chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching at injection site; Redness at injection site; Warmth at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE WARMTH (Warmth at injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE WARMTH (Warmth at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE WARMTH (Warmth at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report from a publication. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons in the are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the "safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer
Pt came in for primary dose of Covid vaccine.  Pt was given bivalent dose instead of monovalent dose.
Loss of balance, Headaches, Ringing of the ears, Experienced loss of balance and fell during a walk.
2:56 pm Post vaccination reports/ stated "feeling hot and tired" w/associated chest tightness, no sob; BP 145/90 P8  Medical monitoring, "feeling better".   3:03 BP 135/ 57 P 80 Released to home w/ daughter.
June 25, I had a dry cough, I believed it to be allergies. Dry cough became worst. I took a COVID-19 test and it came back positive. I felt fatigue and my chest was heavy. The following Monday, I had a telehealth. I was prescribe PAXLOVID. The symptoms left and came back. My blood sugar became high as well.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, injection site pain, chills, fatigue Narrative:  Employee reports injection site pain, fever, chills, headaches, joint pain, body aches, fatigue, and nausea. Reports using OTC Tylenol (no dose/frequency provided). RN taking report recommended to continued OTC Tylenol and treatment of symptoms. Recommended to rest and monitor temperature.
STOMACH DISCOMFORT; This spontaneous case (PVX2019-910) was received from a nurse on 17-Apr-2019 for two consumers.   Based on the information obtained from the nurse, two individual case safety reports PVX201904-000300 (PVX2019-910; consumer 1) and PVX201904-000301 (PVX2019-910; consumer 2) were created and cross-linked in the database.  This case report describes an adult consumer who experienced stomach discomfort, after the administration of Vivotif for an unknown indication.  Case report: The consumer experienced stomach discomfort after taking Vivotif. The consumer took only two doses.  Action taken with Vivotif was dosage discontinued.  The clinical outcome of the event stomach discomfort was unknown.  Company's Comment: In this case, it was reported that the consumer experienced stomach discomfort after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced stomach discomfort after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible. US-PaxVax Berna GmbH-PVX201904-000301:
11 days after Moderna booster, full body hypersensitivity of the skin started appearing. Physical urticaria on arms, chest, face, neck, groin which causes red spots and itching. Itching symptoms subdued by taking antihistamines (Zyrtec) but red spots persist whenever something comes into contact with skin.
Starting the 8th of this month, I am experiencing extreme fatigue. I also had a headache started in the evening on Aug 8th lasted for days 24 hours a day. Ibuprofen or acetaminophen help with discomfort. Starting the 11th of this month, I am experiencing palpitations, a feeling on pins, tingling throughout my body and numbness in my face, hands and toes. This is extremely uncomfortable; it feels like my legs are going to give out on me.
Erythema of upper arm with itching and tenderness, starting approximately 6pm on vaccination day. Pt took 1 dose of diphenhydramine. Resolved in 2 days.
About a month later, I began to develop joint and muscle pains throughout my body (lower back, hips, elbows, wrists, lower neck and ankles).
Initial report received on 10 May 2007 from a health care professional. A 15-year-old female patient, with no known past medical history, had received a left deltoid, intramuscular injection of Menactra, lot number U2228AA; and a right deltoid, intramuscular injection of Gardasil, lot number 0389U; on 07 May 2007. On the same day following vaccination, the patient "passed out" and fell to the floor. She was unresponsive for approximately 40 seconds. The patient did not experience any respiratory distress, and the event fully resolved without medical intervention.
Pt received vaccine on 7/2/21, on 7/3/21 pt stated she felt "under the weather". Pt was a G2P1001 with an EDD of 08/02/21. Pregnancy complicated by gestational diabetes, history of a prior c-section, and an inpatient admission for threatened pre-term labor. On 7/4/21, at approximately 1600, pt experienced PPROM at 35.6 weeks, requiring delivery via c-section. Infant's birth weight was 2565g.
Started getting severe headache, chills, running temp of 101 degrees 2 days later broke out in red patch above left eye where one year ago I had a detached retina surgery, oil pack then cataract surgery Started blistering and moved all over eyebrow of left eye then into hairline got blisters Virus caused scratched cornea in left eye  Nausea, vomiting
Sudden onset tinnitus at the same time the rest of my vaccine related symptoms appeared (when I woke up the morning following the shot).  It's now been six months and I still have constant 24/7 tinnitus that has not resolved at all since the shot.  I had never had ringing in my ears prior to receiving the booster shot of the COVID vaccine.  I have been told that this is likely permanent (and have read that others have experienced the same issue, including a vaccine physician from the Clinic).  It is debilitating.
Approx 5 hours after immunization was given patient reported feeling soreness and pain at injection site. Also states that injection site was red and warm to the touch. The day after the vaccination was given patient stated that she could not lift her arm and/or open doors. States it was extremely painful. States two days after vaccination pain had improved but still had some pain.
Headache; Spiked fever 101.6; Sore arm; Exhaustion, very fatigued, tired; This case was reported by a consumer via patient support programs and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included COVID-19 VACCINE for prophylaxis. The patient's past medical history included endometrial ablation, ulcerative colitis and hysterectomy. Concurrent medical conditions included heart disorder (may have some heart issues). On 6th December 2021, the patient received Shingrix and COVID-19 VACCINE. In December 2021, less than a week after receiving Shingrix, the patient experienced headache, fever, pain in arm and exhaustion. In December 2021, the outcome of the headache, fever, pain in arm and exhaustion were recovered/resolved. It was unknown if the reporter considered the headache, fever, pain in arm and exhaustion to be related to Shingrix. Additional details were provided are as follows: The patient has had some medical condition as, endometrial ablation, ulcerative colitis, hysterectomy and might have some heart issues (still getting some tests run to rule out with doctor, which might be inconclusive). The patient received a dose of Shingrix and less than a week, after vaccination, the patient had headache, spiked fever 101.6 degree, sore arm and very fatigue or tired. The patient stated if anyone asks then did not took Covid vaccine and Shingrix at once, she was feeling really exhausted. It was unknown if the reporter considered the headache, fever, pain in arm and exhaustion to be related to Covid-19 vaccine. The reporter consented to follow-up. Note: There is discrepancy regarding the onset date of adverse event and vaccination date, conservatively captured partial onset date for all event and tto was captured in accordance with  receipt date, dates would be clarify in upcoming follow-up.
nauseous; pain in my arm from the shot was unbearable; Initial information received on 04-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 68 years old female patient who experienced unable to use my right arm or lift it above my waist without terrible pain. (nausea) and pain in my arm from the shot was unbearable (pain in extremity), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-Nov-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious unable to use my right arm or lift it above my waist without terrible pain. (nausea) and pain in my arm from the shot was unbearable (pain in extremity) 24 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was Pain in arm and nauseous.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for nauseous. and as Not Recovered for Pain in arm.  Information on the batch number was requested.
Subsequent to receiving one dose of varicella virus vaccine live the pt presented with chickenpox that consisted of greater than 200 lesions. The pt was treated with Benadryl, calamine, premoxine, and camphor (Aveeno).
Red irritation around ZOSTAVAX injection site. Patient now feels better, but came in to report.
Vaccine Failure/ Shingles after 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. In April 2020, between 5 and 7 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose of Shingrix in October 2019 and experienced shingles in April 2020 hence she did not receive 2nd dose of vaccine within the time frame. The reporter wanted to know the recommendation for the 2nd dose vaccination. The reporter consented to follow up.
Shingrix: Episode of Shingles after 1st dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received 15 years ago).   On 18-NOV-2021, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingrix: Episode of Shingles after 1st dose of Shingrix).  The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 11-SEP-2023 The pharmacist had several questions on Shingrix. The patient got first dose of Shingrix but never came for the 2nd dose. The patient also developed 2 bouts of shingles (date unknown) after the first dose of Shingrix. The call was transferred by agency- product agent Via phone, agent mentioned that the AE for late 2nd dose was collected and was transferred to MI.  During conversation with the provider the MI agent noted that HCP mentioned the patient had 2 bouts of shingles (date unknown) after first dose of Shingrix as well so the the above AE- was filed as MI agent believes this was not told to agency -product agent and could have been missed in the AE form filed by the agent.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 03-NOV-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M021731 with expiration date 29-OCT-2017 (dose and route of administration were not reported). The reason of the call was temperature alarm received via a Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 degrees Celsius for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Patient was told to wait 15 minutes after getting vaccines. During that time patient started to have ringing in her ears and started to feel lightheaded and very dizzy. She was also experiencing her arm feeling heavy. Patient was then monitored and given a PEDIALYTE popsicle and told to wait another 15 minutes. She still felt the same after waiting so she was told to lay back down and after about 10 minutes she stated that she was feeling better. She was checked again and was told they could leave.
COVID 19 Treatment, Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID 19 Treatment, Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left 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: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma, insulin resistant; "Insulin resistant" (unspecified if ongoing), notes: other medical history: Asthma, insulin resistant. Concomitant medication(s) included: METFORMIN, start date: 01May2022, stop date: 15May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment, Did you/the patient previously receive a COVID-19 Vaccine?: Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Remains antigen test negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti-viral details: The COVID 19 Treatment (Paxlovid). Treatment received on 07May2022 and stop date: 11may2022. Indication is used for treatment of COVID-19. Other medication in 2 weeks product Metformin on 01May2022 and stop date 15May2022. The patent experienced adverse event Recurrence of symptoms 4 days after completion of treatment. Remains antigen test negative on 15May2022 at 03:00 AM. If the patient is Recovering. If the patent did not receive treatment. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash started within 12 hours whole body, itch resolved over 1-2 weeks.
Fever; I feel terrible, I had body ache everything; I feel terrible, I had body ache everything; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).     A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot number was not reported; Expiry date: unknown) dose 1 via an unspecified route of administration on 26Mar2021 as dose 1, single (at the age of 46-year-old) for covid-19 immunization.The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, Consumer stated, that she had side effects from the vaccine, she took pfizer vaccine yesterday after which she felt terrible, she had a fever and body ache everything. The outcome of the events were unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sharp left-sided chest pain 3-5 hours after injection, felt on "full breaths," felt similar to a pulled muscle, on the same side as my cardiac pacemaker- subsided after 24 hours  Fever of 100-101 degrees F beginning within 2 hours of injection, intense and severe body aches and chills for 24 hours, nausea and upset stomach for 24 hours,  Extreme fatigue for 24 hours - moderate for the next 5-7 days  Arm swollen and stiff at injection site (despite heavy arm movement while in 15 min. waiting area)  Mild dizziness and lightheadedness for first 5 minutes immediately after injection  Severe headache for 48-72 hours
ADULT OBSTRUCTIVE SLEEP APNEA ACUTE ON CHRONIC RESPIRATORY FAILURE
right side face curled up also right hand pulled up and body pulled down right leg became weak spasms lasted one second repeated ever 3 to 5 minutes as time went on spasms became stronger and more often 5 to 8 at one time
Moderna shot made me sick; terrible aches and pains; flu like symptoms; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Moderna shot made me sick), PAIN (terrible aches and pains) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 68-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Johnson n Johnson Covid vaccine (at beginning of pandemic. No negative effects at all.). Past adverse reactions to the above products included No adverse event with Johnson n Johnson Covid vaccine.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Moderna shot made me sick), PAIN (terrible aches and pains) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, ILLNESS (Moderna shot made me sick), PAIN (terrible aches and pains) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved.            No concomitant medication was reported.  Patient was in good medical shape.  Reportedly, patient had all the symptoms for 24 hours. Pfizer shot did the same thing.  No other vaccines such as flu has ever made patient sick.  No treatment information was provided.
mom states pt cried unconsolably for 3 hrs; ran no temp states even if you touched pt on arm pt screamed; did take to ER & MD @ that time states just had a cold;
Shortness of Breath Chest Pain Throat Tightness/Closure Rapid Pulse Flushing Nausea/Vomiting Action taken: Antihistamine given., Epinephrine given., Physician contacted, and 911 called. Outcome: Patient transported to ED at 10:53 AM.
Patient received Zoster vaccine 12/19/11 and was diagnosed with shingles at an outside hospital 12/29/11. This new diagnosis required pharmacologic intervention and further evaluation by medical professionals. Patient had no history of imuunocompromise and was appropriate to receive zoster vaccine according to inclusion/exclusion criteria.