chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is experiencing a red warm area on the arm where the vaccine was administered. Vaccine administered 11/02 and red area did not appear until 11/07. Pt was referred to urgent care for treatment.
10 x 16 cm pink/red area where injection was administered including itching and warmth. No open area. No vesicles or pustules. Normal arm movement and strength when evaled on 2/24/15 in office visit. Topical BENADRYL and hydrocortisone cream.
About 24 hours post injection patient experienced pain in arm grade 3 as well as swelling of the arm and into the neck and shoulder region; also lymphadenitis of the neck and clavicle on left side with visible swelling; difficulty turning head/neck; also had malaise, fatigue; Swelling still visible at 4 days post injection when she reported to me.
A large circular patch which was hot for a couple of days.  Iced and felt better, but can still see the circular reaction, just not hot anymore.
Got a cold with the other three shots; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (Got a cold with the other three shots) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A, 008B212A and 011A21A) for COVID-19 vaccination.     Patient did not have allergies. Patient did not have ever had COVID positive test or diagnosis.  Concurrent medical conditions included Blood pressure high, Osteoarthritis, High cholesterol and Type II diabetes mellitus.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NASOPHARYNGITIS (Got a cold with the other three shots). At the time of the report, NASOPHARYNGITIS (Got a cold with the other three shots) outcome was unknown.      The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to MOD-2022-681468 (Patient Link).
Flublok Quadrivalent was given to a 15 year with no reported adverse event; Initial information was received on 06-Jan-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 15 years old male patient who was treated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Jan-2023, the patient received total 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (product administered to patient of inappropriate age) (latency same day) (lot UJ903AA and expiry date 30-06-23) via intramuscular route in the right deltoid for immunization.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable.  At time of reporting, the outcome was Unknown for the event flublok quadrivalent was given to a 15 year with no reported adverse event.  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 the 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.
about a month after receiving the J&J shot I started experiencing abnormal joint pain mostly in my knees.  This continued for about 2 months.  I started taking Tylenol about twice a week.  I also started taking Vital Proeins Collagen Peptides and this seems to help.
Wife reported, described no pain at time of injection friday morning (10/25/19).  Pain started in both shoulders Sunday evening (10/27/19) and continued into Monday.  Right shoulder pain resolved Monday, but left shoulder pain continued into Tuesday.  Family went to ER to rule out cardiac issues, ER MD diagnosed shoulder impingement & prescribed Ibuprofen & hot/cold packs.  As of 10/31/19 wife reports patient continues to have severe left shoulder pain, can not lift left shoulder and can not sleep on it. She came to the pharmacy 10/31/19 to report and ask for advice. Recommended patient follow up with PCP for next steps
Projectile vomited the oral vaccine, cried uncontrollably even after nursing, legs very tender to touch. This continued for 2 weeks. He cried nonstop all the time he was awake, his legs hurt him while I changed his diapers, and they felt very swollen at the injection site for all 2 weeks. I received no papers or pamphlets that would have given me information that this was truly an adverse reaction.
pain in the left arm; does not have full range of motion of his left arm; difficulty putting the arm up past his head; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm, joint range of motion decreased and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm, joint range of motion decreased and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, joint range of motion decreased and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain in the left arm after receiving 2nd dose of Shingrix.  It still hurts but not as much. The patient did not have full range of motion of his left arm.  The patient had difficulty putting the arm up past his head. No further details were provided.
Chest pain. Left side of chest sore when I move. Awareness of chest sensation when lying in bed and turning or changing position. I've had anxiety before and this was different. This was specific sensation of the heart. I could also feel it when I was straining.
Severe pain in stomach; Diarrhea; A spontaneous report was received from a consumer, concerning an 82-year-old female patient, who received Moderna's COVID-19 vaccine and experienced severe pain in the stomach/abdominal pain upper and diarrhea.  The patient medical history was not reported. Products known to have been used by the patient, within two weeks prior to the event were carvedilol, rosuvastatin, spironolactone, losartan and acetylsalicylic acid.  On 12 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) on her left arm for COVID-19 infection prophylaxis.  On Friday 12 Feb 2021, after receiving Moderna's COVID-19 vaccine, the patient had no problem. On Saturday 13 Feb 2021,  the patient had severe pain in the stomach and diarrhea which lasted till Sunday (14 Feb 2021). T reatment medications included omeprazole for 14 days.  Action taken with mRNA-1273 in response to the event was unknown  The outcome of the events severe pain in stomach/abdominal pain upper and diarrhea were considered as resolved on 14 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
An adverse event wasn't reported from this vaccine administration. However, the patient received an expired dose of the Moderna COVID19 vaccine. The vaccine had expired from its 30 days in the refrigerator on 7/15/22 at 9:30 AM, but the patient received a dose on 7/15/22 at 2:00 PM.
I got sick after getting the injection.  Later, after purchasing three small envelopes at the drug store in order to send a key, I got news that the location suffered an armed robbery.
pt recv vax;sensitive to touch, unable to touch, usually sore for the past 2 days at inject area;
Patient desires reported that received first dosage of Pfizer on 2/8/2021 and with diverticulitis on 2/26/2021. Received second dosage of Pfizer on 3/1/2021 and with UTI on 3/15/2021
Patient received the shot on 11/18/2019. At the time of administration patient had no reactions. Per patient the pain started later on in the evening around the injection site only. Few weeks later patient still complains about pain around the injection site but also now radiating to shoulder area. Patient also complains worsen at night.
Information has been received from a certified medical assistant concerning a 16 month old female with a codeine allergy who on 01Feb05 was vaccinated with a SC dose of varicella virus vaccine live. There was no concomitant therapy. The CMA reported that on 01Jun05, the pt developed a breakthrough case of chickenpox. Unspecified medical attention was sought and diphenhydramine HC1 (Benadryl) was given to alleviate itching. No lab/diagnostic tests were performed. At the time of this report, the pt's breakthrough chickenpox persisted. No further information is available.
pt recv vax approx 2 wk gestation; approx may96, had miscarriage; no further details provided;
This spontaneous report was received from a medical assistance and refers to a 24 year old patient of unknown gender. On 19-DEC-2016, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB 0.5mcg/0.5 ml intramuscular injection (lot # M026309, expiration date 11-NOV-2016, indication and site of administration were not reported). No adverse effect was reported. Additional information has been requested.
Intense pain in head, loss of vision, uncontrollable twitching, disorientation, numbness in extremities, unable to stand or hold head up
I experienced nausea and vomiting,  chills, ran a fever of 100.1F.  I tested positive for Covid 10-27-2020. I also developed migraine headaches and muscle aches and pain for three days.  I felt like I had the Covid again. I talked my PCP on the phone three different times.
Patient had been able to freely eat shrimp, crab, and peanut butter many many times prior to turning 1yr old. Two weeks after turning 1yr (on 2/15/2020) he exhibited severe reaction to peanut butter touching his lips (instant swelling of lips to 3x normal size and redness around his lips and neck). We administered Benedryl immediately and watched symptoms which eventually subsided. We initiated formal allergy testing on 6/15/2020 and it was determined he had a severe allergy to shellfish and all nuts. The only new thing that had been introduced to his body was the 1/15/2020 & 2/6/2020 vaccines which may or may not have been the cause of the new allergies.
Patient reports feeling exhausted, light headed, dizzy, and really tired (fatigue). she had pain in her left arm at the injection site was swollen. Applied cold compress Will continue to monitor and to call back if any change or worsen in your symptoms. Doesn't interfere with ADLs
pt recv vax & exp breakthrough chickenpox;2 patients w/the same exp were reported @ this site;
Patient received J+J vaccine on March 5, 2021 and received a vaccination card. Then, on June 19, 2021 and July 10, 2021, the patient received the Pfizer (Comirnaty) vaccine at a pharmacy in a different state. Patient came to pharmacy on 12/03/2021 with the COVID vaccination card received from the initial J+J vaccination, so patient was determined as qualified for the booster dose due to the pharmacy not being informed of the Pfizer vaccination's. It was only later discovered when entering vaccination information into the system that the Pfizer doses received was discovered. After confirming with the patient, discussed with the patient on potential adverse effects. Pt reported no problems from additional dose.
This spontaneous report as received from a physician refers to a 60 years old patient. The patient was vaccinated subcutaneously with a single dose of ZOSTAVAX (Lot# and dose not reported) on an unspecified date. "10 to 14 days later" on an unspecified date the patient experienced rash on the forehead bilaterally. The patient visited office for medical attention. No treatment was given. At the time of this report the patient had recovered, date unknown. Additional information is not expected.
Systemic: blood blisters on lips and heels-Mild, Systemic: Tinnitus-Medium, Additional Details: blisters resloved ,but ringing in the ear is ongoing
Neck is sore; jaw is sore; ear is sore; injection site is itchy; injection site is warm; lymph nodes are sore; shoulder is sore; injection site is red; throat is sore; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck is sore), PAIN IN JAW (jaw is sore), EAR DISCOMFORT (ear is sore), OROPHARYNGEAL PAIN (throat is sore) and VACCINATION SITE PRURITUS (injection site is itchy) in a 59-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.     The patient's past medical history included No adverse event (no medical history found).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced NECK PAIN (Neck is sore), PAIN IN JAW (jaw is sore), EAR DISCOMFORT (ear is sore), VACCINATION SITE PRURITUS (injection site is itchy), VACCINATION SITE WARMTH (injection site is warm), LYMPH NODE PAIN (lymph nodes are sore), ARTHRALGIA (shoulder is sore) and VACCINATION SITE ERYTHEMA (injection site is red). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (throat is sore). At the time of the report, NECK PAIN (Neck is sore), PAIN IN JAW (jaw is sore), EAR DISCOMFORT (ear is sore), OROPHARYNGEAL PAIN (throat is sore), VACCINATION SITE PRURITUS (injection site is itchy), VACCINATION SITE WARMTH (injection site is warm), LYMPH NODE PAIN (lymph nodes are sore), ARTHRALGIA (shoulder is sore) and VACCINATION SITE ERYTHEMA (injection site is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no treatment provided no concomitant medication given
blood within the stool/ 2 occasions, blood in the stool,; severe diarrhea with mucous; the patient may have had a hypersensitivity reaction; extremely fussy; This spontaneous report was received from a physician referring to a 4 month male patient at the reporting time of unknown age. The patient's concurrent conditions and medical history medications were not reported. His concomitant medications included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (CRM197) (PREVENAR 13). No known drug allergies were reported.   On 13-MAY-2021 at the age of 2 months old, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 milliliters by oral route (lot# 1707408 with an expiration date on 07-JAN-2022) for rotavirus prophylaxis (strength was not reported).     On an unknown date within the first week after the vaccination on an unknown date in May 2021, the patient was extremely fussy (irritability), experienced 8 days of severe diarrea with mucous and on 2 occasions blood in the stool (haematochezia).  The second dose of the vaccine was not administered after this visit.  On 14-JUL-2021, the patient received the second dose of diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (CRM197) (PREVENAR 13), but the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was held by the physician as she suspected the patient may have had an hypersensitivity reaction.  It was reported that no treatment was given.  The outcome of irritability was unknown. The other events were resolved without intervention on an unknown date in 2021.  The causal relationship between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.    Upon internal review, haematochezia was considered a medically significant event.
She had 4 injections, 2 in each arm.  Flu and MMR in her right arm and IPV and DTaP in her left.  Today 2 days after her immunizations, the site of her left arm became 50% more swollen than before, very hot red and itchy.  It has spread around the arm like an arm band.  She had a very bad headache the day after her immunization.
fever (101), headache, body ache Narrative: Too OTC Motrin  Other Relevant History:
MOC called on call doctor 24 hours after administration. Per Doctor's note, patient developed full body hives about 24 hours after his 2nd COVID 19 vaccine. He has not been sick with anything in many weeks, no new fever. Denied wheezing, difficulties breathing, vomiting, chest discomfort, flushing, mouth, tongue, throat swelling, voice changing. No evidence of any other reason for generalized urticarial eruption besides vaccine administration.
intense swelling and fever at injection site reaching 4? diameter. Once swelling and fever reduced, a deep bruise formed and is still fading as of 12/17/21
reddened area (4 cm X 6 cm) below needle site (left upper arm) - Slight bruising (1 X2 cm) beneath needle site warm to touch, slight swelling of red area.
Allergic Reaction, hands swelling and itchy, skin itchy, stiff neck.  Needed to take 2 Benedryl
"Much illness" from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS ("Much illness" from the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS ("Much illness" from the first dose). At the time of the report, ILLNESS ("Much illness" from the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
PATIENT GOT LOBAR PNEUMONITIS WITHIN 8 TO 9 DAYS FOLLOWING VACCINE. THIS IS AN EXTREMELY FIT WOMAN WHO RUNS MARATHONS MULTIPLE TIMES PER YEAR AND NEVER COMES IN WITH ANY TYPE OF RESPIRATORY ILLNESS. SHE HAD NO EXPOSURE TO ANYONE AND HAD NO PRECEDING RESPIRATORY ILLNESS OF ANY KIND. NO RECENT TRAVEL.
This case was reported by a physician via call center representative and described the occurrence of dyspnea in a 45-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine). Concomitant products included vitamin d and Multivitamin. On 2nd November 2017, the patient received Influenza vaccine (intramuscular). On 2nd November 2017, less than a day after receiving Influenza vaccine, the patient experienced dyspnea (serious criteria hospitalization and disability), diaphoresis (serious criteria hospitalization and disability), dehydration (serious criteria hospitalization and disability), chest tightness (serious criteria hospitalization and disability) and light headedness (serious criteria hospitalization and disability). On 7th November 2017, the patient experienced weakness (serious criteria hospitalization and disability) and numbness of lower extremities (serious criteria hospitalization and disability). On 10th November 2017, the patient experienced tachycardia (serious criteria hospitalization and disability). On an unknown date, the outcome of the dyspnea and chest tightness were recovering/resolving and the outcome of the diaphoresis and light headedness were recovered/resolved and the outcome of the tachycardia, dehydration, weakness and numbness of lower extremities were not recovered/not resolved. It was unknown if the reporter considered the dyspnea, diaphoresis, tachycardia, dehydration, weakness, numbness of lower extremities, chest tightness and light headedness to be related to Influenza vaccine. Additional details were reported as follows: Concomitant medication included multivitamin as well. The medical student reported that the flu vaccine (GSK) was given in the patient's left upper arm. The patient was hospitalized on 7th November 2017, was discharged home, and at the time of reporting back in the hospital (unknown admission date). Only partial information was provided by the medical student.
Guillain Barre syndrome with symptom onset 2-3 weeks after Shingrix vaccine. She had bilateral lower extremity weakness and sensory symptoms. She was diagnosed with GBS and treated with 2gm/kg of IVIG (last day was 5/22). Lower extremity weakness improved and she was discharged with plan for PT.
Patient initially experienced dizziness and remained seated.  After approximately 5 minutes he fainted and remained sitting in chair, and did not hit body or head on floor.  His companion and pharmacist made certain he sat back and did not faint again.  He was able to converse and no signs of anaphylaxis.  His skin color remained gray and ashy.  He had some sips of water and stated he was nauseous.  He vomited a few minutes later.  He remained in the pharmacy area for 2.5 hours.  During that time he was sensitive to noises, sometimes dizzy, and vomited a few more times.  After about 2 hours he stated he could try some sips of Gatoraid and his color started returning.  He was able  to leave the pharmacy after 2.5 hours and arrived home safely.  He stated he would also enter his data into V-Safe for tracking.
chills, fever, nausea, headache, bodyaches, muscle pain, sore arm, chest pains, shortness of breath
Nasty metal taste in mouth; A spontaneous report was received from a consumer, concerning a female patient of 56 year age, who received Moderna's COVID-19 vaccine and experienced nasty metal taste in mouth.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 26 JAN 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis .  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event nasty metal taste in mouth, was considered to be not unknown at the time of this report.
Pt's arm had a large knot at injection site. Top half of warm had a "shingles-like" rash. Pt states she had a "nerve headache". This lasted for about 3 days.
Spoke with pt to book her for her 2nd dose, she stated that she does not want to get it because on the 1st one she got really sick that she almost went to the ER states that she felt like the covid symptoms were present "again" and her arm was very sore for more than 1 wk.