chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to an unspecified patient. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On 06-MAR-2018, the patient received an improperly stored dose of VAQTA (lot # N031940; expiry date: 23-NOV-2018) for prophylaxis (product storage error). Dosing details were not reported. The temperature excursion ranged at -0.4 C for 10 minutes and between 0 degree Celsius (°C) to 1°C (1.4C) for 30 minutes. There were no previous temperature excursions. The call was because of a data logger. No adverse effects were reported. Product quality complaint (PQC) was not involved.
Starting about 6 hours after the shot: lower back pain, headache, shaking  7 hours:  additional pain in legs and upper back  8 hours: shortness of breath, dizziness became extreme 9 hours: extreme shortness of breath, vision going dark, continued dizziness and pain, feverish  10 hours: violently shaking, extreme back pain, continued worsening shortness of breath and dizziness  11 hours: extreme headache, anxiety worsened 12 hours: extreme dizziness causing inability to walk, extreme headache, extreme back pain 13 hours-on: pain calming a bit, headache continues, slight dizziness, continues feeling feverish
pt started soreness on the same day pt received the shot on 7/1, but it was a little more intense the second day 7/2.  She looked at the site of injection and noticed the swelling and redness as well.  Pt came to the pharmacy to report the event on 7/3 with a little less severity compared to the day before.  Pt was instructed to take some NSAIDs & Tylenol, and report to MD if symptoms get worse or infection starts on the site.
Case number PHEH2016US029205, is an initial spontaneous report received from a nurse on 25 Oct 2016. This report refers to a 68 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of influenza vaccine (manufacturer unknown, batch number not reported) at an unknown dose intramuscularly on 17 Oct 2016. On the same day after vaccination, the patient experienced the pain in her arm that lasted for an unspecified amount of time. Nurse also reported that, the patient vomited after she got out of the shower on the same day after administration. The outcome of the events was reported as complete recovery on 17 Oct 2016. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Injection site became red, hot, swollen, painful, and itched a little.  It is smaller today by pt report.  Today it measured 13x11 mm of induration and redness.
Family called informing RN that patient was rushed to the hospital on 2/6/21 at around 1:30am because the patient is having chills, fever and mild chest pain that time. At this time, patient is still currently admitted at the hospital.
rash, itching, burning, red skin on both upper arms, across stomach, and on lower half of front of legs, several smaller spots on thigh area and left side of truck
The first nerve pains started on the 14th of February 2022, becoming more intense each day, feeling like electrical shots going from the bottom of my feet to the back of my knees, until I ended up at the ER on February the 19th 2022. Some blood tests/ scans, etc. were done, but no conclusion as to the reason for my discomfort. I was sent home. The next week I made an appointment with a Neurologist to see if some help might be available for what seems to be Peripheral Neuropathy. Subsequently I was given a prescription for GABAPENTIN 300MG (2 capsules a day) to help with the pain.  Over the past 10 months I have had to deal with these debilitating symptoms on my own because  doctors no doctor will discuss any adverse effects from the covid19 vaccines or boosters for fear of loosing their license to practice medicine which leaves those of us with major problems to fend for ourselves. I was a healthy 82 year old until this happened, I wish I never had this vaccination, it has made my life a misery for the past 10 months and no respite in site.  Obviously, for those of us who do some research, we do know that some of those batches contain SPIKE PROTEINS, and other items (metals, etc.) which should never have been in the vaccines, but no one is telling us what to do to get rid of these once and for all, there is probably no way to do so. Another reason why I am disgusted is that if I mention my problems to people who had the vaccines but no reaction, they feel that I must be mentally unstable.  Please HELP
10min p/vax pt exp nausea, dizziness, & diaphoresis;BP was noted to be 80/60 (usual BP 90/70) & pulse was 52 beats/min;sx abated @ which time BP was 118/70 & apical pulse was 82 beats /min;
Admitted to hospital on 10/19/21 for chest pain and shortness of breath. COVID 19 incidental finding - received no treatment for COVID during his stay.
Approximately 1.5 hrs post vaccine pt awoke crying and shaking. Mother noticed while child was sleeping that her lips were blue and she was trembling.
Patient fully vaccinated for COVID-19 (1st dose Moderna given 3/5/2021 lot#029A21A, 2nd dose Moderna given 4/2/2021 lot#020B21A) died on 2/9/2022 due to COVID-19 pneumonia
chest pain that began 24 hours after vaccination, continued and worsened over 24 hours hours, sought treatment at ED  approximately 48 hours after vaccination.  At ED given IV fluids and toradol with notable improvement in pain,
Child was vaccinated with the first dose of Moderna 6-11 at parent's request.  Child's parents did not disclose that the child had had a full series of Sinopharm Covid vaccine until after the child was vaccinated.  Parents were notified that Sinopharm is an approved vaccine and that the child would have been considered fully vaccinated prior to receiving the Moderna dose.  Parents were also notified that Moderna is not approved for a booster dose.  Child was observed post vaccine and had no adverse reaction.
Chills and fatigue.  By 11/4/11 had 5 x6 cm area of cellulitis at the injection site on the R upper arm.
Rabies vaccine was given on 3-6-09 @ 9:35 am.  On 3-16-09 @ 2 pm patient developed a mild headache.  Between 5:30 and 6 pm she developed general malaise, some little generalized aches.  Between 6 and 9 pm she developed joint aches, muscular aches, T 100 - 101 F, extreme nausea without vomiting and throughout the evening all the symptoms became worse.  After 9 pm she developed diarrhea, for which she took 2 OTC anti-diarrhea pills (? name) as directed for initial dose, without any relief.  She also experienced abdominal discomfort prior to and during diarrhea.  They offered no relief and she never took any more of this medication.  During the same night, her symptoms worsened throughout the evening, and could only sleep for 15 mins. at a time.  She experienced night sweats.  She took IBF 400 mg. PO @ 1 - 2 am on 3-19-09, also without relief, so did not take any further doses.  She then took Tylenol 1000  mg.  Q 4-6 hrs., but not more than 4 doses in 24 hrs. with some relief throughout the days that she had these symptoms.  On 3-18 PM or 3-19 PM, she began to take chewable pepto ismal for nausea, because it was so severe.  She also drank juice and water throughout the days of these symptoms.  The fever left either 3-20-09 in the evening or 3-21-09 @ 2 - 3 am, and then she was able to sleep.  All of these symptoms continued, but she was feeling progressively better.  She did not feel well enough to return to work until 3-23-09, but reports that she is not feeling well.  She reports feeling lethargic and joint aches continuing.  She complains especially of cervical neck pain with limited ROM, and has made an appointment with her neurosurgeon, since she had surgery last year.  She also complains of her shoulders and hands bothering her, where she has arthritis.  She has not taken her Voltran in 1 week, because she was taking other medication.  She will be talking with her PMD later today.
the other son felt hot and cold; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 41 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: FEELING OF BODY TEMPERATURE CHANGE (non-serious), outcome "unknown", described as "the other son felt hot and cold"; PAIN (non-serious), outcome "unknown", described as "body aches".   Additional information: Caller commented that she would like to get the Pfizer covid 19 vaccine as it was the least reactionary she thought, but she wishes the Pfizer vaccine was only one vaccine. Caller lives in a rural area, did not have access to a computer and to a reliable car. Her local pharmacist did not have the staffing to administer the shots to people.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no adverse reaction noted; student has hx of asthma and received the intranasal but form was marked NO;  student had also received the flu shot at the clinic on 10/13/2021 but parent was present at time of flumist and signed the concent form.
Nausea, vomiting, injection site edema, pharyngitis, laryngeal spasms, laryngitis, urticaria, pruritis.
Patient developed erythema that started on 2/20/21 just below the vaccine site about 2 weeks after vaccination. There is no respiratory difficulty and it got wider today and a little itchy and red. There are no rashes and no signs of anaphylaxis, no GI symptoms. She also had EMG done on both upper extremities prior to this starting. I advised her to use cold compress and local  / topical 1% hydrocortisone on it. To contact us if symptoms worsen and to the ER if any worsening symptoms or respiratory compromise.
Per patient's mother after the vaccination, he had severe GI pain. She spoke with a friend that was an EMT. He advised the patient be seen by a doctor. The mother took the patient to the emergency room, she was worried he had myocarditis. Per mother, the emergency room did tests to rule-out myocarditis. They believed the patient had an anxiety attack with GI upset. Per mother, she was told her child could get the second dose because there was no cardiac issues.
This spontaneous report as received from a Doctor of pharmacy refers to a 67 years old male patient. The patient was vaccinated with a dose of ZOSTAVAX (dose, route, Lot # and expiration date not reported) on 14-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 17-NOV-2012, "with 3 days of vaccination", the patient started to develop symptoms of pneumonitis. The patient was admitted to hospital on 20-NOV-2012. He was given high doses of prednisone, about 80 mg and oxygen. His blood oxygen level was 58. The patient refused intubation and was admitted to the Palliative Care Unit. The outcome of symptoms of pneumonitis was reported as recovering/resolving. The relatedness for symptoms of pneumonitis was unknown for ZOSTAVAX. Symptoms of pneumonitis was considered medically significant by pharmacist because required intervention to prevent serious criteria. Additional information has been requested.
It is itchy and red; spiked a fever of 102.1; muscle pain; body aches; She first experienced nausea in the afternoon of getting the shot; she is experiencing a swollen lymph node on her neck after she got the 1st shot of the Covid-19 vaccine; It is itchy and red; This is a spontaneous report received from Pfizer sponsored program COVAX US Support from a contactable consumer (patient).  A 52-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 at 09:45 (at the age of 52years old) (Batch/Lot Number: EP6955) as dose 1, single for covid-19 immunisation. Medical history included Covid-19 in Apr2020 fully recovered. No allergies. Concomitant medication(s) included zinc, biotin, Woman Centrum and calcium carbonates (CALTRATE [CALCIUM CARBONATE]), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, at 14:00 hrs, she first experienced nausea in the afternoon of getting the shot, at 20:00, she had muscle pain and body aches. On 24Mar2021, at 01:00 hrs in the night, she spiked a fever of 102.1. On an unspecified date in 2021, she experienced a swollen lymph node on her neck, she added that it was not painful but it was itchy and red. She wanted to know what she should do about the symptoms that she was currently experiencing. The patient underwent lab tests and procedures which included body temperature 102.1 on 24Mar2021. No treatment was received for the adverse events (nausea, fever, muscle pain and body aches). The outcome of nausea, muscle pain and body aches, fever was recovering and outcome was unknown for swollen lymph node on her neck, it was itchy and red.  Follow-up attempts are completed. No further information is expected.
318 patients received dose from vials beyond 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30 day use by date) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30 day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Booster dose of Td administered on 8JUN & went to ER on 9JUN @ 915PM w/fever 38, pain localized, generalized agitation, crying; under doctors order recvd Thiosal 1.5 cc & Diferhidramine 20cc PO;
Pt c/o pain in both arms since received vaccines. Today mom noted large area of erythema and warmth. Complained of itching. Right upper arm with 13 x 8 cm of bright erythema, 5cm of edema. Warmth and tenderness. No fluctuance.  Advised Motrin and Benadryl.
I received a call from mom at 130 telling me she had just taken him to urgent care.  Patient's eye's were swollen shut he was complaining of his mouth feeling funny.  Mom took him to urgent care he was started on steroids and Benadryl.  Mom was given a 5 day coarse of steroids to give at home as well.
her husbands blood pressure was fluctuating for 3 days; violent headache; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 76 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Mar2021 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Multiple myeloma/myeloma cancer (as reported)" (unspecified if ongoing), notes: he has a history of Myeloma cancer, Verbatim: Multiple myeloma; "Blood pressure high" (unspecified if ongoing), notes: usually well managed; "Thyroid issues" (unspecified if ongoing); "sinus infection", start date: Jan2021 (unspecified if ongoing), notes: Back in Jan 2021, he had a sinus infection.; "surgeries" (unspecified if ongoing), notes: had surgeries years and years ago. The patient took concomitant medications. Vaccination history included: Flu shot (whenever he gets a flu shot, he will get chills and feels sluggish right after.), for Flu prevention, reaction(s): "chills", "feels sluggish". The following information was reported: BLOOD PRESSURE FLUCTUATION (non-serious) with onset 13Mar2021, outcome "recovered", described as "her husbands blood pressure was fluctuating for 3 days"; HEADACHE (non-serious) with onset 13Mar2021, outcome "recovered", described as "violent headache"; FATIGUE (non-serious) with onset 13Mar2021, outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient had no prior vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021321065 Same reporter/drug/event and different patient
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown ages and gender. On an unknown date the patients were vaccinated with 0.5 milliliter (ml) ROTATEQ,(lot# and expiration date not reported) orally. Concomitant medications were not reported. On an unknown date the patients had diagnostic stool sample testing for rotavirus. Some of these patients has been diagnosed with ROTATEQ. The patients sought an unspecified medical attention. The outcome of rotavirus infection is unknown. Causality was not reported. Additional information has been requested.
a female patient was administered a booster dose of Tenivac vaccine in wrong muscle at supraspinatus part of the rotator cuff or in the joint or in the bursa; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an unknown age female patient who was administered a booster dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] vaccine in wrong muscle at supraspinatus part of the rotator cuff or in the joint or in the bursa lot number not reported via unknown route on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to vaccine administered at inappropriate site.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
The Moderna vaccine BOOSTER was administered prior to the 6 month recommended interval. Completed primary series with Moderna, second dose administered on 29 July 2021.
Few hours after receiving vaccines listed below, child's left upper arm became painful, red, and swollen.  Mother reports that child "felt" warm.  SHe gave him ibuprofen x ! yesterday.  Today (2pm) child's upper left arm is swollen, warm to touch, red (shoulder to elbow). T-100.2 No enlarged lymph nodes, Less painful today.
Patient developed right-sided Bell's Palsy (facial and tongue paralysis, lacrimation, tinnitus) starting 5/23/2018. Required ED visit to rule out stroke, and was given antiviral and prednisone. Also had corneal abrasion at that time due to inability to close eye. Symptoms are still present though has shown mild improvement since onset.
headache, body aches, fatigue, nausea, blurred vision, short of breath, dizziness
Two days following SHINGRIX vaccine, first dose, developed severe Shingles outbreak. Person had chicken pox as child, shingles in late teen, and ZOSTAVAX on 07/15/2013. Red splotch on hip, pain from hip down whole left side, even to foot.
"This is a 71-year-old gentleman very healthy and not on any medical treatment who received some vaccination 2 weeks ago and 3 days after that started noticing weakness and numbness in his lower extremity.  He was evaluated at the first facility and after imaging was discharged home.  Since his symptoms progressed he went to another facility and underwent an MRI scan of the cervical spine that showed cord abnormality consistent with transverse myelitis.  He was started on high-dose IV Solu-Medrol 1000 mg for 3 days.  Also received 60 mg of prednisone.  Hospitalist at that facility spoke with a specified university and they recommended transfer to our facility for possible plasmapheresis/neurology consult.  After patient arrived here with urology back the patient recommended plasmapheresis.  However there was no dialysis nurse available for plasmapheresis.  Dr. had to go out of his way to find a nurse that would be willing to do it.  Patient has received plasmapheresis on 6/26/2022.  He will get another session on 6/27/2022.  He will need IPR.  Patient is uninsured and case manager to assist"
Developed redness & swelling two days after receiving vaccine in left upper arm. Seen in office 6 days after vaccine reporting symptoms worsening. Prescribed antibiotic treatment for LUE cellulitis today.
Got my first Shingrix shot this past Tuesday / had sore arm at site; Fatigue; Headache; Some chills; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles last year.). Previously administered products included Moderna with an associated reaction of fatigue (received 2nd dose on an unknown date and had severe headache, some chills).   On 25th May 2021, the patient received the 1st dose of Shingrix. In May 2021, 1 day after receiving Shingrix, the patient experienced fatigue, headache and chills. On 25th May 2021, the patient experienced injection site pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, fatigue, headache and chills were recovering/resolving.   It was unknown if the reporter considered the injection site pain, fatigue, headache and chills to be related to Shingrix.  Additional details were provided as follow: The patient self reported the case. The patient received 1st dose of Shingrix on past Tuesday (of reporting date) and experienced injection site pain same day in the evening. On the next morning, the patient experienced  fatigue, headache and chills but not as severe as after having 2nd dose of Moderna vaccine. The patient took Tylenol and drank plenty of water and felt 90 percent better. The patient was hoping, the second dose would be uneventful. No further information was provided.
pt devel facial redness, drody, lip swelling w/20min;crying p/vax;epi, DPH;
At 19:00 6/23/03 began itching and tight feeling. Erythema at injection site progressively worsened even with exercise and cold packs. Edema increased. Came to Imm and RN referred pt to MD. Large local reaction (>120mm) with erythema, warmth and induration. Treated with topical steroids, NSAID's. Advised to avoid exercise with right arm and avoid sun exposure.
4pm 102.5 - 72-24 93% RA dizzy, nausea, headache, c/o SOB, Acetaminophen 650mg PO given, cooling measures started 6 pm Benadryl 50mg PO, 102.5-72-22 126/62 no c/o SOB, cooling measures, no acute distress noted 8pm 98.7-84-20 140/76 94% RA, no acute distress noted, fluids taken 1-15 1am 101-99-18 93% RA sleeping, Benadryl 50mg PO, Acetaminophen 650mg PO given 730am 97.8-76-18 118/72 94% RA reports feels good, ate 100% of breakfast, acting usual self