chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant concerning a 24-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-MAR-2016 and on 19-MAY-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot number: L037339, expiration date: 09-FEB-2018 and lot number: L026602, expiration date: 19-OCT-2017, dose, dose number, anatomical location and route of administration were not provided) respectively. The vaccines underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
was given APAP immed & 2hrs p/receiving vax started unconsolable crying x 3 hrs took ER t101 R;
Dizziness within 1 hour   nasua fever of 104. Body aches, body chills, after 2 hours . The nasua and fever got so bad I had to pull over and dial 911 for an ambulance .
Arm red, warm, 1 inch thick swelling over 4x8" area, arm painful.
This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. From 13-NOV-2016 to 16-DEC-2016, the patients were vaccinated with improperly stored doses of PROQUAD, lot# M031941 with expiry: 27-DEC-2017 and lot# M033215 with expiry: 09-JAN-2018, for prophylaxis. The vaccine lot#s had a temperature excursion of 22.53 degree Fahrenheit for 7 hours 36 minutes. It had no previous temperature excursion. The call was because of data logger. This is one of two cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009548.
Recipiant experienced mildly swollen lips. Gave Benadryl. Went to ER for follow-up, and was subsequently give additional antihistamines, but not epinephrine.
This non-serious spontaneous case, initially received on 15-Mar-2018, was reported by other health professional and concerns a male patient of unspecified age. On an unspecified date first temperature excursion of the vaccine occurred. On 23-Jan-2018, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: XT59906, expiry date: 06-Jun-2018) stored out of range. On an unspecified the vaccine was stored out of range for 65 hours and 35 minutes, reaching a highest temperature of 60 F which was the fifth (5th) excursion with those vaccines.
Pt recvd Engerix-B 2JUL92 & had hives 1st on feet, then on hands, severe back pain, dyspepsia, belching;
Slight chest tightness and very slight difficulty breathing as if he was experiencing allergies; Slight chest tightness and very slight difficulty breathing as if he was experiencing allergies; Slight chest tightness and very slight difficulty breathing as if he was experiencing allergies; fatigue; muscle soreness; injection site soreness; mild nausea; slight nasal congestion; headache; This is a spontaneous report received from a contactable consumer (patient). This 26-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Apr2021 01:15 PM in left arm at single dose (lot number=EN6204) for COVID-19 immunization. Medical history included Attention Deficit Hyperactivity Disorder, Obesity, Temporomandibular Joint Dysfunction, Ocular Migraines. No allergies to medications, food, or other products. Concomitant medications included cannabis sativa. The patient previously received first dose of BNT162B2 (Lot number=ER8730) on 22Mar2021 01:00 PM in left arm for COVID-19 immunization. On 13Apr2021 07:00, the patient experienced fatigue, muscle soreness, injection site soreness, mild nausea, slight nasal congestion, headache. Slight chest tightness and very slight difficulty breathing as if he was experiencing allergies which started 14Apr2021 at around 07:30 am while he was setting up for work and had come and gone. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient did not diagnosed with COVID-19.  Since the vaccination, patient had not been tested for COVID-19. No treatment received for the adverse events. The outcome of events was recovering.  No follow-up attempts needed. No further information expected.
This spontaneous report was received from a registered nurse and refers to a 2 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUL-2016, the patient was vaccinated with the first dose of VARIVAX (exact dose was not reported, subcutaneously, in the left thigh, lot # M003439, expiration date was not reported). The patient had pruritic bumps all over his body for three days and on 13-JUL-2016, he developed varicella. The outcome of varicella was reported as recovered/resolved on 22-JUL-2016. This is one of several reports from reporter. Additional information has been requested.
VOMITING; BODY ACHES; CHILLS; FEVER; NAUSEA; PAIN IN ARM; WEAKNESS; This spontaneous report received from a patient concerned a 21 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 11:40 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced pain in arm. On 12-MAY-2021, the subject experienced weakness. On 12-MAY-2021 22:00, the subject experienced vomiting. On 12-MAY-2021 22:00, the subject experienced body aches. On 12-MAY-2021 22:00, the subject experienced chills. On 12-MAY-2021 22:00, the subject experienced fever. On 12-MAY-2021 22:00, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) Pretty high. The action taken with covid-19 vaccine was not applicable. The patient was recovering from fever, and had not recovered from chills, body aches, nausea, vomiting, pain in arm, and weakness. This report was non-serious.
Mother states child had redness, swelling and discomfort on upper right thigh x2 days after receiving DTAP.  Redness and warmth appeared within a few hours after receiving injection.  Reddened area eventually covered entire thigh above the knee.  Warm compress applied.  Benadryl liquid given by mouth.
Legal guardian stated that childs legs were swollen all the way down to ankles and "walking funny". RN instructed guardian to take to pediatrician office.
Fever, chills, fatigue, body muscle aches, headache - began about 15 hours after vaccine administered   Sore arm about 12 hours after  Redness, swolleness, pain, slight itchiness around injection site
Narrative: post vaccine, L shoulder has progressively been more painful. Limited range of motion consistent with tendinitis. Suspect placement vaccine an issue
Pain reported on 1/31/17. October 4th, 2016 When she got the shot there was a lot of pressure and felt a pain down her arm and into her fingers. Nurse stated "not sure why they sent us these long needles". Very petite person. Gallbladder removed and was on pain meds.did not feel for awhile until off meds. Physical Therapy. Started Steroid and pain went away. Went off steroid and pain came back. Was put on a longer regimen of steroid. Next stepMRI and X-Ray. Can't raise arm above arm above head.
Child developed "tic" jerking of head on 11/13/06. Sometimes it was quite severe. Complained of earache on 11/10/06.  Had headache and fever on 12/06/06. Today, grandmother reports child has not had any jerking since 12/05/2006.   To see pediatric neurologist on 12/21/06.
I received a positive COVID-19 diagnosis following an experience of relevant symptoms (fever, aches, tiredness) and a positive result for my wife.
Rosacea flare up within 10 minutes of injection. Face bright strawberry red. Entire body became hot and had to fan myself (not a hot flash) Approximately 45 minutes later left ear started tingling and then pain followed and only in left ear. An hour after the shot ( and back home) started feeling tingling in lips and face. Face swelled up and smoothed out wrinkles. Lasted about 2 hours and then subsided.  Also metallic taste in mouth during swelling of the face. Metallic taste lasted as long as the face swelling which was about 2 hours. Loose stools and tummy upset which is still going on.
Information has been received from a physician who reported that a medical assistant reported to her concerning a 13 year old female who on 03-FEB-2008 was vaccinated with a 1st dose of Gardasil (lot# not reported). Concomitant vaccinations that same day included MENACTRA (lot# not reported). On 04-FEB-2008 the patient developed a rash on her face, arms and a little bit around her chest area. The patient was treated with MEDROL for approximately one week. On an unspecified date, the patient recovered from the rash on her face, arms and chest area. Additional information has been requested.
lost his appetite; feeling weak; back pain; body pain; fever for 2 days ( around 102-103°F).; headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lost his appetite), ASTHENIA (feeling weak), BACK PAIN (back pain), MYALGIA (body pain) and PYREXIA (fever for 2 days ( around 102-103°F).) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027c21a and 008c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Brain tumor (om medication) in 2016.   On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-May-2021, the patient experienced DECREASED APPETITE (lost his appetite), ASTHENIA (feeling weak), BACK PAIN (back pain), MYALGIA (body pain), PYREXIA (fever for 2 days ( around 102-103°F).) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-May-2021, PYREXIA (fever for 2 days ( around 102-103°F).) outcome was unknown. At the time of the report, DECREASED APPETITE (lost his appetite), ASTHENIA (feeling weak), BACK PAIN (back pain), MYALGIA (body pain) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102-103 f (High) HIGH.         patient concomitant medication was related to post brain tumor surgery.
Rash, hives to body, reddened nose and ears, stuffy nose, drooling. Given Benadryl 25 mg orally at 3:45 pm. Became nauseous but no vomiting. Pt fell asleep 20 minutes after dosing. Nose no longer red. Ears remain red. No wheezing.  Provider ordered Prednisone to take for 3 days. Will follow up in 24 hours in office.
Pt states when she showered today (around 4PM) she noticed a soft lump in her right axilla near her breast. She stated that she has not noticed this before and that she would follow up with her doctor Monday (8/5/18) if it was still there. She also stated she had some bruising around the injection site.
Redness, pain, swelling to injection site several hours after vaccine placement. Treated with MOTRIN, BENADRYL, ice packs.
9/27/11  3:00pm arm, at injection site started getting very sore.  couldn't sleep that night due to pain in arm 9/28/11  9:00am body ache, sore arm at injection site, head ache,  9/28/11  12:00pm body ache, can't lift arm, head ache, nauseous, fever 101.4 F. 9/28/11  2:00pm go to ER for above symptoms. Prescribed Prometh/cod for nausea and body ache. 9/29/11 9:00am injection site worse, very red, bruised and hot to the touch.  Body aches are less servere, still have head ache and fever. 9/29/11 11:30am Go to Dr. office to follow-up from ER.  Was prescribed Hydroco/apap for arm pain
Upset stomach, abdominal pain, fever, chills, muscle aches, fatigue all during night and day after vaccination.
This spontaneous report was received from a registered nurse concerning a 77 year old female patient with pacemaker, arrhythmia, thyroid disease (unspecified) and allergy to BIAXIN, penicillin and AVELOX (unspecified reactions). On 25-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (Lot # J013555; expiration date: 02-MAY-2015) (dose and route were not provided). Nurse reported that the patient experienced severe swelling, pain, and heat at the injection site following administration of PNEUMOVAX 23 in approximately 25-SEP-2014. Nurse reported that the patient was treated with BENADRYL (unspecified dose, frequency) and ice. There were no laboratory tests or diagnosed studies performed. The patient sought unspecified medical attention. The patient recovered on an unspecified date in 2014. This is one of several reports received from the same reproter. Additional information has been requested.
Case was hospitalized for Covid 7 months after the J and J Covid vaccine.  * COVID Assessment & Plan Sxs started 9/30/21; covid + 10-5-21; Got J and J vaccine 3/21   Patient primarily presented with GI sxs that continued with loose diarrhea stools several a day. Then presented with mild hypoxemia and multifocal infiltrates on CXR on admission. ID was asked to see - initially recommended both Dexamethasone and Remdesivir. Discussed with Nephrology, Remdesivir for transplanted kidney with GFR of 32 - not recommended. D/C Remdesivir. Continue Dexamethasone but as hypoxia resolved, dexamethasone was stopped on discharge.. While on Dexamethasone, held mycophenolate but resumed on discharge.
I had a severe reaction which put me in bed for three days.  Symptoms included: fever, chills, aches, severe headache, nausea, loss of appetite dehydration due to inadequate fluid intake.  And insomnia due to fever and pain.   I receive a influenza vaccine each year and hardly notice any consequences. The symptoms I had in response to the Covid-19 vaccine were much worse than when I have had the seasonal flu.
Painful red swelling rashes/hives on left ankle and left pelvis area. Not itching but painful to move. High feverish state. Tylenol and painkillers taken.
Patient with an episode of Bells palsy presenting with vertigo, unilateral neck pain and facial paresthesia and drooping s/p an upper respiratory infection one week prior.
fever; back pain; nausea; diarrhea; This is spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 5 patients. This is the 2nd of 5 reports. A patient of unspecified age and gender received the 1st dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient experienced fever, back pain, nausea and diarrhea all on an unspecified date with outcome of unknown. The events were considered serious as caused patient's hospitalization, because the reaction was so severe.  The information on the lot/batch number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.,Linked Report(s) : US-PFIZER INC-2020096703 Same reporter/ drug/ event, different patient
Pt. developed fever evening after immunizations & continued for next 3 days. Developed significant area of erythema & induration of (R) upper arm. Seen in ER - WBC - 30,000 and CRP of 144 (about 14).
Post vax, the tricep became inflamed, hot, and sensitive to touch. Also felt like it was constantly itching.
A 43 year old female reported that she received an IM injection of a flu vaccine in 2000 at the age of 41 years, and experienced a red knot under her arm that would itch for several days and then resolve. The patient reports she has a possible allergy to preservatives. In 2001 and 2002, after receiving a flu vaccine, the patient experienced a red knot under her arm that would itch for several days and then resolve. Indication for the flu vaccine was immunization. Product was administered in 2000. Dose regimen was 1 dose (IM). Patient was not taking concomitant therapy. After receiving an IM injection of a flu vaccine in 2000, the patient experienced a red knot under her arm that would itch for several days and resolve. No additional information was available at the time of this report.
Patient called about 3 hours after receiving the vaccine with symptoms of stomach upset and vomiting.  She had not eaten anything in over 24 hours and thought it could be that as well, but wanted us to know since it was so close to getting the vaccine.
After the vaccine I had shortness of breath, dizziness, nausea, rash all over my body, they took me to the Emergency Room of the Hospital and they administered me medications by vein, they gave me other oral medications (pills) for the house.
pain started after injection. pain increased 2-3 hrs later. had limited range of motion the next day pain was throbbing. By Monday, pain subside and had better range of motion.
On May 11, 2022 I started to have flu like symptoms: headache, runny nose, sore throat and coughing. I took an at home test and it should up negative. I stayed home from work since May 11th. I went into the urgent care on Saturday, May 14th. I tested positive for covid-19 that day. They prescribe me a cough medication called promethazine DM SYP MOR. I spoke with my PC that Monday and they told me to keep taking the cough medicine.
1ST DAY=Heachache, Dizzines, High blood pressure, Inflamation of hands. 2ND DAY= High blood pressure, headache, chills 3RD Day: Headache, kidney pain 4th Day: Headache, body ache. 5th day: Heachache, leg pain, can't sleep.
Information has been received from a nurse practitioner (N.P.) concerning a female who on an unknown date, was vaccinated with GARDASIL (dose, route, and lot# not reported). It was reported that the patient had a positive HPV reflex come back after being administered vaccination. The patient sought unsuspected medical attention. At the time of report, the outcome was unknown. Additional information has been requested.
COVID vaccine breakthrough case. Janssen 4/30/21 1808982 and boosted Moderna 1/19/22 030H21B
Guillain Barre; It affected his lungs and he had to be intubated; has limited use of his hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23May2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "HIV" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: LUNG DISORDER (hospitalization) with onset 2023, outcome "unknown", described as "It affected his lungs and he had to be intubated"; LIMB DISCOMFORT (hospitalization) with onset 2023, outcome "unknown", described as "has limited use of his hands"; GUILLAIN-BARRE SYNDROME (hospitalization) with onset 21Jun2023, outcome "not recovered", described as "Guillain Barre". The patient was hospitalized for guillain-barre syndrome, lung disorder, limb discomfort (start date: 04Jul2023). Therapeutic measures were taken as a result of guillain-barre syndrome, lung disorder, limb discomfort. Clinical course: He was in the hospital for over two weeks. They were doing every treatment under the sun. The PRIVACY didn't had the specialties to address his medical needs so he was transferred to (PRIVACY) in (PRIVACY). He was getting just a smidge better based on the parameters, but he still did not had any use of his legs, and had limited use of his hands. It affected his lungs and he had to be intubated. They were doing the plasmapheresis. They did 5 treatments and the last one would be the next day. Vaccine was received at the (PRIVACY). He was in (PRIVACY) at the time and he went to an Emergency Care clinic. Was told it wasn't COVID or Strep. He had that report information at home. Specific Relevant Test for Thromboembolic events with Thrombocytopenia were not applicable. He began hospital admission in the regular care, then was moved to the step down unit. He had to be intubated and was moved to the ICU. Right now, he was in the step down unit again. He was currently still admitted. Autopsy Information was not applicable.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This case was reported by a consumer via call center representative and described the occurrence of muscle tension in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 11th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 mg. On 12th August 2018, 1 days after receiving SHINGRIX, the patient experienced muscle tension, back pain and difficulty sleeping. The patient was treated with cyclobenzaprine. On an unknown date, the outcome of the muscle tension, back pain and difficulty sleeping were not recovered/not resolved. It was unknown if the reporter considered the muscle tension, back pain and difficulty sleeping to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient had muscle tension on back and right arm along with soreness (pain) on back. The patient reported that he followed-up with his physician and was prescribed cyclobenzaprine. The patient provided contact detail of his physician.