chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no smell; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (no smell) and DECREASED APPETITE (no appetite) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ANOSMIA (no smell) and DECREASED APPETITE (no appetite). At the time of the report, ANOSMIA (no smell) and DECREASED APPETITE (no appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was provided.  No treatment medications was provided.   Reporter did not allow further contact
The day within 10 minutes I started feeling hot and feverish. Then I started to feel lumping and cramping in my left breast and it persists and it turned in to nausea, vomiting, and dizziness. I also felt body cramping and both of breasts became extremely hard and was not comfortable. I also had muscle aches along with a mild fever for about a week. The pain was persistent. Then on day 2, the headaches started and I couldn't sleep because every time I moved the headache would cause me to vomit. So, I couldn't. My vision was blurry and I was not sure if it was due to the headache or the vaccine. I ended up going to the ER on 05/16/2021  for cramping in my left leg which was down by my ankle and was bruised. I'm still experiencing heart palpitations, tiredness, cramps still happen in my breasts,  and there are still moments when my vision goes in and out.
Visit date 02 SEP 21:- The patient is a 46 yo male with a history of HTN and obesity developed natural COVID infection in APRIL and continued prolonged dyspnea and fatigue. He received Janssen COVID vaccine #1 08 JUN 21 followed by severe flulike symptoms with n/v/d dizziness and vertigo and CP for at least several days. He continued with fatigue, dizziness and vertigo symptoms and was ultimately diagnosed SSS and received a pacemaker in AUG 2021.
Info regarding Prevnar vaccine was received from a healthcare professional regarding a 12 month old female pt who experienced injection site swelling immediate. The pt received the fourth dose in Feb/2006. The pt also received a dose of Varivax in Feb/2006. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered in Feb/2006. Dose regimen was 1 dose 1 time per day, IM. Concomitant therapy included Varivax vaccine. EVENT DETAILS: The pt experienced injection site swelling immediately post/vax at the administration site. The pt remained in the physician's office for 30 minutes for observation. No treatment medications were given. The date of recovery was not provided. No additional info was available at the time of this report.
Hospitalized 9/1/22-9/7/22 SOB, cough, decreased appetite,  dyspnea, weakness, PNA,
Vomiting. Patient called today (8/29/18) to report that she has been vomiting since she received the vaccine.
This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. On an unknown date (also reported as since 11-MAY-2016) the patient was vaccinated with improperly stored dose of ROTATEQ lot#: L038534 orally. No adverse effect reported. The temperature excursion details included exposure to temperature of 47 Fahrenheit for 8 hours. No previous temperature excursions reported. No additional doses have been administered.  This is one of several reports received from the same source. Additional information has been requested.
Initial unsolicited report received from a nurse on 15-May-2018. This case involves an adult patient (age and gender not reported) who was inadvertently vaccinated with an expired dose of MENACTRA (batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any harm 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 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. List of documents held by sender: none.
patient came in to get record of vaccination history, after retrieving her form from vaccine history portal, it was noted that she received 3rd dose of shingrix vaccination, pt did not report any side effects
Shingles; This is a spontaneous report from a contactable nurse reporting same event under the same suspect product for 4 patients. This is third of 4 reports.   A elderly patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Apr2021 as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was one of the 4 seniors that the doctor knew of that has developed shingles on an unspecified date with Pfizer vaccine for COVID 19. The outcome was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021481986 same reporter/drug/events, different patient
The caller received his first dose on 12Apr2021. On 19Apr2012 the caller tested positive for covid; This is a spontaneous report received from a contactable consumer (patient, self-reporting). A 53-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on 12Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On 19Apr2021 (7 days post vaccination), the patient tested positive for COVID-19 virus. The patient already completed his 10 days quarantine and had tested back already which shown negative for the virus on 30Apr2021. The patient was scheduled to receive second dose of the vaccine on 03May2021. There was a product complaint The patient just wanted to check if he can safely get the vaccine given that he previously tested positive with COVID19. The outcome of the event was recovered.  Follow-up #1 (30Apr2021): This is a spontaneous report received from a contactable consumer. No new significant information was updated.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Last menstrual period was 11/16. Received first dose due to vaccine mandate on 11/23/2021. Received the second dose on 12/14/2021. Negative pregnancy test on 12/13/2021, but were actively trying. Told by primary provider and midwife the vaccine was safe even when actively trying and in the 1st trimester and would not sign a medical exemption. I had concerns receiving it during the 1st trimester. On 1/24/22 we had our first appointment at 9 weeks and 6 days. The ultrasound showed no cardiac activity in the fetus. D&C procedure was completed on 1/25/22, completed by Dr.
Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: Pt states she thinks vaccinator hit a nerve.  She is still experiencing pain at injection site.
left injection site arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left injection site arm was sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (left injection site arm was sore). On 29-Dec-2020, VACCINATION SITE PAIN (left injection site arm was sore) had resolved.            No concomitant medications were provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-288149 (Patient Link).
Pt came to the pharmacy to get menactra shot for his school. H e filled out consent form and verified the only thing he is allergic to is the penicillins. He got the shot  and about 5 or so min later, i heard a noise from people around him. I run to him with my emergency kit , picked him up and gave him epipen just to be sure incase if its anaphylactic reaction. I checked his breathing ,he was breathing fine. i asked him if he want me to call 911, he replied no.  I helped him up to seat on the chair, he said he is feeling dizzy.  I gave him water.  He said his back of his head hurt and he thinks he might have hit the floor. He asked for ice pack. I gave him Ice pack. About 5 min or so, i check back with him , he said he is feeling alot better. I asked him again if he want me to call 911, he said no. After about 10 min or so, he start to have seizure where i moved him onto the floor from the chair and moved everything around him I have one of my tech call 911 and I have him on his sides. Th eseizure lacsted for about 1 or so. Once EMS get to the pharmacy,  he had another seizure that lasted for about another min. EMS gave him Ketamin as he was very uncooperative
Pt reported symptoms of chills and very intense shaking, approx. one hour after receiving vaccine. Pt reports going to ED for evaluation and treatment. (Clinic awaiting records). Pt stated he was discharged same day and felt better by end of the following day 2/10/17.
4MAR97 pt had fever 101.2 subsided 5MAR97;6MAR97 t101.4;MD dx flu;sz 3PM 7MAR;went to hosp ER adm t104.7;CSF negative;dx viral infect 7MAR97;small red spots;dx w/OM
EXTREME muscle pain and soreness at injection site. Fever and aches the day after injection.
Soreness in arm, swelling in upper arm, red circle 3" across at injection site which grew bigger during 2/13.
Pain in arm developed after several days. Pain continuing through today 2/24/2021. Soreness in arm not mediated by pain meds, including Tramadol 50 MG that I take for back problems. Injection site was never red nor swollen. Trouble lifting arm without pain. Limited mobility without pain. On scale of 1 to 10 with ten being worst, pain varies between 3 and 7 at times.  Also have developed partially uncontrolled high blood pressure not mediated by heart meds, chiefly losartan. Before first vaccine, I was taking 50 mg daily. Increased to 100 mg daily on 2/1/2021 without stabalizing BP. BP can range during day from 106/60 to 158/86 with Pulse in 60s.
Severe headache, uncontrollable chills, insane sweating, achiness, sleepiness lasting 12 hours. Pain at injection site.
Wed. 03/30/05- took child to ER, 03/31/05 their DX was vaccine induced measles. Child SX coreza, temp 99, cough, red watery eyes, discharge from eyes, and on arm generalized rash.
Patient states: About eight days after receiving SHINGRIX vaccine the nerves on right side of face started to bother him. A few days after that, he started to experience very bad vertigo. More than 3 weeks after the injection, he still had not fully recovered. He cancelled the date to receive the second dose in the series.
This spontaneous report as received from a consumer's mother refers to a male patient of unknown age. Patient's concurrent conditions and relevant medical history was unknown. On an unknown date the patient was vaccinated with two doses of GARDASIL on the same unspecified day. Concomitant medications were unknown. The outcome of the event was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. Additional information has been requested.
This case was reported by a consumer via Merck and described the occurrence of swelling injection site in a child subject of unspecified gender who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of HAVRIX (unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced swelling injection site, fever, red swollen bumps [red bumps and swelling]. The consumer, who is the subject's parent, reported that her child was administered HAVRIX, and experienced injection site swelling, fever, and red swollen bumps. At the time of the report no other information was available. At the time of reporting the outcome of the events were unspecified.
Mom reported via the phone on 7/24/18: Patient received Hepatitis A on 7/19/18 and on 7/21/18 in the evening the patient developed tiredness, neck pain and headache. He then began to vomit. All symptoms resolved in 24 hours.
I26.99 - Pulmonary emboli (CMS/HCC) J18.9 - Atypical pneumonia N17.9 - Acute kidney injury (CMS/HCC) R73.9 - Hyperglycemia A41.9 - Sepsis (CMS/HCC)
Information was received on 07-JUL-2017 from a pharmacist who stated that a 65 year old patient (gender not reported) received ZOSTAVAX 0.65 ml once on 05-JUL-2017 and returned to pharmacy today (07-JUL-2017) with "what appears to be a large mosquito bite (induration) at the injection site". Pharmacist stated the injection site reaction did not resemble a vesicle associated with shingles. Per pharmacist, patient had not been treated and it was not recovered. Per pharmacist, patient takes pravastatin and levothyroxine; medical history unknown. Pharmacist stated patient has a drug allergy to penicillin. Pharmacist provided ZOSTAVAX lot information: N011366, expiration 12-MAR-2018 and diluent information was not available. No further information provided. Additional information has been requested.
75 y/o female presents with being sick for 7 days. c/o fever cough and bodyache. NO
Soreness started day of vaccine-very sore to touch following 3 days. Circular, red raised area about the size of 16 oz foam cup opening. Warm to touch.
Patient had a fever of 101.6. She was nauseated and throwing up. Her muscles ached. She stood up to go to the restroom and was unable to hold herself up and fell on her face.
pt recvd vax 20SEP04 & 22SEP devel hives-like rash; 23SEP rash inc in intensity; took pt to MD 23SEP prescribed Atarax for rash which did alleviate it; 29SEP devel fever of 104.2-adm to hosp on 30SEP w/dx of erythema multiform & tonsillitis
bladder infection; Not feeling good in general; Chills; muscle aches and pain; low fever; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (bladder infection) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bladder cancer.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced FEELING ABNORMAL (Not feeling good in general), CHILLS (Chills), MYALGIA (muscle aches and pain) and PYREXIA (low fever). On 12-Jan-2021, the patient experienced CYSTITIS (bladder infection) (seriousness criterion medically significant). At the time of the report, CYSTITIS (bladder infection), FEELING ABNORMAL (Not feeling good in general), CHILLS (Chills), MYALGIA (muscle aches and pain) and PYREXIA (low fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter'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. Further information has been requested.
Temp 102 fever, severe pain Myalgia, redness on (R) side.
Certain position, like put jacket on /stretches, can't do that anymore /unable to do certain things/ if it hangs it bothers me; I have a bit of a knot there; left arm pain / doesn't hurt all the time; shooting pain / It is so painful.; this is very upsetting to me; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injected limb mobility decreased, injection site mass, pain in arm, pain and emotional distress. On an unknown date, the outcome of the injected limb mobility decreased, injection site mass, pain in arm, pain and emotional distress were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, injection site mass, pain in arm, pain and emotional distress to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient herself. The patient share her email address but did not have the personal fax number. The patient received 1st dose of Shingrix in her left deltoid and thinks that it was given in the muscle. The patient provided her pharmacy's contact information since she was unable to locate the lot number or expiration date on the paperwork. The patient was reported left arm pain and it did not hurt all the time. It was just in certain positions, like when she put the jacket on. The patient used to be able to do these stretches, but she could not do that anymore. The patient was concerned that she would not be able to to her recreational activities like kayaking, river tubing anymore. The patient was really active and she like to enjoy the activities on the lake. The patient used to be able to do these things and she did not know if she would be able to anymore. It was just certain positions, it was like the shooting pain and it was so painful. Sometimes if it hangs it bothers her and she think she had the bit knot there on left arm. The patient had using the heating pad on it and that was  the big inconvenience. The patient felt great before the shot and that was very upsetting to her. The patient stated that she did not think that she was going to received 2nd dose. The reporter consented to follow up.
Angioedema and numbness of tongue, throat, dysphagia, facial swelling.
Information has been received from a nurse referring to a patient of unknown age and gender. On 16-MAR-2015, the patient was administered an improperly stored dose of M-M-R II injection, lot # K008814, expiry date; 19-JUN-2016, (dose and route were not reported). No adverse events were reported. Additional information has been requested.
Red, hot, swollen, round area about 2 in in diameter initially, then dispersing into a 2x4 in solid stripe across my upper arm.
pt stated stated he had chills later on the dame day after receiving the covid vax  and some soreness around the injection site.  Pt states all symptoms have subsided.
macular, papular red blanching rash on the scalp, soles of the feet, palms, diaper area, trunk, face, and extremities; fever; macular, papular red blanching rash on the scalp, soles of the feet, palms, diaper area, trunk, face, and extremities; This spontaneous report as received from a nurse refers to a 12-month-old male patient. His concomitant therapies included pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) and hepatitis a virus vaccine inactivated (HAVRIX). The patient had none pertinent medical history, drug reactions or allergies.  On 08-JAN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA (recombinant human albumin)) (PROQUAD) subcutaneously, lot # S013711, expiration date 01-NOV-2020 (exact dose was not reported) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) (dose, route of administration, indication, lot# and expiration date were not reported).  On 20-JAN-2020, the patient experienced fever, macular, papular red blanching rash on the scalp, soles of the feet, palms, diaper area, trunk, face, and extremities. On 22-JAN-2020, the patient was seen and diphenhydramine hydrochloride (BENADRYL) was prescribed. Lot check was requested by reporter. Samples would be possibly sent for polymerase chain reaction (PCR) analysis to the Varicella Zoster Virus Identification Program (VZVIP). On an unknown date, the flu test was performed and the result was negative. It was reported that the patient sought medical attention and the intervention to prevent serious criteria was needed.   The outcome of the events was reported as resolved on an unknown date. The causality assessment between the events and suspect therapies was not reported.  Upon internal review the events of "fever, macular, papular red blanching rash on the scalp, soles of the feet, palms, diaper area, trunk, face, and extremities" were considered to be medically significant since required intervention to prevent serious criteria.  This is one of five cases received from the same reporter.; Sender's Comments:  US-009507513-2002USA001425: US-009507513-2002USA001507: US-009507513-2002USA001496: US-009507513-2002USA001134:
PT CAME TO VACCINATION CLINIC WITH HIS FATHER WHO SIGNED PREVACCINATION CHECK SHEET.  THE CLINIC WAS HELD AT WHERE THE PATIENT WORKS.  PATIENT IS 16 AND RECEIVED JOHNSON AND JOHNSON VACCINE IN ERROR DUE TO THE FACT HE IS NOT 18.  WE HAVE CHECKED IN WITH PATIENT AND HIS FATHER 4/1/2021 BOTH HAD BODY ACHES, HEADACHE AND CHILLS. I CHECKED IN WITH BOTH THIS AM 4/2/2021 NEITHER ONE HAS ANY SYMPTOMS TODAY.
This spontaneous report as received from a consumer refers to her. The patient was vaccinated IM with dose 1, 0.5 ml GARDASIL (lot # not reported) on 2009, the second dose in July 2012 and third dose on 29-AUG-2012. The patient referred to her physician to provide information on the effectiveness of the vaccinations she's had, and any related information on the risks involved with becoming pregnancy within the 6 month period before she would have her last dose of the re-started regimen scheduled in December. Patient explained that she had a pregnancy test on 29-AUG-2012 that was negative. No further AE information was provided. Additional information has been requested.
I woke up on 03-14-2021 with a "base-ball feeling in my throat". I could not eat or drink anything. I went to Urgent Care where they performed a Covid test as well as a strep throat test which came back as negative.  Today I still have the "base-ball feeling in my throat.
Child developed swelling from L deltoid to elbow the morning of 9/26/18 with feeling of skin numbness and development of tiny wate blisters. She was seen in ER that night and Dx with vaccine reaction. Seen for follow up in our office on 9/27/18 and swelling had improved but was still present.
Rash began on face and spread rapidly all over; patient's mother gave him generic Benadryl at 2:00 PM and brought him to doctor's office at 2:30 PM.
Severe all over  body pain, even on roof of mouth, headache, nausea & vomiting, dizziness and extreme fatigue, joint aches & pain , itchy, raspy sensations
Patient received vaccine and within minutes father found patient slumped over. Father unsure if patient lost consciousness or not. Father thinks that the patient may have lost consciousness for a "couple seconds" and when patient came to he appeared to be coughing as if he was choking.  The patient then felt very drowsy with a hot feeling to face. Patient looked lethargic upon first observation from RN.