chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt is a 15 y.o. with a history of chest pain here today for evaluation. He is an ex 29 weeker with no long term consequences of prematurity.     Pt has been in his usual state of health until he developed intermittent chest pain x a few weeks. Pt had a URI for which he wasn't sure if it was allergies or a cold in April 2021.  He did receive Pfizer Covid-19 vaccine (First dose 5/16/21 and 2nd dose 6/6/21). Pt came to cardiology for echo for chest pain on 6/22/21. Echo showed pericardial effusion. Pt feel that he had chest pain before the vaccine, but Mom feels like it may have no started until after the first vaccine. Pt is quite active in basketball without issues. The pain lasts for a few minutes and is on his left side radiating down. He did notice that the pain worsened in certain positions, especially while lying down. There is no history of syncope, dyspnea, cyanosis, or heart palpitations. On 6/29, Pt was still having intermittent chest pain.
2 days after getting the vaccine my injection site was very swollen, red, and very tender and warm, and I was very weak, dizzy and nauseated and I was unable to work for 3 days.
Following the second "dose" over course of 5 days patient lost mobility until he was unable to stand or walk and was confined to a wheelchair.
Patient came in on 2/22/21 with stroke like symptoms.  It states patient has had lots of old strokes but nothing acute at this time.  Patient's husband concerned that the vaccine may have caused patient to have stroke
to ED from nursing home c/o SOB, sats 70s, had tested + COVID 2 days prior, + pneumonia, D-dimer 9, ? PE,   ; TX: decadron, vit C, zinc, lovenox, Rocephin, Zithromax, not eligible for remdesivir d/t elevated LFTs; develops encephalopathy, family requests hospice, pt worsened with bradycardia/hypotension and expired in hospital
Headache, arm, shoulder, neck, ear and scalp nerve pain and itchiness, exhausted but can't sleep, biting feeling in left heal of foot, joint pain upon use in left shoulder, knee.  Increased all over pain.  Flashes of nerve pain across chest between collar bone and breasts.  Ear pain and everything sounded like an echo for an entire day in my left ear.  Intermittent loss of voice for 2 days.  Muscle spasms from bra line to hip on left side of my back.   Overall worsening of my normal symptoms and pain.
This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received Shingrix for prophylaxis. On 7th September 2018, the patient received the 2nd dose of Shingrix. On 7th September 2018, 8 hrs after receiving Shingrix, the patient experienced chills, headache and general body pain. On 8th September 2018, the patient experienced feeling abnormal. On an unknown date, the outcome of the chills, headache, general body pain and feeling abnormal were unknown. It was unknown if the reporter considered the chills, headache, general body pain and feeling abnormal to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. At 8:30 AM, the patient received 2nd dose of Shingrix after waiting 6 months for it. Exactly 8 hours after receiving Shingrix, the patient experienced severe body aches, chills and headache. Almost 24 hours after receiving Shingrix, the patient felt like her body just got hit by a train. The patient said that she knew this was common side effects but she would like to know if many people complained about this and really how long should it last and what should she be concerned about. The patient thought that she never got this vaccine.
I got my 2nd Covid shot Friday.  Attached is the copy of the white card. This second shot was a real hum dinger.  Started feeling headachey Friday evening, then fever of 101, chills and sick feeling through the night and most of Saturday.  Back to normal on Sunday morning.  I guess this is pretty typical of reactions to Moderna #2.  It calmed down yesterday and I was back to normal.  Still had a little fever, but nothing I could feel.   We did our standard 4 mile hike yesterday.  If wind would calm down we would go snorkeling.A couple of lesser known side effects I noted:  1. Both (name) and I got sensitive gums..discomfort with cold water, etc.  lasted one day.   2.  Peeing was strained for me for about 30 hours, then back to normal.
MOM DESCRIBES LUMP BETWEEN ARMPIT AND NIPPLE ON TORSO LEFT SIDE WITH FEVER. LUMP "SQUISHY" WITH NO OTHER SYMPTOMS.
Rcd. vaccine 2/10/18 broke out in a rash 3 days later on 2/13/18.
Narrative: COVID infection following completion of COVID vaccine series 03/10/2021 COVID vaccine dose #2 06/16/2021 reported onset of rhinorrhea, headache, loss of taste and smell; Pt admitted to close contact with his roommate who was a confirmed COVID positive case; Pt requested test to confirm COVID status 06/21/2021 COVID positive (swab)
Arm was sore during Saturday directly after the shot. Tiredness was felt Sunday morning and arm was still sore. Chills started Sunday evening during sleep. Vomiting occurred around 4:00 am Monday.
Pt. was given HPV after 10-12 min. pt became pale & lethargic, speech unclear, took pt BP 89/51. Pt was lying on exam table for about 20 min. 2nd B/P 90/57. Pt was move to another exam table to be placed trendelenburg position w/ legs elevated. Pt began to be more aware, speech became clear, B/P elevate back 110/70, was discharged.
On 12/11/2022 it started with a frontal headache, chills, and muscle aches. That resolved within around 16 hours and then I developed congestion, mostly in the head. Within a couple of days that moved on into the bronchi and was accompanied with some pretty severe fatigue. I tested myself for COVID-19 on 12/12/2022 and it was positive. I saw my doctor, who prescribed PAXLOVID. Since beginning the medication, I've been getting better every day.
three doses, did not develop antibodies; three doses, did not develop antibodies; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine, the 1st dose of Hepatitis B vaccine, the 3rd dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 1st dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder and therapy non-responder. On an unknown date, the outcome of the therapy non-responder and therapy non-responder were unknown.  Additional details were provided as follows: The age at vaccination was not reported. A nurse reported that one of her colleagues had two rounds of three doses of hepatitis B (manufacturer unknown) and did not develop protective hepatitis B antibodies after either of those two rounds.  The reporter consented to follow up. This case is 1 out of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022001258:Same reporter US-GLAXOSMITHKLINE-US2022001259:Same reporter
Episode of syncope, unknown duration, occuring the day of the vaccination, with associated symptoms of chills, body soreness, migraine type headache, and nausea.  Sought care at UC next day, was evaluated with vital signs, recommend OTC tylenol treatment.  Symptoms continue with lightheadedness and nausea.
On May 1 began to feel ill and was diagnosed on May 10 with endocarditis.
Patient got the shot last Thursday and on Friday, the next day, she came down with a sore throat. Then on Saturday she was sick and slept after work. On Sunday around 4:00 or so she had a tightening of the throat and lungs requiring an ER visit. Patient was given albuterol, Benedryl, an anti anxiety  and a steroid.  No improvement . Suspected viral. Sent home.  At 7:15 am Monday morning, retuned to ER with worsening symptoms of tightening of chest. Gave epinephrine breathing treatment, MRI to check blood clots, blood work, dexmethasone.  Outcome not determined yet.  In ER at present.
9/6/06 Patient's mom reported swollen arm and fever at site to health department at 12:00pm. States child is not complaining of pain at site states it is swollen from shoulder to elbow. Referred to PCP. Stated would bring to HD did not come doesn't answer phone. 9/7/06 Brought child to clinic right arm from shoulder to mid upper arm inflamed and swollen on Zithromax 100mg x 3 days.
Increase heart rate 135, tingling hands and legs, complaint of swollen throat BP 158/85 called for ambulance heart rate 93 heart rate 117 EMS arrived taken to  hospital
administered a dose of Typhim Vi to a 14-month-old child in our practice with no reported adverse event; Initial information received on 28-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 months old and unknown gender patient who was administered a dose of POLYSACCHARIDE VACCINE [TYPHIM VI]  to a 14-month-old child in our practice with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 28-JUN-2022 the patient was administered a dose of Typhim  VI  (lot: T1E371M ; expiry date: 14-Sep-2022 ) to a 14-month-old child in our practice with no reported adverse event (product use issue) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  Action taken : not applicable.  Outcome: unknown   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.
I got the vaccine at 1:30pm at vaccine clinic and waited the mandatory 15 minutes in clinic's observation area.  After release I went to my car and started to drive home.  At the 25 minute mark post vaccine (1:55pm)  I felt numbness and tingling of cheeks and lips (no swelling and no difficulty breathing).  I drove the nearby adult hospital, parked on a side street to wait and see if anything got worse.  After 10 minutes symptoms subsided and I continued home.  At the 50 minute mark post vaccine (2:20) I felt numbness and tingling of my right arm which subsided after 10 minutes.  No further side effects.
I had a high fever, 101F-102F, chills, exhausted, very bad cough, I took a home COVID-19 test that came back negative, I made an appointment with my doctor. She tested me for COVID-19, Strep, Influenza A and B, all tests came back negative. She gave me a prescription for amoxicillin to help get the infection out of my body, I was also given a prescription for TESSALON PERLES to help with the cough. I still have a lingering cough but I am feeling much better.
On 8/8/02, after giving IPV injection, child moved and sustained a laceration approx. 1 1/2"-2" at injection site; dressing applied. Instruction given to check area for fever, achiness on pain and to call MD or go to ER and to call the next day. On 8/9/02, family called and said site is healing and child is fine.
Muscle pain; Joint pain/discomfort on her knees; Sore arm; A Spontaneous report was received from a consumer concerning, a 71 years old, female patient who was administered Moderna (mRNA-1273) and developed sore arm, muscle pain and joint pain/discomfort on her knees.  The patient's medical history was recorded as rheumatoid arthritis. Concomitant product use was not provided.  On 23 Dec 2020, she got first dose of vaccine on her left arm, intramuscularly (Batch number: 011J20A) and on 21 Jan 2021 she got second dose (Batch number: 029L20A) on her left arm. After her first dose, her arm was sore for 2 days and 2 weeks after she also started experiencing muscle and joint pain and felt discomfort on her knees.  For recorded symptoms treatment was given with medicines as Tylenol, Advil, Meloxicam and other: Raloxifene.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events developed sore arm, muscle pain and joint pain/discomfort on her knees  were considered not recovered at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
For the 2nd & 3rd day after vaccination, I experienced intermittent intense vertigo, onset by lying down or having head below shoulders.
Received third dose without being immunocompromised; Received full dose 0.5 ml booster; Flu like symptoms for about 8 hours; Large tender area belowinjection site on arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms for about 8 hours), VACCINATION SITE PAIN (Large tender area belowinjection site on arm), EXTRA DOSE ADMINISTERED (Received third dose without being immunocompromised) and ACCIDENTAL OVERDOSE (Received full dose 0.5 ml booster) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms for about 8 hours). October 2021, the patient experienced VACCINATION SITE PAIN (Large tender area belowinjection site on arm). On 17-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Received full dose 0.5 ml booster). On 18-Oct-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received third dose without being immunocompromised). On 17-Oct-2021, ACCIDENTAL OVERDOSE (Received full dose 0.5 ml booster) had resolved. On 18-Oct-2021, EXTRA DOSE ADMINISTERED (Received third dose without being immunocompromised) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms for about 8 hours) and VACCINATION SITE PAIN (Large tender area belowinjection site on arm) outcome was unknown.            No concomitant and treatment information were reported by the reporter.   This case was linked to MOD-2021-360706 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: New events were added
Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with improperly stored doses of GARDASIL (lot # K008932, expiration date:04-MAR-2017, route, dose and frequency were unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Facial twitching.  Started day after. Corner of eye & whole side of face cheek into chin. Today is day 9....still happening! Duration of several srcs to over 4 mins.  We'd the 24th it started aroundb9 pm & continued  for 10 hrs!!!!! I couldn't sleep fur the whole night. Dr office advise was try Benadryl ???
It was clarified the hearing screening showed a little bit of hearing loss in right ear; buzzing in her ear; UTI; normal pain that went away, this was at the injection site; is interfering with her sleep; This is a spontaneous report from a contactable consumer reported for herself. A 71-years-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in left arm on 26Mar2021 (at around 10-11am) (at the age of 71-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included, lyme disease (had Lyme's disease and was given antibiotics, this was years ago) from an unknown date and unknown if ongoing. Concomitant medication was not reported. Historical vaccination include, PNEUMOCOCCAL VACCINE on Aug2020, patient experienced rash pruritic (With the pneumonia shot patient had a rash on lower back that patient thought was shingles. It was itchy and lasted 3-4 weeks with a little pain but was not like what was normally reported for shingles. Maybe it was not but thought it was. Patient did not have it looked at because patient did not want to go to the doctor at that time due to COVID. The shot was done in Aug2020. Patient had no product name, NDC, Lot, or Expiry for this product, it was given by primary care doctor). History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) and additional Vaccines Administered on Same Date of the Pfizer Suspect reported as none. Prior Vaccinations (within 4 weeks) and adverse events following prior vaccinations reported as none. Patient did hot have medical history (including any illness at time of vaccination). Patient take no medication other than supplements. Investigation assessment reported as yes. Vaccine not administered at military facility. On 2021, it was clarified the hearing screening showed a little bit of hearing loss in right ear, buzzing in ear, uti (urinary tract infection) and normal pain that went away, this was at the injection site and it was interfering with sleep. The patient underwent lab tests and procedures which included acoustic stimulation tests: unknown on 2021. Patient did not visited to Emergency Room and Physician Office, patient went for normal check up at the doctor and mentioned this. The outcome of the event Urinary tract infections and vaccination site pain was recovered on 2021, tinnitus was not recovered while other events were unknown.  Follow-up attempts are completed. No further information is expected.
was extremely tired went to bed, wake up @ 10:30 itching all over especially under arms, @ belt line, where shoes ties;had welts all over;went to ER was advised to use DPH;
I received the shot in my left arm.  By the next morning, I was having pain in my left shoulder area, front and back, with the pain radiating down my arm.  This pain has persisted for 6 days.
This patient has had a break through case of COVID.; This patient has had a break through case of COVID.; This is a spontaneous report from a contactable Pfizer colleague (consumer) reported for an adult male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not positive for COVID-19 prior to vaccination, since the vaccination the patient been tested for COVID-19. On 14Sep2021 it was reported that the patient has had a breakthrough case of COVID. On 16Sep2021 patient underwent lab tests and procedures which included Covid Test: positive. It was unknown if patient received treatment for the events. The outcome of the event was recovering.  The lot number for BNT162b2 was not provided and will be requested during follow up. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101242580 same reporter/product/event, different patients
severe headache, severe generalized joint pain, moderate abdominal pain, moderate back pain, hypotension with BPs of <90mmHg, chilling/low grade fever, fatigue. Sx onset at 24hrs post dose with fatigue/weakness/exercise intolerance. Rapid escalation of other sx by 36hrs post dose. Chilling persisted over 24hrs.  Symptomatic orthostatic hypotension persisted through 72hrs. Arthralgias/abdominal pain persisted through 72 hours.  Home selfcare c/o bed rest, po fluids, ibuprofen, diphenhydramine.  No injection site reaction or urticaria/rash is seen.  There have been no adverse reactions to any prior COVID vaccine dose including Moderna and Pfizer.
Information has been received from a consumer concerning her son, a 7 year old male with no known medical history or allergies who "a year ago," in approximately June 2005, was vaccinated with a SC second dose of MMR II. There was no concomitant medication. On 14-JUN-2006 the patient developed mumps. Unspecified medical attention was sought. Blood work was performed, the results were not reported. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Patient noted sensation of "slightly swollen tongue" approximately 10-12 minutes after administration. Tongue not visibly swollen. Airway patent. Patient also noted a slight "tightness" to her chest. No acute distress noted. Patient denied any shortness of breath or difficulty swallowing. No drooling noted. Patient denied chest pain, noting some general "tightness" while pointing up and down both rib cages with her hands. Patient was speaking clearly and in full sentences. Skin warm and dry and color within normal limits. Patient stated that she has had this same sensation of tongue swelling and chest tightness after eating citrus fruit in the past. She stated that after eating citrus this sensation resolves within minutes of not eating the fruit. Advised that I was going to call EMS, but patient adamantly denied need. She stated that she was in no distress and would rather wait to see if sensation resolved. She verbalized understanding that if symptoms changed or worsened in any way EMS would be called.   Patient monitored closely for additional 15 minutes, after which patient stated that she had to leave to meet one of her own patients. Patient stated that chest tightness and tongue swelling was greatly improving. No swelling of tongue, lips or throat noted. No acute distress noted. Patient was speaking clearly and in full sentences. Discussed after care instructions with patient noting to call 911 or go to ER if she had any further concerns after leaving. She verbalized understanding.   Follow up call placed to patient 12/29 @ 1745. Spoke with patient regarding concerns. She stated that she felt complete resolution of symptoms after approximately 2 hours. She denied any current symptoms and verbalized understanding to call or go to ER if symptoms change or worsen.
TOOK VIVOTIF DOSES WITH FOOD; This case (PVX2019-2190) was received form a pharmacist on 28-Aug-2019. It described a female consumer, who "took Vivotif doses with food" (PT: Product administration error), while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took all 4 doses of Vivotif according to schedule from 17-Aug-2019 to 23-Aug-2019, but she took it with food and not an empty stomach.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took Vivotif doses with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif doses with food" was considered as not applicable.