chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed shingles on left side of body and on his back; A regulatory report was received from a Consumer concerning a 72 years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed shingles on the left side of body and on his back (Herpes zoster).  The patient's medical history includes numerous medical issues and leukemia for 16 years. The relevant concomitant medications reported were also not provided.  On 12 Feb 2021, prior to the onset of the event, the patient received his first dose of two planned vaccine doses of mRNA (Lot number: 031620A) through intramuscular route for prophylaxis of COVID-19 infection.  On 04 Mar 2021, patient developed shingles on the left side of body and on his back. The patient was taken to the clinic and was treated with Famvir 500 mg TID and Cortisone Cream.  No laboratory data was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, developed shingles on left side of body and on his back, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's underlying medical history of leukemia seems to be a strong confounding factor to the reported event.
At 2:35 PM immediately after receiving HPV vaccine, pt became pale, diaphoretic and fainted. Easily aroused after approximately 2-3 sec. Cool wash cloth to neck and monitored  for 25 min with mother present. Pt left clinic ambulatory with difficulty.
Shingles / mild outbreak; Small area about the size of a dime with one tiny blister the size of a straight pin head; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had chronic outbreaks for over 20 years).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles and blister were unknown.   It was unknown if the reporter considered the shingles and blister to be related to Shingrix.  Additional information was reported as follows: The age at vaccination was not reported. Two months before the time of reporting, the patient received a dose of Shingrix. The patient was pretty confident this was a mild outbreak, there was just one small area about the size of a dime with one tiny blister the size of a straight pin head. The patient wanted to know, had broke out with Shingles between a Shingrix Vaccination. The patient was not comfortable to giving out the information online. The GSK pharmacist provided the information that, during clinical trials, evaluation of the efficacy of Shingrix started 1 month after the 2nd dose. Therefore, the efficacy of the vaccine was unknown if the second dose was not received. Also, the GSK clinical trials (ZOE50 and ZOE70) excluded patients who had a history of previous herpes zoster (shingles). The patient guessed that, the patient would contact the physician.
When he coughs it goes away; Phlegm in his lungs; Does not feel so bad nor nauseous but he is nervous; Tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COUGH (When he coughs it goes away), PRODUCTIVE COUGH (Phlegm in his lungs), NERVOUSNESS (Does not feel so bad nor nauseous but he is nervous) and COVID-19 (Tested positive for Covid) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no known allergies.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2022, the patient experienced COVID-19 (Tested positive for Covid). On an unknown date, the patient experienced COUGH (When he coughs it goes away), PRODUCTIVE COUGH (Phlegm in his lungs) and NERVOUSNESS (Does not feel so bad nor nauseous but he is nervous). At the time of the report, COUGH (When he coughs it goes away), PRODUCTIVE COUGH (Phlegm in his lungs), NERVOUSNESS (Does not feel so bad nor nauseous but he is nervous) and COVID-19 (Tested positive for Covid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2022, SARS-CoV-2 test: Positive.         No concomitant medications was reported.  Patient had online doctor assistance. No treatment medications was reported.
I was called to see the patient in the vaccine area. He had a mild to moderate vasovagal episode prior to his vaccine without syncope. He was dizzy, diaphoretic, and pale. He was repositioned and orally hydrated. Mild to moderate vasovagal episode without syncope. This was resolved with hydration and repositioning. He was returned home at baseline with a partner as the driver.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable other-healthcare professional. A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 intramuscular, administered in Arm Left on 17Feb2021 (Lot Number: EN5318) as single dose and dose 1 intramuscular, administered in Arm Right on 27Jan2021 (Lot Number: EN5318) as single dose (Age at Vaccination: 31 Years) for covid-19 immunization. The patients medical history included motor vehicle accident (MVC) (recovering from an MVC). The patient's concomitant medications were not reported. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient was the patient diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. On 09Aug2021, patient developed symptoms of loss of taste and smell and tested positive for COVID by nasal swab test. Adverse events resulted doctor or other healthcare professional office/clinic visit. Treatment information was unknown. The outcome of the events was not resolved.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available the lack of efficacy of the vaccine BNT162B2 cannot be excluded.
I have shortness of breath on same day after receiving the vax. I thought my had chronic asthma has gotten worst. Days later, I can't exactly remember, 2 days later I had heart palpitations. Echo was schedule due to my increase SOB on exertion and palpitations. Presently I still have this palpitations and SOB on moderate exertions. I am asking my MD exemption from booster shot, though i had 2 vax and exposure to COvid. I hope thru this letter you can give me exemption. My MD is not responding to my request.
I am 8 years through menopause and I am now having monthly bleeding (period) May was just 2 days of very very lite spotting, June was 3 days of lite spotting, July 4 days of lite bleeding.  Read that it could last several months and go away again.
This case was reported by a other health professional via call center representative and described the occurrence of ankle swelling in a female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020). On 3rd May 2018, the patient received SHINGRIX. On 5th May 2018, 2 days after receiving SHINGRIX, the patient experienced ankle swelling. In May 2018, the patient experienced joint tightness and pain ankle. On an unknown date, the outcome of the ankle swelling was not recovered/not resolved and the outcome of the joint tightness and pain ankle were unknown. The reporter considered the ankle swelling to be probably related to SHINGRIX. It was unknown if the reporter considered the joint tightness and pain ankle to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced swelling of the ankle the reporter was not sure which ankle. The patient also stated that there was pain and tightness of the ankle. No additional information was provided.
Skin around injection site bright red and warm to touch.  Onset within 3 hr of injection with redness peaking at 48 hr.  At its peak, redness measured 7 cm. Duration 3 days.  No treatment.
7 days after vaccination a large, itchy, red splotch with defined borders appeared on my L arm about 10cm by 5cm over the injection site.  It has continued for the past 2 days staying about the same. I experienced arm pain lasting about 12 hours after my injection and fatigue lasting 7 days.
Received immunizatios @ 1:20 p.m. Returned to clinc @ 1:45 p.m with rash on face and both sides of neck. Nurse adminstered Benadryl 6.25 mg (1/2 tsp) P O for mild reaction per standing orders. After 25 minutes rash seemed to be fading with no spreading; No shortness of breath or swallowing difficulty. Parent left with child with instructions to go to ER if any other problems occur.
Sore arm; Muscle pain; A spontaneous report was received from a consumer concerning a  73-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm/vaccination site pain and muscle pain/myalgia.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On 19 Jan 2021,  the same day as the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch# not provided) intramuscularly in the left non-dominant arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient reported a sore arm and muscle pain after the injection. Treatment information was not provided.   On 16 Feb 2021, the patient received the second dose of of mRNA-1273 (Batch# not provided) intramuscularly for prophylaxis of COVID-19 infection.   The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, sore arm and muscle pain, was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
My iliac crest started hurting, sharp burning pain, it has moved to my hip and it is very painful to stand when I have been sitting for more than 30 minutes.  That was after my first dose. After my second dose which was on Sept 2, 2021 I now have pain in not only my iliac crest, and hip but now it is in my L knee and both ankles.
Fever, Chills, Headache (worst symptom), fatigue, lethargy , sore arm
Information has been 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. On or about 04-DEC-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, 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 condition of herpes zoster. On or about 11-DEC-2015, the patient was treated for an infection caused by the blistering vesicular outbreak of herpes zoster or shingles, which was diagnosed as peripheral neuropathy. On or about 22-JAN-2016, the patient sought subsequent treatment for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed FAMVIR and acyclovir for management of her painful symptoms and chronic pain. 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. Upon internal review, peripheral neuropathy was determined to be medically significant. Additional information has been requested.
Immediately following vaccination, the pt broke out in a red rash and whelps. The pt was treated with Benadryl.
swelling inj site rt deltoid, rt arm pit chest, neck, rt rib cage, pain over rt side of body, t104.2, chills, h/a, whelps on rt arm approx 4 days;
Patient was in the waiting area and they fell to the floor, their parent had just walked away. EMS was called and the patient decided with their parents not to go to the hospital. We were unable to ascertain what exactly happened prior to the event due to the patient's age and her state of mind after (scared and anxious)
WE GAVE PATIENT WHAT THE PHARMACY HAD IN STOCK. THE PATIENT RECEIVED ONLY 1 DOSE OF PFIZER BIVALENT FOR THE PRIMARY SERIES.
asthmatic episodes- happening a lot more ofte; fever; fatigue; Shortness of breath; A spontaneous report was received from a patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, asthmatic episode-happening a lot more often, fever and fatigue.  The patient's medical history was not provided. No concomitant product use was reported.  On 06-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 06-Jan-2021, the patient had experienced shortness of breath. On an unspecified date, it was known that the patient had experienced asthmatic-happening a lot more often, fever and fatigue.  Treatment information included Prednisone.  Action taken with mRNA-1273 was unknown.  The outcome of the events, shortness of breath, asthmatic episode-happening a lot more often, fever and fatigue, was unknown.
Patient presented to the hospital with a positive COVID test and presented with typical COVID symptoms. Treated with typical COVID therapies and went home with home health.
This case was reported by a health professional to a sales representative and described the occurrence of chest heaviness in a 51 year old male patient who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix).  The patient's medical history was notable for diabetes.  The reporter also stated that the patient was afraid of needles.  On 09/30/2004, the patient received the first dose of Twinrix.  Approximately two hours following the first dose of Twinrix, on 09/30/2004, the patient experienced a heavy feeling in his chest.  The patient was seen in an emergency room.  The reporter stated that in the emergency room, they could not locate any cardiac problem and the patient was not admitted.  The patient then was seen by his regular physician.  The reporter stated that, the regular physician could not find any cardiac problems.  The event was ongoing at the time of initial reporting.
This spontaneous report was received from a consumer refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug or allergy history. No concomitant therapies were reported.   The reporter patient said "I had the shingle shot - zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, lot #, expiration date and indication were not reported) approximately in 2010 (reported as about 11 years ago) then it was only 50% active that was why I got it a fourth time, I received two shots earlier this year (2021) both were 95% active."     It was reported that in the fourth time the patient said: "I had it on my face and in my mouth on the right side gosh was I in pain (herpes zoster) and I could not eat for two weeks it was that painful" (appetite decreased) on an unspecified date in 2021.   The outcome of herpes zoster and decreased appetite was not reported. Causality assessment was not provided.; Sender's Comments:  US-009507513-2111USA005096:
On day 1 I felt slight headache arm pain when trying to move. Day 2 I had severe arm pain, headache, severe muscle aches, nausea and vomiting with severe chills. I felt so sick and so cold and severe pain that I went to bed for 4 hours. I can?t lay on my left arm let alone move it. My body just has severe muscle aches slight fever. This was worse then having covid-19.
This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8730) via an unspecified route of administration in left arm on 25Mar2021 at 15:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have allergies to medications, food, or other products. On 25Mar2021 at 15.45, the patient experienced red and swollen at injection site with localized pain, a hard lump at injection site, and low-grade fever. The events did not result in doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. The clinical outcome of the event vaccination site lump, vaccination site pain, vaccination site swelling, vaccination site erythema and low-grade fever was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Intussusception: 5/7/12 vomited. Bloody stools on 5/10/12; 5/14 left otitis media; 5/16/12 bloody stools, poor po intake. Open reduction of intussusception after failed BE.
Patient received first does of Moderna on left arm at 0900 on 03/27/21 in her vehicle. Soon after she felt dizziness, nausea, upset stomach and felty syncope coming on. Patient received medical attention and all vital signs were within normal range. Patient refused to go to hospital. Patient was with her daughter who assumed driving responsibility and would drive the patient home. Patient advised to stay additional time to monitor her.
After first dose  on 4/25/21 things seemed normal the few days after. 6 days after first dose had sharp pain in my chest with slight dizziness. Spoke with advise nurse and did not go to the ER although it was recommended. Pain stopped after about 20 minutes, no other issues occured.  Received my second dose on 5/21/21, and on July 15th while sitting calmly at work the pain came back much more intensely. At first I though it could not be happening again, I was never informed anything like this could occur.  The pain was very sharp and intense, I threw up, had tingling in my left hand. Felt a bit dizzy. This lasted a solid 45 minutes. I was taking to the ER.
Pt. received PNEUMOVAX vaccine on 5/2/11. Iz site became very swollen, red and hot to touch, body aches, skin feels irritated.
pt recv vax;exp localized soreness & devel hives on extremities & back;devel low grade fever & aches in large joints;tx w/ meds;
5/17/21 Patient given Janssen vaccine at 1859.  1905 : patient had an episode of syncope.  BP:90/55, pulse: 50 1906: patient awake , alert and oriented.x4 1910: BP: 114/71, pulse 57. Alert and oriented x4 Patient reports a history of syncope and fear of needles.  1930: patient reports doing well. Vital signs stable, alert and oriented x4
Swollen arm; Swollen lymph nodes on her arm; Fever; Chills; Really bad body aches; Dizziness, lightheadedness; Elevated blood pressure; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness, lightheadedness), HYPERTENSION (Elevated blood pressure), PERIPHERAL SWELLING (Swollen arm), LYMPHADENOPATHY (Swollen lymph nodes on her arm) and PYREXIA (Fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced DIZZINESS (Dizziness, lightheadedness) and HYPERTENSION (Elevated blood pressure). On 13-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), LYMPHADENOPATHY (Swollen lymph nodes on her arm), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Really bad body aches). On 16-Jan-2021, PERIPHERAL SWELLING (Swollen arm), LYMPHADENOPATHY (Swollen lymph nodes on her arm), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Really bad body aches) had resolved. At the time of the report, DIZZINESS (Dizziness, lightheadedness) and HYPERTENSION (Elevated blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Blood pressure increased: elevated (High) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Call from client's neighbor/ interpreter stating client had "big red, itchy, blister like rash" all over the body and scalp, "low grade" temperature. Temp resolved after a few hrs, per caller.
Patient started to feel a tight throat and swelling  in throat about 5 minutes after vaccine. Her vital signs were as follows: BP 119/82, Pulse 100 Pulse O2 98%.  She was given Benadryl at 3:45. After 10 min she felt better. BP 107/73. Pulse 94,O2 sat 98%.
Hub around the needle leaked and didn't receive full dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number H2PE2, expiry date 19th May 2023) for prophylaxis.   On 2nd March 2022, the patient received Shingrix. On 2nd March 2022, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were reported as follows: The pharmacist reported that the Shingrix dose administered to the patient where the hub around the needle on the syringe leaked and the patient did not receive full dose of Shiingrix, which led to accidental underdose. The reporter consented to follow-up.
Between 7-8 AM on 2/8/00 the pt started vomiting profusely, broke out in a rash on his face with puffiness.  On 2/9/00 mother took child to ER. MD diagnosed the child with the flu and the rash on  his face was broken blood vessels from vomiting. Mom stated MD told her there is nothing in the vaccine that would make him sick. Mom stated child is fine today. The puffiness in his face is somewhat improved. Mom was instructed to find a family MD.