chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-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. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients).    This case contains information for the 6 of 100 patients described by the reporter.  No concomitant medications were reported.  Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients are involved, lot numbers unknown to the HCP.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:MASTER CASE
This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. "2 weeks ago", on approximately 30-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, route not reported) for shingles prevention. On an unknown date the patient experienced minor rash on both chest and back. The outcome of the event was reported as recovered. Additional information has been requested.
Patient received pediatric dose (orange cap) of covid-19 Pfizer vaccine instead of adult (purple cap) dose. The pediatric vaccine was also not diluted prior to administration. In addition 0.25mL was given  instead of 0.3mL. The patient had no adverse reaction or symptoms due to the dosing error.
Severe nerve pain in left leg, headache, shivering, 102.4 fever, nausea. Was in the hospital for 3 days. Was kept because of fever and elevated white blood count. Had many tests but no cause was found.
Shingles; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 5YZ5L, expiry date 25-OCT-2024) for prophylaxis.   On 14-JUL-2023, the patient received the 1st dose of Shingrix. On 23-JUL-2023, 9 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 24-Jul-2023 The pharmacist reported that the patient received a dose of Shingrix and one day before the reporting day, developed shingles. The reporter did not consent to follow-up.
On December 16, 2021, at 11:45 am while administering the COVID-19 Pfizer vaccine, the serum leaked down the patient's arm while injecting. Unable to verify the quantity of serum that fell out or where from the syringe it leaked from.
This child had pain, redness, and swelling to the injection site; the pain was radiating down his leg. The child did not want to bear weight on his leg. His fever was controlled with 1 dose of Advil, no temp at office, fussy at home. The child was alert, verbal, and active at the office visit.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Right side of face numb and tingling.  Vision blurred in right eye.  Pain in face.  Diagnosed with Bells Palsy
I received my second Pfizer booster for COVID-19 on 4/7/2022. On the night of 9/23/2022, I began having a lot of head congestion, a severe headache, and a runny nose. I had been outside working in the yard earlier that day, so I figured that maybe I just had an allergy. On 9/24/2022, I felt worse. I had no appetite, and I still had a lot of head congestion, a headache, and sinus drainage. I also felt a strange sensation of being hot and cold at the same time. I took a home test and got a positive result. I had a fever that may have been about 101. I just drank cold water from the refrigerator. When I woke up on the morning of 9/25/2022, the fever was gone. However, the fever returned later that day. During this entire time, my severe headache persisted; I took Tylenol, but it didn't get rid of the pain.  I also still had the head congestion and drainage. On 9/26/2022, I called my doctor's office and had a telehealth visit with his PA, who prescribed me Paxlovid, which I started taking that evening. I still had some fever on the night of 9/26/2022, but the fever went away that night and never returned. On 9/27/2022, I felt much better. The fever was gone, the congestion and drainage had improved greatly, and the headache was gone. While I was on the Paxlovid, the drainage seemed to almost be completely gone. At the time of this writing, though, I still have a little bit of residual congestion and drainage, but it's not major. For all I know, they could be due to hay fever.
Fever, chills, nausea, headache and whole body ache - Same effects when I got the first Moderna vaccine. These side effects did not happen in later boosters. But now they are back. I reported all side effects in Vsafe but I could not get in Vsafe yesterday
rash over head, chest, back, abdomen, very itchy, no respiratory distress, swollen hands and feet. went to ER given steroids and Benadryl resolved within 1.5 hrs
Patient was given a second dose of Moderna 3/30/2021, 17 days from his first dose. Lot # 001B21A Patient did not report any adverse reactions
Loss of voice; Pneumonia; Sinus infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220138480 (Janssen).  A 30 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (Batch/Lot number: unknown) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), intramuscular, administration date 24May2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (Batch/Lot number: unknown). Relevant medical history was not reported. Concomitant medication(s) included: DOXYCYCLINE. The following information was reported: PNEUMONIA (medically significant) with onset Dec2021, outcome "recovering", described as "Pneumonia"; APHONIA (medically significant), outcome "not recovered", described as "Loss of voice"; SINUSITIS (medically significant) with onset 2021, outcome "unknown", described as "Sinus infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. The action taken for risankizumab was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 5 minutes of vaccination being given left arm from shoulder into hand felt cold. Not cold to the touch.  Lasted 1.5 hours.
Initial unsolicited report received from a nurse on 19 June 2015. A 55-year-old female patient had received a dose of ADACEL (batch number: U5214AA, expiry date, dose, dose in series were not reported) via intramuscular route in left deltoid on 10 June 2015. No illness at time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions reported as diabetes type 2 and hypercholesterolemia. Concomitant medications were not reported. On 10 June 2015, after vaccination, the patient developed fever for several days as high as 105 Fahrenheit, body aches, and injection site at left deltoid was painful. Relevant diagnostic tests/laboratory data and corrective treatments were not reported. At the time of this report, the patient was recovered from all the events. Documents held by sender: none. Follow up report received from a nurse on 7 August 2015. The patient received 0.5 ml one dose of ADACEL (expiration date- 4 December 2017) on 10 June 2015. Patient concomitant medications include 20 mg Lipitor daily, 500 mg Metformin daily and 2000 IU Vitamin D daily.
mom said feet turned blue; screaming @ least 1/2 hr; no swelling of thigh; treated w/Motrin
None to date.  Mother notified that patient was to receive 0.2 cc dose but was given 0.3 cc dose.
Right arm redness and swelling in deltoid area 10/28 patient took BENADRYL and applied ice 10/26, 10/27, 10/28. Dr. appt at 3:30pm 10-28-08.
Temperature was 100 F. at 1:15 PM on 19Mar2021 which increased to a maximum of 101 F. at 3:15 PM on 19Mar2021; slightly tender and inflamed axillary lymph nodes on the left (vaccination side); slightly tender and inflamed axillary lymph nodes on the left (vaccination side); minor chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3247, Expiration date: Not reported), via intramuscular route in left arm on 18Mar2021 at 12:30 (at the age of 57-years-old) as dose 2, single for COVID-19 immunization in a workplace clinic. Medical history included sjogren's syndrome. Concomitant medications/other medications the patient received within 2 weeks of vaccination included calcium; chondroitin sulfate, glucosamine sulfate, methylsulfonylmethane (GLUCOSAMINE CHONDROITIN & MSM); hydroxychloroquine sulfate (PLAQUENIL S); vitamin b complex and colecalciferol (VITAMIN D 3). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3247, Expiration date: Not reported), via intramuscular route in left arm on 25Feb2021 at 12:30 (at the age of 57-years-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination and didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient's temperature was 100 F at 13:15 on 19Mar2021 which increased to a maximum of 101 F at 15:15 on 19Mar2021 for which paracetamol (TYLENOL) 1000 mg taken once orally at 16:00. Additionally, the patient experienced slightly tender and inflamed axillary lymph nodes on the left (vaccination side), minor chills and fatigue on 19Mar2021. The outcome of these events was recovered in Mar2021.   No follow-up attempts are needed. No further information is expected.
She got her vaccine, she didn't feel bad that day, through the night she felt congested.  She woke up the next morning with a really bad sore throat, could hardly swallow.  She then got stuffed up later in the morning.  She has been taking the Coricidin HPB flu tablets and this has helped.  She did not call her doctor for this.  She is feeling quite a bit better and she has also been taking cough drops for her sore throat.
Left shoulder blade pain, throat and tongue fuzzy feeling, tingle, vision blurred, head pressure and slight pain. Left arm numbing. Dizzy. POST COVID syndrome symptoms worsened and regressed from recovery.
Case number PHHY2014US049408 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518195) website on 14 Apr 2014. This report refers to a 64-year-old male patient. His medical history included sulfa antibiotic allergies but never had had a bad reaction to triple antibiotic ointment. His current condition included diabetes and hypertension. He was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unknown date, after vaccination she experienced flu like symptoms with general achiness. The outcome, seriousness and causality of the events were not reported.
I have since then  have had a first dose of Covid vaccine  I still have some isolated itching but nothing like it was before.; the thing on my shoulder that looks like a lymph node or the cyst; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 20Mar2021, as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient previously took pantoprazole and experienced itching and had an allergic reaction.  The patient experienced some isolated itching and a thing on her shoulder that looks like a lymph node or the cyst on Mar2021.The patient further stated that it is located on the side of the arm where she got vaccinated, stated that it is almost on her shoulder blade. The outcome of the events was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Blood in stool; PFIZER-BIONTECH COVID-19 VACCINE First dose on 30Mar2021 08:00 and Second dose on 30Mar2021 12:00; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 30Mar2021 08:00 (Batch/Lot number was not reported) and 2nd dose on 30Mar2021 12:00 (Batch/Lot number was not reported) both given via an unspecified route of administration administered on Arm Left as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history was not reported. Concomitant medication included phentermine (PHENTERMINE) taken for an unspecified indication and therapy dates.  On 05Apr2021 03:00, the patient had blood in stool and not yet recovered.  The patient did not receive any treatment for the event of blood in stool . The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. Information on lot and batch numbers cannot be obtained.
I had my vaccine at 12:15 pm. Five hours after vaccine, at 5 pm, I started to get chills. I took Advil and they went away. Once Advil wore off 5 hours later at 10 pm , I had  a fever,  very thirsty, shivers, and small headache. I took two more Advil at 11 pm and my shivers disappeared by midnight. By morning time my fever broke and  I?m left with a small headache.
This spontaneous report as received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions and concomitant medication provided. On an unknown date in January 2013 (reported as on or about 04-JAN-2013), the patient was vaccinated with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot# and expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On an unknown date in August 2016 (reported as on or about 26-AUG-2016), the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events to be related to the ZOSTAVAX.
Nerve pain in shoulder; Arm weakness; Soreness was getting worse daily; Having trouble raising arm; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Nerve pain in shoulder), ASTHENIA (Arm weakness), PAIN (Soreness was getting worse daily) and LIMB DISCOMFORT (Having trouble raising arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEURALGIA (Nerve pain in shoulder), ASTHENIA (Arm weakness), PAIN (Soreness was getting worse daily) and LIMB DISCOMFORT (Having trouble raising arm). At the time of the report, NEURALGIA (Nerve pain in shoulder), ASTHENIA (Arm weakness), PAIN (Soreness was getting worse daily) and LIMB DISCOMFORT (Having trouble raising arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
All day fever 100 to 102....chills so bad body hurt about 5 hours....headache....so tired and drained......big swollen lymph nodes on my left...carvicular area it was big and squishy still there but as went down doctor's said ice and heat....she said 5 to 7 days it's been 6 and still a little swollen and squishy. Arm at shot site was sore for 5 days
Extreme weakness, chills, and nausea lasting for 12 hours, starting the morning following injection. Vomiting. Fever of 100.2 deg F. Felt faint. This was my 2nd SHINGRIX shot.
I received my 2nd Moderna vaccine on April 4th, and on May 7th I went to a local walk-in emergency clinic complaining of heart palpitations, nervousness, and shaky hands (tremors). I have since been for many tests with a cardiologist & to the neurologist. The results so far indicate: ? PVC?S extra heart beats. I wore a monitor for about 5 days and the results showed this. ? Some fluid around my heart. The cardiologist said this often is indicative of a virus.  The neurologist, he had me get MRI of brain & neck, and an EEG. The neck MRI indicated a few herniated disks and arthritis on the right side. I still get the shakiness on my right side, it's harder to form certain letters when I write, the tremors/vibrational type of feelings are on/off, during night or day, strong or mild. My heart palpitations are less now. I wrote to the CDC about my symptoms a few months ago but only received a form letter stating typical possible side effects. I didn't know about this site, VAERS  I never had any of these symptoms before getting the Moderna vaccines. (heart palpitations and tremors.) At first the heart palpitations were strong, I especially felt them at night. It felt like a clenching sharp feeling or a flutter. I still get mild flutters but much less frequently. I do get the tremors still and it's very noticeable when I try to write (like in my journal). Certain letters such as M are hard to form. I also notice if I am nervous about something I seem to feel the tremors more. They are invisible to people around me, and mostly an internal feeling. Occasionally however I can see/feel when I pick up a cup of tea, I shake or when I text it will be hard to hit the right keys. The symptoms are really hard to describe, at times it almost feels like a streaming current running from the top of my shoulder to my hand. I have this at night mostly. There is no numbness or tingling.  The cardiologists I've been seeing are Dr. & Dr.,  Dr. listed above in #14 is my Neurologist
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Tachycardia-Severe, Systemic: Unable to Sleep-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
Patient received ZOSTAVAX. Next day patient had reaction at injection site (redness, swelling) and went to urgent care. MD said she had cellulitis and prescribed Antibiotic, steroid, and pain medication.