chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 36 year old female patient, with chronic hypertension with a history of 2 pregnancies with delivery at 25 weeks with multiple defects and one death associated with her hypertension, who on 12/10/02, when on her menstrual period, was vaccinated with a dose of MMR (second generation) ( lot # 642645/0527M). Concomitant therapy included hydrochlorothiazide (+) valsartan, vitamins and aspirin. Subsequently, she became pregnant. Her last menstrual period was reported as 12/7/02. The patient delivered prematurely, on 6/16/03 (previously reported as 6/18/03), a healthy, normal baby with no congenital defects or complications. It was reported that the premature delivery was related to the patient's hypertension. Follow up information from the nurse practitioner indicated that the patient delivered a 2 pound female baby at 28 weeks gestation due to preeclampsia. It was reported that the patient was diagnosed with gestational diabetes 12 weeks from LMP on approximately 2/28/03. Other concomitant medication included amlodipine besylate (+) benazepril hydrochloride from 12/7/02 until 1/28/03 and the patient was then switched to methyldopa on 1/28/03. Lab and diagnostic studies included a positive urine pregnancy test on 1/28/03, and an ultrasound done at 8.2 weeks gestation which showed a single viable in vitro pregnancy with ultrasound age of approximately 7 weeks and 2 days and ultrasound EDD of 9/20/03. Upon internal review, premature delivery at 28 weeks was considered to be an important medical event (OMIC). A 15-day follow up report received 11/13/2003 adds: In follow up info from the nurse practitioner it was reported that the pt did not experience any adverse events following prior vaccination. It was also noted that "no adverse events occurred and mother and baby are fine." According to the reporter, the pt recovered on 06/16/2003. Upon internal review, premature delivery at 28 weeks was considered to be an important medical event.
spiked a fever up to 103 p/day 7 dose which cont to persist; also has muscle aches & pains w/dizziness; pt also thinks nurse may have hit shoulder tendon when giving shot; p/return to USA was informed a pt cared for died from rabies;
pt recv vax; exp inflam,tenderness,itching,swelling & pain at inject site;myalgia & fever of 102;
Facial and truncal urticaria, no signs of anaphylactic shock or asthma, within 1 hour of administration of vaccine.
Patient states her left upper arm is swollen and sore.  No redness, heat, or skin breaks.  Denies any other symptoms.  She has not sought medical treatment.
Arm is little hard; Arm is swollen; Arm is little red; Arm was hurting a lot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jan-2021 and was forwarded to Moderna on 11-Jan-2021.    This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INDURATION (Arm is little hard) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for an unknown indication.    On 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Arm is little hard). At the time of the report, VACCINATION SITE INDURATION (Arm is little hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment was received.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Menstrual cycle started 11/15 (normal date), but lasted 9 days.  Normal cycle is 4-5 days.
Sore arm 2 weeks later. Hurts to lift or move it Chills-24 hours later Low grade fever, chills, and muscle aches for 2 weeks after shot Diarrhea and vomiting a week after shot
Difficulty breathing. Not severe enough to warrant emergency treatment but needed to put effort into breathing. When I tried to fall asleep I was woken instantly because I stopped breathing. This lasted about 12 hours Severe headache - did not take any medication. Lasted 36 hours Nauseous - did not take any medication. Lasted 36 hours
I noticed on 10/8/15 that my tounge felt like I had burned it and starting to loose my taste. Then on 10/9/15, I noticed that I had developed a pain on the left side of my head under my ear. I thought it was a headache and took Tylenol. Then on 10/10/15 when I tried eatting my breakfast I could not open my mouth all the way. It felt like I had gone to the dentist and I lost all feeling on the left side of my face. I thought I was experiencing a stroke because I couldn't close my left eye, couldn't smile or open my mouth all the way. The left side of my face was paralized. I could only experience taste on the right side of my tounge. I quickly called the OB doctor on call and was told to go to Urgent Care. I was then diagnosed with Bell's Palsy.
Low grade fever day after immunizations with a 5 cm  area of redness, without enduration or heat. On lower right leg and left wrist  1 cm papular rash with endurated center that is yellow.
MODERNA COVID-19 VACCINE EUA: Patient received Moderna vaccine dose on 031121 then reported shortness of breath, narrowing of airway shortly afterward during the observation period. The code team was summoned. She remained communicative during the event. Oxygen saturation initially measured was 99% and remained stable throughout. She received 1 dose of epinephrine SQ (right thigh). The patient remained onsite for continued vital sign monitoring for 1 hour then was released to home.
Rash, fever (102-103) sore throat to ER 22DEC90; MD gave prescription for Ceclor, strep type sx to diagnostic test.
WET MUCUS IN MOUTH; MOUTH WITH FOUL ODOR; MOUTHFUL OF WHITE THICK FLUID; FEELING OVERALL SICK; FATIGUED; FEVER; COULD NOT CATCH BREATH; COUGH; CHEST PAIN; CONGESTION; TACHYCARDIA; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included head injury, and concurrent conditions included cannot read/see very well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805829, expiry: UNKNOWN) dose was not reported, administered to left deltoid on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen, and paracetamol. On 21-MAR-2021, the subject experienced congestion. On 21-MAR-2021, the subject experienced tachycardia. On 21-MAR-2021, the subject experienced chest pain. On 21-MAR-2021, the subject experienced cough. On 21-MAR-2021, the subject experienced could not catch breath. On 21-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99-100. On 22-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102. On 28-MAR-2021, the subject experienced wet mucus in mouth. On 28-MAR-2021, the subject experienced mouth with foul odor. On 28-MAR-2021, the subject experienced mouthful of white thick fluid. On 28-MAR-2021, the subject experienced feeling overall sick. On 28-MAR-2021, the subject experienced fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, chest pain, could not catch breath, and fever on 23-MAR-2021, and feeling overall sick, and fatigued on 31-MAR-2021, and had not recovered from congestion, mouth with foul odor, cough, wet mucus in mouth, and mouthful of white thick fluid. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
It was a Tdap but I am unsure of which type. I hadn't had one in 15 years so I assume it wasn't the booster.  08:00am: Pain and swelling at the injection site, headache, dizziness, extreme fatigue, onset of autoimmune flare.
PT DAUGHTER REPORT BY PHONE: 8/31/21:  FLU-LIKE SYMPTOMS AND BODY ACHE 9/1/21: HANDS TREMBLED ADN MUSCLE PAIN IN LEG. PATIENT TO PCP FOR LAB WORK AND WAS REFERED TO NEROLOGIST, BUT PT WILL GO TO ER INSTEAD TO CALM ANXIETY.
Covid Arm, small red patch around injection site, no pain or swelling just red and sometimes slightly itchy.
pediatric dose of Engerix-B was administered to an adult; pediatric dose of Engerix-B was administered to an adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 43-year-old female patient who received HBV (Engerix B pediatric) (batch number 9KG7R, expiry date 9th May 2022) for prophylaxis.   On 24th August 2021, the patient received Engerix B pediatric. On 24th August 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The clinical team lead reported that, the pediatric dose of Engerix-B was administered to an adult patient, which led to underdose and adult use of a child product The reporter consented to follow up.
wrongful death; shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. No information has been received regarding the pt's past medical history, concurrent conditions, or concomitant medications. In 2013, the pt was inoculated with Zoster Vaccine Live (ZOSTAVAX) at a clinic, by a healthcare professional, for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, anatomical location, lot number and expiration date were not provided). Subsequently, the pt was treated by a healthcare professional at a medical center for shingles (herpes zoster). On an unknown date, the pt died (reported under specific allegations as Count IV: wrongful death) (conflicting information: pt's death was reported, however the pt was reporting on behalf of herself/himself). It was unknown if an autopsy was performed, and the cause of death was not reported. The outcome of herpes zoster was unknown. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).
Patient came into pharmacy on 2-1-18 indicated that after administration of shot on left arm the area had been achy, had become red and hot. RPH looked at area and the area was Indeed red, called PCP, did not receive and immediate response, called back around 4pm and was informed PCP was gone for the day, another doctor at the practice indicated that patient should be seen, this was relayed to the patient and the patient made an appointment to be seen this evening.
yellowing of eyes indicating liver damage; yellowing of eyes indicating liver damage; bronchitis; UTI; severe stomach cramping; diarrhea; This spontaneous case was reported by a patient and describes the occurrence of LIVER INJURY (yellowing of eyes indicating liver damage) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER INJURY (yellowing of eyes indicating liver damage) (seriousness criterion medically significant), OCULAR ICTERUS (yellowing of eyes indicating liver damage), BRONCHITIS (bronchitis), URINARY TRACT INFECTION (UTI), ABDOMINAL PAIN UPPER (severe stomach cramping) and DIARRHOEA (diarrhea). At the time of the report, LIVER INJURY (yellowing of eyes indicating liver damage), OCULAR ICTERUS (yellowing of eyes indicating liver damage), BRONCHITIS (bronchitis), URINARY TRACT INFECTION (UTI), ABDOMINAL PAIN UPPER (severe stomach cramping) and DIARRHOEA (diarrhea) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Since receiving the vaccine, the patient experienced yellowing of eyes which indicated liver damage, bronchitis, UTI, severe stomach cramping and diarrhea.  No treatment medications were reported. Company comment:  This is a spontaneous case concerning a patient of unknown age and gender, with no medical history reported, who experienced serious (medically significant) unexpected AESI of liver injury (reported as yellowing of eyes indicating liver damage) which occurred in context of SPIKEVAX 2023-2024 dose administration which was described as unknown dose of COVID-19 vaccination schedule. Latency cannot be calculated due to event onset date unknown. The event was reported along with non-serious events of ocular icterus, bronchitis, urinary tract infection, abdominal pain upper and diarrhoea. There is no information provided regarding medical history, concomitant medications, diagnostic tests performed, clinical course, etiologic and diagnostic work up with treatment received. The benefit-risk relationship of the SPIKEVAX 2023-2024 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2023: Follow-up information included reference number updated.
Rash all over body and fever of 101.6F on Friday but rash developed on Sunday. Exam on 5/21/2001 showed skin with multiple pinpoint blanching, erythema papules distributed all over his arms, legs and trunk. Pt was prescribed Benadryl 12.5mg and Calamine lotion.
Extreme fatigue, migraine headache, reactivation of latent Epstein-Barr virus
a patient received a Menactra vaccine which was exposed to negative 1.8 Celsius for about 18 hours and was non viable/No AE; Initial information received on 25-Aug-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 11-years-old female patient who was mistakenly vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (single dose vials) (lot U6596AB and expiry date 24-MAY-2021) via intramuscular route at the left deltoid for prophylactic vaccination on an unknown date which was exposed to negative 1.8 Celsius for about 18 hours and was non viable (product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and Human Papilloma Virus (HPV) VACCINE VLP RL1 9V (YEAST) for prophylactic vaccination.  It was an actual medication error case due to product storage error temperature too low.  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.
Patient passed out and ended up falling off the chair hitting his forehead (left side)on the concrete flooring. Patient seemed to be doing okay after being observed by EMS for about 45 minutes. BP 110/74, denied dizziness or nausea but was complaining of headache. Patient's mother refused transport to ER.
PATIENT DEVELOPED SWOLLEN LYMPH NODES IN ARMPITS. DISAPPEARED AFTER A FEW DAYS
The next day about 27 hours  after the vaccine I experienced  chills, 99 degree fever, body aches, headache and lethargy.  Tylenol 500 mgm 2 tabs taken every 6 hours with moderate relief.  Symptoms were gone after 18 hours of bed rest and oral fluids
This reporter received documentation for pt. here for first dose of Pfizer vaccine, found by clinical staff 'slumped over in chair'. Pt. reported to partner feeling lightheaded and dizzy before event. Aid called and pt. laid down on cot. A&Ox4, VSS, diaphoretic. States this has happened before during blood draws. {t/ cleared by EMS to exit facility with partner.
Received vaccine on 09/29/17 at 1:32 pm. On 09/30/17 at 1:30 pm, employee developed a red itchy area the size of a softball.
Raised, Red, Itchy area 1 day after intradermal injection site of monkeypox vaccine. Also, notices redness outside of injection site; but - close proximity. Today is day 3 post vaccination. Instruction to monitor - see medical provider for symptoms that do not resolve or worsen within the next 3 -7 days. Appt already scheduled for annual examination on 10/5/2022.
An 86 year old patient received OncoTICE instillations to treat bladder cancer on 12/10/2002, 12/23/2002, 12/30/2002, 01/09/2003.  It is reported that on 12/17/2002 the patient displayed symptoms of a urinary tract infection and a red groin rash, which had spread over the body "from the neck down" by 01/03/2003.  On 01/09 the rash had resolved and the patient received a further OncoTICE instillation.  On 01/17/2003 the rash continued to resolved.  The patient reported that he took 2 doses of ampicillin before the onset of the rash.  Benadryl 1-2 tablets qhs to treat the rash.  01/03/2003- Zyrtec 1 qd (am) to treat the rash.  Prednisone lotion 2.5% to treat the rash.
Presented wtih SOB/hypoxia; + covid PTA; Dx Covid PNA; CXR: interstitial markings in lung bases d/t pul congestion or interstitial pneumonitis; Labs: D-dimer: 1.33 CRP 9.85 Ferritin 407; TX: Zithromax, Maxipime, remdesivir (1 dose) decadron, Singulair, zinc; FiO2 up to 5 LPM NC and then weaned to 2 LPM NC at D/C She was placed on dexamethasone and later Remdesivir added however due to worsening bradycardia it was stopped. She improved on steroids and once medically stable and at baseline she was discharged back to her facility.
5cmx2cm reddened, painful, and  warm area noted to (L) upper arm  at site of injection with associated  fatigue & chills
Shortly after vaccine was administered, while driving home, pt experienced left neck and arm "tightness" that radiated to jaw. 1/2 Benadryl tablet taken at 4:00PM for same symptoms. Another 1/2 tablet of Benadryl + 200mg of Ibuprofen taken at 8:00PM for pain and tightness of left arm and neck. At 5:00AM on 6/13/2012, pt awoke and stated she felt her throat,ears and neck began to "feel itchy". Pt took 1 Benadryl tablet and 200mg Ibuprofen for itchiness and for slight wheezing. At 9:00AM, pt phoned HD to report this reaction. States "I feel pretty good right now - my eyes are a little puffy, but I don't feel itchy or stiff now". Inst. to seek medical help immediately if breathing is compromised.
I feel wiped out; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:2, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 28Nov2021, outcome "unknown", described as "I feel wiped out".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache; Higher temperature than normal; This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 51-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration on 15Mar2021 (age at the time of vaccination 51-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration on 22Feb2021 (age at the time of vaccination 51-years-old), as a single dose for COVID-19 immunization and patient experienced I get a arm soreness after the first dose. On an unspecified date Mar2021, the patient experienced Headache, and Higher temperature than normal. Caller stated it is possible for people to have no side effects after either dose of the vaccine. Caller wants to know how she can know for sure the vaccine was mixed and administered properly. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered pharmacist concerning a 71 year old female with no pertinent medical history and a drug reaction/allergy to Codeine, who on 11-OCT-2007 was vaccinated SC in the back of the left arm with a 0.65ml zoster vaccine live (Oka/Merck) (lot number: 657766/0620U). On 14-OCT-2007 or 15-OCT-2007 (approximately 3 or 4 days later) the patient developed a 6 inch red mark above and below the injection site. The red mark was not raised and was not hot to the touch. The red mark had become dull but the discoloration was still visible. The outcome was reported as recovering. Unspecified medical attention was sought at the pharmacy. There was no product quality complaint. Additional information has been requested.
Reaction on my skin from the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (Reaction on my skin from the shot) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (Reaction on my skin from the shot). At the time of the report, SKIN REACTION (Reaction on my skin from the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided  No Treatment Medications were provided.   Reporter did not allow further contact