chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination site bruising; Vaccination site discoloration; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Vaccination site bruising), VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and VACCINATION SITE PAIN (Sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising), VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE BRUISING (Vaccination site bruising), VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.
Nursing attempted to call patient back, but could not reach, she was instructed if symptoms worsened to report to urgent care. She never did go in to urgent care, but did return call to describe symptoms. Assuming symptoms resolved as no further documentation is noted about the incident. Nausea, vomiting and pain all over body.
itching in ears, felt like something was wrong;devel high temp, chills, rash & whelps, itching, stinging, burning all over body; devel pneumonia, could not sleep;dx serum sickness;unable to walk;pain joint & hands;infect, h/a;pleurisy; per follow-up received 9/11/00, pt still continues to have severe arthritis in both hands, extreme joint damage with constant pain and swelling; especially in thumbs and wrists.
Febrile Sept 9-11th, with General myalgia.  Substernal chest pain and SOB with exhertion,  began Sept 11, gradually worsening until Sept 13. EKG on Sept 13, "normal". Substernal chest pain continues with exhertion Sept 15., but is gradually improving.
Tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell, nausea, weakness
Narrative: Patient given Pfizer Bivalent instead of Pfizer Monovalent vaccine. Pharmacy contacted. Talked with patient, explained what happened. Per pharmacy patient to return for second Monovalent Pfizer in 28 days, patient agreed to come back on 11/11/2022 for her 2nd Pfizer Monovalent Pfizer vaccine. Pharmacist contacted Pfizer Inc. for clarifcation, per Pfizer patient does not have to return for second dose of Monovalent Pfizer, one dose Monovalent Pfizer and one dose of Bivalent Pfizer is sufficient, Patient was contacted by phone and notified of change of plan. Patient is in agreement and will not return for second dose of Monovalent Pfizer.
*unknown as to  manufacturer  of flu shot Unable to find words to form sentences.  It is worse when he has to think about the  topic , the words just don?t come.  If he is responding with a quick reaction, the words come quickly.   He can think about what  he wants to say but then when he actually tries to say the words they are gone. He understands everything that I spoken TO him.
Starting 7 days after injection, developed tingling down left arm from injection site down to wrist. Gradually became more pronounced, ang started occurring daily.  In the past 2-3 days , it seems to be lessening, in severity and frequency.
left side of lip drooping/ trouble keeping left eye open/ trouble opening left side of lips/ eyes watering/ swelling of whole face mostly on left side/ hard to drink/ hard to speak; left side of lip drooping,almost feels numb; trouble keeping left eye open; trouble opening left side of lips; eyes watering; swelling of whole face mostly on left side; hard to drink; hard to speak; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (left side of lip drooping/ trouble keeping left eye open/ trouble opening left side of lips/ eyes watering/ swelling of whole face mostly on left side/ hard to drink/ hard to speak) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical reported history provided by the reporter.    On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced BELL'S PALSY (left side of lip drooping/ trouble keeping left eye open/ trouble opening left side of lips/ eyes watering/ swelling of whole face mostly on left side/ hard to drink/ hard to speak) (seriousness criterion medically significant), HYPOAESTHESIA ORAL (left side of lip drooping,almost feels numb), OCULAR DISCOMFORT (trouble keeping left eye open), ORAL DISCOMFORT (trouble opening left side of lips), LACRIMATION INCREASED (eyes watering), SWELLING FACE (swelling of whole face mostly on left side) and DYSARTHRIA (hard to speak). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (left side of lip drooping/ trouble keeping left eye open/ trouble opening left side of lips/ eyes watering/ swelling of whole face mostly on left side/ hard to drink/ hard to speak), HYPOAESTHESIA ORAL (left side of lip drooping,almost feels numb), OCULAR DISCOMFORT (trouble keeping left eye open), ORAL DISCOMFORT (trouble opening left side of lips), LACRIMATION INCREASED (eyes watering), SWELLING FACE (swelling of whole face mostly on left side) and DYSARTHRIA (hard to speak) outcome was unknown.            No concomitant Medications were provided by reporter  The patient was treated with Advil (batch number: 017C21A).  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. However, more information regarding tests, diagnostics and treatment details are required for further evaluation.; Sender'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. However, more information regarding tests, diagnostics and treatment details are required for further evaluation.
Pain in my arm at the injection site / persisted these past 6 months / forcing / to seek medical attention; Injured by the Shingrix vaccine / Pain / has continued on for over 6 months; Swelling; Feeling unwell / malaise; Fatigue; This case was reported by a consumer and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2020, the patient received the 1st dose of Shingrix. On 14th August 2020, 1 day after receiving Shingrix, the patient experienced injection site pain, pain, swelling, feeling unwell and fatigue. On an unknown date, the outcome of the injection site pain, pain, swelling, feeling unwell and fatigue were unknown.   It was unknown if the reporter considered the injection site pain, pain, swelling, feeling unwell and fatigue to be related to Shingrix.   Additional details were reported as follows: Reported A description of the possible side effect itself, such as the signs and symptoms experienced, date the possible side effect started and the result of the possible side effect. The vaccine received by patient on 14-AUG-2021, that day patient started the pain, swelling, rash, fatigue and malaise. Patient stated that the pain side effect forcing her to seek medical attention. Her doctor has ordered an MRI to rule out what damage present in her arm.
I started having severe pain in my left arm about, 1 week after my vaccine. About 2 weeks after the vaccine, I had diarrhea for 6 straight days. I have a knot on my arm that is close to my wrist that is on my vain. My arm aches in the area where I received my first shot and, my skin gets really tight in my wrist area. I went to my Doctor on the second day that I had diarrhea and, she told me to take Imodium but, it did not work because, I had diarrhea 4 more days after taking it  as directed everyday. My doctor said that probably had strained my arm and to just rest it for a few days. I am very worried that something is very wrong and need to know what to do because, it is scaring me alot.
After about 1 week my arm started swelling, getting red and itching tremendously and mild pain.
5 inch 0.5 in redness, blisters with induration present at injection site (L) thigh. Warmth present. Tender with exam.
Initially on Friday 11/05/2021 I had a headache and was a little tired. I felt normal on Saturday, but a little rundown as the day went on.  I   took a nap, and during that time, I woke up with chills, body aches, a low-grade temperature (100.4), a headache, and sore throat.   My sore throat continued on Sunday, but I no longer had the body aches, chills, headache.
I did not have an adverse reaction to the vaccine. On 04/01/2023, we had a heavy and wet snowstorm. On the street at my residence, we had a car that got stuck in the snow. I went out to help move the car and got lightheaded and laid down for about a minute. I got up and I still felt lightheaded. A neighbor recommended that I go to the emergency room. About 7 hours later, I did go to the emergency room. I was examined if I had a heart attack. All test was in normal range.
heavy menstrual flow lasting 18 days. Large clots and heavy flow not the typical course.
Received GARDASIL 9 vaccine on 4-26-17. Within 12hrs after the vaccine-C/O HA, vomited 1X, diarrhea couple days, no appetite, not active. Office visit 5-1-17 with cough, congestion, again 5-3-17 with cough, sore throat.
pt recv vax 10AM temp of 104 noted 430PM;APAP given;830PM had sz-EMS-ER;EMS t102 R;pt hosp dx included CSF studies, cult neg;CBC nl;sz activity lasted approx 20min;dx sz ?etiology MMR, febrile, convuls, new onset epilepsy;
I got chills and severe tremors that lasted for hours, was fatigued, nauseated, and had a stomach ache. I put multiple blankets on me, turned on extra sources of heat, took 3/4 mg. of Xanax and finally felt somewhat better around midnight. I was extremely fatigued the next day, and my knees hurt this morning, but I feel better now.
A spontaneous non-serious report of hives, itching, leg pain, bruising and attention deficit/hyperactivity disorder (ADHD) has been received from manufacturer (manufacturer control number 08P-163-0479239-00) concerning a nine-year old female patient subsequent to FLUMIST use. The original reporter was a physician. Medical history included precocious puberty and no known allergies. Suspect medication included leuprolide acetate depot. Concomitant medications obetrol (ADDERALL and ADDERALL XR) 20 mg. On 24-Sep-2008, the patient received FLUMIST for flu vaccination and then her monthly dose of leuprolide acetate depot. Five minutes after receiving leuprolide acetate depot injection, the patient developed hives, itching, pain in entire leg and bruising. The bruising described as multiple red and deep purple blotches, did not originate at the site of the injection. It covered the patient's entire thigh, from top to the knee. Treatment with diphenhydramine was started for the hives and itching. On 01-Oct-2008, leuprolide acetate depot was discontinued. the patient's mother was advised to continue treatment with diphenhydramine until the reactions resolved. The events of hives, itching and bruising were resolving. The event of pain was resolved. The outcome of ADHD was unknown. The physician assessed the events of hives, itching, pain in entire leg and bruising as possibly related to leuprolide acetate depot, but the causality was questionable since the patient had been on leuprolide acetate depot since 2005. FLUMIST was also considered suspect.
Immediately after being injected with the vaccine, baby starts to cry and the nurse tells mom (me) to pick him up. I pick him up and try to comfort him and notice his eyes roll back, his whole body go limp, and he?s not breathing. At this point it had only been 20 seconds since being injected. I yell ?he?s not breathing? and the nurse leaves the room to get help. I laid him on the table and blew on his face and pushed his chest, he starts to cry again and is able to move again just as a team of nurses and doctors rush in. Doctor states that sometimes children pass out from holding their breath from crying too much or getting too upset.  They send us home.
Expired Havrix Administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 42-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th January 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 9th January 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Jan-2023 Reporter's comment: Pharmacist administered Havrix to a patient after the expiration date. The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
armpit pain; Pain; fever; chills; elbow pain; This case was reported by a consumer via call center representative and described the occurrence of axillary pain in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 9277N, expiry date 30th April 2020) for prophylaxis.   On 24th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 24th April 2019, immediately after receiving Shingrix, the patient experienced axillary pain, pain, fever, chills and pain in elbow. On an unknown date, the outcome of the axillary pain, pain, fever, chills and pain in elbow were recovered/resolved.   It was unknown if the reporter considered the axillary pain, pain, fever, chills and pain in elbow to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right deltoid. The patient stated shortly after getting the 1st dose of Shingrix within the same day, she developed a pain in her armpit that then shot down to her elbow and has remained. The pain started as soon as she moves. The patient also had fever, chills and pain that lasted a few days but was now resolved. The patient contacted her doctor who instructed her to take a pain reliever but also recommended she not get the 2nd dose of Shingrix. The reporter did not give consent to follow up.
Vaccine to R deltoid numbness & tingling to L arm. Face & neck felt tingly. Hands cold. BP 170/130 @ 315 150/102 @ 3:40 P92->P 83 O2 100% Has slightly elevated BP regularly normal 140/90. Has a BP cuff @ home Alert & oriented. Talkative. Eye contact Normal Gait & Movement
they withdrew and administered 30 booster doses out of a Moderna Covid-19 Vaccine vial; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (they withdrew and administered 30 booster doses out of a Moderna Covid-19 Vaccine vial). At the time of the report, PRODUCT ADMINISTRATION ERROR (they withdrew and administered 30 booster doses out of a Moderna Covid-19 Vaccine vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment received by the patient.
Sore arm; This is a spontaneous report from a contactable consumer (Patient's husband) via a sponsored program. An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW), the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW), both via an unspecified route of administration on unspecified dates (at the age of 82 years); both as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The husband reported on behalf of his wife who got the first and the second dose of the vaccine, and she experienced sore arms after the vaccine. The clinical outcome of sore arm was unknown.  Information on the lot/batch number has been requested.
Client came to office to explain adverse events. Client's upper lip started swelling late in the evening. This has happened to client before from allergic reaction and from stress. Client took Benadryl and did not help swelling. Client also had couple hives on arms. Instructed client to go to walk-in or call primary care physician.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that in approximately August 2014, reported as in the last three to four weeks, she inadvertently administered a second dose of PENUMOVAX23 intramuscularly, (dose not reported), lot # H015749, which expired on 08-JUN-2014, to the patient. This was supported. The first dose was administered three years ago, in 2011. There were no adverse effects reported. Additional information has been requested.
diarrhea; vivid dreams; headache; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABNORMAL DREAMS (vivid dreams), HEADACHE (headache) and VOMITING (throwing up) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (November 2020).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DIARRHOEA (diarrhea), ABNORMAL DREAMS (vivid dreams), HEADACHE (headache) and VOMITING (throwing up). At the time of the report, DIARRHOEA (diarrhea), ABNORMAL DREAMS (vivid dreams), HEADACHE (headache) and VOMITING (throwing up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test positive: positive (Positive) positive. On 12-Mar-2021, Pyrexia: 99.6 (High) 99.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant information was provided.
redness and swelling at the time of injection.  Was told to ice and take Tylenol.   Redness and warm to the touch continued.  I caught a cold and went to Urgent care to take a COVID test so I could return to work.  I had the Dr.  look at my arm  while I was there.  He said I had cellulitis and put me on antibiotics for 10 days.  It is slowly getting better.
April 2 through April 9, localized soreness and redness in left arm.   April 10 am, generalized swelling, heat, redness, and pain in location of the shot in left arm. Size of a deck of cards.  April 10pm, swelling, heat, and redness has expanded and now covers upper left arm, from shoulder to elbow,  about 70% of arm circumference.  Edges of redness are very defined and area looks like a big welt.  Benadryl treatment begins, as well as ice.   April 11 am, no marked improvement, but not further expansion of swelling, heat, redness, pain.  Benadryl  treatment continues every 4 hours.   April 12 am, swelling, redness, and heat seem to be clearing from upper arm and collecting down toward elbow area on underside of arm.  Pain not as significant. Benadryl at nighttime.   April 13,  almost all swelling , redness and pain have subsided.  Benadryl continued at nighttime.  Entire left arm itchy.   April 14 am, area on underside of left arm surrounding elbow joint now swollen and red, painful, and welt like appearance becoming more prominent.  Entire left arm very itchy.  Benadryl during daytime and at nighttime. April 15, area around left elbow joint swollen, red, and painful.  Looks like inflammation is headed both down toward hand and back up toward shoulder.  Spot near injection site also becoming red again.  Visit to physician.
Information has been received from a physician concerning a female, no demographics provided, who was vaccinated with an unspecified dose of GARDASIL (lot# not reported) on an unspecified date and fainted in the elevator post vaccination. The patient sought unspecified medical attention on an unspecified date. The patient's outcome was not reported. Additional information has been requested. This is one of several reports from the same source.
Pt had a expired pentacel administered on 10/21/21, the vaccine expired on 10/12/21, N/A
Flu  three times, swollen lymph nodes, nasal congestion, sore throat, ear infection, UTI, fever
Patient was given DTAP-IVP and is out of the age range.  Patient needs to get TDAP ASAP as he should have gotten TDAP and Polio and not DTAP-IVP
Several hours after injection was walking in house, fell backward and to floor with jerking movements. Transported via ambulance to hospital and kept overnight. No s/s illness, fever or injury. 06*14 to have neurology consult. Mom reported that only lab that was abnormal was low magnesium. 06/17/02 p.c. to parent of pt, she states she took child to neurologist and he started tp on carbiatrol 200mg and is to take this x 3 years. Reports all test normal except low magnesium. She reports pt had seizure 3 or so hours post #2 HBV. Mother states child may had had seizure 1 x when in the 6th grade post playing basketball at school. States doctor will decide if child should get 3rd dose HBV. Will check back with parent post pt's next visit to neurologist on the 18th.
Patient was given 2nd dose of the series too early; administered 22 days after 1st dose.
FEVER STARTED THAT PM AFTER SHOTS ON 3/29/13. MAX FEVER 105. MOM GAVE TYLENOL TEMP DECREASE TO 103 THAN 99. MOM GAVE TYLENOL EVERY 4 HOURS. ON SAT AND SUNDAY HE WAS ALMOST UNCONSOLABLE AND ONCE ALMOST LOST HIS BREATH.
Approximately 8-10 hours post shot experienced  sore arm with moderate pain no swelling that persisted into next 24hrs.  Limited ROM somewhat.  Most significant effects were increased fatigue and overall muscle pain/rigors and chills with headache and feverish that started that evening and persisted throughout the night.  Symptom lessened but still mild headache and arm pain and overall soreness/body aches the following AM noted.