chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness/achiness; Cold; Flu like symptoms; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness/achiness), NASOPHARYNGITIS (Cold), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and FATIGUE (Fatigue) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Soreness/achiness), NASOPHARYNGITIS (Cold), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, PAIN (Soreness/achiness), NASOPHARYNGITIS (Cold), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. Not Provided          Concomitant product use was not provided.   Treatment information was not provided.      Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25 May 2021 contains :Reporter denied consent to follow up.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 10:49 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 10:51 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.90 for dose administered on 03 Mar 2021 and 67.98 for dose administered on 31 Mar 2021. No concomitant medications were reported.  Batch number 030B21A administered on 31 Mar 2021 underwent temperature excursion with temperature of 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30 Mar 2021 and beyond use date for the vial was reported as 29 Apr 2021. Product moved to clinic on 31 Mar 2021.  Batch number 014M20A administered on 03 Mar 2021 underwent temperature excursion with temperature 34 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 24 Feb 2021 and beyond use date for the vial was reported as 26 Mar 2021. Product moved to clinic on 03 Mar 2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Patient reported redness of the arm that was pointed out to him on 09/13/16 in the afternoon. He reported pain but able to move the arm.
One week after the shot, the area became red, itchy, hot and hard.  The affected continues to get larger as time passes.  I have taken acetaminophen several times.
pt never had pneumonia in life until the vax in 1995 & had pneumonia started p/vax;p/pneumonia;devel asthma & allergies;
Site rash, nub tongue, burning eyes, joint pain especially in knee, fibromyalgia.
Myalgia, Fever, Diarrhea, NauseaVomiting, chills, shortness of breath Narrative:
Client  presented to the vaccination site on 2/28/22. The client reported that she received a first dose of Pfizer COVID vaccine on 2/7/22. Client reported feeling dizzy, lightheaded, seeing spots, ?feeling like everything was spinning?, and having a ?bad headache? the 2nd day after vaccination with her first dose of Pfizer COVID vaccine. Client reported symptoms lasted for one hour. Client reported that she was out in the sun when she started feeling symptoms and thinks it may be related to dehydration. Client reported symptoms were relieved with rest, drinking water, and drinking electrolytes. Client did not follow up with PCP. Client has known allergies or history of fainting. Client reported that she ate something 2/28/22. RN gave client water bottle and encouraged her to stay hydrated. Client drank from water bottle. RN submitted a medical consult via text message to clinical project coordinators requesting to proceed with Pfizer COVID vaccine. Per Dr. approval to proceed with Pfizer COVID vaccine was obtained via text message from , clinical project coordinator. Client received Pfizer COVID vaccine LOT#: FK9895 at 1529 by  LVN. Client did not report any symptoms during 15-minute observation period. RN educated client on possible adverse reactions and when to seek EMS. The client and client's sister verbalized understanding.
This spontaneous report as received from a pharmacist refers to a 69 year old patient. On 05-MAR-2013 the patient was vaccinated with expired ZOSTAVAX (lot # 1657AA, expiration date 21-JAN-2013). Route of administration was not provided. The patient experienced no adverse effect. Additional information has been requested.
Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown gender and age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K010215, expiration date 05-MAY-2017, lot # M014929, expiration date 27-MAY-2017; dose and route were unknown). No adverse effects were reported. The reporter stated that the vaccines were exposed to 52 Fahrenheit degree for 15 hours and then they backed in range. There were no previous temperature excursion. No product quality complaint was involved. This is one of several reports received from the same reporter. Follow up information has been received on 17-SEP-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated.
client called to inofrm that 0n 11-20-2008 she received influenza and tetnus immunization and on 11-22-2008 her arm where she received the tetus shot swelled and was red and painful. she took ibp fro discomfort and today 11-24-2008 it is much better
A nurse reported that a 19 month old male received his 1st dose of Prevnar on 4/26/2000 and that same day, developed an injection site reaction characterized by a 10.5cm by 9cm area of redness, induration and inflammation. Additional info received on 7/5/00 indicated that the pt was seen by the physician on 4/28/00 "when above measurements were taken. Child without limp." He recovered. The pt had a history of frequent otitis media with placement of PE tubes.
Patient with history of diabetes type II. He was brought to the ED by EMS on 12/22/22 for shortness of breath, weakness, fatigue, chills, and cough that began two weeks ago. EMS reports that on arrival, the patient had oxygen saturations at 64% on room air and so was placed on a nonrebreather which increased his sats to 95%. A COVID PCR test performed in the ED resulted positive. Patient was admitted 12/22/22 - 12/24/22 with discharge diagnoses including acute respiratory failure with hypoxia, COVID-19 pneumonia/acute decompensated diastolic heart failure, among other diagnoses. Patient has received the Janssen COVID-19 vaccine.
Patient states she has been in bed for over 3 days.  She had been tired,  headache, body aches  and pain under her arms and around her breasts.  She has been taking pain meds and did not feel like getting out of bed for 3 days.  She said the  area under her arms and around her breasts is still still very painful.
I am fully vaccinated and I tested positive for COVID 19 on January 06, 2022. Onset was a sore throat and then a little bit of nasal drainage and then I got a very bad headache. I had a low grade fever. I had to quarantine for 5 days and then I had to wear a N95 for 5 days because I am a nurse and I am a recovery room nurse. My case was very, very mild.
episode of syncope; atrophy; chronic ischemic change; experience numbness on the right side of his face and arm with some endorsed confusion and was diagnosed with transient ischemic attack; extreme dizziness/vertigo and diplopia and was diagnosed with Meniere's disease; extreme dizziness/vertigo and diplopia and was diagnosed with Meniere's disease; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or around 10-OCT-2016, he was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the zoster vaccine live (ZOSTAVAX), the patient suffered an episode of syncope and was diagnosed with atrophy and chronic ischemic change. On an unknown date, a short time later, he started to experience numbness on the right side of his face and arm with some endorsed confusion and was diagnosed with transient ischemic attack. Around that time, the patient began to suffer extreme dizziness/vertigo and diplopia and was diagnosed with Meniere's disease. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of vaccination, he sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, he suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events were determined to be disabling. Upon internal review, the events of episode of syncope, transient ischemic attack and Meniere's disease were considered to be medically significant.
Information has been received from an unspecified reporter referring to a 3 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 13-SEP-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Fever (~101F)/chills, drowsy, "in a fog." Upon inspection by pharmacist, redness, swelling, warmth, slightly larger in size than a baseball and about 4 inches below injection site.
expired TYPHIM VI was inadvertently administered to patients, no AE; Initial information received on 30-Mar-2021 regarding an unsolicited valid non-serious case from other health professional and physician.  This case involves a 4 years old female patient who was inadvertently given 0.5 ml expired dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (lot R1B741M and expiration date :23-Mar-2021) via intramuscular route in the left deltoid for prophylactic vaccination on 30-Mar-2021 (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) .  It was a case of actual medication error due to expired vaccine used (same day latency).  It was reported that the caller with questions on whether dose needs repeating and in what time frame.  It was not reported whether the patient had any adverse event.  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.
This spontaneous case, initially received on 15-Dec-2016, was reported by a health professional and concerns a patient of unknown age and gender. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced a "knot" in the unspecified vaccinated arm (outcome: not reported).
This spontaneous report was received from a nurse practitioner and refers to an unspecified  number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with an improperly stored dose of VAQTA lot number N003194 with expiration date 28-OCT-2017 (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to 47 F (Fahrenheit) during 72 hours. There was no previous temperature excursion, digital data logger was filled. No adverse effects were reported in any patients. This is one of several reports from the same source.; Sender's Comments:  US-009507513-1707USA004450: US-009507513-1707USA004449:
swelling in neck;redness on arms & neck;itching about 5-6 hr p/vax;SOB, dizziness;dx poss acute allerg rxn to Td;
Starting 01/16/2021, there was itchiness and a cluster of red papules/wheals that showed up on my right back. The rash continued to spread the next few days with increasing papules and itchiness. The rash is localized to my torso. Most are on my right abdomen and right back but is now spreading to my left side and upper back. There are also a few under and on my right breast and below both my armpit areas. The rash is still erythematous, with some that are papular and some appearing like vesicles. There is still itchiness and some stinging sensation. I am currently on Hydroxyzine 25MG at night and Zyrtec OTC during day but it has only been 2 days since I started the meds. The itch does wake me up at night time. So far the antihistamines have helped a bit with the itch. At the same time, I appear to have a sore throat though it feels more like a mild swelling of my throat as whenever I swallow it feels sore.
Headache, Fever, SkinRash, hot, burning arm that spread to back, started on abx, one day of work missed Narrative:
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given.  No treatment medication was given.
Received expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was stated that the  o~Number of doses/vials: "2 doses/ 1 vial"  o~Date the vial was initially stored in the refrigerator:  "He thinks on 31AUG2021 but not 100% sure."          o~"The vial was first punctured and left at room temperature on  01SEP2021 o~"Date(s) of administration of vaccine when applicable: "02SEP2021"  o~Did the vial undergo any previous temperature excursions?  "NO"    o~Total amount of time the vial was exposed to room temperature range (46° to 77° F):  "A little over 24 hours"  Concomitant medications were not reported. Treatment medications were not reported.
Started w/red rash w/blisters under chin on neck, Progressed to left side w/small patches w/blisters on arm, neck, back and breast, hair line. Some localized pain at hair line; left side. Doctor diagnosed as shingles - give VALTREX orally for 7 days, no topical medication. I took TYLENOL for pain Shingles pretty clear by 8/4, except for 1 small patch at hairline, scab off 8/8/18.
Pain and burning at site at time of vaccine. Black and blue with pain in arm for 2 weeks. Then fever and intense ( very intense) pain in arm 12 days after vaccine at vaccine site.
Pt. received 4th dose of Jansen. Previous doses on 9/25/21; 8/31/21; 8/5/21
Rash left arm with vasculitis mildly raised eruption about 1 cm superior to site of flu vaccination, no TTP.
Headache; Horrible calf pain bilaterally; I could barely walk; Horrible calf pain bilaterally; I could barely walk; Major injection site soreness; my arm started getting super sore; Major injection site soreness; my arm started getting super sore; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) at left deltoid on 18Jan2021 12:45 PM at single dose for COVID-19 immunisation in Hospital. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]), just the Vitamins and supplements. Patient was just calling to report the side effects to the Covid 19 vaccine, major injection site soreness, she was having headache today (19Jan2021) and horrible calf pain bilaterally. the first dose was 18Jan2021 and due date of second dose was 08Feb2021. As of causality, nurse practitioner stated Yes, yesterday (18Jan2021) her arm started getting super sore and it kept getting worse and then she woke up this morning and she could barely walk because her calf pain is so bad, in both of her legs. Treatment include she have taken Advil, she took 600 mg today and she took 400 mg last night. As Results of Lab work, she stated she don't have it. She asked if anyone had the calf pain with it. Patient was not recovered from the events. Event relatedness for Covid 19 vaccine with Major injection site soreness; my arm started getting super sore and Horrible calf pain bilaterally; I could barely walk were Related. Relatedness of drug to Major injection site soreness; my arm started getting super sore, Headache, Horrible calf pain bilaterally; I could barely walk per Source of assessment:  Source of assessment. Method of assessment: Global Introspection. Drug result: Related.
Patient went to ER with shoulder pain, was admitted with severe shoulder inflammation. They determined there was no infection. Shoulder was aspirated 3 times.  Discharged on 10/8/2012 on physical therapy and Cephalexin.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 30-JUN-2016, the patient was vaccinated with an improperly stored dose of oral ROTATEQ (lot # L037924, expiration date 22-JUN-2017, orally; exact dose was not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of 48 Fahrenheit degrees for cumulative 14 hours and 50 minutes before administration to the patient. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Pain in right eye, tingling sensation in tongue and lip.  Given 50mg of Benadryl 30 minutes after shot
patient received a second bivalent pfizer covid shot before it was approved.  Patient did not have any adverese reaction to the vaccine