chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a 3 years old male patient was administered an expired dose of Ipol; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a non-health care professional (office staff).  This case involves a 36 months old male patient who was administered an expired 0.5ml dose of IPV (VERO) [IPOL] on 06-Aug-2019 (lot N1G511M, expiry date: 02-Aug-2019 via intramuscular route in the left thigh).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccine included Hepatitis B vaccine.   It was an actual medication error due to expired vaccine used.  No adverse event was reported at the time of report.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of document held by sender: none.
Had vaccine 10/8/08 at 1:00 pm. Fever set in at 7 p.m. that evening. Ranged 101-102 deg- Nausea, vomiting, chills, body ache. His PCP told him to take Ibuprofen-(vomitted). Fever down by Saturday. Missed 2 days work. Today feeling okay, but lacks energy.
tennis ball size lump on lt arm-warm to touch, red & hard; no fever or other sx; MD prescribed ATB Duracef;
Increase in headache's; tiredness; heavy head; anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult (as reported, noted discrepancy) female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2022 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: prior vaccination. Concomitant medication(s) included: ZOLOFT; VYVANSE. Vaccination history included: BNT162b2 (Dose Number: 1; Location of injection: Arm Left), administration date: 11Nov2022, for COVID-19 Immunization. The following information was reported: HEADACHE (disability) with onset 09Dec2022, outcome "not recovered", described as "Increase in headache's"; ANXIETY (disability) with onset 09Dec2022, outcome "not recovered"; HEAD DISCOMFORT (disability) with onset 09Dec2022, outcome "not recovered", described as "heavy head"; FATIGUE (disability) with onset 09Dec2022, outcome "not recovered", described as "tiredness". The events "increase in headache's", "tiredness", "heavy head" and "anxiety" required physician office visit. Therapeutic measures were not taken as a result of headache, fatigue, head discomfort, anxiety. Clinical course: The patient was not tested with Covid post vaccination. No known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
she is a heart attack survivor; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 10Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her first vaccine ended up being a Pfizer vaccine. She received her Pfizer vaccine on 10Mar2021 and the next is scheduled 07Apr2021. She was wondering if she should schedule somewhere else to get another vaccine sooner. The patient was a heart attack survivor on an unspecified date. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
ITP, severe (<2k/mm3), requiring hospitalization on 4/5/21, approx 3 weeks after 2nd vaccine dose
On 4/12/21, nearly a week after my first dose of the vaccine, I experienced intense, sharp pains in the left side of my neck. The pain was intermittent throughout the day and didn't seem to be triggered or alleviated by any specific action, It coincided with a slightly enlarged, hard lymph node along my left external jugular vein, about two inches below my ear lobe. The pain persisted (intermittently) lasting no longer than one to three seconds each time, or in some cases pulsing on and off for 30 seconds. In total, I counted roughly a dozen of these episodes between 4/12 and 4/13. The lymph node has since decreased in size and no longer hurts.
Patient received one dose of Pfizer Covid-19 vaccine and then later was diagnosed with Covid-19 before receiving second Pfizer Covid-19 vaccine; Patient received one dose of Pfizer Covid-19 vaccine and then later was diagnosed with Covid-19 before receiving second Pfizer Covid-19 vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Physician) for a Pfizer sponsored program (170972). A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient received one dose of Pfizer Covid-19 vaccine and then later was diagnosed with Covid-19 before receiving second Pfizer Covid-19 vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: then later was diagnosed with covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
A lot of itching all over.  Sore at injection site, but no worse than a Term is shot.
Pfizer Bivalent booster given by mistake. Should have been given the Monovalent as this was the patients first Pfizer dose. Patient had no side effects.
Had permanent nerve pain; This case was reported by a consumer via other manufacturer and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was not recovered/not resolved.   The reporter considered the nerve pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient experienced permanent nerve pain from a Shingrix shot. No further information was reported. The reporter did not consented to follow up.
Left arm at injection site area redness, bruising, pain, warm to touch. Complained of pain left arm. Augmentin x10days per doctor. 8x2cm patchy area on arm.
Pt began running fever 102-104 degrees F on 08/23/02. Pt broke out with rash on face then trunk and back on 08/26/2002
first 3 days, my arm was sore; On the 9th - I developed upper gastric pain that was radiating through my back up to my upper right shoulder. I was concerned since I'm pregnant that it might have to do with the pregnancy. By 2:00 pain had progressively worsened and I didn't have much of a appetite that day. Around 3:30, I started developing intense nausea - and vomited 3:45 pretty violently. I contacted the OB - and she thought I should come in to be monitored. Hospital is where I went and I got there and they monitored to see how baby was doing; did a urine test - found protein and ketones in there. Drew labs - lipase was significantly elevated - 324. 156 were where my Triglycerides were at- a bit out of range. They dx'd me with Pancreatitis - idopathic since they couldn't determine cause. They admitted me to Hospital from 9th - 16th. While I was in the hospital they did further lab work. I was showing malnourished - after a clear liquids only for two days. I asked to be discharged by 16th. On the 29th, the day I took the vaccine - I had a glucose tolerance test after the vaccine (about 08:30 AM is when I started the glucose monitoring test) - they diagnosed me with gestational diabetes with that two days after vaccine on December 31st. Expected due date - April 20, 2021; low PAP A hormone; 1st pregnancy
Son collapsed and had a small convulsion which lasted about 10 seconds. His blood pressure dropped. He cried for about 20 minutes after.
Chest congestion and severe discomfort in heart  Soreness down left arm from injection site to fingers Headache
No adverse events listed, patient was tested due to exposure and tested positive on 3/29/21
Started with stomach twinges, went away ,5minutes later another hit. Went to eat and when finished meal I started to get double over pain  we went home and that took 15 min. The pain was sharp and continues for a total of 30 min. I payed down with heat pad then it went away .since then I feel very tired, no energy,and my arm still feels weak and  sore  after the first shot .today I go for the second one.
April 8, I got a cold after our preschool grandson (who we babysit) had one. It was a scratchy throat and bad cold. I got also 24 hour headaches - all the time (seemed odd with a cold). I took Nasacort; also at the same time: had  face  pain (tender in face) - my whole head and on my ears. And it stayed there for three or four weeks. There was one week in there that it went away - the first week sort of of May. During this time, though, our grandson who we babysat had a  fever and ear infection. He had a COVID test and it was negative.  On May 8th - face pain came back and got a dry cough and coughed up gunk for four or five days. Face pain got worse and it didn't go away. I wasn't having any other symptoms than face when I saw my doctor on May 20th. When I bend over, it would hurt ( my face pain) - headache in forehead and it hurts in my cheeks. I went in on May 20th- she just took vitals and asked questions and I started Augmentin antibiotics and after about 6 days it was not changing much and they changed me to Doxycycline and I took that for 10 days. It still wasn't gone then. I had it (face pain and headaches) another full month until about June 20th. Now it still comes but it comes intermittently. Today it's here and yesterday it wasn't (face pain - tenderness and some headaches in forehead).
uncontrollable crying x 2 days, sz,anorexia, arrested devel, doesn't see, hearing loss; screamed; slept all the time; pt has sz, not eating well
fever 101.9, tachycardia, uncontrolled hypertension, myalgia, headache moderate localized swelling to right upper arm at Tdap site
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 12:47 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 24.78.  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 09 AM, 10AM, 11 AM, 2 PM, 3 PM temperature was 32, 32, 32, 35, 35 total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Tachycardia x 30 hours >120 (resting HR usually mid 50s), 12 hours of lifetime worst body aches and headache and temps >101, extreme fatigue, chills, anorexia and nausea unable to eat for 36 hours, insomnia from pain for 2 nights.  Now 48 hours out from vaccine # 2, mild body aches, moderate fatigue, intermittent diaphoresis, mild chills.  HA has resolved.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 26-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372; 1310USA008373, 1310USA008374; 1310USA008375; 1310USA008376; 1310USA008377; 1310USA008378; 1310USA008379; 1310USA008380; 1310USA008381; 1310USA008382; 1310USA008383; 1310USA008384; 1310USA008385; 1310USA008386; 1310USA008387; 1310USA008389; 1310USA008390; 1310USA008391; 1310USA008392; 1310USA008393; 1310USA008394; 1310USA008395; 1310USA008396; 1310USA008397; 1310USA008398; 1310USA008399; 1310USA008400; 1310USA008401; 1310USA008402; 1310USA008403; 1310USA008404; 1310USA008405; 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Information has been received from a consumer concerning his approximately 15 month old daughter who on 12-DEC-2007 was vaccinated with a dose of PEDVAXHIB.  Concomitant vaccinations on 12-DEC-2007 included VARIVAX (Oka/Merck) (MSD) and M-M-R II (Wistar RA 27/3) (MSD).  Illness at time of vaccination included a cold and ear infection.  Other concomitant therapy included AUGMENTIN.  In December 2007, "several days later," the patient developed a "huge, red, swollen area on her leg in the precise area where was given her vaccine."  The patient's doctor was called immediately and was told to bring the patient in.  On 24-DEC-207, the patient was diagnosed with an infection in the leg area where her vaccine had been administered.  The patient was immediately treated with CEPHALEXIN.  At the time of the report, the patient still had significant area of leg infected which was extremely painful to touch but "appears to be recovering."  It was reported that the patient's physician said that she may be left with a permanent knot on her thigh.  It was reported that the physician stated that had the patient not been on an antibiotic for an ear infection, the infection could have potentially been "devastational" and that the antibiotics somewhat controlled the infection and controlled it to this isolated area.  No further information is available.
Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022; Expired vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Pharmacy received the vial on 23-Feb-2022. One staff found the expiration date as June-2022 and another staff looked up as 1-Apr-2022 as beyond use date. Vial was initially refrigerated on 4-Apr-2022 and no temperature excursion happened.  No treatment medication was reported by reporter.
Symtom:  shaking with  chills at 1600 . Went to bed in winter nightgown and wool socks under heavy comforter. Woke up at 2000 with no chills.  Don't remember trying to sleep.  Took no medicine.  No fever involved.  No previous Experience with this symtom..  Realize happened after 24 hours.
I was 22 weeks pregnant when I received the first dose of the Pfizer vaccine.  Then, 2 weeks later when I was 24 weeks pregnant, I started having vaginal bleeding. I was in the hospital for 3 days as the doctors believed I may be going into very early labor.  They suspect a partial placenta abruption. As a result, my cervix was found to be short, also indicating potential early labor coming. I was put on bed rest. Two weeks after the bleeding started, I lost much of my mucus plug (at 26 weeks). When at hospital at 24 weeks, I was given  steroids to make my baby?s lungs develop faster just in case he?s born soon. I was also prescribed progesterone which I?ve been taking nightly. I?m now also taking magnesium supplements and drinking chamomile tea.  This may be unrelated, but I have also been found to be low in iron so now I?m taking iron supplements too.   Due date is Aug 2, 2021; I?m 31 years old; I am currently 29 weeks pregnant and still have not gone into labor; This is my second pregnancy, my first pregnancy was two years prior, and it was 100% healthy.
Vaccine given 10/09/2000. Essentially same day baby got the vax she behaved differently i.e. didn't sleep well, had frequent crying spells at night from 10/09/2000 - 10/14/2000. Also had decreased oral intake, only 3 instead of six oz of milk didn't want solid veggie's or fruits.
Bleeding; seeping from lower leg; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration in the right arm, on 03Feb2021 10:30, at a single dose, for COVID-19 immunization. Medical history included breast cancer and chronic obstructive pulmonary disease (COPD). The patient has no known allergies. The patient has many unspecified concomitant medications. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in other facility. On 03Feb2021, at 11:00 A.M., the patient experienced bleeding/seeping from lower leg. The patient did not receive treatment for the events. Outcome of the events not recovered.  Information about lot/batch number has been requested.
On Tues., 10 Jun 2014 he received HepB (ENGERIX-B) dose #1 and on Thursday developed a severe, constant, frontal headache (7/10) where he wanted to go to bed. Symptoms lasted for 3 weeks and he feels the HepB immunization may have caused it because this is the worst in his life.
Erythematous macular rash on truck, legs and arms.  Treatment:  Already is on Allegra D daily.
swelling for two weeks; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling for two weeks) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling for two weeks). At the time of the report, SWELLING (swelling for two weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that she was scheduled for the second dose of covid-19 vaccination on 17-May-2021. Concomitant medications were not reported. No treatment medications were reported.
About 10 hours post injection My arm became sore, vey painful. Unable to lay on it or even use it to adjust my body weight while sitting. Shaking chills began. So cold I couldn't get warm despite a heating pad and several blankets. Awake most of the night, Took Motrin in the AM and worked my 11 hour shift the next day. Motrin every 6 hours. I went to bed at 8pm that night and woke up back to normal.  Of note I had Covid 19 in April 2020
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided