chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heat sensation at upper back area, pain at back area. No hives nor itchiness. No SOB, CP not in distress. Gave a glass of H2O to drink. Monitor and seen by MD 12.15PM. Felt better 12.40pm. Asymptomatic, not in pain no more heat sensation. Discharged 12:45pm. According to patient above symptoms felt after PNEUMOVAX vaccination.
24DEC96 pt had sore throat, chest pain when coughing, high fever & muscle weakness causing pt to fall;pt also coughing up phlegm;pt seen by MD;pt recovered had a relapse around 10JAN97;exp weakness,bladder incontinence, dizziness, hoarse
Pt had chest tightness and difficulty breathing. Pt was given Epi pen IM and followed by another in 1 minute later. After no relief. Albuterol HFA 3 puffs were given sequentially 1 min later 911 was called and pt was picked up by EMT.
Pt given Hep A Vaccine - Adverse reaction of near syncopal episode upon leaving the exam room 10min later. Pt sat down to steady himself. Vitals taken and wnl. Assisted pt back to exam room to lie down and take deep breaths. Pt with increased WOB, stated "my body feels like its burning on the inside." Afebrile, O2 sat 100%, no rash or hives, no change in vitals. Waited 10min with continued monitoring and crash cart outside. Pt able to drink water, juice. Ambulated to restroom with assistance. Pt still felt burning pain inside lying down when returned to exam room, vitals continued to be wnl. CDC Hep A adverse reactions include soreness, HA, low grade fever, syncope. No other reported SE that coincide with pt sx. Given pt extreme burning discomfort, 911 called. EMT arrived, report given, progress note and vaccine information papers provided to take to ED. Mom and brother went with pt in ambulance. Discussed f/u after ED visit. Pt and mom in agreement with plan.
25Feb98 pt recv vax & 03Mar89 pt devel fever (103.5-105f) & rash of "welts". Additional info requested.
Within 6 hrs of immunization, I began to have chills and fever that lasted for approximately 12 hrs. This was accompanied with throbbing pain from the left upper arm across the pectoralis major to the sternum and redness and hot to the touch across my entire upper left arm.
started taking Paxlovid yesterday/received his last Covid vaccine 8 months ago, he is unsure what manufacturer he received; started taking Paxlovid yesterday/received his last Covid vaccine 8 months ago, he is unsure what manufacturer he received; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. An 88-year-old male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "started taking Paxlovid yesterday/received his last Covid vaccine 8 months ago, he is unsure what manufacturer he received". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Having Covid after previous Covid vaccination- manufacturer unknown, potential lack of efficacy if patient did receive Pfizer as last Covid dose. The patient currently has Covid, and received his last Covid vaccine 8 months ago, he is unsure what manufacturer he received. The patient was not immunocompromised started taking Paxlovid yesterday and will be done in 3-4 days.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Doesn't remember any reaction until 2nd MMR vaccine, now remembers after 1st MMR - felt hot, panic attack, nausea but for a 2nd booster - 2-3 days after vaccine given - c/o pain going down legs, cramping, tingling, neck/face spasms and twitching, hands & arms cramping - reported 3/7/12.
FAINTING; DIZZINESS; This spontaneous report received from a patient via a company representative concerned multiple patients of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch no/Lot numbers. No concomitant medications were reported.  On an unspecified date, the patients experienced dizziness and fainted, they came back to consciousness. There was no information about the patients who experienced these symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainting and dizziness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420968-covid-19 vaccine ad26.cov2.s-Fainting. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Pt's wife states day after receiving vaccines, pt's right arm was hot to touch, red and had a knot in it.  Pt also had a headache for about a day.
Bloody diarrhea; Ulcerative colitis; Dizziness; Feeling "very sick"; Fatigue; Fever; Chills; Headaches; Nausea; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) and COLITIS ULCERATIVE (Ulcerative colitis) in a 22-year-old male 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 Asthma and Eczema.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) (seriousness criterion hospitalization), COLITIS ULCERATIVE (Ulcerative colitis) (seriousness criterion hospitalization), DIZZINESS (Dizziness), MALAISE (Feeling "very sick"), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headaches) and NAUSEA (Nausea). On 09-Apr-2021, DIZZINESS (Dizziness), MALAISE (Feeling "very sick"), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headaches) and NAUSEA (Nausea) had resolved. At the time of the report, DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) and COLITIS ULCERATIVE (Ulcerative colitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Colonoscopy: abnormal (abnormal) it appeared to be an "ulcerative colitis" on the entire colon.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication mentioned topical cream NOS for eczema.  Treatment information mentioned IV Methylprednisolone and Metamizole. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Company comments This case concerns a 22-year-old female hospitalized with serious unexpected events of diarrhea hemorrhagic and colitis ulcerative, nonserious unexpected dizziness, malaise, and expected pyrexia, chills, headache, fatigue, nausea. Event onset 24 hours after second dose mRNA-1273. Serious event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt reports HA in PM-restless noc-near syncope at 0300-sweats chills fever.
Initial - Muscle aches, weakness, soreness at vaccination site, headache Later - Fever, nausea, vomiting, weakness, muscle ache, headache, diarrhea
VERY SICK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced very sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sick was not reported. This report was non-serious. This case, involving the same patient is linked to 20220925320.
Pt. claims her arm is very sore & has a quarter size bruise. She also says the next day she had a fever, chills, & vomiting.
Patient noted by historian (mom and grandmother) to have had prolonged crying and poor eating for approximately 5-7 days following administration of combined DTaP, IPV, Hep B vaccine (second dose of three).
21days p/vax pt exp generalized rash w/approx 10 lesions on chest & in mouth.
RECIPIENT BEGAN TO FEEL DISORIENTED, BECAME DIAPHORETIC, SHAKY AND BLURRY VISION. NAUSEA, VOMITING, CHEST TIGHT.  RECIPIENT WAS ALLOWED TO REST, PER HER REQUEST NO OTHER TREATMENT PROVIDED.
fatigue: started day after injection, lasted 2 days nausea: started day after injection, lasted 2 days chills: started day after injection, lasted 1 day arm soreness: started night after injection, resolved by the morning after
Starting 06/24/2022 in the evening, I was fatigued and as the night progressed I developed terrible chills, fever and headache. The next day my fever went up 103.9 and I was concerned. That same day, I tested positive for COVID-19 with an at home test (06/25/2022). The body aches were horrible, and I had chills, fatigue, ear pain and my upper jaw hurt. My eyes burned and my sinuses were congested. Also, I had some vertigo. Each day varied in intensity of the symptoms. On 06/26/2022, I messaged my doctor's office asking if I could have a sinus infection while having COVID-19 due to having a sore throat and a white postule in the back of my throat. They responded on 06/27/2022 stating that I could have a sinus infection with it and instructed me to take over the counter medications to alleviate the symptoms. By 06/28/2022 after normal business hours, I called an urgent care to see if I could be seen for the sinus issues and the ear pain I was having. They said no and instructed me to call my PCP and do a telehealth visit. I did a telehealth visit through my insurance and he told me due to how I sound and my symptoms that I likely had a sinus infection that involved my ears and possibly bronchitis or pneumonia. So, he prescribed me an antibiotic for the upper respiratory infection/bronchitis/pneumonia (Doxycycline) and Benzonatate pearls for cough, and told me to take an over the counter sinus medication. So, I had my husband pick up sinus medicine with a decongestant which I started that night and that helped. I think I have finally turned a corner yesterday, 06/30/2022, and I feel like it's more in my sinuses versus my chest. At this point, the pain in my ears is worse than the sinus pain. I took an at-home COVID-19 test yesterday, 06/30/2022, and it was still positive.
Pt reports severe muscle aches and stiffness for the last 3 weeks since the vaccine was administered.  This has been interfering with her daily activities and range of motion.
aches and pains; low grade fever; chills; nausea from my headache; nausea from my headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches and pains), PYREXIA (low grade fever), CHILLS (chills), NAUSEA (nausea from my headache) and HEADACHE (nausea from my headache) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Oct-2023 at 10:00 AM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches and pains), PYREXIA (low grade fever), CHILLS (chills), NAUSEA (nausea from my headache) and HEADACHE (nausea from my headache). At the time of the report, PAIN (aches and pains), PYREXIA (low grade fever), CHILLS (chills), NAUSEA (nausea from my headache) and HEADACHE (nausea from my headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Low grade fever.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patent received vaccine on 10 a m on Saturday. Thought patient was doing fine but have since had chills low grade fever aches and pains and nausea from headache.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2023: Live follow-up received on 29-Oct-23 with no new information.
Friday, Feb 26th 2021-About a hour after shot I had joint pain in my elbow and wrist.  I took Tylenol 1 hour prior to the shot and 6 hours afterwards. No redness or pain Friday evening. I had insomnia Friday night and did not fall to sleep until 5am.  Saturday, Feb 27th, 2021- I woke up with joint pain to my elbow and wrist. Arm was extremely sore.  I did not eat until 4pm and  I took Tylenol then,  Once I started moving my arm felt better and the joint pain went away. Trouble sleeping Saturday night.  Fell asleep around 4am.  Sunday, Feb 28th- Work up and arm wasn't as sore. Noticed around 1pm I had a red spot under the vaccine spot where I was injected. It was red and painful, about the size of 2 nickels put together.  I took more Tylenol that evening and was ok.  Monday, March 1st- I noticed the red spot had gotten bigger.  It wasn't as itchy and was not bothering me.  Around 8pm, I noticed the spot was bigger and itchy.  I toke a Tylenol and Benadryl and about midnight put an ice pack on the redness for 15 min intervals. I did this 3 times.  I outlined the red spot, which is now as big as a orange to see if it was spreading.  Tuesday, March 2nd - Noticed no spread at 8:30am.  Site beginning to itch.  At 12 noon, taking a Benadryl and Tylenol after eating lunch.
COVID vaccine administration error.  Pfizer mRNA COVID vaccine dose #2 given at wrong interval.   Dose #1 received December 27th, 2020 Dose #2 received January 10th, 2021  Patient apprised of error.  Patient verbalizes understanding that dose will need to be repeated.   Patient was observed for 15 minutes per protocol; no complication noted.   Patient was discharged from clinic.
Patient received influenza vaccine with a pediatric size needle. patient was advised to seek another influenza dose for this season.
-Abrupt      _______ , Nausea, Vomiting, Posterior Headache -Emergency Room Visit -Received tPA, which resolved symptoms -ICU admission for 2 nights
Patient expressed sharp pain at injection, right after injection there was about half a golf-ball sized swelling at injection site. I told patient to stay in waiting area for 15 minutes and watch for other symptoms. After 5-10 minutes she complained of tingling down her left arm and into her hand. Her hand felt nerve-tingling and was abit numb, her index finger on that hand developed a bruise. She is afraid of nerve damage. i told her to closely monitor the situation and if it gets worse or she loses range of motion to reach out to provider immediately.
This spontaneous report was received from a registered nurse concerning an unspecified number of unspecified patients who on unknown dates might have received improperly stored dose of GARDASIL (dose, route and lot # not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected.
Breakthrough case.  Confirmed positive for covid on 9/20/2021 with PCR test
I started getting sick in December 2021. I lost like 30 pounds in 10-12 week. The more wait I lost the more tired I felt. I also had these weird and painful lesions on the palms of my hands that have now been diagnosed as granuloma annulare. I am treating them with a steroid cream. I also started getting these weird lights in my eyes and saw a neurologist. I was diagnosed with ocular headaches without pain. My balance was affected as well. All of these symptoms started at the same time so I thought they were all connected but everything seems to separate. I ended up in the hospital on 03/15/2022 and I have a provisional diagnosis of lymphoma. I am waiting for results from the doctor. It is not confirmed yet. I have blood work done frequently as well.
Inappropriate schedule of vaccine administered; Fatigue; Muscle ache; Nausea; Vomiting; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Muscle ache), NAUSEA (Nausea), VOMITING (Vomiting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Muscle ache), NAUSEA (Nausea) and VOMITING (Vomiting). On 25-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PARACETAMOL (TYLENOL) in August 2021 for Adverse event, at an unspecified dose and frequency. On 25-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, FATIGUE (Fatigue), MYALGIA (Muscle ache), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Vaccine facility information also included , .   This case was linked to MOD-2021-297814 (Patient Link).
On 6/14/99, the pt experienced malaise and a fever. It was indicated that by 6/18/99, the pt had recovered from malaise and fever. On 6/18/99, the pt developed pain and swelling in her ankle and wrist. The pt went to an ER for evaluation. Therapy with analgesics and methylprednisolone was initiated for the treatment of the pain and swelling.
slight sore throat at around 8pm on 08/30/2021, worsening overnight and combining with a runny nose at around 4am on 08/31/2021.
Per  immunization registry  Dose #1 2/2/21 Administered  Dose #2 8/26/21 Administered  Dose #3 9/16/21 - Administered -too early unsure if indicated  Dose #4 1/19/22 - Administered - too early, not indicated
Information has been received from a 33 year old male consumer with "multiple sclerosis" and a history of genital warts, and no allergies who "a couple of years ago" was vaccinated with 0.5 ml dose of GARDASIL three times. Concomitant therapy included insulin and "medicine for multiple sclerosis". "With in the last 2 weeks" on approximately 09-FEB-2010 the consumer experienced a genital wart. There was not laboratory studies performed. When asked if the adverse event improved and about his present status, the consumer stated that his doctor froze the genital warts on 22-FEB-2010 and on 23-FEB-2010 there was a blister where the wart was. Additional information has been requested.
pt recv vax 20AUG96 & lab results revealed that pt failed to seroconvert;
Started feeling very itchy on March 6, then two days later noticed red bumps starting to show. Did not get better so when to the doctor on March 9, 2016.
nursing her infant and he developed fever; nursing her infant and he developed fever; This is a spontaneous report from a contactable other health professional. This other-HCP reported events for mother and baby. This is baby case. An infant male patient of unspecified age received the first dose BNT162B2 (lot number: EK5730), via transmammary on 22Dec2020 at 18:15 in right arm for covid-19 immunization, and the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via transmammary on 11Jan2021 at 18:15 at single dose in left arm for covid-19 immunization. The mother's medical history included hypothyroid, and known allergies: penicillin. The mother's concomitant medication included levothyroxine, biotin, ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), ergocalciferol (VIT D), lactobacillus acidophilus (PROBIO). The patient's mother received the first dose BNT162B2 on 22Dec2020, and received the second dose BNT162B2 on 11Jan2021. The patient's mother had myalgias 16 hours after receiving the 2nd vaccine. The patient's mother was nursing her infant and he developed fever for 3 days without any other symptoms following her vaccination. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021034793 Same reporter/drug, different patient/event.
PT CALLED TODAY 5/5/21 STATED THAT HE WOKE UP ABOUT 2:30AM AND COULD NOT BREATH. HE RECEIVED HIS VACCINE ABOUT 2:55 PM ON 5/4/21.. HE SAID HE FELT LIKE HIS THROAT WAS SWOLLEN, HE HAD A FAST HEART RATE, AND FELT LIGHT HEADED.
pt recvd vax;w/in 2 days,devel t 101; v; joint pain; malaise & previously problematic lt elbow became red & swollen;saw MD 2 days later;md was not particularly convinced that any of the rxn was due to flu vax;
itchy rash came and went on various parts of body ... stomach, then back , then breasts, then back of neck
Pt vaccinated with 2 doses of Engerix-B developed cramps, diarrhea, headache, stiffneck, fever 102-104, and migraine headache.
ZOSTAVAX given 9-11-12. Presented to clinic 9-17-12. Rx'd with ZITHROMAX & Prednisone 25mg BID x 5 days. F/U clinic 9-21-12 - improved but still wheezing so prednisone taper ordered over 12 days. 9-26-12 - Reddened vesicular lesions (R) breast, axilla & (R) back T3/T4 dermatome. Apparent zoster. Started on VALTREX 9-26-12.
Red rash with swelling and heat at site of reaction. Patient states itchy occurring >24 hours post vaccination. No anaphylaxis s/sx. Use ice, diphenhydramine, HC cream, and call 911 if any swelling of face or throat or go to urgent care if worsens.
Case number PHEH2014US001233 is an initial spontaneous report received from a pharmacist on 13 Jan 2014: This report refers to a 14-year-old male adolescent who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5ml on 11 Jan 2014. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 13 Jan 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "Adult product administered to child".
On Wednesday, March 17 around 1 p.m. my left arm ached and felt heavy.  The site of the injection had a red circle about the size of a dime and was raised. It also itched.  Later that afternoon below the injection site I had a red patch that also itched and broke out in hives.  I took Tylenol and put cortisone cream on it.  the injection site cleared up in about 2 days. the red patch is slowly fading.  once in awhile the arm still fees heavy.