chrisvoncsefalvay/vaers-outcomes huggingface dataset:
30-50mm swelling and induration with inflammation left deltoid. Afebrile.
Pt. states that after receiving the 1st dose Moderna 08/02/2021, started experiencing symptoms of 08/16/2021 of a red rash at the injection site, warm to the touch, and experienced an early menstrual cycle. Planned Primary visit 08/19/2021.
Red swollen thigh left - side left day #2 after vaccination.  ER on 4-5-09 No tx.
Information has been received from a consumer concerning her current 17 year old son who in approximately 1994, at the age of 12 months was vaccinated with a first dose of MMR II (Lot# unknown). Second dose of MMR II (Lot# unknown) was given in approximately 1997 at the age of four and a half years. The consumer reported that her son was diagnosed with autism after receiving his first dose of MMR II at age of 12 months, and experienced seizures after receiving his second dose of MMR II at age of four and a half years. Caller also stated that her son's autism had been cured by chelation therapy. At the time of the report, the outcome of seizure was unknown. The patient sought unspecified medical attention. Upon internal review, autism and seizures were considered to be an other important medical events. No further information is available.
Patient was vaccinated on 14MAR21 at 1900.  On 15MAR21 at 0300, she returned to our clinic complaining of injection site (right deltoid) pain and swelling, fatigue and nausea.  Patient states she gets nauseated easily.  She was monitored by one of our registered nurses for 20 minutes before going home.  She is to follow-up with our onsite nurse as needed.
Developed a rash on backs of hands and forearms.  Rash spread to stomach, inner thigh, neck, and nose.
Client walked into clinic stating she thought she was having reaction to HEP B vaccine.  Began having elevated Temp 101 degree F 2am on the 24th.  Even taking TYLENOL over last 48 still has T 101 degree F (taking 3 super strength TYLENOL q 2-4 hr) onset of headache 3pm-25 Sept which has not decreased with med.  Episode of increased wheezing (asthmatic) 8pm - 25 Sept Took Prenotine which helped. Last dose of TYLENOL + 500 today 26 Sept.
This spontaneous report as received from a physician refers to a 16 years old male patient with chronic ear infection and no drug reactions or allergies. The patient was vaccinated intramuscularly with dose 1 of GARDASIL (lot # 0459AE Exp Date 13-DEC-2014; dose not reported) on 09-JUL-2012. No other co-suspects were reported. Concomitant medications included: ZYRTEC. On 09-JUL-2012 the patient almost fainted after receiving the first dose of the vaccine. The patient got very pale and the physician laid down on the bed. The patient recovered with some headaches. The patient sought medical attention by seeing the physician. No treatment information was reported. The outcome of headaches and almost fainted was not reported for GARDASIL. Additional information has been requested.
pt recv vax earlier in day that PM taken to ER d/t t103.4 w/febrile sz;
low grade fever/low grade fever that comes and goes; feels heavy; right arm was achy/arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (feels heavy), VACCINATION SITE PAIN (right arm was achy/arm hurts) and PYREXIA (low grade fever/low grade fever that comes and goes) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 701-224) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE.    On 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced LIMB DISCOMFORT (feels heavy) and VACCINATION SITE PAIN (right arm was achy/arm hurts). On 23-Jan-2022, the patient experienced PYREXIA (low grade fever/low grade fever that comes and goes). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE) for Adverse event, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (feels heavy) and PYREXIA (low grade fever/low grade fever that comes and goes) outcome was unknown and VACCINATION SITE PAIN (right arm was achy/arm hurts) had not resolved.            Patient was icing his arm down Patient is feeling better but arm is still achy No concomitant medications was reported.
I had my 3rd Moderna  vaccination on Monday, October 27, 2021.  Tonight (9/30/21) around 8 pm I noticed a smooth red patch on my vaccinated arm.  It was not hot to the touch, it did not itch and it was not raised.  Now at 11:30 pm if appears to be "spreading/growing" in size.  It is be down from the vaccination site and is starting to circle the upper arm and has some "burning"......still not particularly warm to the touch, or raised.  It has not reached the inside of the arm.  At what may be the injection site (I can't see that part of my arm) is a raised "bump".  I did 1.5 hours of exercise with weights (working with a trainer).....so I have used the arm all day, without difficulty or pain.  On Tue/Wed after the shot, I did experience significant "chills" which I treated with  hot showers and Tylenol/Advil (alternating).
The day after the shot, my left arm was sore, but that soreness went away. Today, I woke up with a round red rash around the injection site. It's hard and itchy and swollen. Since I was born in Poland and have the little round immigrant stamp scar from my vaccines as a kid on that arm, the stamp/scar is a little raised.
Fainted; Fever 101.6; Vomiting; Nausea; Dizzy; This is a spontaneous report from a contactable consumer reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN 9581/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 at 10:45 (at the age of 48 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included lupus, scleroderma, Mixed connective tissue disease (MCTD), and high blood pressure (HBP). The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydroxychloroquine 200 mg, and losartan 50mg.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 at 19:00, the patient experienced fainted, fever 101.6, vomiting, nausea and dizzy. The patient did not receive any treatment for these events. The outcome of the events fainted, fever 101.6, vomiting, nausea and dizzy was unknown. Since the vaccination, the patient had not been tested for COVID-19.
Papular macular exanthem face, abd, extremities, fever 38C, palm and soles involved.
Dizziness & HYPERtension Narrative:  Employee felt dizy had his b/p went up to 152/89 pulse 55 then 143/83 oxygen sats 97 percent on room aiar at 1218
The spontaneous report from a nurse via a sales representative reported similar events for two patients. This is the second of two reports. An 18-year-old female patient received the first dose of TRUMENBA (batch/lot number J29203, expiration date 01JUN2016)) intramuscular at 0.5 ml single in the left deltoid on 29JAN2016 at 4:34 PM. The patient medical history was not reported. Concomitant medications none. On 01FEB2016, the patient experienced severe redness, swelling in limb and arm and cannot move the arm with outcome of recovered on 04FEB2016. Patient chart indicated adverse reaction so patient will not get the 2nd dose. Follow-up (16MAR2016): New information from a contactable nurse includes: patient's details, administration details (batch/lot#, expiration date, dosages; route, anatomical location and date of administration). onset and outcome of the events, additional event (patient will not get the 2nd dose). Follow-up (13MAY2016): Follow-up attempts are completed. No further information is expected.
Presented with worsening weakness No clear signs of infection other than COVID swab positive. UA and CXR neg Weakness likely multifactorial with component due to COVID as well as pancytopenia and recent splenic laceration vs other PT/OT ordered Continue to monitor labs and vitals closely
Mild reaction- Injection site became red and slightly swollen a few hours after it was given.  Approx 24 hours after it was received it was still red at the injection site and became itchy. Slightly warm to touch.  Symptoms still present 36 hours after initial injection.
Maternal exposure during breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On 11-May-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved.            Concomitant medication and treatment information was not reported by the reporter.
Pt reported the symptoms the day after on 10/14/2010 complaining of headache, pain & soreness at the injection site with intermittent numbness and tingling sensation from her Right deltoid to her fingertips. Took OTC pain medication Ibuprofen for pain and headache. Pt. was advised to go to urgent care/emergency room for tingling sensation of her Right arm.
Localized reaction, red, hot swollen, pain in triceps with internal rotation of arm morning of 12/13/2001. Friday 12/14/2001 saw personal physician, gave him Zyrtec, drew circle around reddened area, told pt to return if swelling extended beyond circle. Revisit to MD, put him on 3 days of antibiotic, doesn't remember name.
Fever Chills Swollen Lymph Nodes under arms Entire body pain in joints and muscles  Headache
immed p/shot very sore but pt left & went to lift weights right afterward, trouble sleeping-cont ache; persisted 6 weeks; tender;
pt recv vax 18AUG95 & 15OCT97 pt devel many skin lesions on one leg & some on back;
Left shoulder and left deltoid tenderness and discomfort since vaccine was given on 10/23/2017.
Bell's Palsy started on 5/13 after vaccination on 5/10. Subtle ptosis progressed to facial nerve paralysis by 5/16/21.
back started hurting; Left leg started shaking/When stands up, left leg keeps shaking; This is a spontaneous report from a contactable consumer or other non hcp(patient's Mother).  A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration, administered in arm left on 15Apr2021 09:30 (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced about 25 minutes after the vaccine, back started hurting and her left leg started shaking. When she stand up her left legs kept shaking, both on 15Apr2021 09:55 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to 15 month old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 18-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # M024675 with expiry date on 18-MAY-2018; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA004609.
Patient had severe pain, swelling and redness at the injection site. Patient sought care from physician and was diagnosed with infection.
After my 1st shot in my left arm - I experienced swelling although out your face, neck and armpit but apparently the lymphatic cyst I had that time was filled with liquid and did not drain at first I went to an ENT and did 2 rounds of antibiotics and there were no changes so I had to fine needle aspiration (biopsy) and it was declared that it was lymphatic fluid and I was referred to see a surgeon to perform a surgery to remove my left proboscis gland. Then I went to have the surgery and they had to do a fat transplant in order to protect my facial nerves and removed my left proboscis gland. 2 weeks after the surgery I felt normal again and was able to go back to work.
When entering the vaccine into OSIIS it was found that on 10/15/2021 the client received a Fluzone HD vaccine at clinic. UJ715AB, LD, IM. Verified by clinic. When I called and spoke with client, she stated her husband just passed away a few weeks ago and she has been in a bit of a fog since.  She states she is feeling fine, and I explained adverse reactions and stated if she experiences any of those to proceed to the Emergency Room. She verbalized understanding and asked that we keep this between us.
headache; fever; body aches; fatigue; redness in my arm; This case was reported by a consumer via call center representative and described the occurrence of headache in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, fever, general body pain, fatigue and erythema of extremities. On an unknown date, the outcome of the headache, fever, general body pain, fatigue and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the headache, fever, general body pain, fatigue and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experianced fever, body aches, headache, fatigue and redness on her arm. The patient had very mild symptoms on 1st dose and lasted 2 and half days. The patient wanted to know was this normal to last so long.
Approximately 5 min after vaccination, mother noted redness at area surrounding site of injection area (RVL) developed approx. 1/2 inch hive. MD notified ordered BENADRYL PO. Stayed in office under observation.
5 1/2hr post vax pt had 45sec grand mal type sx w/tonic/clonic movements w/staring & post ictal sleepiness;no fever or illness prior to or during sz;EEG is being done to r/o sz disorder;
Racing heart, cough, mild symptoms of flu. No headache, sore throat, no sore muscles, general malaise.
Immediately after vaccine reported dizziness, sweating, blurred vision, nausea, lump in throat,  tingling in hands and arms.  This lasted approximately 15 minutes.  Provided with water and encouraged slow deep breaths.  Ride was called for patient unable to drive home.  The next day patient reported slight fever, fatigue, tingling in hands/arms.  Also reported chills, muscle ache, joint pain.  The patient reported that he slept for majority of next day.  Also reported severe headache next day and felt pressure in the back of the head.  Pt returned to pharmacy 1 week later and reported he was feeling better but still had some pressure/tingling in hands/arms, muscle pain/pressure, headache.
Fever reached 102.6 on and off for several hours.  Confusion, loss of memory, disorientation. Extreme fatigue, joint pain.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine stored beyond the 30 use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine stored beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine stored beyond the 30 use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient received the vaccine in deltoid.  No concomitant product reported by reporter. Vaccine was stored in fridge longer than 30 days prior to administration. The vial was stored in refrigerator on 27-May-2022. Vial did not undergone any temperature excursion. No treatment medication reported by reporter.
permanent nerve damage, had to go to a clinic to have nerves cut; This case was reported by a consumer via interactive digital media and described the occurrence of nerve damage in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On an unknown date, the patient received Shingles vaccine, Influenza vaccine Quadrivalent unspecified season and PNEUMONIA VACCINE. On an unknown date, unknown after receiving Shingles vaccine and Influenza vaccine Quadrivalent unspecified season, the patient experienced nerve damage. On an unknown date, the outcome of the nerve damage was unknown.   It was unknown if the reporter considered the nerve damage to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season.  Additional details provided were as follows: The case was reported by the son/daughter for his/her mother. Age at vaccination was not reported. The patient received Shingles vaccine, Influenza vaccine and Pneumonia vaccine and had permanent permanent nerve damage nerve damage had to go to have nerve nerves cut. Follow-up would not be possible as no contact details available. It was unknown if the reporter considered the nerve damage to be related to PNEUMONIA VACCINE. The case was linked with case US2021AMR219050, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR219050:Same reporter
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a patient who received FLUARIX quadrivalent (batch number 7994K, expiry date 16th June 2016). On an unknown date, the patient received FLUARIX quadrivalent .5 ml. On an unknown date, an unknown time after receiving FLUARIX quadrivalent, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to FLUARIX quadrivalent. Additional details were provided as follows: This case was reported by a pharmacy intern. The healthcare professional reported that several patients were vaccinated with FLUARIX QIV and they experienced soreness (tenderness) in arm around injection site. The reporter reported that about 90% of patients had reported the pain around injection site, which was an increase from when they administered the product last year. No further information was reported regarding the event.
I developed hive and itchi the day after receiving the flu vaccine. The hives began on my elbows, spreading to my arms, wrists, hands, legs, feet, buttocks, trunk, and lastly eyelids. I never had trouble swallowing or breathing.
Information has been received from a registered pharmacist concerning an unknown number of patients who were vaccinated with a dose of ZOSTAVAX that was possibly transported and improperly stored. No adverse effects was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients. Follow up information was received from the pharmacist who indicated that on 02-Dec-2008 they transported the vaccine to a clinic packed with cold packs in a cooler without a thermometer. So they have no way of confirming the temperature of the vaccine at the time of transport. They did not know to pack it dry ice. The vaccine was in the cooler for approximately 1 hour. She reported that only one patient received this vaccine. He was a 70 year old male who on an unspecified date received a dose of zoster vaccine live (Oka/Merck), lot # 658861/1822U.  When asked if he had any adverse reaction, the pharmacist reported nothing she could identify. She also reported this patient had left inguinal hernia surgery done 06-Oct-2008, prior to the vaccination, and had his right inguinal hernia surgery on 15-Dec-2008. He was discharged the same day. She did not think the procedure had anything to do with the vaccination as he had prior surgery for the other side before the vaccination. Additional information has been requested.
MULTIPLE SUBSEGMENTAL PULMONARY EMBOLI WITHOUT ACUTE COR PULMONALE ACUTE PULMONARY EMBOLISM
Information has been received from a physician via company representative referring to a female patient of unknown age. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot# not reported). Concomitant therapy was not reported. Subsequently the patient developed cold sores on her lips and a rash on an unknown date. It was unspecified if the patient sought medical attention. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
Child received immunizations on 7 May 2008 at about 1600 and returned to the clinic on 8 May 2008 for 1500 appointment due to left arm swollen, red, warm, and tender to touch.  Treated with augmentin.