patient was vaccinated with VARIVAX (Merck), subcutaneous, (dose and dosage schedule were not reported). The patient had allergies to penicillin and amoxicillin. There was not concomitant medication, medical history and laboratories performed. On 04-JUN-2014, the patient experienced swollen tongue, patient experienced raw tongue of the side of his tongue and dry mouth. Patient sought medical attention and was treated with BENADRYL and an unspecified salt water wash. Patient was being directed to visit the occupational health for treatment. The reporter mentioned that this patient had similar symptoms in the past when he received unspecified penicillin and unspecified amoxicillin. The outcome of the events mentioned above was reported as not recovered/not resolved. Additional information has been requested.
Jynneos vaccine was administered intramuscularly instead of prescribed subcutaneous route; Case reference number US-BN-2022-001748 is a spontaneous case report initially received on 01-Aug-2022 from a *nurse* via Bavarian Nordic and concerns a *61-years-old male patient*.  The patient's relevant medical history included *CAD and HTN*. Concomitant medication details were not reported.  On 27-Jul-2022, at 16:00, the patient was vaccinated with the *first* dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP0004) administered subcutaneously (explicitly coded as 'Inappropriate route of vaccination') at an unreported dose or anatomical site for the *exposure to symptomatic positive monkey pox*.   As reported, the patient did not sustain any harm or distress after the vaccination. *At the time of this report, the patient did not experience any adverse events.*  Additional information received from Bavarian Nordic on 04-Aug-2022 included the confirmation of the country of occurrence.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a nurse via Bavarian Nordic on 12-Aug-2022 included additional patient details, medical history, and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 61-year-old male patient was vaccinated with the first dose of Jynneos vaccine, at an unreported dose, or anatomical site for unknown indication, administered subcutaneously which is considered as inappropriate route of vaccination, and for the exposure to symptomatic positive monkey pox. Incorrect route of product administration is considered listed per company convention. At this point, the patient did not sustain any harm or distress after the vaccination and the patient did not experience any adverse events. The patients' relevant medical history included coronary artery disease and hypertension while concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 61-year-old male patient was vaccinated with the first dose of Jynneos vaccine, at an unreported dose, or anatomical site for unknown indication, administered subcutaneously which is considered as inappropriate route of vaccination, and for the exposure to symptomatic positive monkey pox. Incorrect route of product administration is considered listed per company convention. At this point, the patient did not sustain any harm or distress after the vaccination and the patient did not experience any adverse events. The patients' relevant medical history included coronary artery disease and hypertension while concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Metal objects sticking to her, paper clips and iPhone stuck to her chest as well; Arm started itching; Tingling in her fingers; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Metal objects sticking to her, paper clips and iPhone stuck to her chest as well), PRURITUS (Arm started itching) and PARAESTHESIA (Tingling in her fingers) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced VACCINATION COMPLICATION (Metal objects sticking to her, paper clips and iPhone stuck to her chest as well), PRURITUS (Arm started itching) and PARAESTHESIA (Tingling in her fingers). At the time of the report, VACCINATION COMPLICATION (Metal objects sticking to her, paper clips and iPhone stuck to her chest as well) outcome was unknown and PRURITUS (Arm started itching) and PARAESTHESIA (Tingling in her fingers) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she was not on any concomitant medications. Treatment medications were unknown.
Information has been received from a medical assistant referring to a 6 month old male patient. No relevant medical history or concurrent conditions were reported. On 18-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS1507USA011322.  Additional information has been requested.
Patient's father gave incorrect DOB for child. Father stated DOB but patient's actual DOB is different. Patient was 11 years old at time of vaccination.
Pt was brought to the hlth dept by mother on 9/27/02, L arm swollen, red and warm, onset 9/29/02. Mother gave child tylenol and motrin, advised to continue cold compresses this day. Benadryl is being given tsp 1 1/2 with swelling gradually reducing.
Patient reported waking up with rash/hives over the phone and was told that this might be an allergic reaction by the pharmacist on duty. Patient was going to go to the doctor to get medicine.
Severe joint pain, mild nausea, lethargy, and Headache for 5 days. The headache still mildly persists and I have no history of headaches.
fever; tiredness; sore arm.; chili; This case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received Shingrix. On 26th July 2021, 3 days after receiving Shingrix, the patient experienced fever, tiredness, pain in arm and chills. On an unknown date, the outcome of the fever, tiredness, pain in arm and chills were unknown.   It was unknown if the reporter considered the fever, tiredness, pain in arm and chills to be related to Shingrix.  Additional details were reported as follows: The patient was the reporter. The age at vaccination was not reported. The patient received Shingrix and had fever, chills, tiredness and sore arm. The patient asked if this was this normal to be in 3rd day.
nausea with vomiting resulting in low electrolytes needing hospital treatment; nausea with vomiting resulting in low electrolytes needing hospital treatment; low electorlytes; Headache; severe dizziness/feeling faint; balance issues/unsteadiness; right ear pain; buzzing ear sounds; inability to visually focus at times; sensitive to light; sensitive to movement; sensitive to sound; listing to the right when trying to walk,; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received the first dose  bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 09Mar2021 at 10:30 (Batch/Lot Number: EN6208) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included vertigo, migraine (as a child). The patient previously took Omnicef, penicillin ad sulfa and  experienced drug hypersensitivity. Concomitant medications included estrogens conjugated (PREMARIN), cetirizine hydrochloride (CETIRIZINE HYDROCHLORIDE);  fluticasone (FLUTICASONE).   No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  On 15Mar2021, The patient experienced Headache, severe dizziness, balance issues, right ear pain, buzzing ear sounds, listing to the right when trying to walk, unsteadiness, feeling faint, inability to visually focus at times, sensitive to light, sound, and movement, nausea with vomiting resulting in low electrolytes needing hospital treatment. The patient was hospitalized due to nausea, vomiting and low electrolytes.  The adverse events resulted in an emergency room visit and physician office visit. Treatment was given for the events which included Meclazine, Droperidol, Electrolytes. The clinical outcome of the events was recovering.
Pt had a burning sensation of the face this AM 2/2/03, face red and both anterior hands knuckle area red, states he feels like face on fire.  Denies SOB, feels like knot in back of throat.  Denies itching. Had dental work also. Given Benadryl 25 mg 1 q 6 hours until normal.
She had the vaccination around 11am and sat with us afterward feeling okay. She didn't report any adverse events to us until around 2pm. She had never received the flu vaccine before. Patient had elevated pulse and scratchy throat that worsened as she sat with us but never had trouble breathing. Her voice also became hoarse. She took 25mg of diphenhydramine every 4-6 hours and didn't start to feel better until the next morning.
Initial misuse report received from a healthcare professional on 16 May 2013. It was reported that a dose that had expired on 2 May 2013 was given on 15 May 2013. No information was provided regarding the patient. No adverse event was reported. Documents held by sender: none.