chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt states that she went this morning to get the Pfizer vaccine, 1st dose.  a few hours later she developed rash, approx 17:00, two tiny little dots on her back and one larger one, abdomen.    adv that for this very minor "reaction" she may take antihistmine like benadryl, topical hydrocortisone and analgesics as needed.  if it gets worse call back for further recommendations.  if serious effects appear call 911.
Soreness in shoulder.  Chills/sweating/body aches.  Swollen lymph node in left arm.
flu like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   The reporter considered the influenza-like symptoms to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced heavy flu like symptoms after 1st dose of Shingrix.
This is a 70-year-old male patient with a known medical history of CAD, BPH, type 2 diabetes mellitus insulin dependent, hypertension, hyperlipidemia who presented to the ED with chest pain.  He states he tested positive for COVID 2 weeks ago and then negative at an urgent care center 2 days ago and is refusing to get tested for COVID at this time but has agreed after talking to this provider.  He states he did get COVID vaccine.  In the emergency room he was slightly hypoxic with O2 sat at 93% on room air but he has been tachypneic with respirations in the 20s.  Chest x-ray and CT of the chest was done that shows multifocal pneumonia probably viral.  He was given antibiotics and steroids in the emergency room.
Body Aches; Headache; Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:  EL9264) via an unspecified route of administration in the right arm on 03Feb2021 at 13:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease, depression, anxiety and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received ibuprofen (MANUFACTURER UNKNOWN) and codeine (MANUFACTURER UNKNOWN); both on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Feb2021 at 02:00, the patient experienced body aches, headache and injection site pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, headache and injection site pain was recovering at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the right arm on 23Feb2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Rash (small red dots) all over chest, neck and back. Then spread to arms, face and legs with fever ranging from 99.0-102.0 throughout the 5 days she had it. Also swelling of the eyes and cheeks.
After shot, 10 days later I developed a severe itch on my hands legs and feet. It lasted all day for 25 days. My dr. Prescribed an ointment, then he gave me Hydroxyzine HCL.   The itch had no rash associated with it or redness of skin.
Patient developed pain in her arm within a few hours of ingestion. When she woke up the next morning, there was a red lump at the injection site that was firm and painful. Site has continued to be painful to the touch throughout the day. Patient has not tried any remedies at this time, nor has she consulted her provider yet.
Moderna COVID-19 Vaccine EUA: Higher-than-authorized dose volume administered Patient received 0.5 ml dose of Moderna Covid Vaccine on 5/4/21 and a 1 ml dose of Moderna Covid vaccine on 6/1/21.
ADVERSE EVENT TO THE VACCINE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse event to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event to the vaccine was not reported. This report was non-serious.
FLU FEELING; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced flu feeling, and headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and flu feeling was not reported. This report was non-serious.
General Malaise, Intermittent night sweats, Intermittent low-grade fever 100.2. Not feeling Normal.
the next morning after the 2nd vaccine shot when i woke up at 10 am my right ear was feeling clogged and a mild ringing, the clogged and the ringing  decreased and stoped, now my ears feel normal.
small headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 29Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 29Apr2021, outcome "recovered", described as "small headache".  Additional Information: Two hours after vaccination, patient had small headache. It was reported that patient will be fully vaccinated on 04Jun2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
7/24/2021: Pt presents to ED complaining of migrating joint pain and back pain for the past 3 days.  She notes that she did vomit 1 time earlier today, but is no longer nauseous.  She has been compliant with her diabetes medications.  Patient noticed some dysuria earlier today.. The onset was 3  days ago. Patient dc home same day. 7/25/2021: Pt presents to ED with similar symptoms as day prior. Patient tests positive for COVID-19 upon admission. Patient discharged home on 8/1 8/1/2021: Pt presents to ED with CC  SOB. Per patient, recently tested positive for COVID-19 (7/24/2021) and reports having worsening SOB and hypoxia that was recorded at 66% O2 at room air with her home monitoring kit. Pt arrives to the ED in
Client received Pfizer vaccine lot number EL9265 IM left deltoid on 2/1/21 and then received Moderna vaccine lot 03120A left deltoid on 2/20/21. His daughter states he has not had any reactions since receiving Moderna
Moderna COVID-19 Vaccine.   Tiredness and drop in blood pressure drop to 100/63  two days later on Friday 1/22/2021 approximately 54 hours after receiving first dose of Moderna vaccine.
Arm is red and steaking to lower arm; My husband and i had our 3nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm is red and steaking to lower arm) and EXTRA DOSE ADMINISTERED (My husband and i had our 3nd vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Arm is red and steaking to lower arm) and EXTRA DOSE ADMINISTERED (My husband and i had our 3nd vaccine). At the time of the report, ERYTHEMA (Arm is red and steaking to lower arm) outcome was unknown and EXTRA DOSE ADMINISTERED (My husband and i had our 3nd vaccine) had resolved.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
5 hours post vaccination: excessive crying for an 1 1/2. No way to soothe him. More constipation issues and refusal to nurse. This would continue for another month until we had to give up on breastfeeding altogether. The mother changed her diet and tried a variety of things to fix the issue, but was unsuccessful. The constipation was better about a month after the vaccination.
felt sick since receiving her Moderna Covid-19 vaccine booster dose.; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick since receiving her Moderna Covid-19 vaccine booster dose.) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced MALAISE (felt sick since receiving her Moderna Covid-19 vaccine booster dose.). At the time of the report, MALAISE (felt sick since receiving her Moderna Covid-19 vaccine booster dose.) had not resolved.            No concomitant medications were reported. No treatment medications were reported.
administered to patient post excursion with no reported adverse event; product storage error temperature too low (with no reported adverse event); Initial information received on 16-Feb-2023 regarding an unsolicited non-valid non-serious case received from other health professional.  This case is linked to cases 2023SA057733(CLUSTER), 2023SA057309(CLUSTER) and 2023SA068949(CLUSTER).  This case involves adult patient of unknown gender to whom influenza quadrival A-B vaccine [Fluzone Quadrivalent] was administered post excursion with no adverse event and reported product storage error temperature too low with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date there was product storage error temperature too low with no reported adverse event (product storage error) for influenza quadrival A-B vaccine.  On an unknown date, the patient received suspect influenza quadrival A-B vaccine suspension for injection at an unknown dose (lot number: UT7683NA, expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date administered influenza quadrival A-B vaccine to patient post excursion with no adverse event (poor quality product administered) (same day latency) following the administration of influenza quadrival A-B vaccine.  Action taken: Not applicable.  Outcome: Unknown for both the events.   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 set out in the 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.
Patient called around 7:30 p.m. on the day of the vaccination to report that he has been experiencing  significant pain in his left upper arm since he received the vaccination.  He said the pain is located at the upper deltoid area.  He said that if you lift your arm up, you can feel an indentation in the upper arm and that's where the pain is located and that's where he received the vaccination.  He said the pain is significant enough that he will not be able to go to the gym tomorrow and he had trouble using a blower doing his yard work.  He did not say that he is going to go to a doctor for treatment.  He said he's going to use Acetaminophen and heat/ice to treat the pain.
patient reported he, 'felt weird', developed a headache, 20 minutes after vaccination.
No known adverse effects; a patient received an expired dose ofV ARlV AX (lot: N022978; expiration: 08/23/2019).; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 04-SEP-2019, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # N022978, expiration date 23-AUG-2019 (strength, exact dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with unexpired sterile diluent (lot # S003613, expiration date: 22-JUL-2021). No known adverse effects were reported.
tinnitus - both ears  I can't recall if it began after the first (1/31/21) or second injection (2/21/21) The evening of the injection I felt a tingling sensation at the injection site which moved up to my left ear. The next morning both ears were ringing and it has not changed since then.
1- runny nose for 3 days, no treatment required. 2- loss of appetite lasted for about 5-6 days, then resolved on its own, no treatment needed.
Bilateral Facial Edema, Viral Conjunctivitis, Itchy eye (left).
EMS brought pt to ED as a trauma transfer; pt had fallen and found to have multiple rib fx, hemopneumothorax at outisde facility; pt c/o rib pain and SOB; found to be positive for COVID; transferred to ICU; worsening AHRF; given Remdesivir and dexamethasone, ABX; poor oral intake; fed through NG tube; DNR; pt's condition continued to worsen; transitioned to comfort care and pt passed away in the hospital
Pt states she had pain locally at the site and then started to have pain in neck, head, shoulder and throughout arm. Site slightly red and sore. Doctor advised her to take 800mg Ibuprofen TID, apply heat and monitor.
ED to Hosp-Admission Discharged  7/7/2021 - 7/9/2021 (2 days)  Last attending ? Treatment team Chest pain Principal problem  Primary Admission Diagnosis    Medical Problems     Hospital Problems        POA    * (Principal) Chest pain Unknown         Hypertension, essential Yes         Mixed hyperlipidemia Yes         Stage 2 chronic kidney disease Yes         Type 2 diabetes mellitus (CMS/HCC) Yes                    Disposition: Home CODE STATUS (LOI): Full Code     _ Active Issues Requiring Follow-up Chest pain: Unclear etiology patient should have a stress test done after discharge would wait a couple weeks to verify the patient is not developing Covid as the accuracy of the test may be degraded if patient has Covid infection.  May be reflux related so we will start patient on on Protonix for the next 30 days can likely stop it after that time period.  Patient understands to try Maalox or Mylanta She has an episode of pain like this and should return to the emergency department if she has not undergone stress testing if she has recurrence of the pain.     Test Results Pending at Discharge  Outpatient Follow-Up Future Appointments Date Time Provider Department Center 10/11/2021  1:20 PM DO FIFTH IM         Hospital Course   HPI: Chest pain     Hospital Course: Patient is a 92-year-old female with 2 episodes of chest pain lasting about 15 minutes each over the past couple weeks.  Patient had negative troponins.  Patient had prior Covid vaccine.  Patient underwent Covid swab as does everybody admitted to this hospital which returned positive.  Likely incidental finding.  Patient did not have any additional episodes of chest pain unclear is what the underlying etiology is.  Would wait for at least 2 weeks to verify that patient is not developing Covid and should undergo stress test after such time is completed.  Please follow-up with your outpatient provider to arrange this testing.  Patient's been advised to return to the emergency room or seek medical attention if she becomes symptomatic with the Covid including runny nose cough.  I do not believe patient to be contagious though I explained to her do not know that with certainty.
Breakthrough case admission after 4 vaccines 1/16/21 Pfizer Lot# EL3249 2/6/21 Pfizer Lot# EM9810 10/7/21 Pfizer Lot# EW0175 4/13/22 Pfizer Lot# FL3198
administrated with adjuvant only; administrated with adjuvant only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 4ft7z, expiry date 26th August 2023) for prophylaxis.   On 25th July 2022, the patient received Shingrix. On 25th July 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication. On an unknown date, the patient experienced inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 26-Jul-2022 Reporter's Comments: Nurse reported on 26th July 2022, that a patient was administrated with the adjuvant only on 25th July 2022.  The patient did not experience adverse event. The reporter consented to follow up. Additional Supportive Information: The patient was administrated with the adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Severe itching bruising at shot site. Red ring remains 2 weeks later. 3 menstrual periods in 4 week time span. Severe breast pain
29JAN97 rash devel (small vesicular) running low grade temp (MD said hive like);31JAN97 early AM spiked temp of 106.1-taken to MD rx APAP, Ibuprofen, DPH;rash subsided;1FEB97 temp down to 100.5;broke out in chicken pox type rash 3X nl size;
Acute Covid--diagnosed april 2020--Hospitalized about 1 week Day of the vaccination--severe rigors, chills, muscle pains  lasting about 10 hours--very similar to about 5 other people in my office 2-3 days later acute facial rash, involving eyes, conjunctiva on both sides--not responsive famvir, neomycin, eye drops for conjunctivitis. The pictures are much more dramatic than the description----lasted about 5 days.
Initial and follow-up information has been received for the Merck Pregnancy Registry from a medical assistant concerning an 18 year old female who on 18-JUL-2007 was vaccinated IM in the left deltoid with a 0.5 ml dose of GARDASIL (Lot# 657868/0523U). It was reported that the patient experienced no adverse symptoms. On 28-AUG-2007 the patient's urine beta-human chorionic gonadotropin test reported positive for pregnancy. On 28-AUG-2007 the patient had an ultrasound that showed no evidence that the patient was pregnant. At that time, the patient's HCG level was reported to be only 55. It was reported that it was "too soon to see anything." The patient's last menstrual period was 21-JUL-2007, the estimated conception date was 05-AUG-2007, and the estimated date of delivery was 28-APR-2008. The patient did not have any previous pregnancies. At the time of the report, the patient was 10 weeks pregnant. On an unspecified date the patient underwent an ultrasound which revealed oligohydramnios. On 14-APR-2008, the patient delivered a healthy, normal baby boy via caesearean section due to fetal intolerance to labor and nuchal cord at 38 weeks. The birth weight was 5 pounds 11 ounces, and the infant's apgar score was 9/9. The infant was normal with no congenital anomalies. Other medications that were taken during the pregnancy were unspecified prenatal vitamins and PROMETRIUM, 200 mg for low progesterone from 05-SEP-2007 to 05-OCT-2007. At the time of the report, the outcome of the patient was unknown. Upon internal review caesarean section due to fetal intolerance to labor and nuchal cord was considered to be an other important medical event. Additional information is not expected.
Evening of the vaccine, patient states he experienced nausea, diarrhea, abdominal tenderness, stomach cramps.  Patient experienced dizziness the following day.  Patient states he almost passed out on two seperate occasions on the morning of the 7th of June.
Information has been received from a physician concerning a 12 year old male who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot # not provided). The physician reported that the patient was diagnosed with shingles after receiving a dose of varicella virus vaccine live (Oka/Merck). It was not known how long after the vaccine was given that the shingles occurred. The patient sought unidentified medical attention. Additional information has been requested.
5 minutes after receiving the vaccine my arm started to become hot in the area of injection. Within seconds, my body temperature increased, my limbs started to tingle, and my forehead began dripping with sweat.  I called the facility worker in the area and asked "Is it normal to get this hot and tingly?". As my body seemed to lose strength, she told me to put my head down and flagged down a paramedic.  I was wheeled to the back (as symptoms were increasing), and was laid on a bed. They measured my vitals and provided me with water. I was so weak that I couldn't open my eyes and was told that I was clinically hyperventilating (I personally felt calm prior to laying on the bed).  I was monitored for about 45 minutes until I was picked up by a family member. I returned home and slept for almost 18 hours straight, and could hardly move for almost 3 days (as I continued to sleep the following day).
Left upper arm redness and warmth post vaccination. Received MCV, Tdap, annual flu, and HPV 1/17/18 during WCC. Unsure which vaccines he received in his left upper arm. Denies fever or itching. C/o pain with raising left arm overhead. No h/o previous vaccine reactions.