chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough case admission after 3 vaccines Pfixer 2/12/21  Lot# El9267;  Pfizer 3/3/21 Lot# EN6202;  Pfizer 10/22/21 Lot# FF2589
hemorrhage; stroke; intracranial infarction; Information has been received from a lawyer referring to a patient (pt) of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 22-FEB-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as after zoster vaccine live (ZOSTAVAX) inoculation), the pt suffered hemorrhage, stroke and intracranial infarction. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Th pt also experience mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events hemorrhage, stroke and intracranial infarction was not recovered.   The reporter considered the events hemorrhage, stroke and intracranial infarction to be disability.  Upon internal review, the events hemorrhage, stroke and intracranial infarction were determined to be medically significant.
Pt vax 3 doses; Titer approx 1 yr later was neg.
Patient passed out immediately after the shot was administered. He was out for about 1 minute. He regained consciousness, then faded again about 3 minutes later. That second time he was out for about 30 seconds. We monitored breathing and heartrate, which remained normal through and after the events. We monitored for 30 minutes before allowing him to leave. At 4:20pm (10 minutes after leaving) the family called and reported the patient vomited
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: sleepy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Weakness-Severe
Second dose of HPV given on 10-31-07 she states on 10-31-07 she had numbness in both legs- 11-1-07 numbness legs and hands 11-2-07 she stated numbness improved
Yellowish blister to (L) upper arm 24 hour after immunization, lasted for 5 days. Papular rash noted to site.
Fever 101 night of shots 8/9/04 shot area fine. 8/10/04-still running 101 temp-sleeping a lot.
pt recv vax 10JAN97 & 13JAN97 pt devel a fever of 104.7;23MAY97 pt devel 50-60 lesions on head, face, trunk, & neck;
Itching on 8th day after 1st vaccine; redness on 8th day after 1st vaccine; swollen arm on 8th day after 1st vaccine; Itching on Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on 8th day after 1st vaccine), ERYTHEMA (redness on 8th day after 1st vaccine), PERIPHERAL SWELLING (swollen arm on 8th day after 1st vaccine) and VACCINATION SITE PRURITUS (Itching on Injection Site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 120L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on Injection Site). On an unknown date, the patient experienced PRURITUS (Itching on 8th day after 1st vaccine), ERYTHEMA (redness on 8th day after 1st vaccine) and PERIPHERAL SWELLING (swollen arm on 8th day after 1st vaccine). On 12-Feb-2021, VACCINATION SITE PRURITUS (Itching on Injection Site) had resolved. At the time of the report, PRURITUS (Itching on 8th day after 1st vaccine), ERYTHEMA (redness on 8th day after 1st vaccine) and PERIPHERAL SWELLING (swollen arm on 8th day after 1st vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not provided. Treatment information was nor provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-092047, US-MODERNATX, INC.-MOD-2021-028972 (E2B Linked Report). This case was linked to MOD-2021-091728 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Additional information received On 29-Jun-2021: F/U-2 : To confirm NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092047:Daughter's case US-MODERNATX, INC.-MOD-2021-028972:Son-in-law case -Phone number is same in mother case and this case
patient raised hand and motioned to nurses and slumped forward. nurses explained pt had brief lost of consciousness and they laid him down with feet raised on chair. patient then regained consciousness. I arrived and too the patient's blood pressure and gave patient water. we monitored the patient on the floor and their vitals until the patient was able to be seated. patient was seated for approximately one house and then patient was walking and felt normal. then patient was okay to go home and the situation was resolved.
After 3 vaccines had been administered to patient, her head slumped forward, arms and legs began flailing.
potentially given Kinrix SubQ; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5r3kx, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th August 2022, the patient received the 1st dose of Kinrix (subcutaneous) .5 ml and Kinrix Pre-Filled Syringe Device. On 8th August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comments: The caller was a nurse stating that a patient was potentially given a dose of Kinrix Subcutaneously versus Intramuscular.   The patient moved while getting the vaccine so was unsure as to which route the medication was given. The reporter did not consent to follow up. No health care professional for follow up. Additional Supportive Information: The patient received Kinrix subcutaneously versus intramuscular which led to intramuscular formulation administered by other route.
Paroxysmal supraventricular tachycardia 15 days post seasonal TIV injection and H1N1 LAIV. 5 year 11 month old previously healthy female presented 2 weeks ago with several episodes of intermittent nausea and non-bloody, non-bilious emesis without diarrhea or fever. Patient was found to be tachycardic in pediatric clinic that morning and taken to ED for further evaluation. Received seasonal TIV injection and H1N1 LAIV concomitantly 15 days prior to event (10/14/09). Positive for abdominal pain, vomiting, nausea and no other symptoms. Negative for cough, diarrhea, fever and chest pain. No history of ingestion. No significant caffeine intake. No trauma. No concurrent clinical illness. Pulse 211. Temp 97.7 degrees F. Resp 22. Wt 16.9 kg. SpO2 100%. 11/12/09:  Primary care and ED records received from date of service 10/29/09:  Dx:  Paroxysmal Supraventricular Tachycardia. Assessment:  Presented with tachycardia, sent to ED.  EKG suggestive for SVT with inverted P waves.  Hemodynamically stable on room air.  2 mg IV Adenosine administered with no effect, 4 mg Adenosine administered with cardioversion to NSR.  EKG did not show delta waves, suggestive of Wolff Parkinson-White Syndrome.  Sent home with instructions to avoid caffeine.  Repeat EKG one week later WNL.
probably reconstituted with sterile water and administered to a patient; probably reconstituted with sterile water and administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number 44HD4, expiry date 30-MAY-2024) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: probably reconstituted with sterile water and administered to a patient) and inappropriate dose of vaccine administered (Verbatim: probably reconstituted with sterile water and administered to a patient).The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt Date: 23-AUG-2023 The reporter called to inform that during inventory registration, it was discovered that a Shingrix diluent was left with no antigen, which lead them to think that Shingrix was probably reconstituted with sterile water and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter agreed to follow up by e-mail.
Injection site swelling, redness, pruritus, tingling and heat on day 2. Rx Ibuprofen and ice.
approx 7-8 hours after shot began having chills and cold, got tired and felt flush with temp at 100.2.  Slept approx 14 hours that first night and the next day had fever, chills, achy, sweats and lethargic.  Temp was 100.4 that eve.  Also, had a headache for approx 36 hours.  Slept a lot and after 3 days no issues
Feel like I took too much Cold medicine and am not able to focus, lower mental awareness, aches in arms, shoulder and neck, slight fever,  and headache, sore left arm.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A male patient of an unspecified age and race/ethnicity received TRUMENBA at single dose and meningococcal quadrivalent conjugate vaccine, both via an unspecified route of administration in the same arm on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced significant swelling and redness in his arm with outcome of unknown.
Headaches, body aches, fever, chills, sweating, fatigue. 30 hours time course.
sore arm for 10 hours top; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for 10 hours top) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm for 10 hours top). At the time of the report, PAIN IN EXTREMITY (sore arm for 10 hours top) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Heart rate increased: high heart beats per minute (High) rapid heartbeat for 10 hours.         Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-079259 (Patient Link).
Vaccine kept in refrigerator on 11/04/2021, expiration date is 10/3/2021, administered on 11/08/2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 11/04/2021, expiration date is 10/3/2021, administered on 11/08/2021) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 11/04/2021, expiration date is 10/3/2021, administered on 11/08/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 11/04/2021, expiration date is 10/3/2021, administered on 11/08/2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was placed in the refrigerator was 04 Nov 2021. There was no temperature excursion. The reporter reported that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
t105.6 2 hr p/vax shaking poss sz; (no eye rolling no postictal phase);
CHILD'S DATE OF BIRTH WRITTEN AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY PERSON IDENTIFYING AS FATHER. CHILD IDENTIFIED WITH DATE OF BIRTH. SEE VAERS #683070 FOR FIRST DOSE ON 5/14/21.
onset of extreme fatigue within a few hours. by 8 pm strange pains all over my body: toes, fingers , arm, my scalp hurt. Nausea, dizziniess, fever, extreme chills, my head felt so heavy, burned to breathe through my mouth, cloudy vision, dry mouth, extreme pain in left arm pit, painful to lower my arm
after receiving the second shot on June 17th I experienced significant debilitating pain all throughout my body that lasted for 12+ hours. a muscle on the left side of my back has been in constant spasm ever since. the intensity varies from minor annoyance to debilitating pain that interrupts whatever I may be doing. icing doesn't seem to help. I started taking magnesium a few days ago, too soon to tell if it's helping. yesterday my right thumb started spasming without pain and was moving outside of my control. it subsided after a few hours and has not repeated. today the muscles around the left side of my mouth have been spasming. as noted above, back spasms persist daily.
Patient arrived to vaccine clinic with mom who verbalized awareness that Pfizer vaccine is for 12 years and above. Patient was pre-screened, screened, and later administered dose 1 of Pfizer vaccine at 10:42 am, 7/31/2021. Patient was monitored 15 minutes with no adverse effect reported. I was made aware of incident by observation staff. Mom, TF medic OIC and NCOIC informed. DPHSS officials notified immediately.
Swelling of forearm by 60%; muscle spasms in pectorial muscle; This is a spontaneous report from a contactable consumer.  A 36-years-old male patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), lot number=EL3247, via an unspecified route of administration in the left arm,  on 22Jan2021 at 08:45 (at the age of 36 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a doctors office/urgent care. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history was not reported.  Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included lisdexamfetamine mesilate (VYVANSE) received within 2 weeks of vaccination.  On 23Jan2021 at 0800, the patient experienced swelling of forearm by 60%, and muscle spasms in pectoral muscle. The patient was not hospitalized for the event nor received treatment. The clinical outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
1) 2 inch diameter circle -- red, swollen and very painful, even after almost 48 hours; 2) fairly severe nausea, even after almost 48 hours; 3) fatigue, and 4) shivering.
This spontaneous report as received from a registered nurse refers to a 42 year old male patient. On 24-JUN-2013 the patient was vaccinated with the second dose of RECOMBIVX HB, two 0.5 ml pediatric doses were administered to equal one adult dose of 1 ml, in the left arm (route and lot # not reported). The expiry date was reported as 17-MAY-2013. No adverse events reported at that time. Additional information has been requested.
Patient received TIV (0.5mL, Sanofi Pasteur) into the right deltoid on 12-12-2008 in the afternoon.  Mom called 12-12-2008 at 4:21 to report that patient had a bright red, pruritic rash, from head to toe within 1 hour following the Influenza vaccine.  Mom reports  that he has a history of allergy to tomato skin, but to nothing else.  Mom took patient to a prompt care and was given a prescription for Benadryl. The rash was completely gone by Sunday afternoon.
Dx of Hirschsprung's at 1 week of age, previous bowel resection. Returned after 11/20/13 for MMR-V 5/27/14. No complaints until after cecostomy tube 5/27/15. Mom now want VAERS done for incontinent stools.
pt  complaints  about redness  , rash  all over the body and  sore arm
arm was sore at the injection site; hot at the injection site; red at injection site; face got red & blotchy; neck got red & blotchy; mouth got very dry; throat tightened up; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (face got red & blotchy), ERYTHEMA (neck got red & blotchy), PAIN IN EXTREMITY (arm was sore at the injection site), DRY MOUTH (mouth got very dry) and VACCINATION SITE WARMTH (hot at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DRY MOUTH (mouth got very dry) and THROAT TIGHTNESS (throat tightened up). On 25-Feb-2021 at 12:05 AM, the patient experienced ERYTHEMA (face got red & blotchy) and ERYTHEMA (neck got red & blotchy). On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore at the injection site), VACCINATION SITE WARMTH (hot at the injection site) and VACCINATION SITE ERYTHEMA (red at injection site). At the time of the report, ERYTHEMA (face got red & blotchy), ERYTHEMA (neck got red & blotchy), PAIN IN EXTREMITY (arm was sore at the injection site), DRY MOUTH (mouth got very dry), VACCINATION SITE WARMTH (hot at the injection site), THROAT TIGHTNESS (throat tightened up) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
The pt experienced thrombocytopenic purpura. Treated with IVIG infusions.
Vomiting, Diahrrea, Exhaustion for three days (had to miss work for three days), neck and arm  hurt near site of shoulder injection,  treated with loperamide, dramamine, ibuprofen, fluids. No fever, no respiratory symptoms.
14OCT95 p/being involved in a basketball game & getting hot noticed that had a red whelpy type rash all over body, esp on trunk;rash faded over weekend, but when returned to work 16OCT95 again noticed rash when became hot; rash cont red;
Lump developed on the clavicle (left); Inflammed lymph node; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Lump developed on the clavicle (left)) and LYMPHADENOPATHY (Inflammed lymph node) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 03sa21a) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021 at 2:00 PM, received 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 SWELLING (Lump developed on the clavicle (left)) and LYMPHADENOPATHY (Inflammed lymph node). At the time of the report, SWELLING (Lump developed on the clavicle (left)) and LYMPHADENOPATHY (Inflammed lymph node) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: enflamed lymph node (abnormal) enflamed lymph node.         No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-073706 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 25-MAY-2021.Added events outcome from (unknown to not recovered/not resolved)  till date.; Sender's Comments:  MOD-2021-073706:First dose case