chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She felt pain at time of injection that did not resolve with continued swelling 3 to 4 days later. On 11/23 arm was stiff and on 11/26 it was painful to raise her arm.  She saw her PCP on 11/27/2020 and was given a Medrol Dose Pak. Since completing the steroid it has been less painful but still has reduced range of motion. Will follow up with provider.
Pt received Moderna vaccine. Pt complained of chest tightness, throat itching , coughing and lip swelling. Pt was given Benadryl 50 mg and Ativan 0.5 mg. Symptoms improved. Pt was monitored for over 1 hour. pt was discharged home with family  member.
Nose blows; The both eyes discomfort; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RHINORRHOEA (Nose blows) and OCULAR DISCOMFORT (The both eyes discomfort) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced RHINORRHOEA (Nose blows) and OCULAR DISCOMFORT (The both eyes discomfort). On 07-Apr-2021, RHINORRHOEA (Nose blows) and OCULAR DISCOMFORT (The both eyes discomfort) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to INC.-MOD-2021-069919 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-069919:Case for first dose.
tested positive COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 13Sep2021 (Batch/Lot number: unknown) as dose 3, (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), administration date: 13Jan2021, for Covid-19 Immunization; Comirnaty (Dose 2), administration date: 03Feb2021, for Covid-19 Immunization. The following information was reported: COVID-19 (non-serious) with onset 04Jan2022, outcome "unknown", described as "tested positive COVID". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Could not raise arms, chills, body aches, 101 fever.  All eased the next day, but recurred the following evening. As of reporting 10/06/2011, still feel weak and achy in arms.
Revived vaccine on Wednesday and started running a fever on Saturday evening, fever again on Sunday evening.  Tested positive for covid-19 on Monday morning at facility, where I work.
got a Half a dozen last week, with no adverse event; Initial information received on 08-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.   This case involves adult and unknown gender patient who got a half a dozen last week (extra dose administered) while receiving INFLUENZA VACCINE.  The patient medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to extra dose administered [Latency: on the same day].   Details of laboratory data not reported.  At the time of report no adverse event was reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. 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.  There will be no information available on the batch number for this case.
Ten days after the shot, I had a breakout of shingles on the inside of each wrist, approximately 2 inches up each arm from the wrist. It did not hurt, nor did it itch. It lasted about three weeks. I still have faint scars. I am wondering if I should have the second dose.
Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016224273 ) on 07 November 2016. This case involves an 81-years-old female patient who was vaccinated with INFLUENZA VACCINE (dose, dose in series, route and site of administration, batch number and expiry date not reported) on an unspecified date three weeks ago. The patient's medical history was not reported. The patient's concomitant medications included XELJANZ 5 mg tablets. On an unspecified date, after vaccination (reported as three weeks ago), the patient suffered arthritis flare up. Laboratory data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none. Sender's Comments: This case concerns a 81 year old female patient who had an arthritis flare up three weeks after receiving a FLU Shot. However details regarding medical history, concurrent conditions, patient immune status at the time of vaccination and other etiologies would be helpful to further assess this case. Based on the available information, the role of vaccine cannot be assessed.
Patient complaints that she has back pain after she receives Moderna Vaccine. Then, She takes tylenol for 3 days ,and she said she feels better.
Patient has reported abdominal cramping,  nausea/vomiting, and nasal congestion starting day after 2nd COVID vaccination and continuing to present day.
PATIENT WAS ADMITTED INOT ICU AT UMC EL PASO ON 10/28/2009 FOR SEIZURE ACTIVITY.  PATIENT HAS HISTORY OF SEIZURES AND WAS NOT CURRENTLY TAKING PRESCRIBED MEDICATION FOR SEIZURES.   12/8/09 and 12/14/09:  ED Record and Discharge Summary received for dates of service 10/28/09 to 11/6/09.  Dx:  Seizure Disorder, Headache, r/o MVA. r/o brain tumor, hx. cocaine abuse.   Presents with c/o clonic seizures lasting 40 mins. w/ no LOC, involuntary movements of the head and jaw, lip smacking and no bladder or bowel comprimise.  Pt. has hx. of seizures, but no seizures in past 10 years.  Also c/o right sided HA with pressure for past 3 weeks, intensity 10/10 with blurry vision and nausea and vomiting.  On day of admission pt. developed a generalized seizure with LOC and was intubated and admitted to the ICU.  Stabilized and adjusted on antiseizure meds. Discharged home in improved condition.
Pt stated she felt faint, nauseated, sweaty at work.  Felt "throat tightening, difficulty breathing & only able to speak 1 or 2 words at a time".  She said she took her BENADRYL p.o. & decided to go to ER.  Felt better after arriving to ER.  Waited there 2 hours & felt good enough to leave.  She was not seen by an MD.  She is home today & feel "much better"
Patient describes being pain free prior to administration of vaccine. Pain began after injection and has continued daily since the injection date. She describes days when pain is worse than others. Pain is in the deltoid muscle.  She states she cannot lift with Right Arm. She struggles to get herself out of bed and struggles with other activities of daily living. She says this deltoid pain has made her disabled. She has used Lidocaine topical ointment without success. She has not been evaluated by a physician or prescribed any medication for this complaint. She states she will see her PCP soon as she is out of some of her routine medications and will consult with PCP regarding her right arm.
This is a spontaneous report received from a contactable other HCP (patient). A 41-year-old female patient received the 4th (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient also received the COVID-19 vaccine, as dose 1, single (batch/lot# unknown); as dose 2, single (batch/lot number: unknown); and as dose 3 (booster), single (batch/lot# unknown) for COVID-19 immunisation. Medical history included asthma (unspecified if ongoing). Concomitant medication(s) included: Advair. Past drug history included known allergies: Cephalexin, notes: known allergies Cephalexin. The patient experienced ineffective drug (medically significant) and COVID-19/tested positive for COVID-19 (medically significant), onset Apr 2022, with outcome of unknown. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: On day 10 after tested positive for COVID-19 and after taking Paxlovid. Therapeutic measures were taken as a result of ineffective drug; COVID-19 with Paxlovid (Pfizer) from Apr 29, 2022 to May 4, 2022. Clinical course: Experienced rebound of COVID-19 symptoms (profuse runny nose & cough) on day 10 after testing positive for COVID-19 and after taking Paxlovid. Tested positive for COVID-19 on an antigen test on day 11. The information on the batch/lot number for BNT162B2 requested and will be submitted if and when received. Sender's comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
COVID-19; COVID-19; This is a Spontaneous report from a contactable consumer based on the information received by Pfizer from AbbVie (Manufacturer Control No: 21K-163-4056641-00). A 20-year-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: Unknown), via intramuscular route on 01Apr2021 (at the age of 19-year-old) as dose 1, single and second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: Unknown), via intramuscular route on 13Apr2021 (at the age of 19-year-old) as dose 2, single for covid-19 immunisation. Patient also take adalimumab (HUMIRA 40MG/0.4ML(ADALIMUMAB)) (HUMIRA; Solution for injection in pre-filled pen), via subcutaneous route from 2019 to 2021, 40 mg,1 in 7 days for crohn's disease. Medical history included crohn's disease from an unknown date and unknown if ongoing. There were no concomitant medications were not reported. Patient reported at a 19-year-old she experienced COVID on unspecified date in 2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Therapeutic measures were taken as a result of events which included Albuterol. At the time of this report, the outcome of event was not recovered. The reporter's causality for the event of COVID was not provided.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up
3/31 a red spot at injection site re-emerged. On 4/1 it began to itch and developed a bump underneath the skin.
Severe pain in left upper arm; pain in upper right arm; stiffness/pain in upper leg muscles; stiffness across back muscle.
Presents to the ED due to shortness of breath.  Patient reports onset of mild sore throat 11/19. On  11/20  he began to experience acute worsening of chronic shortness of breath prompting his presentation to the ED. Admitted with Acute on chronic hypoxic respiratory failure due to Covid 19 Pneumonia.
fatigue, muscle ache, headache. Treated with two 220mg tablets of naproxen. All symptoms resolved by 6:00am the following morning.
Sore left arm. Limited range of mobility due to sharp pain. Cannot fully move arm behind back or lift fully to the ceiling without pain. Hard time getting dressed due to pain. Started physical therapy about a week ago to work out pain.
Mother called clinic reporting daughters face began to swell at around 10:00 Pm after receiving the first dose of Pfizer vaccine in the late afternoon (4:00 PM )at clinic.
Patient got Pfizer 5-11 pediatric Mono-Valent booster, instead of Pfizer 5-11 pediatric Bivalent  booster
Case completed primary Covivd vaccine series in March 2021, then was hospitalized for Covid in APril 2022. Hospitalized at: Hospital. * Pneumonia due to COVID-19 virus Assessment & Plan Patient presented with cough and shortness of breath for 7-10 days. Has new oxygen requirement of 1-2 liters. Opacity on CXR. WBC normal. Covid positive. Treating for covid pneumonia - dexamethasone 6 mg daily for 10 days - last day May 3. Completed 3 doses of decadron in hospital prior to discharge with seven more doses. On room air without hypoxia on day of discharge  - holding remdesevir as patient has had symptoms for more than a week.  - encourage proning - supplemental oxygen as needed AFVSS on Room air on morning of discharge
arm soreness; stiffened; temp. went from 98.2F to 100.3F; nose bleed/nose bleed without trauma; blood pressure has been spiking up about 5 to 10.5 times higher than normal; haven't sleep for last 2 nights; big emotional upset; heart rate is abnormal, it is irregular; feels lousy; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EN6202, Expiry date: not reported, age at vaccination 57-year-old), via an unspecified route of administration on 12Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included chronic fatigue syndrome (This all started 19 months ago. I mean the chronic fatigue syndrome was in 89 or 91. I started getting symptoms in 89. I did not get diagnosed at that time), fibromyalgia, venous disease, migraine, seizure, stroke, irritable bowel syndrome, vertigo (The vertigo has been going on from 3 different sources, I have allergies issues, oh yes that is part of it too, allergic rhinitis and Eczema. All the immune hyperactivity issues but there is probably some part of my immune system that is depressed in some way), weakness, allergy, dizziness, Bell's palsy (I was born with Bell's palsy), allergic rhinitis and eczema. Concomitant medications included clonazepam (0.25 in evening and 0.125 in the morning), diazepam (5 mg at night), diclofenac (10 mg at night, unsure), claritin (loratadine 10 mg), gabapentin (100 mg), levetiracetam; aimovig taken for migraine, sudafed (pseudoephedrine hydrochloride 120 mg), cardizem (diltiazem, 30 mg). The patient reported, stated with the stress of her father passing away, she feels lousy and already has immune system issues and was supposed to get a blood panel done today because she may have a vascular disorder but had to reschedule. Added after the 1st dose she had arm soreness that was worse than tetanus shot. She was really surprised but she drove for 1 hour after the vaccine so she thinks she was stiffened up. Also her temp. went from 98.2F to 100.3F in last 10 yrs haven't gone this high. She also had a nosebleed without trauma. She had not sleep for last 2 nights and its very big emotional upset. Right now her heart rate is abnormal, it is irregular. Her blood pressure has been spiking up about 5 to 10.5 times higher than normal, mostly top number and it is high and lows so even 10 point higher is still not consider High Blood Pressure but its huge change for her because something is causing it to jump 10 points. Due date of next shot was 2Apr2021. The patient underwent lab tests and procedures which included blood pressure measurement: increased, body temperature: 100.3 fahrenheit, heart rate: irregular on an unspecified date. The outcome of events was unknown.  No follow up attempts are possible. No further information is expected.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 11-APR-2016, the patient was vaccinated with an improperly stored ROTATEQ 2 ml oral injection (lot# L008997, expiry date 04-DEC-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 696 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius) and the second one lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patien't sister just called asking if patient should seek medical attention.  Patient received a Shingrix vaccination yesterday and has a fever, redness and swelling at the injection site and reports being in a significant amount of pain.  I advised patient to go to urgent care due to severity of pain and fever.
Pt was 17 yo and was given vaccine per MD order due to pt risk factors.  No complications noted.
On the 8th day after vaccine I developed a red itchy rash at site of infection. On 9th day (today) the rash has doubled in size and is still itchy.
Patient received PEDIARIX, PREVNAR, Act HIB, and ROTATEQ vaccines on 12-3-08. Per mom patients had diarrhea ever since, even up to 15 episodes in a 24 hour  period. Diarrhea symptoms have gotten better.
headaches, fever, heavy sweats at night, chills (which lasted for 8 days), shortness of breathing, red patches spread over cheeks, neck and body (which started on the 5th day and most visible on the 8th day).  Up to today (July 11th), still experiencing shortness of breath, fatigue, lack of focus, and mild coughing
Shot location became very itchy, red, hot to the touch and swollen.  Benedryl relieved the symptoms (I took 3 doses over a 24-hour period) and after 24 hours the symptoms resolved.
Within 12 hour's after the vaccine I awoke with pain redness in the left deltoid around 4:30am.  The area was hot, painful about a "quarter" size. I had nausea, fever 100.5, malaise, body weakness, exhaustion, thoughts were cloudy. The initial 24 hour period post vaccine was extremely bad. I did not have an appetite for one week. The rash progressed on a daily basis which I documented by photos.
Pt states that she received COVID vaccine on 3/29/21 in the morning. Later that same day she states she thinks she had a stroke and could not move the left side of the body, fell out of the car and was stuck on the ground for 1-2 hours. The patient is well now with a full range of motion returned.
rash on her left shoulder; This case was reported by a consumer via call center representative and described the occurrence of rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 5th June 2020, 14 days after receiving Shingrix, the patient experienced rash. On 5th June 2020, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient developed a rash on her left shoulder near where she received the injection. The patient wanted to make sure it was not contagious.
Sight tingling in both arms; Feels like arms are cold; This is a spontaneous report from a contactable consumer reported for himself. A 37-year-old male patient received BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot number: EN6199), via an unspecified route on 05Mar2021 (age at 37-year-old male), as a single dose for covid-19 immunization. Medical history included hypertension. The patient concomitant medications were not reported. No known allergies were reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Mar2021, patient experienced sight tingling in both arms. Feels like arms are cold. Patient did not receive any treatment for the events. The clinical outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very big, injection site is harder. Lower back at kidney sites are so painful. Weakness. No energy to lift up arms or legs. Have difficult to get up and get out of bed to get medicine or food. So sleepy, maybe because Tylenol 500mg q4h to help for pain but reduce just little from 10 down to 8 for a short time enough to get out of bed to get something.  Ice pack at armpit, heat pat at lower back but just reduce the pain from 10 down to 9 only. No appetite. Eat lentil and rice porridge but indigestible and have to take Pepcid. All symptoms prolong until Friday 1/15/2021 around 1pm. I pushed myself hard to get up to drive to employee health for testing which I missed on Thursday due to unable to get up. After that the symptoms down to moderate that I able to report CDC. I wonder why 2 dose is so horrible to me.
Severe pain at injection site and unable to move or put weight on arm.  Fever, bad chills and body aches began about 11:00 PM 10/22/09
FLU VACCINE HIGH DOSE WAS GIVEN INSTEAD OF REGULAR DOSE  PATIENT WAS INFORMED, NO ADVERSE EFFECTS WAS REPORTED
A red rash with small bumps was observed on the patient's neck and face on the left side on 10/11/2021. It became more prominent with pain and itching on 10/12/2021 resulting in a visit to the doctor's office on that date. The patient also reported some left side neck pain with occasional sharp pains in the left ear. The doctor diagnosed it as shingles. The patient began a 7-day treatment of Valacyclovir Hcl 1gram tablet three times/day on 10/12/2021.
itchy; Injection site warm; Swelling in the injection site (7 inches in length); Redness in the injection site; A spontaneous report  was received from a healthcare facility staff member concerning, a 29 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness/vaccination site erythema and swelling/vaccination site swelling in the injection site (7 inches in length), grade III erythema/erythema, itchy/Pruritus. and injection site warm/vaccination site warmth.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28 Dec 2020, approximately seven days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 4 Jan 2021, the patient experienced redness and swelling in the injection site (7 inches in length), erythema, warm and itchy. On 6 Jan 2021, the patient reported about their symptoms to the reporter (HCP). On 7 Jan 2021, the patient reported Minimum itching, not warm, less red and same size. Th The patient had No sign of Cellulitis and No pain. No laboratory details were provided.  Treatment information for the events provided by the reporter included Benadryl and Cold pack.  Action taken with mRNA-1273 in response to the events was unknown.   On 7 Jan 2021, the outcome of the events, redness and itchy, were considered resolving.  On 7 Jan 2021, the outcome of the event, swelling in the injection site (7 inches in length), was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.