chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received on 27-Sep-2016, was reported by a health professional and concerns a(n) unk patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA for Influenza vaccination from 27-SEP-2016 to 27-SEP-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: 14049222A. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Black spot at the injection site (outcome: Unknown). Special circumstances: Poor quality drug administered. The reporter used the multidose vial and after drawing up the vaccine, the needle seemed to have some sort of residue and after administrating the vaccine, the patient had a black spot at the injection site.
Left arm numbness, tingling, can?t hold arm in a position for to long. Contacted dr for referral for more testing. Still waiting to take test
lying down all day; Her injection site arm couldn't move; Chills; slight fever; body aches; Fatigue; Joint pain; Nauseous; Dizzy/felt just a little dizzy; arm felt heavy and hard to lift up/left arm felt so heavy that I can barely lift my arm; arm pain/left arm started to feel sore; difficult sleeping/could hardly sleep; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/felt just a little dizzy), LIMB DISCOMFORT (arm felt heavy and hard to lift up/left arm felt so heavy that I can barely lift my arm), PAIN IN EXTREMITY (arm pain/left arm started to feel sore), INSOMNIA (difficult sleeping/could hardly sleep) and FEELING ABNORMAL (lying down all day) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (I get east infectiony). Concomitant products included FLUTICASONE for Allergy, VALACYCLOVIR [VALACICLOVIR], ASCORBIC ACID, RETINOL, TOCOPHEROL (OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]), MULTIVITAMINS [VITAMINS NOS] and FISH OIL for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced DIZZINESS (Dizzy/felt just a little dizzy), LIMB DISCOMFORT (arm felt heavy and hard to lift up/left arm felt so heavy that I can barely lift my arm), PAIN IN EXTREMITY (arm pain/left arm started to feel sore), INSOMNIA (difficult sleeping/could hardly sleep) and NAUSEA (Nauseous). On 09-Apr-2021, the patient experienced FEELING ABNORMAL (lying down all day), VACCINATION SITE MOVEMENT IMPAIRMENT (Her injection site arm couldn't move), CHILLS (Chills), PYREXIA (slight fever), MYALGIA (body aches), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). On 12-Apr-2021, DIZZINESS (Dizzy/felt just a little dizzy), LIMB DISCOMFORT (arm felt heavy and hard to lift up/left arm felt so heavy that I can barely lift my arm), INSOMNIA (difficult sleeping/could hardly sleep), FEELING ABNORMAL (lying down all day), VACCINATION SITE MOVEMENT IMPAIRMENT (Her injection site arm couldn't move), CHILLS (Chills), PYREXIA (slight fever), MYALGIA (body aches), NAUSEA (Nauseous), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain/left arm started to feel sore) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Additional Information Received on 24-MAY-2021 Containing Second dose information, Allergy and concomitant drugs updated. On 19-Jul-2021: Non-Significant follow up appended to AER
A physician reported that a 3 year old male received a dose of Prevnar vaccine on 7/31/02 at the county health department. On 10/4/02, he received a dose of Pneumovax vaccine in the reporting physician's office. Medical history included a cochlear implant in the left ear. On 4/21/03, the child developed a fever, vomiting and lethargy. He was seen in the emergency room, and diagnosed with a left otitis media. He had a white blood cell count of -28,000-30,000 with -16%-18% bands and a blood culture that was subsequently positive for pneumococcus. The child was given intramuscular ceftriaxone, a prescription for Zithromax, and sent home. Two days later, he presented to the pediatrician and was hospitalized when his condition had not improved. Blood culture results from the emergency room visit were positive for Streptococcus pneumoniae, serotype 19F. A CSF specimen taken was positive for WBC's. The diagnosis was meningitis. Treatment included intravenous Rocephin and vancomycin. The results of serum antibody titers are pending. As of 6/6/03, the child had survived and was doing well as per the reporting physician.  Follow up received on 08/22/2003: "Follow up information received on 08/08/2003 reported the event as life threatening, and provided patient and vaccine details including laboratory results.  A physician reported that a 3-year old male received his first dose of Prevnar vaccine on 07/31/2002 at the county health department.  On 10/04/2002, he received a dose of Pneumovax vaccine in the reporting physician's office.  Medical history included a cochlear implant in the left ear.  On 04/21/2003, the child developed a fever, vomiting and lethargy.  He was seen in the ER and diagnosed with a left OM.  He had a white blood cell count of -28,000-30,000 with -16-18% bands and a blood culture that was subsequently positive for pneumococcus. The child was given IM ceftriaxone a prescription for zithromax, and sent home.  Two days later, he presented to the pediatrician and was hospitalized when his condition had not improved.  The reporter also considered the event to be life threatening.  Blood culture results from the ER visit were positive for Streptococcus pneumoniae, serotype 19F.  A CSF specimen taken was positive for WBC's.  The diagnosis was meningitis.  Treatment included IV Rocephin and vancomycin.  Serum antibody titers obtained on 05/27/2003 showed serotype 19F - 0.67 ug/mL.  As of 08/08/2003, the child recovered and was doing well as per the reporting physician. A 15-day follow up report received 9/30/2003 adds no new info.
11:30am 7/11/03 redness to both extremities bilat, warm to touch, crying and agitation unconsolable. Benadryl po administered, then epicephine 1:1000 .06 given SC.
Patient states she had incredible muscle fatigue for 2 days. She couldn't get out of bed and eat or drink. States dehydrated also, due to inability to eat/drink
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a physician assistant. The age at vaccination was not applicable for this report.
Headache; Throat irritation; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Throat irritation), PYREXIA (fever), CHILLS (chills) and HEADACHE (Headache) in an 89-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030342) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 07-Oct-2023, the patient experienced PYREXIA (fever) and CHILLS (chills). On 08-Oct-2023, the patient experienced THROAT IRRITATION (Throat irritation). On 09-Oct-2023, the patient experienced HEADACHE (Headache). At the time of the report, THROAT IRRITATION (Throat irritation) and HEADACHE (Headache) had not resolved and PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had no longer has fever or chills. Throat irritation still persists. He previous doses were Pfizer. This was the first time she took Moderna.  No treatment information was reported.
Joint pain through left side arm, shoulder & neck  Loss of hair bald patches on left side of head
Initial report received on 06 February 2008 from a health care professional. A 4 months male patient received on 21 January 2008 a dose of IPOL (sanofi pasteur, lot# Z0547), into the right thigh. The patient also received into the left thigh on the same day: PREVNAR (Wyeth, lot# 870143A) and HIB vaccine (manufacturer unknown, lot# 0076U). The patient also received on the same day oral dose of Rotavirus (lot# 1242U). On 22 January 2008, a day post vaccination, the patient developed a 2 inch bump at injection site of the right thigh. Bruising occurred, followed by a scar. The bump had not gone yet. The patient had not recovered. The patient had no illness at vaccination time, was not taking other medications, and had no medical conditions. His birth weight (at 1 week old) was 8 lb and 8 oz. The patient required a doctor visit. The lot# provided for IPOL is not a sanofi pasteur valid lot#.
Patient reports that he had a burning taste in his tonsils/adenoids immediately after the shot but passed within a couple minutes.  One day after the injection he says he started having spleen pain and lasted 2 days.  Had generalized aching that settled into his joints and felt  "on fire" 1-2 days after injection.  Especially noted in right knee with swelling and bilateral thumb joints.  Approx. 3-5 days after injection  he started experiencing pain around his heart.   To this day he still experiences severe pain in his forearms and fingertips L>R.  When first c/o of side effects per phone  was 11 days after injection and he did not follow advice to be seen for his issues.
appeared nl p/vax until 8PM that noc when pt became very fussy screaming inconsolable & intermittent for 3 hrs; fever 103.8 R the next day which lasted for 48 hr;s
I had severe facial swelling that started on my left cheek and lip the morning after the vaccine. That night the swelling mover to the center of my face (mainly my bottom lip and some of my chin). Day 2 the swelling was most severe and moved to my right cheek and lip. The swelling was less the night of day 2 and even better the morning of day 3 after starting oral prednisone . Today on day four I am Almost back to normal but still some puffiness in both cheeks and bottom lip.  Per my physicians advice I will be on a 5day course of oral prednisone (10mg 2x/day)  The other adverse event I experienced was starting day 2 I had extreme pain and itching as well as some cyst like bumps on both my feet as well as very mild itching on my palms.They are improving on day 4 but still super itchy. I have been advised to take Benadryl as needed for that.
More than 30 minutes after administration warm flush feeling, diaphoretic, rash arms, chest back - resolved. Today mild itching upper back. Redness at site. (took PEPCID and ADVIL then BENADRYL later on).
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 04-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL (lot #K006960 exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Fever, Chills, Body aches, hives 48 hours  New onset Rheumatoid Arthritis
Patient experienced a severe headache five minutes after vaccine. Patient was transitioned to immediate care center within our facility.
pt recv vax 26FEB96 & 23NOV97 pt devel less than 50 lesions on entire body;pt also exp a fever that lasted for one day;the reported considered the lesions to be a mild case of pox;
This spontaneous report was received from a nurse regarding multiple patients of unknown demographics. Information on pertinent medical history and concomitant medications were not reported. On unknown dates, the patients received improperly stored RECOMBIVAX HB lot# N006321 with expiry date of 08-NOV-2019 for prophylaxis (dosing details not reported). Temperature was 47F to 77F (46.8 F). Time frame of the excursion was 62 hours 45 minutes. There was no previous excursion. The call was because of data logger. No adverse effects were reported. This case is linked to 1707USA009603 due to the same reporter. Additional information has been requested.
Weakness in right hip and knees. Followed by sore arthritic like knuckle,  weakness/soreness in wrists and hands, sore sit bones.  Exercise didn't make this worse but also didn't get better with time. Used aspercreme, no help.  Used an essential oil blend on knuckle, this helps when it hurts.  Seems all these joints hurt when pressure is applied.  Sitting  for too long, I have to move around in my seat to get comfortable.  Also when I stand after being seated for a period of time, it takes a bit to straighten up.  These symptoms started around 2 months after the 2nd vaccine. At first I thought it was just I wasn't moving around enough, but walking or yoga didn't really make it better, no worse but not better.  First shot only symptom was a sore arm.  Second shot symptoms, the next day chills, achy.  This went away after 1 day.
member did not have any adverse reaction to vaccine, this is written because member received a complete series of Morderna in February and March of 2021. he then received one dose of Pfhizer on the 24 of September. member didn't not realize that he had completed the series prior to getting a third dose.
8-13-07 Comes in with a 4 day history of a fever up to 101. Had a Menactra vaccine 4 days previous. Mom states that that night started to have a headache. Felt that his arm was sore and also had a fever up to 101. She has been giving him Ibuprofen over the weekend which seems to take care of the fever and the arm soreness. Has complained of a little bit of hand numbness in both of his hands over the weekend as well. With Advil the symptoms wear off and then they come back. Has had no difficulties breathing. There has been no leg weakness. Does state that he has a little bit of a sore throat this morning. Went ahead and went to school today as it was the first day. Mom states that he started feeling bad around 6th period again. Temp. is 101.1. PE: HEENT: NC/AT; PEERL; TM's clear bilaterally; nares patent bilaterally; oropharynx is mildly erythematous. He does have a canker sore under his bottom lip. Neck: Supple without LAD. CV: RRR, no murmurs appreciated. Lungs: CTAB, no wheezes, rhonchi or crackles. Abd: soft, NT/ND; BS present; no HSM. Generally this is a very anxious child, crying here in the office about feeling poorly. Rapid strep screen is negative. A: Viral syndrome, possible vaccine reaction. We will go ahead and report this to the VAERS efforts as mom is pretty convinced that that is why this was occurring. I do want them to return in the next couple of days if he is not better. They can go ahead and give him some Ibuprofen. Encourage them to not go to school while he has a fever. Mom will call with questions or concerns.
SHARP PAIN IN MY STOMACH, FLASHING LIGHTS, DIFFICULTY BREATHING, GAGGING, AND VERY FAINT FEELING.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 01-APR-2015, the patient was vaccinated with a dose of VAQTA (lot # K007827) 0.5 ml (expiration date, route and site of administration were not reported) that underwent temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 79 year old female with an allergy to sulfa and a history of meningitis and chicken pox and measles during childhood who on 10-JUL-2007 was vaccinated with Zostavax vaccine live 0.65ml subcutaneously (Lot # 658081/0743U) in the left arm. Concomitant therapy included LASIX, therapy unspecified and diclofenac. On 10-JUL-2007 the patient developed herpes zoster. The physician reported that on the evening of 11-JUL-2007 the patient began to experience hoarseness, coughing and fatigue. The patient's maximum reported temperature was 38.6C. The physician also reported the patient developed pneumonia. A herpes zoster rash developed on the right side of her head on 15-JUL-2007. The herpes zoster was diffuse and began at the trigeminal nerve. The physician reported that the patient had 30 vesicles which were distributed on the abdomen, back, cheek, face, ear (external auditory canal). The physician reported a lumbar puncture was done on 17-JUL-2007 and revealed an elevated white cell count. The patient was initially started on FAMVIR but has been switched to acyclovir. The physician confirmed the diagnosis of meningitis. The physician reported that the patient had been discharged from the hospital and was "doing much better." It was reported that a specimen was tested at a lab and was VZV positive, however not typed (+40,000 copies). No recent exposure to chicken pox or herpes zoster was noted. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if present to identify if it was associated with the wild-type(WT) VZV strain or with the vaccine VZV strain. The sample of the lesion was collected on 18-JUL-2007. The sample was taken from cerebral spinal fluid. The results were PCR negative. On an unspecified date the patient had a DFA of a lesion which was negative (This was not done through the VZVIP). The physician reported that meningitis, herpes zoster and pneumonia were other important medical events. Additional information has been requested. 8/27/07-records received 07/18-07/24/07-DX: varicella infection. VZV meningitis. Two days after vaccination c/o fatigue, vomiting and right sided facial pain. Prescribed famvir and took 1st dose and developed increasing confusion and fatigue. Chills, cough, non productive, hoarse voice, sore throat, watery eyes, right sided facial pain radiating to right side neck. Clear vesicles on erythematous base found on right neck, right shoulder, left face, back and right abdomen.
No additional AE reported; Patient was administered expired VARIVAX; This spontaneous report was received from a certified medical assistant, referring to a 13-month-old patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions or concomitant therapies provided.  On 13-MAY-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # T015999, expiration date 08-MAY-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse events or product quality complaints were reported (no advere event).
Swollen, hot to the touch, redness, itch, 1 small hive, pain/tenderness
At 5:00 pm several hives appeared.  By 6:30 PM hives appeared on chest, back, and face.  Temp 102.  Seen at Emergency Department.  Treated with Benadryl.  Within 20 minutes hives subsided and temperature came down.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 13-year-old male patient who received FLUARIX QUADRIVALENT. On 25th October 2016, the patient received FLUARIX QUADRIVALENT. In October 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, injection site bruising, headache, fatigue, drowsiness, muscle pain and stomach pain. On an unknown date, the outcome of the injection site pain, injection site bruising, headache, fatigue, drowsiness, muscle pain and stomach pain were unknown. It was unknown if the reporter considered the injection site pain, injection site bruising, headache, fatigue, drowsiness, muscle pain and stomach pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows:  The reporting nurse was patients mother. The nurse stated that the patient received vaccine at hospital. The reporter did not have batch number. The reporter stated she had read the package label and was aware of the continuous discharge certificate (CDC) recommendation, but looking for any additional information. This case is one of the 4 cases, reported by the same reporter.
COUGH, DIFFICULTY BREATHING, FEELING TIRED/SICK, MUSCLE PAIN
Patient states no problems initially after receiving vaccine. Denies pain immediately following injection, but 1/2 hr afterward spoke to sister on phone and sister asked her if she was "drunk" - she felt confused, weak and fatigued and took 1/2 nap - That evening went out to eat and didn't give enough money to pay her bill - confusion lasted 1 1/2 - 2 days. Pain in arm started 2 hrs after shot and lasted 1 week.
Misadministration. KINRIX was mistakenly ordered instead of INFANRIX & IPV separately for a 16 month old child. Thus far pt has had no adverse effects or symptomatology.
Shaking, dizzy, light headed, Admin Diphenhyramine 50 MG, Feeling well after waiting 30 minutes
Patient woke morning after injection with muscular aches that worsened throughout the day to become localized in the lower back region of the spine. Patient tried to rest and recover a few days before finally going to primary care doctor for treatment.
By 11:00 am Monday, March 8, I had a large red knot on my arm, had a bad headache that continued to worsen as the day went on and led to chills and fatigue. I had an active case of Covid in early January but was declared negative on January 19, 2021. I continued to feel these effects for 48 hours.
The pt developed cellulitis on left deltoid with streaking ant and post axilla. Treated with levaqum 500 mg and the symptoms resolved.
Patient passed out and slid out of his chair while waiting after receiving his vaccine. The fall was witnessed by NP and aid was provided, immediately. Patient was laid flat on the floor and his Covid mask was removed. Patient returned to conscious state <5 seconds after onset of event. BP was checked while laying down (130/76 HR 80) and patient was given water and a pillow. Patient was allowed to sit after 5-7 mins but began to get dizzy, again. He was taken by wheelchair to clinic and allowed to lay on an exam table. A snack was provided and NP remained with patient until he was d/c'd at 10:05 am. His d/c BP was 128/78 (HR 65). Patient was reminded to alert staff to this event with his next vaccination.
Headache, Myalgia, chills Received 2nd covid vaccine 2/10/21 and experienced HA, chills, body aches on the same day, all symptoms have resolved as day went on. Employee notified that are normal side effects of vaccine.