chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received both the 1st and 2nd dose on Feb 14, 2021; Swollen arm; Headache; A spontaneous report was received from a family member concerning a 72 years old, female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event received both the 1st and 2nd dose on Feb 14, 2021/Inappropriate schedule of vaccine administered, swollen arm, and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 14 Feb 2021, the patient received her first and second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 14 Feb 2021, the patient received both the 1st and 2nd dose of the vaccine. The patient experienced a headache and a very swollen arm. Ice was used to treat the swelling, and it went down.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, Inappropriate schedule of vaccine administered, was considered recovered on 14 Feb 2021. The outcome of the event, swollen arm, was considered recovering, and the outcome of the event, headache, was unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with associated AEs of swollen arm and headache reported. .
Patient received vaccine on 8/09/2012.  Patient reported the site "flared up" on 8/12/2012 in the afternoon.  Patient reported site is pink and itching, but not bumpy.  Patient reports that pain is "sporadic" but seems to be relieved when he takes Benadryl.  He reports redness is 4 inches wide at injection site and tapers down as the area goes down his arm.  Redness stretches from injection site to 3 inches below the elbow.  Itching relieved by Benadryl.  Patient to continue to monitor and use Benadryl for itching and Tylenol if needed for pain and if does not improve in 2-3 days, will follow up with PCP.
BODY ACHES; LOST TASTE; HIGH FEVER; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced body aches. On 2021, the subject experienced lost taste. On 2021, the subject experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, body aches and lost taste was not reported. This report was non-serious. This case, from the same reporter is linked to 20210500162.
I had a bad headache and started to feel unwell. The next morning I couldn't swallow. I was nauseated. My neck was very stiff. My sinuses flared up so I went and got tested for COVID and it came back positive.
At first, I had abdominal pain quite a bit. I went to the PCP at the beginning of May and was prescribed medicine for GERD; It started to work, but then the pain kept coming back. My PCP ordered a sonogram on my abdomen, and they didn't see any gall stones or anything, so she referred me to an enterologist around June 30th. I went to the enterologist and was ordered to have a scope done. I went to have a scope done, and was getting prepped to have the procedure, and the anesthesiologist noticed I was in AFIB. My heartrate would go up to 149, come down and go back up. The doctor canceled the procedure and sent me to my doctor and a cardiologist. I was diagnosed with atrial fibrillation. I was put in the hospital to be monitored and nothing happened at that time. So, I was sent to the hospital, and they did test to try and figure out what was going on.  I was told I needed to have an ablation done; I had an ablation done on 10/5/21.  I am currently taking medication for this issue, and I had a clean bill of health prior to this. I also had an echocardiogram before and after the ablation and it was normal.
Child was given Motrin before shots had fever after shots and was given motrin 8 hrs later. Pick child up from daycare at 4:45. He had fever and he was shaking real bad. At 8:30 to child to er his temp was 104.2. The er took blood and a urine sample found that child was deyhrated and need iv fluids. Blood work came back fine. Gave him tynonal and mortin at the same time. Left er at 12:30 and his fever was at 100. The next day his fever was 102.0 when we got the after hours clinc. They told me he had colvusions with high fever due to DTAP shot.
Went for my required FLU shot and was asked if I would like a BOOSTER as well, I was told it was safe, and was told multiple people get double shots...24 hours later i became fatigued, chills, nauseous, dizzy, light headed, headache, joint pain, fever (103).
BODY PAIN ESPECIALLY BACK PAIN, NECK PAIN AND JOINT PAIN; This spontaneous report received from a patient concerned an 86 year old female. The patient's weight was 180 pounds, and height was 153.67 centimeters. The patient's past medical history included history of arthritis, heart attack, double hernia surgery, left knee fracture, right leg artery clot, and right toe gangrene, and concurrent conditions included shortness of breath, blood pressure, non alcohol user, non smoker, hay fever allergy, and sticky tape allergy, and other pre-existing medical conditions included no history of drug abuse. the patient had no history of vaccine allergy and no pre-existing acute illness 30 days prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 17:30 for prophylactic vaccination. Concomitant medications included metoprolol tartrate for blood pressure, venlafaxine hydrochloride for blood thinner, calcium for drug used for unknown indication, clopidogrel bisulfate for drug used for unknown indication, losartan potassium for drug used for unknown indication, and oxybutynin hydrochloride for drug used for unknown indication.  On 12-MAR-2021, treatment medications included: acetylsalicylic acid.  On 12-MAR-2021 00:30, the subject experienced body pain especially back pain, neck pain and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body pain especially back pain, neck pain and joint pain. This report was non-serious.
6 inch x 3 inch swelling/warmth to site of DTaP injection, no problem with breathing.
Flu Like Symptoms; Chills; Fever; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, chills and fever. On an unknown date, the outcome of the influenza-like symptoms, chills and fever were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu like symptoms, chills and fever that lasted for about 3 days after receiving Shingrix. No further details were provided.  The patient was reporting event for herself, her friend, and her friends husband.  This case was 1 of 3 cases, reported by same reporter.
pt says she had some uncomfortableness in her private area the morning she woke up to get her vax.  She urinated before getting the vax.  About 30 minutes after taking the vax she has to urinate again and she had pain while urinating and  blood clots in her urine.  She contacted her PCP and was told to the emergency room.  On 5/5/21 she went to ER.  They took vitals and gave her a urine test.  Pt was diagnosed w/ UTI.  They told her that the vax had  flared up this condition.  They gave her Nitrofurantoin mono-mcr 100mg and Phenazopyridine 200mg.  She has other flu like symptoms including cold sweats, shivers, and body aches and pain, body is hot to the touch but no fever.
Headache Site soreness radiating to (R) breast area and down the (R) side of her torso.
This is a spontaneous report from a physician who reported for 3 patients and from a nurse via a Pfizer Sales Representative. This is third of the three reports. A 57 year-old female patient received, on 05Dec2014 at 14:39, PREVNAR 13 (Lot. J49849, expiration date: 02Jan2016) on the right deltoid, at 0.5 ml, single dose. On the same day, on 05Dec2014, she received FLUVIRIN (Novartis, Lot. 1411401, expiration date: 05Jan2015) on her left deltoid, at 0.5 ml, single dose. Relevant medical history included chronic obstructive pulmonary disease (COPD). Concomitant medications were unknown. On 06Dec2014, the patient experienced swelling, redness and pain. The nurse mentioned that the patient was not hospitalized. The patient did not experience the same event before. One of the patients called back to the doctor's office to report the side effects and took a picture to show the reaction and sent it to the office. The nurse mentioned that swelling of arms, redness and pain was due to PREVNAR 13. The patient recovered from the events on an unspecified date. Follow-up (21Jan2015): New information reported from the contactable nurse through a Pfizer sales representative includes: patient details, vaccinations details, reaction data and reporter's assessment.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On unknown dates in 2015, reported as "two years ago", the patient received the first and second dose of GARDASIL 9 (strength, route of administration, Lot # and expiration date were not reported) for prophylaxis. On an unspecified date in 2017, reported as "presently", the patient was at the pharmacy to receive the third dose of the series of GARDASIL 9. No adverse events were reported.
pt devel superficial phlebitis in one leg 24hrs p/vax;No further details were provided
JOINT PAIN BILAT,  SHOULDER/ELBOWS/KNEES/LEFT ANKLE/LEFT BASE OF THUMB-WRIST. INTERMITTENT  SWELLING OF ALL THESE MENTIONED JOINTS NO ERYTHEMA OR WARMTH
08/12/19 Sore arm same day moderate/severe pain at 6, 2nd day 08/13/2019 came down with fever lasting approx. 8hrs. took 1,000mg. of Tylenol approx. up to 102 degrees, sore arm continuing on for 1.5 weeks total, pain level 1st 7 days or so was 6 after that went down to approx. 3.  08/16/19 5th day came down with fever again lasting approx. 16hrs. (longer than 1st fever) took 1,000MG of Tylenol 1hr. later fever had gone higher took addl. 1,000Mg. to get it under control(so total of 2,000Mg),temp up to 102.5, 08/23/19 12th day came down with fever again lasting approx. 6hrs. took 1,000Mg. of Tylenol, temp. up to approx. 101.5. As of today everything appears to be resolved.....  I do get approx. 2 fevers per yr. for no apparent reason. I have never had so many fevers so close together.....
Fever 101°F. Febrile convulsions. Ear pain. Cough. Dry skin. Hives.
On 27May2022, 1 vial was placed in the refrigerator from which 2 doses (0.25mL booster doses) were administered.; Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (On 27May2022, 1 vial was placed in the refrigerator from which 2 doses (0.25mL booster doses) were administered.) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 27May2022, 1 vial was placed in the refrigerator from which 2 doses (0.25mL booster doses) were administered.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (On 27May2022, 1 vial was placed in the refrigerator from which 2 doses (0.25mL booster doses) were administered.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vial did not undergo any temperature excursions. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-589616 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2022: Significant follow-up received: Patient details (age) added.
Arm pain at the injection site that started several hours after the injection. The next day she began having pain in her armpit and under her collar bone on the same side as the injection.
Information has been received from a RN concerning a 7 y/o Asian male in "good health" and with no allergies or medical history who on 10Oct1998 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live during a well check up. Concomitant vaccinations on the same day included measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) an IM fourth dose in the left thigh of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid, and an IM fourth dose in the right thigh of Hib conj vaccine (HIBTITER). It was noted that the pt was not taking any chronic medications. The nurse reported that this previously immunized child presented on 02Sep2003 with a one day history of a new onset of lesions and severe itching. ON examination there were 91 lesions, mainly on the torso and the rest of the upper body, scanty on the extremities, and none on the mucosa. There was no fever on examination and none reported by the parents. There was no known exposure to community chicken pox. The parents reported that iphenhydramine hydrochloride (Benadryl) was not helping. The pt was prescribed  cetirizine hydrochloride (Zyrtec) and recommended calamine (+) camphor (+) pramoxine hydrochloride (AVEENO) bath and calamine lotion. NO diagnostic or laboratory tests were performed. It was noted that the pt had no adverse events following prior vaccination. At the time of the report the pt had not recovered.  A product quality complaint was not involved.  Follow up information was received from the RN which indicated that on 02Sep2003 the pt presented to the clinic with a blister type rash times three days, starting in the AM of 31Aug2003. Approx. 91 lesions were counted, primarily on the upper torso. The pt recovered from the blister type rash and lesions on 05Sep2003 at which time he returned to school. Follow up was received which indicated that there was no additional information. No further information is expected.
Erythema, warm and red to arm, very painful, reported temp as high as 100 degree F. Area tenderness to palpation to the elbow. Pt was treated with Clindamycin 300 mg TID x 7 days and follow up in 2 days at the clinic.
23 hours post vaccine, began to cough and have difficulty breathing. Temperature fluctuations and temperature of up to 101.7. Treated breathing difficulties with asthma inhaler. Took Tylenol for fever. Adverse effects lasted approximately 8 hours and both breathing difficulty and temperature resolved simultaneously.
Fever --> body aches --> altered mental status --> grand mal seizure --> taken to hospital --> transferred to hospital for neuro. consult and observation (on date of vaccine admin.)
Pt called pharmacy on 10/22/15 around 9 am. He said after 7 days of getting Flu shot he now has symptoms such as can't open mouth properly, can't talk properly, has swelling and rash. I told him to see his MD right away. He was concerned why it happened a week later.
his eyes are reddish; He is having an allergic reaction to it.; Runny nose; Eyes watery; Nose is stuffy; Sneezing; This is a spontaneous report from a contactable consumer. A consumer reported for 17-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0170 and expiry date were not reported), via an unspecified route of ad-ministration, in Arm Left, on an unspecified date, as dose 1, single dose for COVID-19 immunization. The patient's medical history included allergy. Concomitant medication included oxymetazoline hydrochloride (CLARITIN) for allergy. The reporter stated the patient was having allergic reaction to Pfizer vaccine, where his eyes were reddish, his nose was running, stuffy, eyes watery and sneezing on an unspecified date. He started getting this after he got the shot. Second vaccination dose date was scheduled on 20May2021. Outcome of the events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
24h after immunization (Td) client developed temp of 101.8 by ear, severe body aches, redness at inj site. Client was sent home from school. Denies N/V, heat at site, swelling or other effects. Did not seek medical attn; slept-symptoms gone 24hr later.
2 wks p/vax pt devel pain & numbness of rt arm, numbness & tingling in hands & feet; improving now
slight headache; weakness; nausea; Vomiting; chills; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (weakness), NAUSEA (nausea), VOMITING (Vomiting), CHILLS (chills) and HEADACHE (slight headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Allergy to antibiotic, Asthma, Hypertension and Hyperlipidemia (Patient was taken off Statin). Concomitant products included TRAZODONE, VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and MELOXICAM for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced ASTHENIA (weakness), NAUSEA (nausea), VOMITING (Vomiting) and CHILLS (chills). On 03-Feb-2021, the patient experienced HEADACHE (slight headache). On 28-Jan-2021, ASTHENIA (weakness), NAUSEA (nausea), VOMITING (Vomiting) and CHILLS (chills) had resolved. On 03-Feb-2021, HEADACHE (slight headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided.  Patient's concomitant medication includes Bico 100 mg/25 mg   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up received contains significant information: Concomitant medication added, Medical history updated, Patient race and height added, Second dose information added.
Pt received Flu vaccine 9/24/12. Developed s/s Bell's Palsy 9/28/12 - facial droop, altered blink reflex. Started VALTREX 1 gram tid x 7 days. Negative CT.
States 1 week after getting vaccination, her L arm swelled with a rash down to her elbow and rash appeared on face.
No other issues or concerns noted; Improperly stored administered VARIVAX/Temperature excursion information: (-11.83C) for 2 hours and 30 minutes; This spontaneous report was received from other reporter, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 28-MAR-2022, the patient was vaccinated with a dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U016065, expiration date: 20-MAY-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: -11.83 degree Celsius for 2 hours and 30 minutes. No other issues or concerns noted (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004055:
Adverse events occurred after my second dose.  I have a constant ringing/buzzing in my ears.  Sometimes this ringing/buzz is louder than other times but always there.  I went to  ENT on June 8, 2021 .  Sometimes the noise is so loud that I can't hear the TV or concentrate on a task.  Dr gave me a prescription to take for 30 days.  No success with prescription.
13 x 9 mm erythemic area on (L) upper arm. Warm to touch; Sore to move swollen upper arm. General malaise.
Nursing Notes: about an hour after COVID injection, severe vertigo, vomiting, severe headache, left arm completely numb, pt states she is sitting in her car in the parking lot of her apt, but not able to get out and walk bc the dizziness is too much. RN recommended ER disposition. Pt is going to take an Uber
Patient had either 10-30 second seizure or vasovagal response after blood draw and immunizations (TB was given right before). Lasted only about 10 seconds but patient stated that she started to feel "woozy" and then hunched forward and then her eyes enlarged and pupils dilated and she moaned slightly and stiffened. With help, was able to get patient's mask down to allow her to breathe and put a pulse ox on her and it was 96-100% with HR in the 90's. No changes in vitals. Patient recovered quickly and was groggy for about a minute and was asking what had happened. Patient informed of instance and she stated that she has had 2 similar events in the last 5 years but one was when she had a UTI and the other when she was dehydrated. Alert and oriented after. Called for ride to pick her up as exam was normal and she refused ambulance at this time. Recommended she follow-up with PCP and ask for neurology consult to check on past events and this event in case it was a seizure and she is at risk of more. Patient in agreement with plan.