chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Chills; Headache; her arms felt horrible, she couldn't move it; her arms felt horrible, she couldn't move it; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Right on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient mentioned she was in a critical situation with the vaccine. She stated on an unspecified date she had fever, chills, headache and her arms felt horrible, she could not move it. She stated she had the vaccine in her right arm but could not move it. She clarified the first dose was in her left arm and the second dose was in her right arm to try and balance it. It was horrible. The outcome of all events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
localized injection site induration, erythema multiforme, and bilateral cheek region induration
PC: Mother called rescue squad, fever 102, lethargic, HR204, went to ER, sent home. No fever the following AM. Explained fever was probably from DTaP not MMR.
A minor consumer, age 17 received the first Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A minor consumer, age 17 received the first Moderna vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A minor consumer, age 17 received the first Moderna vaccine). On 24-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A minor consumer, age 17 received the first Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No adverse event was reported.  No concomitant medications were reported.  No treatment information was specified.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Follow up information was received : added information about vaccine facility, anatomical location of vaccine administered, and information about second dose.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 008B21-2A) with no associated AEs.
I had a sore arm and tired for a day after receiving the vaccine. I tested positive for COVID-19 in 03/2022. I was extremely exhausted, a lost my taste for salt, headache and diarrhea. I contacted my doctor; I was not a candidate for PAXLOVID because of how much time had passed. I self-isolated, drank water and rested. As of today, I continue to have a little brain fog that will happen a couple of times a week.
patient tested + for covid on 12-31-22  had a very complicated course.   admitted 12-31-22 to 3-1-23 at one facility and then transferred to another facility until 3-14-23.
Arms/legs rash 9/28 - Treated 10/14. Hands rash 10/19 - Treatment of Diprolene cream 10/22 by Dermatologist. 10/23 MEDROL Dose Pak.
Severe swelling and pain of the upper arm and shoulder area of injection. Lymph nodes of the arm pit on same arm swollen and painful as well. Low grade fever and persistent headache.
dizziness, headache, fevering for five days, sudden hits of fatigue, nausea, stomach upset, vertigo, blood pressure rise, buzzing under skin
Cellulitis of anterior thigh with swelling erythema, tenderness and warmth. Treated with Keflex.
Pt received Hepatitis A #1 and HPV #1 vaccines at approximately 11:10am on 6/27/13. Within 5 minutes pt reported lightheadedness. I was called to the room, placed pt supine. Pt noted to be diaphoretic, pale. He reported lightheadedness, nausea, a "hum" in his ears. Pt's condition improved upon being supine. BP at onset 101/53 pulse 55. BP prior to release 115/56 pulse 48. Pt reported complete recovery. Was released after I had observed him x20 minutes.
Redness at shot spot, with minor itchiness lasting 11 days so far Increase in chest pain and palpitations also lasting 11 days so far
I had two seizures in December. I went to the emergency room after the first seizure. I had another seizure as soon as I got back home. I went back to the hospital and was admitted. They observed me. The neurologist concluded I had a concussion.
Pt received vaccines on 2/17/00, on 2/18/99 pt developed a fever, and on 2/19/00 it increased to 104. Pt had a febrile seizure in waiting room.
10 minutes following vaccination, patient complained of dizziness and feeling warm.  Vitals showed elevated blood pressure 193/78, normal pulse, oxygenation, and temperature.  She noted mild improvement in symptoms after 30 minutes, but patient was still unsteady to ambulate independently.  BP remained elevated 189/73, 191/86.  She denied headaches, SOB, chest tightness, difficulty breathing, GI symptoms, rash.  Patient noted history of intermittent elevated BP with systolic measurement in 250s, but no diagnosis of hypertension or hypertensive medications. She reported feeling well this morning and having normal breakfast prior to appt.  Ambulance transport was called due to hypertension and persistent dizziness. Patient refused transport upon arrival and was taken by personal driver.
HCP reports patient was accidently administered an expired dose of STERILE DILUENT on Jan 9, 2023. STERILE DILUENT expired on Dec 3, 2022. The expired STERILE DILUENT was used to reconstitute MMR II. However, the MMR II was within date, and not expir; This spontaneous report as received from a Medical Assistant concerning to a male patient of unknown age.      The health care professional (HCP) reported patient was accidently administered an expired dose of STERILE DILUENT on 09-JAN-2023. STERILE DILUENT expired on 03-DEC-2022, lot# T014300 (expired product administered). The expired STERILE DILUENT was used to reconstitute MMR II (lot# W002787, expiration date: 25-JAN-2024). However, the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) was within date, and not expired. Products had no prior temperature excursions.  Products had no prior temperature excursions. No further information provided.  No additional AE reported. No PQC reported.
Itchy erythematous rash on neck, right anterior thigh worsening over 2 weeks
Bells Palsy, 2 days after immunizations.  No other obvious etiology.
Pt is a 24 year old male with hx of IBS and anxiety with reported swelling and pain to the left shin that just popped up prior to presenting to ER.  Complained of pain on Lt shin that started while he was standing at the sink. Started stinging, looked down at shin, he stated it started swelling and stinging. Does not remember any injury, but is unsure. DX - Hematoma to the left lower extremity. BP 155/72 Temp-98.0 HR 77 R- 18
Almost immediately after I got a massive firey headache, numbness and tingling down the left arm and down the left side of my face. I developed a massive stomach ache which all lasted about 3 hrs.  I reached out to my pcp who advised benedryl, pepcid and claritin to help and the benedryl and pepcid took away the numbness and tingling but the headache lingered along with terrible dizziness also.  The next day and still since I still have  terrible headaches an dizziness, the dizziness has gotten better but is still there.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 07-NOV-2012 21:59, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as; 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. IT was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. this is one of several reports received from the same source. Additional information has been requested.
PT HAD RASH RADIATING DOWN LEFT DELTOID TO FOREARM. SITE WAS SENSITIVE AND WARM TO TOUCH. NO EXUDUS. NO PREVIOUS HISTORY OF CHIEF COMPLAINT.
Fever, Vertigo, Nauseousness, Body Aches, Chest Pain. Stiff Neck and Head Ache lasting until now (4 days).
Information has been received from a physician, via company rep, concerning a 77 yr old male, with hypertension, who on an unspecified date was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine (lot unk). On an unspecified date the pt developed swelling and redness from the upper arm to the forearm after receiving the vaccination. The pt was treated with levofloxacin (Levaquin) and recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
On 09/16/2022 I had vaccination. On 10/17/2022 I started to feel aches and stuffiness. I took at home COVID-19 test and it was negative. On 10/18/2022 I took 2 COVID-19 tests and they were both positive. I contacted my doctor office on 10/18/2022 and they prescribed PAXLOVID.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patient of unknown age and gender. On an unknown date the patients were vaccinated with the doses of improperly stored oral, ROTATEQ (doses, routes, lot numbers and expiration dates were not reported). No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
06/09/2019: Follow up received, SHINGRIX NDC # 58160-0819-12. 04/11/2016: All in process quality checks for the lot number in question were satisfactory. The results indicated that the lot number, for this product and other reported products, as applicable, were manufactured in accordance with manufacturing site standard operating procedures. The lot met the requirements for market release. Additional information is not expected. I received vaccine at 3:00 pm on 4/10. At approximately 9:00 on the evening of the 4/10, I first developed sharp pain at injection site. As night progressed, I developed severe muscle aches, bone aches, joint aches over entire body, moderate fever with chills, severe headache, dizziness, chirping sound in ears which lasted 12 hours. These symptoms continued until today around 10 am. I am now about 70% improved.
Patient called pharmacy on Tuesday, 6/1/21 to report an adverse reaction that she believed to be a result of receiving her COVID vaccine. Patient received Janssen/J&J vaccine (207A21A 06/23/2021; L arm) at our store on Saturday, 5/29/21. She reported that Sunday 5/30, the day after receiving the shot, she felt like she ran a marathon, her legs were extremely sore, and she was very weak. Then, on Monday 5/31, two days after receiving the shot, her legs were fine but her arms were very sore. Then, on Tuesday 6/1, three days after receiving the shot, both her legs and arms were very sore and weak. The weakness was severe enough that it was causing her to fall at home (including off the toilet once and in the floor once). I explained that muscle soreness and weakness can be a common side effect of the vaccine, however this seemed more severe than what I would expect. One of her reasons for calling was to ask what she should do about her scheduled CT appointments (Wed 6/2), as she was worried she wouldn't be able to drive. The CTs were ordered by her PCP, so I recommended reaching out to them let them know her symptoms in case they wanted to bring her in to examine her to rule out anything severe that may be going on. If she cannot get in touch with the doctor and this issue persists severe, I recommended seeking urgent care medical help or emergency medical help. I also recommended not driving herself.
Severe muscle aches that moved around all over body (arms, back, chest); nausea without vomiting; headache. Onset: 5 hours after vaccine and still having symptoms but not as severe; occasional aches and still fatigued.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-FEB-2018, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N025929 and expiration date on 18-MAR-2019, for prophylaxis (dose, route of administration and anatomical location were not reported). The sterile diluent (MERCK) lot # M017324 and expiration date on 25-SEP-2018, used to reconstitute the vaccine was properly stored. The administered dose of the vaccine experienced a temperature excursion of -14°C to-10°C for 22 minutes as recorded by a data logger, with a previous temperature excursion report in the range between -14°C to -10°C for 22 minutes. There was no adverse effect reported. No product quality complaint was involved. Lot number N025929 has been verified to be a valid lot number for PROQUAD. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA012119.
Pt recv vax on 4/1/98; on 4/24/98 pt had a positive pregnancy test. On 5/21/98 pt exp an incomplete miscarriage/ the intrauterine sac was too small.  On 5/27/98 an evacuation of the retained products was performed.
L leg swollen slight red  6 x 7'. Warm but no fever. FROM in hip and knee joint.
Report #2000027818-1 describes knee pain in a pt who rec'd Engerix-B. This report was rec'd from a medical student and has not been verified by a physician or other HCP. Allergies and medical history, concomitant vaccines includes: measles-mumps-rubella ad diphtheria-tetanus. On 8/11/00, the pt rec'd his first dose of Engerix-B. On the evening on 8/11/00, he experienced severe knee pain which lasted that night only. As of 9/19/00, the outcome of the event is resolved.
Reported having difficulty relaxing on 1/31/2021. Stated later began to feel heart beating rapidly, nausea, and felt pressure to chest.
This spontaneous report was received from a health care worker (medical assistant) refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R II, lot # L049455 with expiry date: 03-DEC-2017, (dosing details not reported). No adverse effect was reported. The vaccine was exposed to a temperature of excursion of 12.4 degree Celsius for 2 hours and 30 minutes, and it had no previous temperature excursion. The call was because of data logger. No further details provided. This is one of the three reports received from the same reporter. Additional information has been requested.
Headache - 24 hours after getting his HPV #1, 5:30 pm, 11/6/14. Had his HPV 5:45 pm, 11/5/14. Patient had no fever, no vomiting, no nausea. Headache relieved by taking MOTRIN 600 mg PO (didn't take it regularly, only took if headache is intolerable). Headache lasted for 5 days. Headache located back of head and neck.
No additional AE; HBP responsible for vaccine storage calling to report temperature excursion for VARIVAX. Product administered after TE.; This spontaneous report was received from a registered nurse (also reported as HBP) and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-MAR-2023, the patient was vaccinated with improper stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1x dose, lot #W031811, expiration date: 05-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) after temperature excursion of -14.5 degree Celsius for 19 minutes and 17.2 degree Celsius for 19 minutes (product storage error). There was no previous temperature excursion.
One day after injection patient had a rash with pain and itching of left arm that worsened over the course of a week; seen in clinic with erythema, induration, and inflammation of left arm noted around injection site; instructed to take BENADRYL PO and apply ice and continue to monitor for signs of infection or worsening inflammation.
Flu like symptoms, fever, dizziness, muscle pain, headache, vomiting, chest pain, weakness x 3 weeks. Congestion. ER visit for cardiac issues, Echo, stress test etc was normal however chest pain continues. Hypertension.
leaky syringe from needle connection; leaky syringe from needle connection during administration; only a partial dose was received; squirted all over the patient; squirted all over the patient; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 5-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th December 2021, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 7th December 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the patient experienced pharmaceutical product complaint and syringe connection issue. On an unknown date, the outcome of the accidental underdose, exposure via skin contact, inadvertent exposure to vaccine, pharmaceutical product complaint and syringe connection issue were 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 reported as follows: Registered nurse stated this occurred at the time of administration and only a partial dose was received after the device started leaking, which led to accidental underdose. The patient received a dose of Kinrix, where the vaccine leaked and squirted all over the patient, which led to exposure via skin contact and inadvertent exposure to vaccine. Agent requested return of both the prefilled syringe and needle related to the product complaint and the original packaging without further manipulation/handling. Agent requested that a picture of defect be sent. The reporter assumed the leak to be at the tip. The syringe was assembled with needle at time of administration. The size of gauge needle was 23g. Also, safety glide came detached when the needle cap was removed. The reporter consented to follow up.
This is a serious literature case, initially received on 23-Jul-2018, reported by other health professional and concerns a 59-year-old, adult female patient. On an unspecified date, the patient was administered Influenza vaccine, (anatomical location: left arm, dose, route of administration, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date after vaccination (reported as one month after vaccination), the patient experienced severe shoulder pain with restricted range of motion. The patient denied any trauma to the left shoulder, fever or chills. The patient took unspecified over the counter pain relief medications, but that did not help. The patient's serum chemistry and complete blood count were within normal limit. Physical examination was significant for 5/10 pain at the rest and 8/10 pain upon abduction of the left shoulder. There was also continued tenderness directly over the posterolateral border of the acromion and over the infraspinatus insertion. X-ray of the patient's left shoulder showed degenerative subcortical cystic change in the distal clavicle. Magnetic resonance imaging (MRI) of the left shoulder joint showed abnormal marrow signal within the humeral head and neck laterally, especially at the location of the teres minor insertion and edema at my myotendinous junction. Based on those MRI findings, timing of the symptoms after flu vaccine administration, the patient was diagnosed with shoulder injury related to vaccine administration (SIRVA). Six months later, during the follow-up, the patient complained of the left shoulder pain and severe restriction of the left shoulder movement. It was reported that, the needle used to administer the vaccine was longer and the vaccine was administered into the bursa. At the time of this report, the patient had not recovered from the event SIRVA. The report assessed the event as related to suspect vaccine.
Sore muscle off and on since administration. Had a problem with plunger of syringe.
Two days after flu vaccine developed "welts" on face. Saw the Dr, Dr treated with BENADRYL. Had reaction like this before with sulfa. Prior allergy to eggs. Had flu vacc last year with no adverse reaction.
Pt received Trumenba and Menactra vaccine on 11/9/20. Seen via telemedicine on 11/11/20. She had erythema around injection site (L) deltoid area. Given Keflex and triple abx ointment. Will follow up in 2 days
Pt arm was red and swollen, she was also unable to move arm, it was improving 72 hours after injection.
Fainted; Body aches; Vomiting; Fever; never received her second dose; This serious case was reported by a consumer via patient support programs and described the occurrence of fainting in a 64-year-old female patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Co-suspect products included Herpes zoster (Hz/su + AS01B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Hz/su + AS01B and the 2nd dose of Hz/su + AS01B. On an unknown date, an unknown time after receiving Hz/su + AS01B and not applicable after receiving Hz/su + AS01B, [the patient experienced fainting (Verbatim: Fainted) (serious criteria GSK medically significant), general body pain (Verbatim: Body aches), vomiting (Verbatim: Vomiting), fever (Verbatim: Fever) and incomplete course of vaccination (Verbatim: never received her second dose).         The outcome of the fainting, general body pain, vomiting, fever and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the fainting, general body pain, vomiting and fever to be related to Hz/su + AS01B.   The company considered the fainting, general body pain, vomiting and fever to be unrelated to Hz/su + AS01B.   Additional Information: GSK Receipt Date: 13-MAR-2023 The reporter self-reported this case patient. This report was received when speaking with the customer during an outbound call for the support program.  The patient received her first dose of the Shingrix vaccine in either January 2020 or 2021.  The patient stated after her first dose she experienced vomiting, body aches, fever, and fainted. Reporter provided permission to contact healthcare professional. The reporter was consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.