chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 28-JAN-2013, a healthcare provider at a clinic, administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. In 2014, the patient was treated by his 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 the patient's 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 include care for hospitalization, 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.
I started to get or feel like the world was rocking back and forth I felt like I was on a ship, I found it hard to concentrate and I needed bed rest for two to three days.
Uncomfortable itchiness at injection site that continues on  Day 3 after vaccine administration. (I'm not freaking out about it, just reporting it.)
Patient received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a adult female patient who received HAV (Havrix) (batch number ek59b, expiry date 26th February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 12-May-2022 Reporter's Comments: The pharmacist reported that a female patient received an expired dose of Havrix. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix which was already expired which led to expired vaccine used.
Information has been received from a physician concerning a 17 year old female pt with on past medical history who on 10/2/06 was vaccainted with a dose of HPV vaccine, lot 653735/0688F. Concomitant therapy included an unspecified flu shot. It was reported that after receiving HPV vaccine, the pt passed out. Medical attention was sought. the pt recovered the same day. No further information is available.
Three weeks after getting the third dose of the vaccine, I tested positive for COVID-19. I was having trouble breathing and I thought it was Asthma or allergies. I had to use my inhaler more and I was very tired. I went to the ER for a chest X-Ray. I tested positive on 10/29/2021. Three or four days after the vaccine I had some pain in my right arm that lasted for a few days. I was prescribed some Xaralto which seems to help my breathing. I had been wearing my mask and none of my acquaintances have tested positive. I also got my Flu Vaccine about ten days after my booster.
Influenza was accidentally administered to patient on 11/15/21. Parent informed on 11/16/21, patient has no reactions and is doing well.
I had fever, body aches, fatigue, brain fog, sinus issues, upper breathing issues, cough and severe sore throat. I was really sick for about 4 weeks. On Dec 29th, I tested positive for COVID-19. I went do a cardiologist and ER twice. They did 2 CT scan, 2 chest x-ray, Echo cardio, blood work, and a heart motor. It shows that I have pericarditis effusion, which is fluid around my lungs. I also have tachycardia. My blood work showed that I have evaluated blood clots but no blood clots were found. I am still having brain fog and serve fatigue. I have not recovered from this and I am still on leave from work.
Pt recvd vax 22NOV93 & w/in a few hrs pt had t102, nausea, weakness, tired, lt arm very painful & bad h/a; seen by PA;
The day after receiving the vaccine my arm was sore to the touch this lasted a few days. About 6-7 days later it was itchy so I looked at it and it big red circle. This lasted for a few days and it went away.  I went to my doctor and they said it looked like it was a skin allergy and suggested to take Claritin and Tylenol for pain.     I received the 2nd shot 1/28/2021 - and I did not have any reactions with that dose.
Pt rpts h.a., dizziness, nausea, + diarrhea fatigue onset 01/31/2021, progressively worse today. Denies rash/hives SOB, diaphoresis, dysphagia, itching confusion, memory loss, wheezing
I itched and got little pain sparks all over my body; Hard lumps/bumpy feel; Extremely itchy; Nerve endings in her arms and legs were pulsating; Hives all over my body; arms, legs, chest, torso, back; Face was flushed; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Hard lumps/bumpy feel), PRURITUS (Extremely itchy), MUSCLE TWITCHING (Nerve endings in her arms and legs were pulsating), PRURITUS (I itched and got little pain sparks all over my body) and FLUSHING (Face was flushed) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FLUSHING (Face was flushed). On 07-Mar-2021, the patient experienced MASS (Hard lumps/bumpy feel), PRURITUS (Extremely itchy) and MUSCLE TWITCHING (Nerve endings in her arms and legs were pulsating). 07-Mar-2021, the patient experienced URTICARIA (Hives all over my body; arms, legs, chest, torso, back). On 15-Mar-2021, the patient experienced PRURITUS (I itched and got little pain sparks all over my body). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 UNK; CORTISONE (topical) at a dose of 1 UNK and PREDNISONE on 11-Mar-2021 at a dose of 1 UNK. At the time of the report, MASS (Hard lumps/bumpy feel), PRURITUS (Extremely itchy) and MUSCLE TWITCHING (Nerve endings in her arms and legs were pulsating) was resolving, PRURITUS (I itched and got little pain sparks all over my body) had resolved and FLUSHING (Face was flushed) and URTICARIA (Hives all over my body; arms, legs, chest, torso, back) had not resolved.            No Medical history and Lab history are reported Patient stated that he is not using concomitant medications as of now.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Email Describes SE for both vaccines. Dose 1 case will be created.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 12-NOV-2014, the patient was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, subcutaneous that underwent a temperature excursion. No adverse effect was reported. Additional information has been requested.
Immediate reaction of rash, facial flushing. SOB. Tightness of throat and difficulty swallowing.
After second dose not feeling welll for about 4-5 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After second dose not feeling welll for about 4-5 days) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (After second dose not feeling welll for about 4-5 days). At the time of the report, VACCINATION COMPLICATION (After second dose not feeling welll for about 4-5 days) had resolved.            No concomitant medications were reported. No treatment medications were provided.   This case was linked to MOD-2021-376941 (Patient Link).
My left arm felt like it was inside a freezer for about 1hr. It felt really cold about 15mins after the 2nd dose of Pfizer Covid vaccine
No adverse events noted. Pt inadvertently was given PPSV23 instead of PCV13. He is >2 years of age.
Information has been received from the mother of a 14.5 year old female with a history of minor asthma and no drug reactions/allergies who in approximately January 2008 (about 2 months ago), was vaccinated with the first dose of GARDASIL (lot not reported). On 26-MAR-2008, the patient was vaccinated with the second 0.5 mL dose of GARDASIL (lot not reported). There was no concomitant medication. The mother reported that after about five minutes of her daughter receiving the second dose of GARDASIL (lot not reported) she fainted while in the office. She came to in about two minutes and recovered within a few minutes. No laboratory diagnostics test were performed. No further information is available.
This case was reported by a physician via call center representative and described the occurrence of shingles in a 78-year-old male patient who received SHINGRIX for prophylaxis. On 17th May 2018, the patient received the 1st dose of SHINGRIX. On 17th August 2018, 92 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were recovering/resolving. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that her father (patient) was diagnosed with a shingles rash after vaccination. Lot number and expiration date were not available but HCP stated that vaccine administering pharmacy could be called at provided number.
Felt like regurgitating; Injection 'really burned' in left arm; Left arm  was sore; Feeling really nauseous; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (Felt like regurgitating), PAIN IN EXTREMITY (Left arm  was sore), NAUSEA (Feeling really nauseous) and INJECTION SITE PAIN (Injection 'really burned' in left arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced INJECTION SITE PAIN (Injection 'really burned' in left arm). In January 2021, the patient experienced PAIN IN EXTREMITY (Left arm  was sore) and NAUSEA (Feeling really nauseous). On 03-Feb-2021, the patient experienced FEELING ABNORMAL (Felt like regurgitating). At the time of the report, FEELING ABNORMAL (Felt like regurgitating), PAIN IN EXTREMITY (Left arm  was sore), NAUSEA (Feeling really nauseous) and INJECTION SITE PAIN (Injection 'really burned' in left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Consumer reported that she received the first dose of Moderna COVID-19 vaccine in left upper arm on 06-Jan-2021. Expiration Date: Unknown. Consumer reports the injection 'really burned' in left arm. Consumer reports on the second day, feeling really nauseous, felt like regurgitating, was not too tired and left arm was sore, after first dose. Concomitant medications included: Cholesterol pills. No information provided regarding treatment. Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow up received on 2-JUN-2021 has no new information.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
allergic reaction with welts on the body and face; allergic reaction with welts on the body and face; severe itching; This is a spontaneous report from a contactable pharmacist (patient's husband).   A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, Expiry Date: Apr2021, NDC number: 59267100002), intramuscular on 15Jan2021 ("8:30 8:45 PM ") at 0.3 mL, single on "left hip" (as reported) for COVID-19 immunization. Medical history included none. There were no concomitant medications. The first dose of the vaccine was given on 15Jan2021. The pharmacist (patient's husband) drew it up at the pharmacy and took the syringe home and gave it to her at home. He had been doing some of the clinics so he wanted her to get vaccinated just in case. Patient experienced an allergic reaction with welts on the body and face, and severe itching. The whelps on the body started Friday 15Jan2021 and they have resolved completely at this time. Patient's husband says her severe itching started 15Jan2021 and have also resolved completely at this time (also reported as "whelps and itching developed about 10 PM 18Jan2021"). The outcome of the events was recovered on an unspecified date. The adverse events did not require a visit to emergency room or physician office. The seriousness and causality were not provided. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations.
Brief Summary of Hospital Stay:  Per HPI, a 63-year-old male history of uncontrolled type 2 diabetes.  Patient also has a past history of coronary artery disease, CVA and chronic obstructive pulmonary disease.  Patient recently presented to the emergency department on April 24th complaints of abdominal pain.  Workup negative for cause of abdominal pain but he was found to be COVID positive.  Patient discharged home with 5 day course of prednisone.  Patient reports that he was in his typical state of health and feeling fine this morning when he got up.  Around 12:00 p.m. this afternoon he took a shower and then was getting dressed.  Next thing he reach remembers is finding himself on the floor.  He states ?it must have passed out?.  He is uncertain as to how long he had been down.  He denied any preceding chest pain, shortness a breath or palpitations.  He did not injure himself with this syncopal event.  Upon awakening, he was able to crawl to the living room and pull himself up into his chair.  He waited until his son came home from work at around 5:30 and then had him brought to the emergency department.  On arrival to the ER the patient was afebrile and hemodynamically stable.  Workup including CT of the chest showing no pulmonary embolism.  CT of the head with no acute abnormality.  CT of cervical spine with nothing acute.  EKG showed normal sinus rhythm.  Patient has a known history of heart failure with reduced ejection fraction.  Most recent echocardiogram about a year ago showed EF of 35-40%.  Patient also with a past history of coronary artery disease and has had 4 previous cardiac stents.  Because of the coronary artery disease and low EF, patient was transferred to Hospital for further evaluation of syncope.   Hospital Course:  1. Syncope: suspect related to #2, #3. Orthostat negative  - Continue tx for underlying infection   2. COVID-19 infection: afebrile, maintaining adequate saturation on RA - To complete course of prednisone    3. UTI w/ dysuria, leukocytosis. Procalcitonin elevated though improving from previous study. Urine cx growing e.coli, MIC pending at the time of dc  - Pt was started on empiric ceftriaxone, switched to Keflex upon d/c    4. CAD: s/p stents  - ASA, Plavix   5. HFrEF: echo w/ improved LVEF 50-55%. Not in exacerbation  - Started on BB, continue ACEI   6. DM II: pt hyperglycemic, likely component of steroid induced hyperglycemia  - Lantus - Lyrica for PN   7. Hx CVA - ASA, Plavix    8. Obesity    9. Headache  - Esgic    Issues Requiring Follow Up:  - Follow up w/ PCP
12.5 hours after the shot I had chills, headache, muscle ache, fever and fatigue. I was awake from 2:00 am - 6:00 am.  I stayed home and slept from 9:00 am - 2:00 pm. I felt better by 3:00 pm. I had mild headaches for one week after the shot.
pt recv vax; exp fever, rhinitis and cough; 14-15 days later,recovered;
PT RETURNED TO A CLINIC URGENT CARE AREA APPROX. 1.5 HOURS AFTER RECEIVING 3RD MODERNA VACCINE, COMPLAINING OF LEFT-SIDE FACIAL AND BODY NUMBNESS AND TINGLING, WITH ASSOCIATED THROAT IRRITATION THAT MAKES HER REPEATEDLY CLEAR HER THROAT, AS WELL AS DIZZINESS.  DIAGNOSED WITH ALLERGIC REACTION WITHOUT ANAPHYLAXIS; GIVEN 50 MG BENADRYL AND RX 25 MG BENADRYL TID X 3 DAYS AND RX 40 MG PREDNISONE X 3 DAYS.
Pt received vaccine and developed facial swelling and rash within 30 minutes. Wheezing and stomach pain as well. Pt was given 12.5 mg oral BENADRYL 0.5mg albuterol with Neb, and 5 mg Dexamethasone injection. His rash had resolved and only mild swelling around eyes by 3:30pm same day. Breathing had normalized.   11/3/08 Reviewed PCP medical records of 10/22/08. FINAL DX: bronchitis; allergic reaction to varicella vaccine. Records reveal patient experienced cough, nasal congestion & runny nose x 6 days on day of vaccination.  Dx w/bronchitis. Tx w/nebs, antibiotics & cough syrup.  Returned to office wheezing, rash all over, facial & eyelid swelling, ears red, injection site induration.  Tx w/antihistamine, nebs, steroids & d/c to home on same.
hyporesponsive/limp rxn for 10-15min when evaluated-nl;
Because I had a low white blood count that went exceptionally low I had a bone marrow biopsy on June eighth two thousands and twenty two 06/08/2022.
Product temperature excursion issue; No adverse event; Patient received vaccine after temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine after temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event) in an adult 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. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  In March 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 March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine after temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue).    No concomitant medications were reported.  It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Lost power the next day in the middle of the day at 12:00 PM. Had placed all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. On 2-Mar-2023-28-Mar-2023 vaccines were administered to 26 patients. No reported symptoms.  No treatment medications were reported.  This case contains information for the 6th of 26th adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Master case
shingles; post-herpetic neuralgia; Information has been received from a lawyer concerning a case in litigation and refers to female patient of an unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a shingles and post herpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the Company's product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient 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 the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality was related.  The events of shingles and post herpetic neuralgia were considered to be disabling.
Pt presents to ER with CP, + TROP, ST elevation. Pt taken to cath lab and negative for blockage. Echo normal. Dx with myocarditis and STEMI.