chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient's mother stated that her 7 years old son participate in the school's vaccination program and was given the intranasal spray flu vaccine for H1N1 (one squirt in each nostril), Lot #500784P or Lot # 500284P on Nov 10, 2009, at the clinic. On Nov 10, 2009, less than 10 hours, he developed what it looks like a heat rash through the chest and back, child left to school and when came back in the afternoon of Nov 10, his eyes were irritated. On Nov 11, 2009, they visited a night clinic and saw a Dr., now the rash was visible in the arms, legs and neck, the child also developed fever. The Dr. gave him " LAC-HYDRIN(ammonium lactate) Lotion 12% due to the extreme dry skin and rash and Ibuprofen for fever. On Nov 16, 2009, they visit again the night Clinic but the child was not attended due to some issues with the insurance. On Nov 17, 2009, the insurance issued was resolved and the Dr. saw him again this time gave him CERTIRIZINE Liquid and hydrocortisone cream for the skin. Once again on Nov 30, 2009, they visited the Night Clinic now the child have rash all over his body and face, extremely dry skin, fever, and flu like symptoms, this time another Dr saw him and gave him TYLENOL for the fever and two liquids to drink one pink in color and the other clear liquid, no name for these two medication were given. Also, the Dr added two creams in the new prescription but since the medical insurance did not cover those two medications the parents could not purchased them. The child still with rash now with pus all over his body and face, fever, flu like congestions and nasal secretions as today. He missed seven + days of school so far. Four more siblings' age 9 thru 15 were vaccinated the same day with the same type of nasal spray flu vaccine with no adverse reaction.
Falling sensation; Dizziness; Nausea; Felt a slight soreness at thevaccination site; This is a spontaneous report received from a contactable consumer, the patient. A 73-year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6203) via an unspecified route of administration in the left arm on 15Mar2021 at 16:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included prostate cancer and had prostate surgery for medium-risk prostate cancer over 10 years ago (unspecified date). The patient had no chronic health conditions and no signs of cancer have ever been present since his surgery (at the time of this report). The patient had no allergies to medications, food, or other products. The patient was not taking any concomitant medication. The patient had not received any other vaccines within four weeks prior to the vaccination. The patient had not received any medication within 2 weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6201 6121) via an unspecified route of administration in the left arm on 22Feb2021 at 12:15(at the age of 73-years-old) as a single dose for COVID-19 immunisation.  The patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021 at 18:15, the patient experienced falling sensation (about a minute), dizziness (about an hour) and nausea (about an hour) felt a slight soreness at the vaccination site (about 36 hours). It was reported that, about 90 minutes after receiving his second dose of the vaccine, the patient had been driving his car for about a half hour and was experiencing no problems at all. The patient pulled the car over so his wife and he could switch driving duties, and when he got out of the car, he experienced a dizziness where he felt as though he was falling. The falling sensation continued and the patient almost fell down but his wife caught him, the sensation continued quite powerfully for about a minute. The patient got into the passenger seat, where he felt very mild nausea for about an hour, but then there was no further dizziness or nausea of any kind. The patient also felt a slight soreness at the vaccination site starting about a day after the vaccine and lasting about 36 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had not received any treatment for the adverse events. The clinical outcome of falling sensation (about a minute), dizziness (about an hour) and nausea (about an hour) were recovered on 15Mar2021, while that of felt a slight soreness at the vaccination site (about 36 hours) was recovered on 17Mar2021.  No follow-up attempts are needed. No further information is expected.
pt recvd vax; approx 5-6" diam erythematous area at inject site; area itchy; resolved 1 wk;
rash; spots and bumps on his limbs and chest./he also has different spots on the chest and another one on the left leg, 2 on the right leg.; This is a spontaneous report from a contactable consumer. This male consumer reported about himself that:  A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK4176) via an unspecified route of administration, administration on left arm on 18Feb2021 14:00 as dose 1, single (at the age of 78-years) for covid-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (age at vaccination 78-years-old), dose 1, on 28Jan2021 for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. The patient got the first dose of the vaccine on 28Jan2021 and the second dose on 18Feb2021. On 04Mar2021, the patient started to break out in a rash and this rash was on left arm on the bottom part of the forearm on the tender skin, the patient clarified that there was more rash on the left arm than anywhere else on his body. The left arm was also where he got injection.  After the left arm the patient began to notice it on right arm and there was less rash on right arm. The patient had spots on chest and another one on the left leg, 2 on the right leg.  Later noticed the left arm pinky and ring finger got rash in between the 2 fingers. On the right arm, the rash was on ring finger on the top part. There was little spot on the left chest and little spots as big as finger on the left leg on the thigh and the patient also had it down around the ankle on the left leg.  The patient describe the spots  as being reddish pinkish spots and they was bumps and some was spread out. The patient tried putting Cortisone 10 on it and that made it worse so he washed it off. The patient started using Bactine pain relieving cleansing spray on 04Mar2021 and that helped to dry it up a little but it was still not well yet and the patient still using this. The patient stated that he called on Saturday and held for an hour and a half but the number of callers ahead of him did not change so he called back today but it still took a long time. The outcome of the events were unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.   .
sense of smell was heightened; she felt an out of body experience, like she was not really present or there; a weight in her chest, it's not pain; it tore her stomach up and she had loose bowels; stomach was on the fritz/it tore her stomach up and she had loose bowels; made her feel like she had coffee and feels like she is going to go through the roof; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose 1,single for covid-19 immunization.The patient medical history was not reported.There were no concomitant medications.The patient experienced her sense of smell was heightened, she felt an out of body experience, like she was not really present or there,a weight in her chest, it's not pain,it tore her stomach up and she had loose bowels, made her feel like she had coffee and feels like she is going to go through the roof on an unspecified date.The outcome of the event was unknown.The caller only provided her 1st name details.Caller declined to provide a mailing address or email.Caller stated that she was a nurses aide in a nursing home.The caller stated that her son asked her to drink lots of fluids and rest and stay quiet and that is what she is doing.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Gave Td vaccine in left deltoid and told to wait 15-20 minutes. After 15 minutes, patient was pale, shaky when walking and said he felt like he was on drugs. Gave Benadryl 50mg IM to LUQ, which helped muscle spasms, shakiness.
tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive". It was reported that patient had she had fever of 101, headache, sore throat, and fatigue. The patient underwent the following laboratory tests and procedures: Body temperature: 101, notes: had fever of 101; SARS-CoV-2 test: Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
redness, swelling, heat to upper arm from shoulder to elbow. Pt came in approx 2-3 days after injection, instructed to take anti-inflammatory med and use cool compress.
diplopia in the right eye/aggravated; diplopia in the right eye/aggravated; muscle weakness; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diplopia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: DIPLOPIA (non-serious), CONDITION AGGRAVATED (non-serious), outcome "recovered" and all described as "diplopia in the right eye/aggravated"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "muscle weakness". Therapeutic measures were not taken as a result of diplopia, condition aggravated.  Additional information: Patient received the first booster of Pfizer Covid-19 vaccine. Experienced diplopia in the right eye along with muscle weakness. Diplopia lasted for a couple of days. Diplopia resolved on its own without any other interventions. Patient reported she had diplopia prior but the booster dose aggravated it. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received first dose of Pfizer COVID-19 vaccine on 11/19/2021 and presented for second dose on 12/3/2021. Second dose was given at 14 days instead of recommended 21 days.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # M031651, expiration date: 30-MAR-2018, dose, frequency and route were unknown) for prophylaxis(incorrect product storage). The ROTATEQ was exposed to 31 Fahrenheit degree or colder for a time frame of 13 hours. Data logger was involved. No adverse effects reported.; Sender's Comments: US-009507513-1707USA010905:
After receiving his vaccine, client stated he have headache, tingling sensation in L side of his face.  No vital signs obtained by EMS.  Client refuse vital signs as per EMT.  Client states he is feeling better.  Client discharge home.
No adverse effects; adult patient was inadvertently administered a pediatric dose of VAQTA; adult patient was inadvertently administered a pediatric dose of VAQTA; This spontaneous report was received from a medical assistant regarding an adult patient of unknown age and gender. The patient's concomitant conditions, medical history, past drugs, allergies and reactions were not reported. On 31-MAY-2019, the patient was inadvertently vaccinated with pediatric dose of hepatitis a vaccine, inactivated (VAQTA) vial 25/0.5 unspecified units (lot # R009822 and expiry date 12-JUN-2019) via intramuscular route for prophylaxis (product administered to patient of inappropriate age) (incorrect dosage administered). No adverse effects was reported.The outcome of the events was unknown.
burning in fingers; back pain; all kinds of neurological problems; she is scared; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Apr2021 as 1st dose, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced burning in fingers, back pain, all kinds of neurological problems and she is scared. The outcome of event was unknown.  Follow up (14May2021): New Information received from the contactable consumer includes updated events and dates and questions regarding events.  Follow up attempts are completed. No further information is expected.
Pt recv vax on 1/12/99; on 1/21/99 pt exp red spot on face then back to entire body-blotching together; fever (100)
invalid dose interval beyond 36; pain at injection site right arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (invalid dose interval beyond 36) and VACCINATION SITE PAIN (pain at injection site right arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site right arm). On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (invalid dose interval beyond 36). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (invalid dose interval beyond 36) and VACCINATION SITE PAIN (pain at injection site right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided. No lab data was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up information received and outcome was updated and reported declined to FU.
Employee states noticed swelling and redness on upper (L) arm today from the flu vaccine received on 12-1-14.
pt recvd vax & w/in 1 hr began loud shrill cry-mom couldn't console child; pt was seen by MD & instructed mom to only receive DT in future; seen by MD 3DEC93;
Povider ordered the flu vaccinne 0.5cc. Gave the child a flu vaccinne for 18yrs and older. So I immediately notified the Clinc Director.Fluarix lot # AFLUA239BA Exp 06/30/2007
Patient received shingrix (dose 2) and pfizer bivalent covid vaccine at the same time on 12/29/22. The evening of vaccination, patient developed fever and muscle aches. Two days after vaccination, the patient reports developing a widespread rash on her back, arms, and buttocks, as well as trouble breathing. She went to her primary care doctor, who told her it could be due to the Shingrix vaccine. The patient reports that the rash and trouble breathing have still not fully resolved as of 1/23/23, the date these reactions were reported to the pharmacy. The doctor treated her with topical over the counter hydrocortisone for the rash, and she is following up with the doctor still due to the continuing of symptoms.
Pt. noted reddened, swollen, indurated area, painful and warm to touch when waking this morning.
36 hour-long fever (102.8°F), migraine, soar arms, heavy chest, dizziness, and nausea.
Information has been received from a physician concerning a 4 year old male with no allergies who at approximately 24 months of age in approximately 1999 was vaccinated with varicella vaccine. There was no concomitant vaccine or other therapy. Following vaccination, the pt developed a mild swelling at the site of the injection. Two to three weeks post vaccination, the pt developed a rash which his mother described as being a "chicken-pox type rash" in the areas of the left shoulder and left axilla. The pt's rash lasted approximately five days and he had no fever. Approximately three months later, the pt had a recurrence of the rash in the same location, which was described as having vesicular lesions. Subsequently, over the past two years, the pt had a total of four episodes of a similar rash occurring in the same area. Additional info has been requested.
Information has been received from a licensed practical nurse concerning a 12-month-old male with no allergies or medical history who was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live. There was no concomitant medication. Twelve days later, the patient broke out in a rash. Unspecified medical attention was sought and no treatment or prescription drug was required. No diagnostic laboratory tests were performed. Subsequently, the even abated and the patient recovered. It was noted that therapy with varicella virus vaccine live was "discontinued." A product quality complaint was not involved. Additional information has been requested. The licensed practical nurse also reported another patient who broke out in a mild case of varicella after therapy with varicella virus vaccine live (WAES #0401USA00992).
83yr old male presented to ED from the clinic via cart.  Patient was sitting in room and just passed out.  Upon arrival to the clinic the patient was not responding to voice or touch.  Patient was lifted from wheelchair onto cot and wheeled to the ED.  Enroute to the ED the patient became more responsive and was able to open his eyes.  After a couple of minutes of being in the ED the patient was able to speak and answer questions.    Wife states that she did not notice any unusual weakness or changes prior to this incident.  He walked by himself into the clinic.  She states that he is active for a day and then needs a day of rest, but that has become his normal.  Per report from spouse patient has been rubbing his abdomen lately, he did have a mass that she is wondering if it is bothering.   Patient was coming into the clinic ajoining the hospital for a rountine flu shot when he collapsed.  He was driven by his wife, who noted that he seemed fine on the ride over and that he got out of the car and walked normally on his own into the clinic while she parked the car. The patient was joined inside the clinic by his wife after she parked her car, he was sitting with her for her appointment and planned to get his flu shot, his wife noted that he kinda 'made a noise' and she looked over at him to note that he seemed unconscious and was drooling, he was held up in the chair until help arrived and he was placed on a gurney and taken to the ER.  During the initial departure of the gurney, he woke up.   Reason for Visit  Neurological Changes  Diagnoses   Syncope, unspecified syncope type  Loss of consciousness  Leukocytosis, unspecified type  Positive D dimer  Dehydration
Redness and large swelling at injection site, itchy, red area warm to touch. Wait and watch, no antibiotics at present time. Onset was about 10 days post-vaccine administration
This spontaneous report was received from a registered nurse, concerning unspecified patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported.  On unspecified dates, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB (dose, frequency and route were not reported) lot # reported as N003702 with expiration date of 08-NOV-2019, for prophylaxis. The temperature of the RECOMBIVAX HB was between 9 °C and 25 °C for a time frame of 1 hour 27 minutes. No previous temperature excursion occurred, and data logger was involved. No adverse effects were reported. This is one of five reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA002251: US-009507513-1705USA003150: US-009507513-1705USA003157: US-009507513-1705USA003158:
No additional AE reported; VAQTA that was inadvertently administered after its labeled expiry date; This spontaneous report has been received from a registered nurse, concerning a patient pf unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 18-JAN-2021, the patient was vaccinated with an inadvertently expiry dose of hepatitis a vaccine, inactivated (VAQTA) lot # S032359 with expiration date 11-JAN-2021 (frequency, route and anatomical location were not provided) for prophylaxis. There were no known temperature excursions and no additional adverse events were reported.      combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; 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 the criteria for Reportability
No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 11-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).     No concomitant drug was reported. No treatment drug was reported.
Flu like body aches. Arm was swollen, painful and red. Took motrin which helped with pain but not aches.
Itching, then rash which is 6 inches long, red and moving down my left arm.  It is half way to my elbow.  And it is hot.