chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe flu like symptoms. Body hurts to even touch from head to toes, uncontrollable shaking/shivering, freezing hold or suffocating hot, eyeballs keep loosing focus, feeling like I'm having a anxiety or panic attack, short of breath. First day I felt fine, next day I woke up feeling like I was hit by a car and second day after I'm feeling all the symptoms listed above on a scale of 1-10 I'm at a 10 for discomfort
Lower spine started hurting very bad only 5 minutes after receiving the shot along with my right arm. Later the same day around 8:00 p.m. I started getting chills and extreme leg and back pain/ sore muscles.
Moderna COVID-19 Vaccine EUA About 5 or 6 hours after the vaccine was given I developed inflamed toes on both feet.  Puffy and red.  itchy and slight burning.  Three days later still have the symptoms.
7 days later quarter size lump at injection site initially quarter size now 4x6 in size
LMP 10/06/2021  positive pregnancy test first week of December 2021 patient states bleeding from 12/7/2021-1/9/2022 consistent with miscarriage
administration of tdap doses with the interval of less than a year with no reported adverse event; Initial information received on 07-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 years old female patient who was administered diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] dose with the interval of less than a year with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Jul-2023, the patient received 0.5 mL dose 2 of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: U7666AA; expiry date: 08-Mar-2025) via intramuscular route in the right deltoid for immunization with the interval of less than a year with no reported adverse event (inappropriate schedule of product administration) (same day latency).  It was reported that, Adacel was given to patient that had Tdap 11 years and 9 months before that, getting a repeat dose a year later. They want to know what are the ramifications for the patient.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administration of tdap doses with the interval of less than a year with no reported adverse event.  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 the guidelines. 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.; Sender's Comments:  US-SA-2023SA210162:01683487
5+ weeks after the second dose, (July 1, 2021) I developed benign positional vertigo. After a few weeks, the significant spinning lessened but turned into general foggy-headed, mild dizziness, general fatigue, heart palpitations.  This lasted 2.5 months Now, three months later, the fatigue and heart palpations are gone. The dizziness is almost gone but not entirely. I am in physical therapy and being treated for Vestibular Ocular Reflex. I have no idea whether this has anything to do with the vaccine. It could be that I got COVID, am having long term symptoms without having had any of the normal symptoms. Just thought this might be helpful
Myalgia, Arthralgia, Diarrhea, NauseaVomiting, Chills Narrative:
Reddened area around site, warm to touch, no streaking reported by mother. Advised to apply cool compress, Tylenol, and Benadryl and to call if any streaking noted.
No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 30-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA004679: US-009507513-2207USA004710: US-009507513-2207USA004698: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004695: US-009507513-2207USA004690: US-009507513-2207USA004697: US-009507513-2207USA004715: US-009507513-2207USA004700: US-009507513-2207USA004691: US-009507513-2207USA004688: US-009507513-2207USA004712: US-009507513-2207USA004714:
Pt received 2nd dose of Moderna on 4/22, claiming on 5/15 she noticed a large sore on her arm around where she got the shot.  Said it was similar to a whitehead but bigger.  She popped it and said it was painful.  She thought that it may have been that the vaccine was administered incorrectly and had resurfaced.  Informed to contact MD for follow up as never heard of a vaccine showing an injection site reaction that long after the shot was given.
according to mom pt had sz 27JUL94 AM; taken to hosp-pt in coma; 4AUG94 called hosp pt not in hosp call home & child said pt was fine- mom not home
01/07/2005 - Pediarix #1 - High fever within 48 hours, not sure about cause.  04/20/2005 - Pediarix #2 - Patient developed fever, 103-104, and has less action.  Went to doctor.  Patient subsequently developed urinary tract infection - was told by physician on 04/22/2005, it could be due to Pediarix.
Narrative:  Patient received COVID vaccine #1 on 2/26/21 and #2 on 3/26/21. On 4/6/21, he presented to primary care with c/o dizziness, fever, shortness of breath, productive cough, lower extremity swelling and abdominal swelling. One week prior to this he was also seen at urgent care for cough and fever and diagnosed with bronchitis and given azithromycin. He was sent from primary care to the ER. It is also noted he had an elevated ammonia level of 62.3 (history of end stage liver disease). He was evaluated in the ER and admitted to acute care services for a LLL pneumonia. He received ceftriaxone 1gm daily, Duonebs q6h and azithromycin 500mg po daily. On 4/9/21, he was discharged home with his wife on amoxicillin 500mg bid and azithromycin 500mg po daily. On 4/11/21, it was reported that he had passed away. Of note on 4/6/21, his COVID test, flu A &B and RSV test was negative and on 4/7/21, a Biofire was done that was negative also. 16 days from date of second vaccine to date of death.
Woke approximately 12 hours after injection with nightmares. Felt poorly (tired, nauseous, headache) that day (10/6); following day felt slightly better but felt worse on Monday (10/8).  By Tuesday (10/9), feeling worse, began to slur words and had slight difficulty in walking. Went to local hospital and was immediately admitted as a possible stroke patient. Transferred to another hospital (neural ICU) through Thursday, 10/11, then transferred to regular bed through 10/12, when I was discharged.  Dr. was the chief neurologist on my case. When discharged, Dr. indicated that they could find no definite cause for my condition. They were considering the timing of the Shingrix vaccine.  Additional tests are ongoing--I have not received them yet.  Dr. later stated the timing of the vaccine likely was involved but to what extent is unknown.
pt recv vax OCT97 & was reportedly febrile;both pt were reported to have been diagnosed w/Duchenne type muscular dystrophy;both pt were reported to have a hx of fever of unk origin;p/vax pt suffered resp failure hosp required mechanical ven
fatigue; stiff joints; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (004756). The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown"; JOINT STIFFNESS (non-serious), outcome "unknown", described as "stiff joints". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2022 at 12:15 as dose 4 (booster), single (Lot number: FJ4989) at the age of 72 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster),single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive, notes: Four days later began feeling ill again, then re-tested positive; Negative, notes: Tested negative two days after completing the full doses of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Tested negative two days after completing the full doses of Paxlovid. Four days later began feeling ill again, then re-tested positive. No Known allergies. No other medication in 2weeks.
Patient was given an expired dose of ACTHIB on 08/17/23 the expired date was on 08/13/2023,  We have a call out to the patients mother to get a new valid dose given .
This is a spontaneous report from a contactable nurse through a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13 (Lot number and expiration date were not reported) at the rheumatologist's office, with route of administration unspecified on 06Sep2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. In Sep2018, the patient had pain; swelling to the size of a grapefruit; and redness. The patient was prescribed with steroids as treatment for the events. The outcome of the events, pain, swelling to the size of a grapefruit and redness, was unknown.
Parent here requesting vaccinations and TB screening for school entry, no complaints. Patient screening completed, no contraindications to vaccinations noted. Quantiferon-Gold blood specimen collected prior to vaccinations without complications. Informed mother of vaccinations due, Tdap, Hepatitis B, HPV, Meningococcal (MCV4), Influenza and Varicella vaccine. Mother accepted to have only vaccines required for school at this time (Tdap, Hepatitis B and Varicella), mother verbalized understanding. Administered Tdap vaccine on left deltoid, no complaints from patient. Hepatitis B vaccine administered on right deltoid, after administration of Hepatitis B vaccine patient began to complain of right arm feeling heavy. Noted patient becoming pale, clammy, warm to touch and then patient fainted while sitting in the chair, did not fall and did not suffer any injuries. While assisting patient, it was noted that he jumped up and tensed up flexing both arms momentarily. Mother began to scream, and stated "My son had a convulsion!" No uncontrollable muscle spasm/jerking noted, no loss of bowel/bladder control observed, no breathing cessation noted by nurse. Patient stated "my arm began feeling heavy and I began to see blue, and that's when it felt like I fell asleep". Upon noting patient becoming pale, and fainting this nurse began to provide assistance to patient to prevent injury or fall. Clinical nursing staff called and responded to assist. Further assessment included: called patient, responding to name, cold pack and wet towels placed on head and back. Provided apple juice and vitals taken at 2:00PM Blood pressure sitting:100/53, Pulse 58, Respirations: 20. Patient assisted to exam table without incidence, placed lying on left side, repeat vitals at 2:05PM Blood pressure 103/57, Pulse 65 and Respirations: 20, patient oriented to location, self, and time. Provided patient orange juice, and stated "I am feeling better now." Continued to assess patient, patient sitting on edge of exam table, repeat vitals at 2:15PM Blood pressure: 120/77, Pulse: 69, Respirations: 20. Clinical physician came in to evaluate patient, MD indicated "vasovagal syncope". MD assessment: Alert and oriented X 3, no acute distress, heart regular, clear breath sounds. MD recommended to defer varicella vaccine, patient to be discharged home, and to proceed to emergency room if not feeling well. Instructed mother that if she notices that patient gets worse or having an unusual behavior, to take her son to the nearest Emergency room right away. Mother verbalized understanding.
A medical assistant reported that an 18 month old child received an injection of Acel-Immune on 11/01/99 and developed an injection site reaction. This is 1 of 8 patients from this facility who developed an injection site reaction following receipt 0 3 different lots of Acel-Immune.
p/vax pt devel Bell's Palsy;MD visit was required;pt condition not recovered;
?Janssen COVID-19 Vaccine EUA 8 hours after injection I started getting severe chills that wouldn't go away.  I took a shower and felt week and I still had chills. I checked my temp and it was 102.5.  I went to bed for about an hour and still had chills. I got up and drank water and checked my temp. It was 103.7.  I took two tylenol and my fever broke about 40 minutes later. I was so hot. I checked my temp again and it was 102. I tried to eat and drink but I felt sick. I did drink water. I got chills again and took another tylenol. My temp went to 101.  I've had fever and chills all night. I kept taking tylenol and my fever has stayed between 100- 101. I forced myself to eat soup and I took more tylenol.  My current temp is 99.6. I have a throbbing headache. It is 7:15AM.
A few hours after vaccination I felt extreme fatigue and then within 12 hours extreme body aches, worse than when I had Covid19. They lasted for around 20 hours. Then I felt better than I have felt since having Covid. I still hack occasionally but my fatigue is gone.
Pt was admitted to the hospital on 5/27 for a hip fracture following a fall, found to be positive for covid, pt died on 5/30
Started with the right arm turning purple or changing colors when elevated above the head.   This continued for a few weeks.  Then  I started to get a tingling sensation in the elbow that went into the right pinky.  I visited my primary doctor to see what was going on.  She did an evaluation, prescribed Ibuprofen and physical therapy, and had a cervical spine x-ray done.  The X-ray looked great when it came back.  I could not get an appointment with PT for several weeks so I finally went to the chiropractor on 5/13.  He worked on the shoulder area stretching it out.   By the morning of 5/15 I was being taken to urgent care and eventually the ER because the arm was swelling and fingers were turning blue.  They did blood tests, EKG, chest x-ray, and finally an ultrasound that showed a blood clot.  It was DVT in the subclavian vein.  I was given a blood thinner and sent home.  I had a more thorough ultrasound on 5/17 that sent me back to the ER and with vascular surgeons to discuss immediate surgery with lysis therapy.  It was decided that the blood clot had probably been there for weeks and the success rate of the surgery would not be as good.
21 y.o. w/reaction to Smallpox vax. Rash to left FA with scattered papules noted. Follow up c/o extensive crusted and weeping lesions to left FA. Impetigo with eczema. Meds: Dicloxacillin, hyprosyn, Tylenol.
hands broke out, they have pustules, they are red and scaly with raised bumps; hands broke out, they have pustules, they are red and scaly with raised bumps; This is a spontaneous report from a contactable consumer (patient's husband) received via the Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 23Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included rheumatoid arthritis. Concomitant medication included adalimumab (HUMIRA) taken for rheumatoid arthritis. The patient was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 02Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. On an unspecified date in Mar2021, the patient's hands broke out, they have pustules, they are red and scaly with raised bumps. Clinical course of events was as follow: The patient received the first dose of the COVID-19 vaccine on 02Mar2021, and the second dose on 23Mar2021, the patient had reactions to both doses of the vaccine; on the first one, she had a muscular pain or tightness sensation around her back area around "the bra line", this sensation lasted for at least a few days. The patient was taking Humira at the time of administration. Prior to the second dose of the vaccine, her treatment with Humira was suspended. After receiving the second dose of the vaccine, the patient experienced a severe reaction in her hands, her hands broke out, they have pustules, they are red and scaly with raised bumps. This was 90% in her hands with a little bit of reaction in her arm area and mostly in the palm of her hands and in between her fingers. Usually, the patient would receive treatment with prednisone for her skin reaction but the dermatologist refused to give her that treatment to avoid altering the response of the patient to the vaccine. The reporter mentioned that this could be related to the COVID-19 vaccine and the fact that they stopped taking Humira could have made the reaction worst. The reporter wanted to know if there was any information in regards to possible interaction between the use of Humira, Prednisone and the COVID-19 vaccine. The outcome of events hands broke out, they have pustules, they are red and scaly with raised bumps was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt passed out approx 5 min post vaccine administration of Tetanus-Diphtheria and Menomune.
Resident has a private duty aid at all times.  Reported by the company that one of their employees who worked with her on 12/9/21 tested positve for Covid on 12/11/21. Resident was tested on 12/13/21 with a positive result and later sent to the hospital.
CHEST FELL TIGHT HAD SHORT BREATHS  NO TREATMENT LASTED ABOUT LEST THAN 8 MINUTES
Vaccine expired past the 30-day recommendation. At this time there have not been any symptoms of an adverse event.
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
bad headache; knees swollen; exhausted; fever of 100-100.6 degrees; felt really sick; pain in left jaw/pain left gland in left jaw; pain in mouth top and bottom left side; pain in left ear; sensitive mouth; cheek swollen; sharp pain in stomach through to back, hips, and legs; sharp pain in stomach through to back, hips, and legs; sharp pain in stomach through to back, hips, and legs; sharp pain in stomach through to back, hips, and legs; A spontaneous report was received from a consumer concerning a 75-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events bad headache, swollen knees, exhausted, fever of 100-100.6 degrees, felt really sick, pain in left jaw, pain in mouth top and bottom left side, pain in left ear, pain left gland in left jaw, sensitive mouth, cheek swollen, sharp pain in stomach through to back, hips, and legs.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events bad headache, knees swollen, exhausted, fever of 100-100.6 degrees, felt really sick, pain in left jaw, pain in mouth top and bottom left side, pain in left ear, pain left gland in left jaw, sensitive mouth, cheek swollen, sharp pain in stomach through to back, hips, and legs..  On an unknown date, the lab information included body temperature of 100- 100.6 F.  Treatment information included antibiotics.(not specified)  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events- bad headache, knees swollen, exhausted, fever of 100-100, 6 degrees, felt really sick, pain in left jaw, pain in mouth top and bottom left side, pain in left ear, pain left gland in left jaw, sensitive mouth, cheek swollen, sharp pain in stomach through to back, hips, and legs-was unknown.
Patient called day after receiving PNEUMOVAX complaining of extreme pain/soreness radiating down past elbow-arm swollen & red & warm to touch shoulder to elbow. Required antibiotics & pain meds - went to ER 12/2 received BACTRIM & cephalexin for skin infection.