chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 15 year old female on 13 Nov 2006 was vaccinated with a first dose of Gardasil. There were no concomitant medications. On approximately 13 Nov 2006 the patient experienced nausea, lethargy and "mono like symptoms." Subsequently, the patient recovered. On 03 Feb 2007, the patient was vaccinated with a second dose of Gardasil. On 03 Feb 2007 the patient experienced nausea, marked lethargy, "mono like symptoms" and diarrhea for 2 days after the vaccination. On 05 Feb 2007, the patient returned to the doctors office and underwent a complete blood cell count and an Epstein-Barr virus antibodies screen. It was reported that "mono" was ruled out. At the time of the report, the patient was recovering. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 20 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was unknown. On 29-AUG-2014 the patient who was intended to receive (Oka/Merck) VARIVAX was inadvertently vaccinated with ZOSTAVAX (single dose), subcutaneous. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received pneumonia and influenza vaccines from PCP's office on 10/24/18 in the same arm (left). She presented to Urgent Care on 10/26/18 with left arm redness, swelling, and increased tenderness. No signs for cellulitis but pt was given topical triamcinolone 01% cream for topical relief, advised ice/heat as needed and given a prescription for BACTRIM DS BID x7 days to begin if symptoms worsen over the next 24-48 hours.
abscess @ site of inject; seen in hosp ER 2MAY92 & treated w/oral Cephalexin abscess @ lt thigh;
1st had strange sensation in head (2 days) - everything was amplified and overall weakness and muscle weakness. Pins and needles - started on legs - spread to whole body. Arms got very sore - muscle ache.
This case was reported by a pharmacist and described the occurrence of swelling injection site in an adult subject of unspecified gender who was vaccinated with FLUARIX QUARDRIVALENT (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX QUADRIVALENT (unknown). On an unspecified date, 2 days after vaccination with FLUARIX QUADRIVALENT, the subject experienced swelling injection site, injection site warmth and injection site hives. At the time of reporting, the events were improved. The pharmacist considered the events were probably related to vaccination with FLUARIX QUADRIVALENT. This case is one of the 5 cases reported by the same reporter for the same vaccine.
Pfizer vaccine administered to patient who received Janssen vaccine at clinic on 3/8/2021 per CVMS. Patient aware that this was out of protocol and that they can not get the second Pfizer vaccine at a pharmacy at this time. Patient reported that PCP recommended and referred them to our pharmacy to get the vaccine. PCP office was notified that they can not refer patients to get another COVID-19 vaccine at any pharmacy at this time.
High fever, inflamed injection site, lethargic, rash that would come and go like allergic reaction, not eating. Bulging soft spot on babies head (twins), sudden rapid head growth resulting in external hydrocephalus.
Lt arm red swollen 30 cm (Tdap area) 1 hr after inj. Came in on 5/24/11 BENADRYL 25 mg 1-6 hrs #60.
pt developed SOB, CP, dx with pleurisy; pt developed SOB, CP, dx with pleurisy; pt developed SOB, CP, dx with pleurisy; This is a spontaneous report received from a contactable healthcare professional. A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0165), via intramuscular on 07May2021 at 12:00 PM (at the age of 62-years-old, non-pregnant at the time of vaccination) as single dose for COVID-19 immunisation. The patient's medical history included HTN, elevated cholesterol and new onset DM2. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's concomitant medications within 2 weeks of vaccination included paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]), hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE) and atorvastatin. The patient was not pregnant at time of vaccination. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. It was reported that, on 27May2021, the patient developed SOB, CP, dx with pleurisy and on 28May2021, the patient was seen at local ED and hospitalized for 2 days. No prolonged hospitalization. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events was CT scan, labs, IVF, CXR, needed o/p antibiotics. On an unspecified date, the patient underwent lab tests and procedures which included CXR, resulted as unknown and CT scan, resulted as unknown. The outcome of the events was recovering.  Batch/Lot number was obtained. Further information has been requested.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as  part of Pfizer procedures for safety evaluation, including the review and analysis of  aggregate data for adverse events. Any safety concern identified as part of this review,  as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
The night of the second dose: Facial flushing, fever of 101.6, nausea, shivering for extended period during night,  general aches and pains. Through body,  By Thursday evening, fever reduced to 100.5.  Friday morning, temperature was 98.
a 17 years old patient received a dose of Flubok with no adverse event; Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2020SA287443 (13 years old, same reporter).  This case involved a 17 years old male patient who received a 0.5 Ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number-QFAA2047, expiration date unknown) via an unknown route and administration site for prophylactic vaccination on 06-Oct-2020 (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of report no adverse event was 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 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.
Shingle-like rash with pain, 3 years post vax. No other varicella exposure. Treated with Zovirax oral suspension and Orapred oral suspension.
8 days after shot on February 26, awoke with itching and rash at shot area.  Also had large welt at point of injection. Lasted 2 days.  On March 5 rash and itching came back at injection shot, gone within one day.  Used Benedryl creme and took Benedryl pills during those days.
Employee received his vaccine at Clinic on Monday, 9/11/23, and the following day (9/12/23)  he developed left sided numbness and facial droop. He reports having difficulty closing his left eye as well. He denies any similar sx prior to 9/12/2023. Evaluated at local ED on 9/15/23 where diagnosed with new onset Bell's Palsy. Prescribed prednisone and valacyclovir. Taking with mild symptom improvement.
Patient had temp of 102 degrees Fahrenheit and malaise for about 24 hours.
Case number PHEH2015US018912, is a combined initial spontaneous report from a medical assistant on 23 Sep 2015. This report refers to a 15-year-old female patient. Past medical history and concomitant medication were not reported. She received two doses of MENVEO (batch number: A14099/A15019, expiry date: 31 Sep 2016) on 27 Aug 2015 and 03 Sep 2015 respectively within a 7 days period. No adverse event was reported following this administration error. Follow-up information received on 5 November 2015 from physician: Previously administered products included DTaP (4th dose - Previous doses: 1st dose on 18 May 2000, 2nd dose on 7 September 2000 and 3rd dose on 2 November 2000), hepatitis B vaccine (3rd dose - Previous doses: 1st dose on 18 March 2000and 2nd dose on 7 May 2000), MMR vaccine (3rd dose - Previous doses: 1st dose on 14 December 2000 and 2nd dose on 18 July 2001) and polio vaccine (4th dose - Previous doses: 1st dose on 18 March 2000, 2nd dose on 18 May 2000, 3rd dose on 22 June 2000 and 4th dose on 7 September 2000). Concurrent medical conditions included iodine allergy. Concomitant products included MENVEO, PNEUMO 13, VARIVAX and BOOSTRIX. On 3rd September 2015, the patient received the 2nd dose of MENVEO (injection) 1 dosage form(s) 7 days after receiving the 1st dose which leads to an inappropriate schedule. On 4th September 2015, the patient experienced injection site edema. On 2nd October 2015, the patient experienced slight temperature, cough nonproductive, headache, spasms and rhinorrhea. On 5th September 2015, the outcome of the injection site edema was recovered/resolved. On 9th October 2015, the outcome of the slight temperature, cough nonproductive, headache, spasms and rhinorrhea were recovered/resolved. It was unknown if the reporter considered the inappropriate schedule of vaccine administered, injection site edema, slight temperature, cough nonproductive, headache, spasms and rhinorrhea to be related to MENVEO.
vaginal spotting 3 days after injection, injection site delayed hypersensitivity reaction/RASH 8 days after injection
OBSTRUCTIVE SLEEP APNEA 4/12/2023 DM 2 W HYPERGLYCEMIA
Case number PHEH2014US024350, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a follow-up from a nurse received on 22 Jan 2015. This report refers to a 77-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 06 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. Follow-up from a nurse received on 22 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
My daughter at the age of 15 was mistakenly given Janseen vaccine for Covid at the Pharmacy
This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating like a pig) and PYREXIA (Fever of 103) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweating like a pig) and PYREXIA (Fever of 103). At the time of the report, HYPERHIDROSIS (Sweating like a pig) and PYREXIA (Fever of 103) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Body temperature: 103 (High) 103 degree. Symptoms: It was reported that the patient had received second dose of Moderna COVID-19 vaccine six months before.No concomitant medications were reported. No treatment medications were reported.
Headache, shivering, fever, upset stomach, diarrhea, shoulder extremely sore.  Took some aspirin for the headache and went to bed for the rest of the day and night. Feeling a little better morning of 7/31/2019, still have a slight headache and shoulder is still very sore to touch or move.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium
ErythemaMultiform, UrticariaPruritus, Local redness and swelling to inj site. Narrative:  Pt. PCP prescribed Triamcinolone cream topically to injection site w/ mod symptom relief.
TRIANGLE-SHAPED REDNESS & SWELLING OF LEFT DELTOID WHERE VACCINE RECEIVED
Patient stated throat felt warm and chest pressure. Onset about 10 minutes after vaccine. Dissipated after another 10 minutes. Kept under observation for 1 hour. Vitals normal though patient stated BP higher than her norm.  Note from MD: 58 year old female who states 10 minutes after vaccination she developed warm feeling in chest. Possible cardiopulmonary symptoms. No other complaints. No cardiac history or additional symptoms. Symptoms lasted 10 minutes. At time of exam, symptoms were gone. Exam: No throat swelling or rash; otherwise unremarkable. Plan: Discuss possibilities and treatment options with patient. Recommend home with primary care provider follow up. Unlikely to be significant allergic reaction.
Body aches, fever, weakness, fatigue, sharp pains in arms, hands and feet, chills, extreme headache
pt recv vax 12JUL96 & 16JUL96 pt exp a fever followed by an erythema multiforme-type rash described as a macular rash w/a central dusky appearance;
15 minutes after vaccines patient walked 1 block to school. During this week she tells me she fainted 2X. Patient went to her teacher who told her to go home but call 911 or clinic if any trouble breathing. Teacher told this nurse patient was shaky. I called patient at home X3. Call if symptoms reoccur or elevation of symptoms. "I feel fine". Reviewed v/s again over the phone. She has them with her. Guardian is with her & says she is good. Will call 911 if symptoms reoccur.
late evening & throughout noc 1SEP92 to 2SEP92 fever to 104 had been given APAP since vax; called ER due ot pt twitching & glassy eyed;
Chills/fever beginning Saturday afternoon, progressed to body aches and respiratory symptoms by Saturday night.  Symptoms continued until I presented at urgent care with shortness of breath and EKG changes on 10/27/2016.  I was transported by ambulance to the emergency room where I was admitted for 4 days with pneumonia and EKG changes.  Discharge on 10/30/2016 with numerous at-home medications and follow-up appointments.
In the middle of the night 12/19/19 approx 1:00am  (approx 16hrs after the flu shot, I moved from the couch - 18inches high - to bed  -29inches high, after walking room to room for a minute eg using the bathroom, turning off lights; After getting up on the bed, I leaned on my left hip to lie down and as I went to put my head on the pillow it felt like the bed and room were moving.  I had a sensation of falling.  This passed once I settled in bed.      The same thing happened going to bed that night Thurs 12/19/19.   12/20/19 I had the sensation while turning over.  For one week from Weds 12/18/19 I had a vague sensation it was starting a few times so I moved slowly when transitioning/turning over.   I had no trouble walking, driving, shopping,  shovelling snow.   I did not faint.  I also woke up with a headache -  I believe it was Sat 12/21/19  This is not uncommon but also not a regular thing.  I took 1000mg Tylenol and it resolved in a few hours.  My throat/voice were raspy as if I were coming down with a cold for a day and this passed.
EXTREME TIREDNESS;  FEVER OVER 100;  EXTREME WEAKNESS;  NEED TO SLEEP - 23.5 HOURS
On the evening of November 09, 2019 Pt. began to experience symptoms of a sinus infection. Pt. treated symptoms with Tylenol at the standard dose, and with Clindamycin HCL, 300 mg. q 6 hours for three days. Symptoms improved, however pt. experienced unusually dark urine the morning of November 12, 2019. Pt. is prescribed standing order clindamycin due to frequency of UTI secondary to urinary catherization, but had not taken any drugs for several weeks prior to the vaccination. If symptoms continue, pt. will receive care via either Emergency Department or a PCP as appropriate. There is nothing further to report at this time.
About 3-4 hours following shot, became very tired, eye pain, pressure headache.  Symptoms have continued.  Went to the doctor in December, received prednisone, and it reduced the eye pain.  Fatigue and headaches are still continuing.
Myalgia & Arthralgia  Narrative:  dose 2-soreness in arms, back, upper legs, headache, chills and fatigue   Other Relevant History:
Systemic: palpitations and rapid heart rate/rythm-Medium, Systemic: Tachycardia-Medium
Child here for school vaccines. Discussed Tdap, Meningitis and HPV vaccines. No contraindications noted. Today received Tdap, menactra and HPV vaccines. After she received vaccines she walked across room to sit down in another chair and within 1 minute of vaccines child became pale, body started to go limp in chair. Called for help, child was limp in chair, eyes rolled back in head, child lost brief consciousness @ 10-15 seconds, nurse was standing in front of child. Once child regained consciousness, her body stiffened and she had a brief jerky movement of her upper and lower extremities lasted only a few seconds. Dr. (clinic medical director) was in the room, supporting child's head. Child was slow to respond to questions asked. Laid her down on clinic bed. BP 90/42 HR @80. Ice pack applied to forehead. Child was able to answer basic questions but slow to respond. Had her drink some juice and laid in clinic bed for 30 minutes after incident. BP 115/50 HR @80. Dr. and RN spoke with mom. Dr discussed that child may have had a seizure and that she needs to be seen by her doctor for follow up and consult with neurologist for possible further testing. Mom asked appropriate questions and agreed to do the follow up. Child slowly became more awake and alert after lying down for over 30 minutes. Child stated that she felt tired but was able to verbalize and stand up and walk. Dr assessed child and was ok with child leaving to go home with mom. Walked with child and mom to the car. Child was back to herself and feeling better. Received mom's info to follow up with her.
Twelve hours post-injection, fever, chills, fatigue, shakey, aches. Continued for 23 hours and counting. Injection site pain moderate for 20 hours.
Baby was born. We visited with the baby. The baby was then taken to the nursery for hep B shot. Baby was brought back to mother to feed. After feeding, father noticed baby's fast heartbeat and wheezing sound. Nurse took baby away. Doctor informed parents that the baby was having difficulty breathing and an usually fast heart beat. Baby was entered into NICU where they continued to treat baby for "illness." Doctors could not detect what the "illness" was and did not inform parents of possible adverse reaction to the hep B vaccine. Baby was discharged 2 weeks later.
VACCINES GIVEN IN ERROR. HEP A GIVEN TOO EARLY. DTAP NOT NEEDED.
Oculo- Respiratory syndrome symptoms, sore throat, cough, tightness of breath, bilateral red/tearing eyes with conjunctivitis like characteristics plus fever (100.6 -101) occurred starting one hour after injection and braking 6 hours after injection. Overview faxed to VAERS. She quoted the Guillain-Barre Syndrome.
fatigue; Swelling of lymph node region under arm and into left breast.; Temperature increase of 1.9°F above normal; headache; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration in left arm on 11Mar2021 at 13:45 (at the age of 46-years-old) as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient neither diagnosed with COVID-19 prior to vaccination nor tested post vaccination. On 12Mar2021 at 04:45, the patient experienced fatigue, swelling of lymph node region under arm and into left breast, temperature increase of 1.9 degree fahrenheit above normal, headache. On 12Mar2021, the patient underwent lab tests and procedures which included body temperature result: increase (temperature increase of 1.9 degree fahrenheit above normal), body temperature: 1.9 degree Fahrenheit (temperature increase of 1.9 degree fahrenheit above normal). No treatment was received for the events. Outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
~10 minutes after injection of Zostavax, Pt stated that she had an itchy throat and that her ears felt itchy.  Administered diphenhydramine.  After observing pt for ~20 min, she stated that she felt better and left pharmacy.  Called pt ~3 hours later, only had sore throat.  Called again ~1 hour later, no sore throat only hoarseness.
Received 2nd dose of Moderna on 1/26/21 and was admitted to the hospital (IVCH) for septic right knee on 2/17/2021