chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a pharmacist, describes the occurrence of product administered to patient of inappropriate age (AE of giving a vaccine to 17 year old) in a 17-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 016B21A) for COVID-19 immunization. No medical history reported. On Mar 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; unspecified dose. On an unknown date, patient experienced product administered to patient of inappropriate age (AE of giving a vaccine to 17 year old). The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments. Most recent follow-up information incorporated: On Apr 22, 2021: First dose date added; additional information. On Apr 22, 2021: No specific follow-up information recorded.
Patient has a short episode of fainting,  about 5 minutes after receiving vaccine. Patient fell to the floor and was able to regain consciousness in about a minute. EMS was contacted and they took over care for the patient. Patient was taken to the hospital for further evaluation.  Patients doctor was contacted to notify them of the incident..
p/vax pt devel T101.2; nasal congestion & inj site rxn of redness; swelling; warmth; pain & hives; tx: topical & oral DPH
Reportedly on 6/14/00, the pt was dx and hospitalized with bacteremia. Confirmed culture of Haemophilus Influenza type B. 15-day follow-up states the pt has recovered. 15-day follow-up states tests provided normal results. Antibody titers for influenzae type B are present at significant levels. Also,infection should be added to this report. From the follow-up info received on 07/18/2000, it was reported that the pt recovered from this experience and no further info available regarding this pt because it was reported that the vaccines were given at other practice, the route and sites for vaccine administered are unknown.
Patient presented to pharmacy to fill rx for antibiotic following reaction in vaccination arm. Right arm was visibly swollen, red, and patient said hot to touch.
Hurt in the arm after receiving both doses; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 25Jan2021 (Batch/Lot number: unknown) as dose 1, single and administration date 15Feb2021 (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Hurt in the arm after receiving both doses".  Additional information: Patient mentioned that she experienced minor adverse events like hurt in the arm after receiving both doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A few days after shot, I noticed I hard a large raised hard bump at injection site.  It has persisted for 4-5 days and is also hot and itchy.
This spontaneous report was received from an administrator, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of PROQUAD (strength, dose, route of administration or anatomical location were not reported), for prophylaxis. For the lot # M044575 with expiration date on 04-MAY-2018, the storage temperature was reported as 15 to 46 degrees Fahrenheit (°F) (-9 to 8 degrees Celsius (°C)) for a time frame of 24 hours (dates between 04-MAY-2017 and 01-JUN-2017); but it was reported that there were multiple previous temperature excursions, under that temperature with a total cumulative time frame of 360 hours. This lot # was also exposed to a storage temperature of 6 to 14 degrees Fahrenheit (°F) (-14 to 10 degrees Celsius (°C)) for a time frame of 24 hours (on 25-MAY-2017). Data logger was involved but no adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested. Sender's Comments: US-009507513-1706USA011485: US-009507513-1706USA011490: US-009507513-1706USA011487: US-009507513-1706USA002362: US-009507513-1706USA011489: US-009507513-1706USA011484: US-009507513-1706USA011486:
Dizziness, Headache, Fever, red swollen area at the injection site Narrative:  Other Relevant History:
Dizziness; headache; tired; woke up nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), NAUSEA (woke up nauseous), HEADACHE (headache) and DIZZINESS (Dizziness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FATIGUE (tired) and NAUSEA (woke up nauseous). On 05-Mar-2021, the patient experienced HEADACHE (headache). On 08-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, FATIGUE (tired), NAUSEA (woke up nauseous), HEADACHE (headache) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Severe pain at site of injection. Unable to move/elevate arm due to shoulder pain. With Active ROM, she is only able to elevate arm to 90 degrees. With passive ROM to 160 degrees. Injection site is about 1 cm below head of humerus. Site is clean. no redness, swelling, warmth. Distal pulses strong. No tingling or numbness in arm or shoulder. Patient was given 800mg Motrin and 5mg Flexeril. Was told to f/u if arm not better in 1-2 days.
Shingles. I went to urgent care 2 days after 1st symptom and they were unable to diagnose me, so they sent me to my primary physician. She did a physical exam and sent me for a CT scan due to back pain. She was able to diagnose me in the office.
Twinrix maladministration due to expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 42-year-old female patient who received HAB (Twinrix) (batch number 93K5F5, expiry date 20th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 3rd March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The health care professional reported a Twinrix maladministration due to expired dose. The patient received Twinrix which was already expired in 20th February 2022, which led to expired vaccine used. The reporter consented to follow up.
Arm achy and sore the day vaccine was given. Arm also "hot and swollen" the day vaccine was given. Ice helped. Advised Tylenol and Motrin as needed. Took 5 days to recover.
Red round area of arm that was vaccine site appeared on 3/23 (vaccine dose 1 on 3/15); warm to the touch; became larger, swollen, with hardened 'lump' and itchy over the next 2 days; arm was sore to the touch.  Researched and found information about "vaccine arm" experienced by some recipients. Applied recommended therapy of ice pack that did help the swelling and itching diminish. I'm writing this on 3/30, a full week after adverse symptoms occurred (and 2 wks after initial dose) and while symptoms have significantly diminished, there is still redness of the skin in the vaccination site area.
He received the covid vaccine, and then got up the next morning his leg was semi numb. Clarifies that it is not his entire left leg. He only has numbness in the front and back of his calf.; He feels breathlessness whenever he is lifting things. He gets more tired than before.; He feels breathlessness whenever he is lifting things. He gets more tired than before.; This is a spontaneous report from a contactable consumer (Patient). A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER2613), Solution for injection, via an unspecified route of administration, administered in Deltoid Left on 07Apr2021 around 2:00 to 3:00PM as single dose for covid-19 immunisation. Medical history was reported as none. Family history included heart disease, Alzheimer's and Diabetes. The patient's concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect. Patient did not receive any vaccine within four weeks prior to Pfizer suspect. The patient received the covid vaccine, and then got up the next morning on 08Apr2021, his leg was semi numb. Clarified that it was not his entire left leg. He only had numbness in the front and back of his calf also he felt breathlessness whenever he was lifting things. He got more tired than before. Patient noticed that numbness was getting worse whenever he was walking. He had not been doing any strenuous exercise. Whenever they gave him the covid vaccine in his left shoulder, it was pretty painless. He did not think that his semi leg numbness and the covid vaccine were related. His leg numbness was not that intense. He described that it feels like, if someone was to do a lot of squats, and then feel numb. That was the exact feeling, and it was annoying. He also felt breathlessness whenever he was lifting things. He got more tired than before. He was concerned about getting the second dose, because he did not want his symptoms to get worse. He was not taking any medications. He had no medical history. He did not require to visit emergency room or Physician office due to adverse events. He was scheduled to receive his second dose of the covid vaccine on 28Apr2021. The outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
Headache; Sore arm; Enlarged lymph node (left armpit); Lethargy; Intense pain in thighs; Hot to touch thighs; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration in the left arm on 13Apr2021 at 09:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration on 23Mar2021 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. On 14Apr2021, the patient experienced headache, sore arm, enlarged lymph node (left armpit), lethargy, intense pain or hot to touch thighs. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, sore arm, enlarged lymph node (left armpit), lethargy, intense pain or hot to touch thighs was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Approximately 1am 1/27/21, woke up with chills and nausea (Both Grade 2 CTCAE Version 5).  No meds taken.  About 9am 1/27/21, fever began, eventually reaching 101.5 degrees Fahrenheit around 3pm, even with Tylenol ES-2 tabs every 4 hours.  Fever and chills subsided around midnight 1/27/2021.  Also had body aches, malaise, loss of appetite, and pain at injection site.  Nausea subsided 1/29/2021. Fatigue worsened to Grade 2, and stayed at until 1/31/2021.  Developed left axillary lymph node pain 1/28/2021, which resolved from Grade 2 to Grade 0 on 2/1/2021.   Of note--only side effect after first injection 12/29/2021 (Lot Number 011J20A) was pain at injection site, lasting until 1/1/2021.
Headache with burning lips burning and stinging in right side of face with slight swelling.  Pulsating area below lip on right side of face. Pulsation visable when looking at face. On the first day, Jan 19, 21. Nausea,dizzyness and off balance,headache. Second day 1/22/21 just general unwell feeling all day with headache.
Fever, headache, muscle and joint pain, painful lymph nodes,  fatigue, pain and swelling at the injection site
a 61 yo female who presents today for her first Moderna vaccination. Vaccine was administered at 1312 in the left deltoid. After receiving the vaccine, the patient was sent to the observation area where she reports that she, ?began to feel her throat closing.? At 1315, she was brought to the medical tent area with worsening complaints of ?throat closing? and ?difficulty breathing.? EMT's immediately placed the patient on the monitor for vital signs monitoring. Patient denies feeling lightheaded, dizzy, confusion, loss of consciousness, shallow breathing, wheezing, increased heart rate, swelling to the tongue, n/v/d or clammy skin. Provider administered 50 mg of PO Benadryl at 1318, with water. Medications tolerated well. Patient also self-administered own albuterol MDI, as directed and prescribed. EMS notified at 1305 and at bedside by 1315. Patient transferred to Hospital for further evaluation. Patient left with all personal belongings and medications.
soreness on injection site; insomnia; minor headache; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Jul2021 at 14:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included melatonin (MELATONIN GUMMIES) for unknown indication from an unknown date. The patient did not have any allergies to medications, food or other products. On 29Jul2021 at 14:00, the patient experienced soreness on injection site, insomnia and minor headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness on injection site, insomnia and minor headache were recovered with sequelae on an unknown date in 2021 at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a 62 year old female registered nurse who in February 2007, was vaccinated SC on left arm with a 0.65 ml zoster vaccine live (Oka/Merck). In February 2007, same day after vaccination the patient experienced pain on left arm. The next day she developed itching and pain which lasted for 2 weeks. It was reported that the itching had gone away but the pain had not resolved and extended from her shoulder to elbow, especially if she lays on it the wrong way. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
After my fourth shot, I felt pain in my arm, and I thought it was from the shot, then I realized the pain was under my arm. I felt under my arm and my lymph nodes were really swollen. This lasted for a couple days and then went away. I was also really tired, and nauseous. I am fine now though.
Leg cramp alerted me to deep vein thrombosis (DVT) and pulmonary embolism (PE) .  I had the second dose of Moderna Monday afternoon. First cramp Tuesday evening. Mild infrequent leg pain Wednesday. Intense morning cramp on Thursday, hospitalized Thursday night with confirmed DVT w/PÉ. Discharged Sunday afternoon.   Was fully hidrates at the time, no recent travel by car or plane. No extended period of inactivity such as bed rest or sitting.  No evidence I?d internal trauma or injury. No recent surgery. No sign of any form of cancer.   Vaccine listed as suspected cause of the DVT
From initial information received on 10/09/03, from a health care professional, regarding an adverse event occurring in the U.S.A., it was reported that a 55 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1089AA, given intra muscularly in the left arm on 10/04/03. The following day, 10/05/03, the patient developed a rash at the injection site as well as on both legs. The recovery status was reported as unknown. This is the same reporter as case 200302313. From additional information received on 11/18/03, from a health care professional, it was reported that the patient also developed a rash on her stomach, legs and chest. The rash was not itchy and the patient was fine otherwise and she did not seek medical care. The rash cleared after one week and the patient recovered. No further information is anticipated, this case is considered closed.
Patient fell out of the chair about 5-10 minutes after receiving the vaccine. He woke up and was a little disoriented but quickly came back to himself.
The vaccine greatly exacerbated my neuropathy, causing burning pain in my legs and feet,; The vaccine greatly exacerbated my neuropathy, causing burning pain in my legs and feet,; pain in my feet; pain in my legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 09:15 (Batch/Lot number: unknown) at the age of 65 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "surgery", start date: 2017 (unspecified if ongoing), notes: benign spinal cord tumor that was removed 4 years ago.; "benign spinal cord tumor" (unspecified if ongoing), notes: benign spinal cord tumor that was removed 4 years ago. Concomitant medication(s) included: DULOXETINE; VITAMIN D [COLECALCIFEROL]; CALCIUM. The following information was reported: CONDITION AGGRAVATED (non-serious), BURNING SENSATION (non-serious) all with onset 19Mar2021 00:15, outcome "not recovered" and all described as "The vaccine greatly exacerbated my neuropathy, causing burning pain in my legs and feet,"; PAIN IN EXTREMITY (non-serious) with onset 19Mar2021 00:15, outcome "not recovered", described as "pain in my feet"; PAIN IN EXTREMITY (non-serious) with onset 19Mar2021 00:15, outcome "not recovered", described as "pain in my legs". Therapeutic measures were not taken as a result of condition aggravated, burning sensation, pain in extremity, pain in extremity.  Additional details: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications in two weeks: Duloxetene, Multivitamin, Vitamin D, Calcium. if treatment ae: Prior to vaccination, the patient was not with COVID-19. the patient has been tested for COVID-19. known allergies: No. other medical history: None  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At 10am pt & mom were in pt. room discussing possible vaccines to receive today; they decided to have Gardasil and Menactra administered today; at 10:15am this nurse injected Gardasil IM into her (L) deltoid muscle; was applying bandaid & mom said "call the doctor!!" & pt closed her eyes and "slumped" forward. Mom saw a color change in face; pt. had jerking movements & was unresponsive for 1 to 2 min. M.D. came into room and Epipen Jr was injected into thigh and Menactra never was injected.
Psoriasis came back all over my body.  Psoriasis on hands for the first time!  Extreme burning on skin lesions.  Headache, weak, overall feeling sick.   I had Covid over thanksgiving 2020.  I still had antibodies when I got my Covid vaccine.
No additional AE reported; vaccines were previously short dated for 1 month after excursion and then were administered after the short date; This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's medical history, previous drug reactions or allergies, and concomitant medications were not provided      On 20-OCT-2021 (also reported as 1 month after excursion and after the short date), the patient was vaccinated with an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route of administration, and anatomical location were not reported; lot number T03232, had been verified to be a valid number; expiration date 22-SEP-2022). The  temperature  excursion was at 55.9 degrees Farhrenheit on 15-SEP-2021 for a time frame of 30 minutes. No additional adverse event reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2111USA002247:
Breakthrough case admission after 2 vaccines Pfizer 1/12/22 lot# FJ1614;  Pfizer 2/1/22 lot# FJ1614
Dose 1: I had progressively worsening arm pain. Nausea and dizziness within the first 3 hrs. Night 1 experienced chills, fever, night sweats and rigor in left arm. General fatigue and malaise lasted three days.
worst side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (worst side effects) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (worst side effects). At the time of the report, VACCINATION COMPLICATION (worst side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Follow-up  received on 12-Jun-2021, contains no new information.
12/26/99, developed rash at base of spine & down L/leg & foot. DR gave us no medicine & diagnosed it as shingles.She did run a fever of 101.6 for awhile & now has scars all down her leg. I'm not sure if this could break out again.