chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two weeks after my COVID booster, I woke up in the middle of the night with itching all over my body.  I noticed that I was breaking out in hives, it was itchy, not painful.  I was thinking that it was going to go away on its own so didn't take any medicine.  The following day, I got up early, I thought I was past it all since about 80% of the bumps were gone in the morning.  Later in the day, my entire body was covered in hives again.  Since at this point, I'm now traveling, I decide to use a telemedicine app to see a doctor virtually.  The doctor asked me a ton of questions and said that I'm having an allergic reaction to something, she recommended taking Allegra during the day and Benadryl at night for 4 days to see if my condition improves.  It's now eight days later as of today and I'm still experiencing the hives if I do not take medicines.
Pt experienced swollen, hot, red arm 22 x 12 cm. Arm also itches and hurts. No systemic symptoms, no lost duty time.
Information has been received from a physician concerning a 31 year old female with an allergy to flaxseed oil pills and no pertinent medical history who on 18-DEC-2007 was vaccinated with Gardasil, 0.5 ml, intramuscularly in the left deltoid. There was no concomitant medication. On 20-DEC-2007 the patient developed flu-like symptoms of diarrhea, achiness and fever that lasted a "few days (unspecified)." The patient then developed dryness of the lips and skin. The patient went to her brother, a dermatologist, that performed a biopsy of the skin condition on 24-DEC-2007. The biopsy determined the skin condition was orthokeratosis. The patient was given prednisone and BENADRYL for the orthokeratosis and was recovered by 29-DEC-2007. Additional information has been requested.
Severe local rxn to inject site rt deltoid, such as swelling, redness & pain; pt also c/o dizziness; muscular aches, joint pain, generalized weakness & fever & chills the next day p/immun given;
Employee became dizzy after vaccine administration. Employee was laid down with an ice pack at the back of her neck and monitored. Her heart rate was 75 and her POX was 99%. She immediately felt better.
Tinnitus ongoing. Sought help from 2 specialists to no avail. Have third appointment with another ear specialist next month
17 year old female who at the time of vaccinations denied being pregnant. Screening Questionnaire for child and teen immunizations utilized and client answered no to the question Is the child/teen pregnant or is there a chance she could become pregnant during the next month.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient with no pertinent medical history and no drug reactions or allergies. On 10-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose: 0.65 ml, subcutaneous, anatomical location not provided, lot # K009199, expiration date 27-SEP-2015). Concomitant therapies included simvastatin (manufacturer unknown), omeprazole (manufacturer unknown), VICODIN and sertraline hydrochloride. On unspecified date in October 2014, the patient experienced injection site reaction and came to the pharmacy. Injection site was red and itching and there was bruising around it. The reporter stated that reddened area was 4-5 inches in diameter. The patient sought medical attention via a pharmacy visit. No lab diagnostics were performed. There was no treatment given for the adverse events. The outcome of the events: injection site reaction, injection site red and itching and bruising around it was reported as not recovered/not resolved (at the time of the report). The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Developed high fever 101-102 and then redness at site within 12 hours of vaccination. Redness has much warmth to palpation, non tender, no Fluctuance (site of Pedivax vaccination).
ITCHING, HEADACHE, DIZZY, BODY ACHES, FEVER,CHILL, EAR ACHE AND FATIGUE
This spontaneous report was received from a registered nurse (R.N.) via telephone call on 20-OCT-2015, concerning a 16 year old patient of unknown gender. No concurrent conditions or medical history were reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA (lot # K005958, Expiration date was not reported) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Rash around injection site, with extreme itching and slight bumps like tiny insect bites. Rash was 3 to 4 inches in diameter. Researched it immediately and found info saying this delayed reaction had already been seen in a small percentage of patients. Source suggested ice and topical antihistamine, so I applied a bit of Benadryl liquid (for bug bites) to decrease the intense itching.
patient was given a dose of SHINGRIX with only the adjuvant component; patient was given a dose of SHINGRIX with only the adjuvant component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient was given a dose of SHINGRIX with only the adjuvant component) and inappropriate dose of vaccine administered (Verbatim: patient was given a dose of SHINGRIX with only the adjuvant component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-NOV-2023 The reporter stated that a patient was given a dose of Shingrix with only the adjuvant component. The patient was not given the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up.
Super cold; Achy; Tired; Chills; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Super cold), PAIN (Achy), PAIN IN EXTREMITY (Sore Arm), FATIGUE (Tired) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 12-Mar-2021, the patient experienced FEELING COLD (Super cold), PAIN (Achy), FATIGUE (Tired) and CHILLS (Chills). At the time of the report, FEELING COLD (Super cold), PAIN (Achy), PAIN IN EXTREMITY (Sore Arm), FATIGUE (Tired) and CHILLS (Chills) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Redness & soreness at injection site R forearm for 1 week. Felt generalized muscle aches and fatigue on   2/20- developed cold sore on mouth. Took famcyclovir. 2/21  Woke up with redness & soreness increased, site itched and area became swollen size of large grape. Armpit and neck on left side was sore with raise lymph nodes.-Took Tylenol and applied ice to arm.
This spontaneous report was received from a other health professional refers to a 48 year old patient. On an unknown date the patient was vaccinated with PROQUAD for prophylaxis. On an unknown date the patient experienced drug administered to patient of inappropriate age and no adverse event. The outcome of drug administered to patient of inappropriate age and no adverse event is unknown. The reporter considered drug administered to patient of inappropriate age and no adverse event to be not related to PROQUAD.
Pt recvd vax 17FEB94 seen by MD for fever (39), vomiting, lethargy & irritability; adm to hosp, spinal tap indicated haemophilus influenzae infect type B; treated w/Rocephine; pt recovering;
shivering; fatigue; injection site soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (shivering), FATIGUE (fatigue) and INJECTION SITE PAIN (injection site soreness) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 immunization.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CHILLS (shivering), FATIGUE (fatigue) and INJECTION SITE PAIN (injection site soreness). On 10-Mar-2021, CHILLS (shivering), FATIGUE (fatigue) and INJECTION SITE PAIN (injection site soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Raised knot at injection site, warmth, and redness. Patient instructed to use warm compresses and use Ibuprofen or Tylenol for pain.  Patient recovered.
The pt develped moderate to severe hair loss one week after Prevanr on two different occasions (07/24/2001 and 04/30/2002).
A report had been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning an adult, female subject, enrolled in a post-marketing study. FLUMIST was administered on an unknown date. There was one report of unspecified complication of pregnancy after receiving QLAIV3 during pregnancy. The outcome of the event of pregnant patient received LAIV3 and unspecified complication of pregnancy was unknown. The report was considered to be non-serious. The company physician considered the causality between suspect FLUMIST with the events of pregnant patient received LAIV3 and unspecified complication of pregnancy to be No.
nauseous; sore all over; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NAUSEA (nauseous) and MYALGIA (sore all over) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced NAUSEA (nauseous) and MYALGIA (sore all over). At the time of the report, NAUSEA (nauseous) and MYALGIA (sore all over) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
After receiving second dose of the Shingrix 4 days later stated an outbreak. Called doctor and prescribed me the Valtrex bck on November 30, 2021.  Since that point I am having outbreaks every 3-4 months.  My last 2 outbreaks occurred September 26, 2022 and no November 6, 2022.  I have to make sure that I have the Valtrex medication in my home.  I can be fine all day then wham I get nailed, if I leave it go by morning there is lots of bubbles and itches terrible.  Cannot wait to get in to see doctor to get meds it hits that fast.
patient was given ActHIB after it had reached temperatures of 29C for up to 3 days in error, no AE; Initial information received on 16-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA290256 (same reporter).  This case involves a 15 months old male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] lot UJ161AA, expiry date: 02-May-2021, via intramuscular route in the left thigh on 23-Sep-2019 which had reached temperatures of 29C for up to 3 days in error.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  It was a case of actual medication error due to incorrect product storage.  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Redness measuring 6 cm x 5 cm around injection site. Will resolve on own, give 3/4 tsp. BENADRYL as needed every 6 hours until redness gone.
The pt had a legal complaint. An attorney reported that a 57 year old male received Orimune vaccine sometime after 1960, when the pt was over 15 years old. The pt has a medical history of cigarette smoking and spinal injury. On or about 8/00, the pt was dx'd with malignant mesothelioma. He also developed shortness of breath, anatomical changes to his alveoli and other lung damage (not specified). It is alleged that the pt was exposed to the SV40 virus. The pt also alleges asbestos exposure while employed at various organizations. This case was considered "serious" since malignant mesothelioma was considered "Medically Important" (OMIC) for this case. Follow-up information received on 03/10/2005. Follow-up information received from the attorney provided a revised onset date, revised coding and outcome. An attorney reported that a 56-year-old male received Poliovirus vaccine (manufacturer unknown) sometime in the early 1960s. The patient had a medical history of cigarette smoking and spinal injury. On or about October 2000, the patient was diagnosed with mesothelioma. He also developed shortness of breath, anatomical changes to his alveoli and "invariably fatal cancer of the serosal membranes." Lab results included an aspiration of the pleural caviry revealing fluid with reactive mesothelioma. On 22-Jul-2002, the patient subsequently died from mesothelioma. The attorney alleges the decedent contracted, suffered and died form mesothelioma as a result of exposure to both teh SV40 virus in the poliovirus vaccine and to asbestos while employed at various organizations.
Patient had a local reaction to DTAP #5 to right deltoid, received vaccine 4-11-11 with reaction forming 4-12-11, redness measured 17 x 17 cm with induration of 14 x 12 cm, warm & itching.
Around 2am of 12Aug I woke up with a rash all over my face,where I got injected , my legs,  and breast.; Around 2am of 12Aug I woke up with a rash all over my face,where I got injected , my legs,  and breast.; itchy; my face was red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 11:30 (Lot number: EW0173) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), VACCINATION SITE RASH (non-serious) all with onset 12Aug2021 02:30, outcome "recovering" and all described as "Around 2am of 12Aug I woke up with a rash all over my face,where I got injected , my legs, and breast."; PRURITUS (non-serious) with onset 12Aug2021 02:30, outcome "recovering", described as "itchy"; ERYTHEMA (non-serious) with onset 12Aug2021 02:30, outcome "recovering", described as "my face was red". Therapeutic measures were not taken as a result of rash, vaccination site rash, pruritus, erythema.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, she was not diagnosed with COVID-19. Since the vaccination, she has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Information has been received from a consumer concerning a 91 year old female consumer with no known allergies and no pertinent medical history who on 05-FEB-2008 was vaccinated IM with 0.65mL of zoster vaccine live (Oka/Merck). There was no concomitant medication. On 05-FEB-2008, the patient experienced injection site pain. On an unspecified date the patient recovered. There was no product quality complaint involved. This is one of several reports from the same source. Follow-up information indicated no further information is available.
03/03/2022 I took my band aid off and noticed my arm was a little red. On May 1, 2022 I noticed my arm was very sore to the touch, only hurt if I touched it. There was a lump there. It was red and started itching. I used cortisone 10 on my arm. The redness has moved down my arm a little. The cream makes the redness go away but feels a little warm. It still feels a little sore when I touch it. It still itches.
Patient got his vaccine and when he stood up and fell- had a syncopal episode, BP was 123/51 Sats:  were normal  100 % on RA.  Blood Sugar 69mg/dl . exam was normal, we had him lie down for about 35 mins and recheck he did well BP repeat 119/79- lying 112/74 standing, . Was sent home.
Not feeling all together; A slight headache; Chills all over her body; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling all together), HEADACHE (A slight headache) and CHILLS (Chills all over her body) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced MALAISE (Not feeling all together), HEADACHE (A slight headache) and CHILLS (Chills all over her body). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 21-Feb-2021, MALAISE (Not feeling all together) and CHILLS (Chills all over her body) had resolved. At the time of the report, HEADACHE (A slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
lymph nodes were swollen in her armpit and in the back of her neck; rash in her armpit; rash on the shoulder where she got vaccinated; This is a spontaneous case received contactable consumer or other non-health care professional (patient). A 24-years-old female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 16Mar2021 (age at the time of vaccination was 24 years old) as a dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced lymph nodes were swollen in her armpit and in the back of her neck, rash in her armpit and rash on the shoulder where she got vaccinated. Caller received the first dose of the Pfizer-BioNtech Covid-19 vaccine on Tuesday 16MAR2021, the following day her lymph nodes were swollen in her armpit and in the back of her neck the nodes in her arm pit are still la little bit and those in the back of her neck hurt when she touched them, the following day her lymph nodes were not swollen but she had a rash in her armpit. Today around 11 she had a rash on the shoulder where she got vaccinated, it was not too big, it was the size of her hand, this lasted for 3 hours and is gone now. She would like to know if it's safe for her to receive the second dose of the vaccine. She wants to know if she should be concerned. And if she should still get second dose. The clinical outcome of rash on the shoulder where she got vaccinated was recovered on an unspecified date in 2021, while clinical outcome of lymph nodes was swollen in her armpit and in the back of her neck and rash in her armpit was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
While sitting in the recovery area of the vaccine site, I began to experience body aches, a sore arm, and a mild fever. The symptoms occurred less than ten minutes from the time I received the vaccine. The body aches and the mild fever lasted two days, and the sore arm lasted three days. I could not sleep on my left side because the arm was tender. These symptoms only occurred for the first vaccine; I did not experience any of the symptoms mentioned above with the second dose.
Red, dry circular spot next to injection site. It popped up a few days after the vaccine. I received the vaccine on Saturday and noticed the red spot Thursday. I'm not sure if it came earlier than that.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M003659, expiration date reported as 20-SEP-2017 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 55 degrees Fahrenheit for 187 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received form the same reporter. Additional information has been requested.
Malaise, headache, fatigue, 5pm Additionally: Chills and fever and body aches  7pm Additionally: Sore throat 7pm
Hot to the touch reddened area that grew to be softball size over the course of 3 days. Went to a walk-in facility on 9/2/17 and was diagnosed with cellulitis, and given antibiotics. Prior to the going to the walk in, they used ice and MOTRIN.
Patient is a prostate cancer patient and receives chemotherapy and goes to the Clinic.  They do not have vaccines so they sent him to pharmacy.  He said that his doctor told him to get the flu shot. I gave the shot at approximately 10:05am.  At approximately 4:30, the patient's wife called to let me know her husband had chills.  I said possibly due to the chemo or flu shot.  I decided to call her back to see if he had a fever or given Tylenol.  She said no to both.  She then told me after they got home, he worked outside.  It is only around 60 degrees around 2:00pm.  She then said that could be why he has the chills.  She said she would give it a couple hours and if still has chills she would call the squad.  She appreciated me following up and my concern and said she would follow up with me.  I will also follow up with patient or his wife.    adverse event was chills at around 2:30pm  on 09/18 - received call from wife to report adverse effect of chills - will do follow up
Effects presented one hour after administration - Headache, slight stiffness on the left side of the face, discomfort in the arm. After 10 hours of administration of the vaccine - Insomnia, chills, hypersensitivity and tingling throughout the left side of the body. currents that ran from the administered area to the face, and to the hands. and all over the left foot.