chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SEVERE SINUS DRAINAGE/COUGHING UP PHLEGM, FEVER, CHILLS, DIZZINESS, VOMITING, WATERING EYES, HEADACHE LASTING FOR 12 HOURS.
States left arm still hurts from injection at injection site especially when rolling over in bed or when lifting left arm
Initial report received on 05 March 2007 from a health care professional.  A patient, whose reported age was "2", had received a fourth dose of DAPTACEL on an unknown date.  The lot number, route and site of administration was not provided.  At an unspecified amount of time later, the patient developed swelling (site not reported).  The recovery status of the patient is unknown.  The patient subsequently experienced severe right thigh swelling after the fifth dose of DAPTACEL on 09 January 2003, this event is reported in case 2006-00348.
Pt comes into office 2 days after receiving shots. Lt upper arm red, hot, inflamed at site of Dtap and MMR. MOC had been putting ice directly on child's arm so there was some mild irritation from that as well. Telephone call w/mom 2 days later reveals child has completely recovered.
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32° degrees Fahrenheit and the highest was 54° degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47° degrees Fahrenheit and the highest was 49° degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up information was received from the physician on 27-OCT-2017. This report refers to 8 month old patient. On 17-JUN-2017, the patient was vaccinated with improperly stored doses of PEDVAXHIB lot# N000235 with expiration date: 24-OCT-2019. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA007325: US-009507513-1709USA012766.
3/19/2004-Hep B vac 2nd dose 8AM, 11:30AM, Nausea, vomiting and diarrhea, tired. 3/20/04-muscle aching, arms, legs, back, neck, restless at night, awoke sweating and chills, no fever. 3/21/04-face, neck swollen and itchy, ringing in ears, then hands, arms, chest, itchy, no SOB or constricted airway. 3/22/04 No gI symptoms. Some itching. 3/23/04-returned to work. Slight itching only, didn't want to see a doctor.
Pt was at a special annual immunization event. Clinic was helping at the event. Pt is not out pt and unsure of primary MD. Pt had suspected synovial seizure- to the floor had brief seizure x 15 seconds, eyes rolling and unresponsive. crying, recovered. Parents took pt to ER.
less than 24 hours I started getting fever, chills.  by the end of the 2nd day I couldn't walk for 3 days, my legs felt very heavy.  I had a headache, blurred vision, palpitations, extreme fatigue, body aches for 15 days.  I tested twice for COVID and was negative.  for 45 days I continued with same symptoms.  Symptoms lessoned but I would randomly wake up feeling like I was having a heart attack.  Since the vaccine my heart run tachy.
Patient received both FluzoneHD and Pneumovax23 vaccinations on same day.  She began to feel flu-like symptoms that evening, which lasted about ten days.  She also experienced a red/swollen upper arm where the vaccines were administered.  She was unable to recall around which injection site that the reaction started.
About 3-4 days after 3rd Hepatitis B injection (given on 3/21/03) pt reports she experienced sore, red hands and wrists. She also complained her ankles and neck were sore. It cleared after 3-4 days.
After around 3 minutes getting Pneumovax #23, patient complained of shortness of breath.  "I can't breath".  Patient looks distressed.  Administer 8 hrs O2/NC.  911 was called.  After 15 minutes patient not in distress anymore, no shortness of breath.  Later she told us that she had chest pains during the episode.  Patient then was taken to ER for further evaluation.  Patient was attended by MD during episode.
Dizziness, bad headache, followed at 3:15 by lump in throat the size of a golfball; Painful sore throat, low-grade fever, and hoarseness, followed by 4-5 episodes of vomiting around 5:30 p.m. Eyes filled with gunk so I could not see out of them to do the crossword. Too sick to watch TV. Needed help from adult son and daughter, who brought fluids, cleaned up the carpet, and took the dog overnight. Slept the entire next day (yesterday), able to eat toast around 4:00 p.m. Functioning OK now 48 hours post-vaccination, but still hoarse.
rt upper arm swollen, red, hard;tx warm compresses, exercise & advise it not better;25FEB95 rt arm unchanged no temp; 6cm c 8cm read area, non tender, no induration, no lymphadenopathy;ROM nl; sam tx
Headache, NauseaVomiting, chills, fatigue Narrative:  reports about 30 hours after vaccine developed a headache. about 48 hours had flu-like s/s, chills, nausea, fatigue, denies other s/s.  These flu like s/s resolved within 24 hours, but headache continues, in milder form.
he tested positive for Covid-19; he thought this could be an allergy; cough; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient, his wife and son received the first dose of the vaccine on 08Apr2021. He started with symptoms last Friday (16Apr2021), with cough, he thought this could be an allergy. On Monday (19Apr2021), he tested positive for COVID-19. His wife and son tested positive for COVID-19 on Tuesday (20Apr2021), they are asymptomatic. Their second dose is scheduled on 29Apr2021, he would like to know if there's a time recommended for him/them to receive the second dose of the vaccine, because some people say seven days, others say 14 days and if someone is asymptomatic 10 days. The outcome of the events was unknown.   Information on the batch/lot number has been requested.
Shortly after injection I began coughing. Overnight I developed shortness of breath and generalized facial swelling, periorbital edema, and around the nose. My sinuses were full of clear mucus and I had a headache upon waking at 5 AM. At 5:30 AM I took a XYZAL and an ALLEGRA and the swelling had subsided almost completely by noon.
Starting January 9, 2022 I noticed a small firm lump under my right armpit. The doctor described it as the right axillary lymph node. Over the course of the month, it continued to grow. It was swollen enough that it was pressing on nerves in my arm which caused pain. In regards to treatment, they put me on antibiotics to see if it was an infection causing the swelling. I had an MRI and CAT scan to get imaging done just to double check and make sure it was nothing serious. Late March (March 28, 2022), I got the final results of everything. The whole course took about 2 months. None of the imaging showed anything there besides it being physically felt. Imaging showed nothing so I'm just living with it. It has stopped growing after a month, and the pain subsided and it has been the same size since then. Size of the lump at largest was an inch in diameter and is about the same size, maybe a little under now.  Lump is still present, but has not negatively impacted my daily living.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a 27-month-old male child. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the first dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Fatigue, headache, soreness at injection site started almost right away. Followed by hot flashes/chills and nausea later in the day. 5 days later a non itchy rash has appeared on face.  Nausea, head ache, and Fatigue are better but still present after 5 days. Taking Tylenol or ibuprofen to manage soreness and headache. Benedryl for the rash
presented to the clinic to receive her first dose of Pediatric Pfizer (Lot FK5127-H). She received a dose at 0944 to her RD and moved to the observation area with her mother. At approximately 0950, she c/o nausea to the observation RN and had a small amount of emesis. RN alerted another RN to assist. At 0955, the client transferred to the cot and accepted water, drinking it without difficulty or further emesis. She reported that she felt better after laying down. SPO2 at 0955 was 95% on RA, HR was 84. She denied any sensation of itchiness, tingling, or difficulty breathing and showed no signs of facial/tongue/lip swelling or rashes. She reported that she had been very anxious about receiving the vaccine before injection and that she has a fear of needles.  At 1000, she sat up on the cot, denied nausea and reported that she felt ?90% normal.? SPO2 was 98% on RA, HR was 94. At 1004, she rose and transferred to a nearby chair without difficulty. Visual assessment of facial tissues continued to show no signs of swelling, no rashes noted on skin. The client and her mother were educated on s/s anaphylactic responses, what to watch for, and when to seek medical care. Aside from the brief episode of N/V, she exhibited no s/s of an allergic reaction. She remained under observation until 1019, at which point she reported she felt ?better than ever? and her SPO2 was 99% on RA with an HR of 83. She exited the facility at 1020 with her mother, to be monitored by her mother at home.
Patient has received second dose of Moderna COVID-19 on 28May2021; Patient has not received second dose of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has received second dose of Moderna COVID-19 on 28May2021) and PRODUCT DOSE OMISSION ISSUE (Patient has not received second dose of Moderna) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management and Hypercholesterolaemia. Concomitant products included TRAMADOL and DEXLANSOPRAZOLE (DEXILANT) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has received second dose of Moderna COVID-19 on 28May2021). 28-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received second dose of Moderna). On 28-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has received second dose of Moderna COVID-19 on 28May2021) and PRODUCT DOSE OMISSION ISSUE (Patient has not received second dose of Moderna) had resolved.            Concomitant drug included some unknown medication for  blood pressure  and cholesterol .  Treatment medication was not reported.   This case was linked to MOD-2021-163762 (Patient Link).
10/24/09 Admitted to hospital with knee pain. 4-5 day history of progressive lower extrm pain, weakness and numbness.
Started with pain and swelling at the site. I tried hot packs and cold packs. it was very painful. Tried to go to bed and my whole body hurt. my joints and everything else. I would wake up yelling in pain. I deal with chronic pain all the time but this was extreme. I had a fever this morning. I have confusion and dizziness trying to walk. I tried to drive and couldn't. I took a covid test and it was negative.
Jansen COVID-19 Vaccine EUA I received the vaccination on 3/12/2021, about 8:30AM, at Fairgrounds. I needed the J&J vaccine, one Moderna or Pfizer as I have a history of anaphylaxis. County Public Health received about 200 does of the J&J and 800 of Moderna and Pfizer.   I waited at the vaccine site about 40 minutes after the vaccine. I went home, ate, read, and became unusually sleepy so took a nap. I woke up about 2:00PM and noticed my lips and tongue were swollen, and sore. I took 2 Benadryl. The Benadryl seems to have worked as expected. I will take 2 more when I go to bed, about 11:00.  I'm unusually sleepy, and my joints ache. Overall, however, I think I am experiencing a very mild reaction and I'm thankful for the vaccine. I sent my doctor a message through the patient portal, telling him of the reaction. His office is closed so he will get the message on Monday.
1. Fever (100.7F), aches, and pains for 24 hours starting the second day. 2. Ear Ache and sore throat starting the third day.
Patient was administered 4th dose on 1/20/22. Pt. did not inform us it was 4th dose. Contacted pt. on 1//28/22 and she stated she was unaware it was 4th dose. States no issues post vaccine.
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. no adverse rection
Pt recvd DTP/HIB on 13JUL92; started running inc temp later that day; was taken to hosp ER that noc w/t105; according to pts mom pt turned red all over & was having some resp distress (breathing was irreg & labored);
Patient received Covid Vaccine Dose 1 (Moderna) on 1/14/2021.  1/15/21 I experienced arm soreness, lethargy, body aches, achy joints, and felt like crap.  1/16/21 I developed two red swollen spots on my left arm (injection arm).  The red areas were swollen, hot to touch, and each were a hard lump a little larger than a marble.  These two spots were about 3 inches below the injection site and an inch closer to the body midline.  These red spots worsened and joined together.  1/28/21 I was still experiencing the red raised area that had grown in size, still hot to the touch and now red and rashy around the outer edge.  Redness diminished over the weekend and resolved by 2/3/21.  Arm and shoulder still are achy and sore.
Patient came into the clinic to update his immunizations for college. All questions on immunization consent form were asked to mother and she answered no to all. After discussion the client and his mother decided to get the TDAP and HEP A vaccine. The patient was sitting on the exam table when the vaccines were administered. The patient, his mother and myself left the first exam room and walk approximately 10 feet to another exam room when the patient stated "I feel like I am going to pass out" he sat down in the chair immediately and slumped over to the right losing consciousness and I caught him before he could hit the floor. I leaned back up where he was resting his head on his mother's chest. I immediately called for RN to bring me a blood pressure cuff. During the time she was getting the cuff the patient seem to have a seizure as evident by a blank state, head thrown back, and decorticate posturing. I then advised PHT to call 911. I put the BP cuff on the patient and attempt to get a reading, however the machine would not pick one up. The patients pulse was present but slow and weak. I advised RN to get a wet cloth for the patient and she did and gave it to the patient's mother who applied it to his forehead and face. The patient was cold and clammy and mumbling. I advised PHT to get the Emergency medical supplies from the lab and attempted to repeat the blood pressure. The reading was 77/54 02 Sat was 90 on room air and pulse was 34. The patient appeared to then have another seizure and showed the same symptoms as above and then lose consciousness. At this pint I advised that we need to move the patient to the exam table. The patient was picked up from the chair by his mother, PHT, and me. After placing the patient on the table I advised PHT to elevate the patient's legs. The patient started to gain consciousness and his blood pressure at this point was 101/53, pulse 60, O2 Sat 99, EMS on scene. Continued to monitor patient. Blood pressure reading of 99/69 and 112/68. Patient remained in supine position while evaluating BP. Patient started getting some color back. EMS had patient sit on table for a couple of minutes. We then had the patient stand and repeated the blood pressure at which time patient experienced dizziness, turned very white, and started to appear to lose consciousness again. Blood pressure cuff would not even read due to orthostatic hypotension. We immediately placed patient back in supine position. EMS advised pt should probably be seem by ER or personal M.D. Patient's mother contacted M.D. office who advised her to have EMS take him to the ER. Patient was transported by EMS to Medical Center. Patient's mother at approximately 1:15. She advised that her son had been released from the ER. Blood work had been performed that demonstrated slight elevation of WBC's. EKG was normal. She also reported that the patient received 2 liters of Normal Saline. She reported that she is to follow up with her son's primary physician to see if he should get the second of HEP A.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 13-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius(C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082:
raised bubble in the rash; itchiness; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itchiness, raised bubbles in the rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced itchiness, raised bubbles in the rash..  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events  itchiness, raised bubbles in the rash was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Body aches; Body chills; Nausea; 101 degree fever; Headache; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 18Apr2021 at 13:45 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, endometriosis, and asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), ethinylestradiol, norgestimate (SPRINTEC) and fexofenadine hydrochloride (ALLEGRA); all for unknown indication from unknown date, and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. On 19Apr2021 at 05:00, the patient experienced body aches, body chills, nausea, 101 degree fever, headache, and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 19Apr2021, the patient underwent body temperature test and the result was 101 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events body aches, body chills, nausea, 101 degree fever, headache, and dizziness were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient reported ringing in ears, became lightheaded and had brief syncopal episode. Pt. laid down, feet elevated. Recovered in just a couple minutes. Ambulated to car without diff. after 20 min. observation.
lost her sense of taste and smell; lost her sense of taste and smell; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative. The reporter is the patient.  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "lost her sense of taste and smell".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.