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. On or about 12-JAN-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown later in 2012, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term 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.
Right and left arm numbness, fever, area was swollen and painful when touch. I also feel nervous.
4 inches by 4x pustular rash with irregular erythemic borders - location left deltoid at injection site; 4 inches by 4x pustular rash with irregular erythemic borders - location left deltoid at injection site; This is a spontaneous report from a contactable physician. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8737 and expiration date were not reported), via intramuscular route administered in left deltoid on 03Apr2021 at 10:00 (at the age of 29 year old) as single dose for COVID-19 immunization. The patient received the vaccine at public health clinic/administration facility. The patient's medical history included lactose - food sensitivity. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced 4 inches by 4x pustular rash with irregular erythemic borders - location left deltoid at injection site on 03Apr2021 at 16:00. These events result in the physician's office visit/emergency room (ER) visit. It was unknown if the patient received treatment for these events. The outcome of these events was not recovered.  No follow-up attempts are needed. No further information is expected.
Information has been received from a CMA concerning an 11 year old male with no known allergies who on 10/27/95 was vaccinated with varicella virus vaccine live (Lot # 609295/0440B). There was no concomitant medication. On 09/26/03 the pt presented in the office with chickenpox.  It was reported that the pt complained of pain but no itch. The rash appeared on his face and then spread over his body.  The number of lesions was not noted. The pt sought unspecified medical attention. There were no lab or diagnostic tests performed. Additional information has been requested.
Within 15-minutes of vaccination, the patient reported feeling dizzy and near-syncopal. EMS monitored the patient's condition on-site.
devel red itching blotches on chin around nose forehead & above eyes; 10OCT92 in the AM p/took flu vax about 1130AM-9OCT92-says still has itching on face;
Patient received booster dose (0.25ml) 16 days earlier than recommended time frame.  No adverse reactions were noted at the time of administration.  Primary series completed  11/24/21.  Booster administered 04/08/22.
Mom states got vaccines at 2pm. At 5-6pm started crying loudly, high pitched screaming and cried for 3-3.5hrs. Fever 101-102 orally. Leg no redness or swelling but knots. Did not got pediatrician or emergency room but notified at next visit.
An adult patient was administered Prevnar pediatric pneumococcal vaccine instead of Pneumovax an adult pneumococcal vaccine. The reporter stated the products are confusing especially to new pharmacy tech because the generic names are on the first line of their pharmacy labels. The attached cover letter has additional information and Wyeth Reference #.
The day after receiving the pneumonia vaccine patient experienced redness, extreme pain and excess swelling.  Patient also experienced fatigue and a heaviness in his chest accompanied by a difficulty breathing.  Patient took benedryl, which improved the chest pressure and breathing so that the patient didn't feel the need to go to the doctors.  Patient also used hydrocortisone cream that helped with the redness.   Monday morning the injection site was still red and inflamed and painful.  Patient reports no chest pressure or breathing difficulty and improvement of local symptoms.
fever; nausea; tiredness; Headache; This is a spontaneous report from a contactable consumer (patient's father) reported for his daughter. A 21-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0180, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 21-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received past drug BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0172, Expiration date: Unknown), via an unspecified route of administration on 24May2021 as dose 1, single for COVID-19 immunization and do not experience any reaction for dose 1. The patient experienced fever, nausea, tiredness and headache on an unspecified date. It was reported that she received the second dose of Pfizer vaccine last week, last Wednesday. She didn't had any reaction on the first dose but for second dose, she had fever, nausea and headache and it continued with those symptoms and it's the fifth day since the second dose. She received treatment with Tylenol and hot water for the events on an unspecified date. It was reported that she had been resting but the symptoms of the after second dose haven't disappeared. The outcome of the events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.
48 hours after first vaccine patient reports experiencing numbness to bilateral tops of arms down to wrists. Pt reports sx worse on right side where shot was given. 9 hours after second vaccine patient experienced body aches that lasted 24 hours, and numbness worsened in both arms, pt states "numbness and severe pain from fingertips up." States pain is getting worse every day and not improving. Pt's PCP aware and pt has appt next week. ER precautions discussed, understanding voiced.
On 01/08/23 I started having a sore throat that kept getting worse throughout the night. It was the worse sore throat I have ever had in my life. I used a home COVID-19 test before I called to make an appointment with my doctor. The day I was scheduled to see my doctor 01/10/23 I retested with a home COVID-19 test, this one came back positive, I called the doctor, he told me to come on in just wear my mask. I was prescribed a Z-PAK and prednisone. It did take me a couple of weeks to test negative.
"Hot-legs, sweating, lightheaded" Resolved after approximately 15 minutes, No loss of consciousness. "Weak the next Day" then OK.
blacked out; fatigue; dizziness; nausea/vomiting; nausea/vomiting; symptoms like food poisoning; Hit a pole while driving; This is spontaneous report based on the information received by Pfizer.  A contactable consumer reported for herself.  A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient was  blacked out  on an unspecified date with outcome of unknown , had fatigue on an unspecified date with outcome of unknown , dizziness  on an unspecified date with outcome of unknown , nausea/vomiting  on an unspecified date with outcome of unknown , symptoms like food poisoning  on an unspecified date with outcome of unknown , hit a pole while driving  on an unspecified date with outcome of unknown.  The event blacked out was considered an Important Medical Event. Course of the event: Patient stated she got her Covid (Pfizer) vaccine on 09Apr2021 she experienced fatigue, dizziness, nausea/vomiting, symptoms like food poisoning was able to move around few days later but she got very dizzy, blacked out and hit a pole while driving.   No follow-up attempts are possible. No further information is expected.
Swelling and raised red welt at injection site 1 week after injection.  Also shortness of breath at the same time
patient reported fever chills and headach for 3 days after vaccine given in arm. Reported local reaction starting day after the vaccine-described as warm reddened  ~ 50mm (size of an orange) swelling at site, warm to touch, 0 drainage, pain in upper extremity into arm pit.
Mild rash, low-grade fever, sleeping issues (will not sleep for more than 20 min incraments), and acting in pain.
Information has been received from a physician concerning a 14 year old female patient with hypoglycaemia, anxiety and light headedness and a history of syncope episodes who on 15-JAN-2010 was vaccinated with the third dose of GARDASIL. Concomitant therapy included anxiety medication (name unspecified). Seven days later, on 22-JAN-2010, the patient experienced chest pain, shortness of breath, nausea, headache, walking slowly, twitching eyes, abdominal pain and was taken to ER. Multiple tests were performed and everything came back normal.  The patient was referred to the rheumatologist, psychologist and cardiologist. On 25-JAN-2010 the patient was taken again to the ER with the same symptoms. Tests were performed and everything came back to normal again. Lab tests included electroencephalography, electrocardiogram, numerous blood tests like comprehensive metabolic panel, C-reactive protein thyroid, other blood tests: everything came back normal. It was noted that the patient's parents want to reported this because they thought that the syncope episode, hypoglycemia and light headedness worsened after their daughter received GARDASIL. It was noted that the patient was fine after the first and second GARDASIL dose. At the time of the report the patient had not recovered. Additional information has been requested. On 22-JAN-2010, the patient was taken to ER, and on 25-JAN-2010 was taken to another ER.
Excruciating shoulder joint pain that lasted for several days. Actual shoulder joint (not injection site).; Chills; lethargy for two days following receipt of vaccine; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via an unspecified route of administration, administered in left arm on 24Feb2021 11:00 (at the age of 55-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient did not receive other vaccine in four weeks. The patient had no medical history. The patient's concomitant medications were not reported. On 24Feb2021 14:15 the patient excruciating shoulder joint pain that lasted for several days. Actual shoulder joint (not injection site). Chills, lethargy for two days following receipt of vaccine. The events resulted in Doctor or other healthcare professional office/clinic visit. The events were treated with Ice, NSAID's, Tylenol. The outcome of events was recovering.   No follow-up attempts are possible. No further information is expected.
Patient came into pharmacy on the evening of 10-19, she wanted pharmacist to take a look at her arm, she reported an intense itching rash. Pharmacist looked at the injection site. There was an injection site reaction that was slightly warm to touch, she indicated that this area had decreased in size since after the shot. She had a rash under the arm, down her sides, across the back to the other arm and a rash on the arm that had not been administered a shot. She reported that the rash was very itching and uncomfortable. She had not tried any medication, just lotion to help sooth the itch. Due to the large area of rash, I recommended that she see her primary care doctor to check out. I called the prescriber and informed her of the above, she indicated that she would call me after she assessed patient. After assessing patient, prescriber called me and diagnosed a rash due to drug reaction, she indicated that there was no signs of angioedema etc but believed that the symptomology was that of an allergic reaction to a medication. She prescribed hydroxyzine HCL for the itch as well as triamcinolone cream. Patient came in a short while later to pick up the prescriptions.
Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022; doses were administered past the 12 hour post puncture period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered past the 12 hour post puncture period) and PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered past the 12 hour post puncture period). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered past the 12 hour post puncture period) and PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 13-Jun-2022, the patient received booster dose (batch no. 058A22-2A) of Moderna COVID-19 Vaccine.  Vial was initially stored in the refrigerator on 09-Jun-2022 and was first punctured on 10-Jun-2022 at 1:05 PM. Post puncture vial was stored in a container to protect from the light and kept in the fridge. All 4 doses administered on 13Jun2022 at 11:24 AM, 12:30 PM, 1:30 PM, 3:00 PM. Vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree C = 46 degree to 77 degree F) was Approximately 5 times, but did not reported a exact amount of time. Vial was not exposed to room temperature for more than 24 hours. It was unknown that Patient was experiencing any symptoms.  No treatment medications were reported.
Severe redness and swelling of upper arm/delt, fever of 103 degrees x 2 days.
I felt a pain in my lower back vertebrae that was only noticeable if I pushed a knuckle into the area; It just feels like inflammation; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW1053) via an unspecified route of administration on 10Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient experienced as, i felt a pain in my lower back vertebrae that was only noticeable if i pushed a knuckle into the area, it just feels like inflammation on 21Apr2021. Reported as, patient received his second dose of BioNTech COVID Vaccine on 10Apr2021. It was now 22Apr2021. Yesterday, he felt a pain in his lower back vertebrae that was only noticeable if he pushed a knuckle into the area. Today, that pain is there without any prodding. The pain was not debilitating, it was just noticeable. It just feels like inflammation, nothing serious. He do not know if this pain was related to the vaccine, but he could not imagine what else could have caused it. He know this pain was minor, and possibly unrelated to the vaccine, but he feel obligated to at least report the condition. The enquiry did not involve a report of exposure during pregnancy. Outcome of the events were not recovered.  No follow-up attempts are needed. No further information is expected.
Information has been received from a consumer concerning a 15 month old daughter with no pertinent medical history or drug allergies, who on 01-JUL-2002 was vaccinated with a 0.5ml dose of MMR II. There was no concomitant medication. On approximately 3-JUL-2002 the first seizure occurred. The patient was unable to hold up head or control body; the seizure lasted about a minute. The patient developed a total of 4 seizures after vaccination. On approximately 03-JUL-2002 the patient's mother also reported blood in stool. Unspecified medical attention was sought. Diagnostic studies included an ECG, no labs were performed. The child's recovery status was unknown and the child's last seizure was in 2003. There was no product quality complaint. Upon internal review, convulsion considered an other important medical event. No further information is available.
I've had a chronic hives/rash breakout across various parts of my body for the past several months since my second dose. I recently had a significant flare for 10 days post my third dose. It first started around 2 weeks post my second dose. I did not think it would have been related to the vaccine at the time. After about 5 months of treating with antihistamine, I saw an allergist. The allergist diagnosed the condition as chronic idiopathic urticaria and advised to continue to treat with antihistamines daily. The symptoms subsided with the use of a daily dose of Allegra. However, 10 days after my third dose, I again broke-out in a severe rash while on the morning Allegra dose. I have increased the dose to include Zyrtec in the evening, which has helped with some of the symptoms. Symptoms include itchy red, raised bumps of various sizes/patterns across different areas of the body. Hives come and go in various areas including legs, feet, thighs, neck, face, arms, torso, etc.
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Started to get sick), HEADACHE (Really bad headache), MYALGIA (Body ache) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 031M20A) for COVID-19 vaccination.     Concomitant products included VALSARTAN for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced ILLNESS (Started to get sick), HEADACHE (Really bad headache), MYALGIA (Body ache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ILLNESS (Started to get sick), HEADACHE (Really bad headache), MYALGIA (Body ache) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Pneumonia; she is too weak to move; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. This consumer reported similar events for two patients. This is the first of two reports.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia (pneumonia) on an unspecified date. It was also reported that the patient was unable to receive her second dose since she was too weak to move on an unspecified date. Outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021233483 Same reporter, drug, similar event and different patients
Thursday, 3-25-21   12:30 p.m. - Started feeling  slight soreness and pain, slight numbness in my right hip. This progressively got worse throughout that night.  Friday, 3-26-21.  7:00 a.m. - Woke up in more pain in my right hip and right leg. I almost cried trying to get out of bed. Felt like a car ran into my right hip. Very painful to walk. Saturday, 3-27-21. Extreme pain to get out of bed, walk. EXTREMELY painful to lift my right leg to try to go up stairs. Wife wanted me to go to the Emergency Room, but I suspected this was a reaction to my Covid shot. Sunday, 3-28-21. Same pain in the morning. Suddenly, about 1:00 p.m., the soreness started to subside. At 3:00 p.m. I could walk up and down the stairs without extreme pain. There was still a lot of soreness, but not extreme. Monday, 3-29-21. Woke up this morning and can get out of bed without much pain at all. This afternoon I am about 90% back to normal walking, without pain.
This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift it up she has to help the left hand with the right one), BACK PAIN (major pain that goes to the neck or back), NECK PAIN (major pain that goes to the neck or back), PAIN (pain of 10) and VACCINATION SITE REACTION (hole in left  hand) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient was not tested positive or diagnosed for COVID-19. Patient did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. Concurrent medical conditions included Food allergy (seafoods). On 01-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift it up she has to help the left hand with the right one), BACK PAIN (major pain that goes to the neck or back), NECK PAIN (major pain that goes to the neck or back), PAIN (pain of 10), VACCINATION SITE REACTION (hole in left  hand), HYPOAESTHESIA (numbness in fingers) and VACCINATION SITE SWELLING (left hand swollen). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift it up she has to help the left hand with the right one), BACK PAIN (major pain that goes to the neck or back), NECK PAIN (major pain that goes to the neck or back), PAIN (pain of 10), VACCINATION SITE REACTION (hole in left  hand), HYPOAESTHESIA (numbness in fingers) and VACCINATION SITE SWELLING (left hand swollen) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. AE cause patient to seek urgent care and specialist. It was reported that all the symptoms got worsened.