chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX on or about 01-OCT-2012 as recommended for routine adult health maintenance for the prevention of shingles (lot number, expiration date, dosage and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-SEP-2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as shingles. As a direct and proximate result of these malfunctions, 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.
Next day left arm was sore .Two day later felt sick ,head hurt, leg pain late more than usual, was real tired sleeped most of next few day
Varicella lesions > 50 11/12/2002 had varicella vaccine.
Days after receiving the latest Moderna vaccine I developed a severe psoriasis flare that has now lasted over 4 weeks; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (Days after receiving the latest Moderna vaccine I developed a severe psoriasis flare that has now lasted over 4 weeks) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Psoriasis.    On 26-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 30-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PSORIASIS (Days after receiving the latest Moderna vaccine I developed a severe psoriasis flare that has now lasted over 4 weeks). The patient was treated with CALCIPOTRIENE at an unspecified dose and frequency and BETAMETHASONE at an unspecified dose and frequency. At the time of the report, PSORIASIS (Days after receiving the latest Moderna vaccine I developed a severe psoriasis flare that has now lasted over 4 weeks) was resolving.            No concomitant medications were reported.  Reported that patient had very mild case of psoriasis. Days after receiving the latest Moderna vaccine she developed a severe psoriasis flare that has now lasted over 4 weeks. It was Itchy, burning and very painful. Was prescribed acetonide cream 0.1% that looks to be helping. Calcipotriene and betamethasone did not help.   This case was linked to US-MODERNATX, INC.-MOD-2023-750480 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750480
Vertigo started on fourth day post second shot. It occurs mostly upon movement of my head. I have not seen my physician as of this date but I do have an appointment scheduled.
Ringing in ears, 2 hours following injection.  Fever blister - lip - erupted 12 hours post injection.  Ringing in ears presists at decreased lever on this date.  Still has some ringing in ears.
Underage before the 5/12/21  approval for Pfizer vaccine Suspected falsification of DOB ? unable to contact guardian
Immediately after MMR and Varicella was given in the thigh SQ in the vastus lateralis, injection site started getting red and Dr. was informed and told patient to put ice on the area and to go to the emergency room if patient started having difficulty breathing.
This case was reported by a physician via call center representative and described the occurrence of generalized rash in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced generalized rash and discomfort. On an unknown date, the outcome of the generalized rash and discomfort were unknown. It was unknown if the reporter considered the generalized rash and discomfort to be related to SHINGRIX. Additional details were provided as follows: There were two reporters who were immunization program coordinators at the clinic who oversee the primary care Immunization program. They stated they received this information from other physicians and nurses regarding the consumer's product experience. Within about 12 hours after receiving the SHINGRIX vaccine, the consumer reported a non-injection site rash. The patient had a generalized rash across the body involving the trunk, described specifically as a flat itchy rash over the chest, back, arms and up the neck. Less than a week after receiving SHINGRIX, the patient had significant discomfort. The patient was alive at the time of reporting, and did not require overnight hospitalization for any of the reported symptoms. The reporter's grant permission to be contacted. The reporter's declined to provide concomitant medications or any further related details beyond what was documented above due to time constraints. This call was transferred to the medical information team. The supervising MD field name was for a Nurse Practitioner. It was unable to clarify what was meant by significant discomfort during the call due to time constraints.
A non-serious, spontaneous report of severe asthma and coughing has been received from an adult consumer subsequent to FLUMIST. The subject's medical history and concomitant medications were not reported. In approximately November 2005, the subject received FLUMIST. One week later in November 2005, the patient experienced severe asthma and coughing. On an unknown date in June 2006, the subject reported the adverse events of severe asthma and coughing resolved.
Patient came into the pharmacy today (12/19/17) complaining of burning/itching at the injection site (left arm Subcutaneously). Patient did not have any other symptoms other than the burning/itching at the injection site. Upon examination, the site looked irritated (red, swollen, hot to the touch) and it did seem like there was a lump at the injection site. When asked how long this had been going on she said a few days. When asked about what the patient did to alleviate her discomfort she said nothing. Suggested putting ice on the site and taking some ibuprofen. I outlined the injection site with a Sharpie and told her if it goes outside the line to seek medical attention. Also if the irritation got worse to go see her doctor.
Muscle aches; This is a spontaneous report from a contactable pharmacist (patient) via a Pfizer sales representative. A female patient of an unspecified age received 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) on unspecified date at a single dose for COVID-19 immunization. The patient was fine with the 1st dose, but the patient had muscle aches about 12 hours after the 2nd dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
After receiving the second dose of Pfizer, the next morning my Lymph Nodes become swollen and sore...mostly under the same arm as the injection site.  I also started to experience ringing in my ears, which come and go several times per day, which never happened before I received my second dose.  It's been almost 3 month's and my lymph nodes are still swollen in size and my ears still ring several times per day.
Cough. The injection site on the left arm is lower than the deltoid. The insertion point is red and painful to the touch. There is red streaking going down approx 2 inches on the arm that is painful and swollen to the touch. The skin is warm to the touch. We are watching it tonight and have the red area marked to see if it spreads. If it continues to spread patient will see a doctor.  The clinician who administered the vaccine did not inject correctly.
expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Fever, vomiting and headache developed within 6 hours of receiving the vaccine. Fever went away within a few hours. Vomiting continued through the next day until she was given benadryl, then the vomiting stopped.
He felt like he was having an asthma attack; Blood pressure became elevated; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1283), via an unspecified route of administration at right arm on an unspecified date at 77 years old at 09:30 AM at single dose for covid-19 immunization. Medical history included diabetes, sarcoidosis, hypertension, asthma, Idiopathic thrombocytopenic purpura, sleep apnea, arthritis. Known allergies included X-ray dye and statin medications. Concomitant medication included insulin, amlodipine, folic acid, nebivolol hydrochloride (BYSTOLIC), eicosapentaenoic acid ethyl ester (VASCEPA). No other vaccine in four weeks. No covid prior vaccination and Covid tested was not post vaccination. He felt like he was having an asthma attack and his blood pressure became elevated. He had to wait in the ER until they gave him his blood pressure medicine (Norvasc), a diuretic and an antacid (Pepcid). Adverse event start date was 22Jan2021 10:00 AM. The events resulted in: Emergency room/department or urgent care. Outcome of the events was recovering.
9/28/2022 I had my last vaccine and had no reaction. Two months later I went on my annual physical and they discovered that I have an excess of Monoclonal Protein in my blood. I am following up with my Physician and am scheduled for a Bone Biopsy to rule out multiple myeloma. I believe this is more related to COVID-19 than the vaccination. I tested positive for COVID-19 on 01/2021.
Localized swelling and rash on left bicep 4 x 3.5 inch rash.  Excessive itching.  Flu-like symptoms.
Within 24 hours of getting the Moderna vaccine my temperature got up to 103.4 degrees, I don't know how long that lasted or if it got any higher because I only took my temperature one time. I got a very bad headache and no over-the-counter pain relievers helped. Now three weeks after the vaccine I still have headaches on and off every day. At the same time of getting the vaccine, I got diarrhea that lasted 3 days. My body has hurt and ached and I have felt lethargic ever since. The injection site on my arm had a large knot that looked like a flesh-colored tennis ball had been cut in half and attached to my arm and was extremely painful. The pain and knot lasted roughly 5 days. Smells that I used to enjoy like a scented candle or bacon cooking now have a vile odor. Food has now turned into something that at best is tasteless, but more often has a disgusting flavor. I saw my primary doctor on Oct 7, nine days after getting the vaccine and an X-ray showed I had pneumonia. I was prescribed an antibiotic, a steroid, an inhaler, and a cough suppressant. I spent the night of 10/14/21, 16 days after getting the vaccine, in the ER because I felt like I couldn't breathe and had absolutely no energy. An x-ray was taken and showed the pneumonia was gone, but I had Acute Bronchitis. I was intravenously given 2 bags of saline solution and potassium for dehydration, even though I drink plenty of water. I also got a breathing treatment. I was prescribed another steroid. I have had covid and I can honestly say that the vaccine side effects are multiple times worse than the virus and have (so far) lasted 4 times as long.
Soreness of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness of the left arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21H and 001C21A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included LOSARTAN, METFORMIN, OXYBUTYNIN, PRAVASTATIN and TAMSULOSIN for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, 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 VACCINATION SITE PAIN (Soreness of the left arm). At the time of the report, VACCINATION SITE PAIN (Soreness of the left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, C-reactive protein: 10.78 (High) C- reactive protein levels, 10.78 when went for a routine blood work on 24th May 2021.         Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Left upper arm red and warm to touch, non indurated. Approx 22 x 12 cm erythema. TX antibiotic, antihistamine.
no additional adverse event; patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a registered nurse concerning to a 12-year old patient of unknown gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 09-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number S002393 with expiration date on 23-JAN-2021 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered dose of vaccine experienced temperature excursion of -9 to 8 degrees Celsius (C) (-6.8 C) for 6 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
fever went to 104 R the next PM 102 @ MD office; 104 @ ER noc 29JAN; pt adm w/dx of ? infection or reaction to immun; discharged 1FEB93;
On Friday, 6/14/19, patient presented with fatigue, low grade temperature (fever measurement not available), headache.  and hot flushes.  She slept for 16 hours, which is extensive given her normal sleep habits.  She took one Aleve (Naproxen 220mg) tablet some time on the evening on Friday, 6/14/19 administered by her Father.  On Saturday, at 5am on  6/15/19, patient presented with "pins and needles" feelings in both hands, pain in both hands, difficulty closing hands into a fist, the digits appeared erythemic (red), swollen, and gave off heat.  Her right thumb appeared more swollen than the rest of digits and presented with more pain.  She also displayed joint pain and stiffness in the hands.  Furthermore, patient presented with injection site redness and a rash on the left side of neck.  Patient went to work and contact her Mom at 9:15am, a Clinical Pharmacist. Her Mom scheduled an appointment with Pediatrician on duty for 10:30am and administered to patient at 10am Diphenhydramine 25 mg tablet plus Ranitidine 150 mg tablet STAT.  Pediatrician advised to rest and continue Diphenhydramine 25 mg Q4H.  May continue Ranitidine 150mg Q12Hr if desired for vaccine reaction. Family history is significant for autoimmune disorder:  Father (Psoriasis), Father's Mom (Psoriasis)
Whole body shaking, aching & pain, fever, weakness. Injection site hot, swollen, painful for 60 hours after onset of symptoms. Fever increased and continued from onset of symptoms. Child experienced difficulty moving for over 36 hours and remained in bed.
Patient was accidentally given a Pfizer COVID-19 vaccine for his second dose after receiving Moderna COVID-19 vaccine (Lot 028L20A) for his first dose on 1/20/21. Patient denies any adverse events post vaccination.
Slight arm soreness for 3 days post vaccine. 7 days after the vaccine, an area half an inch to the right of the injection site became blotchy red ( 1" wide x  2"long) it was slightly painful and itchy. It blanched when pressed.  8  days after the vaccine,  the area was paler pink not as red and looked like a sunburn not quite as itchy. (1.5"wide x 2" long). 9 days after vaccine area fading. 10 days after vaccine fading more but still not completely gone.
Night of vaccine had chills, body aches, fever, headache, nausea, bloating in stomach, fatigued.  Next day started numbness and tingling in left leg/foot, left arm and hand, pressure/ fullness in left ear and headache on left side. Very Fatigued, weakness, and brain fog, sensitive to scents.
Patient reports she had a rash at the site of injection (left arm) and on a small area on the left side of her chest. Rash resolved after three days. Patient is currently left with a dry, circular patch of skin at the site of injection. Denies any other issues.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Regained consciousness quickly (less than 30 seconds)
Pt received 1st, 2nd, and 3rd dose of Hepatitis B. Subsequently, the pt was diagnosed with Hepatitis B. Lab tests were performed. Additional information has been requested.
Pt. completed 4 dose course of TYPHOID oral vaccine appropriately. States 2 days after completion, broke out in "hives, rash all over body." Also had diarrhea. Lasted 4 - 5 days - Resolved with use of BENADRYL and time.
Pt developed shingles lesions x 3 on scalp approx 10 days post vaccine;  resolved without SEQUELAR;  Flu call 12/30.  Lesions drying - no further outbreak.
Headache, dizziness. BP 100/59 (pulse 81), O2 sat 100%.
Experiencing involuntary muscle twitches in her leg ,calf. arm, eye, and most noticeable in her thumbs; Experiencing involuntary muscle twitches in her leg ,calf. arm, eye, and most noticeable in her thumbs; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history andconcomitant medications were not reported. The patient received her first dose of Pfizer-Biontech Covid19 vaccine back on 02Apr2021. On an unknown date in Apr2021, she has since been experiencing involuntary muscle twitches in her leg, calf, arm, eye, and most noticeable in her thumbs. She stated that the twitching has been getting worse, and was affecting her daily life, stating "its difficult to put toothpaste on my toothbrush". She wanted to know if she should get the second dose, and if it will counteract the first. She was frustrated because she's seen reports of this on social media, but no information about how long the symptoms last or if they'll go away on their own. The outcome of the events was not recovered.  No follow up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a licensed practical nurse (L.P.N.) who was told by a patient's mother that she heard from someone concerning 2 female children who were vaccinated with doses of GARDASIL on an unspecified date. Subsequently the patients experienced seizures. At the time of reporting, the outcome were unknown. Upon interview review, seizures was considered to be an other important medical event. Attempts are being made to verify the existence of an identifiable patient and reporter. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Pt experienced bruising, bumps, aching muscle, cool and tingling hands. Bruise was 7cm x 4.5cm with a nodule.
1-After 5 minutes of taking the vaccine I started to sneeze few minutes later it pass. At about 12midnight  My arm was sore and in pain and very warm to the touch 2- on Tuesday morning I was very cold and very tired . 3- Around none or so I notice my self cleaning my mouth the left side , it feel like you just where out of the Dentist , like went you anesthesia from the dentist is running out. I have feeling but it almost feel like my drooling like my saliva is out of my mouth and also my left eye felt heavy and at first very watery and the dry . My left side of my mouse feel different and I?m connately cleaning my mouth.
AGE INAPPROPRIATE VACCINE ADMINISTERED TO PATIENT.  MD NOTIFIED.  MOTHER STATED PATIENT HAD NO ADVERSE REACTION TO VACCINE
myositis; This is a spontaneous report from a contactable physician.   A 43-year-old male patient received  first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date in Dec2020 reported as around the end of December,  at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported.  On an unspecified date after he received the vaccine he had right arm pain and swelling (states it was in his bicep brachial radialis in the muscle) which is the opposite arm of the injection site. He had an MRI done on an unknown date that showed myositis. He thinks could be due to the vaccine since it started two days after he received the vaccine. His pain peaked at about a week and a half and now the pain was improving and the swelling was down. He still had function in the right arm but when he strained it would hurt. His concern was that the reaction may be an autoimmune reaction and the first response was muted. He was worried the second dose may elicit a larger response. At the time of the reporting the patient was recovering from the events.  Information on Lot/Batch number has been requested.; Sender's Comments: Based on the available information, the company considers that a causal relationship between the myositis and vaccination with BNT162B2 cannot be excluded. Additional information regarding onset latency, relevant medical history, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 06-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.