chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 23 year old female patient with no pertinent medical history and no drug reactions/allergies. On 25-JUN-2013 the patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot #, expiration date unspecified), intramuscular with no adverse effects. On 26-AUG-2013 the patient was vaccinated with the second dose of 0.5 ml GARDASIL (lot #, expiration date unspecified), intramuscular. On 26-AUG-2013 immediately after the injection, the patient seeing black spots in vision and her ears felt clogged and felt like they were "stuffed with cotton", a feeling of being hot, dizzy, light headed and wanting to pass out. The nurse stated that the patient did not lose consciousness. The patient had no additional symptoms until reporting day, 13-NOV-2013 the patient was vaccinated with the third dose of 0.5 ml GARDASIL (lot #, expiration date unspecified), intramuscular. No concomitant medication was reported. On 13-NOV-2013 the patient experienced the same symptoms. The nurse stated that the symptoms were transient and resolved while the patient was kept in the office for observation after the injection. The nurse stated that the patient reported that she experienced no symptoms between doses. No lab diagnostics studies performed. No treatment was given. Additional information has been requested.
Developed right axillary pain, fullness, and warmth starting Monday, January the 18th,  7 days after receiving the vaccine. The morning of January 19 experienced noticeable right arm swelling, decreased range of motion, and a 4x6cm area of erythema around the injection site. Significant general fatigue starting Monday the 18th. 2x2cm abdominal rash developed on Wednesday the 20th. Resolved right arm erythema and abdominal rash on January 21st. General Fatigue and right arm discomfort are improved but still remain.   Was prescribed Methylprednisolone 4 mg dose pack and cephalexin 500 mg TID on Tuesday the 19th. Did not start medical treatment due to quick improvement of symptoms.
Dizzy, anxious, elevated heart rate, nervous stomach; monitored HR and BP for about an hour till patient was feeling better. She was fine once she got home--I called and checked in with her.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. No medical history, concurrent conditions or concomitant therapies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot #, dose, route of administration and anatomical location were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as the reporter did not wish to be contacted.
no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 19-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
A serious spontaneous report of falling down has been received from a physician concerning a seven-year-old male, subsequent to FLUMIST. The patient had no significant medical history, no concomitant medications and no family history of seizures. On 28-Sep-2011, the patient received FLUMIST. From 08-Nov-2011 through 15-Nov-2011, the patient would either be sitting or standing and would suddenly "fall-out". On 28-Nov-2011, the physician saw the patient and he continued to have the episodes of falling. On 07-Dec-2011, the patient was seen by a neurologist; an EEG was abnormal. The neurologist decided to continue to observe the patient. Eventually, the patient recovered. The outcome of the event falling down was resolved.
Febrile seizure 10 days following ProQuad vaccination - Treated and released from ER.  Return for malaise to children's clinic less than 24 hours.
Left arm, top of the front of shoulder is a lump, soft to touch. Aching pain. Noticed today, because of the  pain starting today.
Pt. complained of a rash with extreme itching on the left upper arm above the elbow which lasted for 1 day then resolved with no further treatment.
daughter stated patient was found on the floor at her facility and was transported to the hospital where she was diagnosed with a CVA.  Unknown if this event was related to her COVID vaccine.
Urticaria occurring 24 hours after vaccine administration.  Treated with Benadryl.
Felt itchy, then at 9:00 PM noticed hives all over torso. Patient took a zyrtec and symptoms relieved by the next morning of 4/12/2017.
Approximately 6 days after receiving immunizations, patient developed a rash on both arms, one leg and her back.  There was no fever or itching.  Patient was seen by 2 MD's who told the Mother that this was "mosquito bites", not a reaction to vaccine.  One month later the rash persists.
PNEUMOVAX 23 and FLUZONE HD administered in left upper arm (1 inch apart). Fever onset evening, redness and swelling and pain of arm. Reported on 9/28 swelling better according per patient.
As per mother, the child became slightly pale around his mouth, 2-3 hours after vaccinations.  It lasted only for a very short time.  He got better by sprinkling cold water on his face.
Runny nose; Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) and RHINORRHOEA (Runny nose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced COVID-19 (Tested positive for Covid). On an unknown date, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, COVID-19 (Tested positive for Covid) and RHINORRHOEA (Runny nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Company Comment: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the event RHINORRHOEA, causality is assessed as possible, however this event could be due COVID-19.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.For the event RHINORRHOEA, causality is assessed as possible, however this event could be due COVID-19.
Information had been received on 19-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 28-JUL-2014 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 23-JUL-2015, the patient was hospitalized for a period of seven days at a medical facility for a painful rash that was diagnosed as a severe case of shingles. Although the shingles virus is an incurable condition, the patient was prescribed Gabapentin for the management of his symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA009630: US-009507513-1704USA009568: US-009507513-1704USA009805: US-009507513-1704USA009830: US-009507513-1704USA009869: US-009507513-1704USA009894:
had a lump on the vaccination area/developing a lump on her arm where she had the injection; her arm was a little sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 20Sep2023 as single dose (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE MASS (non-serious) with onset 2023, outcome "unknown", described as "had a lump on the vaccination area/developing a lump on her arm where she had the injection"; PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "unknown", described as "her arm was a little sore". Additional information: Reported the first week, her arm was a little sore but nothing she was concerned about however going into the 2nd week, she started developing a lump on her arm where she had the injection. States she still has the lump. She   saw her hcp yesterday who told her the lump was either due to the way it was given and there is resulting trauma at the site she had  a reaction to the shot  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
large red spot by injection site (gets larger everyday just about) that is warm to touch as well as itch pretty much everyday since been injected. Also noticed bruising/rash on the same arm just on the other side as well as a brown discolored patch
Intussusception 5-8-08 reduced by air enema on second attempt. 9/8/08-records received for DOS 05/05/08-DC DX: Intussusception. Presented to ED with C/O drowsiness starting morning of ED visit. Poor oral intake and decreased urinary output and no BM today. Observed grabbing at left ear. In ED passed currant jelly stool followed by bloody stool. Observed for 23 hours and discharged.
7 cm X 5 cm raised, red, itchy area surrounding initial injection site - warm to touch, slightly painful to touch.
This case was reported by a consumer (the subject's grandmother) and described the occurrence of seizure in a 7-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's older sister experienced a seizure following an unspecified vaccination; she had been seizure-free for 4 years at the time of reporting. A member of the subject's father's family had also experienced a seizure following an unspecified vaccination. The subject's medical history included fever following various unspecified vaccinations administered in the past. Historic vaccination included 1st dose of hepatitis A vaccine inactivated; manufacturer unspecified; unknown given in June 2010; hepatitis B vaccine recombinant; manufacturer unspecified; unknown series given in 2003 and twice in 2004. On 9 August 2011 at 11:15 the subject received 2nd dose of HAVRIX (.5 ml, unknown route, left arm). On 9 August 2011, within minutes of vaccination with HAVRIX, the subject experienced "head felt funny" and was "burning all over". She went to the restroom and passed out and experienced convulsions. Her complexion turned bluish-white. An ambulance was called and she was diagnosed with having a seizure. The next day, she was dizzy and stated that her head hurt. The subject was hospitalised. At the time of reporting the events were resolved.
Patient complaints of pain, redness, and edema noted at the injection site of a Pneumovax vacinne (lot#J009689). Patient also complains of generalized fatigue, achiness, and headache.
Soreness in arm, exactly the same as what I experienced upon original vaccine. It's a pain/soreness only the upper left arm and it's causing a lot of discomfort but I cannot correlate it to any other experience.
Administration of vaccine past 30 days in the fridge; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past 30 days in the fridge) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past 30 days in the fridge). On 27-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past 30 days in the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
positive to SARs-COV-2; positive to SARs-COV-2; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Feb2021 (second dose) and on an unspecified date (first dose); both via unspecified routes of administration at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was positive to SARs-COV-2. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Headaches, body aches, pain at injection site (left arm sore) and exhaustion.   lymph nodes in left armpit became swollen and painful to the touch starting on 1/8/21 until 1/11/21.
Felt so bad; Coudn't walk; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt so bad) and GAIT DISTURBANCE (Coudn't walk) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (cholesterol). Concomitant products included ALBUTEROL [SALBUTAMOL] for Product used for unknown indication, LEVOTHYROXINE, WARFARIN, LOSARTAN, ALLOPURINOL, ISOSORBIDE, ISOSORBID [ISOSORBIDE], FUROSEMIDE (LASIX [FUROSEMIDE]), METOPROLOL, TRAMADOL, POTASSIUM and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced FEELING ABNORMAL (Felt so bad) and GAIT DISTURBANCE (Coudn't walk). On 31-Jan-2021, FEELING ABNORMAL (Felt so bad) and GAIT DISTURBANCE (Coudn't walk) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.
12-month patient was inadvertently given a dose of Flublok with no reported adverse event; Initial information regarding an unsolicited non-valid non serious case was received from other health professional via Regulatory Authority (RA) Reference number: 00832897) and transmitted to Sanofi on 28-Oct-2021 in.  This case involves a 12-year-old female patient who was inadvertently given a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Oct-2021, the patient received a 0.5 mL total dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [Frequency-1X, Strength: standard, lot QFAA2138, expiry date: 30-Jun-2022] via intramuscular route in the deltoid for prophylactic vaccination.  This was actual medication error case due to Inappropriate age at vaccine administration (latency same day).  It was reporter "Licensed practical nurse (LPN) reported that a 12-year-old patient was inadvertently given a dose of Flublok, yesterday. She requested guidance on how to proceed."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was 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 had contributed to or is to be held liable for the occurrence of this medication error.
chills; nausea/she felt like vomiting all night; It was awful; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (It was awful), CHILLS (chills) and NAUSEA (nausea/she felt like vomiting all night) in an 83-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031283) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in January 2023. Previously administered products included for COVID-19 vaccination: Moderna Covid-19 vaccine (Dose Number: 1, Batch/Lot No: 026L20A) on 01-Jan-2021, Moderna Covid-19 vaccine (Dose Number: 2, Batch/Lot No: 029L20A) on 08-Feb-2021, Moderna Covid-19 vaccine (Dose Number: 3 and Batch/Lot No: 037F21A) on 18-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine. Concurrent medical conditions included Penicillin allergy and Drug allergy (Percocet and a medication for pain (did not remember name)).    On 02-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 02-Oct-2023, the patient experienced FEELING ABNORMAL (It was awful) and NAUSEA (nausea/she felt like vomiting all night). On 02-Oct-2023 at 7:00 PM, the patient experienced CHILLS (chills). At the time of the report, FEELING ABNORMAL (It was awful), CHILLS (chills) and NAUSEA (nausea/she felt like vomiting all night) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient received Spikevax on 02-Oct-2023 at the morning. By 10:00 PM she was so chilled she could not even hold anything. She went to bed and could sleep for 2 hours. She got up with such nausea and felt like she was going to vomit until 5 AM. Patient fell asleep and woke up after noon. It was not mild, she felt like vomiting all night. She was really sick. Patient reported that her arm was perfect, she did not even have a sore arm. She never experienced something like this for past Moderna vaccine doses.  Treatment information was not reported.
Patient received Moderna COVID vaccine on 2/20/21 (lot # 012M20A), 3/18/21 (lot # 045A21A), and 9/15/21 (lot # 004F21A). On 5/31/22, patient admitted to our inpatient facility with COVID-19 infection, weakness/SOB, and ESRD on dialysis. As of today (6/3/22), patient is still admitted in our med/surg unit.
Pt developed redness, arm tightness and warm to touch in arm she received vaccine starting yesterday. She stated it has progressively become worse over the last 24 hours
@ 1150AM on 22APR93 called school to report not feeling too well; very very tired w/lack of concentration & cold; tiredness started about 20 mins p/inject; 1215 BP 122/86 P60, t97.3; 215PM BP 118/88 MD recommended not complete series;
Pts grandmother stated that the pt was having a reaction to her shots. Nurse obtained information from grandmother; pt had fever of 105F, temperature is now 103.4F; pt having nausea and vomiting; pt jerking in her sleep. Grandmother states pt was seen by her MD and was told that she is allergic to Hep B vax.
Arm, hand and shoulder soreness. Chills. Shaking. Muscles spasms in intercostal (between rib) muscles front and back, legs and abdomen  muscles. Headache, eye pain, weakness, nausea.
After I recieved the first and second dose of Pfizer Covid 19 vaccines, I experienced the same effect on the evening of the vaccine. I had very sore muscles, intermittent joint pain and exhaustion to the point that I slept on and off for 3 days. Following those vaccines I returned to feeling "normal" again by the fifth day. After the Booster dose of Moderna, again in the evenng I began to experience the same very sore muscles, very painful joints and exhaustion. This time though, the muscle aching and joint pain never stopped. In fact, it got worse over time and I developed extreme muscle weakness that excellerated to the point where I could hardly raise my arms above my chest elevation without whincing in pain.
Frequent arrhythmia episodes (PVCs, non-sustained V-tach). Transient tachycardia alternating with transient bradycardia (HR fluctuating from 130s to 50s).
Patient had tonic clonic seizure activity for 20 seconds after walking back to waiting area post vaccine. Patient also fell out of chair and bumped his head. Patient stated he had feels of a panic attack coming on prior to falling out of his chair. Patient was not well hydrated prior to vaccine. He was brought water, and felt better shortly after getting back into his chair.
Patient became pale was standing sat in chair - 3-4 jerks of arms lasted < 15 seconds. Patient able to lay on table. Felt improved within 5 minutes. Patient had not eaten all day.
Patient reported no adverse event. Vaccine was expired and administered to patient. After speaking with Co State Health department vaccine specialist, it was determined patient would need a duplicate vaccine in date.
pt suffered cardiopulmonary arrest @ home while aware 11 days p/clinc visit for hlth supervisior; pt asymptomatic prior to occurence; autopsy listed cause of death as SIDS;
Information has been received from a registered nurse concerning her 16 year old daughter, with a history of seasonal allergy and no other pertinent medical history who on 28-NOV-2007 was vaccinated subcutaneously in the arm with a dose of GARDASIL. On 29-NOV-2007 the patient's arm hurt and it was bruised with a lump on the arm where she was vaccinated. Unspecified medical attention was sought. The patient recovered on 02-DEC-2007. No diagnostic laboratory tests were performed. No product quality complaint was involved. Additional information has been requested.