chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of behavioral changes in a 5 year old male pt who received DTAP (Infanrix) for prophylaxis. A physician or other health care professional has not verified this report. In April 2003 the pt received the 5th dose of Infanrix. At an unknown time post-immunization, the pt experienced behavioral changes, aggression, low-grade fever and "severe" upper arm swelling. The outcome of the events is unknown. The reporter declined to provide additional information and declined to grant authorization to manufacturer to contact the vaccine provider.
Became "lethargic" 1 hour after MMR Then developed rectal temp 105 F approx. 8-10 hrs after vaccine.
MODERNA COVID VACCINE #3 GIVEN 11/2/21, LOT #045C21A; patient had a previous hospitalization for COVID pneumonia and respiratory failure (dates and tx not in medical records); patient had a second hospitalization from 2/4/22 - 2/14/22 for worsening hypoxia and increasing heart rate, complicated by aspiration pneumonia; patient finished steroids and ABX in hospital; required supplemental O2; DNR/Comfort Care; DC'd to hospice care where he passed away.
Soreness, redness and large welt developed. Site hot and painful. 5/5-5/7 worsening with increased area of redness, swelling and pain. Now transverses the arm. Worsening despite heat/ice therapy.  Taking Celebrex already.
I received the vaccines on Tuesday afternoon and woke up around 11;00 p.m. with chills, fever100.7-102.5, body aches, tiredness, nausea, severe flu-like symptoms. The symptoms have continued thru Thursday at the same level not improving yet. The site of injection is red swollen and has some whelp looking places.
HARD LUMP AT INJECTION SITE THAT IS STILL THERE AT PRESENT (OVER 1 MONTH SINCE SHOT)
2 mo old infant experienced fever 101, swelling, increased warmth & mild induration at injection site, becam very irritable with unconsolable crying for approx 3 hrs & restless sleep throughout the night following first DTP/OPV immunization
This spontaneous report as received from a nurse refers to an 8 months 21 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) Liquid PEDVAXHIB (injection, lot # K016965, exp. date: 20-JUL-2007) (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. NO additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
19APR96 t102;20APR96 rash, t105;21APR96 seen @ hosp ER-tx w/amoxicillin dx w/ear infect;23APR96 t102.7, irritable referred back to ER
Although vaccinated twice for MMR, he never mounted mumps specific IgG; Literature report:.   This literature marketed report has been received from authors of the literature article entitled as stated above. Acute Otitis Media (AOM) was one of the most common reasons for antibiotic use in early childhood. The article explored the challenges when AOM fails traditional therapies and immunologic evaluation did not identify a commonly described immunodeficiency.  This report referred to an 18 months old male patient, who presented with 12 episodes of AOM and recurrent purulent otorrhea requiring intravenous antibiotics. Laboratory evaluation revealed a normal complete Blood Count (CBC), normal immunoglobulins (IgG 588 (unit unknown), IgA 76 (unit unknown), IgM 63 (unit unknown), IgE 12 (unit unknown)) and IgG subclasses. Lymphocyte subset panel was normal. Initial responses to diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTaP) and pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) boosters were normal, however, there was rapid decline to tetanus and pneumococcal antibody titers.   On unknown dates, the patient was vaccinated with twice measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis.     Although vaccinated twice for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), he never mounted mumps specific IgG (mumps antibody test negative). Mitogen response to phytohemagglutinin (PHA) was normal with decreased responses to concanavalin A (ConA) and pokeweed and no detectable tetanus nor candida responses. Further investigation revealed decreased non-class and class switched memory B-cells. The patient was recently vaccinated to Pneumococcal Vaccine, Polyvalent (23-valent) and at the present time has protective titers.  The outcome of mumps antibody test negative was unknown. The reporter considered mumps antibody test negative to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown).     A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports obtained from the same literature (link # 2008USA002279).; Sender's Comments:  US-009507513-2008USA002279:
Next day I woke up to complete body soreness and fatigue.  Day 2 had same symptoms as when I had Covid.  Consisted of muscle cramping, fatigue, headache, chills, fever of 100 degree. Day 3 symptoms went away.  Had positive Covid test December of 2020.
This vaccine was used after BUD. Parent  did not report any  adverse reaction after receiving this vaccine.
PT EXPERIENCED INCREASED REDNESS THAT BEGAN AT THE INJECTION SITE AND SPREAD DOWN TO THE ELBOW. THERE WAS ALSO SWELLING AND BODY ACHES.
This spontaneous report was received from a medical assistant refers to a patient of unknown age (gender unspecified). On 26-SEP-2012, the patient was vaccinated with a dose of expired PNEUMOVAX23 (lot # 669382/1490Z, expiry 14-AUG-2012). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Severe vertigo; This is a spontaneous report from a non-contactable consumer, the patient. A 79-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration on the right arm on 02Mar2021 at 14:45 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (COMIRNATY, Lot number: EN6201) via an unspecified route of administration on the right arm on 09Feb2021 at 02:15 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. On 05Mar2021 at 07:00, the patient experienced severe vertigo. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included scheduled therapist visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe vertigo was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with their second dose of GARDASIL 9 (lot #, expiration date, exact doses and route of administration were not reported) as late as 6 months after the scheduled due date for second dose. No adverse effects were reported. Additional information has been requested.
sore arm/Arm pain; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/Arm pain) and HEADACHE (slight headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm/Arm pain) and HEADACHE (slight headache). At the time of the report, PAIN IN EXTREMITY (sore arm/Arm pain) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
extremely dizzy when first got out of bed.  Difficult to walk.  Mostly abated in a few minutes.  Very sore at location of shot
30JUN92 @ approx 1030AM pt recvd vax & @ 1035AM pt fell to floor; first aid & assessment given on site immed (02 given, feet up, BP taken, pulse also, etc) pt was ashen colored, lips blue, skin cool & clammy, eye non-dialated & unfocused;
03/23/2023 I had a sore throat, intermittent cough, body aches, headaches, no appetite, cold extremities, shortness of breath, High Grade fever, I called PCP telehealth line and left a message and heard from them within 24 hours. I was prescribed a course of PAXLOVID. I still have lingering fatigue I usually sleep about 6-7 hours a night since COVID-19 I am so fatigued that I sleep 10-12 hours per night. I took OTC DAYQUIL, NYQUIL, TYLENOL, ALEVE, cough drops and a VICKS vaporizer for congestion.
Patient received first dose of COVID 19 vaccination Pfizer on 04/09/2021, he received his 2nd dose of vaccination COVID 19 Moderna on 04/28/2021.
Patient reported dizziness. Elevated blood pressure at 148/93 mmHg. Heart rate and temp were within normal limits. 5 minutes after vaccine administration, patient reported feeling better. She denies numbness, tingling, pain, and headache. Blood pressure was 148/84 mmg.
pale, clammy, responded to voices 5min p/vax; BP @ 2min intervals: 114/72, 116/74, 112/72 p/45min became alert, warm & dry;
Noticed missing hair just below and to the right of the crown of head about the size of a quarter on 7/29/2021.  Checked regularly and about 8/17/2021 noticed the size of the missing hair had grown to about the size of a half-dollar.  The following day 8/18/2021 noticed substantial chunk of hair dandling from left temple. Gently tugged and it came out with any force.  Scheduled dermatologist appointment for as soon as possible to determine official diagnosis, treatment and expected outcomes.  Soonest available times are weeks out (8/27/2021).  Suspect this could be Alopecia Areata.
Information has been received from a pharmacist concerning a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with VAQTA, intramuscularly for prophylaxis (dose, lot# and expiry date were not reported). On an unknown date the patient experienced incorrect dose administered and no adverse event. Follow up information has been received from a registered nurse concerning the 32 year old male patient. The patient had no illness at the time of vaccination and adverse event following a prior vaccination. On 12-JUL-2017, the patient was administered a pediatric dose of VAQTA (25U/0.5ml) intramuscularly in the left shoulder, lot# N012324 with expiry date 05-APR-2018. Company gave full dose (adult) vaccine to the patient.
swelling and redness of the left lower eyelid; swelling and redness of the left lower eyelid; itching and swelling below the area of a typical vaccine, mid-tricep area and not in deltoid; itching and swelling below the area of a typical vaccine, mid-tricep area and not in deltoid; slight redness which is not vesicular; This case was reported by a physician via call center representative and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th May 2021, the patient received the 1st dose of Shingrix. On 9th June 2021, 13 days after receiving Shingrix, the patient experienced pruritus, swelling and erythema. On 10th June 2021, the patient experienced swelling of eyelid and erythema eyelid. On an unknown date, the outcome of the pruritus and swelling were not recovered/not resolved and the outcome of the erythema, swelling of eyelid and erythema eyelid were unknown.   It was unknown if the reporter considered the pruritus, swelling, erythema, swelling of eyelid and erythema eyelid to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in left arm. Two days before day of reporting patient had onset of itching and swelling below the area of a typical vaccine, mid-tricep area and not in deltoid, with slight redness which was not vesicular. On day before reporting she had onset of swelling and redness of the left lower eyelid. No further details provided during the time of reporting. The reporter stated the dose was not administered by him, so he did not have the lot number available for the dose. The reporter consented to follow up..
severe tinnitus, hearing loss along with body aches the day following 2nd dose of Moderna.  The body aches cleared after one day, the tinnitus and hearing loss has not.  The symptoms are more pronounced and severe in the morning and clears to more manageable levels by mid-day
I was fine when I went to bed the night I got the shot 02/05/2021 then the next morning I woke up with hives covering the arm opposite of the shot, and my knees had small spots as well it went away an hour later and then come back about 2 hours later and I was covered again all down my legs and arms were covered in hives. I also had body ache and a horrible headache the whole day. I took Benadryl for the hives and it seemed to have worked. The adverse events happened on 02/06/2021
Pt developed an anaphylaxis reaction to vaccine with resultant "throat tightening" and voice changes.  Epi administered.  EMS was alerted and patient was transported to the hospital.  Of note, prior to leaving she received benadryl.
Patient reports noticing a rash that encircles the area of the left arm where the vaccine was given.
I received my 4th dose of Pfizer Bivalent Booster on 09/24/2022. After 1 month of my COVID-19 vaccine I got a cold. My cold symptoms started on 10/27/2022 in the morning as soon as I woke up at 8:00AM. I had severe sore throat for 2 days straight, chills, nasal congestions and cough. My sore throat changed to a minor sore throat. I did a telehealth with my doctor on 11/02/2022. He prescribed me with benzonatate. I had thick phlegm cough that lasted for 8 weeks. I was very congested. It was hard for to sleep because of the cough which occurred continuously. I never had this before. As of today I am completely recovered.
Patient states she had no appitite after her shot and then went to bed. The next day she said she was making tea, got off the couch and then passed out hit her knees and head. She stated she has had postural hypotension and was possibly hypoglysemic. SHe was advised to contat her doc to report the event.
Severe fever, chills, 3 days straight-right foot big toe and second started itching with hives. Started 4 days ago.
Seizures after giving 6 month vaccines Dtap, IPV, Hib, PREVENAR, Rota, seizure (GTC) occurred on the night of the visit.
Vertigo. No rash, or fever or nausea. Lack of balance. Lighted clock face moved up and down in the dark when I was still. Disorientation.
On December 4th I suffered from Broken Heart Syndrome.  My husband had fallen that evening and I had the attack when the emergency crew was here.
Patient was due for her menstrual cycle the first week of August. Last menstrual period was around 7/3/21 or so. Pt got first Moderna vaccine 8/1 and the second shot 9/1 and her menses are still absent. Unclear if this is related to the vaccine but workup is being done.
Observation 6/26/22-6/27/22 Fever, UTI, malaise, tachycardia, sepsis, decreased appetite,
Shivering; fever; Muscle pain in top of left arm; nausea; pain in the injection site / pain in his upper left arm; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th January 2021, the patient received the 1st dose of Shingrix. In January 2021, 24 hrs after receiving Shingrix, the patient experienced injection site pain, fatigue, nausea and muscle pain. On 29th January 2021, the patient experienced shivering and fever. On an unknown date, the outcome of the injection site pain, fatigue, shivering, nausea, muscle pain and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fatigue, shivering, nausea, muscle pain and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid. The patient experienced fever and shivering which started about 8 hours after the vaccination and resolved the next day. On 30th January 2021, the patient experienced pain in the injection site, pain in his upper left arm, tiredness, and nausea which resolved 3 to 4 days later. The patient was concerned if he would experience injection site pain when he gets his next Shingrix vaccination. The reporter consented to follow up.
Patient arrived at mass vaccination clinic in no distress.  Has hx of migraine disorder - mom states its been "many years since last seizure".    States neurologist recommends vaccine.  Patient tolerated well but complained of frontal headache soon after administration.  Was given juice and crackers and did well.  Over the next 30 minutes, she complained of more sx including nausea, diarrhea, and chest pain.  Vitals - BP - 98/60, HR - 84.  EMS was called d/t c/o of chest pain.  She was transported to ED via ambulance.  Left facility in stable condition.
Rash, slight swelling at injection site on left arm, blotches with redness.
Received only the adjuvant; Received only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA729A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-DEC-2022 Reporter's Comment: The reporter was clinical supervisor.  The reporter reported, one of their patient received only the adjuvant, instead of the reconstituted vaccine.  The reporter reported not being certain of whether this patient was the one who received only the adjuvant, as they had narrowed it down to two possible patients. The reporter consented to follow up.  Additional Supportive Information: The reporter reported, one of their patient received only the adjuvant, instead of the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022184438:Same reporter
The day following vaccination, the patient experienced a rapid, tachycardic, and irregular heartbeat. During the subsequent days heart related symptoms worsened and the patient's heart became extremely painful when breathing in. Any amount of physical movement, whether getting up from a chair or walking at a slow pace, caused the patient's heart to beat rapidly and intensely. The patient's resting heart rate also remained elevated even during periods of physical inactivity  These symptoms worsened and on October 18, 2021, the patient experienced heart attack symptoms starting with a numb and squeezing feeling beginning in the left arm/tricep. This squeezing feeling intensified and the patient's heart rate increased alongside the intensity of heartbeats, to the extent that the patient's heart palpitations were visible through a sweatshirt. He experienced pressure in the chest which felt like a weight on his heart as well as tightness between the chest and left shoulder and an increased difficulty breathing. The patient called an ambulance and was taken to the emergency room and diagnosed with heart palpitations   Following the emergency room visit, these symptoms have not subsided. The patient continues to experience a racing and pounding heart, arrythmia, and exercise intolerance. Previously a lifelong athlete, the patient is no longer able to physically exert himself beyond a minimal level without return of the symptoms of tachycardia, difficulty breathing, and chest tightness
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 40-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 16-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter US-GSK-US2023AMR061580:same reporter US-GSK-US2023AMR062067:same reporter US-GSK-US2023AMR061582:same reporter US-GSK-US2023AMR061583:same reporter US-GSK-US2023AMR061581:same reporter US-GSK-US2023AMR062059:same reporter US-GSK-US2023AMR062065:same reporter US-GSK-US2023AMR062063:same reporter US-GSK-US2023AMR063143:Same reporter US-GSK-US2023AMR063144:Same reporter US-GSK-US2023AMR063145:Same reporter US-GSK-US2023AMR063147:Samer reporter US-GSK-US2023AMR063148:Same reporter US-GSK-US2023AMR063149:Same reporter US-GSK-US2023AMR063143:same reporter US-GSK-US2023AMR063144:Same reporter
an opened Ipol vaccine that was opened and exposed to a lowest temperature of 1.7C for 16 minutes and a highest temperature of 9C for 22 minutes/ no AE; Initial information received on 28-May-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves adult patient (younger than 18/ gender not reported) who was vaccinated with a dose of IPV (VERO) [IPOL] (batch number: P1A242M and expiry date: 26-APr-2020) via intramuscular or subcutaneous route in the arm on an unknown date.  Relevant medical history: Most likely received more Ipol in the past.  Concomitant medications were not reported.   It was a case of actual medication error due to incorrect product storage.  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 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.   Documents held by the sender: none.