chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin Rashes 2 weeks after booster; Little bubbles / pimples on the skin 2 weeks after booster Similar to mosquito bites on the skin 2 weeks after booster; Itching skin 2 weeks after booster; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Skin Rashes 2 weeks after booster), ACNE (Little bubbles / pimples on the skin 2 weeks after booster Similar to mosquito bites on the skin 2 weeks after booster) and PRURITUS (Itching skin 2 weeks after booster) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A, 004C21A and 003321-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2022, the patient experienced RASH (Skin Rashes 2 weeks after booster), ACNE (Little bubbles / pimples on the skin 2 weeks after booster Similar to mosquito bites on the skin 2 weeks after booster) and PRURITUS (Itching skin 2 weeks after booster). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and COCONUT OIL ongoing since an unknown date for Itch, at an unspecified dose and frequency. At the time of the report, RASH (Skin Rashes 2 weeks after booster) and ACNE (Little bubbles / pimples on the skin 2 weeks after booster Similar to mosquito bites on the skin 2 weeks after booster) outcome was unknown and PRURITUS (Itching skin 2 weeks after booster) had resolved.            No concomitant medication was provided.
Fever 101.7- 102.0, body aches, fatigue, joint pain, headache, chills, nausea, hot flashes, feeling all around unwell.  I was so tired in the middle of the night I did not wake up when I was coughing and could not breath and was gasping for air.  Because i was so fatigued I almost suffocated.
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 months old female patient who received 0.5 ML of vaccine PENTACEL that was mixed with PROQUAD and not the HIB portion of the vaccine, (lot C5572AA and expiration date 31-Oct-2019) via intramuscular route in the right thigh on 17-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR for Immunisation; and HEPATITIS B VACCINE for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was not reported if the patient had any adverse event. 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.
Stroke, treated with TPA followed by 7 weeks hospital/inpatient therapy, outpatient  therapy ongoing
Information has been received from a LPN concerning a 30 month old white male with no medical history and no known allergies who on 03/11/02 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Lot # 639901/1152L). There was no concomitant medication. On the evening of 08/05/03 the pt developed breakthrough chickenpox with approximately 15 vesicles, "bumps", a low grade fever, pruritis and fussiness. On 08/06/03 at 09:45 the pt "now" had more "bumps"; some with small blisters. Unspecified medical attention was sought. Subsequently, the pt recovered. No product quality complaint was involved. It was also reported that a 27 month old female was vaccinated SC in the right arm with a dose of varicella virus vaccine live (Lot # 639901/1152L) and developed breakthrough chickenpox (WAES # 0308USA01109).  No further information is expected.
Metal taste in my mouth, very very tired and all my muscles hurt. My arm swelled up at injection site
Patient had syncope episode. 3 sutures in (R) chin. Vital signs were WNL.
no adverse effects; ROTATEQ vaccine series on 10/18/2019 that was administered outside the Prescribing Information forROTATEQ; ROTATEQ vaccine series on 10/18/2019 that was administered outside the Prescribing Information forROTATEQ; This spontaneous report as received from a registered nurse and refers to a 15 month old patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 18-OCT-2019, the patient was vaccinated with a fourth dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 milliliter, oral(lot# and expiration date were not provided), for prophylaxis  that was administered outside the Prescribing Information for rotavirus vaccine, live, oral, pentavalent(ROTATEQ). Nurse reported no adverse effects for the patient.
Cough, fever, chills for about 24 hours then pt was fine, started a few hours after administration.
Initial case received from a healthcare professional on 01 March 2012. A 15-year-old female patient received an intramuscular injection of DTAP, manufacturer and lot number unknown, (site not reported) on 12 June 2006. The patient's past medical history was reported as Attention Deficit Disorder (ADD) and hypothyroidism, and the patient was taking ADDERALL, (reported as ATAROL) and EFFEXOR medications concomitantly. The patient had no illness at time of vaccination and had no known drug allergies. The reporter stated that the now 21-year-old patient received DTAP (Tdap) at age 15 years, and now the patient has a possible case of pertussis. The patient was seen in the local emergency room (ER) on 25 February 2012, and culture results were pending. On 01 Mar 2012, the reporter stated that the patient's nasal swab tested positive for pertussis. The patient did not require hospitalization, but was given an antibiotic. The patient was currently feeling better and without fever. The patient's outcome was not recovered. Documents held by sender: None.
administer expired vaccine to patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses.  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contain primary reporter address updated.
aches and pains everywhere, almost crippling, taking Tylenol. Outcome: feeling like I can work the rest of my 12 hour shift
The patient states that the day following administration of the vaccine she developed severe pain in her right arm and could not lift it above shoulder level.  She had received the vaccine in her right arm.  She then reported that the symptoms seemed to travel and effect the right side of her body.  First her arm, then her neck/throat, and then her jaw.  The symptoms were moderate and were worse when swallowing/talking/eating.  The symptoms slwly improved and had completely resolved by 4 days post-immunization.
TEMPERATURE, JOINT PAIN, CHILLS, TIREDNESS PRESENTED AFTER 24 HOURS AND LASTED 12 HOURS AFTER 40 HOURS OF TAKING THE VACCINE TOOK TYLENOL 250  TIREDNESS AND JOINT PAIN LASTED FOR 3 DAYS
Patient received first dose moderna and secod dose pfizer bivalent; Patient received first dose moderna and secod dose pfizer bivalent; Patient received first dose moderna and secod dose pfizer bivalent; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose moderna and secod dose pfizer bivalent), INTERCHANGE OF VACCINE PRODUCTS (Patient received first dose moderna and secod dose pfizer bivalent), COVID-19 IMMUNISATION (Patient received first dose moderna and secod dose pfizer bivalent) and NO ADVERSE EVENT (No adverse event) in a 45-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and second dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose moderna and secod dose pfizer bivalent), INTERCHANGE OF VACCINE PRODUCTS (Patient received first dose moderna and secod dose pfizer bivalent), COVID-19 IMMUNISATION (Patient received first dose moderna and secod dose pfizer bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose moderna and secod dose pfizer bivalent), INTERCHANGE OF VACCINE PRODUCTS (Patient received first dose moderna and secod dose pfizer bivalent), COVID-19 IMMUNISATION (Patient received first dose moderna and secod dose pfizer bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose moderna and secod dose pfizer bivalent), INTERCHANGE OF VACCINE PRODUCTS (Patient received first dose moderna and secod dose pfizer bivalent) and COVID-19 IMMUNISATION (Patient received first dose moderna and secod dose pfizer bivalent).    Concomitant medications were not reported.   Patient received bivalent as the second dose of the primary series. Which is Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent Dose/Dosage from Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than or equal to 12 years.  Treatment medications were not reported.
Information has been received from a pharmacist concerning an unidentified male patient who was vaccinated with Hepatitis B vaccine recombinant. Subsequently, the patient experienced elevated enzymes. The patient sought unspecified medical attention. Additional info has been requested.
Information has been received from a licensed visiting nurse concerning a 4 year old male patient with no allergies or medical history who on 5/25/01 was vaccinated with a first dose of varicella virus vaccine live (lot # 637979/1899K). Concomitant vaccination on the same day included a first dose of MMR (lot # 638512/0165L), a fourth dose of HIB conjugate vaccine (lot # 637878/1414K), and a third dose of poliovirus vaccine inactivated (lot # T0624). Illness at the time of vaccination included a runny nose. The patient was noted to be on amoxicillin at the time of vaccination. On 6/30/04, the patient developed breakthrough chicken pox. On 7/1/04, the patient was examined in the physician's office and had only two of the classic vesicular lesions, the rest were diffuse mosquito bite-like lesions all over his body. The patient was generally itchy and afebrile. There was no treatment and the adverse event did not abate. The patient was not recovered at the time of the report. A product quality complaint was not involved. Follow up information was received from a licensed visiting nurse who indicated that on 6/30/04 in the PM, the patient had papular and vesicular lesions in various stages scattered over the trunk and extremities and itching. Subsequently, the patient recovered on 7/8/04. No diagnostic laboratory tests were performed. The patient had no adverse events following prior vaccination. No further information is expected.
This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 23-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
I contracted Shingles from immune system being knocked down so low. 4 days after the shot.  No change to daily life or diet.
They would be in the fridge about 1-3 days; Administered moderna vaccine beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccine beyond the use date and/or expired) and PRODUCT STORAGE ERROR (They would be in the fridge about 1-3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccine beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They would be in the fridge about 1-3 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccine beyond the use date and/or expired) and PRODUCT STORAGE ERROR (They would be in the fridge about 1-3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.
Flu-like symptoms after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st dose) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Previously administered products included for an unreported indication: PNEUMOCOCCAL VACCINE in March 2021 and INFLUENZA VACCINE in March 2021. Concurrent medical conditions included Reaction to previous exposure to any vaccine.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st dose). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st dose) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-075311 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075311:2nd dose
PATIENT CALLED MONDAY MORNING,06/22/20 AND REPORTED HER ADVERSE EVENTS. SHE RECEIVED HER SECOND DOSE SHINGRIX ON 06/18/2020 AROUND 11:30AM, SHE STARTED TO FEEL SORENESS ON HER LEFT ARM AROUND 2PM SAME DAY THEN AROUND 5PM STARTED TO FEEL LITTLE UNDER THE WEATHER KIND OF AND THEN SYMPTOMS CONTINUED TO PROGRESS WITH REDNESS ON HER ARM. DIDN'T CHECK TEMPERATURE BUT FELT FEVERISH. FROM FRIDAY AFTERNOON ON SHE WAS IN BED WENT TO URGENT CARE ON SUNDAY MORNING HAD SLIGHT FEVER 99.7. MD PRESCRIBED KEFLEX FOR CELLULITIES. NOW FEELING BETTER HAS A FOLLOW UP VISIST WITH PCP ON TUESDAY 06/23/2020. PATIENT WENT TO URGENT CARE.
Office visit 5/25/05. Notices 4-5 lesions on cheek, arms, and abdomen; not blistered.
Pt. developed rash and hives. Pt came to pharmacy 1 week later and reported incident.  Pt self treated with Benadryl.
Very small amount of blood and liquid drained at injection.  Could not go back to show and tell them at that time.  Also muscle pain, sleepy, little fatigued
fever to 103.8 x 2 days;large reddened area around vaccine-approx 3" x 8"-reddened, not tender, ice to area ibuprofen given;
10:30 AM - 15 min after administration, pt said she felt numb and had scratch throat. Administered 50mg IM BENADRYL and sx had completely resolved by 30 minutes later.
Right arm, right side of neck and upper right back are all very stiff and very sore.  I couldn?t lift my arm above my head .  If I tried the pain was simply unbearable.  My neck keeps pulling to the right.  My back shoulder on my right side has knots in it.  My heart rate is fluttering.  My wrist, fingers and elbow have sharp pains.  I am extremely tired and feel like all I want to do is sleep.  When I woke up this morning my right arm was not functioning.  It felt like a heavy weight I had to carry.  I couldn?t turn my head left or right because of the muscle contracting in my neck.  My hand and are are in severe pain. Last night my Stomach cramped up and I was in extreme pain.  I could feel a hard strained muscle in my lower right abdomen.  The muscle was so contracted under my skin  that you could see the knot protruding from my stomach..   I am concerned about getting a second vaccine I cant?t go through this  voluntarily after the extreme pain I have endorsed
7 hours post vaccination, right arm stiffened with shooting nerve pain from neck to fingers. At 9 hours post vaccination, also developed nausea, muscle/joint aches, fever, chills, and severe headache. Tmax was 102 F, but averaged at 100 F for at least 24 hours (11 PM 1/20/21 - 11 PM 1/21/21); cannot gauge what occurred after 11 PM on 11/21/21 due to sleep. However, right arm nerve pain continues now on to day 3 (1/22/21) with also the development of small wart-like bumps on left ring finger. Tmax today is 99.8 F accompanied by mild chills, nausea and abdominal pain.
Fatigue, fever, nausea, I am diabetic, my sugar readings ran extremely low.  My appetite was at one point extremely low and I could not keep the little food I did eat down.  I was vomiting, my stomach hurts.
Reports child had 2 lesions approx 1/25/05 - one on leg, 1 on trunk.  Now has 4 lesions in different areas.  First one is "scabbed over."  Red, raised, w white center.  Started nausea & "uncontrollable" vomiting last night & has vomited today also but not uncontrollably, denies fever.  Advised to contact PCP, encouraged fluids & no ASA
they ran out of the 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (1st dose receied on an unknown date, and had shingles).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, had shingles from the 1st shingle vaccine. Apparently they ran out of the 2nd dose & could not gave the 2nd dose, which led to product supply issue. The patient then got shingles a week after. The patient's physician refused to acknowledge that she had given me the shingles. This case was linked with case US2021AMR203604, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR203604:same reporter same patient
Headache, Body Aches, Fatigue, No appetite, Listless. Approximately 1 week.
Pt seen in ER the day (evening) 5 immunization for erythema & swelling of left arm. No fever, no systemic symptoms. Treated with antibiotics & resolved within 3 days completely ? inflammatory reaction vs. cellulitis.
Muscle ache, Joint ache, pain mostly in upper pelvic bone area.  Feeling tired, loss of appetie, likely Polymyalgia Rheumatica
Information has been received from a physician concerning an 87 year old male patient who on 09-APR-2010 was vaccinated SC with a dose of VARIVAX (Merck) (lot number not provided) instead of a dose of ZOSTAVAX (Merck). The physician reported that the office realized the mistake on 04-AUG-2010. No adverse event was reported. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
swelling; Drug dose administration interval too long; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of swelling (1st dose received on 13th August 2018, for reference Kindly refer case US2019204789).   On 16th April 2019, the patient received the 2nd dose of Shingrix. On 16th April 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced injection site swelling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient had Shingrix second dose in his right arm which was late, which led Lengthening of vaccination schedule. The patient had slight injection site swelling. Additional information was not provided. The reporter did not consent to follow.
Pain at injection site, itching at injection site, swelling at injection site, redness at injection site, warmth at injection site, 5cm x 7cm area.
Starting the night after receiving vaccine (previously received Johnson and Johnson and received Pfizer as a booster--listed above as dose 3)--body aches, fever, headache and diarrhea.  A week after receiving vaccine, symptoms including diarrhea continued.  On December 1, patient was seen at primary care clinic and was found to be dehydrated.  Patient was rehydrated with normal saline at hospital as an outpatient.