chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in a 5-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included MMR vaccine (non-gsk) ;Merck given on 14 June 2011; varicella virus vaccine (non-gsk) ;Merck given on 14 June 2011. On 14 June 2011 at 16:56 the subject received 2nd dose of KINRIX (.5 ml, unknown route, left thigh). On 14 June 2011, less than one day after vaccination with KINRIX, the subject experienced injection site cellulitis. The healthcare professional reported that the subject was not able to walk. The healthcare professional considered the event was clinically significant (or requiring intervention). The subject was treated with KEFLEX. At the time of reporting the outcome of the event was unspecified.
Felt lightheaded at work. Sent to ER had BP 183/101 hr 127, given IV fluids and discharged . Later that evening had fever and chills.
Headache, Myalgia, Arthralgia & Fever Narrative:  Employee got the second dose covid vaccine 2/3/21 at 340pm Employee claimed that she developed fever,worsening headache , bodyache ,  fatigue as the day progresses.  Employee missed work 02/04/2021 She claimed that she had some relief with tylenol   Other Relevant History:
Adverse Event = Expected arm soreness, headache, and low grade fever a few hours after getting second dose but after went to bed that evening started having difficulty breathing and throat swelling  Treatment = Ice packs on chest and took a second Allegra 180 mg tablet when began to feel throat swelling as felt like an allergic reaction.   Outcome = 30 min after taking Allegra dose and continued ice packs on throat and chest felt relief and relief of all symptoms. I was able to finally fall asleep without any further issues.
1/28/11 - received Hep A/PCV 13/Flu in AM brought to ED in evening because of febrile seizure. Also w/prior hx of febrile seizure & am in ED. Given antipyretic & Amoxil.
Information has been received from a school nurse concerning a child who on an unspecified date as a baby/toddler was vaccinated with a 0.5 ml dose of VARIVAX (Merck). Subsequently the patient developed a "less severe" case of chicken pox (also reported as small rashes of chickenpox). There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Chills, headache, congestion, runny nose, sneezing, sore throat, tonsils hurt.  Started with my head hurting a bit like I was getting a headache then I got the chills NEVER a fever NEVER lost taste or smell.  Congestion stared. Then I was blowing nose a lot.  Sneezing occasionally head hurts a lot but taking Motrin helped it go away.  Throat hurts a little and I cough only because it?s like dry and itchy. As of right now it?s your regular icky cold.  But I do not have any aches in my body that where not there before and they did not increase.
Gave second dose 5 days sooner than recommendation; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave second dose 5 days sooner than recommendation) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Not provided and 027C21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 20-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave second dose 5 days sooner than recommendation). On 20-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave second dose 5 days sooner than recommendation) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Drug dose details updated.
Right arm swollen 4"x3", warm to touch, itchy. Given Benadryl and recommended cool compresses.
Significant swelling, redness, and heat at site of immunization. Swelling approximately the size of a baseball. Appears similar to side effects from an Anthrax immunization. Treatment: rest, cool packs, anti-inflammatory.
I was exercising and I started having a really bad headache. I got a scan and had blood in my brain
Pt.'s mother reports her daughter became ill "exactly 1 wk after receiving vaccinations." Pt. became ill with "waves of nausea." Periods of nausea occur with meals and with activities. Not noted at any certain specific time - can be morning, evening, etc. Pt. currently still having symptoms of nausea with meals and activities. Pt. taking Cyproheptadine 4mg in evening and ZOFRAN 8mg.
Tightening of the muscle at the injection site; This is a spontaneous report from a  contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced tightening of the muscle at the injection site on an unspecified date. Clinical outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
This spontaneous report was received from a healthcare worker/medical assistant and refers to an unspecified number of patients of unknown age and gender. On an unknown date, since 27-APR-2015, the patients were vaccinated with exposed to temperatures outside of the recommended range, VAQTA (dose, route of administration were not reported, lot number: K000943, expiry date: 24-SEP-2016, lot number: K012457, expiry date: 04-JUN-2017). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
no AE; VAQTA was administered on 21JAN2021 however it was documented to have been expired on 11JAN2021; This spontaneous report as received from a physician referring to a specific patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 21-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # "5032358" for prophylaxis (dose, route and site of administration, were not reported). The reporter called to verify the expiration date of hepatitis a vaccine, inactivated (VAQTA) since it was documented to had been expired on 11-JAN-2021 (expired vaccine used).  The reporter denied adverse events or product quality complains.   Upon internal validation, lot # "5032358" was evaluated and changed to the valid Lot #S032358 valid for hepatitis a vaccine, inactivated (VAQTA)formulation prefilled syringe, expiration date of 11-JAN-2021. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Pt developed a rash on medial forearm bilaterally. Hot flash/warm flushed, anxiety and pt states had SOB. O2 100%, IV 0.9 NS and Benadryl.
Information has been received from an unspecified reporter via an online article, regarding a 16 year old female patient. There was no relevant medical history or drug reactions/allergies reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route, lot# and expiration date unspecified). On an unknown date the patient lost her eyesight and was taken to a hospital. Doctors at the hospital believed the vaccine might have caused her blindness. Outcome of the event was unknown. Upon internal review, the event "lost her eyesight" was considered to be medically significant. This is one of several reports from the same source. Additional information is not expected.
Information regarding PREVNAR was received from a healthcare professional regarding a 19-month-old female patient who experienced bacteremic pneumonia.  The patient received the fourth dose in Sep-2007.  Relevant medical history was not provided.  Product was administered in Sep-2007.  Additional suspect medication included PREVNAR, PREVNAR and PREVNAR.  Concomitant medications were not reported.  The patient experienced bacteremic pneumonia on 12-Jan-2008.  The patient was hospitalized.  Outcome was reported as recovered (Jan-2008).  No additional information was available at the time of this report.
Fever; Pain in the stomach; Burning head; felt very hot; discomfort in stomach; not feeling hungry; do not have energy/Very weak; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ABDOMINAL PAIN UPPER (Pain in the stomach), HEADACHE (Burning head), FEELING HOT (felt very hot) and ABDOMINAL DISCOMFORT (discomfort in stomach) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 22-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 PYREXIA (Fever), ABDOMINAL PAIN UPPER (Pain in the stomach), HEADACHE (Burning head), FEELING HOT (felt very hot), ABDOMINAL DISCOMFORT (discomfort in stomach), APPETITE DISORDER (not feeling hungry) and ASTHENIA (do not have energy/Very weak). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Fever, at an unspecified dose and frequency. On 25-Jan-2021, PYREXIA (Fever), ABDOMINAL PAIN UPPER (Pain in the stomach), HEADACHE (Burning head), FEELING HOT (felt very hot), ABDOMINAL DISCOMFORT (discomfort in stomach) and APPETITE DISORDER (not feeling hungry) had resolved. At the time of the report, ASTHENIA (do not have energy/Very weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; 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.
Patient developed stridor, laryngeal edema, myocardial infarction, within 24 hours after receiving influenza vaccine. The medical record received on 1/23/04 states stress and reaction to flu vax. The 60 day follow up received on 01/13/04 states pt experienced MI following vaccination. She is 94 y/o although I do not have further info it is unlikely she completely recovered from this event.
20 mins after receving 1st dose pt began to have itchy throat, EMS presented to patient, called medical. 50 mg Benadryl was given and 1 puff of patients own proair. VSS. After 5 mins, patient began to feel better. Pt informed to call wife to drive him home after receiving the medication.
2 days following vaccination developed pruritic confluent facial rash, with areas on both upper and lower extremities
Patient states that after receiving her flu shot her upper chest on her left side is now swollen and there is a nodule on her clavicle bone that she can move. She states she had a similar reaction to a TDaP vaccine about a year ago that she received from her doctor's office.
dizziness, SOB, fainting  - 5 minutes post vaccination. Symptoms resolved without intervention. Taken to the ED for eval.
Thrombocytopenia worsened, levels previously >10k and now thrombocytopenia with baseline levels less than 10k.
Pfizer-BioNTech COVID-19 Vaccine EUA Pin and needle feeling throughout body with flushing and hives. Mouth and throat felt tight with numbness sensation in mouth. Voice became very raspy and breathing felt somewhat difficult. Tachycardiac and Hypertensive Reported to the ED, received 50 mg IV Benadryl, 125mg Solu-medrol and 40 mg Pepcid, symptoms began to suside after about 5-10 minutes. Had report throat tightness at approximately 1700 and self medicated with Benadryl 2 times throughout the evening.
Pt was with her parents to get a flu shot.  She sat still in the chair, got the flu shot and left.  Probably 2 minutes later, she was walking away from the pharmacy area and she fainted and hit her face on the wall corner.  Pharmacist grabbed a chair to have her sit and parents were holding patient.  Pt was limber and fainted for about 30 seconds, then she was sitting in the chair.  She yelled out and was slightly pale in the face.  she was able to respond to her name and where she was....but was feeling embarrassed.  Her parents had her sit down for another 15 minutes in a chair before they left.  Stated that she has never fainted before......but did say she was nervous.
This spontaneous report as received from a nurse refers to a 29 unspecified patients of an unknown age and gender. There was no information about the patients' concurrent conditions, medical history and concomitant therapy provided. On an unspecified multiple dates, the patients were administered an improperly stored dose of PROQUAD (lot number M033908, expiration date 16-JAN-2018), (route, dose and frequency not reported) for prophylaxis. The call was because of Digital Data Logger, the temperature excursion was reported as > -15 Celsius degrees but < -10 Celsius degrees, for the time frame of 38 minutes. There was no previous temperature excursion reported. Additional information has been requested.
Patient recieved immunizations  3/12/07 at routine well check. On 3/13/07 in evening per mother noted swelling, red, and hot at site of Varicella immunization. On 3/14 Mom called office to report to RN that lump was size of a small egg. No other swelling noted away from site (left upper arm). Child was at school and acting fine.  Advised to give Ibuprophen or Tylenol, alternate ice/heat and to come in if swelling, redness, or pain increases.
This spontaneous report as received from a pharmacy student refers to a newborn patient of unknown age and gender. On an unknown date, the patient was vaccinated with a first dose of RECOMBIVAX HB (strength, dose, route and site of administration, lot# and expiry date were not reported) and then 12 hours later inadvertently received another dose of RECOMBIVAX HB (strength, dose, route and site of administration, lot# and expiry date were not reported). No symptoms were reported. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 23 year old female patient. The patient's pertinent medical history reported as irritable bowel syndrome. Drug reactions/allergies were reported as none. On 18-SEP-2013 the patient was vaccinated with GARDASIL dose 3, 0.5 ml, intramuscular (lot# not reported). It was also reported that patient had also vaccinated with first 2 doses of GARDASIL on an unknown date. No concomitant medications were reported. On 17-MAY-2014, the patient experienced diarrhea, hives and a rash after the third dose of GARDASIL. Nurse reported that the patient never had any side effects after receiving the first 2 doses of GARDASIL. Lab diagnostics studies are not performed. At the time of reporting the diarrhea is still occurring but the rash and hives are getting better and are just behind patient's ears now (date is unspecified of when rash and hives started getting better). It was also reported that patient was using hydrocortisone cream for the rash and hives. The patient was not hospitalized due to experience. The experience was not life threatening. There was not a persistent or significant incapacity. No death. Intervention to prevent serious criteria was not required. Product quality complaint was not involved. Additional information has been requested.
Case number PHHY2015US157419, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 596564) website on 24 Nov 2015. This report refers to a 9 months old female patient. Past medical history and concomitant medications were not reported. Vaccination history included administration of first dose of Hepatitis B vaccine (manufacturer unknown) and PREVNAR 13. The patient had no allergies or relevant family history. She was vaccinated with seasonal influenza vaccine (other manufacturer and batch number: UT41199), PENTACEL (batch number: C381899), Hepatitis b vaccine (manufacturer unknown and batch number: 15172) and PREVNAR 13 (batch number: 916599) all received intramuscularly on 16 Nov 2011. On the same day after the vaccination, the patient experienced febrile seizure (several) for which she was taken to the emergency room for evaluation. Treatment of event included TYLENOL. The patient was evaluated on 17 Nov 2011 by the physician at a follow up visit with no treatment. Outcome of the events reported as recovered without sequelae. Event was reported as non serious and causality was not reported. Seriousness of the event febrile convulsion was upgraded based on the available information in the source document. Following an internal review done 29 Jan 2016, it was confirmed that, previously reported batch number (UT41199) belongs to other manufacturer (invalid Novartis vaccine batch number). Hence, this case will be deactivated.
No adverse effects reported; Patient was vaccinated with a dose of improperly stored GARDASIL 9; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot #R032766, expiration date on for prophylaxis (strength, dose and frequency were not reported). The temperature of storage and time frame of the excursion were above 47°F (92.3° F) for 13 hours 11 minutes and above 47°F (73°F) for 9 hours. There was a digital data logger involved, but there was no previous temperature excursion.   No adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA007468: US-009507513-1907USA007439: US-009507513-1907USA005368: US-009507513-1907USA005362: US-009507513-1907USA010550: US-009507513-1907USA010551: US-009507513-1907USA010552: US-009507513-1907USA010553: US-009507513-1907USA010555: US-009507513-1907USA010556: US-009507513-1907USA010557: US-009507513-1907USA010558:
about 12 hours after the shot I was woken out of sleep with a strong shaking reaction that lasted about an hour. This is opposed to "chills", it was involuntary body movement in the limbs, torso and neck. I attempted to stop by focusing on relaxing but would creep back. it occurred in bed and also standing.  My heart rate was also elevated.
Adverse reaction: rash patch, red with itchiness. Rx: Triamcinolone 0.1 %: Apply 3 times a day.
patient passed away and was found dead over a day after receiving the vaccine; expiration date of vaccine 11/25/21; patient received this as a booster dose he had first and second dose in the Spring
The morning after the injection the pt experienced lightheadedness, shaking, felt as if he would "pass out". Late the same evening, the pt began to have a fever and chills, hot and cold flashes, noticed moderate swelling from top of arm to elbow, small bumps on the front of arm. Swelling progressed beyond elbow to mid forearm with redness. The pt was taken to the ER.
Small reddish area contiguous to injection site, minor itching , very slight tenderness in shoulder area six days after injection; increasing in redness, itching and tenderness on 9th day after injection.  Irritation and pain remain at about, or just slightly above, 1 on pain scale.
Sometime after the vaccination, the pt experienced a red area around injection site. Reportedly the pt was "seen by physician". From additional information received on 11/17/1998, it was reported that the pt recovered from this experience.
Rash. Treatment: loratadine 10 mg every day; diphenhydramine 25 mg HS.
Received first rabies vaccine 09/15/2014, that is when all the symptoms started. Numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches, tightness in chest. Per my school, they said I was ok to get the second vaccine. The symptoms got worse after the second dose 09/22. Went to the ER 09/22/2014 at 2:40PM. Blood work and chest X-ray completed- WNL. Told me I was having a very bad vaccine reaction and needed to report it as well as follow up with a neurologist. 3/4 of my class has had bad vaccine reactions to the rabies and we are all being asked to come into the school clinic.
Patient arrived at appointment to receive 3rd Pfizer COVID vaccine and received a dose of the Moderna COVID vaccine. Patient did not experience any symptoms by receiving the incorrect vaccine.
After receiving the 3rd dose of Pfizer COVID-19 vaccine, patient experienced congestive heart failure, was admitted to the hospital and succumbed 10 days later. She received the 3rd dose of the vaccine on September 28, 2021.
Sore arm at injection site; chills; tiredness/no energy; slept a lot; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient received second dose bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration in Arm Left on 24Feb2021 11:15 (Lot Number: EN6203, Expiry date: Unknown) as single dose for COVID-19 immunisation. Medical history included arthritis, type II diabetes, hypertension, hypothyroidism and seasonal allergies. There were no other vaccines with in four weeks. The patient previously received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration in Arm Left on 03Feb2021 12:45 (Lot Number: EM9810, Expiry date: Unknown) as single dose for COVID-19 immunisation. It was reported that there was no COVID prior vaccination and COVID not tested post vaccination. Concomitant medications included allopurinol, levothyroxine, lisinopril and nabumetone. The patient had known allergies for aspirin, penicillin, septra, levaquin, motrin, naprosyn, feldene, lodine, lipitor, zocor and hydrocodone. On 24Feb2021 16:30, the patient experienced Sore arm at injection site, chills, tiredness/no energy and slept a lot for 48-hours. Therapeutic measures were taken with Tylenol. The outcome of all events was recovered.  No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist referring to a female patient of unknown age. No pertinent or historical conditions were reported. On 21-NOV-2015, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously to get vaccinated (lot # L015414, expiration date 01-AUG-2016). There was no concomitant medication reported. On an unknown date of November 2015, the patient reported that there was swelling and her skin felt hard and lumpy around the injection site. The patient also reported that the hard lump was spreading around the injection site and noted that the lump was getting bigger. The pharmacist reported that the lump was not a rash, but an injection site reaction. The patient sought medical attention via calling the pharmacist. No treatment or lab diagnostics studies were performed to the patient, at the time of reporting, the outcome of events was reported as not recovered. Causality between event and ZOSTAVAX was not reported. Additional information has been requested.