chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient received less than a full amount of a Pentacel dose due to a malfunction of a syringe and needle, no adverse event; a patient received less than a full amount of a Pentacel dose due to a malfunction of a syringe and needle, no adverse event; Initial information received on 03-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four months old male patient who was vaccinated with a  0.5 ml second dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ016AA and expiration date 26-Oct-2020) via an unknown route in the left thigh on 03-Dec-2019. However the patient received less than a full amount of a pentacel dose due to a malfunction of a syringe and needle, there was 0.1 mL to 0.2 mL remaining in the syringe that was not given.  The past vaccination included first dose of pentacel and concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error case due to vaccine underdose.  Also this was a case of syringe issue.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Severe aching/inflammation in the hip groin area at random times during the day or night for no particular reason even after adequate resting.      This lasted for about 2-3 weeks.
rash over trunk & neck with sparing of face hands & feet; rash prusitic with onset 6/30/03 temp 98.8 F on 7/2/03.
Fever,pain from head to sole of feet. Lump under left arm .. near armpit and left breast
Shingles; A spontaneous report was received from a pharmacist concerning a 92-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shingles.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, after the first dose of vaccination some point the patient experienced shingles  No treatment details provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event shingles was unknown.
Patient stated he had pain radiating up his back and neck. He also stated he moved a significant amount of weight/load at work the previous day.
Child received her second Gardasil vaccine at around nine in the morning.  By 6pm she had an itchy rash all over and by the next day the rash had intensified (darker red) in the original spots (trunk and face and neck) and was spreading to extremities.  Benadryl helped somewhat by mouth as did topical pramoxine.  Rash was deeply erythematous macules, 5-7 mm diam widely spaced on extremities (3 cm apart) to closely spaced and confluent on neck and trunk.  Face involved as well.  No respiratory distress.
Fever; Headache; Throat pain; Sore arm; Body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 15Dec2021 17:00 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Headache"; OROPHARYNGEAL PAIN (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Throat pain"; PAIN IN EXTREMITY (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Sore arm"; PAIN (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Body ache". Therapeutic measures were taken as a result of pyrexia, headache, oropharyngeal pain, pain in extremity, pain.  Additional information: The reporter stated that her daughter got a Pfizer vaccine on Wednesday evening like at 5:00 pm and then after, next day, like from Thursday she was having fever, headache, she was having throat pain as well, sore arm and she kept complaining about all the body ache. So, the reporter gave her Tylenol, then gave her Ibuprofen, again Tylenol but still she was having the fever again (further clarification unknown, hence Tylenol and Ibuprofen not captured as suspect). So, the reporter wanted to know, was there any document that could provide the information regarding the medication that the reporter could use for her.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Early in the morning the day after my second shot, I woke up nauseous, with a massive headache, fever of 101.2 and severe full body muscular pain that included joint stiffness. These symptoms continued through 5/30/2021 though the full body muscular pain has yet to stop.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration in left arm on 27Jan2021 11:00 (at age 43-years-old) at a single dose for COVID-19 immunization. Medical history included blood pressure. The patient did not have  COVID prior vaccination. No known allergies. Concomitant medications included atorvastatin (LIPITOR), amlodipine besilate (NORVASC), sildenafil citrate (VIAGRA), and amfetamine sulfate (AMPHETAMINE SALTS). The patient tested positive for SARS-CoV-2 on 12Feb2021, patient was symptomatic (cough, diarrhea, headache) since 06Feb2021. Covid test post vaccination via Nasal Swab, (NAAT Aptima SARS-CoV-2 assay) on 12Feb2021 with covid test result Positive. Treatment received included Aspirin. The outcome of the events was not recovered.
Noted swelling on L deltoid and severe 10/10 pain approximately 5 hrs after vaccinated with Pneumococcal vaccine. Reported to PCP who prescribed Vicodin. The patient took 2 tablets of Vicodin with pain relief. However, noticed that swelling was spreading and thus, presented to ED for further evaluation. Of note, R deltoid where flu vaccine was administered was normal.
Dizziness, Headache, Arthralgia, Fever & NauseaVomiting Narrative:
during injection, syringe withdrew prior to completion of injection. small amount of vaccine spilled, no other issues
Sore arm Headache- all over pain like a sinus infection body sweats nausea weakness dry heaves fatigue
On 11/15/11 at 09:35 patient received flu vaccine, on 11/16/11 reported to employee wellness with rash to neck & what appeared to be flea or insect bites all over her legs. Sent to occupational health MD. He treated an allergic reaction to flu vaccine.
Throat Super Dry - Itchy allover (no rash) (3:00pm) Tired and achy (1-29-2021) (5:00pm) Fever (101.6) about (11:28 am) chills (11:28 pm) Blood pressure (9:26am) (1-30-21) (156/90 HR 102) Headache (1-29-20- present)
Pain in right arm at injection site, shoulder and neck. Pain in these areas continue to this day. Use of right arm decreased. Taking ASA 3-4 times a day for the pain.
Initial case received from a healthcare professional on 11 June 2014. A female infant, with no reported medical history, received a third dose of DAPTACEL (lot number C4617AA) on an unspecified date. The patient's mother reported that one hour post-vaccination, the patient experienced loss of consciousness lasting approximately 10 minutes. The event subsequently recovered. No additional information was reported. Documents held by sender: None.
Headache, nausea, vomiting, fatigue, chills and dizzy started about 48 hours after second dose and lasted about 24 hours.
Severe 8/10 chills, body aches, pain in the joints especially in the extremities.  Came on 24 hrs. after dosing.  Severe (and I mean severe and painful) for 2 hrs+ then started coming in waves and now intermittent.   Other mild to moderate - fatigue, pain in arm at vaccination site, axillary lymph node is 3 x 2 cm on vaccine side, cough, mucous production, headache.   Only reason I didn't go to ER is coworker (also in health related field) and neighbor had experienced similar severe chills, joint pain, body aches but their symptoms also included fever of 101 to 103 for 3 days.  Had I not known about that, I would have gone to the ER because I would have thought I was sick.  This was worse than when I had influenza with pneumonia a few years back.
Received shot at 6pm thursday. Friday I felt tired, and by late afternoon had temperature of of 100.4.  I felt fine when I woke on Saturday, and felt pleased that my immune system was apparently working properly  Seeing nothing in the Moderna fact sheet about avoiding alcohol,  at dinner I had 3 and a half cocktails. Had no problem walking home and walking the dog, but after getting in bed, I had a much stronger reaction to the alcohol than I ordinarily would - vertigo, and the next day, extreme tiredness.  Though I don't ordinarily drink that much, I'm a large man, and it doesn't affect me as  much.  I'm concerned that the alcohol may have affected the efficacy of the vaccine, and wonder if avoidance of alcohol should be mentioned in the fact shett.
Arm pain, tightness, hotness, rash from top of shoulder to elbow on arm that received injection.
After arrival at select specialty he made slow but gradual recovery of renal function and was able to wean successfully from dialysis.  His oxygen requirements improved to the point of not requiring supplemental oxygen on a regular basis.  He remained quite weak in a bedbound state but had progressed to sitting on the side of the bed standing with assistance.  His course was complicated by urinary tract infection which responded appropriately to antibiotics.  He however had a acute decline in respiratory status and appeared to have developed worsened acute systolic heart failure repeat echocardiogram confirmed further deterioration of his low ejection fraction down to 10%.  He was dependent on noninvasive positive pressure ventilation.  His shortness of breath failed to improve with diuretics inotropic support.  After long discussion with the patient and his family they did not wish to pursue intubation or further ICU level support.  After an additional 24 hours with failure to improve with conservative management the patient requested transition to comfort care BiPAP and inotrope support was discontinued.  Medications were given for shortness of breath and anxiety he passed away with family at bedside on 6/22/2023 and was pronounced dead by on-call provider.
Within a few minutes after administration , child complained of feeling sick at stomach, was moving arm due to soreness, then passed out for a minute or two at post- vaccination area. Continued observation occurred without further sequelae. Phone call to home later in day revealed no further side effects reported by parent
Patient received the above vaccines, because she was entering kindergarten. However, after giving the vaccines I looked at her immunization record and she had rec'd the above vaccines at age 4. This was an extra dose of the Dtap/IPV, MMR and VARIVAX.
Child was given 0.2cc of Jannsen vaccine accidentally.  Mom states that child had a small rash around his mouth that resolved with benedryl.  Mom was notified about child getting Jannsen  and not the Pfizer.   No other problems reported.
Fever of 103.3 that would not go down after taking Tylenol or ibuprofen. Set in 5 hours after vaccination and continues to persist 24 hours after vaccination. Muscle/body aches, fatigue, chills
pt recvd vax;w/in 24 hrs of dose 2, exp ha; tx advil & apap;ha lasted x 2 wks; recovered
Patient may have received 0.5 ml of diluent and not diluent mixed with powder
This spontaneous report was received from a nurse refers to a unspecified patients of unknown age and gender. On 05-MAY-2015, 19-MAY-2015, 11-JUN-2015, 16-JUN-2015 and 21-OCT-2015, the patients were vaccinated with improperly stored doses of Other suspect therapies included VAQTA (dose, frequency, route of administration and indication were not reported, lot # L023232 with expiration date: 27-FEB-2017). No adverse event was reported. This is one of the several reports received from the same source. Additional information has been requested.
Breakthrough case admission after 4 vaccines Pfizer 3/9/21 Lot# EN6199;  Pfizer 3/30/21 Lot# ER8732;  Pfizer 12/7/21 Lot# 33130BA; Pfizer 9/16/22 Lot# GJ2524
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 12:00 as dose number unknown (booster), single (Lot number: GJ6739) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 31Jan2023 to 05Feb2023.  No follow-up attempts are possible. No further information is expected.
After RN administered TdaP (Tetanus, diphtheria, acellular pertussis vaccine), Menactra (meningococcal vaccine), and Fluzone (influenza vaccine), the patient collapsed and RN immediately moved the client to a supine position.  RN applied a cold cloth.  The patient was pale but color returned after 1 minute lying down.  The patient improved slightly, but then after two minutes he experienced a second unconscious episode and was unresponsive for 30 seconds.  RN assessed the patient the client opened his eyes, began mumbling, and was able to respond to verbal commands.  RN elevated his legs while other RN took his blood pressure (100/60), pulse steady and strong.  Continued to monitor the client.  After approximately 5 minutes, the patient's speech became unintelligible.  His tongue and lips appeared swollen. Requested assistance. RN assessed the client and determined that he had difficulty breathing and some itching.  RN immediately administered 0.3 ml Epinephrine IM per Standing Orders.  Requested that 911 be called.  RN noted a marked improvement in the client following epinephrine injection including more alertness.  Paramedics arrived and placed an IV.  They gave IV Benadryl and transported the patient to Medical Center.   When he left our facility, the client was conscious, showed no signs of respiratory distress, and was responsive to questions. 1/8/09-records received for DOS 12/9-12/10/08-DC DX: Anaphylactoid reaction most likely to Menactra vaccine. 15 minutes after receiving vaccine C/O tightness in throat and seemed to pass out. facial edema.
Temp of 100.3 noted 02/03/2003. Was given Advil. Headaches. No problems at injection site. Temp was actually 103 degrees: reduced with Advil to 101. No fever this morning. Runny nose like a cold today (02/04/2003) As pt developed temp 4 days post vaccination and has developed rhinitis/cold symptoms, temp may not be related to vaccination.
fever; fatigue; headache; muscle pain; thirst; insomnia; This is a spontaneous report from a non-contactable other health professional (HCP) reported for himself. A 29-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration in the right arm on 16Feb2021 at single dose for COVID-19 immunization. The relevant medical history included covid-19 (if covid prior vaccination: Yes) from an unspecified date. Concomitant medications included chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX). The patient previously received first dose of BNT162B2 at the age of 28 years old on 27Jan2021 for COVID-19 immunization (lot number: EL3247, vaccine location: Right arm). The patient experienced fever, fatigue, headache, muscle pain, thirst, severe enough to cause insomnia and interfere with work on 16Feb2021. No treatment was received for the events. The seriousness was reported as non-serious. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Pt is a 73 yo female, s/p full Pfizer COVID vaccination: dose 1 on 2/25 and dose 2 on 3/18. On 8/6, pt reported new onset cough, muscle/body aches, headache. Other health conditions include DM2 and HTN. Patient confirms exposure to COVID positive individual. COVID PCR results positive on 8/6. Pt received casirivimab/imdevimab infusion on 8/10.
Fever (103), uncharacteristic behavior: unable to sleep, unable to eat, irritable, complained of severe abdominal pain for several days, visibly affected by the vaccine; emailed doctor and sought medical attention.
On April 15th all day starting around 10:00am: 1) Fatigue, continued all day 2) Ear fullness, ringing, my tinnitus was loud all day, ended before next day 3) Mild injection site pain, all day On April 16th: 1)  fatigue, which ended by next day 2) Mild injection site pain, all day, ended by next day
Breakthrough case admission after 2 vaccines Moderna 2/27/21 Lot# 025A21A;  Moderna 3/27/21 Lot# 028A21A
Headache initially within hours of getting the shot, lasted  12 hours Nausea within hours of getting the shot Body Aches next day, diminshed in intensity but still present testicular pain dull ache on the right side started 2 days later ache in the left armpit  a couple days later also dimishing but still present, pain peaked at 48 hours
She received the vaccine, no problems initially, no real arm soreness.  The next morning when she woke up she could not walk, had to hold onto something to walk, and has a lot of pain, and has not improved even with taking pain medications.  There has been no improvement from the pain.  There are times that she feels just a little better, but then returns back to where it was.  She went to the ER on 3/17/21, they said that she had arthritis which she had but she has not had this type of pain until the vaccination.  They gave her some pain medicine which did not help at all.  She again is taking some pain medication now but the pain is still there.  She can stand on her leg and it doesn't hurt, but when she moves her leg is when it hurts.  She is now using a walker which she did not have to use before the vaccine.
Fever and chills beginning 1 am lasting 9 hours muscle soreness in legs.
Within 24 hrs was having flu like symptoms, headache, body ache, fatigue, general malaise, skin reaction inflamed (3x7 inch), soreness in arm, fever starting 7 pm second day, fever 100.2,.  After 72 hrs soreness and inflammation in left arm remain other symptoms generally gone except tired.
Tinnitus started after first dose. Came on stronger after second dose. Was subsiding. Booster set off the ringing in my ears again.
This case was reported by a lawyer and described the occurrence of arthralgias an in adult male subject who was vaccinated with LYMErix (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMErix.  On an unspecified date after vaccination with LYMErix, the subject experienced arthralgias, myalgias, sleep problems, fatigue and rashes.  In addition, he suffers from rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMErix.  The subject also has decreased activities of daily life and decreased ability to participate in recreational activities.  At the time of reporting the outcome of the events was unspecified.  This information was received via a Statement of Injuries.  Upon follow up information received via medical records on 16 January 2008, the subject was identified as being in his fifties with a history of basal cell skin cancer.  No other information was provided at that time.  Follow up information was received on 28 February 2008 via medical records.  The subject reportedly had a history of hepatitis, cervical spine stenosis at C2 and C3, sciatica, and "insignificant" cardiac arrhythmia, each of which were diagnosed on an unspecified date.  He also had a history of Bell's palsy in approximately 1997.  On 01 August 2002, diagnostic findings included discogenic disease and degenerative arthritis from L4 to L5 and at T11 to T12, slight scoliosis, and limited flexion and extension consistent with muscle spasm.  On 04 September 2003, he was evaluated for a history of lower back pain and bilateral leg pain with numbness, with findings including diffuse osteoarthritis with degenerative disc disease, spinal canal stenosis associated with disc herniation, and mild dextroscoliosis.  On 26 April 2004, an X-ray revealed mild degenerative arthritis of the right knee.  Between August 2002 and July 2005, the subject was evaluated for multiple complaints including lumbar radiculitis and hip tenosynovitis (01 August 2002), multi-site joint pain (31 July 2003), lumbar degenerative joint disease (21 August 2003), lumbar spinal stenosis and disc osteophyte complex (23 September 2003), swollen and sore knees (26 April 2004), leg cramps and myalgias (09 August 2004), cervical radiculitis (15 September 2004), joint swelling in the legs and knees and muscle spasms, cervical stenosis, and medical compartment syndrome associated with bilateral knee pain (31 May 2005), muscle spasms (18 July 2005), muscle cramps and fasciculations of the left lower extremity (11 August 2005), and cervical pain with numbness and tingling of the shoulder and arm (05 September 2006).  Treatment included Bextra, Flexeril, and Percocet.  Based upon follow up information, this report was assessed to be medically significant by GSK.
"Sensation" on skin of arm at injection site.  Like a light tingling sensation.  Occurs periodically.  Lasts hours and disappears and comes back within a day or days.
client complained of feeling "foggy and strange "  after receiving vaccine.  He was reclined in his seat and monitored for confusion.  He was released when symptoms improved.  Blood Pressure 128/87 Pulse 84 and oxygen saturation 100%
Vertigo (room spinning) upon waking from sleep, continued vertigo and dizziness the whole day (and still going). Nausea and loose stools. Chills but no fever.
Sore arm within 8 hrs. Fever of 103, body aches, fatigue, headache
pt recvd vax 19MAR93 & 27MAR93 devel a rash which spontaneously remitted w/no tx; No further details were provided;
Pain in arm a few hours after vaccine. Lethargy the next day and more intense pain in arm. That evening had upset stomach and diarrhea and nausea. The next morning left arm was red and warm and still intense pain. Feeling of fatigue and overall sickness.