chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2011, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2014, the patient was treated by a healthcare provider at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Information has been received from a consumer concerning her daughter a 4 year old female who was vaccinated with a dose of hepatitis B virus vaccine (lot # 0875N). In 2004, the patient developed autism. It was unknown if medical attention was sought. There was no product quality complaint involved. The patient's autism was considered to be an other important medical event (OMIC). No further information is available.
This spontaneous report as received from a Licensed Practical Nurse, refers to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 14-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L015046, expiration date 14-SEP-2015. No concomitant therapies were reported. No adverse effects were reported. Additional information is not expected, since there was no consent to follow up.
Left pontine CVA. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 26-JAN-2015 the patient was received improperly stored VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
No adverse event; Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. as7180b) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that the vaccine was administered to 12 patients after the use by date of 06-Apr-2023. The vaccine was administered to 3 patients on 22-Apr-2023, 5 patients on 21-Apr-2023, 2 patients on 20-Apr-2023, 1 patient on 16-Apr-2023 and 1 patient on 12-Apr-2023. The patients involved were all over the age of 65. No other adverse events were reported.  Treatment medications were not provided.  This case was reported for patient 2 of 12.   This case was linked to US-MODERNATX, INC.-MOD-2023-721060 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721060:Patient 1
16 year old patient was given Moderna. Patient was scheduled for and given 2nd dose Moderna as recommended.
Day 8- site became red, hot, swollen.  Day 9 site reaction continued. Entire arm hurt. Cramps in right leg Day 10 site reaction improved. Cramps in left leg Day 11- site reaction continues to improved Day 12- bilateral legs cramping Day 13 severe back spasm Day 14- back pain  Day 15- sores on lips and mouth
no additional adverse event; administered after a temperature excursion; This spontaneous report was received from a medical assistant concerning a 15-month-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-DEC-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly on the left thigh as prophylaxis (strength, and indication were not provided), after a temperature excursion on 01-DEC-2022 at a temperature of 47.9 Fahrenheit degrees for 47 minutes (Product storage error). It was reported that the patient received 2 previous doses. No additional adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009943:
4 days ago.  Severity level is moderate.  It occurs constantly and is worsening.  Location: left foot (midfoot).  The pain radiates to the left side of body.  The pain is burning.  Context: there is no injury.  The pain is aggravated by walking.  Associated symptoms include numbness. Hand Dominance: right.  Additional information: 44 y/o female started to experience these symptom's since her vaccination on Sat 3/6/2021
Allergic to vaccine; Injection site really hot; Injection site hard; Injection site swollen/swelling to my fingers and up under my armpit; Injection site was bright red; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Allergic reaction), VACCINATION SITE WARMTH (Injection site really hot), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE SWELLING (Injection site swollen/swelling to my fingers and up under my armpit) and VACCINATION SITE ERYTHEMA (Injection site was bright red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.   No Medical History information was reported.  On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site really hot), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE SWELLING (Injection site swollen/swelling to my fingers and up under my armpit) and VACCINATION SITE ERYTHEMA (Injection site was bright red). On an unknown date, the patient experienced VACCINATION COMPLICATION (Allergic reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse reaction, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Allergic reaction), VACCINATION SITE WARMTH (Injection site really hot), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE SWELLING (Injection site swollen/swelling to my fingers and up under my armpit) and VACCINATION SITE ERYTHEMA (Injection site was bright red) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medication were reported.  Treatment details included antibiotics.  After experiencing the events patient went to urgent care and they said the swelling might be due to cellulitis and prescribed antibiotics. After taking high dose of prednisone, they said that it was not a cellulitis but instead an allergic reaction.   This case was linked to MOD-2021-339248 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow-up was received and contains significant details: primary source reporter, patient information, suspect information, event details, treatment drugs were updated. On 01-Oct-2021: Follow-up was received and contain significant details: vaccination dates were updated.
Sinus Infection (sneezing & runny nose); Sinus Infection (sneezing & runny nose); headache; fatigue; Sinus Infection (sneezing & runny nose); Sinus infection was reported as worsened; This is a spontaneous report from a contactable other health professional reporting for himself. A 31-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot# Lot EH9899), intramuscular in left arm, on 23Dec2020 at 12:00 PM, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced sinus infection (sneezing & runny nose) on 25Dec2020 at 12:00 PM with outcome of not recovered, headache on 25Dec2020 12:00 PM with outcome of not recovered, fatigue on 25Dec2020 at 12:00 PM with outcome of not recovered. The event sinus infection was reported as worsened in Dec2020 with outcome of unknown. No therapeutic measures were taken as a result of the events. The events were considered as non-serious.
Pt exp uncontrollable crying for 8 hrs-4hrs post vax had slight fever; Pertussis rxn;
diarrhea. No fevers.  Occasional cough. No loss of taste or smell.
1 DAY AFTER PATIENT RECEIVED SECOND COVID-19 VACCINATION, HE STARTED WITH VOMITING, STOMACHACHE AND HEADACHE. MOM FEELS LIKE THIS IS RELATED TO HIM RECEIVING HIS SECOND COVID VACCINE 1 DAY PRIOR.
Pt with cellulitis/blistering on right thigh. Also with induration on right thigh.
i urinated blood for 2 times; This is a spontaneous report from a contactable consumer (patient himself). A 60-years-old male patient received second dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that he got the second dose of vaccine for covid last friday and 48 hrs after that he urinated blood for 2 times in in 4hrs and once again on tuesday morning. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
4/24/2021 Pt was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, he experienced an adverse reaction with the following symptoms:  tingling of tongue.   Assessment : Time of assessment 1100 Alert and oriented. Denies dyspnea, no visible swelling noted,.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN.  VS taken at 1055- BP- 142/105, P- 116, O20 99%, recheck at 1110- BP- 150/89. P- 105, recheck at 1140- BP- 147/98, P- 113       Medications administered: Loratadine (Claritin) 10 mg  by mouth. Time: 1100. Administered by RN. Famotidine (Pepcid) 20 mg by mouth. Time: 1100. Administered by RN. Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 1110. Administered by self supply by patient.   Disposition: Reports no further symptoms of adverse reaction after observation for 60 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/24/2021 10:21 AM 0.3 mL 2/25/2020 Intramuscular
Given first dose of Prevnar on 12/11/2001. Had two episodes of tremors with eyes rolling back for a few minutes on the forth and fifth day after receiving the Prevnar.
RIGHT UPPER LOBE PE PATIENT PRESENTED TO WALK IN CLINIC 9 DAYS POST INJECTION #1 WITH CHEST PAIN IN RIGHT UPPER CHEST. SENT TO ER AS D-DIAMER ELEVATED. DX'ED WITH RUL PE AND STARTED ON  ANTICOAGULATION.
VARIVAX AND PROQUAD were administered after temperature excursion; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) Lot# T032144 and expiration date 20-MAR-2022, Lot# T032144 expiration date 20-MAR-2022, Lot#T034610 and expiration date 10-APR-2022, and Lot# T034829 and expiration date 11-APR-2022 (exact dose, route of administration and frequency were not reported) as prophylaxis. On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) lot#U016064 and expiration date 20-MAY-2023 as prophylaxis. It was reported that, VARIVAX AND PROQUAD were administered after temperature excursion (Product storage error). The vaccine underwent a temperature excursion of 14.3 degree Celsius for a period of 35 minutes. There was no previous temperature excursion.  The case is non-valid due to lack of patient identifier.
Week 2: sore throat, congestion, cough, headache, malaise, low-grade fever x4 days Week 3: numbness and tingling in feet Week 5: Balance difficulties, diffuse muscle pain, nausea, dyspnea Exam @ wk 5: unable to walk, prox>distal LE weakness, LE areflexia, ¯ pinprick to plantar surfaces Diagnosis: Guillain-Barre Syndrome variant Week 5: Progressive LE weakness Week 6: Given IVIg 2g/kg over 3 days Same week- Deficits stabilized Week 7: Discharged to acute rehabilitation Week 9: Sensory deficits resolved Week 13: Discharged to home Week 17: Ambulatory Complete functional recovery at 1 year
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a  patient of an unknown age and gender 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 second 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. On 25-Jul-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.            The patient broke out hives. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
This spontaneous report as received from a registered nurse refers to a 24 year old male patient. On unspecified dates the patient was vaccinated with VARIVAX (Merck) (batch number not provided) doses, 0.5 ml, subcutaneous for prophylaxis. When titers were drawn on an unspecified date the result was equivocal with 0.97 result. The outcome and relatedness were not provided. The patient did not seek medical attention. Additional information is not expected.
Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Severe, Additional Details: occured about one hour after shot upon patient trying to jog.  Besides above symptoms, pt. became very pale.  Recovered after resting and drinking water
DID NOT TAKE VIVOTIF ACCORDING TO THE SCHEDULE; This spontaneous case report (PVX2019-2961) was received from a nurse on 03-Dec-2019. It described a 26-year-old female consumer who "did not take Vivotif according to the schedule" (PT: Inappropriate schedule of product administration). She was receiving oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the first two doses of Vivotif according to the schedule and then waited three days to take the third dose. It was reported that she did not take the fourth dose yet.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A consumer took the first two doses of Vivotif according to the schedule and then waited three days to take the third dose (Inappropriate schedule of Vaccine administered). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer took the first two doses of Vivotif according to the schedule and then waited three days to take the third dose (Inappropriate schedule of Vaccine administered). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Fever 101.5F Chills Nausea Generalized myalgia Headache
After the patient received the Pfizer vaccine, she began to complain being dizzy. We gave her water, but afterwards, she began to lose conscious. We gave her 1 epinephrine (0.3 mg) dose, injected into her thigh. Thirty minutes later, the patient regained consciousness and was able to stand up and walk.
Headache, NauseaVomiting, left axillary lymphadema, myalgias Narrative:  Other Relevant History:
One week after injection - rash, swelling, itching, warm to touch - site about 3 inches in diameter at injection site Matches "COVID arm" reactions on internet.  Just started yesterday, so hasn't gone away yet.  Haven't contacted doctor (it is a Saturday, and Monday is a holiday, and no medical treatment required)
Woke the next morning, on 9/28  with severe shoulder/arm pain. The pain is sharp, aches, burns, tingles and sometimes causes a tingling/numbing sensation from shoulder to fingertips. It's now been 17 days of constant pain. Went to my physician on 10/4/18 and 10/11/18. Currently have an MRI scheduled for 10/17/18 to determine the cause/source of pain.
Eight hours after the vaccine, I had diarrhea.  Three hours later, I was vomiting.  Three hours after that, I had aches, pains, stomach pains, and lethargy.  By that night, I was trying to drink water, and take clear broth.  The next day, I still felt bad, but was able to drink some tea and eat bland foods.  Within about 40 hours of the vaccine, I started feeling alright.
FLUZONE HD administered 9/12/12 3pm. At 2 am patient had difficulty breathing. Right arm was red, inflamed and itching at 9/14/12 4:15 pm (2 days later) when she came in. No breathing problem.
2 days after receiving the vaccine I had severe pains in my stomach, vomiting and diarrhea. I felt weak and had a severe headache. This persisted for 3 days. I felt better on the fourth day, tried to resume my normal day and became violently ill and was rushed to the hospital with the same symptoms as described above. While in the hospital after several tests were performed a blood clot was found in my lung. I had none of the typical symptoms you would get from a blood clot. I had the issue with my digestive system for 2months following the vaccine. My stomach issues have gotten better, however I have to be tested in September to see if the clot has dissolved.
This spontaneous report as received from a physician refers to a currently 80 year old female patient with diabetes, elevated creatinine, degenerative joint disease. On 27-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 lot # M013156 (dose number and route of administration were not reported), for prophylaxis. Administered vaccine expired on 15-OCT-2017. Concomitant therapies included NAPROSYN, metformin, lisinopril (manufacturer unknown), lovastatin (manufacturer unknown), TYLENOL, vitamins (unspecified) and triamcinolone cream. The patient had no laboratory data. No adverse event was reported.
Mom called 9/28/06 at 1520 states left arm red, hard, swollen from shoulder to almost the elbow.  To Dr 9/28/06 at 1700.  Given Benadryl.  10/03/06 Mom states arm o.k. now.
Daughter in hospital. Not on any medications.  received second vaccination on June 26th. No history of mental illness.  On July 10th, they found her disoriented, barefoot, wandering the neighborhood in middle of the night near my parent's home. She was staying with them this weekend. I was worried she took 'shrooms based on behavior, but they don't test for psylocybin in standard ER drug panels. She came up negative for drugs like THC, meth, and cocaine.
mom called on 18NOV92 that immun including vax on 31AUT92; pt had temp of 104 for 9 1/2 hrs unresponsive to APAP; also cried x 9 1/2 hrs; pt to receive DT next time;
9 hours post injection she reports body aches, shaking, off-balance, knocking into walls, extreme fatigue, fever