chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Runny nose; Sore throat; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (Runny nose) and OROPHARYNGEAL PAIN (Sore throat) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Jun-2022, the patient experienced RHINORRHOEA (Runny nose) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, RHINORRHOEA (Runny nose) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications was reported.  It was reported that the patient woke up in the morning with a runny nose and a sore throat. The patient wanted help with getting an examination at rite aid. Patient was told to call to get tested for COVID. It was unknown whether the patient took Moderna COVID19 Vaccines.  No treatment medications was reported.   Reporter did not allow further contact
I still have the arm pain (Left) the second day I had lower back pain and tingling on my legs at the same time. The tingling it is still ongoing. my back is better now and occasionally I have the tingling in my arms but not all the time. I feel the tingling mostly on right leg. as I'm speaking to you I'm feeling the tingling.
Itchy sore red patch about 2 1/2 inches round on arm at injection site.  Also experiencing itchy mouth which I get when I eat something I to which I am allergic.
Rotarix vaccine was inadvertently administered intramuscularly instead of orally on 9/26/19 by a per diem nurse working in this office.  The nurse filing this report received a call from mom today who wanted to inquire why the rotavirus vaccine was given IM because she researched and found that it is only given orally.  Reviewed chart and found that the nurse did document it as given in the Right thigh on the consent form.   Patient had some irritability and and one episode of vomiting but patient did receive other vaccinations that day as well.  Spoke to Glaxo Smith Kline regarding this and was advised that there are no studies on the safety of IM injection for Rotavirus but was advised to bring patient back in ASAP to administer an oral dose as the IM dose is invalid.  Patient was brought to the office on 9/30/19 and received an oral dose of Rotarix.  Injection sites were assessed at this time and no symptoms noted.  There was no swelling, redness, or bruising of any of the injection sites.
10/12/2022 I woke up with a headache and slightly stuffy nose. My throat felt weird, did not hurt and loose stools. Because I had been exposed to COVID, I took a home test and it was positive. I then took a PCR test at my healthcare facility and tested positive. I was prescribed PAXLOVID and had my first dose that evening. I did not get any worse. As the days went on, I started feeling better. I took my last dose today. I had no symptoms yesterday or today.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Is feeling nasty) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The patient's past medical history included No adverse effect (No reported medical history.). On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FEELING ABNORMAL (Is feeling nasty). At the time of the report, FEELING ABNORMAL (Is feeling nasty) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator. No treatment medications provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 08-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vaccine was stored in refrigerator that was at a temperature greater than recommended (due to loss of power during hurricane). Patient without any adverse side effects from vaccine.
pt recv vax 31JUL96 & 1AUG96 pt exp a h/a;As of 5AUG96 pt had exp a h/a every day since vax;pt presented to MD;3wk post vax pt wa still c/o frequent recurrent h/a;
Rash and pain at injection site, chills, fever, headache/neck pain, muscle pain, fatigue
Patient reported a sore arm that did not subside as of 11/18. Patient was advised by immunizing pharmacist to take Advil or Tylenol and call back if symptoms persisted. Patient stated she might visit a clinic if her arm was still sore. I tried following up 11/17 in afternoon but was unable to reach pt. Will try make contact again on 11/18.
This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 25-NOV-2014 was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported, lot # K003597, expiration date: 12-MAR-2015), that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
I am only reporting this because I have never had a reaction/side effects after receiving a flu vaccine.  I started feeling pain in my left arm & could hardly lift my arm.  I then became very weak and had to lay down.  After laying down for awhile I became nauseated & vomitted x 1.  I went to bed and then started running a fever of 100.6 and throughout the night I moaned and my muscles stiffened as if I was stretching.  This "stretching" happened about 10 times. I was afebrile 12 hours after this started.  I am still feeling extremely weak and unable to eat very much.  I don't have an appetite.
Patient came in to receive 2nd dose of the Pediatric Pfizer vaccine series. After vaccine was administered it was realized that the vial was not diluted.
injection site abscess, URI possible OM fever of 102.5 A  Tx Keflex 250 BID x 10 days, heat to area
Patient complained of feeling lightheaded and dizzy.  Patient was laid down for 30 minutes.   BP 101/59,  pulse 74, respirations 16.
Information has been received from a receptionist concerning a female patient who was vaccinated with a dose of GARDASIL (lot # not specified). On 12-OCT-2009 her jaw started to hurt. The patient sought unspecified medical attention. Additional information has been requested.
Covid arm- hard, red, swollen area warm to touch at injection site.  Itchy. Appeared 9 days after shot. Outcome tbd
After the second dose I experienced pain in my left chest area when I twisted my body or had to raise my arm up. At first I thought it was a sprained muscle but the pain was deeper than that. The pain last about 5 days and by the second and third day it is at its worst. It does go away but since recieving the second dose it keeps coming back every month or so.
10/27/21 hemorrhagic stroke. Significant residual effects of stroke. He was hospitalized for 3 months. Paralyzed on left side and has significant cognitive deficit. He had a large 7 cm brain bleed. He had only 10% survival rate. He had a 2nd stroke as well. He had CDIF and ring worm in the hospital. He had cellulitis. He had a peg tube. He had a fever of 108 in the hospital. He was intubated 2 times.
got vaccinated, experience shingles/suspected vaccination failure; shingles symptoms less than severe; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got vaccinated, experience shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles symptoms less than severe). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2023 The case was received from the patient's wife interactive digital media. The reporter stated that her husband and she both got vaccinated with Shingles vaccine. The patient did just recently experience shingles, but symptoms were much less than severe than what they had heard. A The reporter stated that apparently the vaccination was 90 percent effective. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition and medical history was not provided. Concomitant therapies included sterile diluent (manufacturer unknown). On 08-NOV-2017, the pharmacist inadvertently administered ZOSTAVAX to the patient intramuscularly rather than subcutaneously, lot # M042850, expiry date 18-JAN-2018, (dose and site administration were not reported). No adverse effects reported.
While on changing table mom noticed child staring blankly and then stiffened. She then had jerky of extremities and shallow breathing. Neighbors called EMS. Mom states episode lasted 4-5 minutes. EMS transferred patient to Hospital for evaluation  Temperature of 37.9 C on arrival to ED. Sleepy, but arousable. Pt. was observed. CXR results were normal. Obtained Bloodwork (CBC with Diff., CMP, Phosphorus level, magnesium level, urinalysis, & urine culture) ED consulted Neurology who recommended outpatient EEG and to return to ED with any repeated seizure activity. Discharged home. CBC normal except for: Neutrophils 68% - H Lymphocytes 19% - L Absolute Lymphocytes 1.50 k/ul - L CMP normal except: C02 1.9 - L osmolality 273 - L urine normal except: Ketones - 10 Mucous - rare Urine culture - Negative  Magnesium - 2.3 - Normal Phosphorus - 5.1 Normal  Per mom, seen at Urgent Care Clinic on 4/26/2020 for fever up to 103.4F and cough. Per notes, negative swabs for flu, strep throat, & RSV. Tested for COVID-19. Results pending.
Redness at injection site.  Swollen and hot.  Redness spread down and underneath the right arm.  Had rash and hives on body, mostly on the face.  Shortness of breath.  Doctor said I got Cellulitus.
Rash first starting to present mildly on 1/8/21 after receiving the first vaccination on 1/6/21. However after the vaccination on 2/3/21, the rash spread and became more severe. On 2/10 the nurse manager stated the following: The rash is located on bilateral arms, back, chest, upper bilateral thighs, and groin area. The areas present as little bumps that are raised and have been scratched open. Resident is saying they are extremely itchy and causing her much distress. Resident went to the ER on 2/10/21 and received a steroid, antihistamine, and diflucan and they also prescribed Doxycycline and Triamcinolone cream.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-JUL-2016, the patient was vaccinated with a dose of improperly stored PROQUAD (lot # M010478, expiration date: 01-SEP-2017; dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reports a cough that started the day after vaccination, which still lingers (9 days later). He's also experienced a "sporadic headache", which he believes is from coughing so much.  "Stuffiness" started 2-4 days ago. He was advised to follow up with his doctor.
Information has been received from an 84 year old female who on approximately 21-MAY-2007 (reported as "2 1/2 weeks ago") was vaccinated with a dose of Zostavax (Oka/Merck). The patient reported that she developed a "few scattered little bumps" under her breast and on arms after receiving the vaccination. The patient could not recall specific dates and did not seek medical attention. At the time of the report, the patient had not recovered. There was no product quality complaint. No further information is available.
dizziness; unable to eat; had swelling all over her left arm and shoulder that she was not able to lay down; felt bad; had swelling all over her left arm and shoulder that she was not able to lay down; fever; chills; throwing up; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness), FEEDING DISORDER (unable to eat), PERIPHERAL SWELLING (had swelling all over her left arm and shoulder that she was not able to lay down), FEELING ABNORMAL (felt bad) and JOINT SWELLING (had swelling all over her left arm and shoulder that she was not able to lay down) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history was provided.     On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced DIZZINESS (dizziness), FEEDING DISORDER (unable to eat), PERIPHERAL SWELLING (had swelling all over her left arm and shoulder that she was not able to lay down), FEELING ABNORMAL (felt bad), JOINT SWELLING (had swelling all over her left arm and shoulder that she was not able to lay down), PYREXIA (fever), CHILLS (chills) and VOMITING (throwing up). At the time of the report, DIZZINESS (dizziness), FEEDING DISORDER (unable to eat), PERIPHERAL SWELLING (had swelling all over her left arm and shoulder that she was not able to lay down), JOINT SWELLING (had swelling all over her left arm and shoulder that she was not able to lay down), PYREXIA (fever), CHILLS (chills) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was unknown.  Treatment information was unknown.
Information has been received from the mother of a patient via an online article dated 14-MAR-2019 regarding a case for GARDASIL (# 1903USA007559) concerning a male patient (age unknown). On an unspecified date the patient was administered GARDASIL (lot #, indication for use, and route of administration were not provided). The mother of the patient reported "He received the HPV vaccine and had a bad reaction to it". The onset date and outcome of the event were not provided. Additional information is not expected. Sender's Comments: US-009507513-1903USA007559.
Patient experienced soreness in left arm; soreness in injection site went away, but general shoulder pain persisted and got worse; pain is spreading to neck; patient has difficulty turning neck; swallowing is sometime uncomfortable; patient has seen PCP who has recommended physical therapy; patient is trying Bengay, hot showers and heating pads.
Patient had soreness of arm and felt like she cannot lift arm, even 3 weeks after injection
Fever, low oxygen saturation, severe encephalopathy, kidney failure, bilateral pulmonary infiltrates, sepsis, tachycardic, acidotic, intubated on ventilator since admission, paralyzed/sedated, ABG results showed high CO2 and O2 retention, edema, electrolyte imbalance, ARDS, low hemoglobin and hematocrit levels, blood transfusion needed
Pt emailed writer, RN that administered the TdaP vaccine, at 0713 on 10/12/2017 regarding suspected s/sx adverse reaction to the TdaP vaccine. Pt stated, "I am quite sick since getting that shot yesterday. Started about 10pm severe headache, stiff neck, nausea with emesis, slight dyspnea and a bounding heartbeat at times. Any suggestions?  I am not working today because if this please contact me on my personal phone." Writer sent CDC information regarding the TdaP vaccine (gave VIS as well on 10/11/2017) and assured pt that writer would follow-up with manager at 1022. Manager responded to writer's email at 1044 that pt should call her healthcare provider and ask if she needs to be seen or if there is necessary treatment and/or follow-up and the manager also directed writer to fill out a VAERS form. Writer call pt at 1101 and advised her to call her provider and to call 911 if necessary. Writer requested that pt call back with any information or updates. Pt verbally told writer that she felt dizzy and nauseous when she stood up. No report of emesis. Right-sided headache.
10 Minutes after receiving Vaccines (Tdap and Menactra) Patient suddenly passed out in hallway (syncope), was arched and right arm flex to chest for 5-10 seconds, no loss of
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 29-JAN-2010, the patient was inoculated with ZOSTAVAX by a physician for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus that ZOSTAVAX is intended to prevent. In 2015, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Awaken at 03:00 AM with severe headache and aching muscle pain to complete right side of body. Aching pain lasted about 8 hours. Headache lasted 10.5 hours.
22FEB96 mom noticed that pt arm&legs were shaking,like tremors;pt was pale,listless&seemed dazed;no crying;pt felt warm,but not hot to touch;did not take temp;episode lasted 5-10mins;mom called MD who advised to take to ER to be eval
Narrative: Patient experienced muscle pain in the shoulder after receiving the first dose of the COVID-19 series.
I had swelling at the injection site and minor pain. I had a low-grade fever, and sweating. This lasted for 2 days. I went to my doctor and spoke with him about it, but he did not prescribe any medications for this. I am not dealing with this at this time.
Started to feel bad overall - headache mostly, the got feverish.  I took my temperature and it was 101.46 degrees.  I was fatigued and I didn't want to eat and I was really thirsty.  I took my temperature again before going to bed and it was 101.76 degrees.  I continued to be feverish with chills until morning, then my fever broke, but was still registering 99.8 degrees.  I felt nauseous and I didn't want to eat or drink anything.  I napped most of the day because my head hurt so much.  I felt like I had been beat up with lots of body aches.  I slept very well that night and felt fine the next day.  On the mild side, my arm was sore as well.
This is a spontaneous report from a Contactable Physician. A 75-year-old male patient received the third dose of BNT162B2 (BNT162B2, Lot No. FF2587) intramuscular at single dose on 24Sep2021 for COVID-19 immunization (75-year-old at the time of vaccination). Relevant history included HTN, HLD, OA, HX cervical spine fusion. No known drug allergy. Relevant concomitant drug included amlodipine, hydralazine, atorvastatin calcium (LIPITOR) and lisinopril. The patient previously received first dose of BNT162B2 (Lot No. EN6201) intramuscular at single dose on 05Feb2021 for COVID-19 immunisation, the second dose of BNT162B2 (Lot No. EN6201) intramuscular at single dose on 26Feb2021 for COVID-19 immunisation. The patient had also received Flu Vaccine on 23Sep2021. The patient experienced transverse myelitis vs ADEM per MRI with contrast on cervical/thoracic spine; paraplegia in bil LE; bil UE weakness and progressive loss of sensation up to T4; loss of bladder continence since 26Sep2021. The events reported as serious due to hospitalization (15 days). The outcome of events was not resolved.  Treatment therapy included IV solumedrol; plasmapheresis, IVIG. The patient did not have COVID prior vaccination. The patient had NAAT on 05Oct2021 with negative result (Nasal Swab). MRI on 05Oct2021 showed transverse myelitis vs ADEM per MRI with contrast on cervical/thoracic spine.; Sender's Comments: Based on the information available, a possible contributory role of suspect product BNT162B2 to the reported all the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate
Individual reported that her arm started burning at 3 am on 12/29/20, which woke her up. She reported that there was no pain prior to that. She also felt nauseated, dizzy, and light headed. Also noted that there were about 8 inches of redness in diametere around the injection site, which was warm and painful. The individual called employee health on 12/31 to report the symptoms. She was instructed to put ice on her arm and take benadryl. Since then, the redness, pain, and swelling is reportedly improving.
Patient started with tingling in hands/lip approximately 10 minutes after administration.  Tingling in hands/lips worsened and pt started to c/o tongue swelling.  Epi and IM benadryl were administered and a rapid response was initiated.