chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAIN IN LEFT SHOULDER RADIATING ALL THE WAY DOWN FOREARM INTO DIGITS AND EXTENDS INTO THE SHOULDER; SUSPECTED INAPPROPRIATE ROUTE OF VACCINATION; DIZZY; SWELLING AT INJECTION SITE; INTENSE PAIN AT THE INJECTION SITE THAT SEEMS TO HAVE GOTTEN WORSE; UNABLE TO SLEEP AT NIGHT DUE TO PAIN; LARGE HEMATOMA AT INJECTION SITE; UNUSUAL AMOUNT OF BLOOD IN ARM AFTER INJECTION; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient was treated with covid-19 vaccine (intramuscular, and 205AZ1A, serial number, model number, UDI number, and expiration were not reported) therapy dates not reported for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the patient experienced large hematoma at injection site, unusual amount of blood in arm after injection, unable to sleep at night due to pain, swelling at injection site, and intense pain at the injection site that seems to have gotten worse. Laboratory data included: Pain scale (NR: not provided) 7/10. On 08-MAY-2021, the patient experienced pain in left shoulder radiating all the way down forearm into digits and extends into the shoulder, suspected inappropriate route of vaccination, and dizzy. Treatment medications (dates unspecified) included: hydrocodone, and ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from pain in left shoulder radiating all the way down forearm into digits and extends into the shoulder on MAY-2021, and dizzy on 08-MAY-2021, had not recovered from intense pain at the injection site that seems to have gotten worse, large hematoma at injection site, and swelling at injection site, and the outcome of unusual amount of blood in arm after injection, unable to sleep at night due to pain and suspected inappropriate route of vaccination was not reported. This report was non-serious. This case is a duplicate of 20210544916.; Sender's Comments: V0-Medical assessment comment is not required as per standard procedures, as the case was assessed as non-serious.
Pt recv vax on 4/22/99; on 4/25/99 pt exp diarrhea of yellow-green color, vomiting, fever (100); pt imp 5/1/99
arm had a rash, was swollen, and couldn't hardly move it; arm had a rash, was swollen, and couldn't hardly move it; arm had a rash, was swollen, and couldn't hardly move it; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm had a rash, was swollen, and couldn't hardly move it), HYPOKINESIA (arm had a rash, was swollen, and couldn't hardly move it) and RASH (arm had a rash, was swollen, and couldn't hardly move it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm had a rash, was swollen, and couldn't hardly move it), HYPOKINESIA (arm had a rash, was swollen, and couldn't hardly move it) and RASH (arm had a rash, was swollen, and couldn't hardly move it). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 05-Apr-2021, PERIPHERAL SWELLING (arm had a rash, was swollen, and couldn't hardly move it), HYPOKINESIA (arm had a rash, was swollen, and couldn't hardly move it) and RASH (arm had a rash, was swollen, and couldn't hardly move it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included unspecified blood pressure medication.
Localized red lump at the injection site.  Hot to the touch.  No other reaction present except at the injection site.  Advised mother to give a dose of oral benadryl.  Seek medical attention if no improvement or if symptoms worsen.
unspecified allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic (gentamycin allergy).   On an unknown date, the patient received Fluarix Quadrivalent 2018-2019 season at an unknown dose. On an unknown date, less than 2 years after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were received as follows: The case was reporter by patient's mother. The age at vaccination was not reported. The reporter stated that after vaccination the patient experienced unspecified allergic reaction. No other details were available at time of reporting. The reporter did not consent to follow up.
Vomiting, lethargy, pale started 8am morning of 2/28/17 in MD office. Child brought in because infant didn't "look right" air enema was performed and was successful to reduce intussusception.
This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received SHINGRIX for prophylaxis. On 16th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. No other information was provided.
Patient experienced syncope in car.  By the time nurse arrived to patients side he had regained consciousness.  Patient was alert and oriented but lethargic and slow to answer basic questions.  Patients vitals checked and were within normal range.  Skin  pale and clammy.  Ice pack was placed on back of head, and fluids provided.  Patient did not fully recover within 15 minutes, EMS call was placed.  Nurse remained with patient till arrival and report given to paramedics.  Paramedics evaluated patient vitals rechecked and still within range, EKG normal.  Paramedics  determined patient  was ok to go home and be monitored by parent.  Parent advised to monitor patient and to call EMS, if it needed.   Parent verbalized understanding and agreed with plan.
post herpetic neuralgia; issues with her vision; congestive heart failure; heart attack; bacterial infection; herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions and concomitant medications. On or about 30-AUG-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered from a painful blistering rash, which recurred multiple times; herpes zoster; post herpetic neuralgia; issues with her vision; nerve pain; congestive heart failure; heart attack; and bacterial infection. As a result of these symptoms, the pt was seen and treated by medical providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the vaccination, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccination, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the vaccination, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of post herpetic neuralgia, abnormal vision, cardiac failure congestive, heart attack, bacterial infection and herpes zoster was not recovered. The reporter considered post herpetic neuralgia, abnormal vision, cardiac failure congestive, heart attack, bacterial infection and herpes zoster to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of cardiac failure congestive and heart attack were determined to be medically significant.  The reporter considered post herpetic neuralgia, abnormal vision, cardiac failure congestive, heart attack, bacterial infection and herpes zoster to be disabling.
3:00 AM Tightness in chest, Pain in back,  12:00 AM 100% Blockage, Left Anterior Descending, Angioplasty, Stent
A few minutes post vax pt state "I feel dizzy" and passed out. Pt hit head hard on metal door. Awoke immediately scared and crying. Rolled to back and given cool rags and fan. Pt was pale and diaphoretic. C/O of head throbbing, nausea, dizziness.  Pt was given a snack and reported feeling better. When pt attempted to sit up he became pale and dizzy. Pt started having chest aches. BP 110/80; apical 72 and regular. Pt was given Tylenol. Pt continued to experience dizziness now with SOB. Pt was then transported to the ER. Pt was sent home from hospital with head trauma warnings and ER physician stated it was caused by allergic reaction to Hep B vaccine.
At approximately 5:00 PM I had abdominal pains just below rib cage area.  There were 3  episodes that lasted less then 5 minutes over a 30 minute period.  Then at approximately 2:00 AM on 2/27 I experienced another event described above with severe intensity lasting approximately 30 to 45 minutes. This event was concerning.   I?ve not experienced any further symptoms except a bit of fatigue and mild soreness at the injection site.
Dizzy for three days.; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Feb2021 at 09:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, atrial fibrillation and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included anastrozole (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID), apixaban (ELIQUIS), rosuvastatin calcium (CRESTOR) and montelukast sodium (SINGULAIR); all for unspecified indication from unknown date and unknown if ongoing. On 23Feb2021 at 09:30, the patient experienced dizziness for three days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizzy was resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Receives Covid 19 Booster vaccine of Pfizer at vaccine event on 03/24/2022, starts to have side effects on 03/24/2022 same day of  Heart Palpitations (occurred with Primary Series Dose 1 and 2), Nausea, vomiting, and headache, She took Tylenol to help alleviate pain and assist with fever.  Her HR gotten up to 140 and she went to ER, they ran test and ER provider Dx. with Myocarditis, advised her that she needs to see a Cardiologist and follow up. Continue to monitor for the next 48 hours and be advised by ER provider for future care .
1. Onset roughly 12 hours after injection lasting until approximately 32 hours after injection: fever, chills, body aches, nausea, sore left arm. Treated with 600 mg Ibuprofen every four hours. Fever would break and then come back.   2. Onset roughly 51 hours after injection lasting until approximately 55 hours after injection: fever, chills. Treated with 600 mg Ibuprofen. No symptoms since.
The patient received Bivalent Pfizer vaccine incorrectly instead of her second dose.    On 12/07/2022 around 8:00, I followed up with the patient. Patient informed  regarding this administration error.    We assured the patient there is no safety concern that receiving the bivalent Pfizer as a second dose by error insured the primary monovalent vaccine.    And explained the recommendation after getting the second dose is to get a bivalent pfizer booster after 2 months of the second dose. Also, I answered all the questions she had. She understood our recommendation, and assured us she will get the bivalent booster after 2 months.  I provided the patient information to see a medical attention if she experienced any adverse effect.   Patient denied experienced  any symptoms after the vaccine.  Also,  I provided my contact information to call or email if she experienced any adverse effect.
My daughter had an absent seizure, (pupils were fixed and dilated, her body was limp, she was smacking her lips and was unresponsive for 1-2 minutes) waiting to see if it happens again before starting diagnostic testing
On 8/31, started with macular rash and temp 101.  Seen on 9/5/08 - Has 8-10 macular/pyretic lesions on arms and legs.  Exam otherwise negative.  On 9/11, has only 2 lesions remaining.  No fever.
mom states pt screamed all afternoon (immun admin mid morning) did not seem to be related to leg pain; no fever & cried self to sleep, slept briefly, awoke screaming; no other sx; no med care sought; better next day;
tingling in lower L arm Treatment: vitals, monitored Received 2ND dose 1/26/21 - No adveRse reaction
Information has been received from a physician concerning a 24 year old female with asthma who on 17-JAN-2007, at 14:00, was vaccinated with a first dose of Pneumovax 23 (lot #654977/0888F) concomitantly with a dose of influenza virus vaccine (unspecified).  Other concomitant therapy included FLOVENT, albuterol and hormonal contraceptives (unspecified).  On 18-JAN-2007, at 15:00, the patient developed a fever as high as 103 and shaking chills despite therapy with TYLENOL.  The patient also experienced nausea, headaches, and pain and mild swelling at the injection site.  The patient sought medical attention and was treated with ADVIL, TYLENOL and supportive measures.  There were no laboratory or diagnostic tests performed.  On 19-JAN-2007, the patient recovered.  Additional information has been requested.
Moderna COVID-19 Vaccine EUA 04/22/21 01:00 - pounding headache woke me, lasted most of the day 04/24/21 15:04 Garmin watch indicated high HR 144 bpm walking around the yard (avg. resting HR 65 bpm, avg. high HR 120)
About 1 1/2-2 hours after injection, mom called to report that patient's arm was swollen and twitching. Had him return. (L) deltoid area was slightly swollen & tender to palpation, (L) arm had twitching (whole arm). Several episodes noted over 5-10 min period. Neuro exam & function of LUE normal. Advised ibuprofen & ice. Sent home from school on 9/15 secondary (L) arm twitching. Was seen - no twitching episodes noted over 10-15 minutes in ofc. Continue same plan.
Patient returned on 9/29/06 with swollen left upper arm at injection site. Induration 8cmx3cm and erythema 10cmx5cm. Warm and tender. No history of previous reactions.
no local rxn but cried constantly for several hr following administration of vax;no tx was required;recovery was complete;
I got so sick; Pain; Weight has dropped from 239 down to 178; my body is aching; Vomiting has been non stop; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I got so sick), PAIN (Pain), WEIGHT DECREASED (Weight has dropped from 239 down to 178), MYALGIA (my body is aching) and VOMITING (Vomiting has been non stop) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-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 an unknown date, the patient experienced ILLNESS (I got so sick), PAIN (Pain), WEIGHT DECREASED (Weight has dropped from 239 down to 178), MYALGIA (my body is aching) and VOMITING (Vomiting has been non stop). At the time of the report, ILLNESS (I got so sick), PAIN (Pain), WEIGHT DECREASED (Weight has dropped from 239 down to 178), MYALGIA (my body is aching) and VOMITING (Vomiting has been non stop) had not resolved.            Concomitant information was not reported. Treatment information was not reported.
patient received covid vaccine while breastfeeding. infant developed mild congestion 4 days after mother received both doses of vaccine. Infant's symptoms self resolved over several days. no medications needed.
Large bruise at injection site, red inflamed spot progressing down arm toward elbow hot to touch - dx cellulitis by MD pt reports starting day after in came to pharm. clindamycin 150 every 8 hours for 7 days after.
Two weeks after the Gardasil vaccine was administered, began complaining of tingling in her feet.  It rapidly progressed to numbness in the feet, and now it is tingling all the way up to her waist.  We are worried sick.  We have visited our primary care physician and done blood work and a nerve conduction test, all with "normal" results.  Our next step will be to consult a neurologist.
Received vaccine on Thursday, 4/8/21 @ 10:10 am, 1st symptom (fever & chills, pain at the injection site and pain under left underarm begins at 7p). Took 2 Motrin. Day 2, golf size swelling left underarm. Very painful. Scale from 1-10, it was a 9. Lymph Nodes swelling is not listed on the Johnson & Johnson vaccine factsheet. Pain stayed for 5 days. Pain is less when taking Motrin. On Day 4, woke up with slight migraine. Took motrin. Took blood pressure, high diastolic reading at 110/91 and Day 5, 116/95 since vaccinated.
Hives on various areas, mostly on forearms. A few on neck, legs, back, hands, wrists. The bumps range in size from marble size to quarter size and severely itch. I take Benadrel orally and apply Calamine lotion on bumps. I am currently  still having hives.
Varicella, Injection site erythmea- Information has been received from a registered nurse concerning a 22 year old male patient who on 17 May 2000 was vaccinated sc with one dose of varicella virus vaccine live .  On 28 May 2000 the patient developed a fever and one lesion with a clear center at the injection site.  Unspecified medical attention was sought.  it was noted that as of 02 Jun 2000 a grapefruit size redness had developed around the lesion at the injection site.  additionally, more pox have developed it was reported that the patient's antibody was negative prior to vaccination.
No adverse event; 1 dose of Moderna COVID-19 Vaccine Bivalent for adults was administered approximately 22 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna COVID-19 Vaccine Bivalent for adults was administered approximately 22 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Latex allergy.    On 31-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 31-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna COVID-19 Vaccine Bivalent for adults was administered approximately 22 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna COVID-19 Vaccine Bivalent for adults was administered approximately 22 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna COVID-19 Vaccine Bivalent for adults was administered approximately 22 hours post puncture).    No concomitant medications were reported.   The patient did not experience any adverse events.  No treatment details were reported.
Pentacel was ordered for the 6 month old patient but Adacel was administered; Pentacel was ordered for the 6 month old patient but Adacel was administered; Initial information received on 17-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 6 months old patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that Pentacel was ordered for the 6 month old patient but Adacel was administered.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administered.  It was not reported if any adverse event occurred or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 31-AUG-2017, the patient was vaccinated with the first dose of VAQTA for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 05-OCT-2017, the patient was vaccinated with the second dose of VAQTA lot # N002921 with expiration date of 08-APR-2018, for prophylaxis (dose and route of administration were not reported). Sender's Comments: US-009507513-1803USA002923:
sharp pain and soreness in the left upper arm for a few hours . It comes and goes after got vaccine on on 02/23/2023