chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 05-FEB-2019 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) on or about 11-APR-2008 at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated at a medical center for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the vaccine ZOSTAVAX and/or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Vaccination was given to several members after the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccination was given to several members after the expiration date) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccination was given to several members after the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccination was given to several members after the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment medications were not provided.
Patient is 7 years old and was given the bivalent covid Pfizer vaccine for 6-mo-4 years.
SHIVERING; This spontaneous report received from a parent concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced shivering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shivering was not reported. This report was non-serious.
Fever chills major body aches Arm very sore couldn't lift arm for a day and got very dizzy and could not stand and walk without help
administered adjuvant without antigen powder; administered adjuvant without antigen powder; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2021, the patient received Shingrix. On 23rd September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and 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 details were provided as follows: The pharmacist reported that, physician who works at practice with her administered Shingrix adjuvant vial to patient without reconstituting with antigen powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not have any details regarding the name of who administered the adjuvant, the patient who received the adjuvant, or the vial lot or expiration number. No additional information was provided by the caller. The reporter did not consent to follow up.
Fever, nausea, extreme joint pain, muscle spasms, migraine lasting for days, nose bleeds, broken blood vessels in eyes and on face
welts began to appear on arm and shoulder  within about 1.5 hours -2 hours after injection. Hot, swollen, welts
Varicella breakthrough, had vaccine 08/11/1997. Seen in our office 06/16/2005 by MD and DX with varicella. Had about 60 vesicles on trunk, legs, face, no fever. Rash broke out 06/16/2005 and crusted by 06/21/2005.
fever 103 degrees axillary, and fussiness within the first 24 hours post vaccines
Moderna COVID?19 Vaccine EUA  9 days after injection my left arm at the injection site is red, hot, and itchy. There is mild tenderness and the skin is more firm than the rest of my skin.
Patient vaccinated on 2/22/2021 with first dose of series and then  again on 3/1/2021 with same vaccines due to an error in patient identification.  Pt lives in congregate setting and issues with patient identification were multi-factorial.  RN on site at the facility states that patient has denied any adverse effects from receiving vaccines at the incorrect intervals and within such a short window.  Pt with documented temp of 99.8F on 3/1/2021.  Patient to be continually monitored by RN in facility as well as will be followed by clinician.
Heart rate of 30 beats per minute higher than normal over  a period of hours. Fever of about 100.2.  Oxygen levels is mid 90s
This patient developed a diffuse rash over his body, varicella like. He required symptomatic treatment.
little bruising on her shot site; aches; Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), VACCINATION SITE BRUISING (little bruising on her shot site) and PAIN (aches) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN (Pain) and PAIN (aches). On an unknown date, the patient experienced VACCINATION SITE BRUISING (little bruising on her shot site). On 21-Apr-2021, PAIN (Pain) and PAIN (aches) had resolved. At the time of the report, VACCINATION SITE BRUISING (little bruising on her shot site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided. No relevant concomitant medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-082980, US-MODERNATX, INC.-MOD-2021-082892, MOD21-079885 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-082980:1st dose US-MODERNATX, INC.-MOD-2021-082892: MOD21-079885:
redness, swelling, fever @ site of DTP area approx 40mm diameter; taking APAP;
Pt recv vax on 3/3/99; on 3/4/99 pt exp fever, decreased appetite, 3/6/99 pt exp diarrhea, cough
Since receiving vaccine, patient states she has had nausea, fatigue, malaise and some shortness of breath.  She also states that she has had a headache that is atypical for her.  Patient is treated with diphenhydramine, ketorolac and metoclopramide with improvement.
Shortly after receiving vaccines, patient describes feeling headache and generally unwell (malaise and fatigue). A couple days later erupted in an itchy rash all over. Physician could not find any other exposures  and thought symptoms may have been related to IgE-mediated true allergic reaction (headache, fatigue, malaise in a quick onset) but atypical because rash was delayed and not urticaria.
COVID-19 vaccine administered in left deltoid around 9:13 am on 8/3/2022. Less than a minute after vaccine administration, patient slouched forward, passed-out while sitting on clinical room table. He was laid down on the table. Patient came back to as was being laid down. His feet were raised. Vital signs taken at 9:15 am. Pulse oximeter 99%, pulse 60 and blood pressure 100/72. Patient given juice and had head raised. He was alert and oriented. He stated he felt better. Patient given Tdap vaccine afterward. Checked on patient 20 minutes later. Had him sit up for a bit. Retook vitals at 9:44 am. Pulse ox 99%, pulse 61 and blood pressure 102/64. Had patient get up and walk down the hall with me and another nurse behind. Patient walked steady and needed no support. He stated felt perfectly fine. He left clinic after.
9hrs after administration, I began having extreme muscle aches, chills and nausea. By 11:10pm I had a fever of 100.8 and by 11:25pm I had a fever of 103.7. I then began to have painful tingling in my hands and feet which lasted about 10 minutes. By the morning my fever had broke and I was left with body aches and continued hot and cold flashes for the last two days.
Mother reports child had high pitched screaming immediately following injections 4-5 hours later after sleeping he awoke and again had high pitched screaming lasting 30-45 min.
Initial report was received on 28 November 2011 from a health care professional which involved vaccination during pregnancy. A healthy pregnant female patient (date of birth not reported) had received on 02 November 2011 dose one intramuscular injection of ADACEL, lot number C3922AA and one week later after vaccination on 09 November 2011, the patient experienced a miscarriage. The patient was hospitalized (dates not reported). The patient's last menstrual period and estimated date of delivery were not reported. The outcome was not reported. Documents held by sender: None.
We gave the shot to a person who was younger than the requisite age of 18 .  She did not have any allergic reaction and tolerated the immunization well
pt started to feel light headed after vaccine. was placed supine and legs elevated. given po drink and food. evaluated by doctor and onsite medics and rn. pt vitals  hr 72  bp 121/74 100 02 sat. pt was watched for 30mins in observation and sent home in care of mother
Patient called saying that he has been having arm pain  at the site of injection since the date of injection on 10/12/20. He said that it has progressively been getting worse and he is going to consult his doctor about it.
vertigo; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the 1st of two reports.  A male patient (Age: 75, Units: unknown) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date were not reported), via an unspecified route of administration on 30Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he and his wife received the first dose of the pfizer covid 19 vaccine on Saturday 30Jan2021. The patient wanted to report that he and his wife experienced vertigo type symptoms. The outcome of the event was unknown.  Information about lot/batch number has been requested
Severe chest pain within 24 hours of vaccine. Feels like needles being poked into chest. Severe chest pain while lying on my side trying to sleep. Today is 6th day since vaccine and symptoms have not subsided at all.
Flu like symptoms for 24 hrs including 101 fever, chills, vomiting, diarrhea muscle pain- Headache Received Shingrix shot - Had symptoms 1st shot but 2nd shot severe
50 y/o female with past medical of Hypertension, Diabetes and Hypercholesteremia, who presents with nausea post vaccination. Patient states that this is her 2nd dose in the two- dose series. Patient also states that this past weekend she has had some issues with her BP being elevated. Patient states that she took both her BP meds this am without difficulty (Lisinopril and Amlodipine). Patient denies headache, sore throat, difficulty breathing or chest pain. Patient BPs were markedly elevated ranging 157/100- 174/107. Remaining vitals normal. EKG NSR.  Patient then started complaining of chest discomfort that she couldn?t quite describe, stating that she felt ?something? to the left side of her chest that would come and go. At that point, due to elevated BPs and chest discomfort, Fire Rescue was called. Fire rescue arrived and assessed patient. Patient glucose was noted to be 261. Patient still complained of chest discomfort, so it was advised that patient be transported to the ER for further evaluation. Patient refused to be transported and signed out AMA with Fire Rescue. Patient also provided and signed the Logistics and IEM AMA form, witnessed by the NP. Patient left vaccination site with husband.
Headache (intense) - lasted about 36-48 hours,  Body aches - onset around 12 hrs later - lasted about 24-36 hours Chills - onset around 12 hrs later - lasted about 24-36 hours Fatigue - lasted about 48 hrs Pain in left armpit/breast/lymph area - about 32 hours after and persisted for another 18 hrs or so I know that this was probably just a strong immune response, but it was highly uncomfortable. I am glad to be protected from COVID!
Itching skin - Began on arms and legs but has extended to chest, face, scalp, back, etc.; No hives but itching and skin became red; hot in areas; Muscle soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL 3247), via an unspecified route of administration at the left arm on 27Jan2021 10:00 at SINGLE DOSE for covid-19 immunization. The vaccine was administered in a Workplace Clinic. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amoxicillin. The patient experienced Itching skin - began on arms and legs but has extended to chest, face, scalp, back, etc. No hives but itching and skin became red and hot in areas. Itching started around 12 hours post-dose. Muscle soreness at injection site - started approximately 12 hours post-dose. It was reported that event started on 27Jan2021 22:00. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The outcome of the events was not recovered.
Headache, nausea, fatigue, light sensitivity, body ache, body feels weighed down and left arm sore where injection sight is
1/31/17 - temp 100.6. Site reaction: was very red and area was spreading and some bumps at injection site. 2/1/17 - presented at emergency room. DX: IgE mediated allergic reaction treatment: BENADRYL and naproxen.
This spontaneous report was received from a licensed practical nurse and refers to a 8-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 28-SEP-2016, the patient was vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916.
Intense back aches and joint aches, acute fever, shortness of breath, and exhaustion. Treatment consisted of increased hydration, 3 rounds of 800 milligrams of ibuprofen, and many hours of sleep and rest. Symptoms persisted for 18 hours.
On 03/31/21 Pt was administered the Moderna Covid19 vaccine and 36 hours later and intermittent/transient paresthesias on the L side, same side as the vaccine which then spread to both UE and LE bilaterally. She continues to have symptoms 6 weeks later, primarily in feet and lower leg bilaterally. Neuro exam and labs were normal. Received the 2nd Moderna vaccine on 5/6/21 without any symptoms.
On 02 September 2022, CDC recommendations for COVID-19 vaccine boosters were updated to recommend bivalent vaccine boosters for patients aged 12 and over.  Consequently, in data released on 06 September 2022, the Agency recommended that monovalent mRNA vaccines are no longer authorized as a booster dose.  Agency published a memorandum dated 18 September 2022 reiterating that monovalent mRNA vaccines are no longer authorized as a booster for people ages 12 years and older.  On 14 September 2022, a medical department representative submitted a request for vaccines through the Department to the Hospital Preventive Medicine Department.  This request included 315 doses of the ?COVID-19 mRNA Vaccine; 2-dose series.?  At the time, Hospital was not issuing the bivalent COVID-19 MRNA vaccine.  The request was filled with monovalent vaccine on 19 Sep 2022.  On 20 September 2022, medical department representatives inoculated a total of 49 personnel with the monovalent COVID-19 mRNA vaccine before this error was discovered.
17 pt's who were vax w/2 doses of varicella vax & lab eval 6-7wk post vax revealed 11 neg titers & 6 equivocal titers;
Vaccine had been stored within EUA requirements which provides a 70 day stability; however, vaccine was administered on day 71.
Pt called to c/o adverse effect to pfizer vaccine received at stadium on 4/22/21. Pt said evening of Thursday 4/22/21, he felt tingling on tongue and back of throat. Friday tingling increased and by evening, per pt, increased tingling, shaking of lips, itchiness all over body. Pt called PCP advise nurse and was advised to take benadryl, Per pt, he took benadryl on Friday evening. On Saturday, there was increased tingling and itchiness, took another benadryl and eventually symptoms subsided on Sunday. Pt advised to f/u with PCP.
post occipital headaches; malaise; decrease appetite; lack of stamina; usual sore arm; low grade fever; This case was reported by a physician and described the occurrence of occipital headache in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 months before the date of reporting).   On 31st December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced occipital headache, malaise, decreased appetite, energy decreased, pain in arm and low grade fever. On an unknown date, the outcome of the occipital headache, malaise, decreased appetite and energy decreased were not recovered/not resolved and the outcome of the pain in arm and low grade fever were unknown.   It was unknown if the reporter considered the occipital headache, malaise, decreased appetite, energy decreased, pain in arm and low grade fever to be related to Shingrix.  Additional details were provided as follows: The patient had post occipital headaches, malaise, decreased appetite, and lack of stamina, usual sore arm and low grade fever.  The polymerase chain reaction test was negative for COVID. The patient had no symptoms after the first vaccine.  Lot number and expiration date were not available to physician at the time reporting.  The reporter consented to follow up.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Rec'd FLULAVAL on 11/7/08.  Noted on Tuesday, 11/11/08 upon awakening that she was itching, noted "whelp" on chest, back, arms, face, buttocks, thighs (back) states her POP was not able to see here 11/11/08 + did go to ER, just stayed at home, did not take med.  except routine meds.  Reported to OHC 11/12/08.
Vaccine stored under refrigeration beyond 30 days. Moderna : lot number 056M21A maintained the activity necessary to protect against the SARSCoV-2 (COVID-19) virus at time of administration. Did not contact patient per no action required.
Pfizer COVID19 12+ vaccine was given. Should have been Pfizer COVID19 5-11 year vaccine. No reactions or adverse side effects.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Same day after vaccine I noticed a red spot at the injection site, more so than my husbands, and swelling. Arm was sore as is I believe most peoples.  A week later I woke up with the red spot returning and itching this time.  Didn?t itch much immediately following the injection.
Patient contacted the pharmacy on 10/09/2017 @ approximately 10:00 AM complaining of dark spots no her knees that she says appeared the day after she received her vaccination on 10/05/2017. The spots themselves are discolorations and not inflamed or giving the appearance of a rash. Patient says that the spots do hurt at night w/ sharp pain. While I do not believe this reaction is stemming from her pneumonia vaccine administration, I am reporting to VAERS system as she is convinced that it is. I recommmended that the patient consults with a physician and especially if the condition worsens.
Left upper arm warm to touch with slight induration in center approximately 3cm wide. Diagnosed with cellulitis and prescribed Duricef 250/5 1 teaspoon BID for 7 days.
Headache, Myalgia, Joint pain,Faigue, Migraine, flared up Asthma,  Narrative: