chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient experienced swelling and pain in the left deltoid where the dose was administered; the patient experienced swelling and pain in the left deltoid where the dose was administered; This spontaneous report was received from a nurse via a company representative and refers to a currently 17-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly in the left deltoid (exact dose, lot # and expiration date were not reported) for human papilloma virus (HPV) prevention. On an unknown date after the administration of the dose, the patient experienced swelling and pain in the left deltoid where the dose was administered. The patient sought medical attention by visiting the office. No treatment was given for the events. The outcome of injection site swelling and injection site pain was reported as recovering/resolving. No causality assessment was provided by the reporter.
Back pain; Chills; Headache; Myalgia; Fatigue; shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Myalgia) and FATIGUE (Fatigue) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced BACK PAIN (Back pain), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Myalgia), FATIGUE (Fatigue) and ARTHRALGIA (shoulder pain). On 08-Apr-2021, BACK PAIN (Back pain), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Myalgia) and FATIGUE (Fatigue) had resolved and ARTHRALGIA (shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was provided. No treatment information was provided.
PAIN IN BACK, HORRIBLE SHAKING, MUSCLE HURTING ON MONDAY (9/27).  ON TUESDAY, STILL WEAK BUT NOT AS MUCH. TOOK ACETAMINOPHEN. ON WEDNESDAY, FEELING BETTER (IMPROVING)
The patient developed an area of redness, soreness around 1230 the day after his immunization. There was no fever. Due to his intellectual disability and the face he's non-verbal, difficult to determine if there was pain. No induration.
Rash/Hives on arms legs stomach back and neck still present today Rash/hives prescribed creams antihistamines  steroid shots  light box treatments
Approximately 6 hours after the injection (3pm local time) I became fatigue, tired, and had a minor headache.  At approximately 8pm, 11 hours after injection, I began to experience a sore body and muscles.  Lastly, throughout the night I had sore muscles, joints, and minor chills.  These symptoms were moderate; however, I did not take any prescribed or over-the-counter medications to treat the symptoms as I did not want to interfere with the vaccine.  All symptoms subsided by mid-morning the next day.
itchiness; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that she only experienced itchiness with the first dose on an unspecified date. Right after receiving the second dose of the vaccine, she started with an itchy arms, back and neck. She stated she had a scratchy throat 1-2 hours after receiving the second dose of vaccine on 25Mar2021. Outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
7:00pm Feb 11:  chills, fever (101.7), vomited, diarrhea - only lasted about 2 hours
G62.9 PERIPHERAL NEUROPATHY 5/26/2021 ANTINEOPLASTIC CHEMOTHERAPY INDUCED PANCYTOPENIA I26.99 PULMONARY EMBOLISM, UNSPECIFIED     8/19/2021 ANTINEOPLASTIC CHEMOTHERAPY INDUCED PANCYTOPENIA
The patient states the patient had extreme fatigue and barely remembered a 48 hour period for which she was hospitalized.  She also had extreme arm pain.
Patient was given a dose from a vial that was initially punctured 29 hours prior. Per Moderna, the dose is valid.
FELT ITCHY, WARM, LARGE CIRCULAR BLOTCHES STARTED ON ARMS AND LEGS AND THEN EXTENDED TO CHEST AND NECK RASH PERSISTED UNTIL 11/22.
Pt  20year old male- came to the pharmacy for a walk in  covid vaccine. He filled out the vaccine consent form. I asked him if he was feeling ok today - he said yes. he presented as looking in healthy condition. I then asked him if he has ever had a bad reaction to a vaccine  and he said not that he knew of but that he did not like needles. I told him that was normal, explained the shot was a quick pinch no stinging and would be over before he knew it. I encouraged him to relax his arm muscle and as soon as he did I gave the vaccine. I started to tell him he could take Tylenol or ibuprofen if he should get  a sore arm and to make sure he is drinking plenty of water as hydration helps our bodies- he then asked if he could have some water and then tilted his head back and was passed out for i'd say 4 seconds. I massaged his arm and neck as he became kinda ridged and talked him back. he was out for about 4 seconds. I yelled for our store co manager who happened to be close by to come to the pharmacy and call 911. When he regained consciousness he started to sweat. he said he felt cold and thirsty. I gave him some water to drink. I explained to him what had happened and told him that we had called 911 out of precaution. I discussed with him calling parents and he wanted to call himself - he made the call to his mom on his cell phone to have her come pick him up. EMS arrived in about 10 minutes. they said his blood pressure was really low 100/60 and wanted to take him in but the patient refused. he also refused getting his blood sugar tested as he now told us he was deathly afraid of any medical procedure. ems left. I offered him some more water and chips. he drank 2 full bottles of water and ate a small bag of chips. his mom showed up a few minutes later to drive him home- we explained to her what had happened.. I told her to monitor his blood pressure at home (she said she had a machine)she said she should have known better than to let him come alone as she knew he reacted bad to medical situations. He left about 30 minutes after he got his vaccine. walked out on his own needed no assistance.
About 10 minutes after receiving the vaccine, I was sitting in a well organized waiting area I started feeling flames in my throat. My throat was literally on fire. I raised my hand as I was instructed to do. I asked for water, they brought me a bottle water, I started to drink it. My throat was having a difficult time swallowing. They brought me over to nursing area. I went into this area and the nurses were there. They made me take my mask off, they took my blood pressure was way lower then normal (110/30). Then they gave me 50MG Benadryl. They called EMS and I refused to go. I had to wait at the clinic until the Benadryl took effect. The "flame" feeling began to lessen. When I got home I took another dose of Benadryl.  The "flame" feeling went away but then I was left with a sore throat for the rest of the night and the following morning. It felt like there was an actual fire in my throat that the Benadryl put out but then it felt as if the after effects of a burn in my throat.    I do have a call in to my primary care provider and still waiting for a call back.
3 days after vaccination, he developed L elbow redness, pain, swelling. no injury or previous hx of arthritis or joint complaints in the past.
rashes on arm, trunk and neck; swelling on arm; redness on arm; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 34ys7, expiry date 23rd January 2023) for prophylaxis.   Co-suspect products included COVID 19 VACCINE PFIZER for prophylaxis.   Concurrent medical conditions included cancer and lymph node cancer metastatic (has a lymph node due to cancer). Concomitant products included VIRAL VACCINES (COVID VACCINE (NOS)) and INFLUENZA VACCINE.   On 1st October 2021, the patient received the 1st dose of Shingrix and COVID 19 VACCINE PFIZER. On 1st October 2021, less than a day after receiving Shingrix, the patient experienced rash, swelling arm and localized erythema. On an unknown date, the outcome of the rash, swelling arm and localized erythema were recovered/resolved.   It was unknown if the reporter considered the rash, swelling arm and localized erythema to be related to Shingrix.  Additional details were provided are as follows: The registered pharmacist reported that the patient received a dose of Shingrix in unknown arm along with Covid shot (Pfizer) and that afternoon patient developed rashes on the arm, redness and swelling. 1day after vaccination, the patient developed rash on the trunk and neck. The patient requested both shot to be injected on the same arm as patient had has a lymph node due to cancer  on one of the arm (did not knew which one).  The reporter reported another batch number as 344s7. The patient received 1st dose of covid and flu shot on 10th September 2021. On an unknown date, the rashes went after couple of days. The reporter consented to follow-up.
Moderna COVID-19 Vaccine EUA On my  2nd shot of the vaccine on April 8, I had a mild fever of 99.7 which steadily increased to 100.7 for four (4) days.  My second symptoms was having rashes since last Wednesday, April 14 that spread throughout my body, primarily on my arms, armpit, legs, buttocks, and back until today, April 21.
Patient received the Fluzone Quadrivalent instead of the Fluzone High-Dose Quadrivalent vaccine, no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient's wife).  This case involves a 67 years old male patient who received 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], all that his workplace had on hand at the time of his vaccination about 2 weeks ago, instead of the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination on an unspecified date (PT: wrong product administered).  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong vaccine administered (same day latency).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
big red spots with swelling on right arm 3 inches in diameter; two inch disc around the injection site on the left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (big red spots with swelling on right arm 3 inches in diameter) and PERIPHERAL SWELLING (two inch disc around the injection site on the left arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M20A) for an unknown indication.     Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PERIPHERAL SWELLING (two inch disc around the injection site on the left arm). On an unknown date, the patient experienced RASH ERYTHEMATOUS (big red spots with swelling on right arm 3 inches in diameter). At the time of the report, RASH ERYTHEMATOUS (big red spots with swelling on right arm 3 inches in diameter) had resolved and PERIPHERAL SWELLING (two inch disc around the injection site on the left arm) outcome was unknown. Not Provided          No Treatment information provided
Redness, inflammation, extreme warmth 3inx2in diameter area, 1 inch distal to injection site
Information has been received from a licensed practical nurse concerning a 35 year old female with idiopathic thrombocytopenia and no known allergies who on 2/18/04 at 10:30 was vaccinated IM in the left deltoid with a first dose of pneumcococal 23v polysaccharide vaccine (lot # 647635/0864N). There was no concomitant medication. The patient had a splenectomy secondary to idiopathic thrombocytopenia at the time of vaccination. On 2/18/04, at 16:30 the patient developed redness, swelling and pain in her left (previously reported as right) arm at the injection site and a fever of 101.0 degrees F. On 2/19/04 the patient again noted a fever, swelling, pain and stiffness of the left arm. Unspecified medical attention was sought and the patient was treated with acetaminophen for her fever and warm compresses for her left arm. Subsequently, the patient recovered. No product quality complaint was involved. No further information is expected.
This is a spontaneous report from a contactable consumer who reported for his 2 daughters. These patients experienced the same events after first and second dose of vaccine. This is the second of 2 reports for the patient 2. A 20-year-old female patient received on 04Aug2015 at 3:30 pm the second single dose of TRUMENBA. Relevant medical history included pink eye from 2015 (Ongoing). Had no allergies. Concomitant medications included birth control pills and antibiotic for Pink eye. The patient received the first dose on 05Jun2015 intramuscular and experienced minimal pain at the injection site. Immediately after second vaccination, the patient felt tingling throughout the body like someone was sticking needles in it. The event lasted for 2 hours. No treatment was provided. Laboratory tests were not performed. The same reactions occurred to her sister after first and second vaccination with meningococcal group b performed respectively on 05Jun2015 and 04Aug2015. Follow up (07Aug2015): New information received from the same contactable consumer includes: details of patient. Follow-up (03OCT2015): Follow-up attempts complete. No further information expected.
itchiness on scalp, back and abdominal area; Her arm still hurts; injection site pain; unable to lift arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox. Concurrent medical conditions included psoriasis.   In August 2022, the patient received the 1st dose of Shingrix (intramuscular). On 13th August 2022, 12 days after receiving Shingrix, the patient experienced pruritus. In August 2022, the patient experienced injection site pain, injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, pruritus and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, pruritus and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's comments: The reporter was the patient herself. She had received her first Shingrix dose about 2 weeks ago. She immediately had experienced injection site pain. Her arm still hurts and she was unable to lift it due to the pain. About 2 days ago she had experienced itchiness to areas on her scalp, back and abdominal area. She felt that the itchiness to scalp may be due to her psoriasis. She had nothing else to report. The reporter had declined to provide DOB or contact information (other than email). The reporter did not consented to follow-up.
pt recv vax;exp inflammation of the interior nasal tissue manifested by a purulent discharge which lasted approx 3 days;in addition,exp malaise & muscle aches;
SHOOTING PAIN GOING DOWN RIGHT ARM, COLD ALL OVER GOLF BALL SIZE SWELLING AND REDNESS, FEVER OF 100 DEGREES.   PAIN SUBSIDED AFTER USING DIAZEPAM.
pt recvd flu vax & devel flu-like sx & supraclavicular lymphadenopathy on the side of the inject;
After MENACTRA, Tdap, Hep A and HPV, fainted while sitting on mom's lap; 2 beats of arms seizure activity. Self-resolved all lasted approximately 5 sec.
Lymph node in left arm pit swollen  the size of a large grapefruit.  No treatment as of now.
she tested positive for Covid-19/patient vaccinated first dose 21Jan2021; she tested positive for Covid-19/temperature rose to 98.7; This is a spontaneous report from a contactable consumer (patient). A 70 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249), via an unspecified route of administration on left arm on 21Jan2021 (at the age of 70 -years-old), single dose for COVID-19 immunization. Medical history included hypertension. The patient's concomitant medication included unspecified hypertension medicine. The patient received the first dose of the Pfizer-BioNTech Covid-19 Vaccine last 21Jan2021, and was originally scheduled to receive the 2nd dose on 11Feb2021. However, she tested positive for Covid-19 on February 4, 2021 performed via swab in the mouth, under the tongue and the tonsils. She said she had been in quarantine ever since. She also mentioned that her temperature rose to 98.7, and had to take two tylenol for it. The patient has continued isolation/quarantine, has not gone around anyone. She is by herself and does not go around other people anyway. She feels fine. She did not get the second dose of Pfizer COVID-19 Vaccine as scheduled on 11Feb2021. She wanted to stay in quarantine as she is supposed to. The outcome of the events was unknown.
RED CHEEKS, UNABLE TO SPEAK EMS TRANSPORT AFTER EPINEPHREN ADMINISTERED ON SITE. PARAMEDIC ADVISE POSSIBLE TIA/STROKE VS. VACCINE RXN.
Swollen lymph nodes in the left side of neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes in the left side of neck) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history reported.    On 23-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 LYMPHADENOPATHY (Swollen lymph nodes in the left side of neck). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes in the left side of neck) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant medications have not been specified.  Treatment not provided.
I started having numbness from the waist down. Was admitted to hospital for 5 days and had a diagnosis of demyelinating disease.
Syncope. Patient got lightheaded, had a small, dizzy-spell and fainted. Patient then fell out of her chair. She is now feeling fine. Patient received the shot; went to have a seat; got lightheaded 5 minutes later; then fell. Patient regained conscience and laid down till she felt okay to stand up.
Pain in extremities, numbness, tingling, paralysis.  11/19/09 ED records received service date 11/15/09. Assessment: SOB, tingling all extremities, losing coordination. Patient presents short of breath, tingling in arms and legs, unable to control movements. Breathing labored. Skin warm, flushed. Unable to hold arms up. Transported to higher level facility.  11/23/09 Medical records received service dates 11/15/09 - 11/20/09 Assessment: Probable Guillain-Barre syndrome with possible associated neurogenic bladder. Community-acquired left lower lobe pneumonia. Three days ago patient felt prickly feeling in feet which progressed up legs. Muscle pain and achiness all over. Feet and hands became numb, muscles weak, difficulty moving hands and feet. Diaphragm sore, short of breath, painful to take deep breath. Choking, gagging, tightness in throat. Fever, chills, nonproductive cough. Urinary retention. Suprapubic discomfort. Overweignt. Decreased hand grip strength, cannot lift legs off bed, deep tendon reflexes absent. Cranial Nerve V - sensory deficit. Decreased sensation to pin prick and touch. IVIG given. Headache. Tingling and numbess resolving, strength returning. Diarrhea.
This spontaneous report as received from a health professional refers to a 13 month old patient. On 28-MAY-2014 the patient was vaccinated w ith (Oka/Merck) VARIVAX lot # J012377 expiration date 03-OCT-2015 dose and route not reported) and M-M-R II (lot # J013315, expiration date 18-OCT-2015, dose and route not reported) which were stored improperly. There was no adverse affect reported. This is one of several reports received from the same source. Additonal information is not expected.
pt immed exp severe anaphylactic rxn, characterized by rash, chest burning, apprehension, n/v, tightness & swelling;antivenin was discontinued a/first full vial given;tx w/epi, solu-medrol, & inhaled bronchodilators for wheezing & dyspnea
Pt got PNEUMOVAX and FLUZONE is same arm, and developed a rash on entire arm that looked bruising. Got KEFLEX from doctor.
Breakthrough case admission after 4 vaccines  Moderna 1/14/21 Lot# 027L20A;  Moderna 2/11/21 Lot# 027L20A;  Moderna 12/9/21 Lot# 032H21A;  Moderna 6/9/22 Lot# 054A22A