chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site was raised and irritated the day following injection (12/13) with worsening 2 days after receiving the shot. On 12/14, I noticed the area was raised, red, itchy, and bruised. The affected area around the injection site was about 2-2.5? in diameter. I applied hydrocortisone cream and applied ice to the area.  The area did go down, but on 12/19 she woke up with hive-like spots on her back and torso and had congestion. I gave her a decongestant before I realized she had hives. The rash became more red and itchy, and eventually made its way to her face. Zyrtec given at 12:00 with further evaluation from her pediatrician later that afternoon. Benadryl given at 12:00 midnight and again at 6 AM with no relief. The next day the rash had tripled in size and covered the majority of her trunk, limbs, and almost all of her face. Decreased appetite and fever now accompanied the rash. She was taken to the ER after I noticed she was biting her lips and was experiencing facial swelling. The initial injection site was also raised and itchy outside of the area that was first affected. ER gave her a dose of oral prednisone, Benadryl, and Motrin to combat fever. Antibiotic was switched to Zithromax and we were discharged. The next day there was no improvement. The areas of skin first affected by the rash were now darkening and turning more purple, but newer areas were pink. She was taken back to her pediatrician where she was evaluated. Her pediatrician advised we take her to the emergency room to be treated for HSP. ER physician suspected serum sickness. She was treated with IV fluids, IV steroids, hydroxyzine.
fever 100.8 14MAY93 100.6 ax; 5 hrs screaming w/APAP; pt had a fever of 102.5 the noc a/vax; (99.4 @ time of vax);
At approximately 1510, DON was alerted by LPN, resident not feeling well. Initial assessment VS 97.8 110 32 117/63, purse lipped breathing with accessory muscle use, pallor with circumoral cyanosis, blood glucose 192. Resident only able to speak in 1-2 works phrases. Hands cold, unable to obtain pulse ox. Oxygen on at 2 L/M via nasal cannula.  Head of bed elevated to ease breathing, O2 changed over to mask at 5 LM.  Directed nurse to call and ask wife her wishes for care, resident rep requested transport to Facility. 911 initiated.  Call also placed to Dr., assessment reviewed, made her aware of resident rep request and 911 initiated, she is in agreement. Follow up assessment 163/89, 59, 43 97.6, no audible wheezing, mentation at baseline, color is dusky O2 on via mask at 5 L/M. EMS arrived, report provided, aware wife prefers Facility but medic states Reading due to proximity and acute needs of patient. Resident lifted to litter and taken to ambulance for transport.  Resident death was pronounced in ambulance in Parking lot at 1545 by EMS staff. Resident still transferred to Hospital after pronounce death. Dr. aware.
Patient fainted (syncope) and dizziness  for 15 minutes. She was fine later on
Approximately 18 hours post 1st injection of Pfizer vaccine, patient developed 103.5 fever with the following additional symptoms which lasted approximately 24 hours: numbness tingling in toes teeth and gums hurt blood vessels in eyes felt like they were spasming felt brief momentary pains up through legs and in chest
Presented with SOB/ chest tightness, hypoxic; Covid + ED; Admit 9/26 medical Covid PNA/COPD exacerbation, on 3 LPM O2; tx with 9/26 Maxipime, Rocephin, steroids, vanc, lovenox started  9/27 Zithromax, levaquin, singulair, zinc started; O2 initially at 3 LPM and down to 2 LPM (baseline) at time of d/c
Reported severe back and left flank pain 1 week after vaccination which progressed to abdominal and pelvic pain. Pain has persisted since vaccination and was severe 9-10/10 severity initially. Pain is decreasing slowly with time. Evaluations by gynecology and chiropractor were normal.
Only reaction is a slightly itchy red patch the size of a quarter at the injection site, developed about a week after the injection. (The first two days had a smaller red patch at the injection site that went away.)
Patient was unsure if she received the new bivalent booster and asked if she could receive it that day. Unsure if patient brought her COVID card with her that day or had to go home and bring it back. Her profile/history was not checked for the date that her last dose was received (on 9/13/22) and she received a second bivalent booster dose (on 10/28/22). Patient  called us on 10/29/22 to let us know that she checked her card/receipts and that she did receive both doses and reported she felt a little fatigued but was starting to feel better, otherwise she was not experiencing any adverse reactions. I let her know that some side effects may be expected similar to receiving a booster (fever, chills, fatigue) but that if she experiences any other issues or reaction to let us know.
Patient presented with swelling, redness and fever at injection site that began approx. 1 day after vaccination. Patient stated that shoulder and arm were very sore. Patient also had a rash on the same arm. I recommended BENADRYL and acetaminophen but patient did not want take BENADRYL. I referred her to MD to prescribed a steroid (per patient).
Patient was administered with vaccine that had undergone temperature excursion issue; No symptoms were reported after administration of vaccine; Patient was administered with vaccine that had undergone temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion issue), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion issue) and NO ADVERSE EVENT (No symptoms were reported after administration of vaccine) in a 1-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. As1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Jul-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion issue). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion issue) and NO ADVERSE EVENT (No symptoms were reported after administration of vaccine). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion issue), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion issue) and NO ADVERSE EVENT (No symptoms were reported after administration of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No symptoms were reported after administration of vaccine) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion issue).    No concomitant medications were reported.  It was reported that excursion happened on 18-Jul-2022 for two and half hours and the maximum temperature reached was 8.76 °C and minimum temperature reached was -4.5°C. The vials were still frozen after excursion.  It was determined even though there was a temperature excursion one time that the vaccines was still viable and can be used until the end of the expiration day.  No treatment medications were reported.
her lymph nodes were affected; she is still in pain and she has pain in Wrist, Knee and Ankles; Red bump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (her lymph nodes were affected ), PAIN (she is still in pain and she has pain in Wrist, Knee and Ankles) and VACCINATION SITE ERYTHEMA (Red bump at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (her lymph nodes were affected ), PAIN (she is still in pain and she has pain in Wrist, Knee and Ankles) and VACCINATION SITE ERYTHEMA (Red bump at injection site). At the time of the report, LYMPHADENOPATHY (her lymph nodes were affected ) and VACCINATION SITE ERYTHEMA (Red bump at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: TCR received
On 3/27/03 Client reported rash on abdomen 20 small pimple-like bumps.  Just one or two were blister-like  treatment:  Benadryl 25 mg HS.  Had headache for 24 hours (3/27/03 to 3/28/03) took tylenol two for relief.  On 4/02/03 "rash improved alot, said client, fading, flat, dry and 0 drainage, and 0 itching.
HEAVY MENSTRUATION WITH PAINFUL CRAMPS; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: perimenopause. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-AUG-2021, the patient experienced heavy menstruation with painful cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heavy menstruation with painful cramps was not reported. This report was non-serious.
pt recv vax 31JUL96 & had 2 prev vax w/o problems;mom also states has been giving child eggs & peaches-advised stop new foods;pt was red-whelp like rash over body (urticaria) also has diarrhea;
Died since taking your COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died since taking your COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Reporter also reported that he/she has countless sick friends thanks to it. Stated that the clock was ticking, the truth will prevail.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020087 same reporter/drug/event, different patient.;; Reported Cause(s) of Death: Died since taking your COVID vaccine
Patient had zero side effects to this injection. Having to report patient was given Moderna injection as 3rd dose of COVID vaccine.
I am a little concern my neck is stiff; horrible horrible pain in the arm of injection, even up into my neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (I am a little concern my neck is stiff) and VACCINATION SITE PAIN (horrible horrible pain in the arm of injection, even up into my neck) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (I am a little concern my neck is stiff) and VACCINATION SITE PAIN (horrible horrible pain in the arm of injection, even up into my neck). At the time of the report, MUSCULOSKELETAL STIFFNESS (I am a little concern my neck is stiff) and VACCINATION SITE PAIN (horrible horrible pain in the arm of injection, even up into my neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. Treatment information was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up received on 12-Apr-2021 did not contain any new information. On 07-Jun-2021: Outcome of events changed to recovered or resolved.; 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.
Hives on neck, chest, belly, back - but they don?t itch.  Had same reaction to first shot but wasn't sure it was related I mentioned this to pharmacy when I went for the second vaccine and they were unaware of hives being a reaction, however I just looked up the SHINGRIX vaccine and hives is listed as a severe reaction! This reaction was NOT listed on the paperwork provided with the vaccine!
Information has been received from a pharmacist concerning a patient (age and gender not reported) who on 08-OCT-2007 was vaccinated with ZOSTAVAX. On 10-OCT-2007 the patient experienced reddened area 2" X 1" on upper arm at injection site. At the time of reporting, the area was starting to go away, but he patient had not fully recovered. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007. Information has been received from a pharmacist concerning a 66 year old female who on 08-OCT-2007 was vaccinated with ZOSTAVAX (Lot # 658084/0888U). On 10-OCT-2007, the patient experienced reddened area 2" x 1" on upper arm at injection site. In follow-up, it was reported that red, itchy, localized to site 2" x 1". On 23-OCT-2007, the physician reported that it was "still red." On 27-OCT-2007, the physician reported "gone." The physician reported that as of 27-OCT-2007, the patient was recovered. The patient was treated with BENADRYL/ice. The patient sought unspecified medical attention. No further information has been requested.
Information was received on 14-JUN-2017 regarding a case in litigation concerning a male (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On or about 10-SEP-2010 the patient received a dose of ZOSTAVAX (lot # and dose not specified) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-APR-2015 the patient was treated in a  clinic by a physician for a vesicular outbreak that was diagnosed as severe shingles. On or about 11-MAY-2015 he was treated again for worsening symptoms accompanied by hearing loss due to shingles spreading to the ear. The patient was prescribed valacyclovir (VALTREX) and hydrocodone for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review the event of hearing loss due to shingles spreading to the ear was determined to be medically significant. Additional information has been requested.
Patient said that she started to develop redness in both arms on Friday, the 9th after the vaccines but the next day she had "hives" on the left arm, which she received the SHINGRIX vaccine. I questioned her about what the hives looked like and she said it was like little pimples so it sounds more like a rash and not hives. I advised that unless she was very concerned that she should take Benadryl and just keep an eye on it but to see a doctor if it got worse or if she was very worried about it. Today, after calling to check up on her she said it is improving but is still warm and red, which I again explained can be a normal side effect of the vaccines. She wants this reported but I am leary about saying that it is a true allergic reaction or whether it is a normal reaction. She didn't want to go in to be seen by the doctor if she didn't have to since influenza is so rampant right now and she didn't want to be exposed.
Patient was given the incorrect volume of Havrix. Patient was given 1ml instead of 0.5ml. No adverse events have been reported at this time.
patient was administered pentacel DTAP-IPV component was administered, not the ACT-HIB portion with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old male patient was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] onlyl DTAP-IPV component was administered, not the ACT-HIB portion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live, rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (Proquad); measles vaccine, mumps vaccine, rubella vaccine (MMR) and pneumococcal for Immunisation.  On 10-Oct-2022, the patient received 0.5ml (dose 3) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (lot UJ668AAA; Expiry date: 13-May-2023)via intramuscular route in the right leg (right thigh) for Immunization.  On 10-OCT-2022 the patient was administered only dtap-ipv component was administered, not the act-hib portion with no reported adverse event (product preparation error) (latency; on same day). This situation is reported as a medication error due to the incorrect administration of PENTACEL. Only the liquid DTAP-IPV portion was administered to the patient  Action taken : not applicable.  Outcome: Unknown.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
tinnitus; head pressure; palpitations; very frustrated; dizziness; sick for 3 straight days; Lymph nodes; hypersensitivity reaction; atrial fibrillation; nausea; headache; intensive foreboding and doom; I felt like I was going to die; arm was swollen/lymph nodes; tongue felt like it was burnt; fever; joint aches; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Immunocompromised since an unknown date.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION COMPLICATION (intensive foreboding and doom), FEELING ABNORMAL (I felt like I was going to die), PERIPHERAL SWELLING (arm was swollen/lymph nodes), TONGUE DISCOMFORT (tongue felt like it was burnt), PYREXIA (fever), ARTHRALGIA (joint aches) and MYALGIA (muscle pain). On an unknown date, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion medically significant), TINNITUS (tinnitus), HEAD DISCOMFORT (head pressure), PALPITATIONS (palpitations), FRUSTRATION TOLERANCE DECREASED (very frustrated), DIZZINESS (dizziness), ILLNESS (sick for 3 straight days), LYMPHADENOPATHY (Lymph nodes), HYPERSENSITIVITY (hypersensitivity reaction), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), VACCINATION COMPLICATION (intensive foreboding and doom), FEELING ABNORMAL (I felt like I was going to die), PERIPHERAL SWELLING (arm was swollen/lymph nodes), TONGUE DISCOMFORT (tongue felt like it was burnt), HEAD DISCOMFORT (head pressure), PALPITATIONS (palpitations), FRUSTRATION TOLERANCE DECREASED (very frustrated), DIZZINESS (dizziness), ILLNESS (sick for 3 straight days), LYMPHADENOPATHY (Lymph nodes), HYPERSENSITIVITY (hypersensitivity reaction), PYREXIA (fever), ARTHRALGIA (joint aches), MYALGIA (muscle pain), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown and TINNITUS (tinnitus) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer has received a request for follow up for an adverse event multiple times with the following numbers. MOD2021-081732, MOD2021-081760, MOD2021-052313, MOD2021-081760. She has also submitted a VAERS report and her doctor has also submitted a VAERS report.   Consumer has received a request for follow up for an adverse event multiple times with the following numbers. MOD2021-081732, MOD2021-081760, MOD2021-052313, MOD2021-081760. She has also submitted a VAERS report and her doctor has also submitted a VAERS report.; 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.
Complete numbness in lower right leg; massaged and moved leg until numbness decreased; during next few days experienced moderate numbness in both arms.
Patient complained of dizziness following vaccine for about five minutes. Vital signs monitored. Blood pressure was elevated. Advised patient to seek medical care but she declined. She stated she would call her doctor.
Received Recombinant Vaccine. Extreme headache, Chills, Fever, Pain in joints. For 24 hours. Second of two SHINGRIX Zoster shots.
Child was in lobby playing, while sibling was being seen. Seemed to have fainted to floor. Mom was behind child. Tried to assist child up, child was limp and not responding. Mom ran to water fountain (nurses right behind) splashed him with water, child came to. Alert and oriented x 3. Child seemed pale, slightly sleepy. Mom wanted us to call clinic for child to be seen. Nurse practitioner stated child needed to be seen in an Emergency room facility and then seen by a pediatrician to follow up. This was advised for Mom to do. Mom stated she wanted to go home and discuss situation with husband. I stressed the importance of child needing to go to ER and be checked out.
ACUTE PULMONARY EMBOLISM 4/1/2022 PNEUMONIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/1/2022 PNEUMONIA HYPOXIA 4/1/2022 PNEUMONIA
Pt contacted  us c/o possible "allergic reaction" to Varicella vaccine received on 6/23/2020. Pt c/o pain, redness, itchiness, swelling and feeling a few blisters at administration site. Pt stated no fever was noted. Pt was instructed by Health Dept staff - LVN - to seek medical attention for her complaints.  This Nurse contacted patient to follow up with her. Pt stated she was currently at Hospital ER and was to be Rx'd steroid medication to apply to help with inflammation and itchiness. Pt stated she also received a steroid injection.