chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous case, was received from other health professional on 12-Dec-2017, concerns a 26-year-old adult female pregnant patient. The patient's medical included spontaneous abortion in 2015. Her family history includes Huntington's disease. Her concomitant medications included prenatal vitamins. On 10-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, batch no: 195229, expiry date: 31-May-2018, route of administration and anatomical location: not reported). On 06-Dec-2017, the patient was administered with second dose of FLUCELVAX Quadrivalent. The reporter states that pregnant patient might have received 2 doses of FLUCELVAX (explicitly coded as drug overdose) and the reporter is not sure whether the patient was given an actual second dose. It was given that the patient did not experience any event following vaccination. The estimated date of delivery reported as 29-Jan-2018. The reporter assessed this case as non-serious. Follow received from report 15-Jan-2018: It was reported that the reporter not confirmed about the second dose of FLUCELVAX and there was no further information available. It was stated that FLUCELVAX administered in error or Tdap (reason unknown). No adverse events reported.
Onset of flu-like symptoms about 26 hrs after vaccination (Thursday, 12 PM). By 32 hrs after vaccination (6 PM), severe body aches, headache, malaise, nausea, sweating, dizziness, loss of appetite. Took H2O and ibuprofin at 34 hr after vaccination (8 PM), which began to give relief from most symptoms within 90 min. Able to get some sleep. Symptoms returned about 6 AM (Friday), less severe, but still significant. Took ibuprofin again at 7 AM. Symptoms again returned at about 5 PM. Took ibuprofin again at 7 PM. Experienced intestinal distress with diarrhea throughout night. Lower level of symptoms througout following day (Saturday). Took ibuprofin 2 more times. Fatigue remained for 2 more days (Sunday & Monday). Back to 100% 6 days after vaccination (Tuesday, 11/06/2007).
This case was reported by a consumer and described the occurrence of lightheadedness in a 47-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 12 August 2009 at 12:30 the subject received 1st dose of ENGERIX B (left arm). On 13 August 2009, 1 day after vaccination with ENGERIX B, the subject experienced lightheadedness and dizziness. On 20 August 2009, 8 days after vaccination with ENGERIX B, the subject experienced disorientation and blood pressure dropped. On an unspecified date(s), an unspecified time after vaccination with ENGERIX B, the subject experienced chest pain, intermittent and inability to concentrate. At the time of reporting, lightheadedness, dizziness, disorientation, blood pressure dropped and inability to concentrate were unresolved. The outcome of chest pain, intermittent was unspecified. On 13 August 2009, the subject experienced "vaccine lightheadedness and dizziness". On 20 August 2009, she experienced disorientation and blood pressure dropped into the 80's. She also experienced intermittent chest pain. The disorientation and drop in blood pressure comes and goes in waves. She can be fine for a few hours and then both issues return. She visited her physician the afternoon of 20 August 2009. She has been drinking more water to get her blood pressure back up and making sure she has iodine. She has not been able to get her blood pressure above the mid-90's. The night of 23 August 2009, she became disoriented again. The morning of 24 August 2009, her blood pressure was in the mid-80's. She can not concentrate. Follow-up information was received on 24 September 2009. The subject reported that the symptoms she previously reported (lightheadedness, dizziness, disorientation, blood pressure dropped) are all worse since last reported on 24 August 2009. The subject reported that this weekend (19 September 2009) she began to experience migraine headaches and visual problems (vision will go in and out of focus and not related to the migraine). The subject planned to continue follow-up with her physician and be evaluated by a neurologist on an unknown date. The subject reported that she has been unable to work because of her condition.
No adverse reaction noted.  Wrong vaccine administered.  Given bivalent booster instead of monovalent for first dose.
This spontaneous report was received from a 65 years old female patient with penicillin allergy. The patient was vaccinated with ZOSTAVAX on an unspecified date for shingles vaccination. Lot # and administration route were unspecified. Concomitant medications included PROMETRIUM, ELESTRIN and LIPITOR. On an unknown date the patient was administered ZOSTAVAX and she developed a small saucer sized red, hot, bumpy, itchy spot near the injection site. No treatment was given. Outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
body ache; chills; milder headache; fell asleep; This is a spontaneous report received from contactable reporter (Consumer). Other Case identifier: 2023NVX-US-000000150 (Novavax). A 63-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1; lot number: unknown), administration date: 19Mar2021, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "did not eat for 2 days", "she had a severe headache", "chills", "body aches", "nausea", "feverish"; BNT162b2 (Dose 2; lot number: unknown), administration date: 08Apr2021, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "a low grade fever", "fatigue", "chills", "body aches", "was falling asleep". The following information was reported: PAIN (non-serious), outcome "unknown", described as "body ache"; CHILLS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "milder headache"; SOMNOLENCE (non-serious), outcome "unknown", described as "fell asleep".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax & approx 3 days p/immun, pt exp pain in legs; hopsitalized 3-4 days; dx radiculoneuropathy in 1 leg (knee); pt recovered;
Nurse administered Influenza vaccine too high in her left arm. When the nurse went to push the vaccine after the poke, she felt a zing to her elbow and it was painful right away. Employee was seen by PT/PCP and was diagnosed with tendonapathy of the rotator cuff muscle and has fluid in her bursa.  She has been receiving steroid injections in her left shoulder as a result and is continuing to see PT and practicing her exercises to aid with mobility. This employee has family medicine appointments  and PT sessions. She also continues to take anti-inflammatory medication to assist in her recovery.
Information has been received from a healthcare professional referring to a 21 month old patient of unknown age. On 28-DEC-2015 the patient received an expired dose of VAQTA (lot # K008254, expiration date: 12-NOV-2015, dose and route were unknown). The patient had not experienced any adverse effects. Additional information has been requested.
HIVES COVER THE ENTIRE BODY STARTING WITHIN 3 HOURS AFTER RECEIVING VACCINE.  HIVES CONTINUED FOR 2 MONTHS OFF AND ON.  ALSO, SEVERE, DEBILITATING STOMACH CRAMPING, NAUSEA, AND DIARRHEA LASTED FOR 4 DAYS.
Admit for COVID w/ asthma exacerbation. Vaccine completed Feb 2021. Treated w/ O2, zinc, vit-c, steroids, lovenox, pulmicort, albuterol, remdesivir. she wanted to be discharged home with home health, the PT was working with the patient during all these days in the hospital,patient thinks she got improvement and she feel much better and she is safe to be discharged home with home health.
Presented to ED w/AMS; admitted for ESRD & COVID-pna; 10/30 - tx w/ Cefipime; 10/31 - added Vit C, zinc & steroids; 11/6 - pt suffered acute stroke; required minimal O2 during stay and was weaned to RA by 11/7; pt DC to acute rehab d/t stroke.
hives worsened; This is a spontaneous report received from a contactable consumer (patient). A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 1, single on 29Apr2021 (at the age of 63-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated she received the first dose of the Pfizer covid 19 vaccine 29Apr2021 in the late evening (as reported on Thursday). Caller stated that after the shot she noticed different things going on. Caller reiterated that after the shot things started happening and things started intensifying. Caller stated she has hives on 29Apr2021. She mentioned she started to get the hives right after getting the shot and she let the nurse know when she got it while sitting there. She was given Benadryl, but she still experienced the hives for some reason. She was looked at and was informed she would be fine. However, a couple of days have gone by, and things were progressively worse. Her whole back, back of her neck and face have broken out. It does not look right. She felt the hives, but it was intensifying now. Caller did not have full HCP details to provide. While capturing HCP Details caller mentioned her son was calling and asked for us to hold. Caller stated she did yard work earlier in the week. Caller stated this shot was given by the state. Caller asked who was going to pay for the adverse reactions, as she was unemployed and wanted to know how a person that was unemployed and had side effects how was that handled. Caller asked if she was to go see her doctor. Therapeutic measures were taken as a result of hives with Benadryl. At the time of this report, the outcome of event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Severe flu like systoms with nausea and cramping.  Lightheaded, clamy, cold to the touch. No fever. Passed out 3 times - per my husband trying to go the bathroom. These systoms lasted from 10.30 pm till 8.00am the next morning. Severe nausea continued and my doctor prescribe ondansetron.  This is the sickest I can remember being in my life.  I am very concerned about me passing out.
Approx 1 day after vaccines given, pt's mother reported high fever and talking to herself as if delirious for approx 5 hours.  Called on call physician, but did not seek medical attention.  Fever lasted 48 hours then resolved. No other symptoms.
Information has been received from a registered nurse concerning a 12 year old female with seasonal allergy who on 23-MAY-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot #653735/0688F). There was no concomitant medication. On 23-MAY-2007 the patient experienced temperature of 102 F, headache and"arm blew up". Unspecified medical attention was sought. She was treated with TYLENOL and ice. Subsequently, the patient recovered. On 24-JUL-2007 the patient was vaccinated IM with a 0.5 ml second dose of Gardasil and no adverse symptoms were noted. This is one of two reports from the same source. Additional information has been requested.
Pain all over, very fatigue, foggy, chest tiredness, exhaustion with ambulation, plum size swelling, pain and redness under right armpit, slight sore throat, ear ache, and stuffy nose gradually got worse since 23 April
This spontaneous report as received from a non medical healthcare worker refers to three unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concurrent conditions and concomitant medications was reported. On an unknown date in March 2015, the patients were vaccinated with improperly stored doses of VARIVAX (Merck), lot # K009759, expiration date: 09-JUL-2016, (dose, route of administration and injection site were not reported). No adverse events were reported. Follow up information has been received on 25-MAY-2015 from the reporting non medical healthcare worker. The reporter provided patient identifiers. It was stated that the patient was vaccinated with improperly stored VARIVAX (Merck) on 31-MAR-2015. This is one of several reports received from the same reporter. Additional information has been requested. Patient details, suspect therapy details, event details and narrative were updated.
Dose administer post 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administer post 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administer post 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administer post 12 hours) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.
FEVER up to 103 F; Chills; Aches; headache; congestion in chest; nauseous; strong ache in left arm; Rash on arm of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jan2023 at 13:45 as dose 3 (booster), single (Lot number: GJ6742) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: adhesive on some band aids" (unspecified if ongoing), notes: known allergies: adhesive on some band aids. Concomitant medication(s) included: ATORVASTATIN; MIRTAZAPINE. Vaccination history included: BNT162b2 (Dose Number: 2, Brand: PFIZER, SARS-COV2 (COVID-19) VACCINE, Batch/Lot No: Lot number: #EW0151, Location of injection: Arm Left), administration date: 08Apr2021, when the patient was 60-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Lot number: #EN6207, Location of injection: Leg Left), administration date: 18Mar2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "Location of injection: Leg Left". The following information was reported: PAIN (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered", described as "Aches"; CHILLS (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered"; PYREXIA (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered", described as "FEVER up to 103 F"; VACCINATION SITE RASH (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered", described as "Rash on arm of injection"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered", described as "congestion in chest"; HEADACHE (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered"; NAUSEA (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered", described as "nauseous"; VACCINATION SITE PAIN (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered", described as "strong ache in left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain, headache, respiratory tract congestion, nausea, vaccination site pain, vaccination site rash.  Additional information: No other vaccines reported to have administered in four weeks. Medications in two weeks included mirtazapine 15 mg /atorvastatin 10 mg. Patient did not had covid prior vaccination nor tested positive post vaccination but reported known allergies to adhesive on some band aids.
large reddened area approx 10cm x 15cm at injection site. warm to touch
Starting itching, swelling, hot, red with rash. First noticed rash on forearm. Pain under arm with swollen lymph in axilla area. Continued to worsen over several days. By 08/13/2012 showed to Medical Doctor and started ice and heat. Started looking and feeling better by 08/16/2012. No other treatments. MD stated reaction to the vaccination.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck). On an unspecified date, the patient developed joint pain, leg pain, swelling in the legs, pruritus in the eyes, and sore throat. The events did not appear until three to four days after receipt of the vaccine. As of 09-MAY-2007, the patient had not recovered. Additional information has been requested.
Patient had a febrile seizure with a temperature of 106.8 degrees and rising 7 days post MMRV shot.  He'd had a double-ear infection as well at the time of the seizure, but I can't remember if he had that prior to immediately prior to vaccination or not. He also had subsequent febrile seizures.  Initial seizure was 12/7/06.
Lethargy Chills and fever beginning 17 hours after vaccination lasting approximately 12 hours accompanies by mild headache and mild body aches
102.5 fever, vomiting, diarrhea.  Unable to eat for 3 days.  Was treated for Dehydration at local ER.
- Got the vaccine in the afternoon and by evening her arm was sore for several hours, about 6-7 hours post her shot she was fatigued. -She then experienced light headedness and headache roughly 10 hours or so after the shot, she had chills but no fever. She went to sleep. -Pt went took Tylenol around 11pm for headache and join pain. Woke up the next morning and took Tylenol again, she had some severe dizziness around 0730 next day that was made her feel like she was fainting and panicking, she took her BP and it was 76/40. She then took it 20mins later it was back to normal at 116/80. She spoke with her PCP over the phone and they advised her to continue to observe herself at home and go to hospital if it happens again. -On 2/14/2021 at 2pm, her joints are still aching and hands are swollen/itchy/red on the backs of her hands.  Followed up later on 2/14/2021 Follow up attempt: Spoke with patient and she is doing better, symptoms are resolving. Ibuprofen taken recently, just managing joint pain and headache with OTC meds. Hand swelling resolved. Advised caller to call us back with further questions or concerns as needed, seek medical attention if dizziness or hypotension occurs
PT REPORTED PAIN RADIATING FROM SHOULDER TO ELBOW, AND NAUSEA
Information has been received from a health professional concerning a 33 month old female with no past medical history who on 08/20/1999 was vaccinated with the first dose of varicella vaccine SC. There was no illness at the time of vaccination. On 05/14/2001, the pt experienced breakthrough chicken pox that consisted of 14-20 lesions that were reported to be "not bothering her." On an unspecified date, the pt recovered. It was noted that the pt had developed her chicken pox about 2 1/2 weeks after her brother, who had also been vaccinated with varicella vaccine and developed them. Additional info is not expected.
seven year old patient received a QUADRACEL vaccination with no A/E; Initial information received on 01-Sep-2021 regarding an unsolicited valid non-serious case received from an other health care professional via consumer via physician. Inquiry Number: 00750368).  This case involves a seven-years old female patient who received a quadracel vaccination with no adverse event (Product administered to patient of inappropriate age) DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  On 30-Aug-2021, the patient received a fifth 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number: C5851AA and expiry date: 25-Mar-2023 via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported "Caller states that a 7- years old patient received a QUADRACEL vaccination in the office on 30-Aug-2021 and asked what the protocol was in this situation. Caller states that the patient was new from another practice and that this would have been their fifth dose of DTAP."  At the time of reporting, no adverse event reported.  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 guidelines. 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.
Client stated had immediate pain upon injection, then suffered from being unable to move that arm for a day or so.  1 week after injection she is still unable to use full range of motion in left shoulder and unable to raise her left arm higher than shoulder height.
Headache. Low grade fever. Glands/nodes under chin swollen. Left and right arm from shoulder to wrist muscle aches.  Very uncomfortable throbbing ache in the middle of the night. Lethargic. Felt sick. Took aspirin which helped.  Less severe symptoms started day of vaccine.  Inactive next day and a good night's sleep the following night made a big difference.  Still not back to 100% be feeling okay.  Additional info: I'm a seasonal visitor to this area and my home is in another location.
Dizziness.  Vitals: 12:42 pm: BP= 123/75, HR= 70, O2 sats RA= 97%. Temp= 36.3 C, RR=18; 13:13 pm: BP= 135/81, HR= 63, O2 sats RA= 98%. Temp= 35.7 C, RR=18
SORE THROAT, COUGH, RUNNY NOSE.  CURRENTLY PREGNANT
Weakness, nausea, tiredness, confusion, off balance AM & PM, racing thoughts and actions in the AM.  2/25/09 MR received.  HPV vax 12/2/08 and 1/5/08. Pt to be seen for cognitive eval on 1/23/09, but pt was 45 minutes late.  Pt c/o dizziness, weakness and difficulty concentrating.  Referred to ER for physical complaints.  Not seen in ER. Consult (+) for hyperreflexia of R upper extremity. Sent for MRI. 3/9/09 Additional records received. Psych consult states pt has hx of depressive sx since 2003.  Recently d/c antidepressant.  Started on another recently.  Exam with some psychomotor slowing and depressed mood.  DX: Dysthymia.  Cluster B personality features. Arthralgia of knees.  Anemia-on iron.  Later eval reports sx may be r/t Lupus dx since MRI (-)