chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccinated with an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA82AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 7th April 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 7-APR-2022 Reporter's Comment: The patient received an expired dose of Bexsero. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Bexsero which was already expired on 31st January 2022, which led to expired vaccine used.
Patient was given vaccine that had been diluted the previous evening, so vaccine was past the recommended 6 hour dilution time period.
Received a rotarix vaccine that was 2 days expired on 18-July-2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number unknown, expiry date 16th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 18th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 18th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-Jul-2022 Reporter's comment: Nurse reported that the patient received Rotarix vaccine that was 2 days expired on 18th July 2022.  The consented to follow up was given. Additional supportive information: The patient received Rotarix vaccine that was 2 days expired on 18th July 2022, which led to expired vaccine used.
Symptoms similar to head cold: fatigue, headache, runny nose, sneezing starting 48 hours after vaccination
Approx 30 min after receipt of vaccine, pt reported throat itching. Denied SOB, swelling, or generalized pruritis. No WOB, no facial/lip/tongue swelling, no hives. Throat itching remained persistent x 1h during prolonged monitoring, no change, no new sx. No therapeutics administered. Pt then sent to urgent department for immediate f/u, counseled on s/sx anaphylaxis
Allergic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a adult 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 allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, after vaccination, the patient had allergic reactions. No further details were provided. The reporter consented to follow up.
I felt really tired, and I had a fever, it started about 04:00pm. I tried to massage and exercise my arm (on injection site). Those lasted for two days. No treatment. I noticed that my right foot has been swelling up a lot ever since the vaccine or maybe since having COVID. I had COVID in December 2020. I recently went to the doctor (Sept 2) for the foot swelling and really bad back pain. I was diagnosed with kidney issues which I didn't have before. October, another doctor visit is coming up to determine treatment. Ongoing symptoms still for foot swelling and back pain is ongoing at this time until I get treatment.
Patient started with fussiness and a fever at home, rash began roughly 36 hours after dose given. Started flat and red then quickly progressed to vesicular and fluid filled, covering legs, groin, arms, some to trunk/neck, mom noted some in mouth. Patient seen in office on Friday (roughly 72 hours after immunization). PO intake improving, no more fevers, rash still present with primarily vesicles present, some starting to scab.
Initial report received from parent of a patient on 13 May an 18 year old, male patient (with a medical history of hayfever and lactose intolerance) developed low grade fever, body aches, fatigue after he received MENACTRA (lot number U2234AA, route and site of administration not provided), Tetanus vaccine and TB Test (manufacturer, lot number, route and site of administration not provided) on 13 November 2007. He was seen at the Medical Center ER X 2 and given antibiotics (CIPRO, AUGMENTIN, AVALOX) with no response. His CAT Scan showed swollen nasal passages. He did not have any illness at the time of vaccination. At the time of the report, he had not recovered.
soreness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and FATIGUE (fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-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 (soreness) and FATIGUE (fatigue). At the time of the report, PAIN (soreness) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
an hour later it started to itch her eyes, nose, her legs, feet, back, between her legs, a hell of a rash; an hour later it started to itch her eyes, nose, her legs, feet, back, between her legs, a hell of a rash; her eyes are really red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (an hour later it started to itch her eyes, nose, her legs, feet, back, between her legs, a hell of a rash), RASH PRURITIC (an hour later it started to itch her eyes, nose, her legs, feet, back, between her legs, a hell of a rash) and OCULAR HYPERAEMIA (her eyes are really red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE), LEVOTHYROXINE SODIUM (SYNTHROID) and FISH OIL (OMEGA 3 [FISH OIL]) for an unknown indication.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021 at 2:30 PM, the patient experienced PRURITUS (an hour later it started to itch her eyes, nose, her legs, feet, back, between her legs, a hell of a rash), RASH PRURITIC (an hour later it started to itch her eyes, nose, her legs, feet, back, between her legs, a hell of a rash) and OCULAR HYPERAEMIA (her eyes are really red). The patient was treated with PARACETAMOL (TYLENOL) in June 2021 at an unspecified dose and frequency. At the time of the report, PRURITUS (an hour later it started to itch her eyes, nose, her legs, feet, back, between her legs, a hell of a rash), RASH PRURITIC (an hour later it started to itch her eyes, nose, her legs, feet, back, between her legs, a hell of a rash) and OCULAR HYPERAEMIA (her eyes are really red) outcome was unknown.            Concomitant medication also included an unspecified anxiety medication. Action taken with mRNA-1273 in response to the events were not applicable.
This is a spontaneous report from a non-clinical study program, from a contactable consumer who reported for herself. An 82-year-old female patient received on 20Jan2015 at 11 am first dose of PREVNAR 13 at 0.5 ml single dose intramuscular in left arm. Vaccination was performed by a pharmacist at pharmacy. No other vaccine was administered on the same date. Relevant medical history included ongoing compromised immune system due to hepatitis C since about 15 years and ongoing nosebleeds. Concomitant medication included Vitamin D, Milk Thistle for hepatitis C, Omega 3/Vitamin E, Kelp, COQ 30, aspirin, Vitamin E. Previously, about 6 years before this report (1999), the patient received an unspecified pneumonia vaccination. On 20Jan2015, the patient felt fine. On 21Jan2015, the patient woke up with chest congestion, pain in all her joints and her hips, knees, fingers, and back of neck hurt. On an unspecified date, she was too weak to walk or do everyday tasks. There was never any head congestion, she received lung decongestants as treatment. She did not think she had the flu because she was not running a fever and had not any upper respiratory disorder. According to the reporter, a physician advised her not to do influenza vaccine because of her compromised immune system due to having Hepatitis C. On 23Jan2015 the patient had 2 nosebleeds, but since she has gotten nosebleeds before, she did not think that nosebleeds were related to PREVNAR 13. The next day (date unspecified) the patient was hospitalized for the events pain in all her joints and hips, knees, fingers, and back of neck hurt/hands, fingers the most. The outcome for all events was recovered. Follow-up (23Apr2015): New information obtained from a contactable consumer includes: new event (too weak to walk or do everyday tasks), additional concomitant drugs, hospitalization, treatment, outcome.
Administer expired vaccine to 450 patients after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Health care professional (HCP) administered expired vaccine to 450 patients, after the manufacture date of expiration. Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 102 doses. Dates of administration of vaccine were reported as 25-Oct-2021. The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live non significant follow-up appended contains: Reporter details added.
Around 12:20pm, patient came to the pharmacy to pick up a script for a family member and said he wanted a flu shot which is required for his place of employment. When he filled out the consent form, he did indicate he has history of fainting after receiving a vaccine. We counseled him that if he wants to continue with the vaccine, he can but will need to sit for a couple mins with us in case something similar happens. He felt anxious the whole time and was vocal about being scared of receiving vaccines and scared of needles in general. He received the vaccine, remained sitting and then after 2 mins he seemed to black out and passed out onto the floor. He fell and did hurt his jaw but was awake and communicated the whole time. We called 911 and they arrived and did some checks and said he was okay. After about a half and hour he said he was okay, his BP was normal and left. Was not upset and the paramedics said he was cleared to leave on his own.
Patient received 3rd Pfizer dose on 5/25/2022 at 7w5d gestation. She presented to the emergency department on 6/3/2022 for vaginal bleeding. She began having cramping on 5/31, then had mild spotting on 6/1, which progressed to more significant bleeding on 6/2, and heavy bleeding with clots on 6/3. She believes she may have passed fetal tissue on 6/3, which brought her to the ED.   She is a G2P0020. She had a terminated abortion for her first pregnancy. This was her second pregnancy.
Broke out in hives at injection site then spread to rest of body, rash started at 1100 next day, resolving about 24h after onset oral Benadryl and topical cortisone, no breathing problems.
PT. REPORTED HIVES ALL OVER BODY (EXCEPT FACE AND TORSO)THAT STARTED OFF WITH AN ITCH AROUND 6:30PM AND SPREAD QUICKLY. SHE WENT TO THE ER AT ABOUT 5AM WHEN THE HIVES BECAME UNBEARABLE AND WAS GIVEN BENADRYL AND PREDNISONE, SHE WAS DISCHARGED AT 6:30A.
Injection site pain, weakness, shortness of breath, muscle aches, joint pain, dizziness, abdominal cramps, headache, chills, night sweats, diarrhea. Still experiencing dizziness, weakness, and abdominal cramps 5 days out, also intermittent diarrhea.
PT IS ONLY 18. SHOULD HAVE RECEIVED PEDIATRIC DOSE. NO ADVERSE EVENTS REPORTED BY PATIENT.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 05-DEC-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # K004204, expiry date 12-JAN-2017) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This case was reported by a lawyer and described the occurrence of GUILLAIN BARRE syndrome in a 73-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. There were no concurrent medications. On 27 October 2010 the subject received a dose of FLULAVAL in the left deltoid. Within several days of vaccination with FLULAVAL, the subject developed GUILLAIN BARRE syndrome. The subject was hospitalized for three months and in rehabilitation for an additional three months. As a result, the subject developed lung problems, bed sores and suffered from pneumonia several times. At the time of reporting, GUILLAIN BARRE syndrome was improved and the outcome of the other events was unspecified.
Broke out in chickenpox lesions 05/26/2005.  Varicella, either Zoster or Varicella.
Child received Flu mist at 11:30, waited in observation 10 minutes with out incident, 11:45 child walked back into immunization area reporting he felt nauseated, his stomach hurt, his head hurt and that he was very dizzy.  Child was pale and obviously distressed.  No difficulty breathing, but unable to sit in chair, child place prone on floor, no LOC, 100/50, p. 110, r. 28.  Child reports he had a vinegar taste in his mouth after receiving the flu mist, child reported persistent dizziness, "not feeling worse, but not good".  100/48, 120, r 28 pale, face flushed, skin warm, dry, pulse irregular.  Apple juice given, child reported, still feeling poorly and dizzy with headache. 911 called, EMS arrived 12:05. Child able to walk short distance to stretcher, transported to Hospital.  Child was monitored X 2 hr., ER reports child was discharged to home, no meds, no treatments necessary in ER.
Pasting clinicians note below: Patient is 61 year old female with hx of anaphylaxis presenting for Covid-19 vaccine, Dose #1.  She developed itching in there throat within 30 minute waiting period.    She was taken to Rapid Response Room.   Symptoms progressed from itchy throat, to congestion in throat/upper chest, clearing her throat, watery eyes.  Then dry cough.    No nausea, no vomiting, no light headed feeling.  No facial swelling  No hives.    OBJECTIVE: Vitals -  154/97, 105, 100%RA Neck -  Supraclavicular mild retractions, end inspiratory stridor CV: tachy, regular, no murmur pulm - diminished breathe sounds throughout, no wheezing.  Speaking full sentences.    Assessment/ Plan:   Anaphylaxis to Covid-19 Vaccine: -  emergency responders - epi 0.3 mg IM administered to L mid outer thigh at 9:35 am by me - epi 0.3 mg IM administered to R mid outer thigh at 9:41 am because symptoms not subsiding by me -benadryl 50 mg IM x 1 L deltoid by RN 9:45 am - Itching in throat subsided but still retracting and clearing throat so albuterol 3 puffs given at 9:50 am   Vitals stable entire time (see midas report)   EMS arrived to transport to local hospital.
Patient developed "bumps" that itched on her hand. These continued to increase in numbers and developed over her whole body. They itch and some are pus-like filled, others are hard/solid she has been taking BENADRYL as she suspected an allergic reaction.
mom called 2-3 day later, reporting redness & swelling less than fifty cents peice, was told to watch for any more adverse effects; 15JAN93 came in for appt; mom mentioned leg had been bruised & a knot was in thigh where shot was given;
Case PHEH2016US025475 is an initial spontaneous report received from pharmacist on 30 Sep 2016. This report refers to female patient of unknown age, Medical history included bovine allergy. The patient was vaccinated with single dose of FLUVIRIN (batch number and expiry date not reported) at a dose of 0.5 ml intramuscular on an unknown date. On an unspecified date, patient experienced rosacea, skin warmness, sweating and oily hair. The outcome of events was unknown. The seriousness of the event sweating was reported as non serious and for other events seriousness was not reported. The causality of the events was not reported.
Rcvd H1N1 vaccination @ school clinic on 1/12/10, 1/13/10 felt tired and began small, open sores around injection site and spreading to neck and face.
As soon as I received vaccine, I had metal taste - and I was feeling my throat closed. Difficult to breathe and dizziness. They had me lay down and they gave me something to drink. When I went home, very dizzy with a lot of headaches and I laid down and slept most of the day. I was feeling kind of different after vaccine. I had brain fog. I was trying to do something and I lose the train of thought - and I start doing something else. I had to see a doctor because that bothered me the most. They sent me to a specialist. For the moment, I can hardly exercise or walk because I get tired. I get tired and body aches. I have a lot of fatigue. They recommend that I take a little less time to work - I know work four days a week instead of 5. My body aches get worse and I have more pain. They sent me to a Rheumatology Dr. - they sent me to Fibromyalgia specialist. Sometimes I feel better, and sometimes I can hardly move my arms. I was okay before the vaccine. Now it is so hard for me to finish one thing - even to clean the house. Now with my brain, I am thinking of something but then I do something else. I have to go back and look again at what I wanted to do first. Pain and brain fog and fatigue are hard for me now. I wake up and I can hardly get out of bed because it's very hard for me.  I am in a program -for exercising - 6 session - three so far for that. And a night - they gave me a relaxation program to relax. They told me to do heat and cold treatment.
Approximately a week or 2 weeks later I notice a rash on the left breast, on the middle and on the left side. It was extremely sore, and it felt like shingles. I thought it was shingles. I went to see Doctor because it was so painful. They didn't know what it was. They sent me to a dermatologist. By the time I can get in 3 weeks later it was almost all cleared up. No testing was done because it was all clearing up. I had a heart attack in August. I also have shortness of breath since February 2020 due to getting COVID.
Short headache on 2/18 (30 min) took no treatment; spontaneously ended; Sore throat on 2/19 (morning only) drank hot tea and disappeared within a few hours
Received TDaP vaccine around 2:30pm in left arm.  At 5pm patient complained of "nausea, chills", (no rash).  7p-8p chills and achy all over.  12am-12:30am vomited x2, 5:30am vomited again.  9A-9:30A stomach still upset, by 12 noon felt better and ate some canned peaches.  By 5pm - felt much better.  No local redness - just soreness at site per patient.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 29-OCT-2012 14:16, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
rapids fluttering heart beats; fast heart beating; palpitations of my heart; nervous; This is a spontaneous report from a contactable consumer (patient). A 64 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 01Sep2021 (at age of 64 years old, Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rapids fluttering heart beats, fast heart beating, palpitations of heart, nervous on 01Sep2021 after 5 hours received vaccine. No admission to hospital involved. The patient reported after five hours of received the pfizer vaccine she had very fast heart beating, palpitations of her heart for about six hours very fast hard beating and by nervous and finally I was able to fall asleep and then the next day she continue to have fast but not as bad as the day before, but continued rapids fluttering heart beats for most of the day. Now her heart just continues to beat heavier than what it normally was, but it's not as bad and palpitating as it was for the two days. The outcome of the event "fast heart beating" was not recovered. The outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had severe fatigue.  I had shoulder, neck, and arm pain that comes and goes.  These symptoms have been going on since I got the shot.  I have swollen glands on the side that I got my shot.
Swelling, burning, pain and rash at the injection site Delayed hypersensitivity reaction- angioedema of the eyes and nose, redness and rash, nausea and GI distress