chrisvoncsefalvay/vaers-outcomes huggingface dataset:
one 16 month old patient received improperly stored VARIVAX; No adverse effects  reported; This spontaneous report was received from a registered nurse concerning to a 16 months child patient of an unknown race and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were unknown by the reporter.  On 26-JUN-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R017640 with expiration date on 20-JUN-2020 (exact dose, and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent.  Administered doses of vaccine experienced temperature excursion between 6 degrees Fahrenheit up to 14 (12 F) degrees Fahrenheit for 4 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA004715: US-009507513-1907USA004800:
This case was reported by a other health professional via sales rep and described the occurrence of lethargy in unspecified number of patients who received BEXSERO. On an unknown date, the patients received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patients experienced lethargy and tiredness. On an unknown date, the outcome of the lethargy and tiredness were recovered/resolved. It was unknown if the reporter considered the lethargy and tiredness to be related to BEXSERO. Additional details received were as follows: Medical Science Liaison indicated that an office manager contacted her to report that a female patient (not much info known), no lot, no expiration date, no vaccination date, or age of the patient was vaccinated with BEXSERO, and then the next morning, could not get up, was lethargic and tired for two days; pain at the injection site; stayed home from school for two days (see case US2016046410). Office manager then mentioned that another patient (see case US2016GSK049200) who received also BEXSERO and experienced a soft-ball like swelling at the injection site. Also mentioned about some other patients concerned in this case who also received a dose of BEXSERO vaccine and felt tired and lethargic for about two days then the symptoms were resolved. The office manager indicated that she would be happy to be contacted by GSK for more information gathering if needed.
got Influenza A; Initial information received on 21-Dec-2022 regarding an unsolicited valid Social Media non-serious case received via consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got influenza A after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.    On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for flu.  On an unknown date the patient had a non-serious event of got influenza a (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported  I got the shot and then got Influenza A  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
Front torso papular rash with itching treated with 2% hydrocortisone cream. Physical symptoms of rash still present but improving . Pt reports itching resolved when hydrocortisone is applied
Lump in arm away from site of injection now muscle in uper arm very weak and uncomfortable. Hard to carry things with any weight in my left hand
Migraine headaches, body aches, fatigue, weakness, diarrhea, stomach pain, minimal appetite, digestive issues, no stamina, difficulty breathing after any exertion
Arm pain; Red rash around the injection site; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), RASH ERYTHEMATOUS (Red rash around the injection site), FATIGUE (Fatigue) and PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced FATIGUE (Fatigue). On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), RASH ERYTHEMATOUS (Red rash around the injection site) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Arm pain), RASH ERYTHEMATOUS (Red rash around the injection site), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Blood pressure measurement: increased (High) increased.         Concomitant Product information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.
Dose 1 site soreness Dose 2 severe muscle and bone pain, chills, night sweats, fever, axillary lymphadenopathy, fatigue, nausea-evaluation for symptoms- no prescribed treatment
I woke up with a throbbing eye that was burning. I had hives on my eyelid which was halfway swollen shut yesterday. Today the hives are still there but  its not swollen shut, the throbbing is gone, the itching is gone its just the hives.
Periodic nightmares / migraines Ringing in ears Numerous extreme Inflamation Flairs requiring steroid treatments ( oral and injection), buzzing feeling in body, fatigue, exacerbated bodily pain, with/without inflammation... irregular blood pressure, very high very periodically.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: Patient started having symptoms 4/6/2022 at 11:00pm, from wrist to shoulder on inner under arms and on torso, belly, ribs, chest, has a hives rash that is not responding to benadryl. There is also a 10-inch large splotch on upper inner thieghs. I told her to go to urgent care since the benadryl is not taking it down, and to rule out other causes of the rash since it was 5 days later and had no previous allergic reaction to other 3 doses of pfizer.
Pt reports a "golf ball" size knot at the injection site the night of receiving his pneumonia vaccine.
Pt with anaphylaxis, swollen face, tongue, tachycardia, low 02 saturation, stridor and wheezing. Rx started 8-10 min after administration and treated with EPIPEN x2 oxygen and 911 called with transport to hospital.
Child received vaccines at clinic 7/31/18. Child then broke out in head to toe rash and fever. Symptoms started 8/9/18. No itching. No wheezing noted.
Patient indicates that after the immunization her arm got swollen to the point she is unable to move. Had to go to the emergency room. She received the vaccine on December 2 and went to the emergency room on December 4. She notified the pharmacy December 8 indicating she doctor ordered a CTScan
pt nervous; c/o nausea prior to receiving immun; c/o nausea & lightheadness; no erythema @ inject site, no rash;
THE PHARMACIST USED THE DILUENT FROM ZOSTAVAX NDC00006430901 TO MIX WITH SHINGRIX AND ADMINISTERED TO PATIENT.
This evening, I noted a large red ring around the injection site on my right arm.  Red ring is slightly raised.  Lesion is asymptomatic.  Diameter 2-3 inches.
Headache, Myalgia, NauseaVomiting, chills, fatigue, back ache, neck stiffness, collarbone pain  Narrative:
experienced hives daily since receiving the booster; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (experienced hives daily since receiving the booster) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient experienced URTICARIA (experienced hives daily since receiving the booster). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at a dose of daily. At the time of the report, URTICARIA (experienced hives daily since receiving the booster) had not resolved.            Concomitant product use was not provided by the reporter.
Client received 0.5 ml dose as booster dose instead of 0.25 ml dose of Moderna on Friday 11/19. Unable to reach pt for f/u after several attempts.
Information has been received from a registered nurse concerning a 42 year old female employee with no allergies and no past medical history who on 11/12/03 was vaccinated IM in her right arm with a dose of hepatitis A virus vaccine inactivated (lot # 646663/0652N). There was no concomitant medication. Exactly 23 hours later on approximately 11/13/03, the patient developed large welts all over her body, which was also described as a rash. Unspecified medical attention was sought, but laboratory tests were not performed. The patient took diphenhydramine hydrochloride, Subsequently, the rash completely resolved and the patient recovered. A product quality complaint was not involved. Additional information has been requested.
COVID-LIKE SYMPTOMS; LIGHTHEADEDNESS UPON STANDING  UP; DIZZY; NAUSEA; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: -JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced covid-like symptoms. On APR-2021, the subject experienced lightheadedness upon standing up. On APR-2021, the subject experienced dizzy. On APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, nausea, lightheadedness upon standing up and covid-like symptoms was not reported. This report was non-serious.
Hives starting in AM and increasing throughout day; covered from head to foot w/hives by evening.  Used OTC Benadryl for comfort.
No additional AE or PQC reported; HCP reported a patient only received a partial dose of VAXNEUVANCE due to moving their leg during the administration.; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 23-MAY-2023, the patient only received a partial dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) due to moving the leg (unspecified laterality) during the administration, (lot # W027250, has been verified to be a valid lot number for pneumococcal 15v conj vaccine [crm197] [VAXNEUVANCE], expiration date reported and upon internal validation established as 09-JUL-2024) (dose, and route of administration were not reported). The vaccine was administered for prophylaxis. The reporter was unsure of the exact amount of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) that was administered (Incorrect dose administered).  No additional adverse event reported.
This is a spontaneous report received from a pharmacy technician regarding a 76-year-old female who received a dose of ZOSTAVAX on an unknown date in 2003 (lot # not reported). On an unknown date in October of 2016, the patient developed shingles on the forehead. The patient has not recovered. Additional information has been requested.
Patient began developing hives from breast down to knees, radiating to her rear.  Rash was extremely itchy, especially around pelvis.  Around 7pm, Pt vomited once.
Vaccination Adverse Reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination Adverse Reaction) in a 34-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Apr-2023, the patient experienced IMMUNISATION REACTION (Vaccination Adverse Reaction). At the time of the report, IMMUNISATION REACTION (Vaccination Adverse Reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not reported.  Treatment medications were not reported.  The number was reported.   Reporter did not allow further contact
rt arm swollen from shoulder to elbow & warm to touch-pt may have had sl fever;c/o very little discomfort w/it though;occurred 24hr p/shot;
p/vax pt exp bilat tremors of hands;no other sz activity;no loss of consciousness;
Pt. came in for 4 month vaccinations and received Pediarix (DTap, Hep B, IPV) in Right Thigh.  Pt. had fever of 102.5 which started about 4-5 hours post injection and continued with fever for 4 days.  On the 3rd day post-injection (20 Sep 09) mom noticed rash starting on trunk of body.  The following day 21 Sep 09 Noah's body was covered with a fine rash from head to toe with continued spikes of fevers as well.  Mom stated she has not changed laundry detergents, soaps or clothing.  Pt. instructed to follow-up with pediatrician ASAP.
Severe body cramps/spasms - started approximately 1am and continued sporadically through the day on Tuesday Drank pedialyte  Fever- 101.6 was highest Took Tylenol
About 1 1/2 hours after my second injection, I had a severe, total body  hot flash, nausea and blurred vision. Unfortunately, I was driving at the time so I pulled over to wait until my vision improved enough to continue home. I was light headed and pulled over one more time before I was able to get home. I immediately went to bed with chills and continued nausea for several hours. I was finally able to eat something probably 6 hours after the event then went to sleep. The following day I was tired and had body aches. No medical attention sought. Totally for the two days after the vaccine.
Fever 100+ x36 hours. Body aches. Headache. Fatigue. Shivers. Jittery. Unable to eat or drink.
Dizziness, fell out of chair Loss of vision Plae Diaphoretic  Vasovagal P90 BP 137/98 O2 98%
Large red rash around vaccine site. Rash is not itchy, but is red and raised. Measures approximately 1.5 by 2 inches.
thrush, nerve jerking, headaches, confusion, humming in head, vision issues, left 3 toes move on their own, right arm nerve jerks.  Continuous since February 5, 2022.
Moderna Covid vaccine. This was the patient's second dose. They had had a Monovalent dose 3/6/2023. The dose that was given was 0.2 mL from the vial with the pink cap. The correct dose would be 0.25 ml from the Moderna with the blue cap.
Per mother-"He woke up the next morning complaining of his heart "racing". I used an app on my phone and he had a fast heart rate with irregular rhythm. He rested and he was O.K."
My body broke out in hives for 4 straight days beginning Friday, 1/14/22 in the evening and continued to get worse until saturday morning, when i finally treated with Benadryl.  As soon as the benadryl wore off (approximately 6 hours) the hives would immediately come back, in new areas, all over my body. this persisted until i had a call with my dr. Monday morning, 1/17 and she recommened trying an antihistamine with longer effective time as well as prescribed a steroid for a course of 5 days.
first shot gave her lots of energy  2nd shot - arm tiredness, muscle cramps and fatique
pt recvd vax;devel Koplik's spots,cough & a rash;
Chills Fever Pain in the middle of the chest Arthralgia Headache.          Tylenol and Advil depending on the severity of symptoms at the moment
I received my 4th dose on 04/22/2022 and my adverse event started on 04/22/2022 at night around 10:00PM my arm was very sore; Body aches; I slept all day long; In the injection site my arm was red and swollen. On 04/24/2022 Sunday I experienced the same symptoms. I took ALEVE for body aches. I was back to normal on Monday. My nose had a lot of mucus which I had to blown every few minutes. On Monday 07/18/2022 my  right nose was stuffy and I had drainage back of my throat as well as  severe cough. On Wednesday 07/20/2022 I went to my doctor he thought that it might be a viral infection. He prescribed me azithromycin 250 milligram 5 days and also benzonatate for 5 days. I am still recovering. My right nose is producing mucus.
This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) from medical information team. A 20 year-old male patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization; Janssen (had received the Jansen covid vaccine one month ago. instead of 2 months.). The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious) all with onset 24Nov2021, outcome "unknown" and all described as "received a Pfizer BTC vaccine booster dose"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "had received a Jansen covid vaccine 2 months ago". Additional info: It was reported, Calling regarding a 20 y/o adult who received a Pfizer BTC vaccine booster dose (purple cap,12 and older formula ) today, 24Nov2021, and stated he had received a Jansen covid vaccine 2 months ago. After the shot was given the HCP was told he had received the Jansen covid vaccine one month ago. instead of 2 months. Are there any safety concerns we should be aware of? The lot number for bnt162b2 was not provided and will be requested during follow up.
patient stated the next day she felt really bad, entire body hurt, splitting migraine, difficulty breathing, increased heart rate . But she said she didn't go to the emergency room or the doctor. she called the pharmacy on Monday 08/12/2019 at that point she said she was feeling much better. But she was not happy that it caused so much side effects and discomfort. She was not expecting so much body aches and pain.
gastric increases; heart rate increases; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (Manufactruer Unknown)), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE (Manufactruer Unknown)), for Covid-19 immunization. The following information was reported: GASTRIC PH DECREASED (non-serious), outcome "unknown", described as "gastric increases"; HEART RATE INCREASED (non-serious), outcome "recovering", described as "heart rate increases". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gastric ph decreased.  Additional information: It was reported that patient received the Pfizer COVID-19 vaccine booster and then experienced gastric increases and heart rate increases. Has been almost 5 months now. Patient wanted to know when the vaccine will be out of body. Heart concerns are now better. Has been taking medicine for stomach issues and caller had an endoscopy for stomach.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 4-year-old male who on 27-MAY-2004 was vaccinated subcutaneously in the left arm  with a first dose of varicella virus vaccine live (Oka/Merck) (lot# 647265/1097N). On 19-OCT-2007, the patient developed breakthrough chickenpox with a rash and 20 lesions on the trunk and upper arms. There was no fever. It was reported that no medical attention was sought. No outcome was reported. Follow-up information indicated that the patient sought medical attention with a doctor's visit. Around 24-Oct-2007 the patient recovered. This is one of several reports from the same reporter. Additional information is not expected.
17 year old male with no significant past medical history who presents with chest pain and elevated troponins following his second Covid vaccination. He received the dose 11/3/21.  After his vaccine, he had flu-like symptoms, similar to after his first dose. On 11/6, he felt mild SOB in the afternoon without associated pain.  Later that night at 0100 the morning of admission, he experienced left sided, non-radiating, sharp pleuritic chest pain.  Taking deep breaths made the pain worse and there was nothing he could do to make the pain better. He experienced no nausea, vomiting, numbness, tingling, jaw claudication, or diaphoresis. He does admit to tender lymph nodes in his left axilla, which he also had after his first dose of the vaccine.   He presented to an outside emergency room this morning. At that time he was found to have tachycardia, with an EKG notable only for sinus tachycardia. Troponin was elevated at that time. Due to concerns for myocarditis, he was transferred to our facility for echo evaluation, which showed good function. His pain also improved. As such, he was admitted for ongoing monitoring.
Patient was dizzy, lightheaded, warm all over, and had chest pain. EMS was called. BP was 100/60, HR 136, RR 25, temp increased to 99.5 F. She was observed for 15-20 minutes by EMS. She then left on her own and was not taken by the EMS.
A non-serious spontaneous report of runny nose and congestion has been received from a patient parent concerning a 30-month-old male subsequent to FluMist. This case is submitted in accordance with the manufacturer's post-marketing commitment or accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The patient's medical history and concomitant medications were not reported. The patient received FluMist on 08-Oct-2009. On 11-Oct-2009, the patient began to experience runny nose and congestion described as "cold" symptoms. The outcome of the events was not reported. Required follow-up attempts have been performed, requested information unable to be obtained.  22-Feb-2010.