chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 09-JAN-2017 from an other health professional regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was accidentally vaccinated with PROQUAD, lot number M025690 (expiration date not reported) unknown route for prophylaxis that was improperly stored. The vaccine had been stored in the refrigerator for over a week before being administered to the patient. No adverse reaction was reported. No further information was reported. This is one of two reports received from the same reporter. Lot number M025690 is an invalid lot number for measles, mumps, rubella (oka-merck) virus vaccine live. Additional information has been requested.; Sender's Comments: US-009507513-1701USA004688:
This case was reported by a healthcare professional and described the occurrence of fever in a 8-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenzae type b vaccine; manufacturer unspecified; unknown; unknown given on 18 August 2010; diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined; GlaxoSmithKline; unknown; unknown given on 18 August 2010; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 18 August 2010. On 18 August 2010 at 16:30 the subject received 1st dose of ROTARIX (intramuscular, unknown) reconstituted with a non-recommended normal saline diluent, and experienced inappropriate route of vaccination and inappropriate preparation of medication. On 18 August 2010, less than one day after vaccination with ROTARIX, the subject experienced fever of 102 degrees Fahrenheit (rectally). At the time of reporting the outcome of the event was unspecified.
rash at the injection site.; itching at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash at the injection site.) and INJECTION SITE PRURITUS (itching at the injection site.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (rash at the injection site.) and INJECTION SITE PRURITUS (itching at the injection site.). At the time of the report, INJECTION SITE RASH (rash at the injection site.) and INJECTION SITE PRURITUS (itching at the injection site.) outcome was unknown.            It was reported that patient had 4th Moderna shot on  Apr-2022. No concomitant medication were provided. No treatment medication were provided.
Muscle ache in left leg on the outside from the ankle to the knee and pelvis joint pain on both right & left sides but more pain on left side--in the SI joint areas.
2 weeks post vaccine, developed 2 blisters on my right arm, and one in the left corner of my mouth My elbow and knee joints have been painful to bend.  (Mildly painful but wasn't prior to vaccine)  No other changes in exercise, or behavior.  Been mostly in the home when not working, and wearing n95 masks at work.
Dec 5th - Hives (L) thigh. Both facial cheeks, took to urgent care-Loratadine, prednisone started at 830 pm. Dec 6th - hives on both arms and (R) leg, took to hospital was given BENADRYL and continue with other tx and BENADRYL as needed.
Dizziness, weakness, rapid heart rate, tunnel vision, fever, feeling as if about to faint.
Information has been received from a physician concerning a 22 year old female patient who in approximately August 2008, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # not reported). It was reported that the patient was fine after the first dose. On 02-AUG-2010, 2 years after the first dose, the patient was vaccinated intramuscularly with the second 0.5ml dose of GARDASIL (lot # not reported). On 02-AUG-2010, the patient experienced a vasovagal reaction that lasted  for about 15 minutes. The patient was given cold water and she started shivering. The patient was fine when she left the office. No further information is available.
Extreme fatigue was noted a few hours after the administration of the injection.  A few facial hives became evident later in the day.  10/27/10 woke up and face was covered with numerous small hives.  Slight itching.  It is 9PM now, hives have still not resolved.  Some labored breathing noted.  No throat swelling evident.
Moderate pain in left arm in the hour following the injection, and muscle pain in arms and legs later that evening. Chills overnight. Mild pain at injection site, headache, tiredness, and nausea the next day. Nausea and headache resolved by midday, tiredness and pain at injection site persisted into the afternoon.
This spontaneous report as received from a licensed practical nurse refers to a 17 year old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 19-MAR-2014, the patient was vaccinated with first dose of GARDASIL (lot# H021346, expiry date: 01-OCT-2015), on 16-MAY-2014 second dose of GARDASIL (Lot# J015378, expiry date: 09-APR-2016) and with third dose of GARDASIL on 19-SEP-2014 (lot# K001631, expiry date: 06-NOV-2016). On 11-JAN-2016 the patient was vaccinated with GARDASIL 9. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
No event on first dose.  Second dose resulted in large red, raised area at site of shot, followed by an even larger red circle lower on the same arm as shot that occurred about 3 days later.  Within 3 days of the second dose I had chills and cold sweats for about 24 hours.  Within 5 days of the second shot, a 2 year existing area of allergic eczema (caused by latex allergy) on the right hand cleared up and at the same time a new area of eczema appeared on right arm inside elbow.
prolonged crying & irritability began 2hrs p/vax lasted 24hrs;low grade subjective fever;APAP administered q 4hrs basis;
Patient DOB: EXACT came into vaccination site on 12/20/21 for COVID-19 Moderna Booster. Patient received first dose on 2/20/21 and second dose on 3/19/21. Patient reported to RN a history of COVID-19 diagnosis about one year ago which she managed at home. Patient reports a history over about the last year of shortness of breath, agitation, fatigue, vertigo, nausea, and itching on her head and skin accompanied by a rash. Patient does not recall when symptoms began. Patient cannot confirm nor deny if symptoms started within a few hours after the vaccine. Her son is with her and denies she had any adverse reactions to the vaccine. Patient states all symptoms are intermittent. Patient stated that she did see her PCP. PCP states that her symptoms are related to having been diagnosed with COVID and stated that it is up to her if she wants to get her booster vaccine. Patient stated that she has a history of diabetes, hypothyroidism, and hypertension. Patient stated that she is taking losartan, trazadone, atorvastatin, levothyroxine, metformin, and glipizide. Patient denies any allergies. Patient stated that she feels nervous about getting COVID vaccine today and feels itchiness on head today. EMT took patients vital signs. BP: 166/72, HR: 77, O2: 97%. Patient states that this about her normal BP. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Moderna booster. Per CDC guidance, approval to proceed with COVID vaccine Moderna booster was obtained from medical consult team, Vaccine Operations Lead RN via Dr. approval. Patient received COVID vaccine Moderna LOT# 069H21A at 1525. Patient was educated on adverse effects of COVID vaccine and when to seek EMS. Patient verbalized understanding. Patient left vaccination site with her son at 1550 unassisted and with a steady gait.
Patient received vaccine on 7/15/21, on 7/23/21 arm became swollen, red, warm to touch, painful.
Right arm swollen and red in area around injection site, and hot to touch. Also painful to move upper-arm or shoulder at all and made me nauseous. Ice helped but a tepid shower really made the shoulder/bicep burn like it was on fire; nausea continued. 7/21/2010 I kept ice on it all day at work, but the arm was so swollen it barely fit in my dress' arm hole. Redness around injection site was then visible and it was itchy; nausea continued. 7/22/2010 ice and Benadryl have brought down the swelling and calmed the itching, but the clinician prescribed a steroid for it. I begin the steroid tonight.
Feeling tired; Muscle aches; Chills; Headache; Dizziness; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2022, the patient received Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced tiredness, muscle pain, chills, headache and dizziness. On an unknown date, the outcome of the tiredness, muscle pain, chills, headache and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, muscle pain, chills, headache and dizziness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received vaccine about 26 hours ago. The patient experienced feeling tired, muscle aches, chills, headache and some dizziness. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Headache, chills, fever, body aches, pain in arm & in armpit of arm where injection given, fatigue.
2 days after the vaccines, a warm splotchy rash developed distal to the injection site left thigh, The child had no fever or signs of illness. We recommended Benadryl and Motrin.
about an hour after shot started to get a headache on left side of head, from eye allthe way back to neck. Never had a headache like this before. Still going on 9 days later
cold; stuffy nose; sneezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 at 16:30 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Shellfish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 11Nov2023, outcome "recovering", described as "cold"; SNEEZING (non-serious) with onset 11Nov2023, outcome "recovering"; NASAL CONGESTION (non-serious) with onset 11Nov2023, outcome "recovering", described as "stuffy nose". Therapeutic measures were not taken as a result of nasopharyngitis, nasal congestion, sneezing.  Additional information: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.
rash starting on back of hands and then spreading medially towards elbows bilaterally. continuing to spread medially toward shoulders bilaterally. pruritus with rash.
Patient stated she had noticed a swollen lymph node in her RIGHT arm 4 days after receiving  Moderna COVID19 vaccine.
Sore arm; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown 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: 11-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient got the Shingles vaccine with no issues other than a sore arm for about a week. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Enlarged red, area spreading to inner arm, which is warm to touch, swollen and a bit sore; chill (for two days); and headache (for two days).
Swelling/Red soreness in left arm at injection site, severe headache, neck stiffness and throat swelling (per pt).
Mild pain in the heart area. I got my third vaccine COVID19 Moderna (booster) at 6 pm on 08/26/22.  I started to feel dizziness and mild pain in the heart area around 9 pm on 08/26/22. I didn't go to a doctor but this kind of pain is very unusual for me. I am a healthy person, who runs almost every day 2-3 miles.
joint pain in left arm and left shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date 26th January 2022) for prophylaxis.   On 24th October 2019, the patient received the 1st dose of Shingrix .5 ml. On 24th October 2019, less than a day after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was not recovered/not resolved.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix in left arm. The patient complained of joint pain in his left arm and left shoulder.  The reporter consented to follow up.
Temperature 100.7 in the ER; generalized tonic/clonic seizure-2-3 w/v-ER and exam unremarkable.
Pt reported that on the same night she rec'd the flu vaccine (11/29/01). She developed welts to her face with itching. This persisted Thursday evening 11/29/01 and Friday 11/30/01. She considered taking Benadryl, but didn't as symptoms didn't progress, she continues to have spots on her face as of 12/4/01, but no pruritis. She also had itching to her scalp, neck and arms but did not observe any welts.
Fever, pain in injected arm (left arm), pain up into the left side of the neck, down the left side of the body, lack of feeling in hands, arms, feet, legs, tingling in extremities, dizziness, breathing difficulty.
This spontaneous report was received from a healthcare worker refers to 15 unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, route, lot # were not reported) which were exposed to 25.7F for 6 hours and 25 minutes. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Patient developed a bruise the size of a quarter that has not gone away yet (it's been 12 days).
TIGHTNESS IN THE CHEST; MIGRAINE HEADACHES WHEN STANDS UP FROM BED; PAIN IN THE ARM; This spontaneous report received from a consumer concerned a 32 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced tightness in the chest. On APR-2021, the subject experienced migraine headaches when stands up from bed. On APR-2021, the subject experienced pain in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the arm, tightness in the chest and migraine headaches when stands up from bed was not reported. This report was non-serious.
Swollen axillary lymph nodes; moderate to severe pain radiating; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO176) via an unspecified route of administration in the left arm on 20May2021 at 17:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea, narcolepsy and anxiety. The patient had no known allergies.Concomitant medications included escitalopram oxalate (LEXAPRO), medroxyprogesterone (MANUFACTURER UNKNOWN) and modafinil 300 (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO176) via an unspecified route of administration in the left arm on 30Apr2021 at 17:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021, the patient experienced swollen axillary lymph nodes with moderate to severe pain radiating. 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, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome for the events swollen axillary lymph nodes and moderate to severe pain radiating were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
7 days post 1st dose I had red, itchy, warm area around the vaccination site. It lasted 3 days. I used Ibuprofen and cold compresses for relief.
This spontaneous report was received from a licensed practical nurse refers to a 5 patients of unknown age and gender. On an unknown date in 2012 the patients were vaccinated with a dose of RECOMBIVAX HB (dose, route not reported), (lot # (671326/1522AA), exp date 21-APR-2014 which was stored in a refrigerator reading 36-46 F, but in a section of the refrigerator with intermittent excursion to 30 F since 11-JUN-2012. No adverse effect reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Pentacel was given with only the liquid diluent (which contains DTaP/IPV), and not with the power (HIB) component to a 4 year old; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four years old patient who vaccinated DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: U6613AA and batch number: 22Feb-2019) with only the liquid diluent (which contains dtap/ipv) and not with the power (hib) component via intramuscular route in the left deltoid on 14-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ACICLOVIR (VIRCELLA); and INFLUENZA VACCINE (INFLUENZA VACCINE).  It was actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  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.
Greater than 35 days between doses of Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between doses of Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between doses of Moderna Covid-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between doses of Moderna Covid-19 vaccine) had resolved.            Concomitant medication list was not provided. Treatment information was not provided.  Patient received her second dose of Moderna Covid-19 Vaccine sometime during the week of 13 July 2021.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up received and contains no new information.
Received immunizations on 1/4/08 started with redness at injection site that progressivley redness spread, became raised, warm to touch, and sensitive to touch. Upon exam 1/07/08 12.5 x 9 cm erythematuous, slightly warm, blanching lesion surrounding DTaP injection site and minimally painful.
Information has been received from a nurse practitioner concerning an 83 year old female who was on an unspecified date vaccinated with a single dose of Zostavax (Oka/Merck).  Subsequently, a week after vaccination the patient developed shingles.  Unspecified medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  Additional information is not expected.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed shingles on the 2nd or 3rd day following of Shingrix. It was a short episode that lasted 4 to 5 days. The reporter consented to follow up. The registered pharmacist had no other details.  The registered pharmacist wants to call MD to confirm this.  All information provided to registered pharmacist was from patient.