chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness; Swelling; Hot; Hard lump; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (Redness), PERIPHERAL SWELLING (Swelling), FEELING HOT (Hot) and INDURATION (Hard lump) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness), PERIPHERAL SWELLING (Swelling), FEELING HOT (Hot) and INDURATION (Hard lump). At the time of the report, ERYTHEMA (Redness), PERIPHERAL SWELLING (Swelling), FEELING HOT (Hot) and INDURATION (Hard lump) outcome was unknown.        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.   Concomitant medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-128176, US-MODERNATX, INC.-MOD-2021-128305, US-MODERNATX, INC.-MOD-2021-128643, US-MODERNATX, INC.-MOD-2021-128612, US-MODERNATX, INC.-MOD-2021-128689 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128176: US-MODERNATX, INC.-MOD-2021-128305: US-MODERNATX, INC.-MOD-2021-128689: US-MODERNATX, INC.-MOD-2021-128612: US-MODERNATX, INC.-MOD-2021-128643:
Intense itching followed by rash that looks like either fungal  infection (jock itch) or pityriasis rosea (on back, trunk, under arms, on top of hand), a little over a month, still ongoing.
COMPLETELY PALE NOT COHERENT BUT CONSCIOUS. LAID TO FLOOR. BENADRYL 50 MG ADM LT ARM 12:35 PM. MONITORED BP CALLED 911 EVALUATED BY EMS AND DR. RELEASED TO HOME BY EMS AND DR ON SITE DURING EVENT. BP 127/81 140/78 HR 67. FOLLOW UP CALL TO MOM DONE AT 6:45 PM 15-12-11 CLIENT DOING WELL.
I had swelling in my feet and i have red blotches all over my feet and leg.
cried for 5 hrs, stomach cramps, vomiting, t100, (high-pitched); seen in ER 28MAY92;
Pt rec'd vaccines on 8/12/19 2:45-3 pm.  Next evening reports feeling itching legs, and on 8/14 AM woke up with hives on legs and arms.  Had temp of 100.5.  Applied aloe vera.  Came to clinic on 8/15/19 pm.    Pediatric Exam          General: VS Reviewed, Well-developed, well-nourished, non-toxic, alert and appropriate.          Skin: Left arm: erythema on top of hand with big patch of hive mid forearm, Another patch on forewarm below elbow joint and into the joint and around lateral side. Delta area: erythema with firm bump inside redness, redness is 50 x 48 mm in size. Chest: areas that are scattered with papules on abd, little underneath breast area bilateral with scratch marks on upper torso, little erythemic papules scattered from shoulder to shoulder. Left leg: erythemic hive-looking papules on left thigh, in a irregular pattern central to lateral on thigh. Rt thigh: scattered erythemic papules. Rt deltoid: 98 x 98 mm in size, warm to touch, erythemic and swollen, scattered erythemic patches on upper forearm on inside of arm, down on rt wrist, abobve rt ulna side, radial side with patch 45 x 38 mm in size. Back: little area across shoulders. Face: little erythemic papuless on cheeks posterioir legs above knees on back.   Treatment:      Hives          Start Benadryl Allergy Tablet, 25 mg, 2 tablet, Orally, every 6 hrs X 5 days, 5 days, 40 Tablet, Refills 1          Notes: Medication education done: most common medication side effects, interactions, and possible adverse reactions discussed.Patient/caregiver exhibited understanding. Questions answered. Return to clinic tomorrow if rash does not improve.      Cellulitis of right upper extremity          Start Keflex Capsule, 500 mg, 1 capsule, Orally, every 12 hrs, 10 day(s), 20, Refills 0          Notes: Medication education done: most common medication side effects, interactions, and possible adverse reactions discussed.Patient/caregiver exhibited understanding. Questions answered. Since Keflex is a cousin of Amoxicillin, monitor for allergic reaction in patient. Marked outer limit of cellulitis, if you notice that it grows outside this border, retrun to clinic for possible injection of antibiotic.      Adverse effect of vaccine, initial encounter          Notes: Reported vaccine rxn to our vaccine coordinator at clinic. VAERS done. [8/15/2019 5:49PM]
Fatigue, weakness, trembling, feels hot, sweaty, nausea, nervousness post vax x > 1 week. Mild crawling type sensation in extremities. Temp 99.3
Moderate to severe muscle pain at injection site lasting 4-5 days.  Overall body aches lasting 2 days.  High Fever (over 101) with intermittent periods of chills and then sweating for 48 hours which turned into an nocturnal fever (100.1) the second 48 hours.
Dizzy to the point of collapse if I didn't stand up very slowly, unable to focus on the numbers on the bedside clock.  Symptoms have subsided as of around 3:00 PM on 09/28/2011.
Severe pain in arm that was injected and also the left arm , shoulder blades and spine also have headache and chills  today is March 12 th still no sign of reducing symptoms  Basically upper body pains and slight pain in the heart   And chest
After the vaccine was given I began to feel sensitivity around the shot location. So badly the sheet covering the shoulder was unbearable. I lost the strength to even roll over and my legs give way while walking. I sweated profusely while just putting on a t shirt and had to have assistance from feeling so weak and a 99.1 temperature at 09:00 a.m.  At approximately 02:00 p.m. I could not become warm with jeans shirt jacket heated blanket and an additional 3 comforters. I attempted to sleep but could not with 102.5 fever while sweating profusely.
Not hungry & vomited approximately 1 hr. after receiving flu vaccine. Vomited x 3+ on 10-6-11 and x1 today. Fever 7pm 10-6-11 99.8 this am 10:30 100.2. Feeling better at this time 12:52. Child reports another child was sick in his class at school. Mother & brother received vaccine same day no problems.
pt recvd vax 1DEC95 & exp muscle weakness & paresthesia on 3DEC; adm to hosp 6DEC w/extensive w/u for large muscle group weakness & paresthesias-poss meningoencephalitis
Pt reports "I'm not feeling right" about 5 minutes after receiving vaccine. Pt instructed to sit down and prop feet up. Pt's eyes immediately closed and he began shaking. Pt was lowered to the floor and was responding to verbal stimuli. Pt. was evaluated by a physician and escorted to the ED.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Heart failure (The patient's pre-existing medical condition includes left side heart failure,). Concurrent medical conditions included Asthma (The patient's pre-existing medical condition includes asthma) and Obesity (morbidly obese).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-138275 (Patient Link).; Sender'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.
red itchy round patch on arm of injection site, intermittent  nausea subsided after 5 days
Subjective   HPI Cc: f/u reaction to vaccination of R thigh.    Had been seen at Urgent care 7/19 on amoxicillin for OM. 1.5 cm raised redness, with large knot underneath per Mom.     No limp. + tenderness to touch.  No fever.  No drainage.    Reviewed and updated this visit by provider: Meds | Problems | Med Hx | Surg Hx | Fam Hx |      Review of Systems    The following systems are negative for significant symptoms except as documented in the assessment/HPI: General, ENT, CV, Resp, GI, GU, MS, Derm, and Neuro g     Objective    Pulse 144  | Temp 36.6 °C (97.9 °F) (Temporal)  | Resp 32  | Wt 12.9 kg (28 lb 7 oz)  | BMI 18.64 kg/m²    Physical Exam    Playing and active in exam room as I entered. No limp.    R thigh. 1.5 cm area of blotchy redness. Deep to this there is a silver dollar sized area of induration. No fluctuance to this. The entire area is tender to the child.     Assessment    1. Adverse effect of vaccine, initial encounter        PedvaxHib given R thigh, 7/25/2019 Probably delayed type sensitivity to a vaccine component, possibly aluminum.    VAERS report done.      Plan     Observation for the next 48 hours. Call for any drainage, worsening redness. Fever. Brief review of literature on these types of reactions. Consultation with Dr. as well.  Today, I personally spent 25 minutes in direct face to face time with the patient, of which greater than 50% of the time was spent in patient education, counseling, and coordination of care as described above.
pt recvd vax;rigors for several hrs; approx 36 hrs p/ vax;
4/18/21-Patient calls into triage questioning if she is having a reaction to her pneumovax vaccine.  States that above the injection site is hard, and a bit swollen.  Denies redness or warmth.  States that the left side of her face may be slightly more numb than the right, and that the left pinky finger may be more numb as well.   Just over 2 weeks ago she received a Pneumovax 23 vaccine.  When she was receiving the vaccine she had an acute episode of discomfort that radiated from her arm up to the top of her head however it resolved.  She then began to have arm swelling and pain several hours after that have been persistent for the last 2 weeks.  She was allergic to a preservative in a GH (omnitrope) injection and is concerned that she is having allergic reaction to the Pneumovax.   She has also been having swelling of her left arm as well as some numbness and tingling in her hand that was not present prior.   5/3/21-She has also been having some chest pain/ shortness of breath.  She initially had some after her accident in 2018 however this resolved but since having the vaccine she has been having more symptoms.  She has had 3 episodes since her annual visit just over 2 weeks ago.  They occur at night, are not brought on with exertion.  She is not aware of any history of coronary artery disease. 5/14/21 Just over 2 weeks ago she received a Pneumovax 23 vaccine.  When she was receiving the vaccine she had an acute episode of discomfort that radiated from her arm up to the top of her head however it resolved.  She then began to have arm swelling and pain several hours after that have been persistent for the last 2 weeks.  She was allergic to a preservative in a GH (omnitrope) injection and is concerned that she is having allergic reaction to the Pneumovax.   She has also been having swelling of her left arm as well as some numbness and tingling in her hand that was not present prior.   She has also been having some chest pain/ shortness of breath.  She initially had some after her accident in 2018 however this resolved but since having the vaccine she has been having more symptoms.  She has had 3 episodes since her annual visit just over 2 weeks ago.  They occur at night, are not brought on with exertion.  She is not aware of any history of coronary artery disease.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX vaccine on or about 22-SEP-2015, at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and subsequently the patient contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 19-JAN-2017, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Sudden hearing loss in both ears about equally from 40% to 70%; Hearing was normal before with no problems
swelling upper eye lids; pinpoint papules w/surrounding redness; confluent on face papules all over body, irritability;
A 33-year-old female Td, TB skin test and MMR on 11/28/11. On 11/29/11, the patient noticed a large red welt at the injection site for the Td vaccine (left deltoid); the patient also reported warmth, induration and some soreness with occasional shooting pain. The patient went to the medical office on 11/30/11; no treatment was given. The patient returned to the medical office on 12/6/11. Patient has recovered.
16FEB95 c/o pain lt shoulder to MD;apparently expressed to MD-poss from hep B inj;
Information has been received from a physician concerning a 12 month old health white female, with no allergies, who on 04Oct05 was vaccinated with a 0.5ml SC first dose in her left arm of varicella virus vaccine live (lot648087/0099P). Concomitant vaccination that day included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar). There was no illness at the time of vaccination. That afternoon on 04Oct05, the pt developed a low grade fever. Cefdinir (Omnicef) was given to the pt for potential infection. On 10Oct05 the pt was seen in the office. He had a runny nose on and off, diarrhea x 1 day, a rare cough and pharyngitis. The pt was treated with ibuprofen (Advil) at 8:30AM. Urinalysis, urine culture and CBC were performed. It was reported that the CBC was consistent  with a virus, see lab section. The pt's chest was clear and she did not have a rash. On 14Oct05 the pt presented to the office. Her temp was 101 at home and 98.1 axillary at the office. She did not have a fever yesterday. She was more sleepy acting today. She was given ibuprofen (Motrin) at 12:25. The pt had pharyngitis with a clear chest and no cough. A urinalysis was done that was ok. She was treated with cefdinir (Omnicef) 125/5, 1/2 tsp. BID for 5 days. On 17Oct05 the pt was seen in the office. Her temp was 98.7 axillary, it was 100.2 in the morning. She did not have a cough and her chest was clear, but her nose was congested. She had mild pharyngitis without a rash. A CBC was performed, see lab results. On 18Oct05 the pt was seen in the office with a croup cough. There was no wheezing or stridor. Her chest was clear. She was treated with chlorpheniramine maleate (+) phenylephrine hydrochloride (+) phenyltoloxamine citrate (Nalex) 1.5 to 2mL every 6 hrs, at night PRN for bad cough, and albuterol (unspecified) 2mL PO every 6 hrs and PRN for tight cough or wheeze. On 19Oct05 the pt was seen in the office. Her temp  was 97.8 and her respiratory rate was 26. She sounded more croupy and congested. She had mild stridor with crying and pharyngitis, and her chest was clear. She was given acetaminophen (Tylenol) at 5:30. She was treated with azithromycin (Zithromax) 200/5, 3/4 tsp everyday for 4 days, and prednisolone sodium phosphate (Orapred) 15/5, 3/4 tsp everyday for 4 days. It was reported that on 20Oct05 the pt's fever resolved. The pt's outcome was recovered. There was no product quality complaint involved. Additional information is not expected.
This spontaneous report as received from a physician refers to a 9 week old patient. On 28-AUG-2017, the patient was vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 28-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
t103 ax, rash over all of body-papular &macular;tonsillitis & OM;
syncope: Immediately after receiving the vaccine, patient complained of being dizzy, weak, 'turning black' and pale. Her mother said that she had a similar reaction to her HPV vaccine. It looks like this was primarily due to anxiety to vaccine. Patient was instructed to lie down on supine with feet elevated. Patient never lost consciousness. After 2-3 min of lying down, patient was able to get up by herself and was instructed to take a seat in waiting area for 15-20 more min.  AFter 15 min, the family left and patient was feeling normal.
Pt experienced pale coloring and  clammy skin. Pt reclined with feet elevated, pt unresponsive for approximately 10 seconds. Pt was given apple juice and was discharged alert.
Patient call and complained that her arm was sore, swollen, red and itchy. Referred patient to her physician or er, outcome unknown
Per caller the patient has not reported any issues or concerns.; Customer called to report that a patient was administered PROQUAD and VARIVAX in the same day about two weeks ago.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On approximately 13-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, dose number, route of administration, anatomical location, lot # and expiration date were not provided for both) for prophylaxis (overdose). The patient had not reported any issues or concerns (no adverse event).
Exactly one week following first dose, racing heart rate (resting at 120bpm), palpitations, flush lasting for ~4hrs straight and then has been sporadic since. Heart rate more easily elevated and easily also out of breath.  Symptoms after initial episode have persisted since, inconsistently. Also experienced abdominal pain.  Liver lesion discovered and now under observation
Info has been received from an RN concerning an 8 month old female twin, with a healthy pertinent medical history born prematurely at 28 weeks and no known drug reactions/allergies, who in 6/04, was vaccinated in another country with a dose of varicella virus vaccine live. A varicella lab diagnostic studies was performed on 4/1/05, which came back negative. Outcome unknown. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up info was received from an RN indicating that the pt was vaccinated again on 4/19/05. The reporter also noted that the pt's twin sister was vaccinated with a dose of varicella virus vaccine live and has a negative titer. Additional info has been requested.
a clear water blister on the injection site; red around the blister / on the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: VACCINATION SITE VESICLES (non-serious) with onset 01Apr2021, outcome "unknown", described as "a clear water blister on the injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 01Apr2021, outcome "unknown", described as "red around the blister / on the injection site".  Additional information: Patient received the second dose of the Pfizer COVID the day before (31Mar2021) and had no problems and no side effects. She mentioned that she did not remove the band aid until this morning (01Arp2021) where it got pulled off as she was changing gowns. She then found out that she had a clear water blister on the injection site. She mentioned that it was small but noticeable and has gotten bigger since she's gotten up. It was red around the blister but it was not painful. She was asking if this was common.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu & Pneumoccacol vacines lt arm. Pain developed in arm during day Flu like symptoms that night for two days. Today (11/15/2018) arm remains sore, headache. Reported to the RN that he felt better today and did go to work.
itchy rash below the injection site; increase in her previously stable blood glucose levels; This case was reported by a consumer via call center representative and described the occurrence of diabetes mellitus aggravated in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 4RF5J, expiry date 25th April 2022) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On 8th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2020, 24 hrs after receiving Shingrix, the patient experienced diabetes mellitus aggravated (serious criteria GSK medically significant) and injection site rash. In September 2020, the outcome of the diabetes mellitus aggravated was recovered/resolved. On an unknown date, the outcome of the injection site rash was recovering/resolving.   It was unknown if the reporter considered the diabetes mellitus aggravated and injection site rash to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient's spouse. The patient had type 1 diabetes and experienced an increase in her previously stable blood glucose levels 24 hours after receiving the vaccine, blood sugar over 400, and this lasted for approximately 12 hours and resolved. The patient developed an itchy rash below the injection site after 24 hours, and this rash had improved but was still ongoing. The reporter consented to follow up. The batch number was updated from 4RFSJ to 4RF5J as per sales data sheet.
Arm pain at injection site location, followed by radiating pain into bicep and elbow, occasionally into the forearm, causing reduced strength and hand weakness. Pain is intensified during exercise.
This spontaneous report was received from a Medical Assistant regarding an "about 2 years old" male patient with no pertinent medical history or drug reactions or allergies reported. The medical assistant reported that the patient who was new to the practice was administered unspecified vaccinations in February 2013 which may include (Merck) VARIVAX (lot number and expiration date not reported) (dose, route and anatomical location not reported). The reporter stated that on an unknown date the patient experienced a "painful rash on his left buttock" which has been diagnosed as possible shingles. No medical history or vaccination records were available at the time of the report. The outcome for the "painful rash on his left buttock" which has been diagnosed as possible shingles was reported as not recovered. No treatment information was specified by the reporter. No laboratory diagnostic studies were performed. The patient sought medical attention by an office visit. The reporter did not assess the relatedness between the "painful rash on his left buttock" which has been diagnosed as possible shingles and (Merck) VARIVAX. Additional information has been requested.
Member recieved smallpox vaccine 10Aug2013 and confirmed pregnancy 15Nov2013.