chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; patient might have received a dose of VARlVAX administered intramuscularly; This spontaneous report as received from a pharmacist refers to a patient of unknown age or gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 18-NOV-2021 the patient might have been vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) intramuscularly, 0.5 milliliter, lot # U019904, expiration date 24-JUN-2023, for prophylaxis (formulation, concentration, dose number, frequency, were not reported). The patient was very lean and the angle used to administer varicella virus vaccine live (oka/merck)(VARIVAX) might have reached the patients muscle. No additional adverse event was reported. No product quality complaint (PQC) was involved.
pt recv vax 19NOV98 & 20NOV98 1130AM devel fever;21NOV98 presented to ER 12:05AM;tx w/med;21NOV98 transferred to another hosp;
About 3 months after the 2nd shot, my left 5 digit at the middle joint slowly starting swelling with no known injury. The pinky finger continued to swell and I was losing the ability to bend my finger.  Six months after the 2nd shot, I sought out a doctor visit as my pinky finger was continuously swollen, painful to bend and extremely painful if bumped.  Per the doctor, there was significant inflammation around the joint and the other joints in the hand had decreased cartilage.  He offered a silicone sleeve for the pinky finger to decrease the swelling and said at this stage there was nothing else to do.  Currently, my left pinky remains swollen, has significant loss of movement and my other fingers are becoming deformed at the joints in 1 year's time.  This is not normal.
Patient experienced chills, fever, cramping, diarrhea, hypotension, weakness, fatigue and dizziness at approximately 12 am on 1/8/2021 at her home. Patient is recovering at home.
PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 10-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006064: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474:
flu; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious media case from a consumer or non-healthcare professional via.  This case involves patient (unknown demographics) who had flu (influenza) after receiving INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE  It was reported that, this is the first year without a flu shot for the patient in years. Each year patient got the flu with having the shot.  It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Influenza vaccine was also unknown.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on lot number for this case.
2/7/22 pt admitted to hospital in respiratory failure due to COVID pneumonia; positive COVID test on 1/28/22; limited medical records received; O2 supplementation; pt became more lethargic; condition worsened; transitioned to comfort care; hospice where he expired
A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer and a health care professional concerning a 22-year-old female.  The patient's medical history and concomitant medications were not reported.  On 06-Oct-2008, the patient presented at the base clinic and was given FLUMIST via nasal administration by an immunization health technician.  The vaccine was found to be expired (expiration date 24-Mar-2008).  The expired lot of FLUMIST was given to 17 adult individuals including this patient.  The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.  Follow-up information was received on 09-Apr-2009:  Product Complaint Investigation results.
I experienced a skin rash with red, itchy bumps on the right arm of my body 72 hours after the second dose of the Moderna vaccine. The rash is under my arm, on my chest (near my armpit) and on my back. All of the rash is localized to the right side of my body.
cancer; 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 female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer". Therapeutic measures were taken as a result of neoplasm malignant.  Clinical course: Reported stated they have both had the Pfizer-BioNTech COVID-19 Vaccine primary series and the patient (her husband) has also had the Pfizer BioNTech COVID-19 Vaccine booster dose. She still needs to get her booster dose but was currently being treated for cancer. They spoke to her husband's doctor and they suggested he take acidophilus, which he has been taking along with Imodium DM, which was not helping the symptoms. He has one more dose and he may not take it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Allegra for allergy. Vaccination history included: Bnt162b2 (1st dose and experienced "a little bit of a swollen arm but it was no big deal"), administration date: 18Feb2021, for Covid-19 immunization, reaction(s): "swollen arm". The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headaches".  Additional information: It was stated that the patient received her first dose of the Pfizer COVID-19 vaccine on 18Feb2021 and experienced "a little bit of a swollen arm but it was no big deal" and she received her second dose of the Pfizer COVID-19 vaccine on 11Mar2021. She had been experiencing headaches and she was not sure if they were side effects from the vaccine or if they were due to her not taking her allergy medication (Allegra). She stopped taking her Allegra a few days before receiving the second dose of the vaccine because she did not want anything to interfere with the efficacy of the vaccine. The caller wants to know if we have any information on whether or not she can take her headache medication, butalbital-acetaminophen-caffeine or ibuprofen to help with her headache and whether it would interfere with the Pfizer COVID-19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Heart inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CARDITIS (medically significant), outcome "unknown", described as "Heart inflammation". The patient's wife called on behalf of the patient to see if Pfizer was offering any reimbursement to cover hospital expenses due to adverse reactions from the Pfizer-BioNTech COVID-19 Vaccine. During the call caller stated that her husband had the Pfizer vaccinations both of them and he had heart inflammation.    Additional Information: Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Palpitations - sinus tachycardia sustained 100-130 x 12 hours
Fever 101-102F, chills, bodyaches, headache, fatigue, lasting 4-5 days. Day 3 - Left arm swelling/rash 3 inches below injection site.
Shortness of breath; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, Expire Date: Apr2021), via an unspecified route of administration on 15Jan2021 09:00 at single dose, right arm for covid-19 immunization. Indication reported as "Hopes she wouldn't get COVID", Stated that was why she got the Measles vaccination. The patient's medical history and concomitant medications reported as none. The patient previously got flu shot for immunization in Oct2020. The patient experienced shortness of breath on 17Jan2021. Caller told the woman administering it that she had been short of breath and was advised it was alright to receive the COVID-19 Vaccine. The patient had been really short of breath ever since. She wasn't very short of breath before the COVID-19 Vaccine. She was more so short of breath after the COVID-19 Vaccine. Shortness of Breath was noticed increase on 17Jan2021 at night. She was fine during the day, but could not lie down to go to sleep in bed. Sat up all night. Then it just came and went. Sometimes thought it was gone, but shortness of breath came back. The patient called doctor and was advised to go into an urgent care. She was going at time of the report. Relevant tests reported as none, regular check up at doctor. She wanted to know if she could get the second COVID-19 vaccine on 06Feb2021. The outcome of the event was unknown.
Not feeling well; Arm started to hurt/arm tender to the touch; Site a little bit raised; Arm started getting itchy; Arm still hot, it was hot to touch; Rash on the injection site; A spontaneous report was received from a consumer concerning a 70-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm started to hurt, arm tender to the touch (vaccination site pain), site a little bit raised (vaccination site swelling), arm started getting itchy (vaccination site pruritus), arm still hot (vaccination site warmth), rash on injection site (vaccination site rash) and not feeling well (malaise).  The patient's medical history was not provided. Concomitant medications were omeprazole, levothyroxine, lovastatin, carvedilol and aspirin.  On 9 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection.  Patient received the vaccine on 09 Feb 2021 and her arm started to hurt was a little bit raised and tender to the touch. Later that night it started to get itchy. Patient stated arm was hot and tender.  Treatment information mentioned says took Tylenol PM and Benadryl. Lab tests not provided.  Action taken with response to mRNA-1273 was not reported.  The outcome of the events, arm started to hurt, arm tender to the touch, site a little bit raised, arm started getting itchy, arm still hot, rash on injection site and not feeling well was considered unknown.
Small sporadic red spots over abdomen. Some are under axillary with clear fluid. Itching but no fever.
There are no adverse events. The wrong vaccine was given. I gave the Pfizer pediatric undiluted dose 0.3ml was given.
On 28 Jul 05, at approximately 1500, pt received the JEV (Lot # ENJ214A) in the Left Mid 1/3 upper arm. Pt was monitored for 30 min after the injection. She reports today that "on the following Wednesday night (3 Aug.05) she experienced moderate chills, fever, abdominal aching pains, mild constant all over headache. The following morning Fever was 99.0. Body ache continued thru today at present. She medicated herself with 100mg of Imitrex. Medicine did not affect her condition.
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 33-year-old, adult, female patient. The patient had no relevant medical history. The patient was not taking any medication at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019] (explicitly coded as extra dose administration). At the time of this report, no adverse events were reported. This case: 201804688 was cross-linked to the source case: 201804657 reported by the same reporter.
22 year old female with reaction to smallpox including rash,non virulent pustulosis,  10 days after vaccination.
Inappropriate schedule of vaccine; Sore Arm; Tiredness; Headache; Chills; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of chills (1st dose received on 14th January 2021 and experienced chills, headache, tiredness and sore arm, refer linked case US2022088490).   On 2nd June 2022, the patient received the 2nd dose of Shingrix. On 2nd June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In June 2022, the patient experienced pain in arm, tiredness, headache and chills. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, tiredness, headache and chills were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm, tiredness, headache and chills to be related to Shingrix.     Linked case(s) involving the same patient:  US2022088490   Additional Information: GSK Receipt Date: 03-Jun-2022 Reporter's Comments: The patient stated that with both doses she had experienced chills, headache, tiredness, and a sore arm.  Adverse events filed.  Gave medical disclaimer.  The reporter consented to follow up. Additional Supportive: The patient received her second dose later than the recommended standard interval, which led to lengthening of the vaccination schedule.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022088490:same report
Nausea, vomiting, and diarrhea-occurring for one week after vaccination. Redness and swelling of upper left arm around injection site-occurring for 10 days after vaccination. Soreness and pain in upper left arm near injection site-intense for 14 days and still occurring intermittently.
No adverse reaction.   Reporting an early vaccine administration error only 4 months after 2nd Moderna in the series
The COVID-19 vaccine administered through vaccine administrator, Health Authority, between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days.  A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
Shortness of breath and pain in left abdomen. CT scan on 3/27/21 showed the following: Bilateral segmental pulmonary emboli. Findings were communicated to P.A., by telephone by Dr. on 3/27/2021 at 1:40 PM. At the request of the ordering provider, the patient was instructed to go to the emergency department for further evaluation and treatment.  I, (name) MD, have reviewed the images and verify the above interpretation on 3/27/2021 2:12 PM.  Electronically signed by (name) , MD on 3/27/2021 2:12 PM  My treatment was to get on Eliquis, a blood thinner.
pt says she started having constant pain from her left leg from the knee to her hip along with muscle spasms that she has had for the past 3 days.  She is taking ibuprofen and muscle rub.  Pt will contact a doctor if her symptoms get worse.
3 days after injection developed headache x 4 d. followed by erythematous rash of upper body x 2 after headache.
This mishap was my fault because, I was not clear on the JJ part.  After I gave the okay, I did check with the clinical staff and was told it had to be both series of JJ.  I misread the Algorithm for the additional booster.  Going for I will be sure the check first with clinical team if I am unsure.  Received 1st dose of JJ vaccine May10 /21 and a Pfizer booster on July 6 21 at a pharmacy. Patient states she's here for additional booster as recommended. Discussed with Nurse Evaluator and DOH supervisor on site. Clearance given for patient to receive additional booster.
she felt like she was dying, it was a strange feeling, like out of body feeling, she knew she was feeling sick; fall; bladder issue; sinuses; body aches; she was miserable; this was painful than the other shots she has taken; Chills; she was worn out/She was tired; nausea; Malaise/feeling sick; her "armpit" hurting; muscle and joint pain; muscle and joint pain; headache; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCIN) lot number: EL3247, via an unspecified route of administration, administered in left arm on 10Feb2021 as single dose for COVID-19 immunisation. Medical history included multiple sclerosis, Chronic obstructive pulmonary disease (COPD), overactive bladder, osteoporosis, sinus headache, allergies also bother her, back issues, and broken femurs from 2019. Concomitant medications were not reported. The patient received her first dose of the Pfizer COVID vaccine on 10Feb2021 and is due for the second dose tomorrow. The patient stated that she has really heavy reaction from the first dose, she felt like she was dying, fall, bladder issue, had headache, nausea, sinuses, body aches, muscle and joint pain, she was miserable, her "armpit" hurting, this was painful than the other shots she has taken. The patient wanted to know if its ok to take her nebulizer and other pain medications she is taking generic for Norco. The patient clarified that she had headaches, feelings with her muscles and joint, nausea, and then there was the big symptoms that hit her, she felt like she was dying, it was a strange feeling, like out of body feeling, she knew she was feeling sick. She herself didn't know what was wrong and so she couldn't go to the ER, she doesn't know what this is, it lasted 24 or more hours. The patient stated that it was the malaise, she's never had malaise before, it scared her. She is getting the second dose tomorrow and she is scared to death. The headache, muscle and joint pain and armpit hurting started 10Feb2021 while nausea and malaise/feeling sick started on 11Feb2021. The patient recovered from the event armpit hurting and malaise/feeling sick on an unspecified date. The outcome of the event headache, muscle and joint pain, was not recovered. The outcome of other events was unknown.
Pt came in today with symptoms of stands/sits bend neck feels tingling down back and ten has gradually gone down his thigh area and towards right shoulder pair tender to touch with charlie horses.
A few days after receiving 4th Moderna shot I started to get cold symptoms and larangitis. On April 29th I went to prompt care doctor because I wanted to determine whether I had Covid or just a bad cold. Test determined I had just a cold. Cold persisted for almost 2 weeks and is finally abating although it has left me very week.
body rash; slight throat swelling; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received (BNT162B2, formulation: Solution for injection, Lot Number: EW0151), via an unspecified route of administration, administered in Arm Right on 12Apr2021 16:45 (age at vaccination 26-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included Known allergies to crawfish, hay fever, Allergy pollen all from an unknown date and unknown if ongoing. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19 Prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included cefalexin (CEPHALEXINE), Vitamin D Complex taken for an unspecified indication, start and stop date were not reported. the patient received multivitamin within 2 weeks of vaccination. It was reported that the patient was not a pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced diarrhoea on 13Apr2021, body rash on an unspecified date, slight throat swelling on 14Apr2021. The patient did not receive treatment for the events. The clinical outcome of the event Diarrhea was recovering and for slight throat swellingit was recovered in Apr2021, for body rash recovered in 2021.  No follow-up attempts are needed. No further information is expected.