chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I missed work; common side effects; my arm was very sore; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, activities of daily living impaired and adverse drug reaction. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the activities of daily living impaired and adverse drug reaction were unknown.   It was unknown if the reporter considered the pain in arm, activities of daily living impaired and adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of Shingrix and experienced all of the common side effects to the point where the patient missed work and the patient's arm was sore for a week. The patient felt like overmedicated and body of the patient had difficulty processing the drug. The patient also enquired about the percentage of immunity would the patient have if the patient did not take the second dose. Consent to follow up was requested.
When administering the vaccine, it leaked out and pt did not received the appropriate dose recommended. Patient was re administered in the opposite arm per cdc guideline.
tired; had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (Lot number: ER8731) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, LOT-ER8735), administration date: 01Apr2021, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had a sore arm".  Additional information: It was reported that she received her booster on Friday 19Nov2021 in her right arm and now has a bruise that is slightly above the injection site and a red spot that is getting worse and itches below the injection site that is painful and itchy and asks if this is normal,  asks what to put on it some kind of cream, states she had no problem with the first dose and with the second she was kind of tired and had a sore arm and is sure this time the bruise is from her hitting the vein. Caller asks how long will this last. Question about the booster, caller states she got the booster on Friday 19Nov2021, has a bruise right about injection site which she is not comfortable about, states there is a red spot underneath the injection site which is getting bigger, it is painful and itchy, states it is about 5 inches by 1 inch and is just getting bigger, wants to know if this is normal. Follow-up attempts are completed. No further information is expected.   No follow-up attempts are possible. No further information is expected.
Noticed pink rash ion chest n the evening next day pink rash covered torso, both arms and thighs .
Blanchable maculopapular rash on chest/abd/back; extending down arms (legs/diaper area).
For 2 days, pt had pain at the injection site, then stiffness in the arm, left neck and left back with triggered a migraine.
High fever 1 week later and next day rash chest, upper arm, stomach upper legs.
Swelling in upper left shoulder site is warm to touch and redden patient complains of pain.
This spontaneous report was received from a medical assistant refers to an unknown number patient of unknown demographics. Medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. On unspecified dates, these patients were inadvertently vaccinated with improperly stored MMRII (strength, dose/frequency, lot # unspecified). Concomitant medication was not reported. No adverse effects were reported. This is one of five reports received from the same reporter. Additional information is not expected, no contact details were provided.
After immunization, patient fainted.  He was unconscious approximately 1 minute.   I had him remove his mask and gave him a bottle of water.  I sat with him for 10 minutes, then had his girlfriend sit with him another 15 minutes.  After that time he felt fine and they left the phamacy area.
Covid arm; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) and TYPE IV HYPERSENSITIVITY REACTION (Covid arm) 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.    On 19-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 MYALGIA (sore arm) and TYPE IV HYPERSENSITIVITY REACTION (Covid arm). At the time of the report, MYALGIA (sore arm) and TYPE IV HYPERSENSITIVITY REACTION (Covid arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Raised skin rash, extremely itchy, occurring over most of body. Extremely itchy and burning. Back, upper legs and upper arms the worse. Some raised bumps developed into fluid-filled blisters. Burning; itchy; Raised skin rash, extremely itchy, occurring over most of body. Extremely itchy and burning. Back, upper legs and upper arms the worse. Some raised bumps developed into fluid-filled blisters. Burning; Some raised bumps developed into fluid-filled blisters.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 79 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Single, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Single, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 4, Single, unknown manufacturer), for COVID-19 Immunization. The following information was reported: BURNING SENSATION (non-serious), RASH (non-serious) all with onset Oct2022, outcome "not recovered" and all described as "Raised skin rash, extremely itchy, occurring over most of body. Extremely itchy and burning. Back, upper legs and upper arms the worse. Some raised bumps developed into fluid-filled blisters. Burning"; BLISTER (non-serious) with onset Oct2022, outcome "not recovered", described as "Some raised bumps developed into fluid-filled blisters."; PRURITUS (non-serious) with onset Oct2022, outcome "not recovered", described as "itchy". The events "raised skin rash, extremely itchy, occurring over most of body. extremely itchy and burning. back, upper legs and upper arms the worse. some raised bumps developed into fluid-filled blisters. burning", "itchy" and "some raised bumps developed into fluid-filled blisters." required physician office visit. Therapeutic measures were taken as a result of burning sensation, pruritus, rash, blister. Additional information: Raised skin rash, extremely itchy, occurring over most of body. Extremely itchy and burning. Back, upper legs and upper arms the worse. Some raised bumps developed into fluid-filled blisters. Burning/itching fluctuates but has never cleared. AE treatment: Antihistamines, topical cortisone, prednisone. Patient did not received any other vaccine in four weeks. Patient received other medication in two weeks: Anti rejection thyroid. Patient did not had COVID prior vaccination. Patient was not tested for COVID post vaccination. Known allergies: No.
breakout rash again, but more on lower legs and lower arm. This was less of a flat rash but raised and round.; Rashes itched; This is a spontaneous report from contactable consumer (patient). This 82-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Sep2021, as the second single dose, in upper left arm, for COVID-19 immunization. Medical history included ongoing high blood pressure. The patient received the first dose of BNT162B2 vaccine on 28Jul2021 at 08:00 AM, at the age of 82 years, in upper left arm experiencing upper arm, right arm started itching and red rash which continued to spread down that arm and then to other arm and then to lower legs. Prior vaccination (within 4 weeks): none. Concomitant drugs: none. After the 2nd dose, on an unspecified date in Sep2021, the patient had a breakout rash again, but more on lower legs and lower arm. This was less of a flat rash but raised and round. Rashes itched and the patient went to Doctor who gave steroids. The area still itched occasionally and was still healing. The events were resolving.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101064198 Same reporter/patient, different dose/AEs.
patient received Fluzone QD instead the Flublok, no AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 52 year old patient (gender not reported) who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Flublok).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of Wrong vaccine administered.  At the time of the report, 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 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.
Patient presented with cellulitis like symptoms. Redness/swelling/warm to the touch/pain. Dr. placed on antibiotics.
101.3 fever on and off overnight, chills, severe body aches, headache, injection site pain and swelling along with lymph node swelling left armpit. At 24 hrs no treatment, clinic closed for New Year?s Day.   Intake of extra water, bananas for dehydration and acetaminophen for fever.
Pt complained of cough 10 min after vaccine, then felt throat closing at 15 min. Was given BENADRYL.
Severe headache, soreness at injection site, weakness in legs, fatigue, rapid heartbeat, difficulty breathing, stiff and clicking neck, clicking jaw, dizziness, light headedness, heavy chest, thick mucus production in throat and chest area, itching and tingling in scalp area, light and noise sensitivity, migraine and vertigo symptoms, double vision, blurry vision at times, feeling faint, ear ringing, easily fatigued during normal activity, elevated heart rate just during normal walking (124 BPM), jerky movements, neck pain at base of skull, neck stiffness, pain on left side of neck, neck clicking, burning sensation at base of skull, thoughts are jumbled, speech jumbled/slurred at times, slow thinking, chills, diarrhea, very sore arm at site injection (right arm), feeling like my head is detaching from my body, can't walk far distances anymore (fatigue easily, fast heartbeat, gait is off, off balance most of the time, dizziness and rapid heartbeat occurs everyday.
Red rash, itchy, sharp pains, swelling, sensitive to touch in area (left side of the back to the front of the body below the breast). Illness began on 02/18/2021. Due to wintery weather I went to the emergency room on 02/20/2021.
Pt had pain in injection site, that is still causing soreness 6 months later at times.  also the day following the shot, had fever, chills, body aches for 3 days after the shot.   Doing report because of continued inject site soreness.
This spontaneous report has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On unspecified dates, the patients received an improperly stored dose of VAQTA with a lot # L004439 and expiration date of 15-FEB-2016, lot # L022259 and expiration date of 06-APR-2017, lot # L013380 and expiration date of 04-NOV-2017, (strength, route of administration and dose were not provided). There was no concomitant therapy reported. No adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
, Additional Details: pt states she had to visit urgent care for a respiratory illness that she believes stems from her moderna vaccination - also reported hemorrhoid symptoms
day p/vax pt exp lt arm warm, erythemic, swelling at inject site. swelling & erythema at posterior elbow plus tender axillary node
Pt recvd Engerix-B on 15MAY92, 17MAY92 & exp nausea, diarrhea, vomiting, flu-like sx, low grade fever, joint pain; tx w/Ampicillin; pt still has little nausea;
This spontaneous report was received from a medical assistant who was also the office manager and refers to an unknown number of patients of an unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL 9 lot number reported as M042859 and expiration date 17-JUL-2017 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA010395.
4hrs p/immun pt pale, dusky, limp, weak cry, trouble breathing; Seen by MD; septic work up nl, EKG neg, CXR neg, PO2 100;
Pt started to have tight throat, lips tingling and numb and numbness tingling at end of tongue within 15 minutes of getting vaccine and had left facility before 15 minutes as wanted to eat... went home and took 2 benadryl from home supply and that helped though continued to have some throat tightness next day for which she continued to take benadryl. Woke up the next day w severely red face and neck, over the course of the next day developed a bright red punctate rash, "like roseola" over chest, abdomen and arms which was severely itchy and which is getting slightly better w continued benadryl and the fluocinide she uses for psoriasis
Pt was on his 15 minutes observation period after the covid-19 vaccine.  About 10 minutes after receiving the vaccine, he said he had pins and needle feeling on his left arm from his elbow to his ring and pinky fingers.   He also had a "warm feeling" at the same area.  We recommended him staying longer for observation.  After about 10-15 minutes he wanted to leave.  He now describe it similar to "numbness on your foot when you sit on it too long".   He said he would be okay and he left.
08/13/22 presents to ED for "chest pain". PMHx of "cigarette smoking, otherwise no medical problems"
Patient experienced swelling, irritation, itching and redness at the injection site the day of the vaccine. The following day the redness and swelling had expanded and eventually would span the length of her arm from her shoulder to her elbow. These symptoms lasted approximately 2 weeks.  She self-treated with calamine lotion and did not seek medical attention.
Shortly after 2nd dose, started seeing red rash on my legs.  Did not go away after week, so saw my dermatologist, who prescribed me with a cream. Did not help. Few weeks later started getting some sor; Few weeks later started getting some sores on my upper legs and back; my skin gets very hot and itchy; my skin gets very hot and itchy; fatigue is a favor; This is a spontaneous report from a contactable consumer (patient). A 66-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810, Expiration date not reported), via an unspecified route of administration, administered in right arm on 12Feb2021 14:15 (at the age of 66 years) as dose 2, single for covid-19 immunization. Medical history included obstructive sleep apnea, thyroid cancer, and known allergy to penicillin, all from an unknown date and unknown if ongoing. Patient previously took first dose of bnt162b2 (Lot number: EL3247, Expiration date not reported) via an unspecified route of administration, administered in right arm on 22Jan2021 14:30 (at the age of 66 years) as dose 1, single for covid-19 immunization. Concomitant medications taken within in two weeks included diltiazem; levothyroxine sodium (LEVOTHYROXIN); and sertraline hydrochloride (ZOLOFT), all taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination and not COVID tested post vaccination. On 19Feb2021, shortly after 2nd dose, patient started seeing red rash on her legs. They did not go away after week, so she saw her dermatologist, who prescribed her with a cream. However, it did not help. Few weeks later patient started getting some sores on her upper legs and back on 19Feb2021. Patient saw her MD who started her on antibiotic, but it did not go away. Then patient went back to dermatologist, and he prescribed a stronger cream. It was reported that, along with the rashes and sores, her skin got very hot and itchy, and fatigue was a favour on 19Feb2021. Now 4 months later rash was a little better, but the other symptoms still bothered her every day. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and patient received treatment with unspecified creams and antibiotic. The outcome of event started seeing red rash on my legs was recovering and rest of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Client is a 47 y/o male observed in observation area slump over in seat in car.  Responds to verbal stimuli.  He complained of tightness in chest and shortness of breath.  Fire Rescue arrived to further evaluate client.  V/S taken BP 109/63, HR 100, Temp 98.7, RR 18, O2 97%, Via room air BS 150.  EKG performed and showed normal sinus with no acute changes noted.  Client complains of weakness and lower back pain and refused hospitalization despite paramedics and nurses encouragement to seek medical attention.  He continued to refuse hospitalization and remained in observation for an additional 15 min for observation.  Client left observation area at 4:40 pm.
no other AE occurred; dose of VARIVAX was administered after the labeled expiration date; This spontaneous report was received from a pharmacy student referring to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medications was not provided.  On 17-FEB-2022, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (valid lot #T002848, expiration date: 23-JAN-2022) (strength, dose and route were not provided). No additional adverse event was reported.
Donor states that she had mild discomfort in her left arm on Wednesday after the injection was given. The next day (Thursday) discomfort to left arm increased to pain, she then took a hot shower that evening to help with the arm pain. After the shower she experienced body aches and pain, temperature went up to 101.3. She then took a Melatonin and an EXCEDRIN and went to sleep. She awoke this am (Friday) feeling just fine.
Severe headache, diarrhea, gait imbalance, confusion. Required ER evaluation. Did not have problems with Pfizer one and two.
14 hours after the shot, experienced sore arm, fever, chills, and headache which subsided within 24 hours (except sore arm is still ongoing). Intermittent coughing is ongoing which is a new event.
Phone call received from mother of patient stating child's thighs were swollen, red, hot, hard and had a few blisters on right thigh only.  Was giving Tylenol beginning 2-7-08.
Felt sleepy, Took a nap woke up around 8:30 pm. Felt nausea. Drink 7-up Laid back down. Woke up still felt nausea. Drink another 7-up, felt sick to your stomach. No appetite. Felt really nausea. Still felling nausea.
Seen by MD on 2/24/2020: Noticed some bumps on the left thigh. The bumps are itchy. Tried some vicks on it but it didn't change. Was previously more swollen and was previously having discomfort to the area but not anymore. No fever. Normal activity. Decreased appetite since 2/22/20. No runny nose, cough, or dyspnea. No vomiting. Peeing and pooping normally.
Pt states that she has nerve pain ever since getting a pneumonia shot in the right arm. She complains of constant pain that gets worse on night. She says that she has to put on pain patches at night and has gotten one massage. Pt did report to going to a doctor about it recently, and it might be due to fibromyalgia, but patient feels it was caused by the pneumonia shot. She reports being on prednisone and LYRICA for the fibromyalgia. She doesn't report the pain getting worse. She was unable to provide any further detail.
arm  soreness; back, kidney pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm  soreness) and RENAL PAIN (back, kidney pain) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm  soreness) and RENAL PAIN (back, kidney pain). At the time of the report, PAIN IN EXTREMITY (arm  soreness) and RENAL PAIN (back, kidney pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medicines were not reported.
Aprox. 12 hours after receiving the vaccine, I developed the following symptoms:  headache, low-grade fever, chills, muscle/body aches, nausea, vertigo, primarily muscle/body aches.  My symptoms resolved aprox. 36 hours later.  Aprox. 60 hours later, I had a couple of episodes of diarrhea, and was just feeling a little "spacey" and slightly tender behind my eyes.
Post vaccination got up, felt dizzy, lightheaded and had syncope. He fell down, hit his head in the back with the fall, woke up in a few seconds. Had headache and dizziness. Observed for 40 min. BP 106/68, P- 88. At the end of the observation he feels much better.