chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered only the liquid component; Administered only the liquid component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, they might have administered only the liquid component of Menveo to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered, but they were not completely sure. The reporter stated that, they had narrow down to 5 patients, no data available for any of them when asked but provided with vaccination dates and lot, patient 1 was vaccinated on 29th October 2021 with batch number AMAA589A, patient 2 was vaccinated on 18th November 2021 with batch number AMVA589A, patient 3 was vaccinated on 26th November 2021 with batch number AMUA589A, patient 4 and 5 were vaccinated on 16th December 2021 with batch number AMAA589A. No further details were provided. The reporter consented to follow up. Note- As we do not have any confirmation which patient was involved out of these 5 patients, vaccine start date and batch number was not captured in the case.
I noticed a pain in my back right leg.  Around the time of me getting ready for bed it was really hurting.  So, I took aspirin.  I also have a fever.  The spot does not stick out, but you could feel something under skin on my leg.  It was not a bit or anything like that.  It has not got worst or better.  It is warm to touch.  I think it is a blood clot.  I have contacted my doctor for an appointment.
Dr. received Moderna Bivalent booster on May 6, 2023. Approximately 2 weeks later, he began experiencing shortness of breath which progressively got worse. On 06/03/23, he presented at the locsl Emergency Department with chief complaints of shortness of breath and dry cough. On 06/04/23, he presented at the the local Emergency Department with same complaints. He was diagnosed with Viral Pneumonitis. On 06/05/23, he presented at the Emergency Department with progressively worsening symptoms. Pulse Ox was 82% at room air. An Echocardiogram was administed which yielded normal results. He is currently admitted to local Hospital being treated with antibiotics for diagnosis of Sepsis with acute hypoxic respiratory failure.
One week after injection woke up with firm, red rash about 2" in diameter. A bit itchy and slightly tender
pt recv vax 17JAN97 & 20JAN97 pt devel a fever of 102.2;
Information has been requested from a consumer concerning her son who in June 2009, was vaccinated with a dose of ATTENUVAX vaccine (Enders-Edmonston). The consumer reported that her son experienced a fever and rash after receiving ATTENUVAX vaccine. The patient was seen at an unspecified urgent care facility. The fever resolved with TYLENOL after 2 days and the rash resolved without treatment in 10 days. No further information is available.
Case previously recorded as MA2009-3757. Initial case report received from a nurse, on 10 NOV 2009. A 36 year-old female patient was vaccinated with 0.5ml of S-OIV FLUVIRIN (batch no. 101716P1A) i.m. on 29 OCT 2009. On 03 NOV2009, 5 days after vaccination, the patient experienced soreness of the left upper extremity. The outcome of the event was reported as recovered.
Placement of vaccine was incorrect: closest to the shoulder joint vs the location closest to the deltoid tuberosity of the humerus. Pain 9/10 on scale 1-10, with 10 being worse pain approximately 5 hours after placement. Unable to lift arm without manipulation. Required Motrin 600-800 mg PO every 8 hours around the clock. Duration of pain = 3 days.
Information has been received from a physician concerning a male patient who was vaccinated with a dose of ZOSTER (Oka/Merck) on an unspecified date.  Subsequently, six months after vaccination, the patient developed shingles on the face.  The shingles was reported as a mild case.  On an unspecified date, the patient recovered from shingles.  The patient sought medical attention and was seen by a physician.  Additional information has been requested.
pt exp  4'' local site bruise/resolving;also felt sickly 2-3 days/resolved;had arthritic feeling arm/shoulder/knees; feeling mentally unfocused/of head having cotton in it & some trouble driving;MD feels recurrence lyme disease
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 06-JUL-2009, patient received improperly stored VARIVAX dose 1, from batch/lot # 663709/0193Y and on 13-AUG-2009, dose 2 of improperly stored VARIVAX from batch/lot # 664468/0684Y (expiry date, dose units, route and anatomical location were not specified). Concomitant medication were not reported.  No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a licensed practical nurse, referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On unspecified dates, the patients were vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number T017686 which has been verified to be valid, expiration date reported and validated as 21-MAY-2022) (lot number T017682 which has been verified to be valid, expiration date reported and validated as 21-MAY-2022) (doses and frequencies were unknown by the reporter; vaccination schemes, routes of administration, and anatomical site of injection were not reported) as prophylaxis. The administered doses of the vaccine were stored on 19-JAN-2021, at a temperature of 9.1 degrees Fahrenheit (F), during a time frame of 2 hours, as recorded by a digital data logger. There were previous temperature excursions reported on 02-DEC-2020, 6 F to 14 F (11 F) during a time frame of 1 hour, and 14 F to 46 F (36F) during a time frame of 3 hours. On 14-DEC-2020, 6 F to 14 F (13.8 F) during a time frame of 6 hours, and 14 F to 46 F (15.8) during a time frame of 42 minutes. On 21-DEC-2020, 6 F to 14 F (8.8 F) during a time frame of 1 hour and 30 minutes. On 07-JAN-2021, 6 F to 14 F (9.5 F) during a time frame of 10 hours. On 18-JAN-2021, 14 F to 46 F (32.4 F) during a time frame of 5 hours 0 minutes and 0 seconds. No additional adverse events were reported in the patients.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the  licensed practical nurse on 28-JAN-2021 regarding a 1 year old female patient. with 2 siblings, birth weight of 5.15  lb. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), hepatitis a virus vaccine inactivated(HAVRIX) and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR). The patient's concurrent conditions and medical history were not provided.   Since 02-DEC-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h.    On 12-JAN-2021, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot# T017686, expiration date 21-MAY-2022, subcutaneously in the left thigh, for prophylaxis, on a private doctor's office/hospital with public funds.  This is one of several reports from the same reporter (US-009507513-2102USA002533,US-009507513-2102USA002536,US-009507513-2102USA002535,US-009507513-2102USA002534 and US-009507513-2102USA002537).; Sender's Comments:  US-009507513-2101USA011364:
transferred from shoulder to her neck; shoulder was in pain/ elbow and shoulder were in pain; injection area is a little sore; I cant sleep at night; She can't position her arm in a way that is not painful; deep muscle ache pain; she was miserable; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received  the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9266, expiration date: Mar2021), via an unspecified route of administration in left arm on 23Feb2021 as single dose for COVID-19 immunization. Patient's medical history included stomach problem and bleeding problems in her stomach. There were no concomitant medications. The patient said that absolutely everything was okay until she went to get the shot, and was even okay the evening of the shot, then it went down hill from there. She said nothing she has that is related to the pain in her arm, or that she feels she should provide. She did not had any other recent vaccinations or started any new medications. The patient stated that the injection area was a little sore and the area became bigger and bigger by Wednesday (24Feb2021). She woke up on Thursday (25Feb2021) and her elbow and shoulder was in pain, described as a dull pain. The patient stated she has a stomach problem where she can't take medicine. She started treating her pain with aspirin cream with Lidocaine. She said that its kind of worked, it didn't take it away, but more manageable. Now it's been 6 days later (01Mar2021), it was reported a deep deep pain in the point she can't sleep at night. She can't position her arm in a way that is not painful. It was getting unbearable. It transferred from shoulder to her neck on Friday (26Feb2021). It got worse Thursday evening and has been the same since. Patient said, "I am not going to get the second shot if this pain does not go away or if I am going to experience this again." The patient was calling about a possible side effect and was wondering if anyone else had it and does it go away. She was suffering, she wanted to know if the pain she is in, that she is still experiencing will go away. She said that she had a deep muscle ache pain to the point she can't sleep at night.  Patient stated that her pain began as soreness at injection site that started Wednesday and then it just got worse and worse and became deeper and deeper just between her shoulder and elbow, a deep constant achy pain. During the day when she is using her arm she can kind of forget the pain, but at night there was no comfortable position she can put her arm in without pain, so she has not been sleeping the last 3-4 nights, she can't sleep, she was miserable. She said she would rather get COVID than this, it was ridiculous. As she has bleeding problems in her stomach, she can't take anything to treat the pain, so she was trying to use lidocaine on her arm, which did at first give some relief but no longer works. She said that the only number listed on the bottle was next to "EXP date, LOT: 19C506, EXP: Mar2021 (as reported)." The outcome of the events was not recovered.
Information has been received from a nurse practitioner concerning a female who in Dec 2004, was vaccinated IM with the first dose (10mcg) of hep B virus vaccine rHBsAg (yeast) (lot unk). In Dec 2004, after the first dose the pt experienced kidney failure, 75% loss of function. Hospitalization was noted. She recovered spontaneously. After missing the normal dosing schedule, she went back to get her second dose in 2005 and received 20 mcg instead of 10mcg (overdose). The pt then experienced high blood pressure, heart palpitations and irregular EKG and was hospitalized for a second time. An EKG was performed. IV nitro was given in the hospital. Therapy was discontinued after reaction. The pt status was reported as recovered, shortly after the second dose. Medical attention was sought. No product complaint was involved. Additional information has been requested.
swelling in his feet, legs; swelling in his knees; swelling in his scrotum; unable to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 64 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single, UNKNOWN MANUFACTURER), when the patient was 64 years old, for covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling in his feet, legs"; JOINT SWELLING (non-serious), outcome "unknown", described as "swelling in his knees"; SCROTAL SWELLING (non-serious), outcome "unknown", described as "swelling in his scrotum"; GAIT INABILITY (non-serious), outcome "unknown", described as "unable to walk". The events "swelling in his feet, legs", "swelling in his knees", "swelling in his scrotum" and "unable to walk" were evaluated at the physician office visit.  Additional information: The patient would be 65 years old in June and received the second dose of the Covid vaccine three weeks ago tomorrow. He received the vaccine at 9:10 a.m. that morning and by 3 in the afternoon he started experiencing swelling in his feet, legs, knees, and scrotum. His scrotum was in the size of a grapefruit and he pees all over himself due to the swelling covering his penis. He was unable to walk or put on pants due to the size of his scrotum and his girlfriend has to help raise his legs into bed due to the swelling. He was unable to get the swelling down and has consulted with his oncologist in which they do not know what to do for him either. And due to the chemo pills he takes, he has to drink 4 bottles of water every day, and the doctor does not want to give him Lasix due to the risk for his kidneys. He was miserable.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The swelling in his lymph nodes, by his armpit; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose 1, single and administration date 04May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "The swelling in his lymph nodes, by his armpit". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Caller verified that he received Pfizer Covid vaccine, first dose on 13Apr2021, second dose on 04May2021, and asked regarding his experience: "the swelling in his lymph nodes, by his armpit" how long may that last?    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A report received from a health professional on 11/05/2002, concerning a female vaccinee of unknown age who received 2 administrations of Fluvirin. The vaccinee was administered 2 doses on 10/23/2002 and 11/04/2002. Both doses were administered intramuscularly in the deltoid region of the arm. No adverse events were observed. The reporter has assessed the relationship of the vaccine to the event as unclassifiable.
It was reported that a female pt received a TD Adult on 3/30/00. Sometime, post vax, the pt developed a swollen, red, hard nodule at the injection site. Additional information is being requested. From correspondence received on 5/4/00, additional information was provided.
After the vaccination i had body aches and was light headed but it went away the same day but a week later my arm pain was really bad and it got worst and worst. I had chest pains and that's when i went to the doctor and they ran test on me EKG and blood work
PAIN, SORENESS, SWELLING IN ARM AND SHOULDER, BODY ACHES, TIREDNESS, WEAKNESS.
body aches, headache, cough, congestion, fever 100, chills, diarrhea starting on 11/6/21
Patient had vasovagal syncope 10 minutes after Moderna vaccine administration. Patient was bradycardic (~40 HR) , pale, diaphoretic, and  vomit x1 . Oxygen saturation at 100% at room air.
entire upper arm is sore, red, and hot to the touch, itching and slight rash. Hurts to raise arm and it is almost 4 days later.
Severe nausea/vomiting began ~6 hours after receiving vaccine. (Tuesday 1/26 at 3 p.m.) Vomiting continued around the clock until Friday 1/29 at 4 p.m. when I went to Urgent Care.  At that time I had not urinated in more than 24 hours.  I received 2 liters of normal saline and 1 dose of IV Zofran and was sent home with a prescription for oral Zofran.  The vomiting began again after the IV Zofran wore off and I could not keep oral Zofran down.  (1/29 at 9 p.m).  Vomited through the night and presented to ER Saturday 1/30 at 7 a.m.   Given 1 liter normal saline as well as IV Zofran and IV Reglan to stop vomiting.  They also did ultrasound of large lump on back of neck that was painful and had started after receiving vaccine.   Had labs drawn.   Sent home with phenergan suppositories.   Currently Sunday 1/31 and have not vomited since 1/30 at 7 a.m.  but have been taking phenergan/Zofran /meclizine around the clock.   Severely nauseous with anything in stomach.  Tolerating 1/2 popsicle every 2-3 hours only.
PT began shaking immediately after vaccine administration. RN stayed in room with Pt to monitor symptoms. Ten minutes later, Pt reported feeling dizzy. She was placed in a recumbent position on the exam twith legs elevated and vital signs were obtained, they were within normal limits. Pt then reported that it felt like she had something in the right side of her throat - she declined epinephrine injection. RN and LVN stayed at bedside. Pt then stated that both sides of her throat felt blocked and gave consent for epinephrine injection. RN administered 0.3 mg epinephrine and activated EMS. Vitals signs, breathing and circulation monitored closely until EMS arrival. Pt was transported by ambulance to the hospital emergency department for evaluation.
syncope episode, vomiting several times over a period of about 1 hour, left clinic, went home, slept, vomited several more times.  went to bed, went to school the next day, appeared to be recovered.
This spontaneous report as received from a Registered Nurse refers to a 20 month old patient of unknown gender. On 20-FEB-2014, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot number not reported) in error. No adverse event was reported, no product confusion discovered. The outcome was not reported. Additional information is not expected.
This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 04-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1704USA001661:
No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 4-year-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 20-APR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009090,2305USA009091, 2305USA009092, 2305USA009094, 2305USA009095.
Left deltoid area warm, red, swollen,  and lymph nodes under left axillary are feeling swollen and mildly uncomfortable
Patient complained of muscle and joint pain approx 18 days after receiving the Gardasil and Varivax vaccine
Patient's arm developed redness and itching at injection site. Advised patient to apply ice and take OTC diphenhydramine at pkg dosage.
Patient with history of syncope following vaccine administration came to the pharmacy for COVID vaccine.  She was accompanied by her father.  They warned me of the history prior to giving the vaccine.  Within a minute after administration, patient fainted in the chair and slide accompanied by myself and dad to the floor.  She was out for about a minute.  She rested on the floor for 5 minutes and then moved to the chair, where she recovered for 10 minutes.  When she felt able to walk, she went the the pharmacy lobby and continued to recover until 4:18pm.
Immediately upon Prevnar being injected into my upper left arm, I had pain in my left shoulder blade.  I took prednisone, had 10 PT sessions (continue to do exercises), and received a cortisone shot.  Pain continues esp. in bed.
Arm pain, injection site redness, itchiness, and tenderness, swelling in armpit area, lymph node swelling and tenderness in the left arm and neck, itchy red bumps on left side of neck and on left arm near injection site. These symptoms lasted for 4-5 days.   On Saturday December 18th around 6pm shivers, aches, and chills happened until after taking ibuprofen.
Rash 50% body develops 12 days after 2nd. Had no rxn at time of injection Txt: Antihistamines steroids
NOT FEELING WELL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced not feeling well. The action taken with covid-19 vaccine  was not applicable. The outcome of not feeling well was not reported. This report was non-serious.