chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications was reported Cartons of vial was stored in from the freezer on 01Sep2021.   This case was linked to MOD-2021-352843 (Patient Link).
Information has been received from the parent of a 28 year old female with history of kidney transplant two years ago was administered with Immunoglobulin and Rabies vaccine after a minor exposure (no bites, just licking) to a pet dog. The dog died suddenly without a definite diagnosis (rabies was not strongly considered by the Vet, he was inclined to think it was Distemper). But since a tissue diagnosis was not done, patient underwent the Immunoglobulin and vaccination necessary. Approximately 3 weeks later, her creatinine rose to 3mg from rejection and 4 months after the anti-rabies shots. Patient is in renal failure and will be starting dialysis next week. Follow up #1 correspondence received on 10/23/02 from the pt's nephrologist. He reported that the pt was showing signs of kidney rejection prior to receiving rabies series. He didn't think the pt's kidney rejection was an adverse event, although the temporal and causal relationship was strong. The pt's exposure to possible rabies occurred in an Asian country. He also stated that the pt completed the entire rabies series but she never developed any detectable antibodies. This case is closed. This case is considered other important medical event.
I became very ill after the second vaccine. Had flu-like symptoms for about 10 days. During that time an existing cyst on my thyroid filled and protruded on my neck. Usually I have the cyst drained and it takes a few years to fill back up. Ive had it drained a handful of times in the last 20 years. This time I had it drained in March and it immediately filled back up. I had to have a lobectomy on 5/4.
Full body turned pink and itchy for 2 days, got fever blisters on mouth after 4 days. no medication. no md visits.
Pain with arm swollen below injection site 10 by 15 cm. Also complained of chest pain: NL EKG; NL enzymes.
Vomit  Diarrhea  Fever Muscle aches  Fatigue Shivering  Headache Dizziness
Swelling of lt arm from shoulder to elbow approx double in size from normal; Md dx cellulitis antibiotics started 4MAR91;
SWEATS; CHILLS FOR TWO WEEKS; FEVER; This spontaneous report received from a patient via a company representative concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient reported that she might had a very mild case of COVID19 last year and reacted to the shot. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sweats, chills for two weeks, and fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from sweats, chills for two weeks, and fever. This report was non-serious.
9/24/15: flu shot administered in the morning.  Stabbing, shooting extreme pain felt deep within my shoulder immediately at time of injection that traveled down my arm into my fingertips which tingled.  My fiance was in the office with me and he saw my reaction to this injection.  I have had flu shots before and while they are not pleasant I have never felt this type of pain with any past injection before. The arm pain continued to get worse.  I used heat thinking it was some sort of muscle soreness and I gave it some time to be sure it wasn't just the soreness associated with the injection site but this was deep within the shoulder, not like past injections where the injection site would be sore. 10/4/15: Notified my Doctor.  Advised to ice the area off and on and to let my Doctor know how it feels after 2 weeks. After the 2 weeks no improvement called my Doctor back.  Advised to do another round of ice for another 2 weeks.  Still no improvement advised to come into the office. 11/2/15: appt with Dr.  She checked it out and prescribed Diclofenac Sod Dr 75mg Tab.  Took as prescribed.  Some improvement while on this medication but soon after I had completed taking all medication the pain came back.  Notified Dr of this. 11/23/16: another round of Diclofenac Sod Dr 75mg Tab.  Same as before- some improvement while taking medication but soon after completing pain came back.  Notified Doctor of this-referred to Shoulder Specialist. 1/4/16: appt with shoulder specialist.  X Rays were taken and cortisone shot adminstered.  Immediate relief from the shot for 2 weeks.  On the 3rd week the pain came back. 1/25/16: follow up visit with shoulder specialist.  At the time of the follow up appt, pain was back.  I am getting married on 2/17/16 so at the time of this appt shoulder specialist said he did not want me to do anything until after the ceremony.  Prescribed Methylprednisolone 4mg DosePak to take if needed at time of wedding ceremony.  Shoulder specialist wants to see me soon after marriage and has mentioned Physical Therapy for future treatment.  Right now TBD.
ID vaccine did not create wheal.  Most likely administration into subcutaneous space.  Pt revaccinated ID successfully Pt stable and released from the vaccination site
VAQTA that had undergone temperature excursion was administered to a patient; no additional AE reported; This spontaneous report was received from a healthcare worker concerning a currently 11 year old male patient. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On an unspecified date, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) lot number reported as U026782 with expiration date 28-OCT-2022 (strength, dose, frequency and route of administration were not reported). Lot number U026782  is an invalid lot number for hepatitis a vaccine, inactivated(VAQTA) and it did not match any company product as confirmed by Lot verification team.   The temperature excursion was reported as 49.6F during a time frame of 32 minutes. There was no previous temperature excursion. No additional adverse event was reported.
CONFIRMED COVID-19 POSITIVE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18022068, and expiry: unknown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-MAR-2021, the subject experienced confirmed covid-19 positive. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 positive was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Very painful injection! I felt this going in immediately. Probably 30 minutes after I also felt a little dizzy but I also have a chronic condition called vestibular migraine. I was fatigued later in the evening. Had full day on day after vax  because I already had things on my calendar but was dragging by the time I got home. Aches all over especially joints, head and injection site was warm to touch and somewhat swollen. Also started running fever one day after. Highest temp 101.9 . I also started having diarrhea, full on three days after. My taste and smell had been off since having covid in august, but I swear they are since taking vax. Today is Tuesday so I'm now five days in and temps normal today. My body aches are also improved but my head is still a bit achy.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with a complete heard block. Vaccination took place on 10/1/2008. According to the physician, relationship to treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon request.  12/31/08 Reviewed study SAE report. Hospitalized 10/8-10/11/2008. FINAL DX: complete heart block Records reveal patient experienced dizziness, diaphoresis, weakness & pain in left arm.  Intensive care.  Pacemaker inserted.
Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 14-SEP-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) PROQUAD (rHA, lot # R002931, expiration date 29-JUL-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# M039639, expiration date 28-MAY-2019). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Have had some bad headaches since just before 2nd dose. A rash appeared on deck down to shoulders a week or so after first dose. Rash starts under ears on both sides of necks and then sporadic at shoulders and chest. Mainly itchy on neck area and have used cortisone.  Just annoying but not serious enough to warrant dr visit.
Chills started approx. 7 1/2-8 hours after the vaccine. A few hours later, I had a fever of 100.5 and an elevated resting heart rate (100-105 bpm while normal is 68-70 bpm). I then developed a massive headache in my entire head/face. I waited until 24 hours after the vaccine to take 2 Tylenol. I showed much improvement 2 hours after that. I took 2 more Tylenol about 6 hours later and went to bed. I slept well and woke up completely fine the next day.
vaccine was inadvertently administered to a patient who was under the recommended age with no reported adverse event; Initial information received on 05-Nov-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old patient (unknown gender) whom INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] was inadvertently administered under the recommended age (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient had no other concomitant vaccines.  On an unknown date, the patient received a dose of suspect FLUBLOK QIV (once, total, 0.5 ml, lot QFAA2152 and expiration date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to Inappropriate age at vaccine administration.  No adverse event reported.  It was reported "Pharmacist reporting that FLUBLOK vaccine was inadvertently administered to a patient who was under the recommended age, she is concerned about possible side effects and also re- administration."  At time of reporting, the outcome was unknown for the 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 the 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.
pt recv vax & devel full blown chickenpox w/300-350 skin lesions;
10/24/17 8pm: injection site was puffed up, red, and hot. RPh counseled pt to wait couple days, and it may be self-limiting. 10/26/17, affected area got larger and symptoms was worse, pt went to urgent care and got prescribed KEFLEX.
In the middle of the night, I started coughing with a dry cough. The next morning, I was still coughing and had a low grade fever. My son had COVID-19 as well. I took an at home COVID-19 test that was positive. I have had headaches, coughing, low grade fever, congestion, and sore throat. I did an online health virtual visit and was prescribed molnupiravir. I still feel bad and I don't know at this moment if the medication is working since I took the first dose on Monday.
just a sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-JUN-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient received the dose of Shingles vaccine two weeks ago before the day of reporting and patient experienced just a sore arm, not a big deal.  The patient reported that as far as side affects, patient thought it depends on your body. Additional supportive information: The follow-up would not possible as no contact details were available.
woken up by a severe pain in my heart area. Bad Headache shortly after receiving the shot. My Left eye won't stop twitching. Rash on upper chest, nausea, upper chest/lungs area feel like they have a slight burning feeling. Chills, Fever. muscle pain my body feels like a truck hit it.
3/17/21 9:45 chills followed by high fever 102.0 took 750mg of Tylenol and about 2:00 am fever subsided.  3/18/21 severe muscle and body aches and severe headache. took Ibuprofen.
Site: Itching at Injection Site-Mild, Additional Details: pt had s few rash and was itchy on both arms
a red, sometimes hot, sometimes itchy, slightly raised rash began on my left breast and continued to spread down my entire abdomen, right breast, and left leg (quickly); a red, sometimes hot, sometimes itchy, slightly raised rash began on my left breast and continued to spread down my entire abdomen, right breast, and left leg (quickly); a red, sometimes hot, sometimes itchy, slightly raised rash began on my left breast and continued to spread down my entire abdomen, right breast, and left leg (quickly); hives; sometimes itchy; This is a spontaneous report from a contactable consumer. This 31-year-old non-pregnant female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0172, Expiry date: unknown), via an unspecified route of administration, administered in Arm Right on 24Apr2021 12:15 (at the age of 31 years old) as dose 2, single for covid-19 immunization. Medical history included anxiety and Known allergies to Penicillin, sulfa and patient also had covid-19 (Prior to vaccination, the patient was diagnosed with COVID-19). Concomitant medication(s) included escitalopram oxalate (LEXAPRO, 20 mg, 1x/day) and gabapentin (100 mg, 1x/day). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8734, Expiry date: unknown), via an unspecified route of administration, administered in Arm Right on 03Apr2021 12:15 (at the age of 31 years old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Lexapro 20mg/day and gabapentin 100mg/day within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient experienced a red, sometimes hot, sometimes itchy, slightly raised rash began on my left breast and continued to spread down my entire abdomen, right breast, and left leg, hives on 27Apr2021 recovering. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures (Prednisone, 40mg/day, xyzal 5mg/day) were taken as a result of the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
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 female patient received bnt162b2 (BNT162B2), administration date 25Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (dose 1, single), administration date: 05Jan2021, for covid-19 immunization, reaction(s): "lethargy", "fatigue".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts were possible; information about lot/batch number could not be obtained. No further information was expected.   Additional information: Vaccinator was "cold and not friendly" with her 2nd dose and caller stated that she was worried that she did not vaccinate her." Caller placed husband, MD HCP , on the phone to received HCP information.  Follow up activities closed: No Follow Up attempts were possible; Information about batch no/ lot no. could not be obtained.
First night (Day 1): severe chills, headache, arm & shoulder pain, nausea  (Day 2) First day after vaccine (took one Advil the night before): extreme fatigue, arm pain, mild headache  Days 3-5: headache, fatigue, heartburn, mild stomach pain   Days 5-7: severe abdominal pain, headache, gas & bloating,  mild diarrhoea, nausea  Day 7-9 (current): headache (very mild but continuous non-stop / does not feel like a common headache), mild drowsiness (feel like I am a little dizzy BUT WITHOUT actually being dizzy or feeling like I will loose my balance or anything similar), mild chills (after having some cold cereal for instance)
Skin on my back peeled, flaky, and itchy. Went to my physical 9/20/2021 at my doctor and looked like eczema and they gave me eczema cream. There is still big patches codeine.
Pt. states that she received the vaccine a little over an hour ago and is experiencing a "tingling like sensation" at the site and down her arm, and in her cheek. She states it is subsiding since calling, but wanted to document the s/sx.
Case number PHEH2013US012757 is an initial spontaneous report from pharmacist received on 17 OCT 2013 with a follow up received on 17 DEC 2013. This case refers to an 82 year old female patient. Her vaccination history included administration of flu vaccines in the past that were tolerated well. She received FLUVIRIN 2013/2014 (batch number: 1309401, Expiry date: APR 2014) at 0.5 ml intramuscularly into right deltoid on 16 OCT 2013. The pharmacist stated that she received FLUVIRIN that had been pre-drawn from multidose vial, held out for approximately 15 minutes and then administered. The seriousness and causality of event was not reported. No adverse was reported due to medication error.  Follow-up was received on 17 DEC 2013: Updated vaccination history of the patient and site of administration of FLUVIRIN.
more than 42 days for administration of second dose; I felt so sick; Difficulty breathing; heart palpitations; Lethargic; Blood pressure seemed elevated; Felt somewhat better but didn't feel good; Sinus infection; Asthma; Funny feeling/felt very poorly; Tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I felt so sick), DYSPNOEA (Difficulty breathing), PALPITATIONS (heart palpitations), LETHARGY (Lethargic) and HYPERTENSION (Blood pressure seemed elevated) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Asthma.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ILLNESS (I felt so sick), DYSPNOEA (Difficulty breathing), PALPITATIONS (heart palpitations), LETHARGY (Lethargic), HYPERTENSION (Blood pressure seemed elevated), MALAISE (Felt somewhat better but didn't feel good), SINUSITIS (Sinus infection), ASTHMA (Asthma), FEELING ABNORMAL (Funny feeling/felt very poorly), FATIGUE (Tired) and PYREXIA (Fever). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose). At the time of the report, ILLNESS (I felt so sick), DYSPNOEA (Difficulty breathing), PALPITATIONS (heart palpitations), LETHARGY (Lethargic), HYPERTENSION (Blood pressure seemed elevated), MALAISE (Felt somewhat better but didn't feel good), SINUSITIS (Sinus infection), ASTHMA (Asthma), FEELING ABNORMAL (Funny feeling/felt very poorly), FATIGUE (Tired) and PYREXIA (Fever) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Negative. On an unknown date, Blood pressure measurement: elevated Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included Allergy Pill. Treatment medication included for sinus infection, Asthma and high blood pressure. After a lung x-ray, doctors said that asthma was not a problem. The patient felt so sick. Patient was experienced fever, difficulty breathing, what it seemed like heart palpitations (patient had a funny feeling). Patient felt tired, lethargic and blood pressure seemed elevated. Patient went back a month later to get second shot and he still felt very poorly. He didn't get it back then (and he still hasn't gotten it). Patient went back two months later and he felt somewhat better but didn't feel good. Patient said that it wasn't until April or May that he started to feel better but he has never felt as good as prior to the vaccine.