chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore left arm shoulder deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm shoulder deltoid muscle) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm shoulder deltoid muscle). At the time of the report, VACCINATION SITE PAIN (Sore left arm shoulder deltoid muscle) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were provided. The patient received the vaccine in her left arm shoulder deltoid muscle.    This case was linked to MOD-2022-461986 (Patient Link).
Got his vaccine, his arm hurt after the vaccine, but nothing severe.  He tried to go to sleep but he cannot sleep at night, has insomnia.  He threw up and ate something in his stomach, but has an aura of a high that he is having.  Doesn't know if he can stay awake or go to sleep.   He has soreness in his arm still.
SHAKING; FEVER; HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced shaking, fever, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headaches and shaking was not reported. This report was non-serious.
INJECTION WAS MADE WITH A 5/8 INCH NEEDLE INSTEAD OF A 1 INCH NEEDLE.  NO ADVERSE SYMPTOMS OR SIGNS.
Found to have myocarditis with troponin of 8 after presenting with three days of chest discomfort following the vaccine. Normal echocardiogram.
Patient came into Pharmacy the day after receiving the Flu and pneumovax vaccine with her left arm extremely red, puffy and hot to the touch. I told her to take some ADVIL and ice it. I wasn't sure if it was cellulitis so I told her to follow up with her primary. She did. MD stated no cellulitis just a reaction to vaccine.
booster have to same portion as Moderna 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (booster have to same portion as Moderna 2nd shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: JANSSEN COVID-19 VACCINE in April 2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On an unknown date, the patient experienced OFF LABEL USE (booster have to same portion as Moderna 2nd shot). At the time of the report, OFF LABEL USE (booster have to same portion as Moderna 2nd shot) had resolved.            No concomitant medication were reported   No treatment information was reported
Have developed heart palpitations as a result.  Did not have palpitations prior to  vaccination.  Occurs primarily at night when trying to get back to sleep after waking up to use the bathroom.  Can feel symptoms during the day on occasion when not overly active.
Got Covid on July 19; quite sick with cough, fever, aches and pains, severe fatigue. Cough and severe fatigue took quite awhile to resolve. 3 weeks later was very dizzy, light-headed and brain fog. Diagnosed wit POTS (postural orthostatic tachycardia syndrome whic i am still suffering with.
At 7:00pm my daughter compained of her throat feeling "weird". Up until approximatly 8:00pm she was acting normal. At 8:00pm she began complaining of having chills and was observed to be shaking harder than what would be considered normal; however, this was non-seizure shaking. Her fever was taken and read at 101.2. She also complained of feeling weak all over. I administered medication to help with the fever and she went to bed. At approximately 10:00pm, she vomited and began crying saying that she felt "so hot that her skin might burn off". Due to a dead battery in the thermometer, I was unable to take her temperature again but felt her skin and it was very hot to the touch. She then complained that her tongue, throat and mouth felt numb. I also observed her face to be slightly swollen-particularly in the nose area and the lower part of the jaws. At approximately 11:45pm she vomited a second time. At approximately 12:00am, these symptoms were reported to her doctor. The doctor suggested that I administer Benadryl and watch her symptoms. At approximately 12:35am, Benadryl was administered and she returned to bed.
Muscle tightness (L) arm & leg - within 1 hr. of vaccination. Dyspnea - onset 60-90 minutes after vaccination (included airway constriction). Used Albuterol PRN 6 times over the 15 hrs. after vaccination. Bruise covered left deltoid. 8-10-10: RN completed this form before leaving employment in June, 2010. The form was seen in the employee's file this week. I'm sending it in case she didn't do so in May.
Initial report received on 17 December 2007 from a patient. A 48 year-old female patient received on an unspecified day in February 2006 (also reported as approximately 1 year ago) DECAVAC (lot# U1879BA) (unsure of site and route of administration) due to injury - she stepped on a rusty nail). That evening, she experienced soreness, redness and swelling in her arm, malaise, fatigue, fever and nausea. She was unable to remember if she had seen a physician at that time. The symptoms persisted for a week. When she was asked if the events resolved she was unsure, therefore, outcome was unknown. The patient did not received any concomitant vaccines. The patient's medical history included: allergy to thimersol, penicillin and hay fever. Last DECAVAC vaccination was given approximately in July 2000.
This morning there is soreness in the area of shot; hard lump in area of shot; hard lump in area of shot; Was very stiff; Was very sore; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2020, the patient received Shingrix. On 9th April 2020, 2 days after receiving Shingrix, the patient experienced injection site pain, injection site induration and injection site lump. In April 2020, the patient experienced stiffness and pain. On an unknown date, the outcome of the injection site pain, stiffness, pain, injection site induration and injection site lump were unknown.   It was unknown if the reporter considered the injection site pain, stiffness, pain, injection site induration and injection site lump to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, just got shot on Tuesday (7th April 2020). Was very stiff and sore. This morning (9th April 2020) there was soreness and a hard lump in area of shot.
Episodes of unilateral facial numbness and tingling. Occurred in 3 separate episodes: First one being 30 minutes after administration of vaccine, 2nd one 8 days later, and 3rd one 10 days later. Each episode lasted about 5-10 minutes. Also reports constant pressure behind both eyes.
Received flu vaccine approx 12:30 PM and by 1:30 PM noted beginning of stiff neck by 3:30 PM very uncomfortable. Applied warm moist compresses at home throughout evening. Took Tylenol. By AM neck stiffness subsided.
Left upper arm is indurated and warm to touch. Arm is itchy. Intermittent shooting pains, achy joints, nausea & all over malaise.
Pt became lightheaded, dizzy, short of breath within a few hours after receiving flu vaccine. She vomited and began shaking. She also developed a fever and increased heart rate.
A mother reported that her son, now two years old, received his fourth dose of Prevnar on 11/11/02. The child's vaccination history includes series of HibTITER and DTP (manuf unk) vaccines as well as polio virus vaccine (manuf unk), MMR II vaccine, and hep B vaccine (manuf unk). When the child was approximately one year old, the mother reportedly noted "symptoms" of speech, language, and social delay. No further info was available at the date of this report. Speech, language, and social delay was considered medically important (OMIC).  Reported on 02/27/2003: "Follow-up information received from the physician on 02/14/2003 provided immunization records (including lot numbers) and additional patient information.  A mother reported that her son, now 2 years old, received his fourth dose of Prevnar vaccine on 01/11/2002.  Physician records indicate the child received his second dose of ActHIB vaccine and a dose of Varivax vaccine on the same date.  The child's vaccination history also includes series of HibTITER, Infanrix, IPOL, and Engerix-B vaccines as well as doses of M-M-R II vaccine and hepatitis B vaccine.  When the child was approximately 1 year old, the mother reportedly noted "symptoms" of speech, language, and social delay.  Speech, language and social delay was considered medically important.    Information regarding this event has been forwarded to each manufacturer.
Headache, vertigo, high fever, body aches, soreness, fatigue, loss of appetite - noticed 8 hours after injection and lasted for roughly 40 hours.  Intermittent rash and itching - began 3 days after injection and often has to be mitigated with Benadryl
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling and injection site muscle pain. On an unknown date, the outcome of the injection site swelling was recovering/resolving and the outcome of the injection site muscle pain was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling and injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. One month ago the reporting, the patient received the 1st dose of SHINGRIX on left deltoid. After receiving the vaccine, the injection site was swollen for the few days and had improved at the time of reporting. Till the time of reporting, the patient still had muscle pain in her upper left arm when she flexes her arm. The patient was wondering that how long it would last. The patient was upset that the pharmacists give these shot and they did not tell that how painful they are. The patient was in doubt that she would get the second injection and wants reimbursement. The patient wanted to remain anonymous.
my teeth was opening and closing as if I was having a seizure; My body was involuntarily twitching; I was cold; shaking; shivering; headaches; 1st dose: 28Mar2021/2nd dose: 14Apr2021; 1st dose: 28Mar2021/2nd dose: 14Apr2021; This is a spontaneous report from a contactable consumer (patient). This 20-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER8731) on 14Apr2021 16:45 at single dose in right arm for COVID-19 immunisation. Medical history was none. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 (lot number ER8733) on 28Mar2021 12:00 in right arm. The patient had no Known allergies. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient had not received other vaccine in four weeks. On 15Apr2021 04:00, his body was involuntarily twitching and his teeth was opening and closing as if he was having a seizure. He thought it was because he was cold so he put on 3 layers of clothes and 2 bundles of blankets and turned the heat up, but his body was still shaking and he was still cold. He tried to go back to sleep to see if that would fix it, but it did not until he went to work and around 7:30 a.m., the shivering stopped, but the headaches persisted and he had to ask to go home and he received an occurrence because he did not have a doctor's note. He clocked out at 8 and he went to sleep for an hour in the car in the parking lot because he was in no condition to drive home. Treatment received for the events included Acetaminophen and rest. The outcome of teeth was opening and closing as if I was having a seizure, body was involuntarily twitching, was cold, shaking, was resolving. The outcome of shivering was resolved. The outcome of headaches was not resolved.
Sudden localized subcutaneous reaction appeared near the neck. Is like a nodule that it moves, it doesn't hurt. No redness, no itchiness. Haven't done anything for it.
PATIENT WAS GIVEN BIVALENT MODERNA BOOSTER ON 12/2/22 BY A NURSE, ALTHOUGH HE ALREADY RECEIVED PFIZER BIVALENT ON 11/4/22
Day of vaccination, arm tender, 7 hours after vaccination, Extreme Fatigue and Sore throat - loss of voice. Day after vaccination, Severe body pain - back, shoulders, hips, abdomen with Muscle aches, Headache, Mild Discomfort in chest and ribs when breathing, and General feeling of  being unwell
Left arm very swollen; Very hot to touch; Red and rashy on entire upper arm; This is a spontaneous report from a non- contactable consumer (patient). A 29-year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8733) (age at the time of vaccination was 29 years) via an UNKNOWN route of administration on 02Apr2021 in left arm as dose 1, single for COVID-19 immunisation. The patient's medical history included drug hypersensitivity, allergies to Sulfa. Concomitant medications included Junel (ETHINYLESTRADIOL, NORETHISTERONE ACETATE). There were no other vaccine in four weeks. There was no Covid tested prior to vaccination and not tested for COVID post vaccination. Patient most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. On 03Apr2021, the patient experienced left arm very swollen, very hot to touch and red and rashy on entire upper arm. No treatment was received for the events. It was reported that the events were started day after vaccination and lasted about 5 days. The clinical outcome of the event left arm very swollen was recovered in 2021. The clinical outcome of the events very hot to touch and red and rashy on entire upper arm was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 12Feb2021 15:45 at the age of 45 years old (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient has not been COVID-9 tested since the vaccination.  The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included breast cancer from an unknown date treated in 2017, egg, lobster, contrast dye and wasps/hornets allergy from an unknown date. Concomitant medication included tamoxifen, escitalopram, colecalciferol (VITAMIN D), docosahexaenoic acid, eicosapentaenoic acid (OMEGA-3); and bifidobacterium breve, bifidobacterium infantis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus bulgaricus, lactobacillus paracasei, lactobacillus plantarum, streptococcus thermophilus (VISBIOME)' all taken for an unspecified indication, start and stop date were not reported.  The patient previously took neomycin and experienced allergy. On 12Feb2021 18:30, the patient experienced nausea and vomiting three hours after getting the first shot, lasting for approximately 4-5 hours on 12Feb2021. No treatment was given to the patient for the events. The outcome of the events was recovered on 12Feb2021.  No follow-up attempts are possible. Information about lot/Batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 02-MAR-2018, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The Oka/Merck VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Fever, body aches, headache, fatigue. Started aprox 7 hours after vaccination.
08/8/11 mom stated after patient received injections and left home (LA) deltoid and (R) arm subcutaneous began to swell with redness. Patient returned for TB reading 8/10/11 and (L) deltoid was red with a diameter of 5mm as well as (R) subcutaneous with a diameter of 2 1/2 mm. Pt was advised to put cold compresses & medication was prescribed.
Bivalent booster given when he was supposed to get regular Pfizer dose. Patient had 1 Pfizer dose prior to today.
Rec'd DTP @ 1PM; started crying about 2PM & continued crying until 4PM. MD notified. Ordered another dose of Tylenol & child continued to cry & be fretful all nite long. MD ordered DT given in future.
MEDI-0003810 is a non serious spontaneous case from a consumer involving red pimple like dots around nose. The reporter causality is not provided to FluMist. A 34 year old female reported that she experienced red pimple like non-pruritic dots around the nose 2 weeks after receiving FluMist on 12Oct05. There was no medical intervention. The patient has not yet recovered. The patient's husband also experienced the same red pimple like dots a week after they both received the FluMist at their children's pediatrician's office. The reporter causality is not provided. This case is linked to MEDI-0003816.
Received both vaccines in right deltoid (unable to use left deltoid due to lymphedema) on Monday, 11/5/07.  Evening of 11/5 had chills and fever.  Tuesday, 11/6 noted redness on arm approximately 3"x5" and edema.  Had pain and unable to use arm.  Saw doctor on 11/7 and gave Prednisone Taper.  Arm continued to improve with redness, edema and pain.  Has returned to normal activity.
Fussiness started 6 hours after vaccination 103 degrees temp throughout night. 8/19/2004  pt still "very fussy, decreased appetite, fever 101 degrees".
Blisters and Large rush area and deep stabbing pain around the left side of the waist area.
Patient observed slumping over in chair.  When assessed she stated she felt lightheaded and was diaphoretic.  Blood pressure obtained at 1400, BP 63/34, HR 84. EMS contacted and dispatched.  Patient experienced syncope.  1405 EPI administered per protocol. 1414 vital signs as follows: BP, 168/135; HR 60.
Information has been received from a registered nurse concerning a 24 month old female who on 20-Oct-2006 was vaccinated with a "standard dose" of PROQUAD (655625/1091F).  Other vaccinations received the same day included influenza virus vaccine (unspecified) and Vitamin B 12 injection.  On 18-Oct-2007 the patient experienced chickenpox.  The patient had multiple papules and vesicles on her toe, back, arms and legs.  The patient sought medical attention via an office visit on 18-Oct-2007.  At the time of the report, the patient was recovering.  There was no product quality complaint.  Additional information has been requested.
Pt vaccinated with DTP/OPV c/o pain in leg Nov 9,10 & 11.  Temp to 105 mother sponged child & gave tylenol & temp decreased. Child is foster child & not any family hx known. No redness or swelling in leg.
Patient called pharmacy 9/12/19 to report feeling sick since 12:30 AM. Patient reports chills, fever, nausea and vomiting. Patient made appointment with physician for today (9/12/19) at 3 PM for follow up.
Client reported puffy eyes that did not resolve after the 3rd day after vaccine administered on 06/18/21
ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 4/25/2023 ACUTE RESPIRATORY FAILURE WITH HYPOXIA SLEEP RELATED HYPOVENTILATION OR HYPOXEMIA 4/25/2023 ACUTE RESPIRATORY FAILURE WITH HYPOXIA
Pt with history of R thigh mass times 2 weeks, received May 3, 2001 2 shots over week increased nodule now mass no redness or discharge 1x2cm in size. Previous reaction in Nov 2000, requiring surgery.
fatigue; pain at injection site Narrative: per supervisor report: "received the Covid-19 Vaccine on Friday 6/25/2021 and is having symptoms of fatigue, pain at injection site:
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 2/10/2021 and  3/10/2021. Pt.  w/chronic lymphocytic leukemia, HTN and hypothyroidism presented to ED 11/26/2021. Admitted for acute respiratory failure w/hypoxia due to COVID pneumonia. Tx'd with steroids, antibiotics, and RDV. Patient improved. Pt. w/nausea and diarrhea and abd distention, drop in Hgb 13.2 -> 7.9 over 3 days, found to have rectus hematoma thought 2/2 underlying coagulopathy in the absence of trauma. Expired 11/29/21.
Stevens-Johnson Syndrome, angioedema; not responding to initial prednisone and antihistamine
Left ear and cheek numbness for 1 week, noted after her 2nd Moderna shot (1 wk after)  To repeat labs in 2 wks.
Information has been received from a RN concerning a 24 year old female who on 23Apr04 was vaccinated with a first dose of hep B virus vaccine rHBsAg (yeast) (lot 645602/0751N) as part of a school requirement. There were no concomitant vaccinations on the same day. The nurse reported that the pt developed urticaria all over the body, myalgias, and neck pain and had to be seen in the ER on 26Apr04. She was started on oral prednisone. It was noted that the rash resolved in a couple days. Per the pt's last office visit on 21May04, she still had some joint and neck discomfort. The pt was due for a follow up visit on May04. It was indicated that the event abated and that the pt was recovering with sequelae. A product quality complaint was not involved. Additional information has been requested.