chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to two patients of unknown age and gender. The patients' pertinent medical history or concurrent condition was not reported. On 25-AUG-2015 the two patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L005293, expiration date 17-AUG-2016, strength and frequency were unknown, 0.5 ml) subcutaneously. No adverse effects were reported. Additional information has been requested.
After 14 minutes in observation patient reported itching on the right arm, there was no visible rashes on the arm or the body at the time or any time later.  Took patient to a stretcher for further observation and about 5 minutes later he said felt dizzy, his pulse was 84 and chest was clear but he then complained of chest pain and headache for which I called EMS at 2:31 PM.  During the entire time in observation patient appeared well, not pale, no sweating, talking clearly and no visible rashes.  Denies itchy throat and did not complained of pruritus again
Patient  reported the following: "By the evening of the thirteenth I felt generally sick, sluggish, and very fatigued.  Sunday morning I woke up with a headache and aches in every part of my body. Every part of me hurt beyond an ache, every muscle, every joint.  By noon, I could not move without pain, my eyes hurt to move, I tried to drive, but I felt myself falling asleep at the wheel.  I spent the entire day sleeping and drinking water.  I took the dose of tylenol but it didn't dent the pain.  I ran a fever of 103. I woke Monday feeling better but my head still ached and most of my joints still hurt and I stayed home from work."
Immediately after the vaccination I felt warm and clammy. I did not have shortness of breath. I sat down for a few minutes and took off my shoes and I began to feel better. I went straight home and laid down. Throughout the night I felt anxious to where I felt uncomfortable sitting still. I have anxiousness in my chest which travels down my body. My hands and feet are clammy sporadically.
Fever of 102.5, body aches, stomach ache, headache, lips hurting, joints hurting, shaking in the evening. Fever through the night until 4am 11/22/2014 when Tylenol given, then tiredness.
ill-defined disorder; herpes zoster; This spontaneous report was received from a lawyer and refers to a currently 67 years old patient of unknown gender concerning a case in litigation. The patient's concurrent conditions, medical history, historical drugs and concomitant medication were not reported.    On or about 09-MAR-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for the long prevention of shingles and zoster-related conditions.  On an unknown date (reported as subsequently), the patient experienced herpes zoster and other zoster related conditions (ill-defined disorder) and was treated by a physician.      The outcome of ill-defined disorder and herpes zoster was unknown.     The reporter considered herpes zoster and ill-defined disorder to be related to Zoster Vaccine Live (ZOSTAVAX).
Information has been received from a licensed practical nurse for VARIVAX (Merck), a Pregnancy Registry product concerning a 27 year old female patient who on 14-Dec-2009 was vaccinated with VARIVAX (Merck) (Lot#664664/0730Y). Concomitant vaccination on the same day includes MMR II (MSD), DTaP, RECOMBIVAX (manufacturer Unspecified) and TB test. Unspecified medical attention was sought. It was reported that the patient's LMP was in November 2009 and the estimated date of delivery (EDD) is approximately on 08-AUG-2010. On 18-DEC-2009 the patient performed a home pregnancy test and the result was positive. There was no adverse effect reported. Follow up information has been received from the licensed practical nurse who reported that on unspecified date the patient had an spontaneous abortion (<20 weeks). On 19-JAN-2010 the patient was in clinic and reported that "Spontaneous Onset of Labor never formed". The patient's private gynecologist was giving her week to miscarry or would have to Dilation and Curettage. It was unknown if the products of conceptions were examined or if the fetus was normal. It was unknown if the patient was tested for varicella antibodies before vaccination with VARIVAX (Merck). The number of previous pregnancies, birth defects or stillbirth or miscarries occur in any previous pregnancy were unknown. At the time of the report, the patient's outcome was unknown. Upon internal review spontaneous abortion was considered to be an other important medical event. No further information is expected.
Patient lightheaded and sweating excessively. She also mentioned tightness in her chest. Patient seen by EMS. It was determined she likely experienced a panic attack.
Passing dizziness at time of inoculation - not reported Painful palpable enlarged gland under left jaw All over body rash - extreme discomfort from itching
patient received a HIB vaccine instead of a TDAP. She denies any adverse side effects or symptoms. This was discovered by our vaccine champion on 8/30/19 when doing reports. Patient was notified 8/30/19 by the administer of the vaccine. Patient came back into the office on 8/30/19 and received the correct TDaP vaccine.
Patient received Varicella booster 6/29/07, Parent phones office on 7/18/07. Reported patient presented with edema, redness at site of injection, no blisters noted. Edema, redness showed up 6/30/07 - lasted approx 3 days.
On day 8 I experienced itching at the site with some swelling. A red rash appeared around injection site that started the size of a quarter and increased over several days to cover lathe area on upper arm that extended to elbow. The area was slightly warm. No pain involved, just itchiness. The rash faded and is just light as of yesterday. Still slightly tender.
pt recv vax & 7mo p/vax pt was dx w/herpes zoster w/lesions on lt upper back & lt axilla;cult of lesions was unable to detect any virus;
Extreme fatigue - flu like symptoms - redness/itchy at vaccination site - burning/itching in inner ear.
covid-19; sickness; This case was reported by a consumer via patient support programs and described the occurrence of covid-19 in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced covid-19 (serious criteria hospitalization and GSK medically significant) and sickness (serious criteria hospitalization). On an unknown date, the outcome of the covid-19 and sickness were unknown.   It was unknown if the reporter considered the covid-19 and sickness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient unintentionally advised she had been sick and hospitalized with COVID-19 for the past month during a general inquiry. No further information obtained before patient disconnected call.
Pt vaccinated with DTP immediately following cried briefly, no color change, fell asleep for 3 1/2 hrs.
Temp 99; Vomiting, nasal congestion, vomited several times post immunization. Took 5AM feeding and kept down. Vomited again later in morning. Taking Tylenol for temp (with vomiting). 3/31/04 Talked with child's mother. States child is fine now. Dr. was notified after mother talked to me and was given something for vomiting.
She got her vaccine Pfizer Bivalent vaccine, bad news reaction.  Not immediate, but had sore arm that was normal.  Within a couple of days she had an extremely bad headache.  She had some shortness of breath and some chest pains.  When she called her PCP they referred her to more immediate care.  She does not drive and her pastors wife took her and at that point they did an EKG and wasn?t quite sure what was going on.  Immediately she suggested to call an ambulance to take her to a local hospital, enough concern that she was taken to the ER closer to where she lives.  She did not have a heart attack, they were busy there, but the ER nurse told her that she has seen cases where people have a reaction to the booster vaccine.  She had the J&J, then she had two boosters of Pfizer and that was nothing major.  Then she had this one that something went wrong and she will not get another booster again.     While in the ER they said she needed to be assessed for heart issues for the chest pains, and they immediate did another EKG/blood work and put her on a monitor.  If there would have been an issue she felt they would have kept her.  She was told to investigate with her own doctor and was sent home.   She is doing OK now, did not like that experience.  She is not a heart patient at all.  In the past she has had a work up for heart issues when she had a stroke, and no heart condition that she is aware of.    She believes she may have had the flu vaccine within 30 days of this one, but did have a COVID and flu vaccine in the past at the same time and did not have any problems with them.  She had an ischemic stroke.  She is wanting to know if there is an added risk for getting vaccines with an ischemic stroke.
Stroke in the hemipons 30 day from  covid vaccine injection. no family history and in perfect health
Lips began tingling (similar to when administered novocaine at the dentist) and tightness along jawline to left ear after I left the site, approximately 40 minutes after injection. After about 1 1/2  hour the sensation lessened.
pt devel fever (tactile) & sz-like behavior @ home p/vax;pt admitted for observation & r/o sepsis;
Chills, low-grade fever, slight headache (2nd shot only, no symptoms after the first shot in December)
Information has been received from a physician and an office receptionist concerning a 21 months old female patient with no pertinent medical history and no known drug allergies, who on 30-JUN-2009, was vaccinated with the first dose of ROTATEQ (oral, Lot # 663397/0572Y), second dose on 10-SEP-2009 (oral, Lot # 663904/0180Y) and third dose on 17-NOV-2009 (oral, Lot # 664073/1097Y). There was no concomitant medication at the time of the event. It was reported that on 02-MAR-2011 the patient went to the emergency room due to vomiting and diarrhea and was admitted to the Hospital with a diagnosis of rotavirus. An unspecified test was performed and was noted to be positive for rotavirus. The patient received intravenous fluids as treatment for the event. On 05-MAR-2011, the patient was discharged from the hospital. At the time of reporting the patient was recovered on an unknown date. No further information is available.
The inside elbow area of left arm started to really hurt about 20 minutes after injection. It has been one day short of one month since the dose and my arm still hurts. I have not sustained any other injuries in this arm.
Hives starting about seven hours after injection.  Started on sides of chest and abdomen as red bumps that itched.  Went to bed and about six or seven hours later awoke to find my whole chest and abdomen covered in hives.  Heart was racing and felt tingly all over.  Took pictures of hives for doctor. Took an antihistamine and went back to sleep.  Upon awakening the hives were gone.  Called doctors office to report.
Red rash about 3 inch wide, 4 inch long right at injection site; It was red; It was itchy; It was a little tender presses or pushes the area it hurts; A spontaneous report was received from a reporter and other HCP concerning a 50-year-old, female patient, who was pregnant participating in the who received Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  who and experienced    red rash about 3 inches wide and 4 inches long right at the injection site, and it is red and itchy.  The patient's medical history, as provided by the reporter, included type-1 diabetes. Concomitant medications reported included insulin and lisinopril.   The patient received their first of two planned dose of mRNA-1273 on 13jan2021. On 13 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.     After a week  of  receiving mRNA-1273, the patient got a red rash about 3 inches wide and 4 inches long right at the injection site, and it is red and itchy.       Action taken with mRNA-1273 in response to the events was not reported.     The events, injection site rash, injection site erythema, injection site pruritus and injection site pain were considered not resolved at the time of report.   The reporter did not provide an assessment for the events, injection site rash, erythema, pruritus and pain.
Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chickenpox.  Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chickenpox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated patients was a 9 year old patient who on 28JAN1997 was vaccinated with a dose of varicella virus vaccine live. On 28MAR2003, the patient developed chickenpox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other patients that developed chickenpox post vaccination with varicella virus vaccine live were also identified.  Additional information is not expected.
Fever, Night Sweats, Chills,  Soreness in all limbs, Fatigue,Tiredness
This spontaneous report as received from a registered nurse (R.N.) refers to an unknown number of patients of unknown age. It was reported that the patients might have received improperly stored GARDASIL (lot # not reported) which were exposed to 54 F for 96 hours on 04-SEP-2012. No adverse effect was reported. It was unspecified whether the patients sought for medical attention. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Pt. is a 44 y.o. male evaluated with a web video visit for evaluation of side effects after undergoing the Janssen Covid-19 vaccine yesterday. He describes having systemic side effects of fever as high as 100.8F, chills, fatigue, body aches, and headache. He underwent the vaccine yesterday at approximately 1045. He relates that he took Excedrin migraine a few hours ago but is not having relief. He would like to know if it okay for him to take any other medications to treat his side effects. He denies any cutaneous, thrombohemolytic, or analphylaxis side effects.
This spontaneous report was received from a medical assistance referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD lot numbers: M036294, expiration date 24-JAN-2018 and M038860, expiration date 13-MAR-2018 (dose and route of administration were not provided) for prophylaxis. There was no adverse effect reported. Administered doses of PROQUAD were exposed to a temperature excursion of 29°F for 6 hours and 48°F for 3 hours. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA005585: US-009507513-1702USA010877.
Pt developed low grade fever on the evening of injection as reported by Mom.  Fever continued until 11/30/2000 at 9PM.  On 12/01/2000, pt afebrile, acting normal.
Coldness, then slight chills, then chills with shivering, then extreme chills and shivering. No fever until 8 hours after shot. Skin extermely warm heart rate increased from 64 to 110 for over 6 hours.Chills started to reduce around 11 hours after shot Fever of 101.2 at 9 hours after shot Fever of 101.6 at 10 hours. Chills stopped and extereme hotness began. Fever and hotness slowly began reducing until 14 hours after dose.  Fatgue set in.. note during chills also felt extreme hotnwss at same time in all parts of body
Severe hive type breakout by eyes, on face, neck, arms, legs, back, stomach in patches
Narrative: Patient developed fatigue, SOB, and anxiety following administration of covid vaccine. She was transferred to ambulance and taken to ER for further workup. Follow up revealed no acute issues, pt experienced sob and fatigue and was still recovering over a week after having the vaccine.
From initial information received on 07/23/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that two patients (no patient identification provided) may have received a does of Daptacel, lot number C1699AA, in error instead of a Tubersol 5TU skin test on an unspecified date. Sometime after the administration of the product, both patients developed large positive reactions, which were described as induration at the injection site. One area of induration measured 40mm and the other measured 50mm. It was not reported whether the patients recovered from these events. From additional correspondence received on 09/07/04 from the initial reporter, the patient's full name, date of birth, age date of vaccination and adverse event onset, and recovery status were provided. Also, this patient had no pre-existing conditions or allergies and no illnesses at the time of the vaccination. The Daptacel vaccine was given intra-dermal in error instead of Tubersol 5TU. This vaccine was given at a private doctor's office with private funds. This event was not previously reported. From telephone correspondence on 09/08/04, it was reported that the number of patients who experienced reactions after receiving Daptacel in error instead of Tubersol 5TU was only one patient and the information for this patient is included in the follow up information received by the manufacture on 09/07/04. She stated that the second patient originally identified did not receive Daptacel, but did in fact received Tubersol 5TU and had a positive reaction. The second patient did not experience an adverse event. No further information is anticipated, this case is considered closed.
Sore throat started following day on 12/14 am while at school.  Later in day also completed of headache.  In the evening, he had chills and temp of 101.3.  As of 12/16, he continues to have a sore throat, low grade temp of 99.0, and a slight cough.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 26-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372; 1310USA008373, 1310USA008374; 1310USA008375; 1310USA008376; 1310USA008377; 1310USA008378; 1310USA008379; 1310USA008380; 1310USA008381; 1310USA008382; 1310USA008383; 1310USA008384; 1310USA008385; 1310USA008387; 1310USA008388; 1310USA008389; 1310USA008390; 1310USA008391; 1310USA008392; 1310USA008393; 1310USA008394; 1310USA008395; 1310USA008396; 1310USA008397; 1310USA008398; 1310USA008399; 1310USA008400; 1310USA008401; 1310USA008402; 1310USA008403; 1310USA008404; 1310USA008405; 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
No adverse events.  Administration error.  Patient is 15 and vaccine not approved for this age group.
Starting the Sunday after the vaccine, I started getting a headache that wouldn't go away. It was centered behind my eyes and wouldn't go away with ibuprofen and water. I went to the eye doctor 12/23/2021 because I needed glasses and he said that there was centralized inflammation on the optic nerve which was in the left eye at first but began in the right eye as well. I was referred to the wills eye hospital and had testing done 12/24/2021. Diagnosed Idiopathic intercranial hypertension. I was prescribed Diamox to decrease the pressure in my head. And I need to go see neuro-ophthalmologist in the next 6-8 weeks to continue treatment.
On 09/18/2001, mother called and stated child had 2 -3 bumps and redness on left leg at injection site. Also stated child cried 2 - 3 hours. Stated bump are larger, the size of 50 cent piece. On 09/19/2001, mother said she took child to doctor and doctor informed her the child had a reaction to diptherma.
pt recvd vax & exp fever, chills, lethargy; also exp redness & swelling @ inject site; no further details are available;
LARGE RASH PRESENTED AT THE INJECTION SITE. STARTED OFF AFTER DAY 2-3 OF FIRST DOSE AND WAS INITIALLY THE SIZE OF A QUARTER. OVER THE COURSE OF THE NEXT DAYS, THE RASH GREW IN SIZE AND BECAME HOT TO THE TOUCH. PATIENT HAD NO FEVER.
June18  12:00pm I just felt like I had a bad cold  June 19   I tested positive for COVID-19 with a home test and then I went to the pharmacy and tested and received results on June 20th.   June 20th   Test results from the pharmacy were positive Called my PCP and left a message and he called in a prescription for Paxlovid. I took as prescribed. A few days later I started to feel better not that I felt horrible just symptoms of a cold.
12 year old was administered the first dose of the Moderna Covid19 Vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old was administered the first dose of the Moderna Covid19 Vaccine.) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE and HYDROXYZINE for an unknown indication.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old was administered the first dose of the Moderna Covid19 Vaccine.). On 16-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old was administered the first dose of the Moderna Covid19 Vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information was reported. This is a case of Product administered to patient of inappropriate age for this 12-year-old male patient with no relevant medical history reported. The patient received the first dose of mRNA-1273  vaccine on 16-Sep-2021. No adverse events were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a case of Product administered to patient of inappropriate age for this 12-year-old male patient with no relevant medical history reported. The patient received the first dose of mRNA-1273  vaccine on 16-Sep-2021. No adverse events were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
I woke up at 8:30 am and had the sensation of floating and the world around me was spinning. I went back to sleep and did not awake until noon. When I got up, I felt very weak and my head was foggy. I also kept stumbling when I walked. I drank plenty of water in case I was dehydrated and ate protein, but these symptoms lasted the entire day. The next morning I woke up with a mild headache but mostly felt normal.