chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of pain in arm in a 58-year-old male patient who received FLUARIX Quadrivalent (batch number 5J594, expiry date 5th May 2018. Previously administered products included AFLUIRA with an associated reaction of pain in extremity (received in left and experienced left arm pain). On 31st August 2017, the patient received FLUARIX Quadrivalent (intramuscular) .5 ml. On an unknown date, less than a year after receiving FLUARIX Quadrivalent, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved. The reporter considered the pain in arm to be related to FLUARIX Quadrivalent. It was unknown if the reporter considered the injected limb mobility decreased to be related to FLUARIX Quadrivalent. Additional details were reported as follows: The patient received FLUARIX Quadrivalent in right deltoid. The patient noted he had pain from the AFLURIA flu vaccine in 2016, which was given to him in his left arm and that is why he chose the right arm with the present vaccine. The patient had arm pain at the injection area after the vaccine, which he thought it was just the shot, but he continued to have right arm pain still. The patient had a really painful arm which was hurting and he cannot lift his arm beyond the ear. The patient reported these events to the pharmacy in December. The pharmacist was unaware if these events had been reported by the patient to his physician. The patient denied any other vaccines on his questionnaire, when he was asked about other vaccines on this day or 4 weeks prior to this vaccination. It was reported that, the pharmacist who gave the vaccine was no longer working at the pharmacy. The pharmacist stated that, it was their protocol to report to VAERS. She was encouraged to follow her protocols and make aware GlaxoSmithKline would report to VAERS as well. The pharmacist reported that, the patient requested manufacturer's phone number. A search of the patient's name did not find a previous report.
Developed pain, weakness to the left shoulder and left upper arm approximately 8 hours after injection of vaccine. On 11/5/2020 came to the walk in clinic because pain continues and not better. Labs, US ordered and xray of the left shoulder and upper arm. Will refer to Orthopedic. Given toradol IM in office , and Prescription of Meloxacam.  Will follow up and monitor response. z
3/23 pain points - complaint of bug bites - no bites seen; 3/24-3/30 small red spots appearing to be itchy bug bites that would not subside.  Topically using cotton balls saturated in apple cider vinegar.  3/31 itching on small sites and intense pain.  4/1-4/6 hot baths with apple cidar vinegar and epson salts seem to stay itch - no blisters seen.  4/7 pictures were taken after baking soda bath with apple cider viinegar produced large red splotches.  Called 24/7 hotline on evening of Friday or Saturday 4/8 or 4/9 - Dr. did not think what I described was shingles because no visible blusters.  Take Tylenol with coding (300 mg 0n hand) and 2 hours later take 4 ibprofen.   No fever
On 02/03/2002 am came down with having red bumps to stomach and back approx. 50 spots. 02/04/2002 still present today and are much better per phone conversation with the child's mom. On 02/06/2002, mom verbalizes red bumps gone by night on 02/06/2002.
bouts of nausea and stomach cramping; bouts of nausea and stomach cramping; Eventually the cramping turned in to violent diarrhea; high fever with chills; high fever with chills; waves of tiredness; This is a spontaneous report from a contactable consumer, the patient. An elderly non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 26Mar2021 at 17:45 as a single dose for COVID-19 immunisation. Medical history included pre-diabetic and pace maker. The patient received unspecified medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 05Mar2021 at 16:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Mar2021 at 02:00 the patient experienced bouts of nausea, stomach cramping, violent diarrhoea, high fever, chills and waves of tiredness that come for no apparent reason. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the nausea, stomach cramps, diarrhoea, fever, chills and tiredness was recovering.   No follow-up attempts are needed. No further information is expected.
The patient passed out 3-5 min after vaccination. He notified staff of feeling faint. He was unconscious <1 minute. He was pale, diaphoretic and felt weak.  However, he was alert and speech was clear. Within 5 minutes his palor improved and the diaphoresis and weakness began to improve. Cold ice packs were applied. No treatment given.  The patient reported he "has done this before." He remained onsite for 1 hour, at which time he reported he "felt normal". Also, I spoke with him by phone at 5:30 pm and he stated " I made it home fine and I'm good".
Patient has pain in the arm the vaccine was administered. Patient has been in pain since the vaccine was administered.
headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   Reporter did not allow further contact
Changes in Menstrual cycle when normally extremely regular (28 days). Started period much earlier than usual, spotting a few days after vaccines after each dose. Changes were more apparent after 2nd dose. Also experiencing out of ordinary breast tenderness/pain at unusual timing in cycle (have not experienced breast pain in years, mainly since pregnancy) also altered breast fullness, which began occurring after vaccines.
STOMACH PAIN (RIGHT-SIDE); HEADACHE; TIREDNESS; FOGGY; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and have no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced foggy. On MAY-2021, the subject experienced tiredness. On 03-MAY-2021, the subject experienced stomach pain (right-side). On 03-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy, and tiredness on MAY-2021, and stomach pain (right-side) on 04-MAY-2021, and had not recovered from headache. This report was non-serious. This case, from the same reporter is linked to 20210506681.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Pain in right anf numbing from shoulder to elbow, elbow to wrist and to fingers. Patient still feels symptoms as of this date.
Day of no reported problems. 2nd day-Developed itching-2 hives/rash on face, at base of thumb and red patch below injection site. Felt light-headed so rested all day and used Benadryl cream to alleviate itching (not used at injection site). 3rd day-top side of inj arm from top of arm to wrist was slightly redder than normal-underneath side of arm ok. As of 10/20/16, symptoms are slowly subsiding.
A pharmacist reported that a 7 month old male received an injection of Prevnar on 4/1/00 or 4/2/00. Later that day he developed a fever of 101 and was "very fussy". He was taken to the ER. Blood cultures were negative. The infant recovered within 36 hours. No further information was available at the date of this report.
he had a little soreness in that arm; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program  Support.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced he had a little soreness in that arm on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Information has been received from a physician and a licensed practical nurse concerning a 12 year old female with attention deficit/hyperactivity disorder and no known drug allergies, who on 14-JUN-2010 was vaccinated with the first dose of GARDASIL (lot # 1487Y). Concomitant therapy included VYVANSE (for the attention deficit/hyperactivity disorder). No other vaccines were given on the day GARDASIL was administered. On 16-JUN-2010, the patient demonstrated symptoms of facial droop and impaired speech, so went to the ER (not admitted), and was diagnosed with bell's palsy made based on symptoms. No diagnostic testing was performed. The patient was ordered oral ACYCLOVIR, oral PREDNISONE, and ophthalmic erythromycin ointment for 10 days. The patient went to follow-up with an ENT physician (no details). The patient was seen in office on 21-JUN-2010 and 06-JUL-2010, and was still recovering. The event was considered disabling, but not life threatening by the licensed practical nurse. Additional information has been requested.
Pt came into the office to get the FLUMIST AT 3:30 PM. Pt left and called to office at 4 PM stating that she was itching all over. Dr. advised the pt. to take BENADRYL every 6 hours and CLARITIN.
Began taking Paxlovid within 12 hours of onset of Covid symptoms; Began taking Paxlovid within 12 hours of onset of Covid symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 25Apr2021 as dose 1, single (Lot number: EW0171), in left arm and on 23May2021 as dose 2, single (Lot number: EW0185) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Dec2021 as dose 3 (booster), single (Lot number: 021C21A) for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Sulfa drugs" (unspecified if ongoing); "Known Allergies: Penicillin" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Began taking Paxlovid within 12 hours of onset of Covid symptoms". The event "began taking paxlovid within 12 hours of onset of covid symptoms" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not hospitalized due to the events. Reporter assessed seriousness as non-serious. Since the vaccination, the patient was not tested for COVID-19.
HEART BURN; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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, start therapy date were not reported for prophylactic vaccination. Batch number is not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced heart burn. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart burn was not reported. This report was non-serious.
She received her first dose of the Covid vaccine and then tested positive for Covid; She received her first dose of the Covid vaccine and then tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program. A contactable 27-year-old female other HCP (medical assistant, patient) received 1st of BNT162B2 (Batch/lot number: EK5730) Intramuscular on 04Jan2021 at single dose (0.3 ml) for covid-19 immunization. Medical history and concomitant drug were not reported. She received her first dose of the Covid vaccine and then tested positive for Covid. She was calling to see what she should do about the second dose. Outcome of the event was unknown.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported "tested positive for Covid".
REDNESS/RASH AND SWELLING AT INJECTION SITE - STILL SWOLLEN 5 DAYS POST VACCINATION.
This spontaneous report as received from a Licensed Practical Nurse refers to a 34 year old female patient with dermatomyositis, rheumatoid arthritis and none drug reaction or allergies. On 18-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (0.5 ml, intramuscular, in the arm, lot# K007262 with expiry date: 25-NOV-2015). Concomitant therapies included biotin, prednisone (manufacturer unknown), omeprazole (manufacturer unknown) and calcium. On 18-NOV-2014, the patient experienced severe muscle weakness, pain in the arm, redness and swelling from injection site, across the anterior arm to the axilla and difficulty moving the injection site arm after receiving PNEUMOVAX 23. There was none lab diagnostic studies performed. The patient was treated with ice to site, tramadol and KEFLEX. The patient sought medical attention via visiting an urgent care and a physician. The outcome of events was not reported. The relatedness between events and PNEUMOVAX 23 was not reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to unspecified patients of unknown ages and genders. Concurrent conditions, medical history and allergies were not reported. On an unknown dated, the unspecified patients were vaccinated with series of hepatitis b vaccine (manufacturer unknown), (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. The reporter stated that the unspecified patients were not considered to be immune to Hepatitis B at a later time when titers were measured on an unknown date. The outcome of hepatitis b surface antibody negative was unknown. The relatedness between hepatitis b surface antibody negative and therapy with hepatitis b vaccine (manufacturer unknown) was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not reported. Temperature excursion was not occurred. No Adverse events were occurred. On 03-Nov-2021, the vaccine was placed in Refrigerator Treatment information was not provided
Aching, pain, redness and warmth at shot site.  Chills.  Fever.  Brain fog. Dry heaves. VERY tired.  Dizzy
Headache, Myalgia, Angina, c/o injection site sore,chills,under left arm swollen,back pain and leg pain Narrative:
No adverse event reported by patient. Pharmacist is filling out a VAERS because we mistakenly administered Shingrix instead of the intended Twinrix. This was the third Shingrix patient has received. Again, patient did not report any adverse events, and no additional treatment was needed.
She had terrible vertigo; She had terrible vertigo, was so dizzy; one Moderna, one Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-000004316 (Novavax).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Meniere's disease" (unspecified if ongoing), notes: had a history of vertigo from Meniere's disease which she had for 6-7 years; "vertigo" (unspecified if ongoing), notes: had a history of vertigo from Meniere's disease which she had for 6-7 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for COVID-19 Immunization; Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: VERTIGO (non-serious), outcome "recovered", described as "She had terrible vertigo"; DIZZINESS (non-serious), outcome "recovered", described as "She had terrible vertigo, was so dizzy"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "one Moderna, one Pfizer".  Additional information: On 23Nov2022, it was reported that the patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine two primary doses and a booster for COVID-19 immunization. It was reported the patient was affected for months with side effects from the boosters she received (one Moderna, one Pfizer). Both side effects began 2 to 2.5 hours after receiving them. She had terrible vertigo, was so dizzy. But she also had a history of vertigo from Meniere's disease which she had for 6-7 years. She was now feeling back to the way she used to. The symptoms from the Pfizer booster only lasted 1 day. No further follow-up was anticipated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client in for Hib and other IZ's due to asplenia and (+) HIV status. Opened new lot of what I thought was Hib vaccine but was actually PENTACEL. Drew up this vaccine with the other 3 vaccines listed below. Administered all IZ's and when done noted that PENTACEL was given in error. Client immed. notified. Info reports Hib is valid and DTaP counts as tetanus booster. Clients Primary Care Provider also notified. Med error report written.
30OCT95 c/o warmth & inflamation in arm;told to apply warm moist packs to arm;1NOV95 c/o redness, warmth & knot in arm;told to see MD;1NOV95 stating had seen MD who said had abscess & prescribed Cipro;2NOV95 pt states seen by MD-local rxn,n
Moderna COVID-19 Vaccine EUA I became lightheaded, dizzy, with weakness in arms and hands, fatigue, sore arm at the injection site about 35-40min after the vaccine was administered. Still feeling lightheaded with weakness 26 hours later.
Red spots (looks like chicken pox) started popping up all over and continued to pop up every hour. He has spots all over his body on 9/12/14 except for his face and legs. Mostly the spots cover his trunk and arms, but some spots are on his neck and buttocks and groin area. They don't itch are unaccompanied with a fever. After a spot has been there for a while it is surrounded by a spreading red circle (and no it does not look like ringworm).
pt recv vax; irritability & low grade fever for 1 wk p/ vax;
Vaccinated with DTaP on  7/24/02-now with increased redness, increased tenderness, increased warmth over past 3 days. Concern of cellulitis. No evidence of abscess. Pt started on Cephalxion on 7/27/02.
Upper arm, shoulder area very sore and stiff. Chills for about 24 hours.
Received Flumist nasal vaccination on 01/11/05. On 01/12/05 awoke with diarrhea and headache. After the diarrhea subsided, stomach was achy all day with persistent nausea x3days. At end of first day (01/12/05) +vomiting x1.
Pt recvd vax on 14AUG92 & approx 28AUG92 devel generalized hives & itching that would come & go; allergy testing revealed that was sensitive to thimerosal; approx 8SPE92 seen by MD;
Flucelvax was given first in the left deltoid,  the patient responded fine. Then approximately 30 seconds later the Spikevax was administered, also in the left arm, approximately 2 inches away from the administration site of the Flucelvax. The patient's head drooped forward immediately when the injection started going into the muscle. I then took the needle out to discontinue the administration. The patient had a full body rigor, head dropped back, her eyes rolled back in her head and she started shaking. The patients mother and I called her name and she was then alert, but drowsy and diaphoretic. 911 was called, blood pressure taken (86/64 ). I stayed with the patient and mom while we waited for emergency services to arrive. The patient was given some water and stayed alert until EMT's arrived. Patient and mother were transported to Hospital Emergency Department.
Immediate pain in right arm and right ear.  Swelling in right arm.  Motion pain when moving arm.  Bruising.  Intense pain when sleeping on right arm.  Pain subsided, then reoccurred.  Still with frozen shoulder symptoms.