chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received multiple vaccines at 10:28 AM on 9/25/01 and a dose of Tylenol immediately afterwards. She cried fairly constantly until 18:00 PM. Motrin given 40 minutes before crying stopped. No other signs or symptoms other than tender injection sites.
The patient was given a dose of the undiluted (Gray cap) Pfizer COVID-19 Bivalent booster that was not stored in an ultra-cold temperature freezer and was instead stored in the regular freezer (between -30 to -20 F). It was moved out of the regular freezer to the refrigerator after more than 3 weeks in the regular freezer. The doses were then used after more than 24 hours in the refrigerator. We have contacted Pfizer about this and according to their off-label studies they provided via file, they are not able to support the temperature excursions that occurred. As guidance, the recommendation is to re-vaccinate the individual with the full authorized dose of any Bivalent vaccine (either Pfizer or Moderna) and we have communicated with the patient for re-vaccination.
4:20 vaccine administered, 4:29 sat down in the chair in waiting room. Arms, torso and legs felt warm and I felt very sleepy.  I was not able to keep my head up or my eyes open.  I nodded out a few times, and asked to woman at the desk "is this normal? I can't stay awake".  I was put on gurney and taken to ER.  Day after (1/16) a rash formed on my left forearm and bicep area. Rash lasted about 1 week.  Perhaps from latex from the glove when nurse gave me IV...
Minor tenderness/persistent soreness over skin at site of injection. Continues (possibly slightly increasing) as of today, Feb 20, though still minor.
VR described a brief syncopal episode several minutes after injection. VR feels almost entirely back to normal after event. She has a history of syncope with injections. She improved without any treatment.
A rash of round, red welts on the skin of my arms and a few in other parts of my body. A little feeling of rash.
30-year-old with no medical history with allergy to seafood presented with mild throat itching after 1st dose of vaccine.  In no acute distress.  Lungs clear to auscultation bilaterally.  No throat swelling.  Uvula midline. VS 120/80. HR 48 79% RA.  Received Benadryl and observed for 30 minutes.  Completely asymptomatic before discharge.  Denies chest pain, shortness of breath, palpitations, dizziness, difficulty breathing, or any other symptoms.  Ambulatory before discharge.  Advised to call 911 or go to nearest emergency room if any symptoms.
This case was reported by a pharmacist and described a patient who did not respond to the hepatitis B vaccine recombinant immunization series.  The patient's medical history, concurrent medical conditions, and concurrent medications were not reported.  On an unspecified date, the patient received the third dose of Engerix-B.  On an unspecified date following the third dose Engerix-B, a hepatitis B surface antibody titer showed no immune response.
Parent falsified patients DOB to make them eligible for COVID-19 vaccine. At the time pediatric doses were not yet approved. Parent reported child's DOB as 12 yo, actual DOB is 10 yo. Patient received 1st Pfizer 0.3 mL dose based on 12 year old adult Pfizer protocol. Discovered at 2nd dose appointment when DOB was confirmed because parent said now it didn't matter because she could receive at 10 years old not realizing dosing is not equivalent. Parent stated the patient has type 1 diabetes and endocrinologist encouraged them to do this so child could receive vaccine now and parent was only "following doctors orders". Explained to parent we cannot give 2nd dose as adult dose, dose was denied at that time and patient was referred to pharmacy administering pediatric doses that day. Patient was given 2nd dose as correct pediatric dose based on 10 year old protocol.
This spontaneous report received from a physician concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of product storage error was not reported. This report was non-serious.
Right upper arm presents with swelling, redness and pain. Pain is throbbing in nature 6/10.  Warm to touch. Treated with HYDROXYZINE HCL 50 MG ORAL TABLET (HYDROXYZINE HCL) 1 by mouth 3 times a day as needed
Information has been received regarding a case in litigation from a lawyer, a 63 year old male patient, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 13-NOV-2015, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a pharmacist at a pharmacy. On or about 04-MAY-2016, the patient was treated by a physician for the following injury resulting from his use of ZOSTAVAX: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Patient describes her arm after shot to be very sore and also patient had a red large rash on the side of her arm that is very itchy
On Thursday, March 18, I had some slight dizziness during the day. After going to bed that night I woke up and the night light in the smoke alarm on the ceiling appeared to be spinning. I sat, then stood, grabbling walls for support and attempted to reach my recliner. At that point I was severely dizzy, completely lost any sense of balance and collapsed into the chair. I could not stand or walk. After 20 minutes, I asked my wife to call an ambulance. I did not think she would be able to get me into our car. The paramedics ran an EKG and tested me for a stroke. Both were normal. I was transported to the ER. The doctor gave me Meclizine. Had a CT scan of my brain, and blood work. All results normal. Dizziness resolved. They tested my balance and then released me at 3:30 a.m. on March 19. I was tired that day, but did not need further medication. During that night, as I turned over in bed, the vertigo returned. I took a Meclizine and went to the recliner for the remainder of the night. I am feeling somewhat fuzzy today, March 20. Not sure how long this will continue, or if it is related to my Covid vaccination. However, I am reporting it in the event that others may be experiencing this problem as well.
First, intense soreness in entire arm that received injection. Then developed fever (102.5 degrees on 11/22) with general body aches, difficulty breathing, and headache. Dr. prescribed Vicodin on 11/23, which helped with body aches and fever, but not headache, which was non-stop and at a pain level of 9/10. After 5 days of pain, my doctor admitted me to the hospital (11/26-27) for 36 hours to get Dilaudid for the headache pain. After I was released, I had reoccurring headaches for about 2 weeks.
Information has been received from a registered nurse (R.N.) concerning a female patient who received two doses of GARDASIL. The patient had no difficulties after the first dose. After the second dose the patient experienced a high fever, soreness in her arm and temporary paralysis. The patient sought medical attention through an office visit. Upon internal review, temporary paralysis was determined to be an other important medical event. No further information is available.
Sore arm; Dry cough; Mind fog; Feeling weak; Tired; Low grade fever; Headache; Lung infection; Covid-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Lung infection) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Smoker.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced PNEUMONIA (Lung infection) (seriousness criterion medically significant) and COVID-19 (Covid-19 positive). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), COUGH (Dry cough), FEELING ABNORMAL (Mind fog), ASTHENIA (Feeling weak), FATIGUE (Tired), PYREXIA (Low grade fever) and HEADACHE (Headache). On 01-Jun-2021, COVID-19 (Covid-19 positive) had resolved. At the time of the report, PNEUMONIA (Lung infection), PAIN IN EXTREMITY (Sore arm), COUGH (Dry cough), FEELING ABNORMAL (Mind fog), ASTHENIA (Feeling weak), FATIGUE (Tired), PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, SARS-CoV-2 test: positive (Positive) positive. On 01-Jun-2021, SARS-CoV-2 test: negative (Negative) negative.         No concomitant medication reported. The patient experienced a sore arm and feeling weak and tired. The patient experienced low grade fever, dry cough, mind fog, and headaches for 2-3 days. The patient developed a lung infection and had to be placed on antibiotics.  Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Headache fatigue and pyrexia are consistent with the product known safety profile.  Based on biological implausibility, Covid-19 and pneumonia are assessed as not related to product use; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Headache fatigue and pyrexia are consistent with the product known safety profile.  Based on biological implausibility, Covid-19 and pneumonia are assessed as not related to product use
Suspected Vaccination failure; have had shingles multiple times; I've had 4 shingles shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis, Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 4th dose of Shingles vaccine, the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: have had shingles multiple times) and extra dose administered (Verbatim: I've had 4 shingles shots). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 The case was received from the patient's wife via interactive digital media. The patient had 4 Shingles shots and have had shingles multiple times per year for the past 40 years. The patient stated that it never ends. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received 3rd and 4th dose of Shingles vaccine, which led to extra dose administered. The follow-up could not be possible as no contact details were available.
after vaccine I experienced soreness in shot area, at 4:00 am I experienced severe dizziness, fizzing & ringing of ears, and past out/fell on the floor upon return from restroom; at this time symptoms include swelling/warmth in shot area, bruise, body soreness from the fall in neck, back, shoulder area, mild headache, soreness of eyes and ear pain
Pfizer-BioNTech COVID-19 Vaccine EUA: patient hospitalized for pyelonephritis, pneumonia, and recurrent nausea and vomiting  after receiving vaccination. Received antiemetics, antimicrobials, and supportive care. Discharged to home medically stable.
Tender axillary lymphadenopathy on left side. Vaccine also given in left deltoid. Started about 24 hours after receiving vaccine. Reporting 48 hours after vaccine and still present/tender.
This spontaneous case, initially received on 07-Sep-2018, reported by a pharmacist and concerns a 63-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 07-Sep-2018, the patient received the suspect vaccine FLUCELVAX QIV (dose: 0.5 ml, batch number: 195124, expiry date: 30-Apr-2018, route of administration and anatomical location: not reported). On the same day, the patient also received  the non-company suspect ZOSTAVAX ([reported as SHINGRIX] (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, the patient was observed for 10 minutes and did not experience any adverse events. This case '201803758' was linked to '201803759' reported by the same reporter. The reporter assessed the case as non-serious.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 at 13:00 as dose 1, single (Lot number: ER8729), on 29Apr2021 at 13:00 as dose 2, single (Lot number: EW0170) and on 06Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; COMBIPATCH; LATANOPROST. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Negative; (17May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that patient received Product COVID 19 treatment, Brand Paxlovid, with start date- 05May2022 and 10May2022 for treatment of COVID-19.
Patient developed a large circular itching rash on back of left shoulder that looks like shingles.
frequent urination over 20 x a day; mild confusion; hot flashes; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (frequent urination over 20 x a day), CONFUSIONAL STATE (mild confusion), HOT FLUSH (hot flashes) and HEADACHE (Headaches) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POLLAKIURIA (frequent urination over 20 x a day), CONFUSIONAL STATE (mild confusion), HOT FLUSH (hot flashes) and HEADACHE (Headaches). At the time of the report, POLLAKIURIA (frequent urination over 20 x a day), CONFUSIONAL STATE (mild confusion), HOT FLUSH (hot flashes) and HEADACHE (Headaches) outcome was unknown.            Concomitant medication were not reported. Treatment medication were not reported.
A report has been received from a Health Professional concerning a 16 year old Male patient, who received Nasal FLUMIST Quadrivalent (Intranasal), 0.2 milliliters, unknown for influenza. FLUMIST Quadrivalent started on 04-JAN-2016. Nurse reported patient received FLUMIST on 4-JAN-2015 then the Flu Shot on 7-JAN-2015.  FLUMIST Quadrivalent (Intranasal) was continued. The outcome of the event of received FLUMIST on 4-JAN-2015 Then The Flu Shot on 7-JAN2015 was unknown. Report provided no information about the lot and how FLUMIST was administered. The report was considered to be non-serious.
On August 17th he experienced numbness on the right side of his body, expressive aphasia-unable to say the words he wanted to say.  He was taken to the emergency room and had MRI/ MRA completed. Symptoms resolved after 2 hours. MRA revealed a notice blood vessel in the left side of the brain. Pending follow up with Neurology.
minor hallucinations; metallic taste; horrible smell that she experiences in which it makes her not want to eat or drink; chills; joint pain; tissue tender; This is a spontaneous report from a contactable nurse (patient).  An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN9581), via an unspecified route of administration, administered in deltoid right on 12Feb2021 (at the age of 80-years-old) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 22Jan2021 for COVID-19 immunisation. The reporter stated that since then (having both doses of the vaccine), she has been to the emergency room 4 different times experiencing side effects. She has a metallic taste and horrible smell that she experienced in which it made her not want to eat or drink. She has minor hallucinations, chills, joint pain, and her tissue is tender. Her joint pain has improved. Then stated, "I'm afraid I'm going to die from it." She asked if anyone has reported these reactions previously and what should she do about them. Her family physician's nurse looked up a study in which 11% of the patients were experiencing a metallic taste. Also stated, "This is very discouraging and depressing." The outcome of the event joint pain was recovering while of the rest was unknown.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of minor hallucinations cannot be excluded due to temporal relationship.  The case will be reassessed should additional information become available.  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.
Shingles, ear ache, sore throat, headache, skin sensitivity, hives, skin rash, skin burning sensation
Both my wife and myself had severe reaction to Pneumonia shot soreness, red swelling approx. 2x 4 on underarm where shot was given. Wife had chills was at a point she just shook for about 2 hours. Both our upper arms looked like it was blown up like a balloon and hurt like hell.  Shot was given under the tender part of the arm which I had never seen before. After three days my are is still somewhat sore but wife still in some pain and still red and sore.  I would expect that I would have some kind of reaction  because of my allergic history but  with my wife getting same reaction I find it very strange and wonder if dosage was faulty.  I am 74 years of age and my wife is 65 and we have never had a reaction like this on other shot.  I called the store and asked if anyone else had a reaction to the shot and they said they had no complaints............I find that hard to believe and would appreciate if you would look into the situation. Thank you.
The patient did not have an adverse event. The patient lied to us stating that she had not received the vaccine even though she had already received dose 1 and 2 in March and April of 2021.  She was informed to lie to us in order to get the vaccines again  as she was told she did not have any antibodies. As of today she has received a total of 3 doses of Moderna.  Per company policy it is required for us to report this to VAERS.
Information has been received from a female patient, who is also a pharmacist, who was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation) "several years ago." Subsequently, the titer drawn shows rubella failure Unspecified medical attention was sought.  Additional information has been requested.
every bone in my body was hurting/my face bones hurt; my skull hurt; I thought I was going to die; I hurt so much I couldn't talk; violent chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (every bone in my body was hurting/my face bones hurt), HEAD DISCOMFORT (my skull hurt), FEAR OF DEATH (I thought I was going to die), APHASIA (I hurt so much I couldn't talk) and CHILLS (violent chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced BONE PAIN (every bone in my body was hurting/my face bones hurt), HEAD DISCOMFORT (my skull hurt), FEAR OF DEATH (I thought I was going to die), APHASIA (I hurt so much I couldn't talk), CHILLS (violent chills) and NAUSEA (nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 13-Feb-2021, BONE PAIN (every bone in my body was hurting/my face bones hurt), HEAD DISCOMFORT (my skull hurt), FEAR OF DEATH (I thought I was going to die), APHASIA (I hurt so much I couldn't talk), CHILLS (violent chills) and NAUSEA (nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported.   This case was linked to MOD-2021-357771 (Patient Link).